25 mg, 75 mg, 150 mg and 300 mg film-coated tablets
maravirok
1. What CELSENTRI is and what it is used for
CELSENTRI contains a substance called maravirok. Maraviroc belongs to a class of drugs called CCR5 antagonist you . CELSENTRI works by blocking a receptor called CCR5, which HIV uses to enter and infect your blood cells.
CELSENTRI is used to treat human immunodeficiency virus type 1 ( HIV- 1 ) in adults, adolescents and children from 2 years of age weighing at least 10 kg.
CELSENTRI must be taken in combination with other drugs that are also used to treat HIV – infection a. These medicines are called anti- HIV medicines or antiretroviral medicines.
CELSENTRI, as part of a combination treatment, reduces the amount of virus in your body and keeps it at a low level. This helps your body increase the amount of CD4 cells in your blood. CD4 cells are a type of white blood cell that are important in helping your body fight infection .
2. What you need to know before taking CELSENTRI
Do not take CELSENTRI
- if you (or your child, if the child is a patient ) are allergic to maravirok, peanuts, soy or any of the other ingredients of CELSENTRI ( listed in section 6 ).
- Consult a doctor if you think this applies to you or your child.
Warnings and cautions
Talk to your doctor or pharmacist before taking or giving CELSENTRI.
Your doctor will take blood samples to see if CELSENTRI is a suitable treatment for you (or your child, if the child is the patient).
Some people who have taken CELSENTRI have developed severe 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 have 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 set or sit up too fast and / or if you are taking any medicine to lower your blood pressure . This is due to a sudden drop in blood pressure. If this happens, you (or your child) should lie down until it feels better. When you (or your child) get up, do it as slowly as possible.
- tuberculosis (TB) or a serious fungal infection . CELSENTRI may increase the risk of infection.
- kidney problems . This is especially important if you are also taking certain other medicines (see ” Other medicines and CELSENTRI” later in section 2) .
- problems with the heart or blood circulation . Only a limited number of people with severe heart or circulatory problems have taken CELSENTRI.
- Tell your doctor if you think any of these apply to you (or your child) before starting treatment.
Conditions that you need 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
- joint pain, stiffness, and skeletal problems.
You need to know important signs and symptoms to be aware of while 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 a spread through sexual contact with someone with infection an, or by transfusion of infected blood (for example by sharing needles). You (or your child) can still transmit HIV infection when you take this medicine, even though the risk of effective treatment is reduced.
- Talk to your doctor about how to avoid infecting others.
Elderly
CELSENTRI has only been taken by a limited number of people aged 65 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 younger than 2 years or weighing less than 10 kg. CELSENTRI is therefore not recommended for use in children younger than 2 years 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 be taking any other medicines.
Tell your doctor or pharmacist if you (or your child) start taking a new medicine while you are being treated with CELSENTRI.
Medicines containing St. John’s wort ( Hypericum perforatum ) can probably prevent CELSENTRI from working properly. You should not take such medicines while taking CELSENTRI.
Some medicines can change the concentrations of CELSENTRI in the body when taken at the same time as CELSENTRI. These include:
- other drugs for treating HIV – or hepatitis C – infection (eg atazanavir, kobicistat, darunavir, efavirenz, etravirine, fosamprenavir, indinavir, lopinavir, nelfinavir, ritonavir, saquinavir, boceprevir, telaprevir)
- antibiotics (clarithromycin, telithromycin, rifampicin, rifabutin)
- medicines for fungal infections ( ketoconazole , itraconazole, fluconazole ).
- antiepileptics (eg carbamazepine, phenytoin , phenobarbital).
- Tell your doctor if you (or your child) are taking any of these medicines. The doctor can then prescribe the correct dose one of CELSENTRI.
Pregnancy and breastfeeding
If you are pregnant, getting pregnant or planning to have children:
- Talk to your doctor about the risks and benefits of taking CELSENTRI.
Women who are HIV -positive should not breast-feed, because HIV – infection one can be transferred to the baby through breast milk.
It is not known whether the ingredients in CELSENTRI can also pass into breast milk. If you are breast-feeding or considering starting breast-feeding:
- Talk to your doctor immediately.
Driving and using machines
CELSENTRI can make you dizzy.
- Do not drive, use bicycles or tools or machines unless you are sure you will not be affected.
CELSENTRI contains soy lecithin and sodium.
If you are allergic to peanuts or soy, do not use this medicine.
CELSENTRI contains less than 1 mmol (23 mg) sodium per tablet, ie it is essentially ‘sodium-free’.
3. How to take CELSENTRI
Always take or give this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.
Your doctor will tell you if it is better to take CELSENTRI oral solution if you (or your child) can not swallow tablets.
How much to take
Adults
The recommended dose of CELSENTRI is 150 mg, 300 mg or 600 mg twice dailydepending on other medicines you are taking at the same time. Always take the doserecommended by your doctor.
People with kidney problems
If you have kidney problems, your doctor may need to change your dose .
- Talk to your doctor if this applies to you.
Adolescents and children from 2 years of age who weigh at least 10 kg
Your doctor will determine the correct dose of CELSENTRI based on weight and other medicines taken at the same time.
CELSENTRI can be taken independently of a meal. CELSENTRI should always be taken by mouth.
CELSENTRI should be taken in combination with other medicines used to treat HIV . Read the package leaflet for these other medicines so that you know how to take them.
If you take or give too much CELSENTRI
If you have accidentally taken or given too much CELSENTRI:
- Contact your doctor or nearest hospital immediately.
If you forget to take or give CELSENTRI
If you (or your child) forget to take a dose of CELSENTRI, take or give the missed doseas soon as possible and then continue with the next dose at its usual time.
If it is soon time for your next dose , do not take or give a dose you have forgotten. Wait until the usual time for the next dose .
Do not take or give a double dose to make up for a forgotten dose .
If you or your child stop taking CELSENTRI
Continue treatment with CELSENTRI until your doctor tells you to stop.
It is important to take the medicine at the right time every day, because it ensures that HIV – infection, one does not increase in the body. Therefore, unless your doctor (or your child) tells you to stop treatment, it is important that you continue treatment with CELSENTRI correctly as described above.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. Talk to your doctor if you notice anything unusual about your or your child’s health.
Serious side effects – contact a doctor immediately
Severe allergic reactions or skin reactions
Some patients taking CELSENTRI have developed severe and life-threatening skin reactions and allergic reactions. These are rare and can affect up to 1 in 1,000 people taking CELSENTRI.
If you get any of the following symptoms while taking CELSENTRI:
- swelling of the face, lips or tongue
- breathing difficulties
- widespread skin rash
- fever (high body temperature)
- blisters and flaky skin, especially around the mouth, nose, eyes and genitals.
- Contact a doctor immediately if you get these symptoms. Stop taking CELSENTRI.
Liver problem
These are rare and may affect up to 1 in 1,000 people taking CELSENTRI.
Characters include:
- loss of appetite
- nausea or vomiting
- yellowing of the skin or eyes
- skin rash or itching
- feeling of enormous fatigue
- abdominal pain or tenderness
- dark-colored urine
- drowsiness and confusion
- fever (high body temperature).
- Contact a doctor immediately if you get these symptoms. Stop taking CELSENTRI.
Other side effects are
Common side effects are
These can occur in 1 to 10 out of 100 people :
- diarrhea, nausea, stomach pain, flatulence ( flatulence )
- loss of appetite
- headache, sleep problems, depression
- skin rash ( see also “Severe allergic or skin reactions” above in section 4)
- lethargy or weakness, anemia (detected in blood samples)
- increase in liver enzymes (detected in blood samples) which may be a sign of liver problems ( see also “Liver problems” above in section 4) .
Uncommon side effects are
These can occur in up to 1 in 100 people :
- pneumonia
- fungal infection of the esophagus
- seizures
- dizziness or fainting when standing up
- kidney failure , egg white in the urine
- elevated levels of a substance called CPK (detected in blood tests) which is a sign that muscles are inflamed or damaged.
Rare side effects are
These can occur in up to 1 in 1,000 people :
- chest pain (caused by decreased blood flow to the heart)
- reduced muscle size
- certain types of cancer such as esophageal cancer or cancer of the bile ducts
- decreased number of blood cells (detected in blood samples)
Other possible side effects are with combination therapy for HIV
People treated with combination therapy for HIV may experience other side effects .
Symptoms of infection and inflammation
People with advanced HIV – infection ( AIDS ) have weak immune systems and are at greater risk of developing serious infection you ( opportunistic infection s ). When they start treatment, the immune system becomes stronger and the body begins to fight infection .
Symptoms of infection and inflammation can develop due to:
- old hidden infection flares up again when the body starts fighting them
- the immune system attacks healthy body tissue (autoimmune diseases ).
The symptoms of autoimmune diseases may develop several months after anti- HIV – infection one began. The symptoms can be:
- muscle weakness
- weakness that begins in the hands and feet and spreads upwards towards the torso
- palpitations or tremors
- hyperactivity (great restlessness and excessive movements).
If you get any symptoms of infection or if you notice any of the above symptoms:
- Tell your doctor immediately . Do not take other medicines for infection one without consulting your doctor.
Joint pain, stiffness and skeletal problems
Some patients treated with combination therapy for HIV develop a condition called osteonecrosis . In this condition, parts of the bone tissue die due to reduced blood supply.
It is not known how common this condition is. You may be at greater risk of getting it:
- if you have been treated with combination therapy for a long time
- if you are also taking anti-inflammatory medicines called corticosteroids s
- if you drink alcohol
- if your immune system is very weak
- if you are overweight
Signs to pay attention to:
- stiffness in the joints
- aches and pains (especially in the hips, knees or shoulders)
- mobility impairment
If you notice any of these symptoms:
- Tell your doctor.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information.
5. How to store 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 can label. The expiration date is the last day of the specified month.
No special storage instructions.
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.
6. Contents of the packaging and other information
Content declaration
- The active substance is maravirok. Each film-coated tablet contains 25 mg, 75 mg, 150 mg or 300 mg maraviroc.
- Other ingredients are:
Tablet core: microcrystalline cellulose, calcium hydrogen phosphate (anhydrous), sodium starch glycolate , magnesium stearate
Film coating: poly (vinyl alcohol), titanium dioxide (E171), macrogol 3350, talc, soy lecithin, indigo carmine-aluminum lacquer (E132).
What the medicine looks like and the contents of the pack
CELSENTRI film-coated tablets are blue, imprinted 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 multiple packs containing 180 (2 × 90) film-coated tablets.
Not all pack sizes may be marketed in all countries.
Marketing Authorisation Holder
ViiV Healthcare BV, Van Asch van Wijckstraat 55H, 3811 LP Amersfoort, The Netherlands.
Manufacturer
Pfizer Manufacturing Deutschland GmbH, Betreibsstātte Freiburg, Mooswaldallee 1, 79090 Freiburg, Germany
Contact the representative of the marketing authorization holder to find out more about this medicine:
| Belgium / Belgique / BelgienViiV Healthcare srl / bvTel: +32 (0) 10 85 65 00 | LithuaniaGlaxoSmithKline Lithuania UABTel: + 370 5 264 90 00info.lt@gsk.com |
| BulgariaThe GlaxoSmithKlein ЕООДTel .: + 359 2 953 10 34 | Luxembourg / LuxemburgViiV Healthcare srl / bvBelgium / BelgiumTel: +32 (0) 10 85 65 00 |
| Czech RepublicGlaxoSmithKline sroTel: +420 222 001 111cz.info@gsk.com | HungaryGlaxoSmithKline Kft.Tel .: +36 1 225 5300 |
| DenmarkGlaxoSmithKline Pharma A / STel: + 45 36 35 91 00dk-info@gsk.com | MaltaGlaxoSmithKline (Malta) LimitedTel: +356 21 238131 |
| GermanyViiV Healthcare GmbHTel .: + 49 (0) 89 203 0038-10viiv.med.info@viivhealthcare.com | The NetherlandsViiV Healthcare BVTel: + 31 (0) 33 2081199 |
| EestiGlaxoSmithKline Eesti OÜTel: + 372 6676 900estonia@gsk.com | NorwayGlaxoSmithKline ASTel: + 47 22 70 20 00 |
| GreeceGlaxoSmithKline Aονοπρόσωπη AEBE:Ηλ: + 30 210 68 82 100 | AustriaGlaxoSmithKline Pharma GmbHTel: + 43 (0) 1 97075 0at.info@gsk.com |
| SpainLaboratories ViiV Healthcare, SLTel: +34 900 923 501es-ci@viivhealthcare.com | PolandGSK Services Sp. z ooTel .: + 48 (0) 22 576 9000 |
| FranceViiV Healthcare SASTel .: + 33 (0) 1 39 17 6969Infomed@viivhealthcare.com | PortugalVIIVHIV HEALTHCARE, UNIPESSOAL, LDA.Tel: + 351 21 094 08 01viiv.fi.pt@viivhealthcare.com |
| CroatiaGlaxoSmithKline dooTel: + 385 1 6051 999 | RomaniaGlaxoSmithKline (GSK) SRLTel: + 4021 3028 208 |
| IrelandGlaxoSmithKline (Ireland) LimitedTel: + 353 (0) 1 4955000 | SloveniaGlaxoSmithKline dooTel: + 386 (0) 1 280 25 00medical.x.si@gsk.com |
| IcelandVistor hf.Phone: + 354 535 7000 | Slovak RepublicGlaxoSmithKline Slovakia sroTel: + 421 (0) 2 48 26 11 11recepcia.sk@gsk.com |
| ItalyViiV Healthcare SrlTel: +39 (0) 45 9212611 | Finland / FinlandGlaxoSmithKline OyPuh / Tel: + 358 (0) 10 30 30 30Finland.tuoteinfo@gsk.com |
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| LatviaGlaxoSmithKline Latvia SIATel: + 371 67312687lv-epasts@gsk.com | United KingdomViiV Healthcare UK LtdTel: + 44 (0) 800 221441customercontactuk@gsk.com |