CELSENTRI 75 MG FILM-COATED TABLETS - patient leaflet, side effects, dosage

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Do not take CELSENTRI

• if you (or your child, if they are the patient) are allergic to maraviroc or to peanut or soya or to any of the other ingredients of CELSENTRI (listed in section 6).

^ Check with 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 test whether CELSENTRI is an appropriate treatment for you (or 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 that your doctor knows if you (or your child) have or in the past had any of the following:

• 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 closely monitored. (See also ‘Liver problems’ in section 4).
• low blood pressure, including dizziness when you stand up or sit up quickly, or if you are taking any medicines to lower blood pressure. This is due to a sudden fall in blood pressure. If this happens, 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 could potentially increase your risk of developing infections.
• kidney problems. This is particularly important if you are also taking some other medicines (see ‘Other medicines and CELSENTRI’ later in section 2).

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

^ Tell your doctor before starting treatment if you think any of these apply to you (or your child).

Conditions you need to look out for Some people taking medicines for HIV infection develop other conditions, which can be serious.

These include:

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

You need to know about important signs and symptoms to look out for while you’re taking CELSENTRI.

^ Read the information ‘Other possible side effects of combination therapy for HIV’ in Section 4 of this leaflet.

Protect other people

HIV infection is spread by sexual contact with someone who has the infection, or by transfer of infected blood (for example, by sharing injection needles). You (or your child) can still pass on HIV when taking this medicine, although the risk is lowered by effective treatment.

^ Talk to your doctor about how to avoid infecting other people.

Older people

CELSENTRI has only been taken by limited numbers of people 65 years or older. If you belong to this age group, discuss with your doctor if you can use CELSENTRI.

Children

The use of CELSENTRI has not been tested in children under the age of 2 or weighing less than 10 kg. Therefore CELSENTRI is not recommended in children younger than 2, 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) begin taking a new medicine while taking CELSENTRI.

Medicines containing St. John’s Wort (Hypericum perforatum ) are likely to prevent CELSENTRI from working properly. You should not take them while you’re taking CELSENTRI.

Some medicines may 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 or hepatitis C infection (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).

^ Tell your doctor if you (or your child) are taking any of these medicines. This will allow your doctor to prescribe the right dose of CELSENTRI.

Pregnancy and breast-feeding

If you are pregnant, if you become pregnant, or if you are planning to have a baby:

^ Talk to your doctor about the risks and benefits of taking CELSENTRI.

Women who are HIV-positive must not breast-feed, because HIV infection can be passed on to the baby in breast milk.

It is not known whether the ingredients in CELSENTRI can also pass into breast milk. If you are breast-feeding, or thinking about breast-feeding: ^ Talk to your doctor immediately.

Driving and using machines CELSENTRI can make you dizzy.

^ Do not drive, cycle, or operate tools or machines unless you are sure you’re not affected.

CELSENTRI contains soya lecithin and sodium.

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

CELSENTRI contains less than 1 mmol sodium (23 mg) in each tablet, that is to say essentially ‘sodium free’.

Always take or give this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Your doctor will advise you whether it is better to take CELSENTRI oral solution, if you (or your child) are unable to swallow tablets.

How much to take

Adults

The recommended dose of CELSENTRI is 150 mg, 300 mg or 600 mg twice per day depending on other medicines that 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 alter your dose.

^ Talk to your doctor if this applies to you.

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

Your doctor will decide the correct dose of CELSENTRI based on weight and on other medicines being taken at the same time. CELSENTRI can be taken with or without food. CELSENTRI should always be taken by mouth. CELSENTRI must be taken in combination with other medicines to treat HIV. Refer to the Package Leaflets of these other medicines for guidance 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 (or your child) miss a dose of CELSENTRI, take or give the missed dose as soon as possible and then continue with the next dose at its regular time.

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

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

If you or your child stop taking CELSENTRI

Keep taking CELSENTRI until your doctor tells you to stop.

Taking your medicines at the right time every day is important, as it makes sure 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 keep taking CELSENTRI correctly, as described above.

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

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Product Information (name, strength, size, market codes):

PP OUTSERT CELSENTRI (ALLE WS) PED GB

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PAA146066

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Like all medicines, this medicine can cause side effects, although not everybody gets them. Tell your doctor if you notice anything unusual about your own health or your child’s health.

Serious side effects — get medical help immediately

Serious allergic or skin reactions

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

If you get any of the following symptoms while you’re taking CELSENTRI :

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

^ Get medical help immediately if you get these symptoms. Stop taking CELSENTRI.

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Kopf an Kopf

Liver problems

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GSK Market is responsible to advise SDC when changes required impact the following: Formulation, Tablet embossing, Storage conditions and Shelf Life

These are rare, and may affect up to 1 in 1,000 people taking CELSENTRI.

Signs include:

• loss of appetite
• feeling sick or being sick
• yellowing of skin or eyes
• skin rash or itching
• feeling very tired
• stomach pain or tenderness
• > dark urine
• drowsiness and confusion

CD

• S fever (high temperature).

^ Contact a doctor immediately if you get these symptoms. Stop taking CELSENTRI.

Other side effects

Common side effects

These may affect 1 to 10 in 100 people:

• diarrhoea, feeling sick, stomach ache, wind (flatulence),
• loss of appetite
• headache, problems sleeping, depression
• rash (see also ‘Serious allergic or skin reactions’ earlier in section 4)
• feeling weak or lack of energy, anaemia (seen in blood test result)
• increase in liver enzymes (seen in blood test results), which can be a sign of liver problems (see also ‘Liver problems’ earlier in section 4).

Uncommon side effects

These may affect up to 1 in 100 people:

• lung infection
• fungal infection of the gullet (oesophagus)
• fits (seizures)
• feeling dizzy, faint or light headed when standing up
• kidney failure, protein in the urine
• an increase in a substance known as CPK (seen in 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)
• decrease in muscle size
• some types of cancer, such as of the gullet (oesophagus) and bile duct
• decrease in number of blood cells (seen in blood test results).

People taking combination therapy for HIV may get other side effects.

Symptoms of infection and inflammation

People with advanced HIV infection (AIDS) have weak immune systems, and are more likely to develop serious infections (opportunistic infections). When they start treatment, the immune system becomes stronger, so the body starts to fight infections.

Symptoms of infection and inflammation may develop, caused by either:

• old, hidden infections flaring up again as the body fights them
• the immune system attacking healthy body tissue (autoimmune disorders).

The symptoms of autoimmune disorders may develop many months after you start taking medicine to treat your HIV infection. Symptoms may include:

• muscle weakness
• weakness beginning in the hands and feet and moving up towards the trunk of the body
• palpitations or tremor
• hyperactivity (excessive restlessness and movement).

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

^ Tell your doctor immediately. Don’t take other medicines for the infection without your doctor’s advice.

Joint pain, stiffness and bone problems

Some people taking combination therapy for HIV develop a condition called osteonecrosis. With this condition, parts of the bone tissue die because of reduced blood supply to the bone.

It is not known how common this condition is. You may be more likely to develop it:

• 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 weak immune system
• if you are overweight.

Signs to look out for include:

• stiffness in the joints
• aches and pains (especially in the hip, knee or shoulder)
• difficulty moving.

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

United Kingdom

ViiV Healthcare UK Ltd

Tel: + 44 (0)800 221441

This leaflet was last revised in 09/2020

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency website:.

Trade marks are owned by or licensed to the

ViiV Healthcare group of companies.

©2020 ViiV Healthcare group of companies or its licensor.

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