Prospect: information for the patient

Mylan Dimethyl Fumarate 120 mg hard gastro-resistant capsules

Mylan Dimethyl Fumarate 240 mg hard gastro-resistant capsules

dimethyl fumarate

Read this prospect carefully before starting to take this medicine, as it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed only for you, and you must not give it to other people even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

What is Dimethyl Fumarate Mylan

Dimethyl Fumarate Mylan is a medication that containsdimethyl fumarateas the active ingredient.

What is Dimethyl Fumarate Mylan used for

Dimethyl Fumarate Mylan is used to treat relapsing-remitting multiple sclerosis (MS) in patients 13 years of age 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 episodes (relapses) of neurological symptoms. Symptoms vary from patient to patient, but often include: difficulties walking, balance problems, and visual problems (e.g., blurred or double vision). These symptoms may disappear completely when the relapse ends, but some problems may persist.

How Dimethyl Fumarate Mylan works

Dimethyl Fumarate Mylan appears to act by preventing the body's defense system from damaging the brain and spinal cord. This may also help to delay future deterioration of MS.

Do not take Fumarato de dimetilo Mylan

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

Warnings and precautions

Fumarato de dimetilo Mylan may affect thenumber of white blood cells, thekidneysand theliver. Before starting Fumarato de dimetilo Mylan, your doctor will do a blood test to get a white blood cell count and check that your kidneys and liver are working properly. Your doctor will do blood tests periodically during treatment. If you experience a decrease in the number of white blood cells during treatment, your doctor may consider additional tests or interrupt your treatment.

Consult your doctorbefore starting to take Fumarato de dimetilo Mylan if you have:

• severerenal disease
• severehepatic disease
• a disease of thestomachor theintestine
• a severeinfection(for example, 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 immediatelyif you suspect you have any of the symptoms of shingles.

If you think your MS is getting worse (e.g., weakness or changes in vision) or notice the appearance of any new symptoms, speak directly with your doctor, as they may be symptoms of a rare brain infection called progressive multifocal leukoencephalopathy (PML). PML is a serious disease that can cause death or severe disability.

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

Children and adolescents

Do not give this medicine to children under 10 years of age because there are no available data in this age group.

Other medicines and Fumarato de dimetilo Mylan

Inform your doctor or pharmacist if you are taking, have taken recently or may have to take any other medicine, in particular:

• medicines that containfumaric acid esters(fumarates) used to treat psoriasis;
• medicines that affect the body's immune system, includingchemotherapy, immunosuppressantsor other medicines used to treat MS;
• medicines that affect the kidneys, includingsomeantibiotics(used to treat infections), “diuretics” (tablets that increase urine elimination), certaintypes of analgesics(such as ibuprofen or other anti-inflammatory medications, and over-the-counter medications) and medicines that containlithium;
• the use of Fumarato de dimetilo Mylan and the administration of certain types ofvaccines(attenuated vaccines) may cause an infection and, therefore, should be avoided. Your doctor will inform you if 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 beverages (with an alcohol content of more than 30%, such as spirits) during the first hour because alcohol may interact with this medicine. It may cause inflammation of the stomach (gastritis), especially in people with a tendency to suffer from this condition.

Pregnancy and breastfeeding

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

Pregnancy

The information on the effects of this medicine on the fetus if used during pregnancy is limited. Do not use Fumarato de dimetilo Mylan during pregnancy unless you have discussed this with your doctor and this 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 inform you if you should stop breastfeeding or if you should stop taking Fumarato de dimetilo Mylan. This decision involves weighing the benefits of breastfeeding for your child and the benefits of treatment for you.

Driving and operating machines

Fumarato de dimetilo Mylan is not expected to affect your ability to drive and use machines.

Fumarato de dimetilo Mylan contains sodium

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

Follow exactly the administration instructions for this medication as indicated by your doctor. If in doubt, consult your doctor again.

Initial dose: 120 mg twice a day.

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

Usual dose: 240 mg twice a day.

Mylan Dimethyl Fumarate is taken orally.

The capsules should be swallowed whole, with some water. Do not break, crush, dissolve, or chew or suck on the capsules because some adverse effects may increase.

Take Mylan Dimethyl Fumarate with food– helps to reduce some very frequent adverse effects (including in section 4).

If you take more Mylan Dimethyl Fumarate than you should

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

If you forgot to take Mylan Dimethyl Fumarate

Do not take a double dose to compensate for the missed doses.

You can take the missed dose if at least 4 hours have passed between doses. Otherwise, wait until the next dose time.

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Severe side effects

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

The symptoms of PML may be similar to those of a relapse of MS. Symptoms may include new or worsening weakness on one side of the body; clumsiness; changes in vision, thinking, or memory; or confusion or changes in personality, or difficulty speaking and communicating that 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 taking Mylan Dimethyl Fumarate.

Also, inform your partner or caregivers about your treatment. It is possible that symptoms may arise that you are not aware of on your own.

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

Severe allergic reactions

The frequency of severe allergic reactions cannot be estimated from the available data (unknown frequency).

Flush (rubefaction) of the face or body is a very common side effect. However, if the flush 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)
• whistling or difficulty breathing, shortness of breath, or lack of breath (disnea, hypoxia)
• dizziness or loss of consciousness (hypotension)

this may then constitute a severe allergic reaction (anaphylaxis).

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

Other side effects

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

• flush (rubefaction) of the face or body, feeling hot, heat, burning sensation, or itching
• loose stools (diarrhea)
• nausea or vomiting
• stomach pain or cramps

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

While taking Mylan Dimethyl Fumarate, it is common for urine tests to show ketones, substances that are naturally produced in the body.

Consult your doctorabout how to treat these side effects. Your doctor may reduce your dose. Do not reduce your dose unless your doctor tells you to.

Common(may affect up to 1 in 10 people)

• inflammation of the intestinal mucosa (gastroenteritis)
• vomiting
• indigestion (dispepsia)
• inflammation of the stomach mucosa (gastritis)
• gastrointestinal disorders
• burning sensation
• sweating, feeling hot
• skin itching (pruritus)
• exanthema
• rosy or reddish patches accompanied by itching on the skin (erythema)
• hair loss (alopecia)

Side effects that may appear in blood or urine tests

• low white blood cell count (lymphopenia, leukopenia) in blood. A decrease in white blood cells can make the body less able to fight infections. If you have a severe infection (such as pneumonia) inform your doctor immediately.
• protein (albumin) in urine
• increase in liver enzymes (ALT, AST) in blood

Uncommon(may affect up to 1 in 100 people)

• allergic reactions (hypersensitivity)
• reduction of platelets in the blood

Rare(may affect up to 1 in 1000 people)

• inflammation of the liver and increase in liver enzymes (ALT or AST simultaneously with bilirubin)

Unknown frequency(cannot be estimated from the available data)

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

Children (13 years of age and older) and adolescents

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

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

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through thenational reporting system included in theAppendix V. By reporting side effects, you can contribute to providing more information about the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the blister pack or bottle and on the box after CAD. The expiration date is the last day of the month indicated.

Do not store at a temperature above 30 °C.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and medications that you no longer need. In this way, you will help protect the environment.

Composition of Mylan Dimepranolone

The active ingredient is dimepranolone.

Mylan Dimepranolone 120 mg: Each capsule contains 120 mg of dimepranolone.

Mylan Dimepranolone 240 mg: Each capsule contains 240 mg of dimepranolone.

The other components are microcrystalline cellulose, sodium croscarmellose (see section 2 “Mylan Dimepranolone contains sodium”), talc, anhydrous colloidal silica, magnesium stearate, triethyl citrate, copolymer of methacrylic acid and methyl methacrylate (1:1), copolymer of methacrylic acid and ethyl acrylate (1:1), 30% dispersion, gelatin, titanium dioxide (E171), brilliant blue FCF (E132), yellow iron oxide (E172), shellac, propylene glycol, ammonium hydroxide, and black iron oxide (E172).

Appearance of the product and packaging contents

Mylan Dimepranolone 120 mg hard-gastrorresistant capsules are blue-green and white hard-gastrorresistant capsules with the imprint ‘MYLAN’ over ‘DF 120’ containing white to off-white enteric-coated pellets and are marketed in blister packs containing 14 hard-gastrorresistant capsules, blister packs containing 14 hard-gastrorresistant capsules, and plastic bottles containing 14 or 60 hard-gastrorresistant capsules.

Mylan Dimepranolone 240 mg hard-gastrorresistant capsules are blue-green hard-gastrorresistant capsules with the imprint ‘MYLAN’ over ‘DF 240’ containing white to off-white enteric-coated pellets and are marketed in blister packs containing 56 or 168 capsules, blister packs containing 56 or 168 capsules, and plastic bottles containing 56 or 168 hard-gastrorresistant capsules.

Only some packaging sizes may be marketed.

Marketing Authorization 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 more information about this medicine, please contact the local representative of the marketing authorization holder:

Last review date of this leaflet:

Other sources of information

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