Celsentri
maraviroc
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. It may harm them, even if their signs of illness are the same as yours.
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side
effects not listed in this leaflet. See Section 4.
What CELSENTRI is and what it is used for
What you need to know before you take CELSENTRI
How to take CELSENTRI
Possible side effects
How to store CELSENTRI
Contents of the pack and other information
CELSENTRI contains a medicine called maraviroc. Maraviroc belongs to a group of medicines called CCR5 antagonists. CELSENTRI works by blocking a receptor called CCR5 which HIV uses to enter and infect your blood cells.
CELSENTRI must be taken in combination with other medicines which are also used to treat the HIV infection. These medicines are all 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 CD4 cell count in your blood. CD4 cells are a type of white blood cell that are important in helping your body to fight infection.
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.
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:
(see ‘Other medicines and CELSENTRI’ later in section 2).
Tell your doctor before starting treatment if you think any of these apply to you (or your child).
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.
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.
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.
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.
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)
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.
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.
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.
CELSENTRI can make you dizzy.
Do not drive, cycle, or operate tools or machines unless you are sure you’re not affected.
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.
on other medicines that you are taking at the same time. Always take the dose recommended by your doctor.
If you have a kidney problem, your doctor may alter your dose.
Talk to your doctor if this applies to you.
Your doctor will decide the correct dose of CELSENTRI based on weight and on other medicines being taken at the same time.
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 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) 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.
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.
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.
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.
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
fever (high temperature).
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).
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.
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.
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.
old, hidden infections flaring up again as the body fights them
the immune system attacking healthy body tissue (autoimmune disorders).
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.
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.
stiffness in the joints
aches and pains (especially in the hip, knee or shoulder)
difficulty moving.
If you notice any of these symptoms:
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects 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.
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 bottle label. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.
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: cellulose microcrystalline, calcium hydrogen phosphate anhydrous, sodium starch glycolate, magnesium stearate
Film-coat: poly (vinyl alcohol), titanium dioxide (E171), macrogol 3350, talc, soya lecithin, indigo carmine aluminium lake (E132).
CELSENTRI film-coated tablets are blue coloured 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 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.
ViiV Healthcare BV, Van Asch van Wijckstraat 55H, 3811 LP Amersfoort, Netherlands.
Pfizer Manufacturing Deutschland GmbH, Betriebsstātte Freiburg, Mooswaldallee 1, 79090
Freiburg, Germany.
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
ViiV Healthcare BV Tel: +370 80000334
ViiV Healthcare BV
Teл.: +359 80018205
Tél/Tel: + 32 (0) 10 85 65 00
GlaxoSmithKline Pharma A/S Tlf: + 45 36 35 91 00
ViiV Healthcare BV Tel: +356 80065004
ViiV Healthcare GmbH Tel.: + 49 (0)89 203 0038-10
viiv.med.info@viivhealthcare.com
ViiV Healthcare BV Tel: + 31 (0)33 2081199
ViiV Healthcare BV Tel: +372 8002640
GlaxoSmithKline Μονοπρόσωπη A.E.B.E.
Τηλ: + 30 210 68 82 100
GlaxoSmithKline Pharma GmbH Tel: + 43 (0)1 97075 0
Laboratorios ViiV Healthcare, S.L.
Tel: +34 900 923 501
GSK Services Sp. z o.o. Tel.: + 48 (0)22 576 9000
ViiV Healthcare SAS Tél.: + 33 (0)1 39 17 6969
VIIVHIV HEALTHCARE, UNIPESSOAL, LDA. Tel: + 351 21 094 08 01
ViiV Healthcare BV Tel: +385 800787089
ViiV Healthcare BV Tel: +40 800672524
GlaxoSmithKline (Ireland) Limited Tel: + 353 (0)1 4955000
ViiV Healthcare BV Tel: +386 80688869
Vistor hf.
Sími: + 354 535 7000
ViiV Healthcare S.r.l. Tel: + 39 (0)45 7741600
ViiV Healthcare BV
Τηλ: +357 80070017
ViiV Healthcare BV Tel: +371 80205045
ViiV Healthcare BV Tel: + 44 (0)800 221441