Dimethyl fumarate Mylan 120 mg gastro-resistant hard capsules EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Dimethyl fumarate Mylan 120 mg gastro-resistant hard capsules

Dimethyl fumarate Mylan 240 mg gastro-resistant hard capsules

dimethyl fumarate

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 other people, even if they have the same symptoms as you. It may harm them.
• If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet. See section 4.

What is in this leaflet

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

1. What Fumarato de dimetilo Mylan is and what it is used for

What Fumarato de dimetilo Mylan is

Fumarato de dimetilo Mylan is a medicine that contains dimethyl fumarate as the active substance.

What Fumarato de dimetilo Mylan is used for

Fumarato de dimetilo Mylan is used to treat relapsing-remitting multiple sclerosis (MS) in patients aged 13 years and older.

MS is a long-term disease that affects the central nervous system (CNS), which includes the brain and spinal cord. Relapsing-remitting MS is characterized by repeated attacks (relapses) of neurological symptoms. Symptoms vary from patient to patient but usually include: difficulty walking, balance problems, and visual disturbances (e.g., blurred or double vision). These symptoms may completely disappear when a relapse ends, although some problems may persist.

How Fumarato de dimetilo Mylan works

Fumarato de dimetilo Mylan appears to work by preventing the body's immune system from damaging the brain and spinal cord. This may also help delay future worsening of your MS.

2. What you need to know before taking Fumarato de dimetilo Mylan

Do not take Fumarato de dimetilo Mylan

• if you are allergic to dimethyl fumarate or to any of the other ingredients of this medicine (listed in section 6).
• if progressive multifocal leukoencephalopathy (PML), a rare brain infection, is suspected or has been confirmed.

Warnings and precautions

Fumarato de dimetilo Mylan may affect your white blood cell count, kidneys, and liver. Before starting Fumarato de dimetilo Mylan, your doctor will perform a blood test to determine your white blood cell count and to check that your kidneys and liver are functioning properly. Your doctor will carry out periodic blood tests during treatment. If you develop a low white blood cell count during treatment, your doctor may consider additional testing or discontinuation of treatment.

Consult your doctor before starting Fumarato de dimetilo Mylan if you have:

• severe renal disease
• severe hepatic disease
• a stomach or intestinal disorder
• a serious infection (e.g., pneumonia)

Herpes zoster (shingles) may occur during treatment with Fumarato de dimetilo Mylan. In some cases, serious complications have occurred. You must inform your doctor immediately if you suspect you have symptoms of shingles.

If you think your MS is worsening (e.g., weakness or visual changes) or you notice new symptoms, speak directly with your doctor, as these could be signs of a rare brain infection called progressive multifocal leukoencephalopathy (PML). PML is a serious condition that can lead to death or severe disability.

A rare but serious kidney disorder called Fanconi syndrome has been reported with a medicine containing dimethyl fumarate in combination with other fumaric acid esters, used to treat psoriasis (a skin condition). If you notice that you are urinating more than usual, feel more thirsty and drink more than normal, your muscles seem weaker, you break a bone, or you simply have aches and pains, inform your doctor as soon as possible so this can be further investigated.

Children and adolescents

Do not give this medicine to children under 10 years of age, as there is no available data in this age group.

Other medicines and Fumarato de dimetilo Mylan

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, especially:

• medicines containing fumaric acid esters (fumarates) used to treat psoriasis;
• medicines that affect the body's immune system, including chemotherapy, immunosuppressants, or other medicines used to treat MS;
• medicines that affect the kidneys, including certain antibiotics (used to treat infections), diuretics (tablets that increase urine output), certain types of painkillers (such as ibuprofen or other similar non-steroidal anti-inflammatory drugs), and over-the-counter medicines, as well as medicines containing lithium;
• the use of Fumarato de dimetilo Mylan together with certain types of vaccines (attenuated vaccines) could cause you to develop an infection and should therefore be avoided. Your doctor will advise you whether you should receive other types of vaccines (inactivated vaccines).

Taking Fumarato de dimetilo Mylan with alcohol

After taking Fumarato de dimetilo Mylan, avoid consuming more than a small amount (more than 50 ml) of strong alcoholic drinks (with an alcohol volume of more than 30%, such as spirits) for at least one hour, as alcohol may interact with this medicine. This may cause stomach inflammation (gastritis), especially in people who are prone to this condition.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

Information on the effects of this medicine on the fetus when used during pregnancy is limited. Do not use Fumarato de dimetilo Mylan during pregnancy unless you have discussed it with your doctor and the medicine is clearly necessary in your case.

Breastfeeding

It is unknown whether the active ingredient of Fumarato de dimetilo Mylan passes into breast milk. Your doctor will advise you whether you should stop breastfeeding or stop taking Fumarato de dimetilo Mylan. This decision involves weighing the benefits of breastfeeding for your child against the benefits of treatment for you.

Driving and using machines

Fumarato de dimetilo Mylan is not expected to affect your ability to drive or operate machinery.

Fumarato de dimetilo Mylan contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per capsule; essentially, it is "sodium-free".

3. How to take Dimethyl fumarate Mylan

Follow exactly the instructions given by your doctor for taking this medicine. If in doubt, consult your doctor again.

Starting dose: 120 mg twice daily.

Take this starting dose for the first 7 days, then take the usual dose.

Usual dose: 240 mg twice daily.

Dimethyl fumarate Mylan is taken orally.

The capsules must be swallowed whole, with some water. Do not split, crush, dissolve, suck, or chew the capsules, as this may increase certain adverse effects.

Take Dimethyl fumarate Mylan with food – this helps reduce some of the very common adverse effects (listed in section 4).

If you take more Dimethyl fumarate Mylan than you should

If you take too many capsules, contact your doctor immediately. You may experience adverse effects similar to those described below in section 4.

If you forget to take Dimethyl fumarate Mylan

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

You may take the missed dose if at least 4 hours have passed until the next scheduled dose. Otherwise, wait until the time of your next dose.

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

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.

Serious adverse effects

Dimethyl fumarate Mylan could reduce your lymphocyte count (a type of white blood cell in the blood). A low white blood cell count may increase the risk of infection, including a rare brain infection called progressive multifocal leukoencephalopathy (PML). PML can lead to death or cause severe disability. PML has occurred after 1 to 5 years of treatment; therefore, your doctor must continue to monitor your white blood cells throughout treatment, and you should remain alert for any possible symptoms of PML, as described below. The risk of PML may be higher if you have previously taken a medicine that has impaired your immune system function.

Symptoms of PML may resemble those of an MS relapse. Symptoms may include new weakness or worsening of weakness on one side of the body; clumsiness; changes in vision, thinking, or memory; confusion or personality changes; or difficulty speaking and communicating, which may persist for more than several days. Therefore, it is very important that you speak with your doctor as soon as possible if you think your MS is worsening or if you notice any new symptoms while being treated with Dimethyl fumarate Mylan.

Additionally, inform your partner or caregivers about your treatment. Symptoms may arise that you yourself may not notice.

• Call your doctor immediately if you experience any of these symptoms.

Serious allergic reactions

The frequency of serious allergic reactions cannot be estimated from the available data (frequency not known).

Flushing of the face or body (rubefaction) is a very common adverse effect. However, if flushing is accompanied by a red rash or hives and you experience any of the following symptoms:

• swelling of the face, lips, mouth, or tongue (angioedema)
• wheezing, difficulty breathing, or shortness of breath (dyspnea, hypoxia)
• dizziness or loss of consciousness (hypotension)

this could then indicate a serious allergic reaction (anaphylaxis).

• Stop taking Dimethyl fumarate Mylan and call your doctor immediately.

Other adverse effects

Very common (may affect more than 1 in 10 people)

• flushing of the face or body, sensation of warmth, heat, burning sensation, or itching (rubefaction)

• loose stools (diarrhea)

• nausea or vomiting

• stomach pain or cramps

• Taking the medicine with food may help reduce the above adverse effects.

While being treated with Dimethyl fumarate Mylan, urine tests may frequently show the presence of ketones, substances naturally produced in the body.

Consult your doctor about how to manage these adverse effects. Your doctor may reduce your dose. Do not reduce your dose unless instructed by your doctor.

Common (may affect up to 1 in 10 people)

• inflammation of the intestinal mucosa (gastroenteritis)
• vomiting
• indigestion (dyspepsia)
• inflammation of the stomach lining (gastritis)
• gastrointestinal disorders
• burning sensation
• hot flushes, feeling of warmth
• skin itching (pruritus)
• rash
• itchy, rosy or reddish skin patches (erythema)
• hair loss (alopecia)

Adverse effects that may appear in blood or urine tests

• low levels of white blood cells (lymphopenia, leucopenia) in blood. A decrease in white blood cells may reduce the body's ability to fight infections. If you have a serious infection (such as pneumonia), inform your doctor immediately.
• presence of proteins (albumin) in urine
• increased liver enzymes (ALT, AST) in blood

Uncommon (may affect up to 1 in 100 people)

• allergic reactions (hypersensitivity)
• reduction in blood platelets

Rare (may affect up to 1 in 1000 people)

• inflammation of the liver and increased levels of liver enzymes (ALT or AST simultaneously with bilirubin)

Frequency not known (cannot be estimated from the available data)

• herpes zoster (shingles), with symptoms such as blisters, burning, itching, or skin pain, usually on one side of the upper body or face, and other symptoms such as fever and weakness in the early stages of infection, followed by numbness, itching, or painful red rashes.
• nasal discharge (rhinorrhea).

Children (aged 13 years and older) and adolescents

The adverse effects described above also apply to children and adolescents.

Some adverse effects were reported more frequently in children and adolescents than in adults, e.g., headache, stomach pain or cramps, vomiting, sore throat, cough, and painful menstruation.

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the national reporting system included in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Dimethyl fumarate Mylan

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

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

Do not store above 30 °C.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging you no longer need. This helps protect the environment.

6. Contents of the pack and other information

Composition of Dimethyl fumarate Mylan

The active substance is dimethyl fumarate.

Dimethyl fumarate Mylan 120 mg: each capsule contains 120 mg of dimethyl fumarate.

Dimethyl fumarate Mylan 240 mg: each capsule contains 240 mg of dimethyl fumarate.

The other components are microcrystalline cellulose, sodium croscarmellose (see section 2, “Dimethyl fumarate Mylan contains sodium”), talc, colloidal anhydrous silica, magnesium stearate, triethyl citrate, methacrylic acid and methyl methacrylate copolymer (1:1), methacrylic acid and ethyl acrylate copolymer (1:1), 30% dispersion, gelatin, titanium dioxide (E171), brilliant blue FD&C No. 2 (E132), yellow iron oxide (E172), shellac, propylene glycol, ammonium hydroxide and black iron oxide (E172).

Appearance of the product and contents of the pack

Dimethyl fumarate Mylan 120 mg gastro-resistant hard capsules are blue-green and white gastro-resistant hard capsules imprinted with ‘MYLAN’ over ‘DF 120’ containing white to off-white enteric-coated pellets, available in blister packs containing 14 gastro-resistant hard capsules, unit dose blister packs containing 14 gastro-resistant hard capsules, and plastic bottles containing 14 or 60 gastro-resistant hard capsules.

Dimethyl fumarate Mylan 240 mg gastro-resistant hard capsules are blue-green gastro-resistant hard capsules imprinted with ‘MYLAN’ over ‘DF 240’ containing white to off-white enteric-coated pellets, available in blister packs containing 56 or 168 capsules, unit dose blister packs containing 56 or 168 capsules, and plastic bottles containing 56 or 168 gastro-resistant hard capsules.

Only certain pack sizes may be marketed.

Marketing Authorisation Holder

Mylan Ireland Limited
Unit 35/36 Grange Parade
Baldoyle Industrial Estate
Dublin 13
Ireland

Manufacturer

Mylan Hungary Kft.
Mylan utca 1
Komárom, 2900
Hungary

Mylan Germany GmbH
Benzstrasse 1, Bad Homburg
61352 Hesse
Germany

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

Date of the most recent review of this leaflet:

Other sources of information

Detailed information on this medicine is available on the website of the European Medicines Agency: http://www.ema.europa.eu/.