CELSENTRI 300 mg film-coated tablets

CELSENTRI is an antiretroviral medicine used in the treatment of Human Immunodeficiency Virus type-1 (HIV-1) infection. Its active ingredient, maraviroc, belongs to a group of medicines called CCR5 antagonists.

CELSENTRI prevents the entry of HIV-1 into the cells in your blood that are attacked by HIV (called CD4 or T-cells). CELSENTRI works by blocking a receptor called CCR5 that HIV use to gain entry into these cells. CELSENTRI reduces the amount of HIV in your body and enhances your immune system.

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

Do not take CELSENTRI if you are allergic (hypersensitive) to maraviroc or to peanut or soya or to any of the other ingredients of CELSENTRI (see section 2, Important information about some of the ingredients of CELSENTRI).

Take special care with CELSENTRI:

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

Before taking this medicine, make sure that your doctor knows if you:

• have problems with your liver including chronic hepatitis B or C as there is only limited experience in patients with liver problems. Your liver function may need to be closely monitored. If you notice symptoms of hepatitis (loss of appetite, fever, feeling sick/being sick and/or yellowing of skin or eyes), rash and/or itching, you should stop taking CELSENTRI and inform your doctor immediately.
• have or previously had low blood pressure and/or if you are taking any medicines to lower blood pressure
• have tuberculosis or serious fungal infections as due to the way CELSENTRI works on certain immune cells, CELSENTRI could potentially increase the risk of developing infections. However, there has been no evidence of an increase in the occurrence of AIDS-related infections associated with the use of CELSENTRI in clinical studies
• have or previously had any kidney problems particularly if you are taking certain antibiotics (clarithromycin, telithromycin, antifungal medicines (ketoconazole, itraconazole) and/or protease inhibitors (except for tipranavir/ritonavir)
• have problems with your heart or circulatory system as there is only limited experience in patients with serious problems of this type.

It is not known if CELSENTRI works in children. Therefore CELSENTRI is not recommended for use in children.

CELSENTRI has only been used in limited numbers of patients 65 years or older. If you belong to this age group please discuss with your doctor if you can use CELSENTRI.

CELSENTRI is not a cure for HIV infection or AIDS (advanced HIV infection). CELSENTRI does not reduce the risk of passing HIV to others through sexual contact, sharing needles or exposure to your blood. It is important to continue to take appropriate precautions to prevent passing HIV to others.

In some patients with AIDS and a history of opportunistic infection (an infection that can occur when your immune system is impaired), signs and symptoms of inflammation from previous infections may occur soon after anti-HIV treatment is started. It is believed that these symptoms are due to an improvement in the body?s immune response, enabling the body to fight infections that may have been present with no obvious symptoms. If you notice any symptoms of infection, please inform your doctor immediately.

Some patients taking combination antiretroviral therapy may develop a bone disease called osteonecrosis (death of bone tissue caused by loss of blood supply to the bone). The length of combination antiretroviral therapy, corticosteroid use, alcohol consumption, severe immunosuppression, higher body mass index, among others, may be some of the many risk factors for developing this disease. Signs of osteonecrosis are joint stiffness, aches and pains (especially of the hip, knee and shoulder) and difficulty in movement. If you notice any of these symptoms please inform your doctor.

Taking other medicines

Please tell your doctor and your pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Some medicines may affect the levels of CELSENTRI in the body when they are taken at the same time as CELSENTRI. Therefore the dose of CELSENTRI may need to be adjusted. Tell your doctor if you are taking any medicines including other medicines to treat HIV infection (e.g. efavirenz, etravirine, lopinavir, saquinavir, darunavir, atazanavir, nelfinavir, indinavir), antibiotics (clarithromycin, telithromycin, rifampicin) and antifungal medicines (ketoconazole, itraconazole). This will allow your doctor to prescribe the most appropriate dose of CELSENTRI for you.

Medicines containing St. John?s wort ( Hypericum perforatum) are likely to prevent CELSENTRI from working properly and should not be taken together with CELSENTRI.

Taking CELSENTRI with food and drink

CELSENTRI can be taken with or without food.

Pregnancy

Tell your doctor if you are pregnant, planning to become pregnant or become pregnant whilst taking this medicine. If you are pregnant, CELSENTRI should only be taken after careful discussion with your doctor. The safe use of CELSENTRI in pregnancy has not been established.
Ask your doctor or pharmacist for advice before taking any medicine.

Breast-feeding

It is not known whether the active ingredient in CELSENTRI can pass into your breast milk. Therefore, mothers should not breast-feed during treatment with CELSENTRI. In general, women infected with HIV should not breast-feed because the virus may be transmitted through the breast milk.

Driving and using machines

CELSENTRI may cause dizziness. If you experience dizziness while taking CELSENTRI do not drive and do not operate any tools or machines.

Important information about some of the ingredients of CELSENTRI

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

Always take CELSENTRI exactly as your doctor has instructed. You should check with your doctor or pharmacist if you are not sure how to take CELSENTRI.

The usual dose of CELSENTRIis 150 mg, 300 mg or 600 mg twice per day depending on othermedicines that you are taking at the same time as CELSENTRI . Always take the dose recommended by your doctor.

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

You should continue to take CELSENTRI for as long as instructed by your doctor.

CELSENTRI must be taken in combination with other medicines used to treat HIV. Please refer to the Package Leaflets of these other medicines for guidance on how to take them.

If you take more CELSENTRI than you should

If you accidentally take more than the prescribed dose of CELSENTRI, contact your doctor or the nearest hospital right away. You may feel dizzy or light-headed when you stand or sit up quickly. This is due to a sudden fall in your blood pressure. If this happens, lie down until you feel better. When you get up, do so as slowly as possible.

If you forget to take CELSENTRI

If you miss a dose of CELSENTRI, take the missed dose as soon as possible and then take your next scheduled dose at its regular time. If it is almost time for your next dose, do not take the missed dose.

Wait and take the next dose at its regular time. Do not take a double dose to make up for a forgotten dose.

If you stop taking CELSENTRI

It has been shown that taking all doses at the appropriate times may greatly increase the effectiveness of your antiretroviral medicines. Therefore, unless your doctor instructs you to stop treatment, it is important to keep taking CELSENTRI correctly, as described above.

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

Like all medicines, CELSENTRI can cause side effects, although not everybody gets them. When treating HIV infection, it is not always easy to identify what side effects are caused by CELSENTRI, by the other medicines you are taking, or by the HIV infection itself. Tell your doctor if you notice anything unusual about your health.

Common side effects (likely to occur in fewer than 1 in 10 patients) include:

• diarrhoea, feeling sick, stomach ache, flatulence
• headache, sleepiness, problems sleeping, depression
• rash, feeling weak, anaemia, loss of appetite
• increased levels of substances that measure the function of the liver. These can be seen in the results of blood tests and can be a sign of reduced function or damage of the liver. If you experience symptoms, such as loss of appetite, feeling sick/being sick and/or yellowing of skin or eyes, you should inform your doctor.

Uncommon side effects (likely to occur in fewer than 1 in 100 patients) include:

• pneumonia, fungal infection of the oesophagus
• fits
• muscle aches and pains
• an increase in a substance which may be found in blood tests when muscles are inflamed or damaged
• kidney failure, passing protein in urine

Rare Side Effects ( likely to occur in fewer than 1 in 1,000 patients) include:

• reduction in number of blood cells, chest pain caused by reduced blood flow to the heart, liver diseases, decrease in the size of muscle, severe skin reaction, some types of cancer like cancer of the oesophagus and bile duct

If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

• Keep out of the reach and sight of children.
• Do not use CELSENTRI after the expiry date which is stated on the carton, blister or bottle label. The expiry date refers to the last day of that month.
• This medicine does not require any special storage conditions.

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

What CELSENTRI contains

• The active ingredient in CELSENTRI is maraviroc. Each film-coated tablet contains either 150 mg or 300 mg of maraviroc.
• The other ingredients are:

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

Film-coat: poly (vinyl alcohol), titanium dioxide, macrogol 3350, talc, soya lecithin, indigo carmine aluminium lake (E132).

What CELSENTRI looks like and contents of the pack

CELSENTRI film-coated tablets are blue coloured with ?MVC 150? or ?MVC 300?.

CELSENTRI 150 mg and 300 mg film-coated tablets are supplied in bottles of 180 tablets or in blister packs of 30, 60, 90 film-coated tablets and multipacks containing 180 (2 packs of 90) film-coated tablets.

Not all pack sizes may be marketed in all countries.

Marketing Authorisation Holder and Manufacturer

The Marketing Authorisation Holder is:

ViiV Healthcare UK Ltd, 980 Great West Road, Brentford, Middlesex, TW8 9GS United Kingdom.

The Manufacturer is:

Pfizer Manufacturing Deutschland GmbH, Betriebsst-tte Freiburg, Mooswaldallee 1, 79090 Freiburg, Germany.

For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

BelgiëBelgiqueBelgien ViiV Healthcare sprlbvba . TélTel 32 02 656 25 11 LuxembourgLuxemburg ViiV Healthcare sprlbvba BelgiqueBelgien TélTel 32 02 656 25 11

Te. 359 2 953 10 34 Magyarország GlaxoSmithKline Kft. Tel. 36 1 225 5300

Malta GlaxoSmithKline Malta Tel 356 21 238131 eská republika GlaxoSmithKline s.r.o. Tel 420 222 001 111 gsk.czmailgsk.com

Danmark GlaxoSmithKline Pharma AS Tlf 45 36 35 91 00 dk-infogsk.com Nederland ViiV Healthcare BV Tel 31 030 6986060 contact-nlviivhealthcare.com

Deutschland ViiV Healthcare GmbH Tel. 49 089 203 0038-10 viiv.med.infoviivhealthcare.com Norge GlaxoSmithKline AS Tlf 47 22 70 20 00 firmapostgsk.no

Eesti GlaxoSmithKline Eesti OÜ Tel 372 6676 900 estoniagsk.com Österreich GlaxoSmithKline Pharma GmbH Tel 43 01 97075 0 at.infogsk.com

GlaxoSmithKline A.E.B.E. 30 210 68 82 100 Polska GSK Commercial Sp. z o.o. Tel. 48 022 576 9000

España Laboratorios ViiV Healthcare, S.L. Tel 34 902 051 260 es-civiivhealthcare.com Portugal VIIVHIV HEALTHCARE, UNIPESSOAL, LDA. Tel 351 21 094 08 01 viiv.fi.ptviivhealthcare.com

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Lietuva
GlaxoSmithKline Lietuva UAB
Tel: + 370 5 264 90 00
info.lt@gsk.com

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