Dimethyl fumarate teva gmbh

Package leaflet: Information for the patient

Dimethyl fumarate Teva GmbH, 120 mg, hard enteric-coated capsules
Dimethyl fumarate Teva GmbH, 240 mg, hard enteric-coated capsules
Dimethylis fumaras
Please read all of this leaflet carefully before taking this medicine because it contains
important information for you.

• 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 specifically. Do not pass it on to others. It may harm someone else, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet

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

1. What Dimethyl fumarate Teva GmbH is and what it is used for

What Dimethyl fumarate Teva GmbH is
Dimethyl fumarate Teva GmbH is a medicine containing dimethyl fumarate as the active substance.
What Dimethyl fumarate Teva GmbH is used for
Dimethyl fumarate Teva GmbH is used to treat relapsing-remitting multiple sclerosis (MS)
in patients aged 13 years and older.
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, periodic episodes of neurological symptoms (called relapses). Symptoms vary between patients but usually include walking and balance problems, and vision impairment (e.g. blurred or double vision). These symptoms may completely resolve after a relapse, but some problems may persist.
How Dimethyl fumarate Teva GmbH works
Dimethyl fumarate Teva GmbH appears to protect the brain and spinal cord by modulating the immune system, which may also help slow the future progression of multiple sclerosis.

2. Important information before taking Dimethyl fumarate Teva GmbH

When not to take Dimethyl fumarate Teva GmbH

• if the patient is 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 has been confirmed in the patient.

Warnings and precautions
Dimethyl fumarate Teva GmbH may adversely affect the number of white blood cells, as well as the function of the kidneys and liver. Before starting treatment with Dimethyl fumarate Teva GmbH, the doctor will check the patient's white blood cell count and assess whether 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 performing additional tests or discontinuing treatment.

Before starting treatment with Dimethyl fumarate Teva GmbH, the patient should discuss this with the doctor if they have:

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

Shingles (herpes zoster) may occur during treatment with Dimethyl fumarate Teva GmbH. In some cases, serious complications have occurred. If the patient suspects 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 progressive multifocal leukoencephalopathy (PML). PML is a serious condition that may lead to severe disability or death.

Rare but serious kidney dysfunction (Fanconi syndrome) has been reported during treatment with dimethyl fumarate in combination with other fumaric acid esters used in the treatment of psoriasis (a skin disease). If the patient notices that they are urinating more than usual, feel increased thirst and drink more than normal, their muscles seem weaker, experience bone fractures, or simply have pain, they should seek medical advice as soon as possible to investigate these symptoms further.

Children and adolescents
This medicine should not be given to children under 10 years of age, as data in this age group are not available.

Dimethyl fumarate Teva GmbH and other medicines
The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take, especially:

• medicines containing fumaric acid esters (fumarates) used in the treatment of psoriasis;
• medicines affecting the immune system, including chemotherapeutic agents, immunosuppressive medicines, or other medicines used to treat multiple sclerosis;
• medicines affecting the kidneys, including certain antibiotics (used to treat infections), diuretics, certain types of painkillers (such as ibuprofen and other similar non-steroidal anti-inflammatory drugs, including over-the-counter medicines), and medicines containing lithium;
• the use of certain vaccines (vaccines containing live microorganisms) during treatment with Dimethyl fumarate Teva GmbH, which may lead to the development of an infection and should therefore be avoided. The doctor will advise whether other types of vaccines (vaccines containing inactivated microorganisms) should be administered.

Dimethyl fumarate Teva GmbH and alcohol
The patient should avoid consuming high-strength alcoholic beverages (over 30% alcohol by volume) in amounts exceeding 50 mL within one hour of taking Dimethyl fumarate Teva GmbH, due to the risk of interaction between alcohol and this medicine. This may lead to gastric irritation (inflammation of the stomach lining), especially in individuals susceptible to this condition.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor or pharmacist before taking this medicine.

Pregnancy
There is limited information on the effects of this medicine when used during pregnancy on the unborn child. Dimethyl fumarate Teva GmbH should not be used during pregnancy unless the patient has discussed this with her doctor and use of the medicine is considered necessary.

Breastfeeding
It is not known whether the active substance of the medicine passes into human milk. The doctor will advise the patient whether she should discontinue breastfeeding or the administration of Dimethyl fumarate Teva GmbH. The decision will be based on an assessment of the benefit of breastfeeding for the child compared to the benefit of treatment for the patient.

Driving and operating machinery
This medicine is not expected to have an effect on the ability to drive or operate machinery.

3. How to take Dimethyl fumarate Teva GmbH

This medicine should always be taken as directed by your doctor. If in doubt, consult your doctor.
Starting dose: 120 mg twice daily.
This starting dose should be taken for the first 7 days, after which the usual maintenance dose should be taken.
Usual maintenance dose: 240 mg twice daily.
Dimethyl fumarate Teva GmbH should be taken orally.
Each capsule should be swallowed whole with water. Capsules must not be divided, crushed, dissolved, sucked or chewed, as this may increase the risk of certain adverse effects.
Dimethyl fumarate Teva GmbH should be taken with food – this helps to reduce the very common adverse effects listed in section 4.
Taking more Dimethyl fumarate Teva GmbH than prescribed
If more capsules than recommended have been taken, you should inform your doctor immediately. Adverse effects similar to those described below in section 4 may occur.
Missing a dose of Dimethyl fumarate Teva GmbH
Do not take a double dose to make up for a missed dose.
A missed dose may be taken later, provided there is at least a 4-hour interval before the next dose. If it is too late, the missed dose should not be taken; instead, take the next dose at the usual time.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like any medicine, this medicine can cause adverse reactions, although not everyone will experience them.
Serious adverse reactions
Dimethyl fumarate Teva GmbH may reduce the number of lymphocytes (a type of white blood cells).
Low white blood cell count may 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; therefore, your doctor should monitor your white blood cell count throughout the entire treatment period, and you should be aware of the symptoms described below, which may indicate PML. The risk of developing PML may be higher if you have previously taken medicines that affect the immune system.
Symptoms of PML may resemble a relapse of multiple sclerosis. These include: new or worsening weakness on one side of the body, coordination problems, vision disturbances, thinking or memory problems, confusion (disorientation), personality changes, speech difficulties, and communication problems lasting longer than a few days. Therefore, if you notice worsening symptoms related to multiple sclerosis or any new symptoms while taking Dimethyl fumarate Teva GmbH, you should contact your doctor as soon as possible. You should also talk to your partner or caregivers and inform them about your treatment. Symptoms may occur that you yourself may not be aware of.
If any of the symptoms listed above occur, contact your doctor immediately.
Serious allergic reactions
The frequency of serious allergic reactions cannot be determined from available data (frequency unknown).
A very common adverse reaction is sudden (episodic) redness of the face or body. If episodic skin redness is accompanied by a red rash or hives and any of the following symptoms:

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

this may indicate a serious allergic reaction (anaphylaxis).
You must stop taking Dimethyl fumarate Teva GmbH and contact your doctor immediately.
Other adverse reactions
Very common ( may occur in more than 1 out of 10 people):

• redness of the face or sensation of increased body temperature, hot flushes, burning or itching of the skin (episodic flushing)
• loose stools (diarrhoea)
• nausea (nausea)
• stomach pain or cramps

Taking the medicine with food may help reduce the adverse reactions listed above.
During dimethyl fumarate treatment, ketone bodies (substances normally produced in the body) are very commonly detected in urine tests.
Talk to your doctor about how to manage these adverse reactions. Your doctor may reduce the dose of the medicine. Do not reduce the dose yourself unless your doctor tells you to do so.
Common ( may occur in no more than 1 out of 10 people):

• inflammation of the intestinal mucosa (gastroenteritis)
• vomiting
• indigestion (dyspepsia)
• inflammation of the stomach lining (gastritis)
• gastrointestinal disorders
• skin burning
• hot flushes, sensation of heat
• itching of the skin (pruritus)
• rash
• pink or red spots on the skin (flush)
• hair loss (alopecia)

Adverse reactions that may be revealed in blood or urine tests:

• low number of white blood cells (lymphopenia, leukopenia). A reduced number of white blood cells may mean that the body is less able to fight infections. If you develop a serious infection (e.g. pneumonia), contact your doctor immediately.
• protein (albumin) in urine
• increased activity of liver enzymes (AlAT, AspAT) in blood

Uncommon (may occur in no more than 1 out of 100 people):

• allergic reactions (hypersensitivity)
• decreased number of platelets

Rare (may occur in no more than 1 out of 1000 people):

• hepatitis and increased activity of liver enzymes (AlAT or AspAT together with bilirubin)

Frequency not known (frequency cannot be determined from available data):

• shingles, with symptoms such as: skin blisters, burning, itching or skin pain, usually on one side of the upper body or face, and other symptoms such as fever and fatigue in the early stages of infection, followed by numbness, itching or red spots with severe pain
• cold (nasopharyngitis)

Children (aged 13 years and above) and adolescents
The adverse reactions listed above also apply to children and adolescents.
Some adverse reactions have been reported more frequently in children and adolescents than in adults, e.g. headache, abdominal pain or stomach cramps, vomiting, sore throat, cough and painful menstruation.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, tell your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions 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 adverse reactions helps to provide more information on the safety of the medicine.
Adverse reactions can also be reported to the marketing authorisation holder.

5. How to store Dimethyl fumarate Teva GmbH

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:
"Expiry date (EXP)" / "EXP". The expiry date refers to the last day of the specified month.
No special storage temperature requirements for this medicine.
Store in the original packaging to protect from light.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the Package and Other Information

What the medicine Dimethyl fumarate Teva GmbH contains
The active substance is dimethyl fumarate.
Dimethyl fumarate Teva GmbH, 120 mg, gastro-resistant hard capsules
Each gastro-resistant hard capsule contains 120 mg of dimethyl fumarate.
Dimethyl fumarate Teva GmbH, 240 mg, gastro-resistant hard capsules
Each gastro-resistant hard capsule contains 240 mg of dimethyl fumarate.
Other ingredients are:

• Capsule contents: microcrystalline cellulose type 112, crospovidone (type A), talc, povidone K30, colloidal anhydrous silica, magnesium stearate, triethyl citrate, methacrylic acid and ethyl acrylate copolymer (1:1), hypromellose, titanium dioxide (E 171), triacetin.
• Capsule shell: gelatin, titanium dioxide (E 171), brilliant blue FCF (E 133), iron oxide yellow (E 172).
• Printing ink for capsule (black ink): shellac, potassium hydroxide, propylene glycol (E 1520), iron oxide black (E 172), concentrated ammonium hydroxide.

What Dimethyl fumarate Teva GmbH looks like and contents of the pack
Dimethyl fumarate Teva GmbH, 120 mg, gastro-resistant hard capsules: capsules
21.4 mm long, with a green cap and a white body, printed in black with “DMF 120” on the body,
containing white to off-white minitablets.
Dimethyl fumarate Teva GmbH, 240 mg, gastro-resistant hard capsules: capsules
23.2 mm long, with a green cap and a green body, printed in black with “DMF 240” on the body,
containing white to off-white minitablets.
Blister packs made of OPA/Aluminium/PVC/Aluminium in cardboard boxes or single-dose blister packs
made of OPA/Aluminium/PVC/Aluminium in cardboard boxes.
Dimethyl fumarate Teva GmbH, 120 mg, gastro-resistant hard capsules
Pack sizes:
14 gastro-resistant capsules (blister packs)
14 x 1 gastro-resistant capsule (perforated single-dose blister packs)
Dimethyl fumarate Teva GmbH, 240 mg, gastro-resistant hard capsules
Pack sizes:
56, 168 or 196 gastro-resistant capsules (blister packs)
56 x 1 gastro-resistant capsule, 168 x 1 gastro-resistant capsule or 196 x 1 gastro-resistant capsule (perforated single-dose blister packs).
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Teva GmbH
Graf-Arco-Str. 3
89079 Ulm
Germany

Manufacturer/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
Teva Operations Poland Sp. z o.o.
ul. Mogilska 80
31-546 Kraków

This medicine is authorised for sale in the European Economic Area countries under the following names:
Austria: Dimethylfumarat !@ctavis 120 mg magensaftresistente Hartkapseln
Dimethylfumarat !@ctavis 240 mg magensaftresistente Hartkapseln
Belgium: Dimethyl Fumarate rtp 120 mg harde maagsapresistente capsules
Dimethyl Fumarate rtp 240 mg harde maagsapresistente capsules
Bulgaria: Диметилфумарат Тева 120 mg стомашно-устойчиви твърди капсули
Dimethylfumarate Teva 120 mg gastro-resistant hard capsules
Диметилфумарат Тева 240 mg стомашно-устойчиви твърди капсули
Dimethylfumarate Teva 240 mg gastro-resistant hard capsules
Croatia: Dimetilfumarat Teva 120 mg tvrde želučanootporne kapsule
Dimetilfumarat Teva 240 mg tvrde želučanootporne kapsule
Cyprus: Dimethyl fumarate/Teva
Czech Republic: Dimethyl fumarát Teva GmbH
Denmark: Dimethyl fumarate Teva
Estonia: Dimethyl fumarate Teva
Finland: Dimethyl fumarate Teva GmbH 120 mg enterokapseli, kova
Dimethyl fumarate Teva GmbH 240 mg enterokapseli, kova
France: DIMETHYLE FUMARATE TEVA 120 mg, gélule gastro-résistante
DIMETHYLE FUMARATE TEVA 240 mg, gélule gastro-résistante
Greece: Dimethyl fumarate/Teva
Spain: Fumarato de dimetilo Teva 120 mg cápsulas duras gastrorresistentes EFG
Fumarato de dimetilo Teva 240 mg cápsulas duras gastrorresistentes EFG
Netherlands: Dimethylfumaraat Teva 120 mg, harde maagsapresistente capsules
Dimethylfumaraat Teva 240 mg, harde maagsapresistente capsules
Ireland: Dimethyl Fumarate Teva GmbH 120 mg Gastro-resistant capsule, hard
Dimethyl Fumarate Teva GmbH 240 mg Gastro-resistant capsule, hard
Iceland: Dimethyl fumarate Teva
Lithuania: Dimethyl fumarate Teva 120 mg skrandyje neirios kietosios kapsulės
Dimethyl fumarate Teva 240 mg skrandyje neirios kietosios kapsulės
Latvia: Dimethyl fumarate Teva 120 mg zarnās šķīstošās cietās kapsulas
Dimethyl fumarate Teva 240 mg zarnās šķīstošās cietās kapsulas
Germany: Dimethylfumarat-ratiopharm 120 mg magensaftresistente Hartkapseln
Dimethylfumarat-ratiopharm 240 mg magensaftresistente Hartkapseln
Norway: Dimethyl fumarate Teva
Poland: Dimethyl fumarate Teva GmbH
Portugal: Fumarato de dimetilo Teva
Slovakia: Dimethyl fumarát Teva GmbH 120 mg tvrdé gastrorezistentné kapsuly
Dimethyl fumarát Teva GmbH 240 mg tvrdé gastrorezistentné kapsuly
Slovenia: Dimetilfumarat Teva 120 mg, 240 mg gastrorezistentne trde kapsule
Dimetilfumarat Teva 120 mg, 240 mg gastrorezistentne trde kapsule
Sweden: Dimethyl fumarate Teva
Hungary: Dimetil-fumarát Teva GmbH 120 mg gyomornedv-ellenálló kemény kapszula
Dimetil-fumarát Teva GmbH 240 mg gyomornedv-ellenálló kemény kapszula
Italy: DIMETILFUMARATO TEVA GENERICS

For further information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Teva Pharmaceuticals Polska Sp. z o.o.
ul. Emilii Plater 53
00-113 Warsaw
tel.: (22) 345 93 00