Label: information for the user

CELSENTRI 25mg film-coated tablets

CELSENTRI 75mg film-coated tablets

CELSENTRI 150mg film-coated tablets

CELSENTRI 300mg film-coated tablets

maraviroc

Read this label carefully before starting to take this medicine, because it contains important information for you.

• Keep this label, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed only for you, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist,even if they are not listed in this label. See section 4.

CELSENTRI contains an active ingredient called maraviroc. Maraviroc belongs to a group of medicines calledantagonistsof the CCR5. CELSENTRI acts by blocking the receptor called CCR5, which HIV uses to enter and infect 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 that are also used to treat HIV infection. All these medicines are referred to asantiretroviralorantiretroviralmedicines.

CELSENTRI, as part of the combined treatment, reduces the amount of virus in your body and keeps it at a low level. This helps your body to increase the count of CD4 cells in the blood. CD4 cells are a type of white blood cell that are important in helping your body to fight off infections.

Do not take CELSENTRI

• if you (or your child, if the patient) areallergicto maraviroc, peanuts, soy, or any of the other components of CELSENTRI(listed in section 6).

• Consult your doctorif you think this applies to you or your child.

Warnings and precautions

Consult your doctor or pharmacist before taking or administering CELSENTRI.

Your doctor must collect blood samples to see if CELSENTRI is an appropriate treatment for you (or your child, if the patient).

Some people who take CELSENTRI have developed severe allergic reactions or skin reactions (see also “Severe adverse reactions”in section 4).

Before taking this medication, make sure your doctor knows if you (or your child) have or have had any of the following problems:

• liver problems, includingchronic hepatitis B 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 standing up or sitting quickly, or if you are taking medications to lower blood pressure.This is due to a sudden drop in blood pressure.If this happens, lie down (or to your child) until you feel better. When you (or your child) get up, do so slowly.

• tuberculosis (TB)or aserious fungal infection. CELSENTRI may potentially increase your risk of developing infections.

• kidney problems. This isparticularly importantif you are also taking other medications (see “Other medications and CELSENTRI”later in section 2)

• heart problemsorcirculatory system problems.Only a limited number of people with severe heart or circulatory problems have taken CELSENTRI.

• Inform your doctorbefore starting treatment if you think any of the above situations affect you (or your child).

Conditions to be aware of

Some people taking HIV medications develop other conditions, which can be serious. These include:

• symptoms of infections and inflammation
• joint pain, stiffness, and bone problems

You need to know what important signs and symptoms to watch for while taking CELSENTRI.

• Read the information on “Other possible adverse effects of combined antiretroviral therapy for HIV”in section 4 of this prospectus.

Older patients

Only a limited number of people 65 years or older have taken CELSENTRI. If you belong to this age group, consult your doctor to see if you can take CELSENTRI.

Children

The use of CELSENTRI has not been tested in children under 2 years or weighing less than 10 kg. Therefore, CELSENTRI is not recommended for children under 2 years or weighing less than 10 kg.

Other medications and CELSENTRI

Inform your doctor or pharmacistif you (or your child)are taking,have taken recently, or may need to takeany other medication.

Inform your doctor or pharmacist if you (or your child) start taking a new medication while taking CELSENTRI.

It is likely that medications containing St. John's Wort (Hypericum perforatum) will prevent CELSENTRI from working correctly.Do not take it while taking CELSENTRI.

Some medications may affect CELSENTRI levels in the body when taken at the same time as CELSENTRI. These include:

• other HIV treatment medications or hepatitis C virus medications (for example:atazanavir, cobicistat, darunavir, efavirenz, etravirina, fosamprenavir, indinavir, lopinavir, nelfinavir, ritonavir, saquinavir, boceprevir, telaprevir)
• antibiotics(claritromycin, telitromycin, rifampicin, rifabutin)
• antifungal medications (ketoconazole, itraconazole, fluconazole)
• anticonvulsant medications (carbamazepine, phenytoin, phenobarbital).

• Inform your doctorif you (or your child) are taking any of these medications. This will allow your doctor to prescribe the correct dose of CELSENTRI.

Pregnancy and breastfeeding

If you are pregnant, think you may be pregnant, or intend to become pregnant:

• Consult your doctorabout the risks and benefits of taking CELSENTRI.

It is not recommendedthat women living with HIV breastfeed because HIV infection can be transmitted to the baby through breast milk.

The components of CELSENTRI are unknown to pass into breast milk. If you are breastfeeding or plan to breastfeed,you must consult your doctor as soon as possible.

Driving and operating machinery

CELSENTRI may make you feel dizzy.

• Do not drive, ride a bike, or operate machinesif you are unsure of its effect.

CELSENTRIcontains soy lecithin and sodium.

Do not take this medication if you are allergic to peanuts or soy.

CELSENTRI contains less than 1 mmol of sodium (23 mg) in each tablet; this is, essentially “sodium-free”.

Follow exactly the administration instructions for this medication as indicated by your doctor.This medicationindicated by your doctor.In case of doubt, consultyour doctor or pharmacist.

If you (or your child) are unable to swallow the tablets, your doctor will consider whether it is better for you to take the oral solution of CELSENTRI.

How much to take

Adults

The recommended dose of CELSENTRI is 150 mg, 300 mg, or 600 mg twice a daydepending on whether you are taking other medications at the same time.Always take the dose recommended by your doctor.

People with kidney problems

If you have kidney problems, your doctor may modify your dose.

• Consult with your doctorif this applies to you.

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

Your doctor will indicate the correct dose of CELSENTRI based on your weight and other medications you are taking at the same time.

CELSENTRI can be taken with or without food.CELSENTRI must always be taken orally.

CELSENTRI should be taken in combination with other medications used to treat HIV. Consult the package insert for these other medications to know how to take them.

If you take or administer more CELSENTRI than you should

If you accidentally take or administer too much CELSENTRI

• Contact your doctor or go to the nearest hospital immediately.

If you forgot to take or administer CELSENTRI

If you (or your child) forgot to take or administer a dose of CELSENTRI, take it or administer it as soon as possible and continuewith the next dose at the usual time.

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

Do not take or administer a double dose to make up for the missed doses.

If you (or your child) interrupt treatment with CELSENTRI

Continue treatment with CELSENTRI until your doctor tells you to.

It is essential that you take your medications every day at the time they are due, as this ensures that the HIV infection does not spread through your body. Unless your doctor tells you to stop treatment, it is essential thatyou (or your child) continuetreatment with CELSENTRI, as described above.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, CELSENTRI can cause side effects, although not everyone will experience them. Inform your doctor about any unusual changes in your health or your child's health.

Severe side effects - seek medical help immediately

Severe allergic or skin reactions

Some people taking CELSENTRI have developed severe skin reactions and potentially life-threatening allergic reactions. These are rare and may affectup to 1 in 1,000 peoplewho take CELSENTRI.

If you experience any of these symptoms while being treated with CELSENTRI:

• swelling of the face, lips, or tongue
• difficulty breathing
• generalized skin rash
• fever (high temperature)
• blistering 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 may affectup to 1 in 1,000 peoplewho take CELSENTRI.

The signs include:

• loss of appetite
• nausea/vomiting
• yellowing of the skin or eyes
• skin rash or itching
• feeling very tired
• abdominal 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

Frequent side effects

These may affectup to 1 in 10 people:

• diarrhea, general feeling of being unwell, abdominal pain, flatulence
• loss of appetite
• headache, difficulty sleeping, depression
• skin rash (see also “Severe allergic or skin reactions”described earlier in section 4)
• feeling weak or lacking energy, anemia (observed in blood tests)
• increase in liver enzymes (observed in blood tests), which may be a sign of liver problems (see also “Liver problems”described earlier in this section 4).

Rare side effects

These may affectup to 1 in 100 people:

• pneumonia
• throat infection (esophagitis)
• seizures
• dizziness, weakness, or feeling faint when standing up
• kidney failure, presence of protein in the urine
• an increase in a substance called CPK (seen in blood tests) that is a sign that the muscles are inflamed or damaged.

Very rare side effects

These may affectup to 1 in 1,000 people:

• chest pain (caused by reduced blood flow to the heart)
• muscle wasting
• some types of cancer, such as throat (esophagus) and bile duct cancer
• reduction in the number of blood cells (observed in blood tests).

Other possible side effects of combined antiretroviral therapy for HIV

People taking combined antiretroviral therapy for HIV may develop 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). After starting treatment, the immune system becomes stronger, and the body begins to fight these infections.

These may developsymptoms of infection and inflammation,caused either by:

• old, hidden infections that break out again when the body starts to fight them
• the immune system attacking healthy body tissues (autoimmune disorders).

The symptoms of autoimmune disordersmay appear many monthsafter starting treatment with HIV medicines. The symptoms may include:

• muscle weakness
• weakness that startsin the hands and feet and ascends to the body trunk
• palpitations or tremors
• hyperactivity (excessive restlessness and movement).

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

• Inform your doctor immediately.Do not take other medications for the infection without consulting your doctor.

Joint pain, stiffness, and bone problems

Some patients taking combined antiretroviral therapy for HIV develop a condition calledosteonecrosis. In this condition, parts of the bone tissue die due to reduced blood supply to the bones.

The frequency of this condition is unknown. It is more likely to develop:

• if you have been taking treatment for a long time
• if you are also taking anti-inflammatory medications called corticosteroids
• if you drink alcohol
• if you have a severely weakened immune system
• if you are overweight.

The signs to watch out for include:

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

If you notice any of these symptoms:

• Inform your doctor.

Reporting side effects

If you experienceany type ofside effect, consult your doctor or pharmacist,even if it is apossibleside effect that does not appear in this leaflet.You can also report them directly through thenational reporting system included in theAppendix V. By reporting side effects, you can contribute to providing more information about the safety of this medicine.

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

Do not use CELSENTRI after the expiration date that appears on the box, blister pack, or bottle label. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the containers and medicines you no longer need. This will help protect the environment.

Composition of CELSENTRI

• The active ingredient is maraviroc. Each film-coated tablet contains 25 mg, 75 mg, 150 mg or 300 mg of maraviroc.

• The other components are:

Core of the tablet:microcrystalline cellulose, anhydrous calcium hydrogen phosphate, sodium glycolate starch, magnesium stearate.

Coating:poly(vinyl alcohol), titanium dioxide (E171), macrogol 3350, talc, soy lecithin, aluminium lake of indigo carmine (E132).

Appearance of the product and contents of the pack

The film-coated tablets of CELSENTRI are blue and engraved 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 60 tablets or in blisters of 30, 60 or 90 film-coated tablets and in multiple packs containing 180 (2 packs of 90) film-coated tablets.

Only some pack sizes may be marketed.

Marketing authorisation holder:

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

Manufacturer responsible:

Pfizer Manufacturing DeutschlandGmbH, Mooswaldallee 1, 79108 Freiburg Im Breisgau, Germany.

For further information about this medicinal product, please contact the local representative of the marketing authorisation holder:

Last update of this leaflet: {MM/YYYY}

Other sources of information

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