Emtricitabine/Tenofovir disoproxil Tillomed 200 mg/245 mg film-coated tablets

Ireland - English - HPRA (Health Products Regulatory Authority)

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Active ingredient:
Emtricitabine; Tenofovir disoproxil fumarate
Available from:
Tillomed Pharma GmbH
ATC code:
J05AR; J05AR03
INN (International Name):
Emtricitabine; Tenofovir disoproxil fumarate
Dosage:
200/245 milligram(s)
Pharmaceutical form:
Film-coated tablet
Therapeutic area:
Antivirals for treatment of HIV infections, combinations; tenofovir disoproxil and emtricitabine
Authorization status:
Marketed
Authorization number:
PA22720/008/001
Authorization date:
2020-10-02

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381 mm

154 mm

32 mm

305 mm

5 mm

5 mm

5 mm

32 mm

32 mm

SAPCODE

Pharma

code

Emtricitabine/Tenofovir disoproxil

Tillomed 200 mg/245 mg

film-coated tablets

SAPCODE

Pharma

code

180620

Product Name

Packaging Material

Size : Foil Repeat Length

Size : Strip Size

PM Style/Type :

Size : Foil Width

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L.381 x H. 305 mm

L. 32 x H. 32 mm

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9

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Ireland

Sap code :

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Reason of change :

Proof 1

23.04.2020

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Remark (If any) :

Folded size may change based on machine suitability.

Developed For :

Emcure - Hinjawadi

Mr. Rushikesh Kurade

Black

04.05.2020

21.05.2020

27.05.2020

12.06.2020

18.09.2020

06.08.2018

Size : PI - Open Size

PI - Folded Size

Size : Carton/Label

5 mm

5 mm

5 mm

If you have hepatitis B or C, your doctor will carefully

consider the best treatment regimen for you.

Know

your

hepatitis

B

virus

(HBV)

infection

status

before starting Emtricitabine/Tenofovir disoproxil. If you

have HBV, there is a serious risk of liver problems when you

stop taking Emtricitabine/Tenofovir disoproxil, whether or

not you also have HIV. It is important not to stop taking

Emtricitabine/Tenofovir disoproxil without talking to your

doctor: see section 3, Do not stop taking Emtricitabine/

Tenofovir disoproxil.

Talk to your doctor if you are over 65. Emtricitabine/

tenofovir disoproxil has not been studied in patients over 65

years of age.

Children and adolescents

Emtricitabine/Tenofovir disoproxil is not for use in children

under 12 years of age.

Other medicines and Emtricitabine/Tenofovir disoproxil

Do not take Emtricitabine/Tenofovir disoproxil if you are

already taking other medicines that contain the components

Emtricitabine/Tenofovir

disoproxil

(emtricitabine

tenofovir disoproxil) or any other antiviral medicines that

contain tenofovir alafenamide, lamivudine or adefovir dipivoxil.

Taking

Emtricitabine/Tenofovir

disoproxil

with

other

medicines that can damage your kidneys: it is especially

important to tell your doctor if you are taking any of these

medicines, including

aminoglycosides (for bacterial infection)

amphotericin B (for fungal infection)

foscarnet (for viral infection)

ganciclovir (for viral infection)

pentamidine (for infections)

vancomycin (for bacterial infection)

interleukin-2 (to treat cancer)

cidofovir (for viral infection)

non-steroidal anti-inflammatory drugs (NSAIDs, to relieve

bone or muscle pains)

If you are taking another antiviral medicine called a protease

inhibitor to treat HIV, your doctor may order blood tests to

closely monitor your kidney function.

It is also important to tell your doctor if you are taking

ledipasvir/sofosbuvir or sofosbuvir/velpatasvir or sofosbuvir/

velpatasvir/voxilaprevir to treat hepatitis C infection.

Taking

Emtricitabine/Tenofovir

disoproxil

with

other

medicines containing didanosine (for treatment of HIV

infection):

Taking

Emtricitabine/Tenofovir

disoproxil

with

other antiviral medicines that contain didanosine can raise the

levels of didanosine in your blood and may reduce CD4 cell

counts. Rarely, inflammation of the pancreas and lactic acidosis

(excess lactic acid in the blood), which sometimes causes death,

have been reported when medicines containing tenofovir

disoproxil and didanosine were taken together. Your doctor

will carefully consider whether to treat you with combinations

of tenofovir and didanosine.

Tell your doctor if you are taking any of these medicines. Tell

your doctor or pharmacist if you are taking, have recently taken

or might take any other medicines.

Emtricitabine/Tenofovir disoproxil with food and drink

Whenever

possible,

Emtricitabine/Tenofovir

disoproxil

should be taken with food.

Pregnancy and breast-feeding

pregnant

breast-feeding,

think

pregnant or are planning to have a baby, ask your doctor or

pharmacist for advice before taking this medicine.

Although there are limited clinical data on the use of

Emtricitabine/Tenofovir disoproxil in pregnant women, it is

not usually used unless absolutely necessary.

If you become pregnant, or plan to become pregnant, ask

your

doctor

about

potential

benefits

risks

therapy with Emtricitabine/Tenofovir disoproxil to you and

your child.

If you have taken Emtricitabine/Tenofovir disoproxil during

your pregnancy, your doctor may request regular blood tests

and other diagnostic tests to monitor the development of your

Before taking Emtricitabine/Tenofovir disoproxil to reduce

the risk of getting HIV:

Emtricitabine/Tenofovir disoproxil can only help reduce your

risk of getting HIV before you are infected.

You must be HIV negative before you start to take

emtricitabine/tenofovir disoproxil to reduce the risk of

getting HIV. You must get tested to make sure that you do

not already have HIV infection. Do not take emtricitabine/

tenofovir disoproxil to reduce your risk unless you are

confirmed to be HIV negative. People who do have HIV must

take emtricitabine/tenofovir disoproxil in combination with

other drugs.

Many HIV tests can miss a recent infection. If you get a flu-

like illness, it could mean you have recently been infected

with HIV.

These may be signs of HIV infection:

tiredness

fever

joint or muscle aches

headache

vomiting or diarrhoea

rash

night sweats

enlarged lymph nodes in the neck or groin

Tell your doctor about any flu-like illness – either in the

month before starting Emtricitabine/Tenofovir disoproxil, or at

any time while taking Emtricitabine/Tenofovir disoproxil.

Warnings and precautions

While taking Emtricitabine/Tenofovir disoproxil to reduce

the risk of getting HIV:

Take Emtricitabine/Tenofovir disoproxil every day to reduce

your risk, not just when you think you have been at risk

of HIV infection. Do not miss any doses of Emtricitabine/

Tenofovir disoproxil, or stop taking it. Missing doses may

increase your risk of getting HIV infection.

Get tested for HIV regularly.

If you think you were infected with HIV, tell your doctor

straight away. They may want to do more tests to make sure

you are still HIV negative.

Just taking Emtricitabine/Tenofovir disoproxil may not

stop you getting HIV.

Always practice safer sex. Use condoms to reduce contact

with semen, vaginal fluids, or blood.

Do not share personal items that can have blood or body

fluids on them, such as toothbrushes and razor blades.

Do not share or re-use needles or other injection or drug

equipment.

Get tested for other sexually transmitted infections such

as syphilis and gonorrhoea. These infections make it

easier for HIV to infect you.

Ask your doctor if you have any more questions about how to

prevent getting HIV or spreading HIV to other people.

While taking Emtricitabine/Tenofovir disoproxil to treat

HIV or to reduce the risk of getting HIV:

Emtricitabine/tenofovir

disoproxil

may

affect

your

kidneys. Before and during treatment, your doctor may

order blood tests to measure kidney function. Tell your

doctor if you have had kidney disease, or if tests have shown

kidney problems. Emtricitabine/Tenofovir disoproxil should

not be given to adolescents with existing kidney problems.

If you have kidney problems, your doctor may advise you to

stop taking Emtricitabine/Tenofovir disoproxil or, if you

already have HIV, to take Emtricitabine/Tenofovir disoproxil

less frequently. Emtricitabine/tenofovir disoproxil is not

recommended if you have severe kidney disease or are on

dialysis.

Bone problems (sometimes resulting in fractures) may also

occur due to damage to kidney tubule cells (see section 4,

Possible side effects).

Talk to your doctor if you have a history of liver disease,

including hepatitis. Patients infected with HIV who also

have liver disease (including chronic hepatitis B or C), who

are treated with antiretrovirals, have a higher risk of severe

and potentially fatal liver complications.

Package leaflet: Information for the patient

Emtricitabine/Tenofovir disoproxil

Tillomed 200 mg/245 mg

film-coated tablets

Emtricitabine/tenofovir disoproxil

Read all of this leaflet carefully before you start taking this

medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor or

pharmacist.

This medicine has been prescribed for you only. Do not pass

it on to others. It may harm them, even if their signs of illness

are the same as yours.

If you get any side effects, talk to your doctor or pharmacist.

This includes any possible side effects not listed in this

leaflet. See section 4.

What is in this leaflet

What Emtricitabine/Tenofovir disoproxil is and what it

is used for

What you need to know before you take

Emtricitabine/Tenofovir disoproxil

How to take Emtricitabine/Tenofovir disoproxil

Possible side effects

How to store Emtricitabine/Tenofovir disoproxil

Contents of the pack and other information

What

Emtricitabine/Tenofovir

disoproxil

is

and

what it is used for

Emtricitabine/Tenofovir

disoproxil

contains

two

active

substances, emtricitabine and tenofovir disoproxil. Both of

these active substances are antiretroviral medicines which are

used

treat

infection.

Emtricitabine

nucleoside

reverse transcriptase inhibitor and tenofovir is a nucleotide

reverse transcriptase inhibitor. However, both are generally

known as NRTIs and they work by interfering with the normal

working of an enzyme (reverse transcriptase) that is essential

for the virus to reproduce itself.

Emtricitabine/Tenofovir disoproxil is used to treat

Human Immunodeficiency Virus 1 (HIV-1) infection in

adults

It is also used to treat HIV in adolescents aged 12 to less

than 18 years who weigh at least 35 kg, and who have

already been treated with other HIV medicines that are no

longer effective or have caused side effects.

Emtricitabine/Tenofovir disoproxil should always be used

combined with other medicines to treat HIV infection.

Emtricitabine/Tenofovir disoproxil can be administered

in place of emtricitabine and tenofovir disoproxil used

separately at the same doses.

People who are HIV positive can still pass on HIV when

taking this medicine, although the risk is lowered by effective

antiretroviral

therapy.

Discuss

with

your

doctor

precautions needed to avoid infecting other people.

This medicine is not a cure for HIV infection. While taking

Emtricitabine/Tenofovir

disoproxil

still

develop

infections or other illnesses associated with HIV infection.

Emtricitabine/Tenofovir

disoproxil

is

also

used

to

reduce the risk of getting HIV-1 infection in adults, and

adolescents aged 12 years to less than 18 years who

weigh at least 35 kg, when taken daily, together with safer

sex practices:

See section 2 for a list of precautions to take against HIV

infection.

What you need to know before you take

Emtricitabine/Tenofovir disoproxil

Do not take Emtricitabine/Tenofovir disoproxil to treat HIV

or to reduce the risk of getting HIV if you are allergic to

emtricitabine, tenofovir, tenofovir disoproxil, or any of the

other ingredients of this medicine (listed in section 6).

If this applies to you, tell your doctor immediately.

5 mm

child. In children whose mothers took NRTIs during pregnancy,

the benefit from the protection against HIV outweighed the

risk of side effects.

Do not breast-feed during treatment with Emtricitabine/

Tenofovir disoproxil . This is because the active substances

in this medicine pass into human breast milk.

If you are a woman with HIV it is recommended that you do

not breast-feed, to avoid passing the virus to the baby in

breast milk.

Driving and using machines

Emtricitabine/Tenofovir disoproxil can cause dizziness. If you

feel dizzy while taking Emtricitabine/Tenofovir disoproxil, do

not drive and do not use any tools or machines.

Emtricitabine/Tenofovir disoproxil contains soya lecithin.

If you are allergic to peanut or soya do not use this medicinal

product.

Emtricitabine/Tenofovir disoproxil contains sodium.

Emtricitabine/Tenofovir disoproxil contains less than 1 mmol

sodium (23 mg) per film-coated tablet, that is to say essentially

'sodium-free'

How to take Emtricitabine/Tenofovir disoproxil

Always take this medicine exactly as your doctor has

told you. Check with your doctor or pharmacist if you are

not sure.

The

recommended

dose

of

Emtricitabine/Tenofovir

disoproxil to treat HIV is:

Adults: one tablet each day, where possible, with food.

Adolescents aged 12 to less than 18 years who weigh at

least 35 kg: one tablet each day, whenever possible with

food.

The

recommended

dose

of

Emtricitabine/Tenofovir

disoproxil to reduce the risk of getting HIV is:

Adults: one tablet each day, whenever possible with food.

Adolescents aged 12 to less than 18 years who weigh at

least 35 kg: one tablet each day, whenever possible with

food.

If you have difficulty swallowing, you can use the tip of a

spoon to crush the tablet. Then mix the powder with about

100 ml (half a glass) of water, orange juice or grape juice, and

drink immediately.

Always take the dose recommended by your doctor. This

is to make sure that your medicine is fully effective, and to

reduce the risk of developing resistance to the treatment.

Do not change the dose unless your doctor tells you to.

If you are being treated for HIV infection your doctor will

prescribe

Emtricitabine/Tenofovir

disoproxil

with

other

antiretroviral

medicines.

Please

refer

patient

information leaflets of the other antiretrovirals for guidance

on how to take those medicines.

If

you

are

taking

Emtricitabine/Tenofovir

disoproxil

to reduce the risk of getting HIV, take Emtricitabine/

Tenofovir disoproxil every day, not just when you think you

have been at risk of HIV infection.

Ask your doctor if you have any questions about how to

prevent getting HIV or prevent spreading HIV to other people.

If you take more Emtricitabine/Tenofovir disoproxil than

you should

If you accidentally take more than the recommended dose of

Emtricitabine/Tenofovir

disoproxil,

contact

your

doctor

nearest emergency department for advice. Keep the tablet

bottle with you so that you can easily describe what you have

taken.

If you miss a dose

It is important not to miss a dose of Emtricitabine/Tenofovir

disoproxil.

If you notice within 12 hours of the time you usually take

Emtricitabine/Tenofovir disoproxil, take the tablet preferably

with food as soon as possible. Then take the next dose at

your usual time.

1

2

3

3

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6

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381 mm

32 mm

305 mm

5 mm

5 mm

5 mm

5 mm

5 mm

5 mm

dizziness, headache

rash

feeling weak

Tests may also show:

decreases in phosphate in the blood

increased creatine kinase

Common side effects

(may affect up to 1 in 10 people)

pain, stomach pain

difficulty sleeping, abnormal dreams

problems with digestion resulting in discomfort after meals,

feeling bloated, flatulence

rashes (including red spots or blotches sometimes with

blistering and swelling of the skin), which may be allergic

reactions,

itching,

changes

skin

colour

including

darkening of the skin in patches

other

allergic

reactions,

such

wheezing,

swelling

feeling light-headed

Tests may also show:

low white blood cell count (a reduced white blood cell

count can make you more prone to infection)

increased triglycerides (fatty acids), bile or sugar in the

blood

liver and pancreas problems

Uncommon side effects

(may affect up to 1 in 100 people)

pain in the abdomen (tummy) caused by inflammation of

the pancreas

swelling of the face, lips, tongue or throat

anaemia (low red blood cell count)

breakdown of muscle, muscle pain or weakness which may

occur due to damage to the kidney tubule cells

Tests may also show:

decreases in potassium in the blood

increased creatinine in your blood

changes to your urine

Rare side effects

(may affect up to 1 in 1,000 people)

Lactic acidosis (see Possible serious side effects)

fatty liver

yellow skin or eyes, itching, or pain in the abdomen (tummy)

caused by inflammation of the liver

inflammation of the kidney, passing a lot of urine and

feeling thirsty, kidney failure, damage to kidney tubule cells

softening of the bones (with bone pain and sometimes

resulting in fractures)

back pain caused by kidney problems

Damage

kidney

tubule

cells

associated

with

breakdown of muscle, softening of the bones (with bone pain

and sometimes resulting in fractures), muscle pain, muscle

weakness and decreases in potassium or phosphate in the

blood.

If you notice any of the side effects listed above or if any of

the side effects get serious, talk to your doctor or pharmacist.

The frequency of the following side effects is not known.

Bone

problems.

Some

patients

taking

combination

antiretroviral medicines such as Emtricitabine/ Tenofovir

disoproxil may develop a bone disease called osteonecrosis

(death of bone tissue caused by loss of blood supply to the

bone). Taking this type of medicine for a long time, taking

corticosteroids,

drinking

alcohol,

having

very

weak

immune system, and being overweight, may be some of the

many

risk

factors

developing

this

disease.

Signs

osteonecrosis are:

joint stiffness

joint aches and pains (especially of the hip, knee and

shoulder)

difficulty with movement

If you notice any of these symptoms tell your doctor.

During treatment for HIV there may be an increase in weight

and in levels of blood lipids and glucose. This is partly linked to

restored health and life style, and in the case of blood lipids

sometimes to the HIV medicines themselves. Your doctor will

test for these changes.

Other effects in children

Children given emtricitabine very commonly experienced

changes in skin colour including darkening of the skin in

patches

Children commonly experienced low red blood cell count

(anaemia). This may cause the child to be tired or breathless

If you notice any of these symptoms tell your doctor.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist.

This includes any possible side effects not listed in this leaflet.

You can also report side effects directly via

HPRA pharmacovigilance

Website: www.hpra.ie

By reporting side effects you can help provide more information

on the safety of this medicine.

How to store Emtricitabine/Tenofovir disoproxil

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated

on the carton and blister. The expiry date refers to the last day

of that month.

Do not store above 30°C.

Store in the original package in order to protect from moisture.

Keep bottle tightly closed.

throw

away

medicines

wastewater

household waste. Ask your pharmacist how to throw away

medicines that you no longer use. These measures will help to

protect the environment.

Contents of the pack and other information

What Emtricitabine/Tenofovir disoproxil contains

The

active

substances

are

emtricitabine

tenofovir

disoproxil.

Each

Emtricitabine/Tenofovir

disoproxil

film-

coated tablet contains 200 mg of emtricitabine and 245 mg

of tenofovir disoproxil (equivalent to 300 mg of tenofovir

disoproxil fumarate or 136 mg of tenofovir).

The

other

ingredients

are

croscarmellose

sodium,

magnesium stearate, microcrystalline cellulose, pregelatinized

starch (maize starch), lecithin (soya) (E322), polyvinyl alcohol-

partially

hydrolyzed

(E1203),

titanium

dioxide

(E171),

talc,

xanthan gum (E415).

What

Emtricitabine/Tenofovir

disoproxil

looks

like

and

content of the pack

White

white,

modified

capsule

shaped,

film-coated

tablets, debossed with “EM” on one side and “144” on other side

of the tablet. The dimensions of the tablet are approximately

19.20 mm x 9.70 mm.

Blister pack:

Film-coated tablets in Aluminium plain foil as lidding material

and Aluminium-Aluminium plain as forming foil, perforated

unit dose blister.

Pack sizes: 30 x 1 and 90 x 1 film-coated tablets.

Bottles:

30 tablets in HDPE bottles containing desiccant (Canister HDPE

containing

silica

gel),

with

polypropylene

child

resistant

closure.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Tillomed Pharma GmbH

Manhagener Allee 36

22926 Ahrensburg

Germany

1

Manufacturer

Tillomed Laboratories Ltd.

220 Butterfield, Great Marlings,

Luton, LU2 8DL

United Kingdom

If you notice 12 hours or more after the time you usually

take Emtricitabine/Tenofovir disoproxil, forget about the

missed dose. Wait and take the next dose, preferably with

food, at your usual time.

If you vomit less than 1 hour after taking Emtricitabine/

Tenofovir disoproxil , take another tablet. You do not need to

take another tablet if you were sick more than 1 hour after

taking Emtricitabine/Tenofovir disoproxil.

Do not stop taking Emtricitabine/Tenofovir disoproxil

If

you

take

Emtricitabine/Tenofovir

disoproxil

for

treatment of HIV infection, stopping tablets may reduce

the effectiveness of the anti-HIV therapy recommended by

your doctor.

If you are taking Emtricitabine/Tenofovir disoproxil to

reduce

the

risk

of

getting

HIV,

stop

taking

Emtricitabine/Tenofovir

disoproxil

miss

doses.

Stopping

Emtricitabine/Tenofovir

disoproxil,

missing

doses,

increase

your

risk

getting

infection.

Do

not

stop

taking

Emtricitabine/Tenofovir

disoproxil without contacting your doctor.I

If you have hepatitis B, it is especially important not to

stop

your

Emtricitabine/Tenofovir

disoproxil

treatment

without talking to your doctor first. You may require blood

tests for several months after stopping treatment. In some

patients with advanced liver disease or cirrhosis, stopping

treatment

recommended

this

lead

worsening of your hepatitis, which may be life-threatening.

Tell your doctor immediately about new or unusual

symptoms

after

stop

treatment,

particularly

symptoms you associate with hepatitis B infection

If you have any further questions on the use of this medicine,

ask your doctor or pharmacist.

Possible side effects

Like all medicines, this medicine can cause side effects, although

not everybody gets them.

Possible serious side effects:

Lactic acidosis (excess lactic acid in the blood) is a rare but

potentially

life-threatening

side

effect.

Lactic

acidosis

occurs

more

often

women,

particularly

they

overweight, and in people with liver disease. The following

may be signs of lactic acidosis:

deep rapid breathing

drowsiness

feeling sick (nausea), being sick (vomiting)

stomach pain

If you think you may have lactic acidosis, get medical help

immediately.

Any signs of inflammation or infection. In some patients

with

advanced

infection

(AIDS)

history

opportunistic infections (infections that occur in people

with a weak immune system), signs and symptoms of

inflammation from previous infections may occur soon

after anti-HIV treatment is started. It is thought that these

symptoms

improvement

body's

immune response, enabling the body to fight infections

that may have been present with no obvious symptoms.

Autoimmune disorders, when the immune system attacks

healthy body tissue, may also occur after you start taking

medicines to treat HIV infection. Autoimmune disorders

may occur many months after the start of treatment. Look

out for any symptoms of infection or other symptoms such

muscle weakness

weakness beginning in the hands and feet and moving

up towards the trunk of the body

palpitations, tremor or hyperactivity

If you notice these or any symptoms of inflammation or

infection, get medical help immediately.

Possible side effects:

Very common side effects

(may affect more than 1 in 10 people)

diarrhoea, being sick (vomiting), feeling sick (nausea)

5 mm

Tillomed Pharma GmbH

Mittelstrasse 5/5a

12529 Schönefeld

Germany

Only actual manufacturer stated on printed leaflet.

This medicinal product is authorised in the Member States

of the EEA under the following names:

Germany

Emtricitabin/Tenofovirdisoproxil Tillomed

200 mg/245 mg Filmtabletten

Austria

Emtricitabin/Tenofovirdisoproxil Tillomed

200 mg/245 mg Filmtabletten

Denmark

Emtricitabin/Tenofovirdisoproxil Tillomed

Finland

Ireland

Emtricitabine/Tenofovir disoproxil

Tillomed 200 mg/245 mg film-coated

tablets

Italy

Netherlands

Emtricitabine/Tenofovir disoproxil Tillomed

200 mg/245 mg filmomhulde tabletten

Norway

Emtricitabin/Tenofovirdisoproxil Tillomed

Poland

Emtricitabine + Tenofovir disoproxil

Tillomed

Portugal

Emtricitabina/Tenofovir disoproxil Tillomed

200 mg/245 mg comprimidos revestidos

por película

Romania

Emtricitabină/Tenofovir disoproxil Tillomed

200 mg/245 mg comprimate filmate

Spain

Sweden

Emtricitabine/Tenofovirdisoproxil Tillomed

200 mg/245 mg filmdragerade tabletter

United Kingdom Emtricitabine/Tenofovir disoproxil

Tillomed 200 mg/245 mg film-coated

tablets

This leaflet was last revised in 06/2020

Emtricitabine/Tenofovir disoproxil

Tillomed 200 mg/245 mg kalvopäällysteiset

tabletit

Emtricitabina e Tenofovir disoproxil

Tillomed

Emtricitabina/tenofovir disoproxil Tillomed

200 mg/245 mg comprimidos recubiertos

con película EFG

SAPCODE

4

5

6

Front

Back

Emtricitabine/Tenofovir disoproxil T

200 mg/245 mg film-coated Tablets

illomed

Emtricitabine/Tenofovir disoproxil

Tillomed 200 mg/245 mg

film-coated tablets

If you take more Emtricitabine/Tenofovir disoproxil

than you should

If you accidentally take more than the recommended dose

of Emtricitabine/Tenofovir disoproxil, contact your doctor

or nearest emergency department for advice. Keep the

tablet bottle with you so that you can easily describe what

you have taken.

If you miss a dose

It is important not to miss a dose of Emtricitabine/Tenofovir

disoproxil.

If you notice within 12 hours of the time you usually

take Emtricitabine/Tenofovir disoproxil, take the tablet

preferably with food as soon as possible. Then take the

next dose at your usual time.

If you notice 12 hours or more after the time you

usually take Emtricitabine/Tenofovir disoproxil, forget

about the missed dose. Wait and take the next dose,

preferably with food, at your usual time.

If you vomit less than 1 hour after taking Emtricitabine/

Tenofovir disoproxil , take another tablet. You do not

need to take another tablet if you were sick more than 1

hour after taking Emtricitabine/Tenofovir disoproxil.

Do not stop taking Emtricitabine/Tenofovir disoproxil

If you take Emtricitabine/Tenofovir disoproxil for

treatment of HIV infection, stopping tablets may

reduce

effectiveness

anti-HIV

therapy

recommended by your doctor.

If you are taking Emtricitabine/Tenofovir disoproxil

to reduce the risk of getting HIV, do not stop taking

Emtricitabine/Tenofovir disoproxil or miss any doses.

Stopping use of Emtricitabine/Tenofovir disoproxil, or

missing doses, may increase your risk of getting HIV

infection.

Do

not

stop

taking

Emtricitabine/Tenofovir

disoproxil without contacting your doctor.I

If you have hepatitis B, it is especially important not to

stop your Emtricitabine/Tenofovir disoproxil treatment

without talking to your doctor first. You may require

blood

tests

several

months

after

stopping

treatment. In some patients with advanced liver disease

or cirrhosis, stopping treatment is not recommended

as this may lead to worsening of your hepatitis, which

may be life-threatening.

Tell your doctor immediately about new or unusual

symptoms after you stop treatment, particularly

symptoms you associate with hepatitis B infection

If you have any further questions on the use of this

medicine, ask your doctor or pharmacist.

Possible side effects

Like all medicines, this medicine can cause side effects,

although not everybody gets them.

Possible serious side effects:

Lactic acidosis (excess lactic acid in the blood) is a rare

potentially

life-threatening

side

effect.

Lactic

acidosis occurs more often in women, particularly if

they are overweight, and in people with liver disease.

The following may be signs of lactic acidosis:

deep rapid breathing

drowsiness

feeling sick (nausea), being sick (vomiting)

stomach pain

If you think you may have lactic acidosis, get medical

help immediately.

Any signs of inflammation or infection. In some

patients with advanced HIV infection (AIDS) and a

history

opportunistic

infections

(infections

that

occur in people with a weak immune system), signs and

symptoms of inflammation from previous infections

may occur soon after anti-HIV treatment is started. It is

thought

that

these

symptoms

improvement in the body's immune response, enabling

body

fight

infections

that

have

been

present with no obvious symptoms.

Autoimmune disorders, when the immune system

attacks healthy body tissue, may also occur after you

start

taking

medicines

treat

infection.

Autoimmune disorders may occur many months after

the start of treatment. Look out for any symptoms of

infection or other symptoms such as:

muscle weakness

weakness beginning in the hands and feet and

moving up towards the trunk of the body

palpitations, tremor or hyperactivity

If you notice these or any symptoms of inflammation

or infection, get medical help immediately.

Possible side effects:

Very common side effects

(may affect more than 1 in 10 people)

diarrhoea, being sick (vomiting), feeling sick (nausea)

dizziness, headache

rash

feeling weak

Tests may also show:

decreases in phosphate in the blood

increased creatine kinase

Common side effects

(may affect up to 1 in 10 people)

pain, stomach pain

difficulty sleeping, abnormal dreams

problems with digestion resulting in discomfort after

meals, feeling bloated, flatulence

rashes (including red spots or blotches sometimes with

blistering and swelling of the skin), which may be allergic

reactions, itching, changes in skin colour including

darkening of the skin in patches

other allergic reactions, such as wheezing, swelling or

feeling light-headed

Tests may also show:

low white blood cell count (a reduced white blood cell

count can make you more prone to infection)

increased triglycerides (fatty acids), bile or sugar in the

blood

liver and pancreas problems

Uncommon side effects

(may affect up to 1 in 100 people)

pain in the abdomen (tummy) caused by inflammation

of the pancreas

swelling of the face, lips, tongue or throat

anaemia (low red blood cell count)

breakdown of muscle, muscle pain or weakness which

may occur due to damage to the kidney tubule cells

Tests may also show:

decreases in potassium in the blood

increased creatinine in your blood

changes to your urine

Rare side effects

(may affect up to 1 in 1,000 people)

Lactic acidosis (see Possible serious side effects)

fatty liver

yellow skin or eyes, itching, or pain in the abdomen

(tummy) caused by inflammation of the liver

inflammation of the kidney, passing a lot of urine and

feeling thirsty, kidney failure, damage to kidney tubule

cells

softening of the bones (with bone pain and sometimes

resulting in fractures)

back pain caused by kidney problems

Damage to kidney tubule cells may be associated with

breakdown of muscle, softening of the bones (with bone

pain and sometimes resulting in fractures), muscle pain,

muscle weakness and decreases in potassium or phosphate

in the blood.

If you notice any of the side effects listed above or if

any of the side effects get serious, talk to your doctor or

pharmacist.

The frequency of the following side effects is not known.

Bone problems. Some patients taking combination

antiretroviral

medicines

such

Emtricitabine/

Tenofovir disoproxil may develop a bone disease called

osteonecrosis (death of bone tissue caused by loss of

blood supply to the bone). Taking this type of medicine

630 mm

Read all of this leaflet carefully before you start taking

this medicine because it contains important information

for you.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor or

pharmacist.

This medicine has been prescribed for you only. Do not

pass it on to others. It may harm them, even if their

signs of illness are the same as yours.

If you get any side effects, talk to your doctor or

pharmacist. This includes any possible side effects not

listed in this leaflet. See section 4.

What is in this leaflet

What Emtricitabine/Tenofovir disoproxil is and

what it is used for

What you need to know before you take

Emtricitabine/Tenofovir disoproxil

How to take Emtricitabine/Tenofovir disoproxil

Possible side effects

How to store Emtricitabine/Tenofovir disoproxil

Contents of the pack and other information

What Emtricitabine/Tenofovir disoproxil is and

what it is used for

Emtricitabine/Tenofovir disoproxil contains two active

substances, emtricitabine and tenofovir disoproxil. Both

of these active substances are antiretroviral medicines

which are used to treat HIV infection. Emtricitabine is a

nucleoside reverse transcriptase inhibitor and tenofovir is

nucleotide

reverse

transcriptase

inhibitor.

However,

both are generally known as NRTIs and they work by

interfering with the normal working of an enzyme (reverse

transcriptase) that is essential for the virus to reproduce

itself.

Emtricitabine/Tenofovir disoproxil is used to treat

Human Immunodeficiency Virus 1 (HIV-1) infection

in adults

It is also used to treat HIV in adolescents aged 12 to

less than 18 years who weigh at least 35 kg, and who

have already been treated with other HIV medicines

that are no longer effective or have caused side effects.

Emtricitabine/Tenofovir

disoproxil

should

always

be used combined with other medicines to treat HIV

infection.

Emtricitabine/Tenofovir disoproxil can be

administered in place of emtricitabine and tenofovir

disoproxil used separately at the same doses.

People who are HIV positive can still pass on HIV when

taking this medicine, although the risk is lowered by

effective antiretroviral therapy. Discuss with your doctor

the precautions needed to avoid infecting other people.

This medicine is not a cure for HIV infection. While

taking Emtricitabine/Tenofovir disoproxil you may still

develop infections or other illnesses associated with HIV

infection.

Emtricitabine/Tenofovir disoproxil is also used to

reduce the risk of getting HIV-1 infection in adults,

and adolescents aged 12 years to less than 18 years

who weigh at least 35 kg, when taken daily, together

with safer sex practices:

See section 2 for a list of precautions to take against HIV

infection.

What you need to know before you take

Emtricitabine/Tenofovir disoproxil

Do

not

take

Emtricitabine/Tenofovir

disoproxil

to

treat HIV or to reduce the risk of getting HIV if you are

allergic to emtricitabine, tenofovir, tenofovir disoproxil, or

any of the other ingredients of this medicine (listed in

section 6).

If this applies to you, tell your doctor immediately.

Before taking Emtricitabine/Tenofovir disoproxil to

reduce the risk of getting HIV:

Emtricitabine/Tenofovir disoproxil can only help reduce

your risk of getting HIV before you are infected.

You must be HIV negative before you start to take

emtricitabine/tenofovir

disoproxil

to

reduce

the

risk of getting HIV. You must get tested to make sure

that you do not already have HIV infection. Do not take

emtricitabine/tenofovir disoproxil to reduce your risk

unless you are confirmed to be HIV negative. People

who do have HIV must take emtricitabine/tenofovir

disoproxil in combination with other drugs.

Many HIV tests can miss a recent infection. If you get

a flu-like illness, it could mean you have recently been

infected with HIV.

These may be signs of HIV infection:

tiredness

fever

joint or muscle aches

headache

vomiting or diarrhoea

rash

night sweats

enlarged lymph nodes in the neck or groin

Tell your doctor about any flu-like illness – either in the

month before starting Emtricitabine/Tenofovir disoproxil,

time

while

taking

Emtricitabine/Tenofovir

disoproxil.

Warnings and precautions

While

taking

Emtricitabine/Tenofovir

disoproxil

to

reduce the risk of getting HIV:

Take Emtricitabine/Tenofovir disoproxil every day to

reduce your risk, not just when you think you have

been at risk of HIV infection. Do not miss any doses of

Emtricitabine/Tenofovir disoproxil, or stop taking it.

Missing doses may increase your risk of getting HIV

infection.

Get tested for HIV regularly.

If you think you were infected with HIV, tell your doctor

straight away. They may want to do more tests to make

sure you are still HIV negative.

Just taking Emtricitabine/Tenofovir disoproxil may

not stop you getting HIV.

Always practice safer sex. Use condoms to reduce

contact with semen, vaginal fluids, or blood.

Do not share personal items that can have blood or

body fluids on them, such as toothbrushes and

razor blades.

Do not share or re-use needles or other injection or

drug equipment.

Get tested for other sexually transmitted infections

such as syphilis and gonorrhoea. These infections

make it easier for HIV to infect you.

Ask your doctor if you have any more questions about how

to prevent getting HIV or spreading HIV to other people.

While

taking

Emtricitabine/Tenofovir

disoproxil

to

treat HIV or to reduce the risk of getting HIV:

Emtricitabine/tenofovir

disoproxil

may

affect

your

kidneys. Before and during treatment, your doctor

may order blood tests to measure kidney function. Tell

your doctor if you have had kidney disease, or if tests

have shown kidney problems. Emtricitabine/Tenofovir

disoproxil should not be given to adolescents with

existing kidney problems. If you have kidney problems,

your

doctor

advise

stop

taking

Emtricitabine/Tenofovir disoproxil or, if you already

have HIV, to take Emtricitabine/Tenofovir disoproxil

less frequently. Emtricitabine/tenofovir disoproxil is

not recommended if you have severe kidney disease or

are on dialysis.

Bone problems (sometimes resulting in fractures) may

also occur due to damage to kidney tubule cells (see

section 4, Possible side effects).

1

2

3

4

5

6

Emtricitabine/Tenofovir disoproxil Tillomed

200 mg/245 mg film-coated tablets

Emtricitabine/tenofovir disoproxil

630 mm

Talk to your doctor if you have a history of liver

disease, including hepatitis. Patients infected with

HIV who also have liver disease (including chronic

hepatitis B or C), who are treated with antiretrovirals,

have a higher risk of severe and potentially fatal liver

complications.

If you have hepatitis B or C, your doctor will carefully

consider the best treatment regimen for you.

Know your hepatitis B virus (HBV) infection status

before starting Emtricitabine/Tenofovir disoproxil. If

you have HBV, there is a serious risk of liver problems

when

stop

taking

Emtricitabine/Tenofovir

disoproxil, whether or not you also have HIV. It is

important not to stop taking Emtricitabine/Tenofovir

disoproxil without talking to your doctor: see section 3,

Do not stop taking Emtricitabine/Tenofovir disoproxil.

Talk to your doctor if you are over 65. Emtricitabine/

tenofovir disoproxil has not been studied in patients

over 65 years of age.

Children and adolescents

Emtricitabine/Tenofovir disoproxil is not for use in children

under 12 years of age.

Other medicines and Emtricitabine/Tenofovir disoproxil

Do not take Emtricitabine/Tenofovir disoproxil if you

already

taking

other

medicines

that

contain

components

Emtricitabine/Tenofovir

disoproxil

(emtricitabine and tenofovir disoproxil) or any other antiviral

medicines that contain tenofovir alafenamide, lamivudine

or adefovir dipivoxil.

Taking Emtricitabine/Tenofovir disoproxil with other

medicines that can damage your kidneys: it is especially

important to tell your doctor if you are taking any of these

medicines, including

aminoglycosides (for bacterial infection)

amphotericin B (for fungal infection)

foscarnet (for viral infection)

ganciclovir (for viral infection)

pentamidine (for infections)

vancomycin (for bacterial infection)

interleukin-2 (to treat cancer)

cidofovir (for viral infection)

non-steroidal

anti-inflammatory

drugs

(NSAIDs,

relieve bone or muscle pains)

taking

another

antiviral

medicine

called

protease inhibitor to treat HIV, your doctor may order

blood tests to closely monitor your kidney function.

It is also important to tell your doctor if you are taking

ledipasvir/sofosbuvir

sofosbuvir/velpatasvir

sofosbuvir/velpatasvir/voxilaprevir

treat

hepatitis

infection.

Taking Emtricitabine/Tenofovir disoproxil with other

medicines containing didanosine (for treatment of

HIV infection): Taking Emtricitabine/Tenofovir disoproxil

with other antiviral medicines that contain didanosine can

raise the levels of didanosine in your blood and may

reduce

cell

counts.

Rarely,

inflammation

pancreas and lactic acidosis (excess lactic acid in the

blood),

which

sometimes

causes

death,

have

been

reported when medicines containing tenofovir disoproxil

and didanosine were taken together. Your doctor will

carefully consider whether to treat you with combinations

of tenofovir and didanosine.

Tell your doctor if you are taking any of these medicines.

Tell your doctor or pharmacist if you are taking, have

recently taken or might take any other medicines.

Emtricitabine/Tenofovir

disoproxil

with

food

and

drink

Whenever possible, Emtricitabine/Tenofovir disoproxil

should be taken with food.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be

pregnant or are planning to have a baby, ask your doctor

or pharmacist for advice before taking this medicine.

Although there are limited clinical data on the use of

Emtricitabine/Tenofovir disoproxil in pregnant women,

it is not usually used unless absolutely necessary.

If you become pregnant, or plan to become pregnant,

ask your doctor about the potential benefits and risks

of therapy with Emtricitabine/Tenofovir disoproxil to

you and your child.

have

taken

Emtricitabine/Tenofovir

disoproxil

during your pregnancy, your doctor may request regular

blood tests and other diagnostic tests to monitor the

development of your child. In children whose mothers

took

NRTIs

during

pregnancy,

benefit

from

protection against HIV outweighed the risk of side effects.

Do

not

breast-feed

during

treatment

with

Emtricitabine/Tenofovir disoproxil . This is because

the active substances in this medicine pass into human

breast milk.

If you are a woman with HIV it is recommended that you

do not breast-feed, to avoid passing the virus to the

baby in breast milk.

Driving and using machines

Emtricitabine/Tenofovir disoproxil can cause dizziness. If

feel

dizzy

while

taking

Emtricitabine/Tenofovir

disoproxil, do not drive and do not use any tools or machines.

Emtricitabine/Tenofovir

disoproxil

contains

soya

lecithin.

If you are allergic to peanut or soya do not use this medicinal

product.

Emtricitabine/Tenofovir disoproxil contains sodium.

Emtricitabine/Tenofovir disoproxil contains less than 1

mmol sodium (23 mg) per film-coated tablet, that is to say

essentially 'sodium-free'

How to take Emtricitabine/Tenofovir disoproxil

Always take this medicine exactly as your doctor

has told you. Check with your doctor or pharmacist if

you are not sure.

The

recommended

dose

of

Emtricitabine/Tenofovir

disoproxil to treat HIV is:

Adults: one tablet each day, where possible, with food.

Adolescents aged 12 to less than 18 years who

weigh at least 35 kg: one tablet each day, whenever

possible with food.

The

recommended

dose

of

Emtricitabine/Tenofovir

disoproxil to reduce the risk of getting HIV is:

Adults: one tablet each day, whenever possible with

food.

Adolescents aged 12 to less than 18 years who

weigh at least 35 kg: one tablet each day, whenever

possible with food.

If you have difficulty swallowing, you can use the tip of

a spoon to crush the tablet. Then mix the powder with

about 100 ml (half a glass) of water, orange juice or

grape juice, and drink immediately.

Always take the dose recommended by your doctor.

This is to make sure that your medicine is fully effective,

and to reduce the risk of developing resistance to the

treatment. Do not change the dose unless your doctor

tells you to.

If you are being treated for HIV infection your doctor

will prescribe Emtricitabine/Tenofovir disoproxil with

other

antiretroviral

medicines.

Please

refer

patient information leaflets of the other antiretrovirals

for guidance on how to take those medicines.

If you are taking Emtricitabine/Tenofovir disoproxil

to reduce the risk of getting HIV, take Emtricitabine/

Tenofovir disoproxil every day, not just when you think

you have been at risk of HIV infection.

Ask your doctor if you have any questions about how to

prevent getting HIV or prevent spreading HIV to other

people.

for a long time, taking corticosteroids, drinking alcohol,

having

very

weak

immune

system,

being

overweight, may be some of the many risk factors for

developing this disease. Signs of osteonecrosis are:

joint stiffness

joint aches and pains (especially of the hip, knee and

shoulder)

difficulty with movement

If you notice any of these symptoms tell your doctor.

During treatment for HIV there may be an increase in

weight and in levels of blood lipids and glucose. This is

partly linked to restored health and life style, and in the

case of blood lipids sometimes to the HIV medicines

themselves. Your doctor will test for these changes.

Other effects in children

Children given emtricitabine very commonly experienced

changes in skin colour including darkening of the skin

in patches

Children commonly experienced low red blood cell

count (anaemia). This may cause the child to be tired or

breathless

If you notice any of these symptoms tell your doctor.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist.

This includes any possible side effects not listed in this

leaflet. You can also report side effects directly via

HPRA pharmacovigilance

Website: www.hpra.ie

By reporting side effects you can help provide more

information on the safety of this medicine.

How to store Emtricitabine/Tenofovir disoproxil

Keep

this

medicine

out

of

the

sight

and

reach

of

children.

Do not use this medicine after the expiry date which is

stated on the carton and blister. The expiry date refers to

the last day of that month.

Do not store above 30°C.

Store in the original package in order to protect from

moisture. Keep bottle tightly closed.

Do not throw away any medicines via wastewater or

household waste. Ask your pharmacist how to throw away

medicines that you no longer use. These measures will

help to protect the environment.

Contents of the pack and other information

What Emtricitabine/Tenofovir disoproxil contains

The active substances are emtricitabine and tenofovir

disoproxil.

Each

Emtricitabine/Tenofovir

disoproxil

film-coated tablet contains 200 mg of emtricitabine

and 245 mg of tenofovir disoproxil (equivalent to 300

mg of tenofovir disoproxil fumarate or 136 mg of

tenofovir).

The

other

ingredients

are

croscarmellose

sodium,

magnesium

stearate,

microcrystalline

cellulose,

pregelatinized starch (maize starch), lecithin (soya) (E322),

polyvinyl alcohol-partially hydrolyzed (E1203), titanium

dioxide (E171), talc, xanthan gum (E415).

What

Emtricitabine/Tenofovir

disoproxil

looks

like

and content of the pack

White to off white, modified capsule shaped, film-coated

tablets, debossed with “EM” on one side and “144” on other

side

tablet. The

dimensions

tablet

approximately 19.20 mm x 9.70 mm.

Blister pack:

Film-coated tablets in Aluminium plain foil as lidding

material and Aluminium-Aluminium plain as forming foil,

perforated unit dose blister.

Pack sizes: 30 x 1 and 90 x 1 film-coated tablets.

Bottles:

30 tablets in HDPE bottles containing desiccant (Canister

HDPE

containing

silica

gel),

with

polypropylene

child

resistant closure.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Tillomed Pharma GmbH

Manhagener Allee 36

22926 Ahrensburg

Germany

1

Manufacturer

Tillomed Laboratories Ltd.

220 Butterfield, Great Marlings,

Luton, LU2 8DL

United Kingdom

Tillomed Pharma GmbH

Mittelstrasse 5/5a

12529 Schönefeld

Germany

Only actual manufacturer stated on printed leaflet.

This medicinal product is authorised in the Member

States of the EEA under the following names:

Germany

Emtricitabin/Tenofovirdisoproxil

Tillomed 200 mg/245 mg Filmtabletten

Austria

Emtricitabin/Tenofovirdisoproxil

Tillomed 200 mg/245 mg Filmtabletten

Denmark

Emtricitabin/Tenofovirdisoproxil

Tillomed

Finland

Ireland

Emtricitabine/Tenofovir disoproxil

Tillomed 200 mg/245 mg film-coated

tablets

Italy

Netherlands

Emtricitabine/Tenofovir disoproxil

Tillomed 200 mg/245 mg

filmomhulde tabletten

Norway

Emtricitabin/Tenofovirdisoproxil

Tillomed

Poland

Emtricitabine + Tenofovir disoproxil

Tillomed

Portugal

Emtricitabina/Tenofovir disoproxil

Tillomed 200 mg/245 mg

comprimidos revestidos por película

Romania

Emtricitabină/Tenofovir disoproxil

Tillomed 200 mg/245 mg comprimate

filmate

Spain

Sweden

Emtricitabine/Tenofovirdisoproxil

Tillomed 200 mg/245 mg

filmdragerade tabletter

United Kingdom Emtricitabine/Tenofovir disoproxil

Tillomed 200 mg/245 mg film-coated

tablets

This leaflet was last revised in 06/2020

Emtricitabine/Tenofovir disoproxil

Tillomed 200 mg/245 mg

kalvopäällysteiset tabletit

Emtricitabina e Tenofovir disoproxil

Tillomed

Emtricitabina/tenofovir disoproxil

Tillomed 200 mg/245 mg comprimidos

recubiertos con película EFG

5 mm

5 mm

5 mm

5 mm

5 mm

75 mm

75 mm

170 mm

5 mm

5 mm

5 mm

5 mm

75 mm

75 mm

170 mm

5 mm

5 mm

Package leaflet: Information for the patient

Pharma

code

3

4

5

6

Product Name

Packaging Material

Size : Foil Repeat Length

Size : Strip Size

Size : Foil Width

Emtricitabine/Tenofovir disoproxil T

200 mg/245 mg film-coated Tablets

illomed

-------------

Pack insert A/W

N.A.

--------------------

---------------

---------------

---------------

Ireland

Sap code :

Reference Artwork

Reason of change :

Proof 1

23.04.2020

Party Artwork

Country :

Pack Size :

Proof 2

Proof 3

Proof 4

Barcode No. :

04.05.2020

21.05.2020

27.05.2020

Front

5 mm

180920

Back

5 mm

SAPCODE

Pharma

code

2

-------------

---------------

L.170 x H. 610 mm

L. x H. mm

Proof 5

Proof 6

Pharmacode :

No. of colours :

1

-------------

12.06.2020

18.09.2020

Size : PI - Open Size

PI - Folded Size

Size : Carton/Label

PM Style/Type :

---------------

9

Proof 7

Proof 8

Proof 9

Min. Font Size :

06.08.2018

Remark (If any) :

Folded size may change based on machine suitability.

Developed For :

Emcure - Hinjawadi

Mr. Rushikesh Kurade

Black

1

Read the complete document

Health Products Regulatory Authority

02 October 2020

CRN008K6S

Page 1 of 31

Summary of Product Characteristics

1 NAME OF THE MEDICINAL PRODUCT

Emtricitabine/Tenofovir disoproxil Tillomed 200 mg/245 mg film-coated tablets

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Each film-coated tablet contains 200 mg of emtricitabine and 245 mg of tenofovir disoproxil (equivalent to 300 mg of tenofovir

disoproxil fumarate or 136 mg of tenofovir).

Excipient with known effect: each film-coated tablet contains 0.76 mg of soya lecithin.

For the full list of excipients, see section 6.1.

3 PHARMACEUTICAL FORM

Film-coated tablet.

White to off white, modified capsule shaped, film-coated tablets, debossed with "EM" on one side and "144" on other side of

the tablet. The dimensions of the tablet are approximately 19.20 mm x 9.70 mm.

4 CLINICAL PARTICULARS

4.1 Therapeutic Indications

Treatment of HIV-1 infection:

Emtricitabine/Tenofovir disoproxil is indicated in antiretroviral combination therapy for the treatment of HIV-1 infected adults

(see section 5.1).

Emtricitabine/Tenofovir disoproxil is also indicated for the treatment of HIV-1 infected adolescents, with NRTI resistance or

toxicities precluding the use of first line agents (see sections 4.2, 4.4 and 5.1).

Pre-exposure prophylaxis (PrEP):

Emtricitabine/Tenofovir disoproxil is indicated in combination with safer sex practices for pre-exposure prophylaxis to reduce

the risk of sexually acquired HIV-1 infection in adults and adolescents at high risk (see sections 4.2, 4.4 and 5.1).

4.2 Posology and method of administration

Emtricitabine/Tenofovir disoproxil should be initiated by a physician experienced in the management of HIV infection.

Posology

Treatment of HIV in adults and adolescents aged 12 years and older, weighing at least 35 kg: One tablet, once daily.

Prevention of HIV in adults and adolescents aged 12 years and older, weighing at least 35 kg: One tablet, once daily.

Separate preparations of emtricitabine and tenofovir disoproxil are available for treatment of HIV-1 infection if it becomes

necessary to discontinue or modify the dose of one of the components of Emtricitabine/Tenofovir disoproxil. Please refer to

the Summary of Product Characteristics for these medicinal products.

If a dose of Emtricitabine/Tenofovir disoproxil is missed within 12 hours of the time it is usually taken, Emtricitabine/Tenofovir

disoproxil should be taken as soon as possible and the normal dosing schedule should be resumed. If a dose of

Emtricitabine/Tenofovir disoproxil is missed by more than 12 hours and it is almost time for the next dose, the missed dose

should not be taken and the usual dosing schedule should be resumed.

If vomiting occurs within 1 hour of taking Emtricitabine/Tenofovir disoproxil , another tablet should be taken. If vomiting

occurs more than 1 hour after taking Emtricitabine/Tenofovir disoproxil a second dose should not be taken.

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Special populations

Elderly: No dose adjustment is required (see section 5.2).

Renal impairment: Emtricitabine and tenofovir are eliminated by renal excretion and the exposure to emtricitabine and

tenofovir increases in individuals with renal dysfunction (see sections 4.4 and 5.2).

Adults with renal impairment:

Emtricitabine/Tenofovir disoproxil should only be used in individuals with creatinine clearance (CrCl) < 80 ml/min if the

potential benefits are considered to outweigh the potential risks. See Table 1.

Table 1: Dosing recommendations in adults with renal impairment

Treatment of HIV-1 infection

Pre-exposure prophylaxis

Mild renal impairment (CrCl 50-80 ml/min)

Limited data from clinical studies support

once daily dosing (see section 4.4).

Limited data from clinical studies

support once daily dosing in

HIV-1 uninfected individuals

with CrCl 60-80 ml/min. Use is

not recommended in HIV-1

uninfected individuals with CrCl

< 60 ml/min as it has not been

studied in this population (see

sections 4.4 and 5.2).

Moderate renal impairment (CrCl 30-49

ml/min)

Administration every 48 hours is

recommended based on modelling of

single-dose pharmacokinetic data for

emtricitabine and tenofovir disoproxil in

non-HIV infected subjects with varying

degrees of renal impairment (see section 4.4).

Not recommended for use in

this population

Severe renal impairment (CrCl < 30

ml/min) and haemodialysis patients

Not recommended because appropriate dose

reductions cannot be achieved with the

combination tablet.

Not recommended for use in

this population

Paediatrics with renal impairment:

Not recommended for use in individuals under the age of 18 years with renal impairment (section 4.4).

Hepatic impairment: No dose adjustment is required in patients with hepatic impairment

(see sections 4.4 and 5.2).

Paediatric population:

The safety and efficacy of emtricitabine/tenofovir disoproxil in children under the age of 12 years have not been established

(see section 5.2).

Method of administration

Oral use. It is preferable that Emtricitabine/Tenofovir disoproxil is taken with food.

The film-coated tablet can be disintegrated in approximately 100 ml of water, orange juice or grape juice and taken

immediately.

4.3 Contraindications

Hypersensitivity to the active substance or to peanut or soya, or to any of the excipients listed in section 6.1.

Use for pre-exposure prophylaxis in individuals with unknown or positive HIV-1 status.

4.4 Special warnings and precautions for use

Transmission of HIV

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While effective viral suppression with antiretroviral therapy has been proven to substantially reduce the risk of sexual

transmission, a residual risk cannot be excluded. Precautions to prevent transmission of HIV by infected individuals should be

taken in accordance with national guidelines.

Patients with HIV-1 harbouring mutations

Emtricitabine/Tenofovir disoproxil should be avoided in antiretroviral-experienced patients with HIV-1 harbouring the K65R

mutation (see section 5.1).

Overall HIV-1 infection prevention strategy

Emtricitabine/tenofovir disoproxil is not always effective in preventing the acquisition of HIV-1. The time to onset of protection

after commencing emtricitabine/tenofovir disoproxil is unknown.

Emtricitabine/Tenofovir disoproxil should only be used for pre-exposure prophylaxis as part of an overall HIV-1 infection

prevention strategy including the use of other HIV-1 prevention measures (e.g. consistent and correct condom use, knowledge

of HIV-1 status, regular testing for other sexually transmitted infections).

Risk of resistance with undetected HIV-1 infection:

Emtricitabine/Tenofovir disoproxil should only be used to reduce the risk of acquiring HIV-1 in individuals confirmed to be HIV

negative (see section 4.3). Individuals should be re-confirmed to be HIV-negative at frequent intervals (e.g. at least every 3

months) using a combined antigen/antibody test while taking Emtricitabine/Tenofovir disoproxil for pre-exposure prophylaxis.

Emtricitabine/tenofovir disoproxil alone does not constitute a complete regimen for the treatment of HIV-1 and HIV-1

resistance mutations have emerged in individuals with undetected HIV-1 infection who are only taking emtricitabine/tenofovir

disoproxil.

If clinical symptoms consistent with acute viral infection are present and recent (< 1 month) exposures to HIV-1 are suspected,

use of Emtricitabine/Tenofovir disoproxil should be delayed for at least one month and HIV-1 status reconfirmed before

starting Emtricitabine/Tenofovir disoproxil for pre-exposure prophylaxis.

Importance of adherence:

The effectiveness of emtricitabine/tenofovir disoproxil in reducing the risk of acquiring HIV-1 is strongly correlated with

adherence as demonstrated by measurable drug levels in blood (see section 5.1). HIV-1 uninfected individuals should be

counselled at frequent intervals to strictly adhere to the recommended Emtricitabine/Tenofovir disoproxil daily dosing

schedule.

Patients with hepatitis B or C virus infection

HIV-1 infected patients with chronic hepatitis B or C treated with antiretroviral therapy are at an increased risk for severe and

potentially fatal hepatic adverse reactions. Physicians should refer to current HIV treatment guidelines for the management of

HIV infection in patients co-infected with hepatitis B virus (HBV) or hepatitis C virus (HCV).

The safety and efficacy of emtricitabine/tenofovir disoproxil for pre-exposure prophylaxis in patients with HBV or HCV infection

has not been established.

In case of concomitant antiviral therapy for hepatitis B or C, please refer also to the relevant Summary of Product

Characteristics for these medicinal products. See also under Use with ledipasvir andsofosbuvir or sofosbuvir and velpatasvir

below.

Tenofovir disoproxil is indicated for the treatment of HBV and emtricitabine has shown activity against HBV in

pharmacodynamic studies but the safety and efficacy of emtricitabine/tenofovir disoproxil have not been specifically

established in patients with chronic HBV infection.

Discontinuation of emtricitabine/tenofovir disoproxil therapy in patients infected with HBV may be associated with severe

acute exacerbations of hepatitis. Patients infected with HBV who discontinue emtricitabine/tenofovir disoproxil should be

closely monitored with both clinical and laboratory follow-up for at least several months after stopping treatment. If

appropriate, resumption of hepatitis B therapy may be warranted. In patients with advanced liver disease or cirrhosis, treatment

discontinuation is not recommended since post-treatment exacerbation of hepatitis may lead to hepatic decompensation.

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Liver disease

The safety and efficacy of emtricitabine/tenofovir disoproxil have not been established in patients with significant underlying

liver disorders. The pharmacokinetics of tenofovir has been studied in patients with hepatic impairment and no dose

adjustment is required. The pharmacokinetics of emtricitabine has not been studied in patients with hepatic impairment. Based

on minimal hepatic metabolism and the renal route of elimination for emtricitabine, it is unlikely that a dose adjustment would

be required for emtricitabine/tenofovir disoproxil in patients with hepatic impairment (see sections 4.2 and 5.2).

HIV-1 infected patients with pre-existing liver dysfunction, including chronic active hepatitis, have an increased frequency of

liver function abnormalities during combination antiretroviral therapy (CART) and should be monitored according to standard

practice. If there is evidence of worsening liver disease in such patients, interruption or discontinuation of treatment must be

considered.

Renal and bone effects in adults

Renal effects

Emtricitabine and tenofovir are primarily excreted by the kidneys by a combination of glomerular filtration and active tubular

secretion. Renal failure, renal impairment, elevated creatinine, hypophosphataemia and proximal tubulopathy (including

Fanconi syndrome) have been reported with the use of tenofovir disoproxil (see section 4.8).

Renal monitoring

Prior to initiating Emtricitabine/Tenofovir disoproxil for the treatment of HIV-1 infection or for use in pre-exposure prophylaxis,

it is recommended that creatinine clearance is calculated in all individuals.

In individuals without risk factors for renal disease, it is recommended that renal function (creatinine clearance and serum

phosphate) is monitored after two to four weeks of use, after three months of use and every three to six months thereafter.

In individuals at risk for renal disease more frequent monitoring of renal function is required.

See also under Co-administration of other medicinal products below.

Renal management in HIV-1 infected patients

If serum phosphate is < 1.5 mg/dL (0.48 mmol/L) or creatinine clearance is decreased to < 50 ml/min in any patient receiving

Emtricitabine/Tenofovir disoproxil, renal function should be re-evaluated within one week, including measurements of blood

glucose, blood potassium and urine glucose concentrations (see section 4.8, proximal tubulopathy). Consideration should be

given to interrupting treatment with Emtricitabine/Tenofovir disoproxil in patients with creatinine clearance decreased to < 50

ml/min or decreases in serum phosphate to < 1.0 mg/dL (0.32 mmol/L). Interrupting treatment with Emtricitabine/Tenofovir

disoproxil should also be considered in case of progressive decline of renal function when no other cause has been identified.

Renal safety with emtricitabine/tenofovir disoproxil has only been studied to a very limited degree in HIV-1 infected patients

with impaired renal function (creatinine clearance < 80 ml/min). Dose interval adjustments are recommended for HIV-1

infected patients with creatinine clearance 30-49 ml/min (see section 4.2). Limited clinical study data suggest that the

prolonged dose interval is not optimal and could result in increased toxicity and possibly inadequate response. Furthermore, in

a small clinical study, a subgroup of patients with creatinine clearance between 50 and 60 ml/min who received tenofovir

disoproxil in combination with emtricitabine every 24 hours had a 2-4-fold higher exposure to tenofovir and worsening of renal

function (see section 5.2). Therefore, a careful benefit-risk assessment is needed when Emtricitabine/Tenofovir disoproxil is

used in patients with creatinine clearance < 60 ml/min, and renal function should be closely monitored. In addition, the clinical

response to treatment should be closely monitored in patients receiving Emtricitabine/Tenofovir disoproxil at a prolonged

dosing interval. The use of Emtricitabine/Tenofovir disoproxil is not recommended in patients with severe renal impairment

(creatinine clearance < 30 ml/min) and in patients who require haemodialysis since appropriate dose reductions cannot be

achieved with the

combination tablet (see sections 4.2 and 5.2).

Renal management in pre-exposure prophylaxis

Emtricitabine/tenofovir disoproxil has not been studied in HIV-1 uninfected individuals with creatinine clearance < 60 ml/min

and is therefore not recommended for use in this population. If serum phosphate is < 1.5 mg/dL (0.48 mmol/L) or creatinine

clearance is decreased to < 60 ml/min in any individual receiving emtricitabine/tenofovir disoproxil for pre-exposure

prophylaxis, renal function should be re-evaluated within one week, including measurements of blood glucose, blood

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potassium and urine glucose concentrations (see section 4.8, proximal tubulopathy). Consideration should be given to

interrupting use of Emtricitabine/Tenofovir disoproxil in individuals with creatinine clearance decreased to < 60 ml/min or

decreases in serum phosphate to < 1.0 mg/dL (0.32 mmol/L). Interrupting use of Emtricitabine/Tenofovir disoproxil should also

be considered in case of progressive decline of renal function when no other cause has been identified.

Bone effects

Bone abnormalities (infrequently contributing to fractures) may be associated with proximal renal tubulopathy (see section 4.8).

If bone abnormalities are suspected then appropriate consultation should be obtained.

Treatment of HIV-1 infection

In a 144-week controlled clinical study that compared tenofovir disoproxil with stavudine in combination with lamivudine and

efavirenz in antiretroviral-naïve patients, small decreases in bone mineral density (BMD) of the hip and spine were observed in

both treatment groups. Decreases in BMD of spine and changes in bone biomarkers from baseline were significantly greater in

the tenofovir disoproxil treatment group at 144 weeks. Decreases in BMD of hip were significantly greater in this group until 96

weeks. However, there was no increased risk of fractures or evidence for clinically relevant bone abnormalities over 144 weeks.

In other studies (prospective and cross-sectional), the most pronounced decreases in BMD were seen in patients treated with

tenofovir disoproxil as part of a regimen containing a boosted protease inhibitor. Alternative treatment regimens should be

considered for patients with osteoporosis that are at a high risk for fractures.

Pre-exposure prophylaxis

In clinical studies of HIV-1 uninfected individuals, small decreases in BMD were observed. In a study of 498 men, the mean

changes from baseline to week 24 in BMD ranged from -0.4% to -1.0% across hip, spine, femoral neck and trochanter in men

who received daily emtricitabine/tenofovir disoproxil prophylaxis (n = 247) vs. placebo (n = 251).

Renal and bone effects in the paediatric population

There are uncertainties associated with the long-term renal and bone effects of tenofovir disoproxil during the treatment of

HIV-1 infection in the paediatric population. There are no data on the long-term renal and bone effects of

emtricitabine/tenofovir disoproxil when used for pre-exposure prophylaxis in uninfected adolescents (see section 5.1).

Moreover, the reversibility of renal toxicity after cessation of tenofovir disoproxil for treatment of HIV-1 or after cessation of

emtricitabine/tenofovir disoproxil for pre-exposure prophylaxis cannot be fully ascertained.

A multidisciplinary approach is recommended to weigh the benefit/risk balance of the use of Emtricitabine/Tenofovir disoproxil

for the treatment of HIV-1 infection or for pre-exposure prophylaxis, decide the appropriate monitoring during treatment

(including decision for treatment withdrawal) and consider the need for supplementation on a case by case basis.

When using Emtricitabine/Tenofovir disoproxil for pre-exposure prophylaxis individuals should be reassessed at each visit to

ascertain whether they remain at high risk of HIV-1 infection.

The risk of HIV-1 infection should be balanced against the potential for renal and bone effects with long-term use of

emtricitabine/tenofovir disoproxil.

Renal effects

Renal adverse reactions consistent with proximal renal tubulopathy have been reported in HIV-1 infected paediatric patients

aged 2 to < 12 years in clinical study GS-US-104-0352 (see sections 4.8 and 5.1).

Renal monitoring

Renal function (creatinine clearance and serum phosphate) should be evaluated prior to initiating Emtricitabine/Tenofovir

disoproxil for treatment of HIV-1 or for pre-exposure prophylaxis and should be monitored during use as in adults (see above).

Renal management

If serum phosphate is confirmed to be < 3.0 mg/dL (0.96 mmol/L) in any paediatric patient receiving Emtricitabine/Tenofovir

disoproxil, renal function should be re-evaluated within one week, including measurements of blood glucose, blood potassium

and urine glucose concentrations (see section 4.8, proximal tubulopathy). If renal abnormalities are suspected or detected then

consultation with a nephrologist should be obtained to consider interruption of Emtricitabine/Tenofovir disoproxil use.

Interrupting use of Emtricitabine/Tenofovir disoproxil should also be considered in case of progressive decline of renal function

when no other cause has been identified.

Co-administration and risk of renal toxicity

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The same recommendations apply as in adults (see Co-administration of other medicinal products below).

Renal impairment

The use of Emtricitabine/Tenofovir disoproxil is not recommended in individuals under the age of 18 years with renal

impairment (see section 4.2). Emtricitabine/Tenofovir disoproxil should not be initiated in paediatric patients with renal

impairment and should be discontinued in paediatric patients who develop renal impairment during Emtricitabine/Tenofovir

disoproxil use.

Bone effects

Use of tenofovir disoproxil may cause a reduction in BMD. The effects of tenofovir

disoproxil associated changes in BMD on long-term bone health and future fracture risk are currently unknown (see section

5.1).

If bone abnormalities are detected or suspected during use of Emtricitabine/Tenofovir disoproxil in any paediatric patient,

consultation with an endocrinologist and/or nephrologist should be obtained.

Weight and metabolic parameters

An increase in weight and in levels of blood lipids and glucose may occur during antiretroviral therapy. Such changes may in

part be linked to disease control and life style. For lipids, there is in some cases evidence for a treatment effect, while for weight

gain there is no strong evidence relating this to any particular treatment. For monitoring of blood lipids and glucose reference

is made to established HIV treatment guidelines. Lipid disorders should be managed as clinically appropriate.

Mitochondrial dysfunction following exposure in utero

Nucleos(t)ide analogues may impact mitochondrial function to a variable degree, which is most pronounced with stavudine,

didanosine and zidovudine. There have been reports of mitochondrial dysfunction in HIV negative infants exposed in utero

and/or postnatally to nucleoside analogues; these have predominantly concerned treatment with regimens containing

zidovudine. The main adverse reactions reported are haematological disorders (anaemia, neutropenia) and metabolic disorders

(hyperlactataemia, hyperlipasaemia). These events have often been transitory. Late onset neurological disorders have been

reported rarely (hypertonia, convulsion, abnormal behaviour). Whether such neurological disorders are transient or permanent

is currently unknown. These findings should be considered for any child exposed in utero to nucleos(t)ide analogues, who

present with severe clinical

findings of unknown aetiology, particularly neurologic findings. These findings do not affect current national recommendations

to use antiretroviral therapy in pregnant women to prevent vertical transmission of HIV.

Immune Reactivation Syndrome

In HIV infected patients with severe immune deficiency at the time of institution of CART, an

inflammatory reaction to asymptomatic or residual opportunistic pathogens may arise and cause serious clinical conditions, or

aggravation of symptoms. Typically, such reactions have been observed within the first few weeks or months of initiation of

CART. Relevant examples are cytomegalovirus retinitis, generalised and/or focal mycobacterial infections, and Pneumocystis

jirovecii pneumonia. Any inflammatory symptoms should be evaluated and treatment instituted when necessary. Autoimmune

disorders (such as Graves' disease and autoimmune hepatitis) have also been reported to occur in the setting of immune

reactivation; however, the reported time to onset is more variable and these events can occur many months after initiation of

treatment.

Opportunistic infections

HIV-1 infected patients receiving emtricitabine/tenofovir disoproxil or any other antiretroviral therapy may continue to develop

opportunistic infections and other complications of HIV infection, and therefore should remain under close clinical observation

by physicians experienced in the treatment of patients with HIV associated diseases.

Osteonecrosis

Although the aetiology is considered to be multifactorial (including corticosteroid use, alcohol

consumption, severe immunosuppression, higher body mass index), cases of osteonecrosis have been reported particularly in

patients with advanced HIV-disease and/or long-term exposure to CART. Patients should be advised to seek medical advice if

they experience joint aches and pain, joint stiffness or difficulty in movement.

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Co-administration of other medicinal products

Use of Emtricitabine/Tenofovir disoproxil should be avoided with concurrent or recent use of a nephrotoxic medicinal product

(see section 4.5). If concomitant use with nephrotoxic agents is unavoidable, renal function should be monitored weekly.

Cases of acute renal failure after initiation of high dose or multiple non-steroidal anti-inflammatory drugs (NSAIDs) have been

reported in HIV-1 infected patients treated with tenofovir disoproxil and with risk factors for renal dysfunction. If

Emtricitabine/Tenofovir disoproxil is co-administered with an NSAID, renal function should be monitored adequately.

A higher risk of renal impairment has been reported in HIV-1 infected patients receiving tenofovir disoproxil in combination

with a ritonavir or cobicistat boosted protease inhibitor. Close monitoring of renal function is required in these patients (see

section 4.5). In HIV-1 infected patients with renal risk factors, the co-administration of tenofovir disoproxil with a boosted

protease inhibitor should be carefully evaluated.

Emtricitabine/Tenofovir disoproxil should not be administered concomitantly with other medicinal products containing

emtricitabine, tenofovir disoproxil, tenofovir alafenamide, or other cytidine analogues, such as lamivudine (see section 4.5).

Emtricitabine/Tenofovir disoproxil should not be administered concomitantly with adefovir dipivoxil.

Use with ledipasvir and sofosbuvir, sofosbuvir and velpatasvir or sofosbuvir, velpatasvir and voxilaprevir

Co-administration of tenofovir disoproxil with ledipasvir/sofosbuvir,

sofosbuvir/velpatasvir or sofosbuvir/velpatasvir/voxilaprevir has been shown to increase plasma concentrations of tenofovir,

especially when used together with an HIV regimen containing tenofovir disoproxil and a pharmacokinetic enhancer (ritonavir

or cobicistat).

The safety of tenofovir disoproxil when co-administered with ledipasvir/sofosbuvir, sofosbuvir/velpatasvir or

sofosbuvir/velpatasvir/voxilaprevir and a pharmacokinetic enhancer has not been established. The potential risks and benefits

associated with co-administration should be considered, particularly in patients at increased risk of renal dysfunction. Patients

receiving ledipasvir/sofosbuvir, sofosbuvir/velpatasvir or sofosbuvir/velpatasvir/voxilaprevir concomitantly with tenofovir

disoproxil and a boosted HIV protease inhibitor should be monitored for adverse reactions related to tenofovir disoproxil.

Co-administration of tenofovir disoproxil and didanosine

Co-administration is not recommended because it results in a 40-60% increase in systemic exposure to didanosine that may

increase the risk of didanosine-related adverse reactions (see section 4.5). Rarely, pancreatitis and lactic acidosis, sometimes

fatal, have been reported. Co-administration of tenofovir disoproxil and didanosine at a dose of 400 mg daily has been

associated with a significant decrease in CD4 cell count, possibly due to an intracellular interaction increasing phosphorylated

(i.e.active) didanosine. A decreased dosage of 250 mg didanosine co-administered with tenofovir disoproxil therapy has been

associated with reports of high rates of virological failure within several tested combinations.

Triple nucleoside therapy

There have been reports of a high rate of virological failure and of emergence of resistance at an early stage in HIV-1 infected

patients when tenofovir disoproxil was combined with lamivudine and abacavir as well as with lamivudine and didanosine as a

once daily regimen. There is close structural similarity between lamivudine and emtricitabine and similarities in the

pharmacokinetics and pharmacodynamics of these two agents. Therefore, the same problems may be seen if

emtricitabine/tenofovir disoproxil is administered with a third nucleoside analogue.

Elderly

Emtricitabine/tenofovir disoproxil has not been studied in individuals over the age of 65 years. Individuals over the age of 65

years are more likely to have decreased renal function, therefore caution should be exercised when administering

Emtricitabine/Tenofovir disoproxil to older people.

Soya lecithin

Emtricitabine/Tenofovir disoproxil contains soya lecithin.

If a patient is hypersensitive to peanut or soya, Emtricitabine/Tenofovir disoproxil should not be used.

Sodium

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Emtricitabine/Tenofovir disoproxil contains less than 1 mmol sodium (23 mg) per film-coated tablet, that is to say essentially

'sodium-free'

4.5 Interaction with other medicinal products and other forms of interactions

Interaction studies have only been performed in adults.

As Emtricitabine/Tenofovir disoproxil contains emtricitabine and tenofovir disoproxil, any interactions that have been identified

with these agents individually may occur with emtricitabine/tenofovir disoproxil. Interaction studies have only been performed

in adults.

The steady-state pharmacokinetics of emtricitabine and tenofovir were unaffected when emtricitabine and tenofovir disoproxil

were administered together versus each medicinal product dosed alone.

In vitro and clinical pharmacokinetic interaction studies have shown the potential for CYP450

mediated interactions involving emtricitabine and tenofovir disoproxil with other medicinal products is low.

Concomitant use not recommended

Emtricitabine/Tenofovir disoproxil should not be administered concomitantly with other medicinal products containing

emtricitabine, tenofovir disoproxil, tenofovir alafenamide or other cytidine analogues, such as lamivudine (see section 4.4).

Emtricitabine/Tenofovir disoproxil should not be administered concomitantly with adefovir dipivoxil.

Didanosine: The co-administration of Emtricitabine/Tenofovir disoproxil and didanosine is not recommended (see section 4.4

and Table 2).

Renally eliminated medicinal products: Since emtricitabine and tenofovir are primarily eliminated by the kidneys,

co-administration of emtricitabine/tenofovir disoproxil with medicinal products that reduce renal function or compete for

active tubular secretion (e.g. cidofovir) may increase serum concentrations of emtricitabine, tenofovir and/or the

co-administered medicinal products.

Use of Emtricitabine/Tenofovir disoproxil should be avoided with concurrent or recent use of a nephrotoxic medicinal product.

Some examples include, but are not limited to, aminoglycosides, amphotericin B, foscarnet, ganciclovir, pentamidine,

vancomycin, cidofovir or interleukin-2 (see section 4.4).

Other interactions

Interactions between emtricitabine/tenofovir disoproxil or its individual component(s) and other medicinal products are listed

in Table 2 below (increase is indicated as "↑", decrease as "↓", no change as "↔", twice daily as "b.i.d." and once daily as "q.d.").

If available, 90% confidence intervals are shown in parentheses.

Table 2: Interactions between emtricitabine/tenofovir disoproxil or its individual component(s) and other medicinal

products

Medicinal product by therapeutic areas

Effects on drug levels

Mean percent change in

AUC,

C

max

, C

min

with 90%

confidence intervals if

available (mechanism)

Recommendation concerning co-administration

with Emtricitabine/Tenofovir disoproxil

(emtricitabine 200 mg, tenofovir disoproxil

245 mg)

ANTI-INFECTIVES

Antiretrovirals

Protease inhibitors

Atazanavir/Ritonavir/Tenofovir disoproxil

(300 mg q.d./100 mg q.d./245 mg q.d.)

Atazanavir:

AUC: ↓ 25% (↓ 42 to ↓ 3)

: ↓ 28% (↓ 50 to ↑ 5)

: ↓ 26% (↓ 46 to ↑ 10)

Tenofovir:

No dose adjustment is recommended. The

increased exposure of tenofovir could potentiate

tenofovir associated adverse events, including renal

disorders. Renal function should be closely

monitored (see section 4.4).

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AUC: ↑ 37%

: ↑ 34%

: ↑ 29%

Atazanavir/Ritonavir/Emtricitabine

Interaction not studied.

Darunavir/Ritonavir/Tenofovir disoproxil

(300 mg q.d./100 mg q.d./245 mg q.d.)

Darunavir:

AUC: ↔

: ↔

Tenofovir:

AUC: ↑ 22%

: ↑ 37%

No dose adjustment is recommended. The

increased exposure of tenofovir could potentiate

tenofovir associated adverse events, including renal

disorders. Renal function should be closely

monitored (see section 4.4).

Darunavir/Ritonavir/Emtricitabine

Interaction not studied.

Lopinavir/Ritonavir/Tenofovir disoproxil

(400 mg b.i.d./100 mg b.i.d/245 mg q.d.)

Lopinavir/Ritonavir:

AUC: ↔

: ↔

: ↔

Tenofovir:

AUC: ↑ 32% (↑ 25 to ↑ 38)

: ↔

: ↑ 51% (↑ 37 to ↑ 66)

No dose adjustment is recommended. The

increased exposure of tenofovir could potentiate

tenofovir associated adverse events, including renal

disorders. Renal function should be closely

monitored (see section 4.4).

Lopinavir/Ritonavir/Emtricitabine

Interaction not studied.

Medicinal product by therapeutic areas

Effects on drug levels Mean

percent change in AUC,

C

max

, C

min

with 90% confidence

intervals if available (mechanism)

Recommendation concerning

co-administration with

Emtricitabine/Tenofovir disoproxil

(emtricitabine 200 mg, tenofovir

disoproxil 245 mg)

NRTIs

Didanosine/Tenofovir disoproxil

Co-administration of tenofovir

disoproxil and didanosine results in a

40-60% increase in systemic

exposure to didanosine that may

increase the risk for

didanosine-related adverse reactions.

Rarely, pancreatitis and lactic

acidosis, sometimes fatal, have been

reported. Co-administration of

tenofovir disoproxil and didanosine

at a dose of 400 mg daily has been

associated with a significant decrease

in CD4 cell count, possibly due to an

intracellular interaction increasing

phosphorylated (i.e. active)

didanosine. A decreased dosage of

250 mg didanosine co-administered

with tenofovir disoproxil therapy has

been associated with reports of high

rates of virological failure within

several tested combinations for the

treatment of HIV-1 infection.

Co-administration of

emtricitabine/tenofovir disoproxil and

didanosine is not recommended (see

section 4.4).

Didanosine/Emtricitabine

Interaction not studied.

Lamivudine/Tenofovir disoproxil

Lamivudine:

AUC: ↓ 3% (↓ 8 to ↑ 15)

: ↓ 24% (↓ 44 to ↓ 12) C

: NC

Lamivudine and emtricitabine/tenofovir

disoproxil should not be administered

concomitantly (see section 4.4).

Health Products Regulatory Authority

02 October 2020

CRN008K6S

Page 10 of 31

Tenofovir:

AUC: ↓ 4% (↓ 15 to ↑ 8)

: ↑ 102% (↓ 96 to ↑ 108) C

: NC

Efavirenz/Tenofovir disoproxil

Efavirenz:

AUC: ↓ 4% (↓ 7 to ↓ 1)

: ↓ 4% (↓ 9 to ↑ 2) C

: NC

No dose adjustment of efavirenz is

required.

Tenofovir:

AUC: ↓ 1% (↓ 8 to ↑ 6)

: ↑ 7% (↓ 6 to ↑ 22) C

: NC

Medicinal product by therapeutic areas

Effects on drug levels Mean

percent change in AUC,

C

max

, C

min

with 90%

confidence intervals if

available (mechanism)

Recommendation concerning

co-administration with

Emtricitabine/Tenofovir disoproxil

(emtricitabine 200 mg, tenofovir

disoproxil 245 mg)

ANTI-INFECTIVES

Hepatitis B virus (HBV) antiviral agents

Adefovir dipivoxil /Tenofovir disoproxil

Adefovir dipivoxil:

AUC: ↓ 11% (↓ 14 to ↓ 7)

: ↓ 7% (↓ 13 to ↓ 0) C

: NC

Adefovir dipivoxil and

emtricitabine/tenofovir disoproxil

should not be administered

concomitantly (see section 4.4).

Tenofovir:

AUC: ↓ 2% (↓ 5 to ↑ 0)

: ↓ 1% (↓ 7 to ↑ 6) C

: NC

Hepatitis C virus (HCV) antiviral agents

Ledipasvir/Sofosbuvir (90 mg/400 mg q.d.) +

Atazanavir/Ritonavir

(300 mg q.d./100 mg q.d.) +

Emtricitabine/Tenofovir disoproxil

(200 mg/245 mg q.d.)1

Ledipasvir:

AUC: ↑ 96% (↑ 74 to ↑ 121)

: ↑ 68% (↑ 54 to ↑ 84)

: ↑ 118% (↑ 91 to ↑ 150)

Sofosbuvir:

AUC: ↔

: ↔

GS-3310072:

AUC: ↔

: ↔

: ↑ 42% (↑ 34 to ↑ 49)

Atazanavir:

AUC: ↔

: ↔

: ↑ 63% (↑ 45 to ↑ 84)

Ritonavir:

AUC: ↔

: ↔

: ↑ 45% (↑ 27 to ↑ 64)

Emtricitabine:

AUC: ↔

: ↔

: ↔

Tenofovir:

AUC: ↔

: ↑ 47% (↑ 37 to ↑ 58)

: ↑ 47% (↑ 38 to ↑ 57)

Increased plasma concentrations of

tenofovir resulting from

co-administration of tenofovir disoproxil,

ledipasvir/sofosbuvir and

atazanavir/ritonavir may increase

adverse reactions related to tenofovir

disoproxil, including renal disorders. The

safety of tenofovir disoproxil when used

with ledipasvir/sofosbuvir and a

pharmacokinetic enhancer (e.g. ritonavir

or cobicistat) has not been established.

The combination should be used with

caution with frequent renal monitoring,

if other alternatives are not available

(see

section 4.4).

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