Maraviroc Waymade 150 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Maraviroc Waymade 150 mg film-coated tablets EFG

Maraviroc Waymade 300 mg film-coated tablets EFG

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

• Keep this leaflet, as you may need to read it again.

  1. If you have any questions, ask your doctor, pharmacist or nurse.

• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.

  • If you experience any adverse effects, consult your doctor, pharmacist or nurse, even if these are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

2. What you need to know before taking Maraviroc Waymade

3. How to take Maraviroc Waymade

4. Possible side effects

5. How to store Maraviroc Waymade

6. Contents of the pack and other information

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

Maraviroc Waymade contains an active substance called maraviroc. Maraviroc belongs to a group of medicines known as CCR5 antagonists. Maraviroc works by blocking a 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 must be taken in combination with other medicines used to treat HIV infection. All these medicines are known as 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 increase the CD4 cell count in your blood. CD4 cells are a type of white blood cell that play an important role in helping your body fight infections.

2. What you need to know before starting to take Maraviroc Waymade

Do not take Maraviroc Waymade

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

?Consult your doctor if 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 must take blood samples to determine whether Maraviroc Waymade is an appropriate 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 “Serious adverse effects” in section 4).

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

• 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 up quickly, or if you are taking medicines to lower blood pressure. This is due to a sudden drop in blood pressure. If this occurs, lie down (or have your child lie down) until you feel better. When getting up, do so as slowly as possible.
• tuberculosis (TB) or a serious fungal infection. Maraviroc Waymade may potentially increase your risk of developing infections.
• kidney problems. This is particularly important if you are also taking other medicines (see “Other medicines and Maraviroc Waymade” later in section 2).
• heart or circulatory system problems. Only a limited number of people with serious heart or circulatory problems have taken Maraviroc Waymade.

?Tell your doctor before starting treatment if you think any of the above conditions apply to you (or your child).

Conditions to be aware of

Some people taking medicines for HIV infection develop other disorders, which may be serious. These include:

• Symptoms of infections and inflammation
• Joint pain, stiffness, and bone problems

You need to know which important signs and symptoms to watch for while taking Maraviroc Waymade.

?Read the information about “Other possible adverse effects of combined 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 determine whether you can take Maraviroc Waymade.

Children

The use of maraviroc has not been studied 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 need to take any other medicine.

Inform your doctor or pharmacist if you (or your child) start taking a new medicine while on Maraviroc Waymade. Medicines containing St. John’s wort (Hypericum perforatum) may prevent Maraviroc Waymade from working properly. You must not take them while taking Maraviroc Waymade.

Some medicines can 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 HIV infection or the 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 doctor if 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, become pregnant, or plan to have a baby:

?Consult your doctor about the risks and benefits of taking Maraviroc Waymade.

Breastfeeding is not recommended for women living with HIV because HIV infection can be transmitted to the baby through breast milk.

It is unknown whether maraviroc components can also pass into breast milk. If you are breastfeeding or planning to breastfeed, you must 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 operate machinery or tools if you are unsure whether it affects you.

Maraviroc Waymade contains sodium

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

3. How to take Maraviroc Waymade

Follow exactly the administration instructions for this medicine given by your doctor. If in doubt, consult your doctor or pharmacist.

What amount to 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 medications at the same time. Always take the dose prescribed by your doctor.

Patients with renal problems

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

?Consult your doctor if this applies to you.

Adolescents and children aged 2 years and older with a body weight of at least 10 kg

Your doctor will determine the correct dose of Maraviroc Waymade based on body weight and other medications being taken concomitantly.

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

Maraviroc must be taken in combination with other medications used to treat HIV. Refer to the package leaflet of these other medications for instructions on how to take them.

If you take more Maraviroc Waymade than you should

If you accidentally take or administer 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 at telephone number 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take or administer Maraviroc Waymade

If you (or your child) forget to take a dose of Maraviroc Waymade, take or administer it as soon as possible and then 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 and take the next dose at its scheduled time.

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

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

Continue treatment with Maraviroc Waymade until your doctor advises otherwise.

It is important to take your medication at the prescribed times every day, as this helps ensure that HIV infection does not spread in your body. Therefore, unless your doctor instructs 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 about the use of this medicine, ask your doctor, pharmacist, or nurse.

4. Possible adverse effects

Like all medicines, Maraviroc Waymade can cause adverse effects, although not everyone experiences them. Inform your doctor of any unusual changes in your health or that of your child.

Serious adverse effects – seek medical help immediately

Severe allergic or skin reactions

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

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

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

? Contact your doctor immediately if you have these symptoms. Stop taking Maraviroc Waymade.

Liver problems

These are rare and may affect up to 1 in 1,000 people taking Maraviroc Waymade.

Signs include:

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

? Contact a doctor immediately if you have these symptoms. Stop taking Maraviroc Waymade.

Other adverse effects

Common adverse effects

These may affect between 1 and 10 in every 100 people:

• diarrhoea, general malaise, stomach pain, gas (flatulence)
• loss of appetite
• headache, difficulty sleeping, depression
• rash (see also "Severe allergic or skin reactions" described above in section 4)
• feeling weak or lacking energy, anaemia (seen in blood tests)
• increased liver enzymes (seen in blood tests), which may be a sign of liver problems (see also "Liver problems" described above in this section 4).

Uncommon adverse effects

These may 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 known as CPK (seen in blood tests), which is a sign that muscles may be inflamed or damaged.

Rare adverse effects

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

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

Other possible adverse effects of combined antiretroviral therapy for HIV

People taking combined antiretroviral therapy for HIV may develop other adverse 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 begins to fight these infections.

Symptoms of infection and inflammation may develop, caused either by:

• old, hidden infections that flare up again as the body starts fighting them
• the immune system attacking healthy body tissues (autoimmune disorders).

Symptoms of autoimmune disorders may appear many months after starting HIV treatment. Symptoms may include:

• muscle weakness
• weakness starting in the hands and feet and moving upward toward the trunk
• palpitations or tremors
• hyperactivity (excessive restlessness and movement).

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

?Contact your doctor immediately. Do not take any other medicines for the infection without consulting your doctor.

Joint pain, stiffness, and bone problems

Some patients receiving combined antiretroviral therapy for HIV develop a condition called osteonecrosis. In this condition, parts of the bone tissue die due to reduced blood supply to the bones.

The frequency of this condition is unknown. It is more likely to occur:

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

Signs to watch for include:

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

If you notice any of these symptoms:

?Contact your doctor.

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse 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 stated on the carton and blister pack. The expiry date refers to the last day of the month indicated.

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 properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Maraviroc Waymade

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

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

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

Appearance of the product and contents of the pack

Maraviroc Waymade 150 mg film-coated tablets EFG

Film-coated tablets, white to off-white in colour, 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 in colour, 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 containing 60 film-coated tablets.

Marketing Authorisation Holder and Manufacturer:

Marketing Authorisation Holder

Waymade B.V.

Herikerbergweg 88,

1101CM Amsterdam,

The 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 under the following names:

Netherlands	Maraviroc Waymade 150 mg film-coated tablets Maraviroc Waymade 300 mg film-coated tablets
Austria	Maraviroc Waymade 150 mg film-coated tablets Maraviroc Waymade 300 mg film-coated tablets
Germany	Maraviroc Waymade 150 mg film-coated tablets Maraviroc Waymade 300 mg film-coated tablets
Spain	Maraviroc Waymade 150 mg film-coated tablets EFG Maraviroc Waymade 300 mg film-coated tablets EFG
France	Maraviroc Waymade 150 mg, film-coated tablet Maraviroc Waymade 300 mg, film-coated tablet
Italy	Maraviroc Waymade
Portugal	Maraviroc Waymade 150 mg film-coated tablets Maraviroc Waymade 300 mg film-coated tablets

Date of the most recent review of this leaflet: September 2025

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