CELSENTRI 300 MG FILM-COATED TABLETS

Introduction

Package Leaflet: 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 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, as it may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the pack

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

1. What is CELSENTRI and what is it used for

CELSENTRI contains the active substance maraviroc. Maraviroc belongs to a group of medicines called CCR5 antagonists. CELSENTRI works by blocking the CCR5 receptor, which HIV uses to enter and infect blood cells.

CELSENTRI is used to treat HIV-1 infection in adults, adolescents, and children aged 2 years and older, weighing 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 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 number of CD4 cells in the blood. CD4 cells are a type of white blood cell that are important for helping your body to fight infections.

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 allergicto maraviroc, peanuts, soy, or any of the other ingredients of CELSENTRI (listed in section 6).

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

Warnings and precautions

Talk to your doctor or pharmacist before taking or administering CELSENTRI.

Your doctor should take blood samples to see if CELSENTRI is a suitable treatment for you (or your child).

Some people taking CELSENTRI have developed severe allergic reactions or skin reactions (see also “Severe side effects” in section 4).

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

• 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 carefully monitored. (See also “Liver problems” in section 4).

• low blood pressure, including dizziness when standing up or sitting down quickly, or if you are taking medicines to lower blood pressure. This is due to a sudden drop in blood pressure. If this happens, lie down (or have your child lie down) until you feel better. When getting up, do it as slowly as possible.

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

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

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

• Tell your doctorbefore starting treatment if you think any of the above applies to you (or your child).

Conditions to be aware of

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

• Symptoms of infection and inflammation
• Pain in the joints, stiffness, and bone problems

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

• Read the information on “Other possible side effects of combination antiretroviral therapy for HIV” in section 4 of this leaflet.

Elderly patients

Only a limited number of people aged 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 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 pharmacistif you (or your child) are taking,have recently taken, or might take any other medicines.

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

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

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

• other medicines for the treatment of HIV or hepatitis C virus (e.g., 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 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, think you may be pregnant, or are planning to have a baby:

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

It is not recommendedthat HIV-infected women breastfeed their babies because HIV infection can be passed to the baby through breast milk.

It is not known if the components of CELSENTRI can also pass into breast milk. If you are breastfeeding or thinking of breastfeeding, consult your doctor as soon as possible.

Driving and using machines

CELSENTRI may make you feel dizzy.

• Do not drive, ride a bike, or use machines or toolsif you are not sure it won't affect you.

CELSENTRIcontains soy lecithin and sodium.

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

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

3. How to take CELSENTRI

Always take this medicine exactly as your doctor has told you. If you are not sure, check with your doctor or pharmacist.

If you (or your child) are unable to swallow the tablets, your doctor will consider whether it is better for you (or your child) 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 day, depending on whether you are taking other medicines at the same time.Always take the dose recommended by your doctor.

People with kidney problems

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

• Consult your doctorif this applies to you.

Adolescents and children aged 2 years and older and weighing at least 10 kg

Your doctor will tell you the correct dose of CELSENTRI based on weight and other medicines being taken at the same time.

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

CELSENTRI must be taken in combination with other medicines used to treat HIV. Check the package leaflet of these other medicines to find out 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 go to 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 it as soon as possible and continue with the next dose at the usual time.

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

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

If you (or your child) stop taking CELSENTRI

Continue treatment with CELSENTRI until your doctor tells you to stop.

It is important that you (or your child) take your medicines every day, as this will help to prevent the HIV infection from progressing in your body. Therefore, unless your doctor tells you to stop, it is important that you (or your child) continue treatment with CELSENTRI as described above.

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

4. Possible side effects

Like all medicines, CELSENTRI can cause side effects, although not everybody gets them. Tell your doctor about any unusual changes in your health or your child's health.

Severe side effects - seek medical help immediately

Severe allergic reactions or skin reactions

Some people taking CELSENTRI have developed severe skin reactions and severe allergic reactions that can be life-threatening. These are rare, can affect up to 1 in 1,000 peopletaking CELSENTRI.

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

• swelling of the face, lips, or tongue
• difficulty breathing
• widespread skin rash
• fever (high temperature)
• blisters and skin peeling, especially around the mouth, nose, eyes, and genitals

• Contact your doctor immediatelyif you have these symptoms. Stop taking CELSENTRI.

Liver problems

These are rare and can affect up to 1 in 1,000 peopletaking CELSENTRI.

The signs include:

• loss of appetite
• nausea/vomiting
• yellowing of the 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 immediatelyif you have these symptoms. Stop taking CELSENTRI.

Other side effects

Common side effects

These can affect up to 1 in 10 people:

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

Uncommon side effects

These can affect up to 1 in 100 people:

• lung infection
• fungal infection of the throat (esophagus)
• seizures
• feeling dizzy, weak, or lightheaded 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 of muscle inflammation or damage.

Rare side effects

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

• chest pain (caused by reduced blood flow to the heart)
• muscle wasting
• certain types of cancer such as throat (esophageal) and bile duct cancer
• a decrease in the number of blood cells (seen in blood tests).

Other possible side effects of combination antiretroviral therapy for HIV

People taking combination 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, so the body starts to fight off these infections.

Symptoms of infection and inflammationmay develop, caused by:

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

Symptoms of autoimmune disorderscan appear many months after starting to take medicines for HIV infection. The symptoms can include:

• muscle weakness
• weakness that starts in the hands and feet and moves up towards the trunk of the body
• palpitations or tremors
• hyperactivity (excessive restlessness and movement).

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

• Tell your doctor immediately.Do not take other medicines for infection without your doctor's advice.

Pain in the joints, stiffness, and bone problems

Some patients on combination antiretroviral therapy for HIV develop a condition called osteonecrosis. In this condition, parts of the bone tissue die due to a reduction in blood supply to the bones.

The frequency of this condition is not known. It is more likely to develop:

• 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 weakened immune system
• if you are overweight.

Signs to look out for include:

• stiffness in the joints
• 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 experience any side effects, talk to your doctor or pharmacist, even if they are 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. Storage of 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 carton, blister, or label of the bottle. The expiry date is the last day of the month stated.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package Contents and Additional Information

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 ingredients are:

Tablet core: microcrystalline cellulose, anhydrous calcium hydrogen phosphate, sodium starch glycolate, magnesium stearate.

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

Appearance and Package Contents of the Product

The film-coated tablets of CELSENTRI are blue, 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 certain pack sizes may be marketed.

Marketing Authorization Holder:

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

Date of the Last Revision of this Leaflet: {MM/YYYY}

Other Sources of Information

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