MARAVIROC WAYMADE 300 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Maraviroc Waymade 150 mg film-coated tablets EFG

Maraviroc Waymade 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.
• 1. If you have any further questions, ask your doctor, pharmacist, or nurse.

• 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, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information

1. What is Maraviroc Waymade and what is it used for
2. What you need to know before you take Maraviroc Waymade
3. How to take Maraviroc Waymade
4. Possible side effects

5. Storage of Maraviroc Waymade

1. Contents of the pack and further information

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

Maraviroc Waymade 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 therapy, 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 the 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 Waymade

Do not take Maraviroc Waymade

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

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

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before taking Maraviroc Waymade.

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

Some people taking Maraviroc Waymade have developed severe allergic reactions or skin reactions (see also “Severe 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 Waymade. 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 your 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 severe fungal infection. Maraviroc Waymade 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 Waymade” later in section 2)

• heart problems or circulatory system problems. Only a limited number of people with severe heart or circulatory problems have taken Maraviroc Waymade.

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 taking 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 Waymade.

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 Waymade.

Children

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

Other medicines and Maraviroc Waymade

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 Waymade. Medicines containing St. John's Wort (Hypericum perforatum)may stop Maraviroc Waymade from working properly. Do not take it while taking Maraviroc Waymade.

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

• other medicines for the treatment of 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 Waymade.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

If you are pregnant, become pregnant, or plan to become pregnant:

Consult your doctorabout the risks and benefits of taking Maraviroc Waymade.

It is not recommendedthat HIV-infected women breastfeed their babies because HIV infection can be passed on 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 Waymade may make you feel dizzy.

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

Maraviroc Waymade contains sodium

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

3. How to take Maraviroc Waymade

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

What dose should you take

Adults

The recommended dose of Maraviroc Waymade is 150 mg, 300 mg, or 600 mg twice daily, 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 decide the correct dose of Maraviroc Waymade based on weight and other medicines being taken at the same time. For children weighing less than 40 kg, other concentrations or pharmaceutical forms available on the market may be used.

Maraviroc Waymade can be taken with or without food. Maraviroc Waymade should always be taken orally.

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

If you take more Maraviroc Waymade than you should

If you accidentally take or give too much Maraviroc Waymade?

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 medicine and the amount taken.

If you forget to take or give Maraviroc Waymade

If you (or your child) forget to take a dose of Maraviroc Waymade, take it 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 to take the next dose at the usual time.

Do not take a double dose to make up for missed doses.

If you (or your child) stop taking Maraviroc Waymade

Continue treatment with Maraviroc Waymade until your doctor tells you to stop.

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

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

4. Possible side effects

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

Severe side effects - seek medical help immediately

Severe allergic reactions or skin reactions

Some people taking Maraviroc Waymade have developed severe skin reactions and severe allergic reactions, which can be life-threatening. These are rare, can affect up to 1 in 1,000 peopletaking Maraviroc Waymade.

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

• 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 Waymade.

Liver problems

These are rare and can affect up to 1 in 1,000 peopletaking Maraviroc Waymade.

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 Waymade.

Other side effects

Common side effects

These can affect between 1 and 10 in 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 earlier in 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 earlier in 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 lightheaded 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 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 inflammationmay 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
• pains (especially in the hip, knee, or shoulder)
• difficulty moving.

If you notice any of these symptoms:

Tell your doctor.

Reporting of 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 to the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Maraviroc Waymade

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

Do not use Maraviroc Waymade after the expiry date which is stated on the carton, blister. 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. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Container Content and Additional Information

Composition ofMaraviroc Waymade

• The active ingredient is maraviroc. Each film-coated tablet contains 150 mg or 300 mg of maraviroc.
• The other components are:

Tablet core: microcrystalline cellulose (E460), anhydrous calcium hydrogen phosphate (E341), sodium carboxymethyl cellulose (type A), hypromellose type 2910 (E464), magnesium stearate (E470b).

Coating: Poly(vinyl alcohol) (E1203), titanium dioxide (E171), macrogols (E1521), talc (E553b).

Product Appearance and Container Content

Maraviroc Waymade 150 mg film-coated tablets EFG

Film-coated tablets, white to off-white, oval, biconvex, engraved with "NAV" and "125" on one side and smooth on the other side with approximate dimensions of 8.7 mm x 15.8 mm.

Maraviroc Waymade 300 mg film-coated tablets EFG

Film-coated tablets, white to off-white, oval, biconvex, engraved with "NAV" and "124" on one side and smooth on the other side with approximate dimensions of 10.7 mm x 19.2 mm.

Maraviroc Waymade is supplied in blister packs of 60 film-coated tablets.

Marketing Authorization Holder and Manufacturer:

Marketing Authorization Holder

Waymade B.V.

Herikerbergweg 88,

1101CM Amsterdam,

Netherlands

Manufacturer:

Drehm Pharma GmbH

Grünbergstraße 15/3/3, 1120 Vienna,

Austria

Waymade B.V.

Herikerbergweg 88,

1101CM Amsterdam,

Netherlands

Local Representative:

Biojam España, S.L.

Avda. De las Águilas 2B, 5º 6ª

28044 Madrid, Spain

This medicinal product is authorized in the EEA Member States with the following names:

Date of the Last Revision of this Leaflet:July 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/