Celsentri

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  • Celsentri
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Staðsetning

  • Fáanlegt í:
  • Celsentri
    Evrópusambandið
  • Tungumál:
  • enska

Meðferðarupplýsingar

  • Meðferðarhópur:
  • Antivirals for systemic use,
  • Lækningarsvæði:
  • HIV Infections
  • Ábendingar:
  • Celsentri, in combination with other antiretroviral medicinal products, is indicated for treatment experienced adults, adolescents and children of 2 years of age and older and weighing at least 10 kg infected with only CCR5-tropic HIV-1 detectable
  • Vörulýsing:
  • Revision: 22

Staða

  • Heimild:
  • EMA - European Medicines Agency
  • Leyfisstaða:
  • Authorised
  • Leyfisnúmer:
  • EMEA/H/C/000811
  • Leyfisdagur:
  • 17-09-2007
  • EMEA númer:
  • EMEA/H/C/000811
  • Síðasta uppfærsla:
  • 29-03-2019

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© European Medicines Agency, 2017. Reproduction is authorised provided the source is acknowledged.

EMA/288232/2017

EMEA/H/C/000811

EPAR summary for the public

Celsentri

maraviroc

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

Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is

not intended to provide practical advice on how to use Celsentri.

For practical information about using Celsentri, patients should read the package leaflet or contact

their doctor or pharmacist.

What is Celsentri and what is it used for?

Celsentri is an HIV medicine used to treat patients from 2 years of age and weighing at least 10 kg

who are infected with human immunodeficiency virus type 1 (HIV-1), a virus that causes acquired

immune deficiency syndrome (AIDS).

Celsentri is used in combination with other HIV medicines, and only in patients who have been treated

for HIV infection before and only when the HIV-1 they are infected with is ‘CCR5-tropic’, which is

determined by a blood test. This means that the virus, when infecting a cell, attaches to a specific

protein called CCR5 on the surface of the cell.

Celsentri contains the active substance maraviroc.

How is Celsentri used?

Celsentri can only be obtained with a prescription and treatment should be started by a doctor who has

experience in the management of HIV infection. Before treatment, the doctor must check that the

patient’s blood only shows infection with CCR5-tropic virus.

Celsentri is available as tablets (25, 75, 150 and 300 mg) and as a liquid (20 mg/ml) to be taken by

mouth. In adults, the recommended dose is 150, 300 or 600 mg twice a day, depending on the other

medicines that the patient is taking. In children, the dose is based on body weight. Patients who have

reduced kidney function may need to take Celsentri less frequently.

Celsentri

EMA/288232/2017

Page 2/3

For further information, see the package leaflet.

How does Celsentri work?

The active substance in Celsentri, maraviroc, is a ‘CCR5 antagonist’. It blocks the CCR5 protein on the

surface of the cells in the body that HIV infects. CCR5-tropic HIV uses this protein to enter the cells. By

attaching itself to the protein, Celsentri prevents the virus from entering the cells. As HIV can only

reproduce itself within cells, Celsentri, taken in combination with other HIV medicines, reduces the

level of CCR5-tropic HIV, and keeps it at a low level. Celsentri cannot work against viruses that attach

to another protein called CXCR4, or when it can attach to both CCR5 and CXCR4.

Celsentri does not cure HIV infection or AIDS, but it may hold off the damage to the immune system

and the development of infections and diseases associated with AIDS.

What benefits of Celsentri have been shown in studies?

Celsentri has been shown to be effective at reducing the levels of HIV in the blood in two main studies

involving a total of 1,076 mostly adult patients with CCR5-tropic HIV infection. In the studies Celsentri

was compared with placebo (a dummy treatment). The patients had previously taken other treatments

for HIV for at least six months, but these had stopped working. All of the patients also took ‘optimised

background therapy’ (a combination of other HIV medicines chosen for each patient to increase the

chances of reducing the levels of HIV in the blood).

Looking at the results of the two studies taken together, the levels of HIV in the blood had fallen by an

average of 99% after 24 weeks in the patients adding Celsentri to optimised background therapy,

compared with 90% in those adding placebo. The proportion of patients who had undetectable levels of

HIV in their blood after 24 weeks was about 45% with Celsentri compared to 23% with placebo.

Similar results were also seen when looking at the patients who continued treatment with Celsentri 300

mg twice a day for 48 weeks.

Additional data indicate that Celsentri given at a suitable dose to children is handled by their body in

the same way as in adults. Based on these data, effectiveness is expected to be similar in children and

adults.

What are the risks associated with Celsentri?

The most common side effects with Celsentri (which may affect up to 1 in 10 people) are nausea

(feeling sick), diarrhoea, fatigue (tiredness) and headache. For the full list of all side effects reported

with Celsentri, see the package leaflet.

Celsentri tablets must not be used in patients who are hypersensitive (allergic) to peanut and soya. For

the full list of restrictions, see the package leaflet.

Why is Celsentri approved?

Celsentri used in combination with other HIV medicines has been shown to be effective at reducing the

levels of HIV in the blood in adults, and similar effects are expected in children. The safety profile of

Celsentri is considered acceptable and no major concerns have been identified.

The Agency’s Committee for Medicinal Products for Human Use (CHMP) therefore decided that

Celsentri’s benefits are greater than its risks and recommended that it be given marketing

authorisation.

Celsentri

EMA/288232/2017

Page 3/3

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

Celsentri?

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

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

package leaflet.

Other information about Celsentri

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

Celsentri on 18 September 2007.

The full EPAR for Celsentri 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 Celsentri,

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

This summary was last updated in 05-2017.

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

B. PACKAGE LEAFLET

Package leaflet: information for the user

CELSENTRI 25 mg film-coated tablets

CELSENTRI 75 mg film-coated tablets

CELSENTRI 150 mg film-coated tablets

CELSENTRI 300 mg film-coated tablets

maraviroc

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 CELSENTRI is and what it is used for

What you need to know before you take CELSENTRI

How to take CELSENTRI

Possible side effects

How to store CELSENTRI

Contents of the pack and other information

1.

What CELSENTRI is and what it is used for

CELSENTRI contains a medicine called maraviroc. Maraviroc belongs to a group of medicines

called

CCR5 antagonists

. CELSENTRI works by blocking a receptor called CCR5 which HIV uses

to enter and infect your blood cells.

CELSENTRI is used to treat Human Immunodeficiency Virus type-1 (HIV-1) in adults,

adolescents and children of 2 years and older, and weighing at least 10 kg.

CELSENTRI must be taken in combination with other medicines which are also used to treat the

HIV infection. These medicines are all called

anti-HIV medicines

antiretrovirals

CELSENTRI, as part of combination therapy, reduces the amount of virus in your body, and keeps

it at a low level. This helps your body to increase the CD4 cell count in your blood. CD4 cells are a

type of white blood cell that are important in helping your body to fight infection.

2

What you need to know before you take CELSENTRI

Do not take CELSENTRI:

if you (or your child, if they are the patient) are allergic to maraviroc or to peanut or soya or to

any of the other ingredients of CELSENTRI

(listed in section 6 ).

Check with your doctor if you think this applies to you or your child.

Warnings and precautions

Your doctor must take blood samples to test whether CELSENTRI is an appropriate treatment for

you (or your child, if they are the patient).

Some people taking CELSENTRI have developed serious allergic reactions or skin reactions (

see

also ‘Serious side effects’ in section 4

Before taking this medicine, make sure that your doctor knows if you (or your child) have or in the

past had any of the following:

liver problems, including chronic hepatitis B or C. Only a limited number of people with liver

problems have taken CELSENTRI. Your liver function may need to be closely monitored.

(See also ‘Liver problems’ in section 4).

low blood pressure, including dizziness when you stand up or sit up quickly, or if you are

taking any medicines to lower blood pressure. This is due to a sudden fall in blood pressure. If

this happens, lie down until you (or your child) feel better. When getting up, do so as slowly as

possible.

tuberculosis (TB) or serious fungal infections. CELSENTRI could potentially increase your

risk of developing infections.

kidney problems. This is particularly important if you are also taking some other medicines

(see ‘Other medicines and CELSENTRI’ later in section 2).

problems with your heart or circulatory system. Only a limited number of people with

serious heart or circulatory problems have taken CELSENTRI.

Tell your doctor before starting treatment if you think any of these apply to you (or your

child).

Conditions you need to look out for

Some people taking medicines for HIV infection develop other conditions, which can be serious.

These include:

symptoms of infections and inflammation

joint pain, stiffness and bone problems

You need to know about important signs and symptoms to look out for while you’re taking

CELSENTRI.

Read the information ‘Other possible side effects of combination therapy for HIV’ in

Section 4 of this leaflet.

Protect other people

HIV infection is spread by sexual contact with someone who has the infection, or by transfer of

infected blood (for example, by sharing injection needles). You (or your child) can still pass on

HIV when taking this medicine, although the risk is lowered by effective treatment.

Talk to your doctor about how to avoid infecting other people.

Older people

CELSENTRI has only been taken by limited numbers of people 65 years or older. If you belong to

this age group, discuss with your doctor if you can use CELSENTRI.

Children

The use of CELSENTRI has not been tested in children under the age of 2 or weighing less than 10

kg . Therefore CELSENTRI is not recommended in children younger than 2, or weighing less than

10 kg.

Other medicines and CELSENTRI

Tell your doctor or pharmacist if you (or your child) are taking, any other medicines, have

recently taken, or might take any other medicines.

Tell your doctor or pharmacist if you (or your child) begin taking a new medicine while taking

CELSENTRI.

Medicines containing St. John’s Wort (

Hypericum perforatum

) are likely to prevent CELSENTRI

from working properly. You should not take them while you’re taking CELSENTRI.

Some medicines may change the amount of CELSENTRI in the body when they are taken at the

same time as CELSENTRI. These include:

other medicines to treat HIV or hepatitis C infection (such as atazanavir, cobicistat, darunavir,

efavirenz, etravirine, fosamprenavir, indinavir, lopinavir, nelfinavir, ritonavir, saquinavir,

boceprevir, telaprevir)

antibiotics (clarithromycin, telithromycin, rifampicin, rifabutin)

antifungal medicines (ketoconazole, itraconazole, fluconazole)

anticonvulsant medicines (carbamazepine, phenytoin, phenobarbital).

Tell your doctor if you (or your child) are taking any of these medicines. This will allow your

doctor to prescribe the right dose of CELSENTRI.

Pregnancy

If you are pregnant, if you become pregnant, or if you are planning to have a baby:

Talk to your doctor about the risks and benefits of taking CELSENTRI.

Breast-feeding

Women who are HIV-positive must not breast-feed, because HIV infection can be passed on to

the baby in breast milk.

It is not known whether the ingredients in CELSENTRI can also pass into breast milk. If you are

breast-feeding, or thinking about breast-feeding:

Talk to your doctor immediately.

Driving and using machines

CELSENTRI can make you dizzy.

Do not drive, cycle, or operate tools or machines unless you are sure you’re not affected.

CELSENTRI contains soya lecithin.

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

3.

How to take CELSENTRI

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

pharmacist if you are not sure.

Your doctor will advise you whether it is better to take CELSENTRI oral solution, if you (or your

child) are unable to swallow tablets.

How much to take

Adults

The recommended dose of CELSENTRI

is 150 mg, 300 mg or 600 mg twice per day depending

on other medicines that you are taking at the same time. Always take the dose recommended by

your doctor.

People with kidney problems

If you have a kidney problem, your doctor may alter your dose.

Talk to your doctor if this applies to you.

Adolescents and children from 2 years of age and weighing at least 10 kg

Your doctor will decide the correct dose of CELSENTRI based on weight and on other medicines

being taken at the same time.

CELSENTRI can be taken with or without food. CELSENTRI should always be taken by

mouth.

CELSENTRI must be taken in combination with other medicines to treat HIV. Refer to the

Package Leaflets of these other medicines for guidance on how to take them.

If you take or give more CELSENTRI than you should

If you accidentally take or give too much CELSENTRI:

Contact your doctor or the nearest hospital immediately.

If you forget to take or give CELSENTRI

If you (or your child) miss a dose of CELSENTRI, take or give the missed dose as soon as possible

and then continue with the next dose at its regular time.

If it is almost time for the next dose, do not take or give the missed dose. Wait for the next dose at

its regular time.

Do not take or give a double dose to make up for a forgotten dose.

If you or your child stop taking CELSENTRI

Keep taking CELSENTRI until your doctor tells you to stop.

Taking your medicines at the right time every day is important, as it makes sure the HIV infection

does not increase in your body. Therefore, unless your doctor tells you (or your child) to stop

treatment, it is important to keep taking CELSENTRI correctly, as described above.

If you have any further questions on the use of this medicine, ask your doctor or your pharmacist.

4.

Possible side effects

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

your doctor if you notice anything unusual about your own health or your child’s health.

Serious side effects — get medical help immediately

Serious allergic or skin reactions

Some people taking CELSENTRI have developed severe and life-threatening skin reactions and

allergic reactions. These are rare, and may affect up to 1 in 1,000 people taking CELSENTRI.

If you get any of the following symptoms while you’re taking CELSENTRI :

swelling of the face, lips or tongue

difficulty breathing

widespread skin rash

fever (high temperature)

blisters and peeling skin, particularly around the mouth, nose, eyes and genitals.

Get medical help immediately if you get these symptoms. Stop taking CELSENTRI.

Liver problems

These are rare, and may affect up to 1 in 1,000 people taking CELSENTRI.

Signs include:

loss of appetite

feeling sick or being sick

yellowing of skin or eyes

skin rash or itching

feeling very tired

stomach pain or tenderness

dark urine

drowsiness and confusion

fever (high temperature).

Contact a doctor immediately if you get these symptoms. Stop taking CELSENTRI.

Other side effects

Common side effects

These may affect 1 to 10 in 100 people:

diarrhoea, feeling sick, stomach ache, wind (

flatulence

loss of appetite

headache, problems sleeping,depression

rash

(see also ‘Serious allergic or skin reactions’ earlier in section 4)

feeling weak or lack of energy, anaemia (seen in blood test result)

increase in liver enzymes (seen in blood test results), which can be a sign of liver problems

(see

also ‘Liver problems’ earlier in section 4)

Uncommon side effects

These may affect up to 1 in 100 people:

lung infection

fungal infection of the gullet

(oesophagus)

fits

(seizures)

feeling dizzy, faint or light headed when standing up

kidney failure, protein in the urine

an increase in a substance known as CPK (seen in blood test results) which is a sign that

muscles are inflamed or damaged.

Rare side effects

These may affect up to 1 in 1,000 people:

chest pain (caused by reduced blood flow to the heart)

decrease in muscle size

some types of cancer, such as of the gullet

(oesophagus)

and bile duct

decrease in number of blood cells (seen in blood test results).

Other possible side effects of combination therapy for HIV

People taking combination therapy for HIV may get other side effects.

Symptoms of infection and inflammation

People with advanced HIV infection (AIDS) have weak immune systems, and are more likely to

develop serious infections

(opportunistic infections)

. When they start treatment, the immune

system becomes stronger, so the body starts to fight infections.

Symptoms of infection and inflammation

may develop, caused by either:

old, hidden infections flaring up again as the body fights them

the immune system attacking healthy body tissue

(autoimmune disorders).

The symptoms of autoimmune disorders

may develop many months after you start taking

medicine to treat your HIV infection. Symptoms may include:

muscle weakness

weakness beginning in the hands and feet and moving up towards the trunk of the body

palpitations or tremor

hyperactivity (excessive restlessness and movement).

If you get any symptoms of infection or if you notice any of the symptoms above:

Tell your doctor immediately. Don’t take other medicines for the infection without your

doctor’s advice.

Joint pain, stiffness and bone problems

Some people taking combination therapy for HIV develop a condition called

osteonecrosis

. With

this condition, parts of the bone tissue die because of reduced blood supply to the bone.

It is not known how common this condition is. You may be more likely to develop it:

if you have been taking combination therapy for a long time

if you are also taking anti-inflammatory medicines called corticosteroids

if you drink alcohol

if you have a very weak immune system

if you are overweight.

Signs to look out for include:

stiffness in the joints

aches and pains (especially in the hip, knee or shoulder)

difficulty moving.

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 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 CELSENTRI

Keep out of the sight and reach of children.

Do not use CELSENTRI after the expiry date which is stated on the carton, blister or bottle label.

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

This medicine does not require any special storage conditions.

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 to protect the environment.

6.

Contents of the pack and other information

What CELSENTRI contains

The active ingredient in CELSENTRI is maraviroc. Each film-coated tablet contains 25 mg, 75

mg, 150 mg or 300 mg of maraviroc.

The other ingredients are:

Tablet core: cellulose microcrystalline, calcium hydrogen phosphate anhydrous, sodium

starch glycolate, magnesium stearate

Film-coat: poly (vinyl alcohol), titanium dioxide (E171), macrogol 3350, talc, soya lecithin,

indigo carmine aluminium lake (E132).

What CELSENTRI looks like and contents of the pack

CELSENTRI film-coated tablets are blue coloured with “MVC 25”, “MVC 75”, “MVC 150” or

“MVC 300”.

CELSENTRI 25 mg and 75 mg film-coated tablets are supplied in bottles of 120 tablets.

CELSENTRI 150 mg and 300 mg film-coated tablets are supplied in bottles of 180 tablets or in

blister packs of 30, 60, 90 film-coated tablets and multipacks containing 180 (2 packs of 90) film-

coated tablets.

Not all pack sizes may be marketed in all countries.

Marketing Authorisation Holder

ViiV Healthcare BV, Huis ter Heideweg 62, 3705 LZ Zeist, Netherlands.

Manufacturer

Pfizer Manufacturing Deutschland GmbH, Betriebsstātte Freiburg, Mooswaldallee 1, 79090

Freiburg, Germany.

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

Authorisation Holder:

België/Belgique/Belgien

ViiV Healthcare sprl/bvba .

Tél/Tel: + 32 (0) 10 85 65 00

Lietuva

GlaxoSmithKline Lietuva UAB

Tel: + 370 5 264 90 00

info.lt@gsk.com

България

ГлаксоСмитКлайн ЕООД

Teл.: + 359 2 953 10 34

Luxembourg/Luxemburg

ViiV Healthcare sprl/bvba

Belgique/Belgien

Tél/Tel: + 32 (0) 10 85 65 00

Česká republika

GlaxoSmithKline s.r.o.

Tel: + 420 222 001 111

cz.info@gsk.com

Magyarország

GlaxoSmithKline Kft.

Tel.: + 36 1 225 5300

Danmark

GlaxoSmithKline Pharma A/S

Tlf: + 45 36 35 91 00

dk-info@gsk.com

Malta

GlaxoSmithKline Malta

Tel: + 356 21 238131

Deutschland

ViiV Healthcare GmbH

Tel.: + 49 (0)89 203 0038-10

viiv.med.info@viivhealthcare.com

Nederland

ViiV Healthcare BV

Tel: + 31 (0)30 6986060

contact-nl@viivhealthcare.com

Eesti

GlaxoSmithKline Eesti OÜ

Tel: + 372 6676 900

estonia@gsk.com

Norge

GlaxoSmithKline AS

Tlf: + 47 22 70 20 00

Ελλάδα

GlaxoSmithKline A.E.B.E.

Τηλ: + 30 210 68 82 100

Österreich

GlaxoSmithKline Pharma GmbH

Tel: + 43 (0)1 97075 0

at.info@gsk.com

España

Laboratorios ViiV Healthcare, S.L.

Tel: + 34 902 051 260

es-ci@viivhealthcare.com

Polska

GSK Services Sp. z o.o.

Tel.: + 48 (0)22 576 9000

France

ViiV Healthcare SAS

Tél.: + 33 (0)1 39 17 6969

Infomed@viivhealthcare.com

Portugal

VIIVHIV HEALTHCARE, UNIPESSOAL, LDA.

Tel: + 351 21 094 08 01

viiv.fi.pt@viivhealthcare.com

Hrvatska

GlaxoSmithKline d.o.o.

Tel: + 385 1 6051 999

România

GlaxoSmithKline (GSK) S.R.L.

Tel: + 4021 3028 208

Ireland

GlaxoSmithKline (Ireland) Limited

Tel: + 353 (0)1 4955000

Slovenija

GlaxoSmithKline d.o.o.

Tel: + 386 (0)1 280 25 00

medical.x.si@gsk.com

Ísland

Vistor hf.

Sími: + 354 535 7000

Slovenská republika

GlaxoSmithKline Slovakia s. r. o.

Tel: + 421 (0)2 48 26 11 11

recepcia.sk@gsk.com

Italia

ViiV Healthcare S.r.l.

Tel: + 39 (0)45 9212611

Suomi/Finland

GlaxoSmithKline Oy

Puh/Tel: + 358 (0)10 30 30 30

Finland.tuoteinfo@gsk.com

Κύπρος

GlaxoSmithKline (Cyprus) Ltd

Τηλ: + 357 22 39 70 00

gskcyprus@gsk.com

Sverige

GlaxoSmithKline AB

Tel: + 46 (0)8 638 93 00

info.produkt@gsk.com

Latvija

GlaxoSmithKline Latvia SIA

Tel: + 371 67312687

lv-epasts@gsk.com

United Kingdom

ViiV Healthcare UK Ltd

Tel: + 44 (0)800 221441

customercontactuk@gsk.com

This leaflet was last revised in

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

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

Package leaflet: information for the user

CELSENTRI 20 mg /ml oral solution

maraviroc

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 CELSENTRI is and what it is used for

What you need to know before you take CELSENTRI

How to take CELSENTRI

Possible side effects

How to store CELSENTRI

Contents of the pack and other information

1.

What CELSENTRI is and what it is used for

CELSENTRI contains a medicine called maraviroc. Maraviroc belongs to a group of medicines

called CCR5 antagonists. CELSENTRI works by blocking a receptor called CCR5 which HIV uses

to enter and infect your blood cells.

CELSENTRI is used to treat Human Immunodeficiency Virus type-1 (HIV-1) in adults,

adolescents and children of 2 years and older, and weighing at least 10 kg.

CELSENTRI must be taken in combination with other medicines which are also used to treat the

HIV infection. These medicines are all called

anti-HIV medicines or antiretrovirals

CELSENTRI, as part of combination therapy, reduces the amount of virus in your body, and keeps

it at a low level. This helps your body to increase the CD4 cell count in your blood. CD4 cells are a

type of white blood cell that are important in helping your body to fight infection.

2

What you need to know before you take CELSENTRI

Do not take CELSENTRI:

if you (or your child, if they are the patient) are allergic to maraviroc or to any of the other

ingredients of CELSENTRI (

listed in section 6

Check with your doctor if you think this applies to you or your child.

Warnings and precautions

Your doctor must take blood samples to test whether CELSENTRI is an appropriate treatment for

you (or your child, if they are the patient).

Some people taking CELSENTRI have developed serious allergic reactions or skin reactions (

see

also ‘Serious side effects’ in section 4

Before taking this medicine, make sure that your doctor knows if you (or your child) have or in the

past had any of the following:

liver problems, including chronic hepatitis B or C. Only a limited number of people with liver

problems have taken CELSENTRI. Your liver function may need to be closely monitored.

(See

also ‘Liver problems’ in section 4).

low blood pressure, including dizziness when you stand up or sit up quickly, or if you are

taking any medicines to lower blood pressure. This is due to a sudden fall in blood pressure. If

this happens, lie down until you (or your child) feel better. When getting up, do so as slowly as

possible.

tuberculosis (TB) or serious fungal infections. CELSENTRI could potentially increase your

risk of developing infections.

kidney problems. This is particularly important if you are also taking some other medicines

(see

‘Other medicines and CELSENTRI’ later in section 2).

problems with your heart or circulatory system. Only a limited number of people with

serious heart or circulatory problems have taken CELSENTRI.

Tell your doctor before starting treatment if you think any of these apply to you (or your

child).

Conditions you need to look out for

Some people taking medicines for HIV infection develop other conditions, which can be serious.

These include:

symptoms of infections and inflammation

joint pain, stiffness and bone problems.

You need to know about important signs and symptoms to look out for while you’re taking

CELSENTRI.

Read the information ‘Other possible side effects of combination therapy for HIV’ in

Section 4 of this leaflet.

Protect other people

HIV infection is spread by sexual contact with someone who has the infection, or by transfer of

infected blood (for example, by sharing injection needles). You (or your child) can still pass on

HIV when taking this medicine, although the risk is lowered by effective treatment.

Talk to your doctor about how to avoid infecting other people.

Older people

CELSENTRI has only been taken by limited numbers of people 65 years or older. If you belong to

this age group, discuss with your doctor if you can use CELSENTRI.

Children

CELSENTRI has not been tested in children under the age of 2 or weighing less than 10 kg.

Therefore CELSENTRI is not recommended for children younger than 2 years, or weighing less

than 10 kg.

Other medicines and CELSENTRI

Tell your doctor or pharmacist if you (or your child) are taking any other medicines,have

recently taken, or might take any other medicines.

Tell your doctor or pharmacist if you (or your child) begin taking a new medicine while taking

CELSENTRI.

Medicines containing St. John’s Wort (

Hypericum perforatum

) are likely to prevent CELSENTRI

from working properly. You should not take them while you’re taking CELSENTRI.

Some medicines may change the amount of CELSENTRI in the body when they are taken at the

same time as CELSENTRI. These include:

other medicines to treat HIV or hepatitis C infection (such as atazanavir, cobicistat, darunavir,

efavirenz, etravirine, fosamprenavir, indinavir, lopinavir, nelfinavir, ritonavir, saquinavir,

boceprevir, telaprevir)

antibiotics (clarithromycin, telithromycin, rifampicin, rifabutin)

antifungal medicines (ketoconazole, itraconazole, fluconazole)

anticonvulsant medicines (carbamazepine, phenytoin, phenobarbital).

Tell your doctor if you (or your child) are taking any of these medicines. This will allow your

doctor to prescribe the right dose of CELSENTRI.

Pregnancy

If you are pregnant, if you become pregnant, or if you are planning to have a baby:

Talk to your doctor about the risks and benefits of taking CELSENTRI.

Breast-feeding

Women who are HIV-positive must not breast-feed, because HIV infection can be passed on to

the baby in breast milk.

It is not known whether the ingredients in CELSENTRI can also pass into breast milk. If you are

breast-feeding, or thinking about breast-feeding:

Talk to your doctor immediately.

Driving and using machines

CELSENTRI can make you dizzy.

Don’t drive, cycle, or operate tools or machines unless you are sure you’re not affected.

3.

How to take CELSENTRI

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

pharmacist if you are not sure.

Your doctor will advise you whether it is better to take CELSENTRI oral solution, if you (or your

child) are unable to swallow tablets.

How much to take

Adults

The recommended dose of CELSENTRI is either 150 mg (7.5 ml), 300 mg (15 ml) or 600 mg

(30 ml) twice daily, depending on other medicines that you are taking at the same time. Always

take the dose recommended by your doctor.

People with kidney problems

If you have a kidney problem, your doctor may alter your dose.

Talk to your doctor if this applies to you.

Adolescents and children from 2 years of age and weighing at least 10 kg

Your doctor will decide the correct dose of CELSENTRI, based on weight and on other medicines

being taken at the same time.

See the diagram and instructions at the end of this section for how to measure and take (or

give) a dose of medicine.

CELSENTRI can be taken with or without food. CELSENTRI should always be taken by

mouth.

CELSENTRI must be taken in combination with other medicines to treat HIV. Refer to the

Package Leaflets of these other medicines for guidance on how to take them.

If you take or give more CELSENTRI than you should

If you accidentally take or give too much CELSENTRI:

Contact your doctor or the nearest hospital immediately.

If you forget to take or give CELSENTRI

If you (or your child) miss a dose of CELSENTRI, take or give the missed dose as soon as possible

and then continue with the next dose at its regular time.

If it is almost time for the next dose, do not take or give the missed dose. Wait for the next dose at

its regular time.

Do not take or give a double dose to make up for a forgotten dose.

If you or your child stop taking CELSENTRI

Keep taking CELSENTRI until your doctor tells you to stop.

Taking your medicines at the right time every day is important as it makes sure the HIV infection

does not increase in your body. Therefore, unless your doctor tells you (or your child) to stop

treatment, it is important to keep taking CELSENTRI correctly, as described above.

If you have any further questions on the use of this medicine, ask your doctor or your pharmacist.

How to measure the dose and take the medicine

Use the oral applicator supplied with the pack to measure your dose accurately.

1. Remove the bottle cap (A). Keep it safely

2. Hold the bottle firmly. Push the plastic adapter (B) into the neck of the bottle so it is fully

inserted.

3. Insert the applicator (C) firmly into the adapter.

4. Turn the bottle upside down.

5. Pull out applicator plunger (D) until the applicator contains the first part of the full dose.

6. Turn the bottle the correct way up. Remove the applicator from the adapter.

7. Put the applicator into your (or your child’s) mouth, placing the tip of the applicator against

the inside of the cheek. Slowly push the plunger in, allowing time to swallow. Do not push too

hard and squirt the liquid into the back of the throat, as that could cause choking.

8. Repeat steps 3 to 7 in the same way until the whole dose has been taken. For example, if the

dose is 15 ml, you need one and a half applicator -full of medicine.

9. Remove and wash the applicator thoroughly in clean water once you have finished using it. Let

it dry completely before you use it again.

10. Close the bottle tightly with the cap, leaving the adaptor in place.

Dispose of any unused oral solution 60 days after first opening the bottle.

4.

Possible side effects

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

your doctor if you notice anything unusual about your own health or your child’s health.

Serious side effects — get medical help immediately

Serious allergic or skin reactions

Some people taking CELSENTRI have developed severe and life-threatening skin reactions and

allergic reactions. These are rare, and may affect up to 1 in 1,000 people taking CELSENTRI.

If you get any of the following symptoms while you’re taking CELSENTRI :

swelling of the face, lips or tongue

difficulty breathing

widespread skin rash

fever (high temperature)

blisters and peeling skin, particularly around the mouth, nose, eyes and genitals.

Get medical help immediately if you get these symptoms. Stop taking CELSENTRI.

Liver problems

These are rare, and may affect up to 1 in 1,000 people taking CELSENTRI.

Signs include:

loss of appetite

feeling sick or being sick

yellowing of skin or eyes

skin rash or itching

feeling very tired

stomach pain or tenderness

dark urine

drowsiness and confusion

fever (high temperature).

Contact a doctor immediately if you get these symptoms. Stop taking CELSENTRI.

Other side effects

Common side effects

These may affect 1 to 10 in 100 people:

diarrhoea, feelingsick, stomach ache, wind (

flatulence

loss of appetite

headache, problems sleeping, depression

rash

(see also ‘Serious allergic or skin reactions’ earlier in section 4)

feeling weak or lack of energy, anaemia (seen in blood test result)

increase in liver enzymes (seen in blood test results), which can be a sign of liver problems

(see

also ‘Liver problems’ earlier in section 4)

Uncommon side effects

These may affect up to 1 in 100 people:

lung infection

fungal infection of the gullet

(oesophagus)

fits

(seizures)

feeling dizzy, faint or light headed when standing up

kidney failure, protein in the urine

an increase in a substance known as CPK (seen in blood test results) which is a sign that

muscles are inflamed or damaged.

Rare side effects

These may affect up to 1 in 1,000 people:

chest pain (caused by reduced blood flow to the heart)

decrease in muscle size

some types of cancer, such as of the gullet

(oesophagus)

and bile duct

decrease in number of blood cells (seen in blood test results).

Other possible side effects of combination therapy for HIV

People taking combination therapy for HIV may get other side effects.

Symptoms of infection and inflammation

People with advanced HIV infection (AIDS) have weak immune systems, and are more likely to

develop serious infections

(opportunistic infections)

. When they start treatment, the immune

system becomes stronger, so the body starts to fight infections.

Symptoms of infection and inflammation

may develop, caused by either:

old, hidden infections flaring up again as the body fights them

the immune system attacking healthy body tissue

(autoimmune disorders).

The symptoms of autoimmune disorders

may develop many months after you start taking

medicine to treat your HIV infection. Symptoms may include:

muscle weakness

weakness beginning in the hands and feet and moving up towards the trunk of the body

palpitations or tremor

hyperactivity (excessive restlessness and movement).

If you get any symptoms of infection or if you notice any of the symptoms above:

Tell your doctor immediately. Don’t take other medicines for the infection without your

doctor’s advice.

Joint pain, stiffness and bone problems

Some people taking combination therapy for HIV develop a condition called

osteonecrosis

. With

this condition, parts of the bone tissue die because of reduced blood supply to the bone.

It is not known how common this condition is. You may be more likely to develop it:

if you have been taking combination therapy for a long time

if you are also taking anti-inflammatory medicines called corticosteroids

if you drink alcohol

if you have a very weak immune system

if you are overweight.

Signs to look out for include:

stiffness in the joints

aches and pains (especially in the hip, knee or shoulder)

difficulty moving.

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 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 CELSENTRI

Keep out of the sight and reach of children.

Do not use CELSENTRI after the expiry date which is stated on the bottle and carton label. The

expiry date refers to the last day of that month.

Store the oral solution below 30°C.

Discard 60 days after first opening.

Write the date the oral solution should be discarded on the

carton in the space provided.

The date should be written as soon as the bottle has been opened for

first use.

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 to protect the environment.

6.

Contents of the pack and other information

What CELSENTRI contains

The active substance in CELSENTRI oral solution is 20 mg of maraviroc in each ml of the

solution.

The other ingredients are: citric acid (anhydrous), sodium citrate dihydrate, sucralose, sodium

benzoate, strawberry flavouring (501440T), purified water

What CELSENTRI looks like and contents of the pack

CELSENTRI oral solution is supplied in a carton containing a high density polyethylene bottle,

with a child resistant cap. The solution is colourless with strawberry flavouring. The bottle contains

230 ml of maraviroc solution (20 mg/ml). The pack includes an oral applicator and a bottle-adapter,

which should be fitted in the bottle before use.

Marketing Authorisation Holder

ViiV Healthcare BV, Huis ter Heideweg 62, 3705 LZ Zeist, Netherlands.

Manufacturer

Pfizer Service Company, Hoge Wei 10, B 1930 Zaventem, Belgium

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

Authorisation Holder:

België/Belgique/Belgien

ViiV Healthcare sprl/bvba .

Tél/Tel: + 32 (0) 10 85 65 00

Lietuva

GlaxoSmithKline Lietuva UAB

Tel: + 370 5 264 90 00

info.lt@gsk.com

България

ГлаксоСмитКлайн ЕООД

Teл.: + 359 2 953 10 34

Luxembourg/Luxemburg

ViiV Healthcare sprl/bvba

Belgique/Belgien

Tél/Tel: + 32 (0) 10 85 65 00

Česká republika

GlaxoSmithKline s.r.o.

Tel: + 420 222 001 111

cz.info@gsk.com

Magyarország

GlaxoSmithKline Kft.

Tel.: + 36 1 225 5300

Danmark

GlaxoSmithKline Pharma A/S

Tlf: + 45 36 35 91 00

dk-info@gsk.com

Malta

GlaxoSmithKline Malta

Tel: + 356 21 238131

Deutschland

ViiV Healthcare GmbH

Tel.: + 49 (0)89 203 0038-10

viiv.med.info@viivhealthcare.com

Nederland

ViiV Healthcare BV

Tel: + 31 (0)30 6986060

contact-nl@viivhealthcare.com

Eesti

GlaxoSmithKline Eesti OÜ

Tel: + 372 6676 900

estonia@gsk.com

Norge

GlaxoSmithKline AS

Tlf: + 47 22 70 20 00

Ελλάδα

GlaxoSmithKline A.E.B.E.

Τηλ: + 30 210 68 82 100

Österreich

GlaxoSmithKline Pharma GmbH

Tel: + 43 (0)1 97075 0

at.info@gsk.com

España

Laboratorios ViiV Healthcare, S.L.

Tel: + 34 902 051 260

es-ci@viivhealthcare.com

Polska

GSK Services Sp. z o.o.

Tel.: + 48 (0)22 576 9000

France

ViiV Healthcare SAS

Tél.: + 33 (0)1 39 17 6969

Infomed@viivhealthcare.com

Portugal

VIIVHIV HEALTHCARE, UNIPESSOAL, LDA.

Tel: + 351 21 094 08 01

viiv.fi.pt@viivhealthcare.com

Hrvatska

GlaxoSmithKline d.o.o.

Tel: + 385 1 6051 999

România

GlaxoSmithKline (GSK) S.R.L.

Tel: + 4021 3028 208

Ireland

GlaxoSmithKline (Ireland) Limited

Tel: + 353 (0)1 4955000

Slovenija

GlaxoSmithKline d.o.o.

Tel: + 386 (0)1 280 25 00

medical.x.si@gsk.com

Ísland

Vistor hf.

Sími: + 354 535 7000

Slovenská republika

GlaxoSmithKline Slovakia s. r. o.

Tel: + 421 (0)2 48 26 11 11

recepcia.sk@gsk.com

Italia

ViiV Healthcare S.r.l.

Tel: + 39 (0)45 9212611

Suomi/Finland

GlaxoSmithKline Oy

Puh/Tel: + 358 (0)10 30 30 30

Finland.tuoteinfo@gsk.com

Κύπρος

GlaxoSmithKline (Cyprus) Ltd

Τηλ: + 357 22 39 70 00

gskcyprus@gsk.com

Sverige

GlaxoSmithKline AB

Tel: + 46 (0)8 638 93 00

info.produkt@gsk.com

Latvija

GlaxoSmithKline Latvia SIA

Tel: + 371 67312687

lv-epasts@gsk.com

United Kingdom

ViiV Healthcare UK Ltd

Tel: + 44 (0)800 221441

customercontactuk@gsk.com

This leaflet was last revised in

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

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