DIMETHYL FUMARATE MYLAN 120 mg HARD GASTRO-RESISTANT CAPSULES

2. What you need to know before you take Mylan Dimethyl Fumarate

Do not take Mylan Dimethyl Fumarate

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

Warnings and precautions

Mylan Dimethyl Fumarate may affect your white blood cell count, kidneys, and liver. Before starting Mylan Dimethyl Fumarate, your doctor will do a blood test to check your white blood cell count and to make sure that your kidneys and liver are working properly. Your doctor will do regular blood tests during treatment. If you have a low white blood cell count during treatment, your doctor may consider additional tests or stop your treatment.

Tell your doctorbefore starting Mylan Dimethyl Fumarate if you have:

• severe kidney disease
• severe liver disease
• a stomach or intestine disease
• a severe infection(e.g., pneumonia)

Herpes zoster (shingles) may occur during treatment with Mylan Dimethyl Fumarate. In some cases, serious complications have occurred. You must tell your doctor immediatelyif you suspect that you have any symptoms of shingles.

If you think that your MS is getting worse (e.g., weakness or changes in vision) or if you notice any new symptoms while being treated with Mylan Dimethyl Fumarate, talk to your doctor directly, as these could 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 esters of fumaric acid, used to treat psoriasis (a skin disease). If you notice that you are urinating more, are thirstier and drink more than usual, your muscles seem weaker, you break a bone or simply have aches and pains, tell 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 is no information available for this age group.

Other medicines and Mylan Dimethyl Fumarate

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

• medicines that contain fumaric acid esters(fumarates) used to treat psoriasis;
• medicines that affect the immune system, including chemotherapy, immunosuppressants, or other medicines used to treat MS;
• medicines that affect the kidneys, including some antibiotics(used to treat infections), diuretics(pills that increase urine production), certain types of painkillers(such as ibuprofen or similar anti-inflammatory medicines, and over-the-counter medicines), and medicines that contain lithium;
• the use of Mylan Dimethyl Fumarate and the administration of certain types of vaccines(live vaccines) could cause you to get an infection and should therefore be avoided. Your doctor will tell you if you should receive other types of vaccines (inactivated vaccines).

Taking Mylan Dimethyl Fumarate with alcohol

After taking Mylan Dimethyl Fumarate, you should 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) for the first hour because alcohol may interact with this medicine. This can cause stomach inflammation (gastritis), especially in people who are prone to this condition.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

There is limited information on the effects of this medicine when used during pregnancy. Do not take Mylan Dimethyl Fumarate during pregnancy unless you have discussed this with your doctor and this medicine is clearly necessary for you.

Breast-feeding

It is not known whether the active substance of Mylan Dimethyl Fumarate passes into breast milk. Your doctor will inform you whether you should stop breast-feeding, or stop taking Mylan Dimethyl Fumarate. This decision will depend on the benefits of breast-feeding for your child and the benefits of treatment for you.

Driving and using machines

Mylan Dimethyl Fumarate is not expected to affect your ability to drive or use machines.

Mylan Dimethyl Fumarate contains sodium

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

3. How to take Mylan Dimethyl Fumarate

Follow the instructions for administration of this medicine exactly as told by your doctor. If you are unsure, ask your doctor again.

Starting dose: 120 mg twice a day.

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

Usual dose: 240 mg twice a day.

Mylan Dimethyl Fumarate is taken by mouth.

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

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

If you take more Mylan Dimethyl Fumarate than you should

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

If you forget to take Mylan Dimethyl Fumarate

Do not take a double doseto make up for forgotten doses.

You can take the forgotten dose if it is at least 4 hours between doses. Otherwise, wait until the next dose is due.

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

4. Possible side effects

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

Serious side effects

Mylan Dimethyl Fumarate may lower 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 will continue to monitor your lymphocytes during treatment, and you should remain alert to any possible symptoms of PML, as described below. The risk of PML may be greater if you have previously taken a medicine that has weakened your immune system.

The symptoms of PML can be similar to those of an MS relapse. The symptoms can 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 talk to your doctor as soon as possible if you think that your MS is getting worse or if you notice any new symptoms while being treated with Mylan Dimethyl Fumarate.

In addition, 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 have any of these symptoms.

Severe allergic reactions

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

Facial or body redness (flushing) is a very common side effect. However, if the redness is accompanied by a red skin rash or hivesandyou have 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 fainting (hypotension)

this could be 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)

• facial or body redness, feeling of heat, heat, burning sensation, or itching (flushing)
• loose stools (diarrhea)
• nausea or vomiting
• stomach pain or cramps

• Taking the medicine with foodmay help to reduce the above side effects.

While being treated with Mylan Dimethyl Fumarate, it is common for urine tests to show the presence of ketones, substances that are produced naturally in the body.

Tell your doctorabout these side effects. Your doctor may reduce your dose. Do not reduce the dose unless your doctor tells you to.

Common(may affect up to 1 in 10 people)

• inflammation of the intestinal mucosa (gastroenteritis)
• vomiting
• indigestion (dyspepsia)
• inflammation of the stomach mucosa (gastritis)
• gastrointestinal disorders
• burning sensation
• hot flashes, feeling of heat
• skin itching (pruritus)
• rash
• red patches or redness accompanied by itching of the skin (erythema)
• hair loss (alopecia)

Side effects that may appear in blood or urine tests

• low white blood cell count (lymphopenia, leucopenia) 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), tell your doctor immediately.
• proteins (albumin) in urine
• increased liver enzymes (ALT, AST) in blood

Uncommon(may affect up to 1 in 100 people)

• allergic reactions (hypersensitivity)
• reduction of blood platelets

Rare(may affect up to 1 in 1,000 people)

• inflammation of the liver and increased 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 pain of 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 infection, followed by numbness, itching, or red spots with severe pain.
• nasal discharge (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, e.g., headache, stomach pain or cramps, vomiting, sore throat, cough, and painful menstruation.

Reporting of side effects

If you experience 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.

5. Storing Mylan Dimethyl Fumarate

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 blister or bottle and on the carton after EXP. The expiry date is the last day of the month stated.

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 no longer required. These measures will help protect the environment.

6. Package Contents and Additional Information

Composition of Dimethyl Fumarate Mylan

The active ingredient 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 ingredients are microcrystalline cellulose, sodium croscarmellose (see section 2 "Dimethyl Fumarate Mylan contains sodium"), talc, colloidal anhydrous silica, magnesium stearate, triethyl citrate, methacrylic acid - methyl methacrylate copolymer (1:1), methacrylic acid - ethyl acrylate copolymer (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 Package Contents

Dimethyl Fumarate Mylan 120 mg hard gastro-resistant capsules are hard gastro-resistant capsules, blue-green and white, with the imprint 'MYLAN' over 'DF 120', containing white to off-white enteric-coated pellets, and are available in blister packs containing 14 hard gastro-resistant capsules, single-dose blister packs containing 14 hard gastro-resistant capsules, and plastic bottles containing 14 or 60 hard gastro-resistant capsules.

Dimethyl Fumarate Mylan 240 mg hard gastro-resistant capsules are hard gastro-resistant capsules, blue-green, with the imprint 'MYLAN' over 'DF 240', containing white to off-white enteric-coated pellets, and are available in blister packs containing 56 or 168 capsules, single-dose blister packs containing 56 or 168 capsules, and plastic bottles containing 56 or 168 hard gastro-resistant capsules.

Only some 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 Last Revision of this Leaflet:

Other Sources of Information

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