Dimethil fumarate Teva

Package Leaflet: Information for the Patient

Dimethyl Fumarate Teva, 120 mg, Gastro-Resistant Hard Capsules

Dimethyl Fumarate Teva, 240 mg, Gastro-Resistant Hard Capsules

Dimethyl Fumarate

Read the Package Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.

• 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 others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

• 1. What is Dimethyl Fumarate Teva and what is it used for
• 2. Important information before taking Dimethyl Fumarate Teva
• 3. How to take Dimethyl Fumarate Teva
• 4. Possible side effects
• 5. How to store Dimethyl Fumarate Teva
• 6. Contents of the pack and other information

1. What is Dimethyl Fumarate Teva and what is it used for

What is Dimethyl Fumarate Teva

Dimethyl Fumarate Teva is a medicine that contains the active substance dimethyl fumarate.

What is Dimethyl Fumarate Teva used for

Dimethyl Fumarate Teva is used to treat Relapsing-Remitting Multiple Sclerosis (MS) in patients aged 13 and over.

Multiple sclerosis is a chronic disease that damages the central nervous system (CNS), including the brain and spinal cord.The relapsing-remitting form of multiple sclerosis is characterized by recurring episodes of neurological symptoms (relapses). Symptoms vary among patients but usually include problems with walking and balance and vision disturbances (e.g., blurred or double vision). These symptoms may completely disappear after a relapse, but some problems may persist.

How does Dimethyl Fumarate Teva work

Dimethyl Fumarate Teva seems to prevent the immune system from causing damage to the brain and spinal cord, which may also help slow down the progression of the disease in the future.

2. Important information before taking Dimethyl Fumarate Teva

When not to take Dimethyl Fumarate Teva

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

Warnings and precautions

Dimethyl Fumarate Teva may affect your white blood cell countand kidney and liver function. Before starting treatment with Dimethyl Fumarate Teva, your doctor will check your white blood cell count and ensure that your kidneys and liver are working properly. These tests will be repeated periodically during treatment. If your white blood cell count decreases during treatment, your doctor may consider additional tests or stop treatment.

• severe kidney disease
• severe liver disease
• stomach or intestinal disease
• severe infections(e.g., pneumonia).

During treatment with Dimethyl Fumarate Teva, shingles (herpes zoster) may occur. In some cases, serious complications have occurred. If you suspect you have any symptoms of shingles, inform your doctor immediately. If your multiple sclerosis worsens (e.g., you experience weakness or vision disturbances) or you develop new symptoms, you should contact your doctor immediately, as these may be symptoms of a rare brain infection called progressive multifocal leukoencephalopathy (PML). PML is a serious disease that can cause severe disability or death.

Children and adolescents

This medicine should not be given to children under 10 years of age, as there is no data available for this age group.

Dimethyl Fumarate Teva and other medicines

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, and any you plan to take, especially:

• medicines containing fumaric acid estersused to treat psoriasis;
• medicines that affect the immune system, including chemotherapy, immunosuppressants, or other medicines used to treat multiple sclerosis;
• medicines that affect the kidneys, including certain antibiotics(used to treat infections), diuretics, certain types of painkillers(such as ibuprofen and other non-steroidal anti-inflammatory drugs (NSAIDs)), and lithium;
• the use of certain vaccines (live vaccines)during treatment with Dimethyl Fumarate Teva may increase the risk of infection, so this should be avoided. Your doctor will advise whether other types of vaccines (inactivated vaccines) can be given.

Dimethyl Fumarate Teva and alcohol

Avoid consuming high-alcohol beverages (more than 30% alcohol by volume) in excess of 50 ml within one hour of taking Dimethyl Fumarate Teva, due to the risk of interaction between alcohol and this medicine, which may lead to stomach upset (gastritis), especially in people prone to this condition.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, 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 use of this medicine in pregnant women. Dimethyl Fumarate Teva should not be used during pregnancy unless your doctor considers it necessary.

Breastfeeding

It is not known whether the active substance of this medicine passes into breast milk. Your doctor will advise whether you should stop breastfeeding or stop taking Dimethyl Fumarate Teva. The decision will be based on the benefit of breastfeeding to the baby and the benefit of treatment to the mother.

Driving and using machines

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

3. How to take Dimethyl Fumarate Teva

Always take this medicine exactly as your doctor has told you. If you are not sure, check with your doctor.

Initial dose

120 mg twice a day.

This initial dose should be taken for the first 7 days, and then the usual dose should be taken.

Usual dose

240 mg twice a day.

Dimethyl Fumarate Teva should be taken orally.

Swallow each capsule wholewith water. Do not divide, crush, dissolve, suck, or chew the capsules, as this may increase the risk of certain side effects.

Take Dimethyl Fumarate Teva with food– this will help reduce the very common side effects (listed in section 4).

If you take more Dimethyl Fumarate Teva than you should

If you have taken more capsules than you should, tell your doctor immediately. You may experience side effects similar to those described below in section 4.

If you forget to take Dimethyl Fumarate Teva

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

You can take a missed dose later, provided that a 4-hour interval is maintained before the next dose. If it is too late, do not take the missed dose, but take the next dose at the usual time.

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

4. Possible side effects

Like all medicines, Dimethyl Fumarate Teva can cause side effects, although not everybody gets them.

Severe side effects

Dimethyl Fumarate Teva may decrease the number of lymphocytes (a type of white blood cell). A low white blood cell count can increase the risk of infections, including a rare brain infection called progressive multifocal leukoencephalopathy (PML). PML can cause severe disability or death. PML has been reported after 1 to 5 years of treatment, so your doctor should monitor your white blood cell count throughout treatment, and you should be aware of the symptoms described below, which may indicate PML. The risk of PML may be higher if you have taken medicines that affect the immune system in the past.

Symptoms of PML may resemble those of a relapse of multiple sclerosis. They include:

• new or worsening weakness on one side of the body
• coordination problems
• vision problems
• problems with thinking or memory
• confusion (disorientation) or personality changes
• speech or communication problems lasting more than a few days

If you experience any of these symptoms, contact your doctor immediately.

Severe allergic reactions

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

A very common side effect is sudden (acute) flushing of the face or body. If the flushing is accompanied by a red rash or hives andany of the following symptoms:

• swelling of the face, lips, mouth, or tongue (angioedema)
• wheezing, difficulty breathing, or shortness of breath (dyspnea)
• dizziness or loss of consciousness (hypotension) may indicate a severe allergic reaction (anaphylaxis)

Stop taking Dimethyl Fumarate Teva and contact your doctor immediately.

Other side effects

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

• flushing of the face or feeling of warmth, hot flashes, burning sensation of the skin, or itching of the skin (acute flushing)
• diarrhea
• nausea
• stomach pain or cramps

Taking the medicine with food will help reduce these side effects.

During treatment with dimethyl fumarate, the presence of ketone bodies (substances normally produced in the body) in the urine is very common.

Ask your doctor how to deal with these side effects. Your doctor may reduce the dose of the medicine. Do not reduce the dose yourself unless your doctor advises you to.

Common (may affect up to 1 in 10 people)

• gastritis (inflammation of the stomach lining)
• vomiting
• indigestion (dyspepsia)
• stomach upset (gastritis)
• gastrointestinal disorders
• burning sensation of the skin
• hot flashes
• itching of the skin (pruritus)
• rash
• red or pink spots on the skin (erythema)
• hair loss (alopecia)

Side effects that may be detected by blood or urine tests

• low white blood cell count (lymphopenia, leukopenia). A low white blood cell count may mean that your body is less able to fight infection. If you have a severe infection (e.g., pneumonia), contact your doctor immediately
• protein (albumin) in the urine
• increased liver enzyme activity (ALAT, AspAT) in the blood

Uncommon (may affect up to 1 in 100 people)

• allergic reactions (hypersensitivity)
• decreased platelet count

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

• liver inflammation and increased liver enzyme activity (ALAT or AspAT together with bilirubin)

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

• shingles, with symptoms such as blisters on the skin, 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 infection, followed by numbness, itching, or red spots and severe pain
• runny nose (rhinitis)

Children (aged 13 and over) 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 pain or cramps, vomiting, sore throat, cough, and painful menstruation.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. By reporting side effects, you can help provide more information on the safety of this medicine.

Side effects can also be reported to the marketing authorization holder.

5. How to store Dimethyl Fumarate Teva

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

Do not use this medicine after the expiry date stated on the blister and carton after "Expiry Date" / "EXP". The expiry date refers to the last day of the month.

No special storage instructions are required.

Store in the original package to protect from light.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Dimethyl Fumarate Teva contains

The active substance is dimethyl fumarate.

Dimethyl Fumarate Teva, 120 mg, gastro-resistant hard capsules

Each gastro-resistant hard capsule contains 120 mg of dimethyl fumarate.

Dimethyl Fumarate Teva, 240 mg, gastro-resistant hard capsules

Each gastro-resistant hard capsule contains 240 mg of dimethyl fumarate.

Other ingredients are:

• Capsule content: microcrystalline cellulose, crospovidone, talc, povidone, silicon dioxide, magnesium stearate, triethyl citrate, methacrylic acid - ethyl acrylate copolymer (1:1), hypromellose, titanium dioxide (E171), triacetin.
• Capsule shell: gelatin, titanium dioxide (E171), brilliant blue FCF (E133), yellow iron oxide (E172)
• Capsule printing ink (black ink): shellac, potassium hydroxide, propylene glycol (E1520), black iron oxide (E172), concentrated ammonia solution.

What Dimethyl Fumarate Teva looks like and contents of the pack

Dimethyl Fumarate Teva, 120 mg, gastro-resistant hard capsules (gastro-resistant hard capsules): capsules 21.4 mm, with a green cap and white body, with black printing "DMF 120" on the body, containing white to off-white mini-tablets.

Dimethyl Fumarate Teva, 240 mg, gastro-resistant hard capsules (gastro-resistant hard capsules): capsules 23.2 mm, with a green cap and green body, with black printing "DMF 240" on the body, containing white to off-white mini-tablets.

OPA/Aluminium/PVC//Aluminium or single-dose OPA/Aluminium/PVC//Aluminium blisters.

Dimethyl Fumarate Teva, 120 mg, gastro-resistant hard capsules

Package sizes:

14 gastro-resistant hard capsules (blister)

14x1 gastro-resistant hard capsules (perforated single-dose blisters)

Dimethyl Fumarate Teva, 240 mg, gastro-resistant hard capsules

Package sizes:

56 gastro-resistant hard capsules (blister)

56x1 gastro-resistant hard capsules (perforated single-dose blisters)

Not all pack sizes may be marketed.

Marketing authorization holder

Teva Pharmaceuticals Polska Sp. z o.o.

ul. Emilii Plater 53

00-113 Warsaw

tel.: (22) 345 93 00

Importer

Pharmadox Healthcare Ltd.

KW20A Kordin Industrial Park

Paola, PLA 3000

Malta

Adalvo Limited

Malta Life Sciences Park

Building 1, Level 4, Sir Temi Zammit Buildings

San Gwann, SGN 3000

Malta

KeVaRo GROUP Ltd

9 Tzaritza Elenora Str. Office 23

1618 Sofia

Bulgaria

This medicine is authorized in the Member States of the European Economic Area under the following names:

Iceland:

Dimethyl Fumarate Teva GmbH

Austria:

Dimethylfumarat ratiopharm GmbH 120 mg magensaftresistente Hartkapseln

Dimethylfumarat ratiopharm GmbH 240 mg magensaftresistente Hartkapseln

Belgium:

Dimethyl Fumarate Teva 120 mg harde maagsapresistente capsules / gélules gastrorésistantes / magensaftresistente Hartkapseln

Dimethyl Fumarate Teva 240 mg harde maagsapresistente capsules / gélules gastrorésistantes / magensaftresistente Hartkapseln

Bulgaria:

Диметилфумарат Тева Фарма 120 mg стомашно-устойчиви твърди капсули

Dimethylfumarate Teva Pharma 120 mg gastro-resistant hard capsules

Диметилфумарат Тева Фарма 240 mg стомашно-устойчиви твърди капсули

Dimethylfumarate Teva Pharma 240 mg gastro-resistant hard capsules

Czech Republic:

Dimethyl fumarate Teva CR

Germany:

Dimethylfumarat-ratiopharm 120 mg magensaftresistente Hartkapseln

Dimethylfumarat-ratiopharm 240 mg magensaftresistente Hartkapseln

Denmark:

Dimethyl fumarate Teva GmbH

Estonia:

Dimethyl fumarate TevaPharm

Spain:

Fumarato de dimetilo Tevagen 120 mg cápsulas duras gastrorresistentes EFG

Fumarato de dimetilo Tevagen 240 mg cápsulas duras gastrorresistentes EFG

Finland:

Dimethyl fumarate ratiopharm GmbH 120 mg enterokapseli, kova

Dimethyl fumarate ratiopharm GmbH 240 mg enterokapseli, kova

France:

DIMETHYLE FUMARATE TEVA SANTE 120 mg, gélule gastrorésistante

DIMETHYLE FUMARATE TEVA SANTE 240 mg, gélule gastrorésistante

Croatia:

Dimetilfumarat Teva GmbH 120 mg tvrde žvrde 20 mg0 m kapsule

Dimetilfumarat Teva GmbH 240 mg tvrde želučanootporne kapsule

Hungary:

Dimetil-fumarát ratiopharm 120 mg gyomornedv-ellenálló kemény kapszula

Dimetil-fumarát ratiopharm 240 mg gyomornedv-ellenálló kemény kapszula

Ireland:

Dimethyl Fumarate Teva 120mg gastro-resistant capsules

Dimethyl Fumarate Teva 240mg gastro-resistant capsules

Italy:

DIMETILFUMARATO TEVA ITALIA

Latvia:

Dimethyl fumarate TevaPharm 120 mg zarn m šķīn mgrm ciettm kapsulas

Dimethyl fumarate TevaPharm 240 mg zarn m šķīn mgrm ciettm kapsulas

Lithuania:

Dimethyl fumarate TevaPharm 120 mg skrandyje neirios kietosios kapsulės

Dimethyl fumarate TevaPharm 240 mg skrandyje neirios kietosios kapsulės

Netherlands:

Dimethylfumaraat Teva 120 mg, harde maagsapresistente capsules

Dimethylfumaraat Teva 240 mg, harde maagsapresistente capsules

Norway:

Dimethyl fumarate Teva GmbH

Poland:

Dimethyl fumarate Teva

Portugal:

Fumarato de dimetilo ratiopharm

Romania:

Dimetil fumarat Teva 120 mg capsule gastro-rezistente

Dimetil fumarat Teva 240 mg capsule gastro-rezistente

Sweden:

Dimethyl fumarate Teva GmbH

Slovenia:

Dimetilfumarat Teva GmbH 120 mg, 240 mg gastrorezistentne trde kapsule

Dimetilfumarat Teva GmbH 120 mg, 240 mg gastrorezistentne trde kapsule

Slovakia:

Dimethylfumarate Teva Slovakia 120 mg tvrdé gastrorezistentné kapsuly

Dimethylfumarate Teva Slovakia 240 mg tvrdé gastrorezistentné kapsuly

Date of last revision of the leaflet: June 2025