CELSENTRI 150 mg Film-Coated Tablets

Зміст інструкції

1. CELSENTRI 25 mg film-coated tablets, 75 mg film-coated tablets, 150 mg film-coated tablets, 300 mg film-coated tablets
   1. What is CELSENTRI and what it is used for
   2. What you need to know before taking CELSENTRI
   3. How to take CELSENTRI
   4. Possible side effects
   5. How to store CELSENTRI
   6. Package contents and other information
2. CELSENTRI 20 mg/mL oral solution
   1. What is CELSENTRI and what it is used for
   2. What you need to know before taking CELSENTRI
   3. How to take CELSENTRI
   4. Possible side effects
   5. How to store CELSENTRI
   6. Package contents and other information

CELSENTRI 25 mg film-coated tablets, 75 mg film-coated tablets, 150 mg film-coated tablets, 300 mg film-coated tablets

maraviroc

Read 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others even if their symptoms are the same as yours because it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What CELSENTRI is and what it is used for
• 2. What you need to know before you take CELSENTRI
• 3. How to take CELSENTRI
• 4. Possible side effects
• 5. How to store CELSENTRI
• 6. Contents of the pack and other information

1. What is CELSENTRI and what it is used for

CELSENTRI contains a medicine called maraviroc. Maraviroc belongs to a group of
medicines called CCR5 chemokine receptor antagonists of type 5. CELSENTRI
works by blocking the CCR5 receptor preventing the HIV virus from entering and infecting blood cells.

CELSENTRI is used to treat Human Immunodeficiency Virus type-1
(HIV-1) infection in adults, adolescents and children 2 years of age and older and weighing at least
10 kg.
CELSENTRI must be taken in combination with other medicines that are also used for the
treatment of HIV infection. These medicines are called anti-HIV or antiretroviral medicines.
CELSENTRI, as a component of combination therapy, reduces the amount of virus in the body and keeps
it at low levels. This helps the body increase the number of CD4 cells in the blood, a
type of white blood cells important in helping the body fight infection.

2. What you need to know before taking CELSENTRI

Do not take CELSENTRI

• if you (or your child, if they are the patient) are allergicto maraviroc, peanuts or soya or to any of the other ingredients of CELSENTRI ( listed in section 6). ➔ Speak to your doctorif you think this applies to you or your child.

Warnings and precautions
Talk to your doctor or pharmacist before taking or giving CELSENTRI.
Your doctor must take blood samples to check if CELSENTRI is a suitable treatment
for you (or for 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 your doctor knows if you (or your child) have or have
had in the past any of the following conditions:

• problems with the liver, including chronic hepatitisB or C. Only a limited number of people with liver problems have taken CELSENTRI. Your liver function may need to be carefully monitored. (See also ‘Liver problems’ in section 4).
• low blood pressure, including dizziness when getting up or sitting quickly, or if you are taking other medicines that lower blood pressure. This is due to a sudden drop in blood pressure. If this happens, lie down until you (or your child) feel better. When you get up, do so as slowly as possible.
• tuberculosis (TB)or serious fungal infections.CELSENTRI may potentially increase the risk of developing infections.
• problems with the kidneys. This is particularly importantif you are also taking certain other medicines ( see ‘Other medicines and CELSENTRI’ below in section 2).
• problems with the heartor circulatory system.Only a limited number of people with serious heart or circulatory problems have taken CELSENTRI. ➔ Speak to your doctorbefore starting treatment if you think any of these conditions apply to you (or your child).

Conditions for which you need to be careful
Some people who take medicines for HIV infection develop other conditions that can
be serious. These include:

• symptoms of infections and inflammation
• joint pain, stiffness and problems with bones You need to be informed about important signs and symptoms so that you can pay attention while taking CELSENTRI.

➔ Read the information in ‘Other possible side effects of combination therapy for
HIV’ in Section 4 of this leaflet.
Elderly people
CELSENTRI has only been taken by a limited number of people aged 65 years or over. If you belong to
this age group, discuss with your doctor whether you can take CELSENTRI.

Children
The use of CELSENTRI has not been evaluated in children under 2 years of age or weighing less than
10 kg. Therefore, CELSENTRI is not recommended in 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
taken them recently or might take any other medicines.
Tell your doctor or pharmacist if you (or your child) are taking a new medicine during
treatment with CELSENTRI.
Medicines containing St John’s Wort( Hypericum Perforatum)are likely to
prevent CELSENTRI from working correctly. Do not take them while you are taking
CELSENTRI.
Some medicines can change the amount of CELSENTRI in your body when they are taken
at the same time as CELSENTRI. These include:

• other medicines to treat HIV or hepatitis C virus infection (such as atazanavir, cobicistat, darunavir, efavirenz, etravirine, fosamprenavir, indinavir, lopinavir, nelfinavir, ritonavir, saquinavir, boceprevir, telaprevir)
• antibiotics(clarithromycin, telithromycin, rifampicin, rifabutin)
• antifungalmedicines (ketoconazole, itraconazole, fluconazole)
• anticonvulsantmedicines (carbamazepine, phenytoin, phenobarbital). ➔ Tell your doctorif you (or your child) are taking any of these medicines. This will allow your doctor to prescribe the correct dose of CELSENTRI.

Pregnancy and breastfeeding
If you are pregnant, are planning to become pregnant, or are trying to have a baby:
➔ discuss with your doctorthe risks and benefits of taking CELSENTRI.
Breastfeeding is not recommendedfor women who are HIV positive as HIV infection can
be passed to the baby through breast milk.
It is not known whether the ingredients of CELSENTRI also pass into breast milk. If you are breastfeeding or
are thinking about breastfeeding you should talk to your doctor as soon as possible.
Driving and using machines
CELSENTRI can cause dizziness.
➔ Do not drive vehicles, ride a bicycle, or use tools or machinesunless
you are sure you are not affected.

CELSENTRI contains soya lecithin and sodium.
If you are allergic to peanuts or soya you should not take this medicine.
CELSENTRI contains less than 1 mmol of sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.

3. How to take CELSENTRI

Take or give this medicine following the instructions of your doctor exactly. If you have any doubts
consult your doctor or pharmacist.
The doctor will advise whether it is better to take CELSENTRI oral solution if you (or your child) are not
able to swallow the tablets.

Amount to take
Adults
The recommended dose of CELSENTRI is 150mg, 300mg or 600mg twice a day, depending on
other medicines 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 adjust the dose.
➔ Talk to your doctorif this applies to you.

Adolescents and children from 2 years of age and weighing at least 10 kg
The doctor will decide the correct dose of CELSENTRI based on weight and other medicines taken at the same
time.

CELSENTRI can be taken with or without food.CELSENTRI must always be taken orally (by mouth).
CELSENTRI must be taken in combination with other medicines for the treatment of HIV. Make

If you take or give too much CELSENTRI
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) forget to take a dose of CELSENTRI, take or give the missed dose as soon as possible and then continue with the next dose at the scheduled time.
If it is almost time to take the next dose, do not take or give the missed dose. Wait for the next dose
at the scheduled time.

Do not take or give a double dose to make up for a missed dose.
If you or your child stop taking CELSENTRI
Continue to take CELSENTRI until your doctor tells you to stop.
Taking your medicines at the right time every day is important as it ensures that 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 continue taking CELSENTRI correctly as
described above.
If you have any questions about using 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.
Tell your doctor if you notice anything unusual in your health or that of your child.

Serious side effects – contact your doctor immediately
Serious allergic reactions or skin reactions
Some people taking CELSENTRI have experienced serious and life-threatening skin and allergic reactions. These are rare and can affect up to 1 in 1000 people treated with
CELSENTRI.
If you experience any of the following symptoms while taking CELSENTRI:

• swelling of the face, lips or tongue
• difficulty breathing
• widespread rash
• fever (high temperature)
• blisters and peeling of the skin, especially around the mouth, nose, eyes and genitals. ➔ Contact your doctor immediatelyif you experience these symptoms. Stop taking CELSENTRI.

Liver problems
These are rare and can affect up to 1 in 1000 people treated with CELSENTRI.
The signs include:

• loss of appetite
• nausea or vomiting
• yellowing of the skin or eyes
• rash or itching
• feeling very tired
• pain or tenderness in the stomach
• dark urine
• sleepiness and confusion
• fever (high temperature) ➔ Contact your doctor immediatelyif you experience these symptoms. Stop taking CELSENTRI.

Other side effects
Common side effects
These can affect 1 to 10 in 100 people:

• diarrhoea, nausea, stomach pain, flatulence
• loss of appetite
• headache, sleep problems, depression
• rash ( see also ‘Serious allergic reactions or skin reactions’ at the beginning of paragraph 4)
• weakness or lack of energy, anaemia (detected by blood tests)
• increased liver enzymes (detected by blood tests) which may be a sign of liver problems (see also ‘Liver problems’ at the beginning of paragraph 4).

Uncommon side effects
These can affect up to 1 in 100 people:

• lung infection
• fungal infections of the throat ( oesophagus)
• seizures
• feeling dizzy, fainting or lightheaded when standing up
• kidney failure, protein in the urine
• an increase in a substance known as CPK (detected by blood tests) which is a sign that muscles are inflamed or damaged.

Rare side effects
These can affect up to 1 in 1000 people:

• chest pain (caused by reduced blood flow to the heart)
• reduction in muscle size
• certain types of cancer such as that of the throat ( oesophagus) and bile duct
• reduction in the number of blood cells (detected by blood tests).

Other possible side effects of combination therapy for HIV
People taking combination therapy for HIV may experience other side effects.

Symptoms of infection and inflammation
People with advanced HIV infection (AIDS) have a weakened immune system and are more likely to develop serious infections ( opportunistic infections). When they start treatment, the immune system becomes stronger so that the body begins to fight infections.

Symptoms of infection and inflammationcan develop, caused by:

• old “silent” infections that re-emerge as the body fights them
• the immune system attacking healthy tissues of the body ( autoimmune disorders)

Symptoms of autoimmune disorderscan develop many months after starting to take the medicine to treat HIV infection. The symptoms can include:

• muscle weakness
• weakness that starts in the hands and feet and spreads to the body
• palpitations or tremor
• hyperactivity (agitation and excessive movement). If you experience any symptoms of infection or notice any of the symptoms listed above: ➔ tell your doctor immediately. Do not take other medicines for the infection without your doctor’s advice.

Joint pain, stiffness and bone problems
Some people on combination therapy for HIV infection develop a condition called

osteonecrosis.As a result of this condition, part of the bone tissue dies due to reduced blood flow to the bone.
It is not known how common this condition is. You are more likely to develop it:

• if you have been taking combination therapy for a long period
• if you are also taking anti-inflammatory drugs called corticosteroids
• if you drink alcohol
• if you have a very weak immune system
• if you are overweight. The signs to watch out for include
• stiffness of the joints
• pain and discomfort in the joints (especially 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 effect, even if not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly through the national reporting system reported in Annex V . By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store CELSENTRI

Keep this medicine out of the sight and reach of children.
Do not use CELSENTRI after the expiry date which is stated on the package, blister or label
of the bottle. The expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how
to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What CELSENTRI contains

• The active ingredient is maraviroc. Each film-coated tablet contains 25 mg, 75 mg, 150 mg or 300 mg of maraviroc.
• The other excipients are: Tablet core: microcrystalline cellulose, anhydrous calcium hydrogen phosphate, sodium glycolate starch, magnesium stearate.

Coating: polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc, soybean lecithin,
aluminium lake containing indigo carmine (E132).

Description of the appearance of CELSENTRI and package contents
CELSENTRI film-coated tablets are blue in colour and have the inscription
“MVC 25”, “MVC 75”, “MVC 150” or “MVC 300”.
CELSENTRI 25 mg and 75 mg film-coated tablets are available in bottles of
120 tablets.
CELSENTRI 150 mg and 300 mg film-coated tablets are available in bottles of
180 tablets or in blister packs of 30, 60, 90 film-coated tablets and in multiple packs of 180 (2 packs of 90) film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
ViiV Healthcare BV, Van Asch van Wijckstraat 55H, 3811 LP Amersfoort, Netherlands.

Manufacturer
Pfizer Manufacturing Deutschland GmbH, Betriebsstātte Freiburg, Mooswaldallee 1, 79090 Freiburg,
Germany.
For further information on this medicinal product, contact the local representative of the marketing authorisation holder:

België/Belgique/Belgien
ViiV Healthcare srl/bv
Tél/Tel: + 32 (0) 10 85 65 00

Lietuva
ViiV Healthcare BV
Tel: +370 80000334

България
ViiV Healthcare BV
Teл.: +359 80018205

Luxembourg/Luxemburg
ViiV Healthcare srl/bv
Belgique/Belgien
Tél/Tel: + 32 (0) 10 85 65 00

Česká republika
GlaxoSmithKline s.r.o.
Tel: + 420 222 001 111
[email protected]

Magyarország
ViiV Healthcare BV
Tel.: +36 80088309

Danmark
GlaxoSmithKline Pharma A/S
Tlf: + 45 36 35 91 00
[email protected]

Malta
ViiV Healthcare BV
Tel: +356 80065004

Deutschland
ViiV Healthcare GmbH
Tel.: + 49 (0)89 203 0038-10
[email protected]

Nederland
ViiV Healthcare BV
Tel: + 31 (0)33 2081199

Eesti
ViiV Healthcare BV
Tel: +372 8002640

Norge
GlaxoSmithKline AS
Tlf: + 47 22 70 20 00

Ελλάδα
GlaxoSmithKline Μονοπρόσωπη A.E.B.E.
Τηλ: + 30 210 68 82 100

Österreich
GlaxoSmithKline Pharma GmbH
Tel: + 43 (0)1 97075 0
[email protected]

España
Laboratorios ViiV Healthcare, S.L.
Tel: +34 900 923 501
[email protected]

Polska
GSK Services Sp. z o.o.
Tel.: + 48 (0)22 576 9000

France
ViiV Healthcare SAS
Tél.: + 33 (0)1 39 17 6969
[email protected]

Portugal
VIIVHIV HEALTHCARE, UNIPESSOAL, LDA.
Tel: + 351 21 094 08 01
[email protected]

Hrvatska
ViiV Healthcare BV
Tel: +385 800787089

România
ViiV Healthcare BV
Tel: +40 800672524

Ireland
GlaxoSmithKline (Ireland) Limited
Tel: + 353 (0)1 4955000

Slovenija
ViiV Healthcare BV
Tel: +386 80688869

Ísland
Vistor hf.
Sími: + 354 535 7000

Slovenská republika
ViiV Healthcare BV
Tel: +421 800500589

Italia
ViiV Healthcare S.r.l.
Tel: + 39 (0)45 7741600

Suomi/Finland
GlaxoSmithKline Oy
Puh/Tel: + 358 (0)10 30 30 30
[email protected]

Κύπρος
ViiV Healthcare BV
Τηλ: +357 80070017

Sverige
GlaxoSmithKline AB
Tel: + 46 (0)8 638 93 00
[email protected]

Latvija
ViiV Healthcare BV
Tel: +371 80205045

United Kingdom (Northern Ireland)
ViiV Healthcare BV
Tel: + 44 (0)800 221441
[email protected]

Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu .

CELSENTRI 20 mg/mL oral solution

maraviroc

Read this leaflet carefully before taking this medicine as it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What CELSENTRI is and what it is used for
• 2. What you need to know before you take CELSENTRI
• 3. How to take CELSENTRI
• 4. Possible side effects
• 5. How to store CELSENTRI
• 6. Contents of the pack and other information

1. What is CELSENTRI and what it is used for

CELSENTRI contains a medicine called maraviroc. Maraviroc belongs to a group of medicines called CCR5 chemokine receptor antagonists of type 5. CELSENTRI works by blocking the CCR5 receptor preventing the HIV virus from entering and infecting blood cells.

CELSENTRI is used to treat Human Immunodeficiency Virus type-1 (HIV-1) infection in adults, adolescents and children 2 years of age and older and weighing at least 10 kg.
CELSENTRI must be taken in combination with other medicines that are also used for the treatment of HIV infection. These medicines are called anti-HIV or antiretroviral medicines.
CELSENTRI, as a component of combination therapy, reduces the amount of virus in the body and keeps it at low levels. This helps the body to increase the number of CD4 cells in the blood, a type of white blood cells important in helping the body fight infection.

2. What you need to know before taking CELSENTRI

Do not take CELSENTRI:

• if you (or your child, if they are the patient) are allergicto maraviroc or any of the other ingredients of CELSENTRI ( listed in section 6). ➔ Talk to your doctorif you think this applies to you or your child.

Warnings and precautions
Talk to your doctor or pharmacist before taking or giving CELSENTRI.
Your doctor must take blood samples to check if CELSENTRI is an appropriate treatment
for you (or for your child, if they are the patient).
Some people taking CELSENTRI have developed severe allergic reactions or skin reactions
( see also ‘Serious side effects’ in section 4).
Before taking this medicine, make sure your doctor knows if you (or your child) have or have
had in the past any of the following conditions:

• problems with the liver, including chronic hepatitisB or C. Only a limited number of people with liver problems have taken CELSENTRI. Careful monitoring of liver function may be necessary. (See also ‘Liver problems’ in section 4).
• low blood pressure, including dizziness when standing up or sitting quickly, or if you are taking other medicines that lower blood pressure. This is due to a sudden drop in blood pressure. If this happens, lie down until you (or your child) feel better. When you get up, do so as slowly as possible.
• tuberculosis (TB)or serious fungal infections.CELSENTRI may potentially increase the risk of developing infections.
• problems with the kidneys. This is particularly importantif you are also taking some other medicines ( see ‘Other medicines and CELSENTRI’ below in section 2).
• problems with the heartor circulatory system.Only a limited number of people with serious heart or circulatory problems have taken CELSENTRI. ➔ Talk to your doctorbefore starting treatment if you think any of these conditions apply to you (or your child).

Conditions for which you need to be careful
Some people who take medicines for HIV infection develop other conditions that can
be serious. These include:

• symptoms of infections and inflammation
• joint pain, stiffness and problems with bones. You need to be informed about important signs and symptoms so that you can pay attention while taking CELSENTRI.

➔ Read the information in ‘Other possible side effects of combination therapy for
HIV’ in Section 4 of this leaflet.
Elderly
CELSENTRI has only been taken by a limited number of people aged 65 years or older. If you belong to
this age group, discuss with your doctor whether you can take CELSENTRI.

Children
The use of CELSENTRI has not been evaluated in children under 2 years of age or weighing less than
10 kg. Therefore, CELSENTRI is not recommended in 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) are taking a new medicine during
treatment with CELSENTRI.
Medicines containing St. John's Wort( Hypericum Perforatum)are likely to
prevent CELSENTRI from working properly. Do not take them while you are taking
CELSENTRI.
Some medicines can 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 infection or hepatitis C virus infection (such as atazanavir, cobicistat, darunavir, efavirenz, etravirine, fosamprenavir, indinavir, lopinavir, nelfinavir, ritonavir, saquinavir, boceprevir, telaprevir)
• antibiotics(clarithromycin, telithromycin, rifampicin, rifabutin)
• antifungalmedicines (ketoconazole, itraconazole, fluconazole)
• anticonvulsantmedicines (carbamazepine, phenytoin, phenobarbital). ➔ Tell your doctorif you (or your child) are taking any of these medicines. This will allow your doctor to prescribe the correct dose of CELSENTRI.

Pregnancy and breastfeeding
If you are pregnant, are planning to become pregnant, or are planning to have a baby:
➔ discuss with your doctorthe risks and benefits of taking CELSENTRI.
Breastfeeding is not recommendedfor HIV-positive women as HIV infection can
be transmitted to the baby through breast milk.
It is not known whether the components of CELSENTRI can also pass into breast milk. If you are breastfeeding or
are considering breastfeeding you should talk to your doctor as soon as possible.
Driving and using machines
CELSENTRI can cause dizziness.
➔ Do not drive vehicles, ride a bicycle, or use tools or machinesunless
you are sure it does not affect you.

CELSENTRI contains sodium benzoate and sodium
CELSENTRI contains 1 mg of sodium benzoate (E211) in each mL.
CELSENTRI contains less than 1 mmol of sodium (23 mg) in each mL, i.e. essentially ‘sodium-free’.

3. How to take CELSENTRI

Take or give this medicine following the instructions of your doctor exactly. If you have any doubts
consult your doctor or pharmacist.
Your doctor will advise whether it is better to take CELSENTRI oral solution if you (or your child) are
unable to swallow the tablets.

How much to take
Adults
The recommended dose of CELSENTRI is 150mg (7.5 ml), 300mg (15 ml)or 600mg (30 ml) twice
a day, depending on the other medicines 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 adjust the dose.
➔ Talk to your doctorif this applies to you.

Adolescents and children from 2 years of age and weighing at least 10 kg
The doctor will decide the correct dose of CELSENTRI based on weight and other medicines taken at the
same time.

See the scheme and instructions at the end of this paragraph on how to measure and take (or
give) the dose of the medicine.
CELSENTRI can be taken with or without food.CELSENTRI must always be taken orally
(by mouth).
CELSENTRI must be taken in combination with other medicines for the treatment of HIV. Make

If you take or give too much CELSENTRI
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) forget to take a dose of CELSENTRI, take or give the forgotten dose as soon as possible and then continue with the next dose at the scheduled time.
If it is almost time to take the next dose, do not take or give the forgotten dose. Wait for the next
scheduled dose.

Do not take or give a double dose to make up for a missed dose.
If you or your child stops treatment with CELSENTRI
Continue to take CELSENTRI until your doctor tells you to stop.
Taking medicines at the right time every day is important as it ensures that the HIV infection does not increase in the body. Therefore, unless your doctor tells you (or your child) to
stop treatment, it is important to continue taking CELSENTRI correctly as
described above.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

How to measure the dose and take the medicine

Use the oral applicator provided with the package to measure the dose accurately.

• 1. Remove the cap of the bottle (A). Keep it safe.
• 2. Hold the bottle firmly. Push the plastic adapter (B) into the neck of the bottleso that it is completely inserted.
• 3. Insertthe applicator (C)firmly into the adapter.
• 4. Turn the bottle upside down.
• 5. Pull the applicator plunger (D)until the applicatorcontains the first part of the entire dose.
• 6. Return the bottle to the upright position. Remove the applicatorfrom the adapter.
• 7. Insert the applicator into the mouth (or the child's mouth), positioning the upper end of the applicator towards the inside of the cheek. Press the plunger slowly, allowing time for swallowing. Do not presstoo hard and do not inject the liquid into the back of the throat, otherwise this may cause choking.
• 8. Repeat steps 3 to 7in the same way until the entire dose has been taken. For example, if your dose is 15 ml, you must take one full applicator and half of the medicine .
• 9. Removeand washthe applicator thoroughly with water once you have finished using it. Let it dry completely before using it again.
• 10. Close the bottle tightlywith the cap, leaving the adapter in the bottle. Discard any unused oral solution 60 days after the first opening of 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 in your health or that of your child.

Serious side effects – contact your doctor immediately
Serious allergic reactions or skin reactions
Some people taking CELSENTRI have experienced severe and life-threatening skin and allergic reactions. These are rare and can affect up to 1 in 1000 people treated with
CELSENTRI.
If you experience any of the following symptoms while taking CELSENTRI:

• swelling of the face, lips or tongue
• difficulty breathing
• widespread rash
• fever (high temperature)
• blisters and peeling of the skin, particularly around the mouth, nose, eyes and genitals ➔ Contact your doctor immediately if you experience these symptoms. Stop taking CELSENTRI.

Liver problems
These are rare and can affect up to 1 in 1000 people treated with CELSENTRI.
Signs include:

• loss of appetite
• nausea or vomiting
• yellowing of the skin or eyes
• rash or itching
• feeling very tired
• stomach pain or tenderness
• dark urine
• drowsiness and confusion
• fever (high temperature) ➔ Contact your doctor immediatelyif you experience these symptoms. Stop taking CELSENTRI.

Other side effects
Common side effects
These can affect 1 to 10 in 100 people:

• diarrhoea, nausea, stomach pain, flatulence
• loss of appetite
• headache, sleep problems, depression
• rash ( see also ‘Serious allergic reactions or skin reactions’ at the beginning of paragraph 4)
• weakness or lack of energy, anaemia (detected by blood test results)
• increased liver enzymes (detected by blood test results) which may be a sign of liver problems (see also ‘Liver problems’ at the beginning of paragraph 4).

Uncommon side effects
These can affect up to 1 in 100 people:

• lung infection
• fungal infections of the throat ( oesophagus)
• seizures
• feeling dizzy, fainting or lightheaded when standing up
• kidney failure, protein in the urine
• an increase in a substance known as CPK (detected by blood test results) which is a sign that muscles are inflamed or damaged.

Rare side effects
These can affect up to 1 in 1000 people:

• chest pain (caused by reduced blood flow to the heart)
• reduction in muscle size
• certain types of cancer such as that of the throat ( oesophagus) and bile duct
• reduction in the number of blood cells (detected by blood test results).

Other possible side effects of combination therapy for HIV
People taking combination therapy for HIV may experience other side effects.

Symptoms of infection and inflammation
People with advanced HIV infection (AIDS) have a weakened immune system and are more likely to develop serious infections ( opportunistic infections). When they start treatment, the immune system becomes stronger so that the body begins to fight infections.

Symptoms of infection and inflammationcan develop, caused by:

• old “silent” infections that re-emerge as the body fights them
• the immune system attacking healthy tissues of the body ( autoimmune disorders)

Symptoms of autoimmune disorderscan develop many months after starting to take the medicine to treat HIV infection. Symptoms may include:

• muscle weakness
• weakness that starts in the hands and feet and spreads to the body trunk
• palpitations or tremor
• hyperactivity (agitation and excessive movement). If you experience any symptoms of infection or notice any of the symptoms listed above: ➔ tell your doctor immediately. Do not take other medicines for the infection without your doctor’s advice.

Joint pain, stiffness and bone problems
Some people on combination therapy for HIV infection develop a condition called

osteonecrosis.As a result of this condition, part of the bone tissue dies due to reduced blood flow to the bone.
It is not known how common this condition is. You are more likely to develop it:

• if you have been taking combination therapy for a long period
• if you are also taking anti-inflammatory drugs called corticosteroids
• if you drink alcohol
• if you have a very weak immune system
• if you are overweight.

Signs to watch out for include:

• joint stiffness
• pain and discomfort in the joints (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 effect, even if not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly through the national reporting system reported in Annex V . By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store CELSENTRI

Keep this medicine out of the sight and reach of children.
Do not use CELSENTRI after the expiry date which is stated on the vial or the carton. The expiry date refers to the last day of that month.
Store the oral solution at a temperature below 30  C.
Discard 60 days after first opening. Write the date on which the oral solution must be discarded
on the carton in the designated space. The date must be written as soon as the bottle has been opened for the
first time.
Do not dispose of any medicine in the wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What CELSENTRI contains

• The active ingredient is maraviroc 20 mg in each ml of the solution.
• The other excipients are: citric acid (anhydrous), sodium citrate dihydrate, sucralose, sodium benzoate (E211), strawberry flavour (501440T), purified water.

Description of the appearance of CELSENTRI and contents of the pack
CELSENTRI oral solution is supplied in a carton containing a high-density polyethylene bottle,
with a child-resistant safety cap. The solution is colourless to strawberry-flavoured. The bottle
contains 230 ml of maraviroc solution (20 mg/ml). The pack includes an oral applicator
and a bottle adapter that must be inserted into the bottle before use.

Marketing Authorisation Holder
ViiV Healthcare BV, Van Asch van Wijckstraat 55H, 3811 LP Amersfoort, The Netherlands.

Manufacturer
Pfizer Service Company, Hoge Wei 10, B 1930 Zaventem, Belgium
For further information on this medicinal product, contact the local representative of the marketing
authorisation holder:

België/Belgique/Belgien
ViiV Healthcare srl/bv
Tél/Tel: + 32 (0) 10 85 65 00

Lietuva
ViiV Healthcare BV
Tel: +370 80000334

България
ViiV Healthcare BV
Teл.: +359 80018205

Luxembourg/Luxemburg
ViiV Healthcare srl/bv
Belgique/Belgien
Tél/Tel: + 32 (0) 10 85 65 00

Česká republika
GlaxoSmithKline s.r.o.
Tel: + 420 222 001 111
[email protected]

Magyarország
ViiV Healthcare BV
Tel.: +36 80088309

Danmark
GlaxoSmithKline Pharma A/S
Tlf: + 45 36 35 91 00
[email protected]

Malta
ViiV Healthcare BV
Tel: +356 80065004

Deutschland
ViiV Healthcare GmbH
Tel.: + 49 (0)89 203 0038-10
[email protected]

Nederland
ViiV Healthcare BV
Tel: + 31 (0)33 2081199

Eesti
ViiV Healthcare BV
Tel: +372 8002640

Norge
GlaxoSmithKline AS
Tlf: + 47 22 70 20 00

Ελλάδα
GlaxoSmithKline Μονοπρόσωπη A.E.B.E.
Τηλ: + 30 210 68 82 100

Österreich
GlaxoSmithKline Pharma GmbH
Tel: + 43 (0)1 97075 0
[email protected]

España
Laboratorios ViiV Healthcare, S.L.
Tel: +34 900 923 501
[email protected]

Polska
GSK Services Sp. z o.o.
Tel.: + 48 (0)22 576 9000

France
ViiV Healthcare SAS
Tél.: + 33 (0)1 39 17 6969
[email protected]

Portugal
VIIVHIV HEALTHCARE, UNIPESSOAL, LDA.
Tel: + 351 21 094 08 01
[email protected]

Hrvatska
ViiV Healthcare BV
Tel: +385 800787089

România
ViiV Healthcare BV
Tel: +40 800672524

Ireland
GlaxoSmithKline (Ireland) Limited
Tel: + 353 (0)1 4955000

Slovenija
ViiV Healthcare BV
Tel: +386 80688869

Ísland
Vistor hf.
Sími: + 354 535 7000

Slovenská republika
ViiV Healthcare BV
Tel: +421 800500589

Italia
ViiV Healthcare S.r.l.
Tel: + 39 (0)45 7741600

Suomi/Finland
GlaxoSmithKline Oy
Puh/Tel: + 358 (0)10 30 30 30
[email protected]

Κύπρος
ViiV Healthcare BV
Τηλ: +357 80070017

Sverige
GlaxoSmithKline AB
Tel: + 46 (0)8 638 93 00
[email protected]

Latvija
ViiV Healthcare BV
Tel: +371 80205045

United Kingdom (Northern Ireland)
ViiV Healthcare BV
Tel: + 44 (0)800 221441
[email protected]

Other sources of information
More detailed information on this medicinal product is available on the website of the European
Medicines Agency: http://www.ema.europa.eu .