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.
• In case of any doubts, consult a doctor or pharmacist.
• This medication has been prescribed to you by a doctor and should not be given to others. It may harm them, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including those not listed in this leaflet, they should inform their 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 medication containing dimethyl fumarate as the active substance.

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. Relapsing-remitting multiple sclerosis is characterized by recurring episodes of neurological symptoms (relapses). Symptoms vary among patients but usually include difficulties with walking and balance, as well as vision problems (e.g., blurred or double vision). These symptoms may completely resolve after a relapse, but some problems may persist.

How does Dimethyl Fumarate Teva work

Dimethyl Fumarate Teva appears 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 the patient is allergic to dimethyl fumarate or any of the other ingredients of this medication (listed in section 6).
• If the patient is suspected or confirmed to have a rare brain infection called progressive multifocal leukoencephalopathy (PML).

Warnings and precautions

Dimethyl Fumarate Teva may have a negative effect on white blood cell countand kidney and liver function. Before starting treatment with Dimethyl Fumarate Teva, the doctor will check the patient's white blood cell count and ensure that the kidneys and liver are functioning properly. These tests will be performed periodically during treatment. If the patient's white blood cell count decreases during treatment, the doctor may consider additional tests or discontinuation of treatment.
Before taking Dimethyl Fumarate Teva, the patient should discuss the following with their doctor:

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

During treatment with Dimethyl Fumarate Teva, shingles (herpes zoster) may occur. In some cases, serious complications have occurred. If the patient suspects they have any symptoms of shingles, they should immediately inform their doctor.
If multiple sclerosis worsens (e.g., the patient experiences weakness or vision problems) or new symptoms appear, the patient should contact their doctor immediately, as these may be symptoms of a rare brain infection called PML. PML is a serious disease that can lead to severe disability or death.
During treatment with a medication containing dimethyl fumarate in combination with other fumaric acid esters used to treat psoriasis (a skin disease), rare but serious kidney problems (Fanconi syndrome) have been reported. If the patient notices they are urinating more, feeling thirstier, and drinking more than usual, their muscles seem weaker, they experience a fracture, or simply feel pain, they should see their doctor as soon as possible for further examination of these symptoms.

Children and adolescents

This medication 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 medications

The patient should tell their doctor or pharmacistabout all medications they are currently taking or have recently taken, as well as any medications they plan to take, especially:

• medications containing fumaric acid esters(fumarates) used to treat psoriasis;
• medications that affect the immune system, including chemotherapy, immunosuppressants, or other medications used to treat multiple sclerosis;
• medications that affect the kidneys, including certain antibiotics(used to treat infections), diuretics, certain types of pain relievers(such as ibuprofen and other similar anti-inflammatory medications, including over-the-counter medications), and medications containing lithium;
• the use of certain vaccines (live vaccines)during treatment with Dimethyl Fumarate Teva, which may lead to infection, and therefore should be avoided. The doctor will advise whether other types of vaccines (inactivated vaccines) can be administered.

Using Dimethyl Fumarate Teva with alcohol

The patient should avoid consuming high-percentage alcoholic beverages (over 30% alcohol by volume) in excess of 50 ml within an hour of taking Dimethyl Fumarate Teva, due to the risk of interaction between alcohol and this medication, which may lead to stomach inflammation (gastritis), especially in individuals prone to this condition.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medication.
Pregnancy
There is limited data on the use of this medication in pregnant women. Dimethyl Fumarate Teva should not be used during pregnancy unless the patient has discussed it with their doctor and the use of this medication is necessary.
Breastfeeding
It is not known whether the active substance of this medication passes into breast milk. The doctor will advise the patient whether to stop breastfeeding or stop taking Dimethyl Fumarate Teva. The decision will be based on the assessment of the benefits of breastfeeding for the baby compared to the benefits of treatment for the patient.

Driving and using machines

The patient should not expect this medication to affect their ability to drive or use machines.

3. How to take Dimethyl Fumarate Teva

This medication should always be taken as directed by the doctor. In case of doubts, the patient should consult their 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.
Each capsule should be swallowed whole, with a glass of water. The capsules should not be divided, crushed, dissolved, sucked, or chewed, as this may increase certain side effects.
Dimethyl Fumarate Teva should be taken with food– this will help alleviate very common side effects (listed in section 4).

Taking a higher dose of Dimethyl Fumarate Teva than recommended

In case of taking more capsules than recommended, the patient should immediately inform their doctor. Side effects similar to those described below in section 4 may occur.

Missing a dose of Dimethyl Fumarate Teva

The patient should not take a double doseto make up for a missed dose.
A missed dose can be taken later, provided that a 4-hour interval is maintained before the next dose. If it is too late, the patient should not take the missed dose but should take the next dose at the usual time.
In case of further doubts about taking this medication, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medications, 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 lead to severe disability or death. PML has been reported after 1 to 5 years of treatment, so the doctor should monitor the patient's white blood cell count throughout the treatment period, and the patient should be aware of the symptoms described below, which may indicate PML. The risk of PML may be higher if the patient has previously taken medications that affect the immune system.
Symptoms of PML may resemble 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 problems or communication difficulties lasting more than a few days

If the patient experiences any of the above symptoms, they should immediately contact their doctor.

Severe allergic reactions

The frequency of severe allergic reactions cannot be determined from the available data (frequency unknown).
A very common side effect is sudden (flushing) redness of the face or body. If 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)

The patient should stop taking Dimethyl Fumarate Teva and immediately contact their doctor.

Other side effects

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

• redness of the face or feeling of increased body temperature, heat, burning of the skin, or itching of the skin (flushing)
• diarrhea
• nausea
• stomach pain or cramps

Taking the medication with food will help alleviate the above side effects.

During treatment with dimethyl fumarate, the presence of ketone bodies (substances normally produced in the body) in the urine is very common.
The patient should ask their doctor how to manage these side effects. The doctor may reduce the dose of the medication. The patient should not reduce the dose themselves unless advised to do so by their doctor.
Common (may affect up to 1 in 10 people)

• inflammation of the lining of the intestines (gastroenteritis)
• vomiting
• indigestion (dyspepsia)
• inflammation of the stomach lining (gastritis)
• gastrointestinal problems
• burning sensation of the skin
• hot flashes, feeling of heat
• itching of the skin (pruritus)
• rash
• pink or red 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 decreased white blood cell count may indicate that the body is less able to fight infection. In case of a severe infection (e.g., pneumonia), the patient should immediately contact their doctor
• 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)

• inflammation of the liver 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 above side effects 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 the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the 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.
Reporting side effects will help gather more information on the safety of this medication.
Side effects can also be reported to the marketing authorization holder.

5. How to store Dimethyl Fumarate Teva

The medication should be stored out of sight and reach of children.
Do not use this medication after the expiry date stated on the blister pack and carton after "Expiry Date" / "EXP". The expiry date refers to the last day of the month stated.
There are no special storage instructions for this medication.
Store in the original package to protect from light.
Medications should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medications they no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Dimethyl Fumarate Teva contains

The active substance of this medication 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, colloidal anhydrous silica, magnesium stearate, triethyl citrate, methacrylic acid, and 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), ammonium hydroxide

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/Aluminum/PVC//Aluminum or single-dose blisters OPA/Aluminum/PVC//Aluminum.
Dimethyl Fumarate Teva, 120 mg, gastro-resistant hard capsules
Pack sizes:
14 gastro-resistant hard capsules (blister pack)
14x1 gastro-resistant hard capsules (perforated single-dose blister pack)
Dimethyl Fumarate Teva, 240 mg, gastro-resistant hard capsules
Pack sizes:
56 gastro-resistant hard capsules (blister pack)
56x1 gastro-resistant hard capsules (perforated single-dose blister pack)
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 medication 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 kapsullo
Dimethyl fumarate TevaPharm 240 mg skrandyje neirios kietosios kapsullo
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