Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - mavenclad

Document Subject

Generated Narrative: MedicinalProductDefinition mpc6f251ac470345e2bc0f62b0b3ff2ff0

identifier: http://ema.europa.eu/identifier/EU/1/17/1212/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: MAVENCLAD 10 mg tablets

type: Full name

part

part: nan

type: Invented name part

part

part: nan

type: Scientific name part

part

part: nan

type: Strength part

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part: nan

type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-c6f251ac470345e2bc0f62b0b3ff2ff0

identifier: http://ema.europa.eu/identifier/EU/1/17/1212/001

status: Final

type: Package Leaflet

category: Raw

date: 2022-02-16 13:28:17+0000

author: Organization ACME industry

title: TEST PURPOSES ONLY - mavenclad

Attesters

What is in this leaflet

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

MAVENCLAD contains the active substance cladribine, a cytotoxic (cell killing) substance that works mostly on lymphocytes, cells of the immune system that are involved in inflammation.

MAVENCLAD is a medicine used to treat multiple sclerosis (MS) in adults. MS is a disease in which inflammation destroys the protective sheath around the nerves.

Treatment with MAVENCLAD has been shown to reduce flare-ups of symptoms and to slow down progression of disability.

Do not take MAVENCLAD

• if you are allergic to cladribine or any of the other ingredients of this medicine (listed in section 6).

• if you are HIV positive, meaning you are infected with the human immunodeficiency virus (HIV).

• if you have active tuberculosis or liver inflammation (hepatitis).

• if you have a weakened immune system due to medical conditions or because you are taking other medicines that weaken your immune system or reduce the production of blood cells in your bone marrow. These include:

• ciclosporin, cyclophosphamide and azathioprine (used to suppress the immune system, for example after organ transplantation);

• methotrexate (used to treat conditions such as psoriasis or rheumatoid arthritis);

• long-term corticosteroids (used to reduce inflammation, for example in asthma). See also 'Other medicines and MAVENCLAD'.

• if you have active cancer.

• if you have moderate or severe kidney problems.

• if you are pregnant or breast-feeding (see also 'Pregnancy and breast-feeding').

Do not take MAVENCLAD and talk to your doctor or pharmacist if you are unsure if any of the above applies to you.

Warnings and precautions

Talk to your doctor or pharmacist before taking MAVENCLAD.

Blood tests

You will have blood tests before you start treatment to check that you can take MAVENCLAD. The doctor will also do blood tests during and after treatment to check that you can continue to take MAVENCLAD, and that you are not developing any complications from the treatment.

Infections

You will be tested to see if you have any infections before you start MAVENCLAD treatment. It is important to talk to your doctor if you think you have an infection. Symptoms of infections can include: fever, aching, painful muscles, headache, generally feeling unwell or yellowing of the eyes. Your doctor may delay treatment, or interrupt it, until the infection clears up.

Shingles

If necessary, you will be vaccinated against shingles before you start treatment. You will need to wait between 4 and 6 weeks for the vaccination to take effect. Tell your doctor immediately if you get symptoms of shingles, a common complication of MAVENCLAD (see section 4), which may need specific treatment.

Progressive multifocal leukoencephalopathy (PML)

If you believe your MS is getting worse or if you notice any new symptoms, for example changes in mood or behaviour, memory lapses, speech and communication difficulties, talk to your doctor as soon as possible. These may be the symptoms of a rare brain disorder caused by infection and called progressive multifocal leukoencephalopathy (PML). PML is a serious condition that may lead to severe disability or death.

Although PML has not been observed with MAVENCLAD, as a precaution, you may have a head MRI (magnetic resonance imaging) before you start treatment.

Cancer

Single events of cancer have been observed in patients who had received cladribine in clinical studies. Talk to your doctor if you have previously had cancer. Your doctor will decide the best treatment options for you. As a precautionary measure, you should follow standard cancer screening recommendations, as advised by your doctor.

Liver problems

MAVENCLAD may cause liver problems. Talk to your doctor before taking MAVENCLAD if you have or have ever had liver problems. Tell your doctor immediately if you develop one or more of the following symptoms: feeling sick (nausea), vomiting, stomach pain, tiredness (fatigue), loss of appetite, yellow skin or eyes (jaundice) or dark urine. These could be symptoms of serious liver problems.

Contraception

Men and women must use effective contraception during treatment and for at least 6 months after the last dose. This is important because MAVENCLAD can seriously harm your baby.

See also 'Pregnancy and breast-feeding'.

Blood transfusions

If you require blood transfusions, tell the doctor that you are taking MAVENCLAD. You may have to have the blood irradiated to prevent complications.

Changing treatments

If you change from other MS treatments to MAVENCLAD, your doctor will check that your blood cell counts (lymphocytes) are normal before you start treatment.

If you change from MAVENCLAD to other MS treatments, talk to your doctor. There can be overlaps in the effect on your immune system.

Children and adolescents

Use of MAVENCLAD is not recommended in patients below the age of 18 years, because it has not been investigated in this age group.

Other medicines and MAVENCLAD

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

Do not start MAVENCLAD together with medicines that weaken your immune system or reduce the production of blood cells by your bone marrow. These include:

• ciclosporin, cyclophosphamide and azathioprine (used to suppress the immune system, for example after organ transplantation);

• methotrexate (used to treat conditions such as psoriasis or rheumatoid arthritis);

• long-term corticosteroids (used to reduce inflammation, for example in asthma). Short-term corticosteroids can be used when advised by your doctor.

Do not use MAVENCLAD together with other medicines for MS unless specifically advised by your doctor.

Do not take MAVENCLAD at the same time as any other medicine. Leave a gap of at least 3 hours between taking MAVENCLAD and other medicines taken by mouth. MAVENCLAD contains hydroxypropylbetadex that may interact with other medicines in your stomach.

Talk to your doctor, if you are or have been treated with:

• medicines which may affect your blood cells (for example carbamazepine, used to treat epilepsy). Your doctor may need to supervise you more closely.

• certain types of vaccines (live and live attenuated vaccines). If you have been vaccinated within the last 4 to 6 weeks, MAVENCLAD therapy must be delayed. You must not receive such vaccines during MAVENCLAD treatment. Your immune system must have recovered before you can be vaccinated, and blood tests will check this.

• dilazep, nifedipine, nimodipine, reserpine, cilostazol or sulindac (used to treat the heart, high blood pressure, vascular conditions or inflammation), or eltrombopag (used to treat conditions associated with bleeding). Your doctor will tell you what to do if you have to take these medicines.

• rifampicin (used to treat certain types of infection), St. John's wort (used to treat depression) or corticosteroids (used to suppress inflammation). Your doctor will tell you what to do if you have to take these medicines.

Pregnancy and breast-feeding

Do not take MAVENCLAD if you are pregnant or trying to become pregnant. This is important because MAVENCLAD may seriously harm your baby.

You must use effective methods of contraception to avoid becoming pregnant during MAVENCLAD treatment and for 6 months after taking the last dose. If you get pregnant more than 6 months after the last dose in year 1, no safety risk is expected but this will mean that you cannot receive treatment with MAVENCLAD while you are pregnant.

Men must use effective methods of contraception to prevent their partner from getting pregnant while being treated with MAVENCLAD and for 6 months after the last dose.

Your doctor will give you guidance on appropriate methods of contraception.

Do not take MAVENCLAD, if you are breast-feeding. If your doctor believes that MAVENCLAD is essential for you, your doctor will advise you to stop breast-feeding during treatment and at least one week after the last dose.

Driving and using machines

MAVENCLAD is not expected to affect your ability to drive or use machines.

MAVENCLAD contains sorbitol

This medicine contains 64 mg sorbitol in each tablet.

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Treatment courses

You will be given MAVENCLAD as two treatment courses over 2 years. Each treatment course consists of 2 treatment weeks, which are one month apart at the beginning of each treatment year. A treatment week consists of 4 or 5 days on which you receive 1 or 2 tablets daily (see Table 1).

Example: if you start your treatment mid April, you take your tablets as shown.

Table 1 Year 1 Year 2 1st treatment week 1 or 2 tablets daily for 4 or 5 days, mid April 1st treatment week 1 or 2 tablets daily for 4 or 5 days, mid April 2nd treatment week 1 or 2 tablets daily for 4 or 5 days, mid May 2nd treatment week 1 or 2 tablets daily for 4 or 5 days, mid May

Before you start a treatment course, your doctor will do a blood test to check that the levels of lymphocytes (a type of white blood cells) are in an acceptable range. If this is not the case, your treatment will be delayed.

Once you have completed the 2 treatment courses over 2 years, your doctor will continue to monitor your health for another 2 years, in which you do not need to take the medicine.

Dose

1. You will be prescribed the correct number of tablets for each treatment week, based on your body weight as shown in Table 2. 2. You will need one or more packs to provide the correct number of tablets.
2. When you receive your supply of medicine, check that you have the correct number of tablets.
3. In the left column of the table below find the row that fits your body weight (in kg), and then check the number of tablets that should be in the pack(s) for the treatment week you will be starting.
4. If the number of tablets in your pack(s) is different from the number shown for your weight in the table below, speak to your doctor.
5. Note that for some weight ranges the number of tablets may vary from one treatment week to the next.

Example: if you weigh 85 kg and are about to start treatment week 1, you will be given 8 tablets.

Table 2 Your weight Number of tablets to take Year 1 treatment course Year 2 treatment course Treatment week 1 Treatment week 2 Treatment week 1 Treatment week 2 less than 40 kg Your doctor will tell you the number of tablets to take 40 to less than 50 kg 4 4 4 4 50 to less than 60 kg 5 5 5 5 60 to less than 70 kg 6 6 6 6 70 to less than 80 kg 7 7 7 7 80 to less than 90 kg 8 7 8 7 90 to less than 100 kg 9 8 9 8 100 to less than 110 kg 9 9 110 kg and above How to take your medicine

Take the tablet(s) at about the same time each day. Swallow them with water and without chewing. You do not have to take the tablets at meal times. You can take them with meals or between meals.

Read the 'Step-by-Step Guide' at the end of this package leaflet on how to handle the child- resistant package and how to take the tablets included in the pack.

Important

• Ensure your hands are dry before picking up your tablet(s).
• Push your tablet(s) through the blister and swallow immediately.
• Do not leave your tablet(s) exposed on surfaces, for example on a table, or handle the tablet longer than necessary.
• If a tablet is left on a surface or if it breaks and fragments fall from the blister, the area must be thoroughly washed.
• Thoroughly wash your hands after handling the tablets.
• If you lose a tablet, contact your doctor for advice.

Duration of a treatment week

Depending on the total number of tablets you have been prescribed, you have to take them over 4 or 5 days, in each treatment week. Table 3 shows how many tablets (1 or 2 tablets) you have to take on each day. If your daily dose is 2 tablets, take them at the same time.

Example: if you have to take 8 tablets, you would take 2 tablets on Day 1, Day 2, Day 3, then 1 tablet on Day 4 and Day 5. Table 3 Total number of tablets
per treatment week Day 1 Day 2 Day 3 Day 4 Day 5 4 1 1 1 1 0 5 1 1 1 1 1 6 2 1 1 1 1 7 2 2 1 1 1 8 2 2 2 1 1 9 2 2 2 2 1 2 2 2 2 2

If you take more MAVENCLAD than you should

If you have taken more tablets than you should, contact your doctor immediately. Your doctor will decide if you need to stop treatment or not.

There is limited experience with overdose of MAVENCLAD. It is known that the more medicine you take the less lymphocytes may be present in your body, resulting in lymphopenia (see section 4).

If you forget to take MAVENCLAD

If you miss a dose and you remember on the same day you were supposed to take it If you miss a dose and do not remember it until the following day Take the missed dose on that day. Do not take the missed dose along with the next scheduled dose. Take the missed dose on the next day and extend the number of days in that treatment week.

Example: If you forget to take the Day 3 dose and do not remember it until Day 4, take the Day 3 dose on Day 4, and extend the total number of days in the treatment week by 1 day. If you miss 2 consecutive doses (for example both Day 3 and Day 4 doses), take the missed doses for the next 2 days, and then extend the treatment week by 2 days.

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

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Some side effects could be or could become serious

Lymphopenia and shingles (may affect more than 1 in 10 people)

The most important side effect is a reduction in the number of white blood cells called lymphocytes (lymphopenia), which is very common and may be severe. Lymphopenia may increase the risk of getting an infection. An infection commonly seen with MAVENCLAD is shingles.

Tell your doctor immediately if you have symptoms of shingles such as a 'band' of severe pain and blistering rash, typically on one side of the upper body or the face. Other symptoms may be headache, burning, tingling, numbness or itchiness of the skin in the affected area, feeling generally unwell or feverish in the early stages of infection.

Shingles will need to be treated, and MAVENCLAD treatment may need to be stopped until the infection is cleared.

Liver problems (uncommon - may affect up to 1 in 100 people)

Tell your doctor immediately if you have symptoms such as feeling sick (nausea), vomiting, stomach pain, tiredness (fatigue), loss of appetite, yellow skin or eyes (jaundice) or dark urine. MAVENCLAD treatment may need to be stopped or interrupted.

Other possible side effects

Common (may affect up to 1 in 10 people)

• cold sore (oral herpes)
• rash
• hair loss
• reduction in the number of certain white blood cells (neutrophils)
• allergic reactions, including itching, hives, rash and swelling of the lips, tongue or face

Very rare (may affect up to 1 in 10,000 people)

• tuberculosis

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

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 cardboard wallet and the carton after EXP. The expiry date refers to the last day of that month.

Store in the original package in order to protect from moisture.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

What MAVENCLAD contains

• The active substance is cladribine. Each tablet contains 10 mg cladribine.
• The other ingredients are hydroxypropylbetadex, sorbitol and magnesium stearate.

What MAVENCLAD looks like and contents of the pack

MAVENCLAD tablets are white, round, biconvex tablets engraved with 'C' on one side and '10' on the other side. Each pack contains 1, 4, 5, 6, 7 or 8 tablets in a blister, sealed in a cardboard wallet and fixed in a child-resistant carton. Not all pack sizes may be marketed.

Marketing Authorisation Holder

Merck Europe B.V. Gustav Mahlerplein 1082 MA Amsterdam The Netherlands

Manufacturer

NerPharMa S.R.L. Viale Pasteur, 20014 Nerviano (MI) Italy

R-Pharm Germany GmbH Heinrich-Mack-Strasse 89257 Illertissen Germany

Merck S.L. Pol gono Merck 08100 Mollet del Vall s (Barcelona) Spain

This leaflet was last revised in .

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site: