Introduction

Label: information for the user

Maraviroc Tarbis 150 mg film-coated tablets

Maraviroc Tarbis 300 mg film-coated tablets

Read this label carefully before you start taking this medicine, because it contains important information for you.

Keep this label, as you may need to read it again.
If you have any questions, consult your doctor or pharmacist.
This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this label. See section 4.

1. What is Maraviroc Tarbis and what is it used for

Maraviroc contains an active ingredient called maraviroc. Maraviroc belongs to a group of medicines calledCCR5 antagonists. Maraviroc acts by blocking the receptor called CCR5, which HIV uses to enter and infect blood cells.

Maraviroc is used to treat Human Immunodeficiency Virus type 1 (HIV-1) infection in adults, adolescents, and children aged 2 years and older, who weigh at least 10 kg.

Maraviroc should be taken in combination with other medicines that are also used to treat HIV infection. These medicines are all referred to asantiretroviralorantiretroviralmedicines.

As part of the combined treatment, Maraviroc reduces the amount of virus in your body and keeps it at a low level. This helps your body to increase the count of CD4 cells in the blood. CD4 cells are a type of white blood cell that are important for helping your body to fight off infections.

2. What you need to know before starting Maraviroc Tarbis

Do not take Maraviroc Tarbis

if you (or your child, if the patient) areallergicto maraviroc, peanuts, soy, or any of the other components of maraviroc (listed in section 6).

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

Warnings and precautions

Consult your doctor or pharmacist before taking or administering maraviroc.

Your doctor must collect blood samples to see if maraviroc is an appropriate treatment for you (or your child, if the patient).

Some people who take maraviroc have developed severe allergic reactions or skin reactions (see also “Severe adverse reactions” in section 4).

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

liver problems, includingchronic hepatitisB or C. Only a limited number of people with liver problems have taken maraviroc. 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 quickly, or if you are taking medications to lower blood pressure. This is due to a sudden drop in blood pressure. If this happens, lie down (or to your child) until you feel better. When you (or your child) get up, do so slowly.
tuberculosis (TB)or aserious fungal infection. Maraviroc may potentially increase your risk of developing infections.
kidney problems. This isparticularly importantif you are also taking other medications (see “Other medications and Maraviroc Tarbis” later in section 2)
heart problemsorcirculatory system problems. Only a limited number of people with severe heart or circulatory problems have taken maraviroc.

?Inform your doctorbefore starting treatment if you think any of the above situations apply to you (or your child).

Conditions to be aware of

Some people who take medications 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 what important signs and symptoms to watch for while taking maraviroc.

?Read the information on “Other possible adverse effects of combined antiretroviral therapy for HIV” in section 4 of this prospectus.

Older patients

Only a limited number of people aged 65 or older have taken maraviroc. If you belong to this age group, consult your doctor to see if you can take maraviroc.

Children

The use of maraviroc has not been proven in children under 2 years or weighing less than 10 kg. Therefore, maraviroc is not recommended for children under 2 years or weighing less than 10 kg.

Other medications and Maraviroc Tarbis

Inform your doctor or pharmacist if you (or your child) are taking, have taken recently, or may need to takeany other medication.

Inform your doctor or pharmacist if you (or your child) start taking a new medication while taking maraviroc.

It is likely that medications containingSt. John's Wort(Hypericum perforatum) will prevent maraviroc from working correctly.Do not take it while taking maraviroc.

Some medications may affect maraviroc levels in the body when taken at the same time as maraviroc. These include:

other medications for HIV infection or hepatitis C treatment (e.g. atazanavir, cobicistat, darunavir, efavirenz, etravirina, fosamprenavir, indinavir, lopinavir, nelfinavir, ritonavir, saquinavir, boceprevir, telaprevir)
antibiotics(claritromycin, telitromycin, rifampicin, rifabutin)
medicationsantifungals(ketoconazole, itraconazole, fluconazole)
medicationsanticonvulsants(carbamazepine, phenytoin, phenobarbital).

?Inform your doctorif you (or your child) are taking any of these medications. This will allow your doctor to prescribe the correct dose of maraviroc.

Pregnancy and breastfeeding

If you are pregnant, think you may be pregnant, or intend to become pregnant:

?Consult your doctorabout the risks and benefits of taking maraviroc.

It is not recommendedthat women living with HIV breastfeed because HIV infection can be transmitted to the baby through breast milk.

Thecomponents of maraviroc are unknown to pass into breast milk. If you are breastfeeding or plan to breastfeed,you must consult your doctor as soon as possible.

Driving and operating machinery

Maraviroc may make you feel dizzy.

?Do not drive, ride a bike, or operate machines or toolsif you are not sure it affects you.

Maraviroc Tarbis contains soy lecithin.

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

Maraviroc Tarbis contains sodium.

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

3. How to Take Maraviroc Tarbis

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult 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 to take the oral solution of maraviroc.

How much to take

Adults

The recommended dose of maraviroc is 150 mg, 300 mg, or 600 mg twice a daydepending on whether you are using other medications at the same time. Always take the recommended dose as indicated by your doctor.

People with kidney problems

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

?Consult your doctorif this applies to you.

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

Your doctor will indicatethe correct dose of maraviroc according to your weight and other medications you are taking at the same time.

Maraviroc Tarbis can be taken with or without food.Maraviroc must always be taken orally.

Maraviroc must be taken in combination with other medications used to treat HIV. Consult the package insert of these other medications to know how to take them.

If you take or administer more Maraviroc Tarbis than you should

If you accidentally take or administer too much maraviroc

?Contact your doctor or go to the nearest hospital immediately.

In case of overdose or accidental ingestion, consult your doctor or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take or administer Maraviroc Tarbis

If you (or your child) forgot to take or administer a dose of maraviroc, take it or administer 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 administer the missed dose. Wait to take the next dose at the time it is due.

Do not take or administer a double dose to compensate for the missed doses.

If you (or your child) interrupt treatment with Maraviroc Tarbis

Continue treatment with maraviroc until your doctor tells you to.

It is essential that you take your medications every day at the time they are due, as this ensures that the HIV infection does not spread through your body. Unless your doctor tells you to stop treatment, it is essential that you (or your child) continue treatment with maraviroc, as described above.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

4. Possible Adverse Effects

Like all medications, maraviroc can cause side effects, although not everyone will experience them. Inform your doctor about any unusual changes in your health or that of your child.

Severe side effects - seek medical help immediately

Severe allergic or skin reactions

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

If you experience any of the following symptoms while being treated with maraviroc:

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

?Contact your doctor immediatelyif you experience these symptoms.Stop taking maraviroc.

Liver problems

These are rare and may affect up to 1 in 1,000 people who take maraviroc. Signs include:

loss of appetite
nausea/vomiting
yellowing of the skin or eyes
skin rash or itching
feeling very tired
abdominal pain or tenderness
dark urine
drowsiness and confusion
fever (high temperature).

?Contact a doctor immediatelyif you experience these symptoms.Stop taking Maraviroc.

Other side effects

Frequent side effects

These may affect 1 to 10 in 100 people:

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

Rare side effects

These may affect up to 1 in 100 people:

pneumonia
throat infection (esophagus) by fungi
seizures
dizziness, weakness, or drowsiness when standing up
kidney failure, presence of proteins in urine
an increase in a substance called CPK (seen in blood tests) that is a sign that muscles are inflamed or damaged.

Very rare side effects

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

chest pain (caused by reduced blood flow to the heart)
muscle wasting
some types of cancer, such as throat (esophagus) and bile duct cancer
reduction in the number of blood cells (observed in blood tests).

Other possible side effects of combined antiretroviral therapy for HIV

People taking combined 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 severe infections (opportunistic infections). After starting treatment, the immune system becomes stronger, and the body begins to fight these infections.

They may developsymptoms of infection and inflammation, caused by:

old, hidden infections that break out again when the body starts to fight them
the immune system attacking healthy body tissues (autoimmune disorders).

The symptoms of autoimmune disordersmay appear many months after starting to take medications to treat HIV infection.The symptoms may include:

muscle weakness
weakness starting in the hands and feetand spreading to the body trunk
palpitations or tremors
hyperactivity (excessive restlessness and movement).

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

?Inform your doctor immediately.Do not take other medications for the infection without consulting your doctor.

Joint pain, stiffness, and bone problems

Some patients taking combined antiretroviral therapy for HIV develop a condition calledosteonecrosis. 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 unknown. It is more likely to develop:

if you have been taking combined therapy for a long time
if you are also taking anti-inflammatory medications called corticosteroids
if you drink alcohol
if you have a severely weakened immune system
if you are overweight.

The signs to watch out for include:

joint stiffness
pain (especially in the hip, knee, or shoulder)
difficulty moving.

If you notice any of these symptoms:

?Inform your doctor.

Reporting side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for the Vigilance of Medicinal Products for Human Use:https://www.notificaram.es.

By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Conservation of Maraviroc Tarbis

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging and blister/bottle, after CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be disposed of through drains or trash.Dispose of the packaging and medications you no longer need at the SIGRE collection pointat the pharmacy.

Ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Contents of the packaging and additional information

Composition of Maraviroc Tarbis

The active ingredient is maraviroc.

Each film-coated tablet contains 150 mg of maraviroc.

Each film-coated tablet contains 300 mg of maraviroc.

The other components are:

Core of the tablet:Microcrystalline cellulose (E460), Sodium carboxymethyl starch (Type A), Anhydrous colloidal silica, Magnesium stearate (E470b), Anhydrous calcium hydrogen phosphate (E341).

Coating:Poly(vinyl alcohol) (E1203), Talc (E553b), Titanium dioxide (E171), Macrogol (MW3350) (E1521), Soy lecithin (E322), Carmine of indigo (E132).

Appearance of the product and contents of the package

Maraviroc Tarbis 150 mg film-coated tablets EFG

Film-coated tablets, blue in color, oval, biconvex, approximately 8.7 mm x 15.7 mm in size, and engraved with “HM” on one side and “150” on the other.

Maraviroc Tarbis 300 mg film-coated tablets EFG

Film-coated tablets, blue in color, oval, biconvex, approximately 19.4 mm x 10.7 mm in size, and engraved with “HM” on one side and “300” on the other.

Maraviroc Tarbis is available in blisters containing 60 film-coated tablets and in perforated single-dose blisters containing 60 film-coated tablets.

HDPE bottles containing 60 film-coated tablets.

Only some package sizes may be commercially available.

Marketing Authorization Holder

Tarbis Farma S.L.

Gran Vía Carlos III, 94

08028 Barcelona

Spain

Responsible for manufacturing

Amarox Pharma B.V.

Rouboslaan 32

Voorschoten, 2252TR

Netherlands

This medicinal product is authorized in the member states of the European Economic Area with the following names:

Germany:Maraviroc Amarox 150 mg/300 mg Filmtabletten

Netherlands:Maraviroc Amarox 150 mg/300 mg, filmomhulde tabletten

Spain:Maraviroc Tarbis 150 mg/300 mg film-coated tablets EFG

Last review date of this leaflet: 02/2024

Further information on this medicinal product is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/