Dimethyl fumarate Mylan

Package leaflet: Information for the patient

Dimethyl fumarate Mylan 120 mg gastro-resistant hard capsules, 240 mg gastro-resistant hard capsules

dimethyl fumarate
Please 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as yours, because it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet

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

1. What Dimetilfumarato Mylan is and what it is used for

What Dimetilfumarato Mylan is
Dimetilfumarato Mylan is a medicine that contains the active substance dimetilfumarato.
What Dimetilfumarato Mylan is used for
Dimetilfumarato Mylan is used to treat relapsing-remitting multiple sclerosis (MS) in patients aged 13 years and older.
Multiple sclerosis is a chronic disease affecting the central nervous system (CNS), that is, the brain and spinal cord. Relapsing-remitting multiple sclerosis is characterized by repeated attacks (relapses) of symptoms affecting the nervous system. Symptoms vary from patient to patient but generally include difficulty walking, a sensation of imbalance, and vision problems (e.g., blurred or double vision). These symptoms may completely disappear when the relapse resolves, although some problems may persist.
How Dimetilfumarato Mylan works
Dimetilfumarato 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 the disease.

2. What you need to know before taking Dimetilfumarato Mylan

Do not take Dimetilfumarato 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 if the diagnosis of PML has been confirmed.

Warnings and precautions
Dimetilfumarato Mylan may affect the number of white blood cells in the blood, the kidneys, and the liver.
Before starting Dimetilfumarato Mylan, your doctor will perform a blood test to count the number of white blood cells and to check that your kidneys and liver are functioning properly. Your doctor will carry out these tests periodically during treatment. If the number of white blood cells decreases during treatment, your doctor may consider further investigations or discontinuation of therapy.
Contact your doctor before taking Dimetilfumarato Mylan if you have:

• severe disease of the kidneys
• severe disease of the liver
• disease of the stomach or intestine
• a serious infection (such as pneumonia)

Cases of herpes zoster infection (shingles) may occur during treatment with Dimetilfumarato Mylan. In some cases, serious complications may arise. Inform your doctor immediately if you suspect you have any symptoms of herpes zoster infection.
If you think your multiple sclerosis (MS) is worsening (for example, if you experience weakness or changes in vision) or if you notice new symptoms, contact your doctor immediately, as these could be symptoms of a rare brain infection called progressive multifocal leukoencephalopathy (PML). PML is a serious condition that may lead to severe disability or death.
With a medicine containing dimethyl fumarate in combination with other fumaric acid esters used to treat psoriasis (a skin disease), a rare but serious kidney disorder called Fanconi syndrome has been observed. If you notice increased urination, increased thirst and fluid intake, muscle weakness, or bone fracture or pain, contact your doctor as soon as possible for further investigations.
Children and adolescents
Do not give this medicine to children under 10 years of age, as there are no data available in this age group.
Other medicines and Dimetilfumarato Mylan
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, especially:

• medicines containing fumaric acid esters (fumarates) used to treat psoriasis
• medicines that affect the immune system, including chemotherapeutic agents, immunosuppressants, or other medicines used to treat multiple sclerosis;
• medicines that affect the kidneys, including certain antibiotics (used to treat infections), diuretics, some types of analgesics (such as ibuprofen and other similar anti-inflammatory medicines and medicines purchased without a prescription), and medicines containing lithium;
• taking Dimetilfumarato Mylan together with certain types of vaccines ( live vaccines ) could cause you to develop an infection and should therefore be avoided. Your doctor will advise you whether other types of vaccines (non-live vaccines) should be administered.

Dimetilfumarato Mylan and alcohol
Consumption of alcoholic beverages with high alcohol content (more than 30% alcohol by volume, e.g., spirits) in amounts exceeding a small quantity (more than 50 mL) should be avoided within one hour of taking Dimetilfumarato Mylan, as alcohol may interact with this medicine. This could cause inflammation of the stomach (gastritis), particularly in individuals already prone to gastritis.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
There is limited information on the effects of this medicine on the unborn child when used during pregnancy. Do not use Dimetilfumarato Mylan during pregnancy unless you have discussed this with your doctor and the medicine is clearly necessary for you.
Breastfeeding
It is not known whether the active substance of Dimetilfumarato Mylan passes into breast milk. Your doctor will advise you whether you should stop breastfeeding or stop treatment with Dimetilfumarato Mylan. This decision will depend on the benefit of breastfeeding for the child versus the benefit of therapy for you.
Driving and using machines
Dimetilfumarato Mylan is not expected to affect the ability to drive vehicles or use machinery.
Dimetilfumarato Mylan contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per capsule, i.e. essentially ‘sodium-free’.

3. How to take Dimetilfumarato Mylan

Take this medicine exactly as your doctor has told you. If you are in doubt, consult your doctor.
Starting dose: 120 mg twice daily.
Take this starting dose for the first 7 days, then proceed to the regular dose.
Regular dose: 240 mg twice daily.
Dimetilfumarato Mylan is for oral use.
Swallow each capsule whole with some water. Do not split, crush, dissolve, suck or chew the capsule, as this could increase certain side effects.
Take Dimetilfumarato Mylan with food – this may help reduce some of the more common side effects (listed in section 4).
If you take more Dimetilfumarato Mylan than you should
If you have taken too many capsules, contact your doctor immediately. You may experience side effects similar to those described in section 4 below.
If you forget to take Dimetilfumarato Mylan
If you forget or miss a dose, do not take a double dose to make up for the missed dose.
You may take the missed dose if at least 4 hours have passed since the previous dose. Otherwise, wait until your next scheduled dose.
If you have any doubts about how to use this medicine, consult 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

Dimetilfumarato Mylan may reduce levels of lymphocytes (a type of white blood cell). Persistently low levels of white blood cells may increase the risk of infections, including the risk of a rare brain infection called progressive multifocal leukoencephalopathy (PML). PML can cause severe disability or death. PML has occurred after 1–5 years of treatment; therefore, your doctor must continue to monitor your white blood cells for the entire duration of treatment. Pay close attention to any potential symptoms of PML, as described below. The risk of PML may be higher if you have previously taken medicines that impair the immune system function.

Symptoms of PML may resemble those of a multiple sclerosis relapse. Symptoms may include the onset or worsening of weakness on one side of the body; clumsiness; changes in vision, thinking, or memory; or confusion or personality changes, or language and communication difficulties lasting longer than a few days.

Therefore, if you feel your MS is worsening or if you notice any new symptoms during treatment with Dimetilfumarato Mylan, it is very important to contact your doctor as soon as possible. Also, inform your partner or caregiver about your treatment, as symptoms may arise that you may not notice yourself.

→ If you experience any of these symptoms, call your doctor immediately

Serious allergic reactions

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

Flushing of the face or body is a very common side effect. However, if flushing is accompanied by a red skin rash or hives and you have any of the following symptoms:

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

this may indicate a serious allergic reaction ( anaphylaxis )

→ Stop taking Dimetilfumarato Mylan and call a doctor immediately

Other side effects

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

• flushing of the face or body, sensation of warmth, intense heat, burning, or itching
• loose stools ( diarrhea )
• feeling of imminent vomiting ( nausea )
• stomach ache or stomach cramps

→ Taking the medicine with food may help reduce the above-mentioned side effects.

The presence of substances called ketones, which are naturally produced by the body, is very commonly detected in urine tests during treatment with Dimetilfumarato Mylan.

Contact your doctor for advice on how to manage these side effects. Your doctor may reduce your dose. Do not reduce the dose unless your doctor tells you to do so.

Common (may affect up to 1 in 10 people)

• inflammation of the intestinal lining (gastroenteritis)
• feeling unwell (vomiting)
• indigestion (dyspepsia), inflammation of the stomach (gastritis)
• gastrointestinal disorder
• burning sensation
• hot flush, sensation of warmth
• itching
• skin rash
• pink or red spots on the skin (erythema)
• hair loss (alopecia)

Side effects that may be detected in blood or urine tests

• low levels of white blood cells (lymphopenia, leukopenia) in the blood. A reduced number of white blood cells in the blood may indicate that you are unable to fight infections adequately. If you develop a serious infection (such as pneumonia), contact your doctor immediately
• protein ( albumin ) in the urine
• increased levels of liver enzymes ( alanine aminotransferase, ALT and aspartate aminotransferase, AST ) in the blood

Uncommon (may affect up to 1 in 100 people)

• allergic reactions ( hypersensitivity )
• reduced platelet count in the blood

Not known (frequency cannot be estimated from the available data)

• inflammation of the liver and increased levels of liver enzymes ( ALT or AST in combination with bilirubin )
• herpes zoster infection (shingles) with symptoms such as blisters, burning, itching, or skin pain, usually on one side of the torso or face, and other symptoms such as fever and weakness in the early stages of infection, followed by numbness, red or itchy spots, and severe pain
• runny nose (rhinorrhea)

Children (13 years of age and older) and adolescents

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

Some side effects have been reported more frequently in children and adolescents than in adults, such as headache, stomach ache or stomach cramps, vomiting, sore throat, cough, and painful menstruation.

Reporting of side effects

If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store 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, bottle, and carton after "Exp.". The expiry date refers to the last day of that month.
Do not store above 30 °C.
Do not dispose of any medicine 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 Dimetilfumarato Mylan contains
The active substance is dimethyl fumarate.
Dimetilfumarato Mylan 120 mg: each capsule contains 120 mg of dimethyl fumarate.
Dimetilfumarato Mylan 240 mg: each capsule contains 240 mg of dimethyl fumarate.
The other components are microcrystalline cellulose, sodium croscarmellose, talc, anhydrous colloidal 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 FD&C #2 (E132), yellow iron oxide (E172), shellac, propylene glycol, ammonium hydroxide and black iron oxide (E172).

Description of the appearance of Dimetilfumarato Mylan and pack sizes
Dimetilfumarato Mylan 120 mg gastro-resistant hard capsules are blue-green and white gastro-resistant hard capsules, printed with 'MYLAN' above 'DF 120', containing enteric-coated granules of white to off-white colour, and are available in blister packs containing 14 gastro-resistant hard capsules, divisible single-dose blisters containing 14 gastro-resistant hard capsules, and plastic bottles containing 14 or 60 gastro-resistant hard capsules.

Dimetilfumarato Mylan 240 mg gastro-resistant hard capsules are blue-green gastro-resistant hard capsules, printed with 'MYLAN' above 'DF 240', containing enteric-coated granules of white to off-white colour, and are available in blister packs containing 56 or 168 capsules, divisible single-dose blisters containing 56 or 168 capsules, and plastic bottles containing 56 or 168 gastro-resistant hard capsules.

Not all pack sizes may be marketed.

Marketing Authorisation Holder
Mylan Ireland Limited
Unit 35/36 Grange Parade,
Baldoyle Industrial Estate
Dublin 13,
Ireland

Manufacturers
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:

België/Belgique/Belgien Lietuva
Viatris Viatris UAB
Tél/Tel: + 32 (0)2 658 61 00 Tel: +370 5 205 1288

България Luxembourg/Luxemburg
Майлан ЕООД Viatris
Тел.: +359 2 44 55 400 Tél/Tel: + 32 (0)2 658 61 00
(Belgique/Belgien)

Česká republika Magyarország
Viatris CZ s.r.o. Viatris Healthcare Kft.
Tel: + 420 222 004 400 Tel.: + 36 1 465 2100

Danmark Malta
Viatris ApS V.J. Salomone Pharma Ltd
Tlf: +45 28 11 69 32 Tel: + 356 21 22 01 74

Deutschland Nederland
Viatris Healthcare GmbH Mylan BV
Tel: +49 800 0700 800 Tel: +31 (0)20 426 3300

Eesti Norge
Viatris OÜ Viatris AS
Tel: + 372 6363 052 Tlf: + 47 66 75 33 00

Ελλάδα Österreich
Viatris Hellas Ltd Viatris Austria GmbH
Τηλ: +30 2100 100 002 Tel: +43 1 86390

España Polska
Viatris Pharmaceuticals, S.L. Viatris Healthcare Sp. z.o.o.
Tel: + 34 900 102 712 Tel.: + 48 22 546 64 00

France Portugal
Viatris Santé Mylan, Lda.
Tél: +33 4 37 25 75 00 Tel: + 351 21 412 72 00

Hrvatska România
Viatris Hrvatska d.o.o. BGP Products SRL
Tel: +385 1 23 50 599 Tel: +40 372 579 000

Ireland Slovenija
Viatris Limited Viatris d.o.o.
Tel: +353 1 8711600 Tel: + 386 1 23 63 180

Ísland Slovenská republika
Icepharma hf. Slovakia Viatris s.r.o.
Sími: +354 540 8000 Tel: +421 2 32 199 100

Italia Suomi/Finland
Viatris Italia S.r.l. Viatris OY
Tel: + 39 (0) 2 612 46921 Puh/Tel: +358 20 720 9555

Κύπρος Sverige
GPA Pharmaceuticals Ltd Viatris AB
Τηλ: +357 22863100 Tel: + 46 (0)8 630 19 00

Latvija United Kingdom (Northern Ireland)
Viatris SIA Mylan IRE Healthcare Limited
Tel: +371 676 055 80 Tel:+353 18711600

Other sources of information
More detailed information on this medicinal product is available on the European Medicines Agency website: https://www.ema.europa.eu/en