MARAVIROC TARBIS 300 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Maraviroc Tarbis 150 mg film-coated tablets EFG

Maraviroc Tarbis 300 mg film-coated tablets EFG

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• 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.

Contents of the pack

1. What is Maraviroc Tarbis and what is it used for
2. What you need to know before you take Maraviroc Tarbis
3. How to take Maraviroc Tarbis
4. Possible side effects
5. Storing Maraviroc Tarbis
6. Contents of the pack and other information

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

Maraviroc contains the active substance maraviroc. Maraviroc belongs to a group of medicines called CCR5 antagonists. Maraviroc works by blocking the CCR5 receptor, which the HIV virus uses to enter and infect blood cells.

Maraviroc is used to treat HIV-1 infection in adults, adolescents, and children aged 2 years and older, weighing at least 10 kg.

Maraviroc must be taken in combination with other medicines that are also used to treat HIV infection. All these medicines are called anti-HIV medicines or antiretrovirals.

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

2. What you need to know before you take Maraviroc Tarbis

Do not take Maraviroc Tarbis

• if you (or your child, if they are the patient) are allergicto maraviroc, peanuts, soy, or any of the other ingredients of maraviroc (listed in section 6).

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

Warnings and precautions

Talk to your doctor or pharmacist before taking or administering maraviroc.

Your doctor should take blood samples to see if maraviroc is a suitable treatment for you (or your child, if they are the patient).

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

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

• liver problems, including chronic hepatitis B 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 down quickly, or if you are taking medicines to lower blood pressure. This is due to a sudden drop in blood pressure. If this happens, lie down (or have your child lie down) until you feel better. When you get up, do it as slowly as possible.
• tuberculosis (TB)or a severe fungal infection. Maraviroc may potentially increase your risk of developing infections.
• kidney problems. This is especially importantif you are also taking other medicines (see “Other medicines and Maraviroc Tarbis” later in section 2).
• heart problemsor circulatory system problems. Only a limited number of people with severe heart or circulatory problems have taken maraviroc.

Tell your doctorbefore starting treatment if you think any of the above applies to you (or your child).

Conditions to be aware of

Some people who take medicines for HIV infection develop other conditions, which can be serious. These include:

• Symptoms of infection and inflammation
• Pain in the joints, stiffness, and bone problems

You need to know what important signs and symptoms to look out for while taking maraviroc.

Read the information on “Other possible side effects of combination antiretroviral therapy for HIV” in section 4 of this leaflet.

Elderly patients

Only a limited number of people aged 65 years 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 tested in children under 2 years of age or weighing less than 10 kg. Therefore, maraviroc is not recommended in children under 2 years of age or weighing less than 10 kg.

Other medicines and Maraviroc Tarbis

Tell your doctor or pharmacist if you (or your child) are taking, have recently taken, or might take any other medicines.

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

It is likely that medicines containing St. John's Wort (Hypericum perforatum)will stop maraviroc from working properly. Do not take it while you are taking maraviroc.

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

• other medicines for treating HIVor hepatitis C virus(e.g., 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 doctorif you (or your child) are taking any of these medicines. 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 are planning to have a baby:

Ask your doctorabout the risks and benefits of taking maraviroc.

It is not recommendedthat HIV-infected women breastfeed their babies because HIV infection can be passed to the baby through breast milk.

It is not known whether the components of maraviroc can pass into breast milk. If you are breastfeeding or thinking of breastfeeding, consult your doctor as soon as possible.

Driving and using machines

Maraviroc may make you feel dizzy.

Do not drive, ride a bike, or use machines or toolsif you are not sure that maraviroc does not affect you.

Maraviroc Tarbis contains soy lecithin.

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

Maraviroc Tarbis contains sodium.

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

3. How to take Maraviroc Tarbis

Always take this medicine exactly as your doctor has told you. If you are not sure, check with your doctor or pharmacist.

If you (or your child) are unable to swallow the tablets, your doctor will consider whether it is best for you (or your child) 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 day, depending on whether you are taking other medicines at the same time. Always take the dose recommended by your doctor.

People with kidney problems

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

Consult your doctorif this applies to you.

Adolescents and children aged 2 years and older and weighing at least 10 kg

Your doctor will tell you the correct dose of maraviroc based on weight and other medicines being taken at the same time.

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

Maraviroc must be taken in combination with other medicines used to treat HIV. Check the package leaflet of these other medicines to find out how to take them.

If you take or give more Maraviroc Tarbis than you should

If you accidentally take or give 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, telephone 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take or give Maraviroc Tarbis

If you (or your child) miss a dose of maraviroc, take or give 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 give the missed dose. Wait and take the next dose at the usual time.

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

If you (or your child) stop taking Maraviroc Tarbis

Continue treatment with maraviroc until your doctor tells you to stop.

It is important that you take your medicines every day, as prescribed, to ensure that the HIV infection does not spread throughout your body. Therefore, unless your doctor tells you to stop treatment, it is important that you (or your child) continue treatment with maraviroc as described above.

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

4. Possible side effects

Like all medicines, maraviroc can cause side effects, although not everybody gets them. Tell your doctor about any unusual changes in your health or your child's health.

Serious side effects - seek medical help immediately

Severe allergic reactions or skin reactions

Some people who took maraviroc have developed severe skin reactions and allergic reactions that can be life-threatening. These are rare and can affect up to 1 in 1,000 people taking maraviroc.

If you have any of these symptoms while being treated with maraviroc:

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

Contact your doctor immediatelyif you have these symptoms. Stop taking maraviroc.

Liver problems

These are rare and can affect up to 1 in 1,000 peopletaking maraviroc. The signs include:

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

Contact a doctor immediatelyif you have these symptoms. Stop taking Maraviroc.

Other side effects

Common side effects

These can affect 1 to 10 in every 100 people:

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

Uncommon side effects

These can affect up to 1 in 100 people:

• lung infection
• fungal infection of the throat (esophagus)
• seizures
• feeling dizzy, weak, or faint when standing up
• kidney failure, presence of protein in the urine
• an increase in a substance called CPK (seen in blood tests) that is a sign of muscle inflammation or damage.

Rare side effects

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

• chest pain (caused by reduced blood flow to the heart)
• reduction in muscle size
• certain types of cancer such as throat (esophageal) and bile duct cancer
• reduction in the number of blood cells (seen in blood tests).

Other possible side effects of combination antiretroviral therapy for HIV

People taking combination 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 serious infections (opportunistic infections). After starting treatment, the immune system becomes stronger, so the body starts to fight these infections.

Symptoms of infection and inflammationcan develop, caused by:

• old, hidden infections that flare up again when the body starts to fight them
• the immune system attacking healthy tissues in the body (autoimmune disorders).

Symptoms of autoimmune disorderscan appear many months after starting to take medicines for HIV infection. The symptoms can include:

• muscle weakness
• weakness that starts in the hands and feet and moves up towards the trunk of the body
• palpitations or tremors
• hyperactivity (excessive restlessness and movement).

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

Tell your doctor immediately.Do not take other medicines for infection without your doctor's advice.

Pain in the joints, stiffness, and bone problems

Some patients on combination antiretroviral therapy for HIV develop a condition called osteonecrosis. 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 not known. It is more likely to develop:

• 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 weakened immune system
• if you are overweight.

Signs to look out for include:

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

If you notice any of these symptoms:

Tell your doctor.

Reporting side effects

If you experience 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 via the Spanish Medicines Agency's online platform: https://www.notificaram.es.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Maraviroc Tarbis

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

Do not use this medicine after the expiry date which is stated on the carton and blister/ bottle after EXP. The expiry date refers to the last day of the month shown.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to a pharmacy for disposal.

Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Packaging Content 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:

Tablet core: 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), soybean lecithin (E322), indigo carmine (E132).

Appearance of the Product and Packaging Content

Maraviroc Tarbis 150 mg film-coated tablets EFG

Film-coated tablets, blue, oval, biconvex, with approximate dimensions 8.7 mm x 15.7 mm and engraved with "HM" on one face and "150" on the other.

Maraviroc Tarbis 300 mg film-coated tablets EFG

Film-coated tablets, blue, oval, biconvex, with approximate dimensions 19.4 mm x 10.7 mm and engraved with "HM" on one face and "300" on the other.

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

HDPE bottles containing 60 film-coated tablets.

Only some pack sizes may be marketed.

Marketing Authorization Holder

Tarbis Farma S.L.

Gran Vía Carlos III, 94

08028 Barcelona

Spain

Manufacturer

Amarox Pharma B.V.

Rouboslaan 32

Voorschoten, 2252TR

Netherlands

This medicinal product is authorized in the Member States of the European Economic Area under 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

Date of the last revision of this leaflet: 02/2024

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