Celsentri

Package leaflet: Information for the user

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

maraviroc
Please read this leaflet carefully before 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 give it to other people, even if they have the same symptoms as you, because it may be harmful.
• If you experience any side effects, including 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 taking 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 CELSENTRI is and what it is used for

CELSENTRI contains a medicine called maraviroc. Maraviroc belongs to a group of
medicines known as C-C chemokine receptor type 5 (CCR5) antagonists. CELSENTRI
works by blocking the CCR5 receptor, thereby 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 aged 2 years and older who weigh at least 10 kg.
CELSENTRI must be taken in combination with other medicines used for the treatment of HIV infection. These medicines are known as anti-HIV medicines or antiretrovirals.
When used as part of combination therapy, CELSENTRI 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 cell important in helping the body fight infection.

2. What you should know before taking CELSENTRI

Do not take CELSENTRI

• if you (or your child, if they are the patient) are allergic to maraviroc, or to peanuts or soya, or to any of the other ingredients of CELSENTRI ( listed in section 6 ). ➔ Consult your doctor if 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 determine whether 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 unwanted effects’ in section 4 ).
Before taking this medicine, make sure your doctor knows if you (or your child) have or have previously had any of the following conditions:

• problems with the liver , including chronic hepatitis B 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 up quickly, or if you are taking other medicines that lower blood pressure. This is due to a sudden drop in blood pressure. If this occurs, 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 may potentially increase the risk of developing infections.
• problems with the kidneys . This is particularly important if you are also taking certain other medicines ( see ‘Other medicines and CELSENTRI’ below in section 2 ).
• problems with the heart or circulatory system . Only a limited number of people with serious heart or circulatory problems have taken CELSENTRI. ➔ Consult your doctor before starting treatment if you think any of these conditions apply to you (or your child).

Conditions requiring caution
Some people taking medicines for HIV infection develop other conditions, which may be serious. These include:

• symptoms of infections and inflammation
• joint pain, stiffness, and bone problems
  You should be aware of important signs and symptoms so you can remain alert while taking CELSENTRI.

➔ Read the information under ‘Other possible unwanted effects of combination HIV therapy’ in
Section 4 of this leaflet.
Elderly
CELSENTRI has been used by only 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 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 medicine , have recently taken any other medicine, or might take any other medicine.
Inform your doctor or pharmacist if you (or your child) start taking a new medicine during treatment with CELSENTRI.
Medicines containing St. John’s wort ( Hypericum perforatum ) may interfere with the effectiveness of CELSENTRI. You must not take them while taking CELSENTRI .
Some medicines may alter the amount of CELSENTRI in your body when taken at the same time as CELSENTRI. These include:

• other medicines to treat HIV infection or hepatitis C virus (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)
• anticonvulsants (carbamazepine, phenytoin, phenobarbital). ➔ Inform your doctor if 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, become pregnant, or are planning to have a baby:
➔ Discuss with your doctor the risks and benefits of taking CELSENTRI.
Breastfeeding is not recommended for HIV-positive women, as HIV infection can be transmitted to the infant through breast milk.
It is not known whether the components of CELSENTRI pass into breast milk. If you are breastfeeding or considering breastfeeding, you must speak to your doctor as soon as possible.
Driving and using machines
CELSENTRI may cause dizziness.
➔ You must not drive, ride a bicycle, or operate tools or machinery unless you are certain that you are not affected.
CELSENTRI contains soya lecithin and sodium .
If you are allergic to peanuts or soya, you must not take this medicine.
CELSENTRI contains less than 1 mmol of sodium (23 mg) per tablet, i.e., essentially ‘sodium-free’.

3. How to take CELSENTRI

Take this medicine exactly as prescribed by your doctor. 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 tablets.
Dosage
Adults
The recommended dose of CELSENTRI is 150 mg, 300 mg or 600 mg twice daily, depending on
other medicines you are taking at the same time. Always take the dose prescribed by your doctor.
Patients with kidney problems
If you have a kidney problem, your doctor may adjust your dose.
➔ Consult your doctor if this applies to you.
Adolescents and children aged 2 years and older with body weight of at least 10 kg
Your doctor will determine the correct dose of CELSENTRI based on body weight and other medicines being taken concomitantly.
CELSENTRI can be taken with or without food. CELSENTRI must always be taken orally (by mouth).
CELSENTRI must be taken in combination with other medicinal products for the treatment of HIV. Refer
to the Package Leaflet of these medicinal products for instructions 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) forget to take a dose of CELSENTRI, take or give the missed dose as soon as possible, then continue with the next dose at the scheduled time.
If it is almost time for 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 forgotten dose.
If you or your child stops treatment with CELSENTRI
Continue taking CELSENTRI until your doctor tells you to stop.
Taking your medicines at the correct time every day is important because it ensures that 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 questions about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Inform your doctor if you notice anything unusual in your health or that of your child.

Serious side effects – contact your doctor immediately

Severe allergic reactions or skin reactions
Some people taking CELSENTRI have experienced severe and life-threatening skin reactions and allergic reactions. These are rare and may affect up to 1 in 1,000 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)
• blistering 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 may affect up to 1 in 1,000 people treated with CELSENTRI.
Signs include:

• loss of appetite
• nausea or vomiting
• yellowing of the skin or eyes (jaundice)
• rash or itching
• feeling very tired
• stomach pain or tenderness
• dark urine
• drowsiness and confusion
• fever (high temperature)

➔ Contact your doctor immediately if you experience these symptoms. Stop taking CELSENTRI.

Other side effects

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

• diarrhoea, nausea, stomach ache, flatulence
• loss of appetite
• headache, sleep problems, depression
• rash (see also ‘Severe allergic reactions or skin reactions’ at the beginning of section 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 section 4).

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

• lung infection
• fungal infections of the throat (oesophagus)
• seizures
• dizziness, fainting, or feeling lightheaded when standing
• kidney failure, protein in the urine
• increase in a substance known as CPK (detected by blood test results), indicating muscle inflammation or damage.

Rare side effects
These may affect up to 1 in 1,000 people:

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

Other possible side effects of combination HIV therapy

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, their immune system becomes stronger and begins to fight existing infections.
Symptoms of infection and inflammation may therefore develop due to:

• reactivation of previous "silent" infections as the body fights them
• the immune system attacking healthy body tissues (autoimmune disorders)

Symptoms of autoimmune disorders may develop several months after starting treatment for HIV infection. Symptoms may include:

• muscle weakness
• weakness starting in the hands and feet and spreading towards the trunk of 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:
➔ Inform your doctor immediately. Do not take any other medicines for infection without consulting your doctor.

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 supply to the bone.
It is not known how common this condition is. The risk of developing it is higher if:

• you have been on combination therapy for a long time
• you are also taking anti-inflammatory medicines called corticosteroids
• you consume alcohol
• you have a very weak immune system
• you are overweight.

Signs to watch for include:

• stiffness in the joints
• joint pain and discomfort (especially in the hip, knee, or shoulder)
• difficulty moving

If you notice any of these symptoms:
➔ Inform your doctor.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system listed 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 stated on the packaging, blister, or label of the bottle.
The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of medicines via 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 substance is maraviroc. Each film-coated tablet contains 25 mg, 75 mg, 150 mg, or 300 mg of maraviroc.
• The other ingredients are: Tablet core: microcrystalline cellulose, anhydrous calcium hydrogen phosphate, sodium starch glycolate, magnesium stearate.

Coating: polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc, soya lecithin,
aluminium lake containing indigo carmine (E132).
Description of the appearance of CELSENTRI and package contents
CELSENTRI film-coated tablets are blue and marked with the imprint
“MVC 25”, “MVC 75”, “MVC 150”, or “MVC 300”.
CELSENTRI 25 mg and 75 mg film-coated tablets are available in bottles containing
120 tablets.
CELSENTRI 150 mg and 300 mg film-coated tablets are available in bottles containing
60 tablets or in blister packs containing 30, 60, 90 film-coated tablets, and in multiple packs containing 180 (2 packs of 90) film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder
ViiV Healthcare BV, Van Asch van Wijckstraat 55H, 3811 LP Amersfoort, The Netherlands.
Manufacturer
Pfizer Manufacturing Deutschland GmbH, Mooswaldallee 1, 79108 Freiburg im Breisgau, Germany.
For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:
België/Belgique/Belgien Lietuva
ViiV Healthcare srl/bv ViiV Healthcare BV
Tél/Tel: + 32 (0) 10 85 65 00 Tel: +370 80000334
България Luxembourg/Luxemburg
ViiV Healthcare BV ViiV Healthcare srl/bv
Teл.: +359 80018205 Belgique/Belgien
Tél/Tel: + 32 (0) 10 85 65 00
Česká republika Magyarország
GlaxoSmithKline s.r.o. ViiV Healthcare BV
Tel: + 420 222 001 111 Tel.: +36 80088309
[email protected]
Danmark Malta
GlaxoSmithKline Pharma A/S ViiV Healthcare BV
Tlf: + 45 36 35 91 00 Tel: +356 80065004
[email protected]
Deutschland Nederland
ViiV Healthcare GmbH ViiV Healthcare BV
Tel.: + 49 (0)89 203 0038-10 Tel: + 31 (0)33 2081199
[email protected]
Eesti Norge
ViiV Healthcare BV GlaxoSmithKline AS
Tel: +372 8002640 Tlf: + 47 22 70 20 00
Ελλάδα Österreich
GlaxoSmithKline Μονοπρόσωπη A.E.B.E. GlaxoSmithKline Pharma GmbH
Τηλ: + 30 210 68 82 100 Tel: + 43 (0)1 97075 0
[email protected]
España Polska
Laboratorios ViiV Healthcare, S.L. GSK Services Sp. z o.o.
Tel: +34 900 923 501 Tel.: + 48 (0)22 576 9000
[email protected]
France Portugal
ViiV Healthcare SAS VIIVHIV HEALTHCARE, UNIPESSOAL, LDA.
Tél.: + 33 (0)1 39 17 6969 Tel: + 351 21 094 08 01
[email protected] [email protected]
Hrvatska România
ViiV Healthcare BV ViiV Healthcare BV
Tel: +385 800787089 Tel: +40 800672524
Ireland Slovenija
GlaxoSmithKline (Ireland) Limited ViiV Healthcare BV
Tel: + 353 (0)1 4955000 Tel: +386 80688869
Ísland Slovenská republika
Vistor hf. ViiV Healthcare BV
Sími: + 354 535 7000 Tel: +421 800500589
Italia Suomi/Finland
ViiV Healthcare S.r.l. GlaxoSmithKline Oy
Tel: + 39 (0)45 7741600 Puh/Tel: + 358 (0)10 30 30 30
[email protected]
Κύπρος Sverige
ViiV Healthcare BV GlaxoSmithKline AB
Τηλ: +357 80070017 Tel: + 46 (0)8 638 93 00
[email protected]
Latvija
ViiV Healthcare BV
Tel: +371 80205045
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 .

Package leaflet: Information for the user

CELSENTRI 20 mg/mL oral solution

maraviroc
Please read this leaflet carefully before 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 give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, contact 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 taking 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 CELSENTRI is and what it is used for

CELSENTRI contains a medicine called maraviroc. Maraviroc belongs to a group of
medicines known as C-C chemokine receptor type 5 (CCR5) antagonists. CELSENTRI
works by blocking the CCR5 receptor, thereby 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 from 2 years of age onwards who weigh at least 10 kg.
CELSENTRI must be taken in combination with other medicines used for the treatment of HIV infection. These medicines are called anti-HIV medicines or antiretrovirals.
CELSENTRI, as part 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 cell 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 allergic to maraviroc or to any of the other ingredients of CELSENTRI ( listed in section 6 ). ➔ Consult your doctor if 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 determine whether 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 undesirable effects’ in section 4 ).
Before taking this medicine, make sure your doctor knows if you (or your child) have or have previously had any of the following conditions:

• problems with the liver , including chronic hepatitis B or C. Only a limited number of people with liver problems have taken CELSENTRI. Close monitoring of liver function may be necessary. (See also ‘Liver problems’ in section 4).
• low blood pressure , including dizziness when standing up or sitting down quickly, or if you are taking other medicines that lower blood pressure. This is due to a sudden drop in blood pressure. If this occurs, 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 may potentially increase the risk of developing infections.
• problems with the kidneys . This is particularly important if you are also taking certain other medicines ( see ‘Other medicines and CELSENTRI’ below in section 2 ).
• problems with the heart or circulatory system . Only a limited number of people with serious heart or circulatory problems have taken CELSENTRI. ➔ Consult your doctor before starting treatment if you think any of these conditions apply to you (or your child).

Conditions requiring caution
Some people taking medicines for HIV infection develop other conditions that may be serious. These include:

• symptoms of infections and inflammation
• joint pain, stiffness, and bone problems. You should be aware of important signs and symptoms so you can remain vigilant while taking CELSENTRI.

➔ Read the information under ‘Other possible undesirable effects of combination therapy for HIV’ in section 4 of this leaflet.
Elderly
Only a limited number of people aged 65 years or older have taken CELSENTRI. 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 for children under 2 years of age or weighing less than 10 kg.
Other medicines and CELSENTRI
Tell your doctor or pharmacist if you (or your child) are taking any other medicine , have recently taken any other medicine, or might take any other medicine.
Inform your doctor or pharmacist if you (or your child) start taking a new medicine during treatment with CELSENTRI.
Medicines containing St John’s wort ( Hypericum perforatum ) are likely to interfere with the proper functioning of CELSENTRI. You must not take them while taking CELSENTRI .
Some medicines may alter the amount of CELSENTRI in the body when taken at the same time as CELSENTRI. These include:

• other medicines to treat HIV infection or hepatitis C virus (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). ➔ Inform your doctor if 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, become pregnant, or are planning to have a baby:
➔ Discuss with your doctor the risks and benefits of taking CELSENTRI.
Breastfeeding is not recommended for HIV-positive women because HIV infection can be transmitted to the infant through breast milk.
It is not known whether the components of CELSENTRI pass into breast milk. If you are breastfeeding or considering breastfeeding, you must speak to your doctor as soon as possible.
Driving and using machines
CELSENTRI may cause dizziness.
➔ You must not drive, ride a bicycle, or use tools or machinery unless you are certain that you are not affected.
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 this medicine exactly as prescribed by your doctor. If you have any doubts,
consult your doctor or pharmacist.
Your doctor will advise whether it is preferable to take CELSENTRI oral solution if you (or your child) are
unable to swallow tablets.
Dosage
Adults
The recommended dose of CELSENTRI is 150 mg (7.5 ml), 300 mg (15 ml) or 600 mg (30 ml) twice
daily, depending on other medicines you are taking at the same time. Always take the dose
recommended by your doctor.
Patients with kidney problems
If you have a kidney problem, your doctor may adjust the dose.
➔ Consult your doctor if this applies to you.
Adolescents and children aged 2 years and older with a body weight of at least 10 kg
Your doctor will determine the correct dose of CELSENTRI based on body weight and other medicines being taken concomitantly.
See the dosing table and instructions at the end of this section on how to measure and take (or
administer) the medicine.
CELSENTRI may 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. Refer to the
Package Leaflet of these medicines for instructions on how to take them.
If you take or administer 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 administer CELSENTRI
If you (or your child) forget to take a dose of CELSENTRI, take or give the missed dose as soon as possible, then continue with the next dose at the scheduled time.
If it is almost time for the next dose, do not take or give the missed dose. Wait for the next dose at the scheduled time.
Do not take or administer a double dose to make up for a forgotten dose.
If you or your child stops treatment with CELSENTRI
Continue taking CELSENTRI for as long as your doctor instructs you to do so.
Taking medicines at the correct time every day is important because it ensures that 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 how to use this medicine, consult your doctor or pharmacist.
How to measure and take the medicine

Use the oral dosing dispenser supplied with the pack to measure the dose accurately.

1. Remove the bottle cap (A). Keep it safe.
2. Hold the bottle firmly. Push the plastic adapter (B) into the neck of the bottle until it is fully in place.
3. Firmly insert the dosing dispenser (C) into the adapter.
4. Turn the bottle upside down.
5. Pull the plunger of the dosing dispenser (D) until the dispenser contains the first part of the total dose.
6. Return the bottle to an upright position. Remove the dosing dispenser from the adapter.
7. Insert the dosing dispenser into the mouth (or into the child’s mouth), placing the top end of the dispenser towards the inside of the cheek. Slowly push the plunger, allowing time for swallowing. Do not push too hard and do not inject the liquid into the back of the throat, as this may cause choking.
8. Repeat steps 3 to 7 in the same way until the entire dose has been administered. For example, if your dose is 15 ml, you must take one full dispenser and half a dispenser of medicine.
9. Remove and wash the dosing dispenser thoroughly with water after use. Allow it to dry completely before using it again.
10. Close the bottle tightly with the cap, leaving the adapter in the bottle. Discard 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 everyone gets them. Inform your doctor if you notice anything unusual in your health or that of your child.

Serious side effects – contact your doctor immediately

Severe allergic reactions or skin reactions
Some people taking CELSENTRI have experienced severe, life-threatening skin reactions and allergic reactions. These are rare and may affect up to 1 in 1,000 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)
• blistering 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 may affect up to 1 in 1,000 people treated with CELSENTRI.
Signs include:

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

Other side effects

Common side effects
These may affect 1 to 10 out of 100 people:

• diarrhoea, nausea, stomach ache, flatulence
• loss of appetite
• headache, sleep problems, depression
• rash (see also ‘Severe allergic reactions or skin reactions’ at the beginning of section 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 section 4).

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

• lung infection
• fungal infections of the throat (oesophagus)
• seizures
• dizziness, fainting or feeling lightheaded when standing
• kidney failure, protein in urine
• 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 may affect up to 1 in 1,000 people:

• chest pain (caused by reduced blood flow to the heart)
• reduction in muscle size
• certain types of cancer such as cancer 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 who take 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 and begins to fight existing infections.
Symptoms of infection and inflammation may therefore develop, caused by:

• reactivation of old “silent” infections as the body starts to fight them
• the immune system attacking the body’s own healthy tissues (autoimmune disorders)

Symptoms of autoimmune disorders may develop several months after starting treatment for HIV infection. Symptoms may include:

• muscle weakness
• weakness starting in the hands and feet and spreading towards the trunk of 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:
  ➔ Inform your doctor immediately. Do not take any other medicines for infection without consulting your doctor.

Joint pain, stiffness and bone problems
Some people receiving 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 supply to the bone.
It is not known how common this condition is. The risk of developing it is higher if:

• you have been on combination therapy for a long time
• you are also taking anti-inflammatory medicines called corticosteroids
• you consume alcohol
• you have a very weak immune system
• you are overweight.

Signs to watch for include:

• stiffness in the joints
• joint pain and discomfort (especially in the hip, knee or shoulder)
• difficulty moving

If you notice any of these symptoms:
➔ Inform your doctor.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system listed 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 stated on the bottle or carton. 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 on which the oral solution must be discarded in the space provided on the carton. This date should be written as soon as the bottle is opened for the first time.
Do not dispose of medicines via 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 substance is maraviroc 20 mg per ml of solution.
• The other ingredients 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 and strawberry-flavoured. The bottle contains 230 ml of maraviroc solution (20 mg/ml). The package includes an oral dosing syringe and a bottle adapter which 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 about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien Lietuva
ViiV Healthcare srl/bv ViiV Healthcare BV
Tél/Tel: + 32 (0) 10 85 65 00 Tel: +370 80000334

България Luxembourg/Luxemburg
ViiV Healthcare BV ViiV Healthcare srl/bv
Teл.: +359 80018205 Belgique/Belgien
Tél/Tel: + 32 (0) 10 85 65 00

Česká republika Magyarország
GlaxoSmithKline s.r.o. ViiV Healthcare BV
Tel: + 420 222 001 111 Tel.: +36 80088309
[email protected]

Danmark Malta
GlaxoSmithKline Pharma A/S ViiV Healthcare BV
Tlf: + 45 36 35 91 00 Tel: +356 80065004
[email protected]

Deutschland Nederland
ViiV Healthcare GmbH ViiV Healthcare BV
Tel.: + 49 (0)89 203 0038-10 Tel: + 31 (0)33 2081199
[email protected]

Eesti Norge
ViiV Healthcare BV GlaxoSmithKline AS
Tel: +372 8002640 Tlf: + 47 22 70 20 00

Ελλάδα Österreich
GlaxoSmithKline Μονοπρόσωπη A.E.B.E. GlaxoSmithKline Pharma GmbH
Τηλ: + 30 210 68 82 100 Tel: + 43 (0)1 97075 0
[email protected]

España Polska
Laboratorios ViiV Healthcare, S.L. GSK Services Sp. z o.o.
Tel: +34 900 923 501 Tel.: + 48 (0)22 576 9000
[email protected]

France Portugal
ViiV Healthcare SAS VIIVHIV HEALTHCARE, UNIPESSOAL, LDA.
Tél.: + 33 (0)1 39 17 6969 Tel: + 351 21 094 08 01
[email protected] [email protected]

Hrvatska România
ViiV Healthcare BV ViiV Healthcare BV
Tel: +385 800787089 Tel: +40 800672524

Ireland Slovenija
GlaxoSmithKline (Ireland) Limited ViiV Healthcare BV
Tel: + 353 (0)1 4955000 Tel: +386 80688869

Ísland Slovenská republika
Vistor hf. ViiV Healthcare BV
Sími: + 354 535 7000 Tel: +421 800500589

Italia Suomi/Finland
ViiV Healthcare S.r.l. GlaxoSmithKline Oy
Tel: + 39 (0)45 7741600 Puh/Tel: + 358 (0)10 30 30 30
[email protected]

Κύπρος Sverige
ViiV Healthcare BV GlaxoSmithKline AB
Τηλ: +357 80070017 Tel: + 46 (0)8 638 93 00
[email protected]

Latvija
ViiV Healthcare BV
Tel: +371 80205045

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.