Maraviroc Waymade

Package leaflet: Information for the user

Maraviroc Waymade 150 mg film-coated tablets, 300 mg film-coated tablets

Equivalent medicine
Please read this leaflet carefully before taking this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. See section 4.

Contents of this 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 a medicine called maraviroc. Maraviroc belongs to a group of medicines known as CCR5 (C-C chemokine receptor type 5) antagonists.
Maraviroc Waymade works by blocking the CCR5 receptor, thereby preventing the HIV virus from entering and infecting blood cells.
Maraviroc Waymade 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 Waymade must be taken in combination with other medicines used for the treatment of HIV infection. These medicines are known as anti-HIV medicines or antiretrovirals.
Maraviroc Waymade, as part of combination therapy, reduces the amount of virus in the body and keeps it at low levels. This helps the body to increase the number of CD4 cells in the blood, a type of white blood cell important in helping the body fight infection.

2. What you need to know before taking 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 for your child, if they are the patient).
Some people who take Maraviroc Waymade have developed serious 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 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. Close monitoring of liver function may be necessary. (See also 'Liver problems' in section 4.)
• low blood pressure, including dizziness when standing up or sitting down quickly, or if you are taking other medicines that lower blood pressure. This is due to a sudden drop in blood pressure. If this occurs, lie down until you (or your child) feel better. When getting up, do so as slowly as possible.
• tuberculosis (TB) or serious fungal infections. Maraviroc Waymade may potentially increase the risk of developing infections.
• kidney problems. This is particularly important if you are also taking certain other medicines (see 'Other medicines and Maraviroc Waymade' in section 2 below).
• heart or circulatory system problems. Only a limited number of people with serious heart or circulatory problems have taken Maraviroc Waymade. Consult your doctor before starting treatment if you think any of these conditions apply to you (or your child).

Conditions requiring caution
Some people taking medicines for HIV infection develop other conditions, which may be serious. These include:

• symptoms of infections and inflammation
• joint pain, stiffness, and bone problems
  You should be aware of important signs and symptoms so you can remain vigilant while taking Maraviroc Waymade.

Read the information under 'Other possible side effects of combination HIV therapy' in section 4 of this leaflet.
Elderly
Only a limited number of people aged 65 years or older have taken Maraviroc Waymade. If you belong to this age group, discuss with your doctor whether you can take Maraviroc Waymade.
Children
The use of Maraviroc Waymade has not been evaluated 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.
Inform your doctor or pharmacist if you (or your child) start taking a new medicine during treatment with Maraviroc Waymade.
Medicines containing St. John’s Wort (Hypericum perforatum) may interfere with the proper functioning of Maraviroc Waymade. You must not take them while taking Maraviroc Waymade.
Some medicines may alter the amount of Maraviroc Waymade in your body when taken at the same time as Maraviroc Waymade. These include:

• other medicines to treat HIV infection or hepatitis C virus (such as 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, think you might be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
If you are pregnant, become pregnant, or are planning to have a baby:
discuss with your doctor the risks and benefits of taking Maraviroc Waymade.
Breastfeeding is not recommended for HIV-positive women, as HIV infection can be transmitted to the baby through breast milk.
It is not known whether the components of Maraviroc Waymade pass into breast milk. If you are breastfeeding or considering breastfeeding, you must speak to your doctor as soon as possible.
Driving and using machines
Maraviroc Waymade may cause dizziness.
You must not drive, ride a bicycle, or operate tools or machinery unless you are certain you are not affected.
Maraviroc Waymade contains sodium.
Maraviroc Waymade contains less than 1 mmol of sodium (23 mg) per tablet, i.e. essentially 'sodium-free'.

3. How to take Maraviroc Waymade

Take (or give) this medicine exactly as prescribed by your doctor. If you have
any doubts, consult your doctor or pharmacist.
Dosage
Adults
The recommended dose of Maraviroc Waymade is 150 mg, 300 mg or 600 mg twice daily,
depending on the other medicines you are taking at the same time. Always take the dose
recommended by your doctor.
Patients with kidney problems
If you have a kidney problem, your doctor may adjust the dose.
➔ Talk to your doctor if this applies to you.
Use in children and adolescents
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
medicines being taken at the same time. For children weighing less than 40 kg, alternative dosage
forms or strengths available on the market may be used.
Maraviroc Waymade can be taken with or without food. Maraviroc Waymade must always be
taken by oral route (by mouth).
Maraviroc Waymade must be taken in combination with other medicines for the treatment of
HIV. Refer to the Package Leaflet of these medicines for instructions on 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 the nearest hospital immediately.
If you forget to take Maraviroc Waymade
If you (or your child) forget to take a dose of Maraviroc Waymade, take or give the missed dose as
soon as possible, then continue with the next dose at the scheduled time.
If it is almost time for the next dose, do not take or give the missed dose. Wait for the next dose at
the scheduled time.
Do not take a double dose to make up for a forgotten dose.
If you or your child stops treatment with Maraviroc Waymade
Continue taking Maraviroc Waymade until your doctor tells you to stop.
Taking your medicine at the correct time every day is important because it ensures that HIV infection
does not increase in the body. Therefore, unless your doctor tells you (or your child) to stop treatment,
it is important to continue taking Maraviroc Waymade correctly as described above.
If you have any doubts about how to use this medicine, consult your doctor, pharmacist or
nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them. Inform your doctor if you notice any unusual changes in your health or that of your child.

Serious side effects – contact your doctor immediately

Severe allergic reactions or skin reactions
Some people taking Maraviroc Waymade have experienced severe and life-threatening skin reactions and allergic reactions. These are rare and may affect up to 1 in 1,000 people treated with Maraviroc Waymade.
If you experience any of the following symptoms while taking Maraviroc Waymade:

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

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

Liver problems
These are rare and may affect up to 1 in 1,000 people treated with Maraviroc Waymade.
Signs include:

• loss of appetite
• nausea or 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 your doctor immediately if you experience these symptoms. Stop taking Maraviroc Waymade.

Other side effects

Common side effects
These may affect 1 to 10 out of 100 people:

• diarrhoea, nausea, stomach ache, gas ( flatulence )
• loss of appetite
• headache, sleep problems, depression
• rash ( see also ‘Severe allergic reactions or skin reactions’ at the beginning of section 4 )
• weakness or lack of energy, anaemia (detected by blood test results)
• increased liver enzymes (detected by blood test results), which may be a sign of liver problems ( see also ‘Liver problems’ at the beginning of section 4 )

Uncommon side effects
These may affect up to 1 in 100 people:

• lung infection
• fungal infections of the throat ( oesophagus )
• seizures
• feeling dizzy, faint, or lightheaded when standing
• kidney failure, protein in the urine
• increase in a substance known as CPK (detected by blood test results), indicating muscle inflammation or damage

Rare side effects
These may 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 cancer of the throat ( oesophagus ) and bile duct
• reduction in blood cell counts (detected by blood test results)

Other possible side effects of combination HIV therapy
People taking combination therapy for HIV may experience 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 ). When they start treatment, their immune system becomes stronger and begins to fight existing infections.
Symptoms of infection and inflammation may therefore develop due to:

• reactivation of old "silent" infections as the body starts fighting them
• the immune system attacking the body's own healthy tissues ( autoimmune disorders )

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

• muscle weakness
• weakness starting in the hands and feet and spreading towards the trunk
• palpitations or tremor
• hyperactivity (excessive agitation and movement)

If you experience any signs of infection or any of the symptoms listed above: contact your doctor immediately. Do not take any other medicines for infection without medical advice.

Joint pain, stiffness, and bone problems
Some people on combination therapy for HIV develop a condition called osteonecrosis. As a result of this condition, part of the bone tissue dies due to reduced blood supply to the bone.
It is not known how common this condition is. It is more likely to occur if you:

• have been on combination therapy for a long time
• are also taking anti-inflammatory medicines called corticosteroids
• consume alcohol
• have a very weak immune system
• are overweight

Signs to watch for include:

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

If you notice any of these symptoms: inform your doctor.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. You can also report side effects directly via the national reporting system at the website
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store 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 pack or on the blister label. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Maraviroc Waymade contains
The active substance is maraviroc. Each film-coated tablet contains 150 mg or 300 mg of maraviroc.
The other ingredients are:
Tablet core: microcrystalline cellulose (E460), anhydrous calcium hydrogen phosphate (E341),
sodium starch glycolate (type A), hypromellose type 2910 (E464), magnesium stearate (E470b).
Coating: partially hydrolysed poly(vinyl alcohol) (E1203), titanium dioxide (E171),
macrogol (E1521), talc (E553b).

Description of the appearance of Maraviroc Waymade and pack contents
Maraviroc Waymade 150 mg film-coated tablets
Film-coated tablet, white to off-white, oval biconvex in shape, imprinted with "NAV" and "125" on one side and plain on the other, with approximate dimensions of 8.7 mm x 15.8 mm.

Maraviroc Waymade 300 mg film-coated tablets
Film-coated tablet, white to off-white, oval biconvex in shape, imprinted with "NAV" and "124" on one side and plain on the other, with approximate dimensions of 10.7 mm x 19.2 mm.

Maraviroc Waymade is supplied in blisters 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 Wien,
Austria

This medicinal product is authorised in the EEA Member States under the following names:
Netherlands Maraviroc Waymade 150 mg filmomhulde tabletten
Maraviroc Waymade 300 mg filmomhulde tabletten

Austria Maraviroc Waymade 150 mg Filmtabletten
Maraviroc Waymade 300 mg Filmtabletten

Germany Maraviroc Waymade 150 mg Filmtabletten
Maraviroc Waymade 300 mg Filmtabletten

Spain Maraviroc Waymade 150 mg comprimidos recubiertos con película
Maraviroc Waymade 300 mg comprimidos recubiertos con película

France Maraviroc Waymade 150 mg, comprimé pelliculé
Maraviroc Waymade 300 mg, comprimé pelliculé

Italy Maraviroc Waymade

Portugal Maraviroc Waymade 150 mg comprimidos revestidos por película
Maraviroc Waymade 300 mg comprimidos revestidos por película