Eviplera

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  • Heiti vöru:
  • Eviplera
  • Lyf við lungum:
  • Mannfólk
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  • Allópatísk lyf

Skjöl

Staðsetning

  • Fáanlegt í:
  • Eviplera
    Evrópusambandið
  • Tungumál:
  • enska

Meðferðarupplýsingar

  • Meðferðarhópur:
  • Antivirals for systemic use,
  • Lækningarsvæði:
  • HIV Infections
  • Ábendingar:
  • Eviplera is indicated for the treatment of adults infected with human immunodeficiency virus type 1 (HIV-1) without known mutations associated with resistance to the non-nucleoside reverse transcriptase inhibitor (NNRTI) class, tenofovir or emtricitabine, and with a viral load ≤ 100,000 HIV-1 RNA copies/mL. As with other antiretroviral medicinal products, genotypic resistance testing and/or historical resistance data should guide the use of Eviplera.,
  • Vörulýsing:
  • Revision: 21

Staða

  • Heimild:
  • EMA - European Medicines Agency
  • Leyfisstaða:
  • Authorised
  • Leyfisnúmer:
  • EMEA/H/C/002312
  • Leyfisdagur:
  • 27-11-2011
  • EMEA númer:
  • EMEA/H/C/002312
  • Síðasta uppfærsla:
  • 19-12-2018

Opinber matsskýrsla

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Send a question via our website

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© European Medicines Agency, 2016. Reproduction is authorised provided the source is acknowledged.

EMA/403881/2016

EMEA/H/C/002312

EPAR summary for the public

Eviplera

emtricitabine / rilpivirine / tenofovir disoproxil

This is a summary of the European public assessment report (EPAR) for Eviplera. It explains how the

Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in

favour of granting a marketing authorisation and its recommendations on the conditions of use for

Eviplera.

What is Eviplera?

Eviplera is a medicine that contains the active substances emtricitabine (200 mg), rilpivirine (25 mg)

and tenofovir disoproxil (245 mg). It is available as tablets.

What is Eviplera used for?

Eviplera is used to treat adults infected with human immunodeficiency virus-1 (HIV-1), a virus that

causes acquired immune deficiency syndrome (AIDS).

It is only used in patients where the virus has not developed resistance to certain anti-HIV medicines

called non-nucleoside reverse transcriptase inhibitors (NNRTIs), tenofovir or emtricitabine, and who

have HIV levels in the blood (viral load) of no more than 100,000 HIV-1 RNA copies/ml.

The medicine can only be obtained with a prescription.

How is Eviplera used?

Treatment with Eviplera should be started by a doctor who has experience in the management of HIV

infection. The recommended dose is one tablet once a day and it must be taken with food.

If patients need to stop taking one of the active substances or if they need to modify their dose,

patients should be switched to separate medicines containing emtricitabine, rilpivirine or tenofovir

disoproxil. If Eviplera is given together with rifabutin, the doctor should prescribe an additional 25 mg

of rilpivirine per day during rifabutin treatment.

Eviplera

EMA/403881/2016

Page 2/3

How does Eviplera work?

Eviplera contains three active substances: emtricitabine, which is a nucleoside reverse transcriptase

inhibitor; rilpivirine, which is a non-nucleoside reverse transcriptase inhibitor (NNRTI); and tenofovir

disoproxil, which is a ‘prodrug’ of tenofovir, meaning that it is converted into the active substance

tenofovir in the body. Tenofovir is a nucleotide reverse transcriptase inhibitor.

All three active substances block the activity of reverse transcriptase, a viral enzyme that allows HIV-1

to replicate in the cells it has infected. By blocking this enzyme, Eviplera reduces the amount of HIV-1

in the blood and keeps it at a low level. Eviplera does not cure HIV-1 infection or AIDS, but it may slow

the damage to the immune system and the development of infections and diseases associated with

AIDS.

All three active substances are already available in separate medicines in the EU.

How has Eviplera been studied?

Eviplera has been studied in two main studies in patients with HIV-1 who had not received HIV

treatment before. In the first main study involving 690 patients, Eviplera was compared with a similar

combination that had efavirenz in place of rilpivirine. The second main study involving 678 patients

compared rilpivirine with efavirenz, both being taken with emtricitabine and tenofovir disoproxil or two

other nucleotide reverse transcriptase inhibitors.

The main measure of effectiveness was based on the reduction in viral load. Patients who attained a

viral load of less than 50 HIV-1 RNA copies/ml after 48 weeks of treatment were considered to have

responded to treatment.

Eviplera has also been evaluated in 532 patients who were switched from their current HIV treatment

to Eviplera. Patient’s previous treatment consisted either of two nucleotide reverse transcriptase

inhibitors and another HIV medicine called a boosted protease inhibitor, or the medicine Atripla. The

main measure of effectiveness was based on the maintained reduction in viral load.

The company also presented studies showing that the tablet containing all three substances is

absorbed in the body in the same way as the separate tablets given concurrently under similar

conditions.

What benefit has Eviplera shown during the studies?

The Eviplera combination compared well with combinations containing efavirenz. In the first study in

previously untreated patients, 83% of the patients taking the Eviplera combination responded to

treatment compared with 84% of the patients taking a combination with efavirenz. In the second

study, 87% of the patients in the rilpivirine group (which included patients taking the Eviplera

combination) responded to treatment. This compared with 83% of patients in the efavirenz group.

The two studies evaluating the effects of switching patients to Eviplera showed that Eviplera was as

effective as the previous treatment and maintained the reduction in viral load.

What is the risk associated with Eviplera?

The most common side effects with Eviplera in patients who had not received previous HIV treatment

(seen in more than 5 patients in 100) were nausea (feeling sick), dizziness, abnormal dreams,

headache, diarrhoea and insomnia. In patients who had received previous HIV treatment, the most

Eviplera

EMA/403881/2016

Page 3/3

common side effects (seen in more than 2 patients in 100) were tiredness, diarrhoea, nausea and

insomnia. Rarely, kidney problems may occur in patients taking tenofovir disoproxil. Patients who have

HIV and hepatitis B may see a worsening of their liver problems when stopping Eviplera.

Eviplera must not be used with the following medicines as they may lead to reduced blood levels of

rilpivirine, and thereby reduce the effectiveness of Eviplera:

carbamazepine, oxcarbazepine, phenobarbital, phenytoin (medicines for epilepsy);

rifampicin, rifapentine (antibiotics);

omeprazole, esomeprazole, lansoprazole, pantoprazole, rabeprazole (proton pump inhibitors for

reducing stomach acid);

systemic dexamethasone (a steroid anti-inflammatory and immunosuppressant medicine) except

when used as a single dose treatment;

St John’s wort (a herbal medicine to treat depression and anxiety).

For the full list of side effects and restrictions with Eviplera, see the package leaflet.

Why has Eviplera been approved?

The CHMP concluded that Eviplera was as effective as combinations containing efavirenz. It also causes

fewer side effects in the early stages of treatment and offers the benefit of being taken as one tablet

once per day. However, the CHMP noted that there was some risk of HIV-1 developing resistance to

rilpivirine and that this risk appeared to be lower in patients with a lower viral load. Therefore, the

CHMP considered that the benefits of Eviplera outweigh its risks in patients with a low HIV-1 viral load,

and recommended that it be granted marketing authorisation for this group of patients.

What measures are being taken to ensure the safe and effective use of

Eviplera?

Recommendations and precautions to be followed by healthcare professionals and patients for the safe

and effective use of Eviplera have been included in the summary of product characteristics and the

package leaflet.

Other information about Eviplera

The European Commission granted a marketing authorisation valid throughout the European Union for

Eviplera on 28 November 2011.

The full EPAR for Eviplera can be found on the Agency’s website:

ema.europa.eu/Find medicine/Human

medicines/European Public Assessment Reports. For more information about treatment with Eviplera,

read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

This summary was last updated in 06-2016.

Upplýsingar um fylgiseðil sjúklinga: samsetning, vísbendingar, aukaverkanir, skammtar, milliverkanir, aukaverkanir, meðgöngu, brjóstagjöf

B. PACKAGE LEAFLET

Package leaflet: Information for the user

Eviplera 200 mg/25 mg/245 mg film-coated tablets

emtricitabine/rilpivirine/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 of the 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 Eviplera is and what it is used for

What you need to know before you take Eviplera

How to take Eviplera

Possible side effects

How to store Eviplera

Contents of the pack and other information

1.

What Eviplera is and what it is used for

Eviplera contains three active substances

that are used to treat Human Immunodeficiency Virus

(HIV) infection:

Emtricitabine, a nucleoside reverse transcriptase inhibitor (NRTI).

Rilpivirine, a non-nucleoside reverse transcriptase inhibitor (NNRTI).

Tenofovir disoproxil, a nucleotide reverse transcriptase inhibitor (NtRTI).

Each of these active substances, also known as antiretroviral medicines, works by interfering with an

enzyme (a protein called ‘reverse transcriptase’) that is essential for the virus to multiply.

Eviplera reduces the amount of HIV in your body. This, will improve your immune system and

reduces the risk of developing illnesses linked to HIV infection.

Eviplera is a treatment for Human Immunodeficiency Virus (HIV)

infection in adults aged

18 years and over.

2.

What you need to know before you take Eviplera

Do not take Eviplera

If you are allergic

to emtricitabine, rilpivirine, tenofovir disoproxil, or any of the other

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

If this applies to you, tell your doctor immediately.

If you are currently taking any of the following medicines

carbamazepine, oxcarbazepine, phenobarbital and phenytoin

(medicines to treat

epilepsy and prevent seizures)

rifampicin and rifapentine

(used to treat some bacterial infections such as tuberculosis)

omeprazole, lansoprazole, rabeprazole, pantoprazole and esomeprazole

(proton

pump inhibitors that are medicines used to prevent and treat stomach ulcers, heartburn,

acid reflux disease)

dexamethasone

(a corticosteroid used to treat inflammation and suppress the immune

system) when taken by mouth or injected (except as a single dose treatment)

products that contain

St. John’s wort

Hypericum perforatum

) (a herbal remedy used

for depression and anxiety)

Warnings and precautions

You must remain under the care of your doctor while taking Eviplera.

You 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 Eviplera you may still

develop infections or other illnesses associated with HIV infection.

Tell your doctor if you had kidney disease,

or if tests have shown kidney problems. Eviplera

may affect your kidneys. Before and during treatment, your doctor may order blood tests to

measure kidney function. Eviplera is not recommended if you have moderate to severe kidney

disease.

Eviplera is not usually taken with other medicines that can damage your kidneys (

see Other

medicines and Eviplera

). If this is unavoidable, your doctor will monitor your kidney function

once a week.

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

HIV patients

with 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, your

doctor will carefully consider the best treatment regimen for you. Two of the active substances

in Eviplera (tenofovir disoproxil and emtricitabine) show some activity against hepatitis B virus.

If you have a history of liver disease, or chronic hepatitis B infection, your doctor may conduct

blood tests in order to monitor liver function.

If you have hepatitis B infection, liver problems may become worse after you stop taking

Eviplera. It is important not to stop taking Eviplera without talking to your doctor: see

section 3,

Do not stop taking Eviplera

Tell your doctor immediately and stop taking Eviplera if you develop a skin rash with the

following symptoms: fever, blisters, redness in your eyes and swelling of your face, mouth

or body.

This may become severe or potentially life-threatening.

Talk to your doctor if you are over 65 years of age.

Not enough patients over the age of 65

have been studied. If you are over 65 years of age and are prescribed Eviplera, your doctor will

monitor you carefully.

While you take Eviplera

Once you start taking Eviplera, look out for:

any signs of inflammation or infection

bone problems

If you notice any of these symptoms, tell your doctor immediately.

Children and adolescents

Do not give this medicine to children

and adolescents under 18 years of age.

Other medicines and Eviplera

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other

medicines.

This includes medicines and herbal medicines obtained without a prescription.

Tell your doctor

if you are taking any of the following:

Any other medicines containing

emtricitabine

rilpivirine

tenofovir disoproxil

tenofovir alafenamide

any other antiviral medicines that contain lamivudine or adefovir dipivoxil

Eviplera may interact with other medicines. As a result, the amounts of Eviplera or other medicines in

your blood may be affected. This may stop your medicines from working properly, or may make any

side effects worse. In some cases, your doctor may need to adjust your dose or check your blood

levels.

Medicines that may damage your kidneys,

examples include:

aminoglycosides (such as streptomycin, neomycin and gentamicin), vancomycin (for

bacterial infections)

foscarnet, ganciclovir, cidofovir (for viral infections)

amphotericin B, pentamidine (for fungal infections)

interleukin-2, also called aldesleukin (to treat cancer)

non-steroidal anti-inflammatory drugs (NSAIDs, to relieve bone or muscle pains)

Medicines containing didanosine (for HIV infection):

Taking Eviplera with other antiviral

medicines that contain didanosine can raise the levels of didanosine in your blood and may

reduce CD4 cell counts. Inflammation of the pancreas and lactic acidosis (excess lactic acid in

the blood), which sometimes caused death, have been reported rarely when medicines

containing tenofovir disoproxil and didanosine were taken together. Your doctor will carefully

consider whether to treat you with other medicines used for treating HIV infection (

see Other

medicines used for HIV infection)

Other medicines used for HIV infection:

Non-nucleoside reverse transcriptase inhibitors

(NNRTIs). Eviplera contains an NNRTI (rilpivirine) and so Eviplera is not to be combined with

other medicines of this type. Your doctor will discuss a different medicine if required.

Rifabutin,

a medicine to treat some bacterial infections. This medicine can decrease the

amount of rilpivirine (a component of Eviplera) in your blood. Your doctor may need to give

you an additional dose of rilpivirine to treat your HIV infection (

see section 3 How to take

Eviplera)

Antibiotics used to treat bacterial infections

including tuberculosis containing:

clarithromycin

erythromycin

These medicines can increase the amount of rilpivirine (a component of Eviplera) in your blood.

Your doctor may need to change the dose of the antibiotic or give you a different antibiotic.

Medicines for stomach ulcers, heartburn or acid reflux

such as:

antacids (aluminium/magnesium hydroxide or calcium carbonate)

-antagonists (famotidine, cimetidine, nizatidine or ranitidine)

These medicines can decrease the amount of rilpivirine (a component of Eviplera) in your

blood. If you are taking one of these medicines your doctor will either give you a different

medicine for stomach ulcers, heartburn or acid reflux, or recommend how and when you take

that medicine.

If you are taking an antacid

(such

medicines containing magnesium or potassium), take it

at least 2 hours before or at least 4 hours after Eviplera (

see section 3 How to take Eviplera)

If you are taking an H

2

-antagonist

(also used to treat stomach acid or acid reflux disease),

take it at least 12 hours before or at least 4 hours after Eviplera. H

-antagonists can only be

taken once a day if you take Eviplera. H

-antagonists should not be taken in a twice a day

regimen. Talk to your doctor about an alternative regimen (

see section 3 How to take Eviplera).

Methadone,

a medicine used to treat opiate addiction, as your doctor may need to change your

methadone dose.

Dabigatran etexilate,

a medicine used to treat heart conditions, as your doctor may need to

monitor the levels of this medicine in your blood.

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

Do not stop your treatment without

contacting your doctor.

Pregnancy and breast-feeding

Ask your doctor or pharmacist for advice before taking any medicine.

Women must not get pregnant

while taking Eviplera.

Use effective contraception

while taking Eviplera.

Tell your doctor immediately if you become pregnant or if you plan to become pregnant.

Pregnant women should not take Eviplera unless you and your doctor decide it is clearly

needed. Your doctor will discuss the potential benefits and risks of taking Eviplera to you and

your child.

If you have taken Eviplera

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, the benefit from the protection against HIV outweighed the risk

of side effects.

Do not breast-feed during treatment with Eviplera:

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

Do not drive or operate machines if you feel tired, sleepy or dizzy after taking your medicine.

Eviplera contains lactose and sunset yellow aluminium lake (E110)

Tell your doctor if you are lactose intolerant or intolerant to other sugars.

Eviplera

contains lactose monohydrate. If you are lactose-intolerant, or if you have been told that you

have an intolerance to other sugars, talk to your doctor before taking this medicine.

Tell your doctor if you have an allergy to sunset yellow aluminium lake (E110).

Eviplera

contains sunset yellow aluminium lake also called “E110” which may cause allergic reactions.

3.

How to take Eviplera

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist

if you are not sure.

The usual dose is one tablet taken each day by mouth. The tablet must be taken with food.

This

is important to get the right levels of active substance in your body. A nutritional drink alone does not

replace food.

Swallow the tablet whole with water.

Do not chew, crush or split the tablet

– if you do it may affect the way the medicine is released into

your body.

If your doctor decides to stop one of the components of Eviplera or change the dose of Eviplera, you

may be given emtricitabine, rilpivirine and/or tenofovir disoproxil separately or with other medicines

for the treatment of HIV infection.

If you are taking an antacid

such

medicines containing magnesium or potassium. Take it at least

2 hours before or at least 4 hours after Eviplera.

If you are taking an H

2

-antagonist

such as famotidine, cimetidine, nizatidine or ranitidine. Take it at

least 12 hours before or at least 4 hours after Eviplera. H

-antagonists can only be taken once a day if

you take Eviplera. H

-antagonists should not be taken twice a day. Talk to your doctor about an

alternative regimen.

If you are taking rifabutin

. Your doctor may need to give you an additional dose of rilpivirine.

Take the rilpivirine tablet at the same time you take Eviplera. Check with your doctor or pharmacist if

you are not sure.

If you take more Eviplera than you should

If you accidentally take more than the recommended dose of Eviplera you may be at increased risk of

experiencing possible side effects with this medicine (

see section 4 Possible side effects

Contact your doctor or nearest emergency department immediately for advice. Keep the tablet bottle

with you so that you can easily describe what you have taken.

If you forget to take Eviplera

It is important not to miss a dose of Eviplera.

If you do miss a dose:

If you notice within 12 hours

of the time you usually take Eviplera, you must take the tablet as

soon as possible. Always take the tablet with food. Then take the next dose as usual.

If you notice after 12 hours or more

of the time you usually take Eviplera, then do not take

the missed dose. Wait and take the next dose, with food, at your usual time.

If you vomit less than 4 hours after taking Eviplera,

take another tablet with food.

If you vomit

more than 4 hours after taking Eviplera

you do not need to take another tablet until your next

regularly scheduled tablet.

Do not stop taking Eviplera

Do not stop taking Eviplera without talking to your doctor.

Stopping Eviplera can seriously affect

your response to future treatment. If Eviplera for any reason is stopped, speak to your doctor before

you restart taking Eviplera tablets. Your doctor may consider giving you the components of Eviplera

separately if you are having problems or need your dose adjusted.

When your supply of Eviplera starts to run low,

get more from your doctor or pharmacist. This is

very important because the amount of virus may start to increase if the medicine is stopped for even a

short time. The virus may then become harder to treat.

If you have HIV infection and hepatitis B,

it is especially important not to stop your Eviplera

treatment without talking to your doctor first. Some patients have had blood tests or symptoms

indicating that their hepatitis has got worse after stopping emtricitabine or tenofovir disoproxil (two of

the three active substances of Eviplera). If Eviplera is stopped your doctor may recommend that you

resume hepatitis B treatment. You may need blood tests to check how your liver is working for

4 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.

4.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Possible side effects: tell a doctor immediately

Lactic acidosis

(excess lactic acid in the blood) is a rare but potentially life-threatening side

effect of some HIV medicines. 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

Tiredness or drowsiness

Feeling sick (

nausea

), being sick (

vomiting

Stomach pain

If you think you may have lactic acidosis, tell your doctor immediately.

Any signs of inflammation or infection.

In some patients with advanced HIV infection (AIDS) and

a history of 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 are due to an improvement in the body’s

immune response, enabling the body to fight infections that may have been present with no obvious

symptoms.

In addition to the opportunistic infections, autoimmune disorders (a condition that occurs when the

immune system attacks healthy body tissue) may also occur after you start taking medicines for the

treatment of your HIV infection. Autoimmune disorders may occur many months after the start of

treatment. If you notice 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, please inform your doctor immediately to seek necessary treatment.

If you notice any symptoms of inflammation or infection, tell your doctor immediately.

Very common side effects

(may affect more than 1 in 10 people)

Diarrhoea, being sick (

vomiting

), feeling sick (

nausea

Difficulty sleeping (

insomnia

Dizziness, headache

Rash

Feeling weak

Tests may also show:

Decreases in phosphate levels in the blood

Increased levels of creatine kinase in the blood that may result in muscle pain and weakness

Increased levels of cholesterol and/or pancreatic amylase in the blood

Increased levels of liver enzymes in the blood

If any of the side effects get serious tell your doctor.

Common side effects

(may affect up to 1 in 10 people)

Decreased appetite

Depression and depressed mood

Tiredness, feeling sleepy (somnolence)

Drowsiness

Pain, stomach pain or discomfort, feeling bloated, dry mouth

Abnormal dreams, sleep disorders

Problems with digestion resulting in discomfort after meals, wind (

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)

Low platelet count (a type of blood cell involved in clotting blood)

Decrease in haemoglobin in your blood (low red blood cell count)

Increased fatty acids (

triglycerides

), bilirubin or sugar in the blood

Pancreas problems

If any of the side effects get serious tell your doctor.

Uncommon side effects

may affect up to 1 in 100 people

Anaemia (low red blood cell count)

Pain in the abdomen (tummy) caused by inflammation of the pancreas

Breakdown of muscle, muscle pain or weakness

Swelling of the face, lips, tongue or throat

Signs or symptoms of inflammation or infection

Severe skin reactions including rash accompanied by fever, swelling and liver problems

Damage to kidney tubule cells

Tests may also show:

Decreases in potassium in the blood

Increases in creatinine in your blood

Changes to your urine

If any of the side effects get serious tell your doctor.

Rare side effects

may affect up to 1 in 1,000 people

Lactic acidosis (see

Possible side effects: tell a doctor immediately

Back pain caused by kidney problems, including kidney failure. Your doctor may do blood

tests to see if your kidneys are working properly

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

Softening of the bones (with bone pain and sometimes resulting in fractures)

The 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 may

occur due to damage to kidney tubule cells.

If any of the side effects get serious tell your doctor.

Other effects that may be seen during HIV treatment

The frequency of the following side effects is not known (frequency cannot be estimated from the

available data).

Bone problems.

Some patients taking combination antiretroviral medicines such as Eviplera

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 a very weak immune system, and 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 HIV therapy 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.

Reporting of side effects

If you get 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 the national reporting system

listed in Appendix V. By reporting side effects you can help provide more information on the safety

of this medicine.

5.

How to store Eviplera

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 bottle and carton after {EXP}.

The expiry date refers to the last day of that month.

Store in the original package in order to protect from moisture. Keep the bottle tightly closed.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to

throw away medicines you no longer use. These measures will help protect the environment.

6.

Contents of the pack and other information

What Eviplera contains

The active substances are

emtricitabine, rilpivirine

tenofovir disoproxil

. Each Eviplera

film-coated tablet contains 200 mg of emtricitabine, 25 mg of rilpivirine (as hydrochloride) and

245 mg of tenofovir disoproxil (as fumarate).

The other ingredients are:

Tablet core:

Microcrystalline cellulose, lactose monohydrate, povidone, pregelatinised maize starch,

polysorbate 20, croscarmellose sodium, and magnesium stearate.

Film-coating:

Hypromellose, indigo carmine aluminium lake, lactose monohydrate, polyethylene glycol, red

iron oxide, sunset yellow aluminium lake (E110), titanium dioxide, and triacetin.

What Eviplera looks like and contents of the pack

Eviplera is a purplish-pink, capsule-shaped, film-coated tablet debossed on one side with “GSI” and

plain on the other side. Eviplera comes in bottles of 30 tablets and in packs made up of 3 bottles, each

containing 30 tablets. Each bottle contains a silica gel desiccant that must be kept in the bottle to help

protect your tablets. The silica gel desiccant is contained in a separate sachet or canister and should

not be swallowed.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Gilead Sciences Ireland UC

Carrigtohill

County Cork, T45 DP77

Ireland

Manufacturer

Gilead Sciences Ireland UC

IDA Business & Technology Park

Carrigtohill

County Cork

Ireland

For any information about this medicine, please contact the local representative of the Marketing

Authorisation Holder:

België/Belgique/Belgien

Gilead Sciences Belgium SPRL-BVBA

Tél/Tel: + 32 (0) 24 01 35 50

Lietuva

Gilead Sciences Poland Sp. z o.o.

Tel: +48 22 262 8702

България

Gilead Sciences Ireland UC

Тел.: + 353 (0) 1 686 1888

Luxembourg/Luxemburg

Gilead Sciences Belgium SPRL-BVBA

Tél/Tel: + 32 (0) 24 01 35 50

Česká republika

Gilead Sciences s.r.o.

Tel: + 420 (0) 910 871 986

Magyarország

Gilead Sciences Ireland UC

Tel: + 353 (0) 1 686 1888

Danmark

Gilead Sciences Sweden AB

Tlf: + 46 (0) 8 5057 1849

Malta

Gilead Sciences Ireland UC

Tel: + 353 (0) 1 686 1888

Deutschland

Gilead Sciences GmbH

Tel: + 49 (0) 89 899890-0

Nederland

Gilead Sciences Netherlands B.V.

Tel: + 31 (0) 20 718 36 98

Eesti

Gilead Sciences Poland Sp. z o.o.

Tel: +48 22 262 8702

Norge

Gilead Sciences Sweden AB

Tlf: + 46 (0) 8 5057 1849

Ελλάδα

Gilead Sciences Ελλάς Μ.ΕΠΕ.

Τηλ: + 30 (0) 210 8930 100

Österreich

Gilead Sciences GesmbH

Tel: + 43 (0) 1 260 830

España

Gilead Sciences, S.L.

Tel: + 34 (0) 91 378 98 30

Polska

Gilead Sciences Poland Sp. z o.o.

Tel: +48 22 262 8702

France

Gilead Sciences

Tél: + 33 (0) 1 46 09 41 00

Portugal

Gilead Sciences, Lda.

Tel: + 351 (0) 21 7928790

Hrvatska

Gilead Sciences Ireland UC

Tel: + 353 (0) 1 686 1888

România

Gilead Sciences Ireland UC

Tel: + 353 (0) 1 686 1888

Ireland

Gilead Sciences Ireland UC

Tel: +353 (0) 214 825 999

Slovenija

Gilead Sciences Ireland UC

Tel: + 353 (0) 1 686 1888

Ísland

Gilead Sciences Sweden AB

Sími: + 46 (0) 8 5057 1849

Slovenská republika

Gilead Sciences Slovakia s.r.o.

Tel: + 421 (0) 232 121 210

Italia

Gilead Sciences S.r.l.

Tel: + 39 (0) 02 439201

Suomi/Finland

Gilead Sciences Sweden AB

Puh/Tel: + 46 (0) 8 5057 1849

Κύπρος

Gilead Sciences Ελλάς Μ.ΕΠΕ.

Τηλ: + 30 (0) 210 8930 100

Sverige

Gilead Sciences Sweden AB

Tel: + 46 (0) 8 5057 1849

Latvija

Gilead Sciences Poland Sp. z o.o.

Tel: +48 22 262 8702

United Kingdom

Gilead Sciences Ltd.

Tel: + 44 (0) 8000 113 700

This leaflet was last revised in .

Detailed information on this medicine is available on the European Medicines Agency web site:

http://www.ema.europa.eu/.