Dimethyl fumarate teva

Package leaflet: Information for the patient

Dimethyl fumarate Teva, 120 mg, enteric hard capsules
Dimethyl fumarate Teva, 240 mg, enteric hard capsules
Dimethyl fumarate
Please read this leaflet carefully before taking this medicine, as it contains important information for you.

• Keep this leaflet for future reference.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm others, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of the leaflet

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

What Dimethyl fumarate Teva is
Dimethyl fumarate Teva is a medicine containing dimethyl fumarate as the active substance.
What Dimethyl fumarate Teva is used for
Dimethyl fumarate Teva 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 works
Dimethyl fumarate Teva appears to suppress the immune system from causing damage to the brain and spinal cord, which may also help slow the future progression of the disease.

2. Important information before taking Dimethyl fumarate Teva

When not to take Dimethyl fumarate Teva

• if the patient is allergic to dimethyl fumarate or to any of the other ingredients of this medicine (listed in section 6).
• if the patient is suspected of or has been diagnosed with a rare brain infection called progressive multifocal leukoencephalopathy (PML).

Warnings and precautions
Dimethyl fumarate Teva may have an adverse effect on the number of white blood cells and on the function of the kidneys and liver. Before starting treatment with Dimethyl fumarate Teva, 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, the patient should discuss this with the doctor if they have:

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

Shingles (herpes zoster) may occur during treatment with Dimethyl fumarate Teva. In some cases, severe complications have occurred. If the patient suspects any symptoms of shingles, they should inform their doctor immediately.
If multiple sclerosis worsens (e.g. the patient experiences weakness or vision disturbances) or new symptoms appear, the patient should contact their doctor immediately, as these may be signs 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 disorders (Fanconi syndrome) have 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 passing more urine, feel increased thirst and drink more than usual, their muscles seem weaker, experience bone fractures, or simply feel pain, they should contact their doctor as soon as possible for further evaluation of these symptoms.
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 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 anti-inflammatory medicines, including over-the-counter products), and medicines containing lithium;
• use of certain vaccines (live attenuated vaccines) during treatment with Dimethyl fumarate Teva, which may lead to infection; therefore, such vaccination should be avoided. The doctor will advise whether other types of vaccines (inactivated vaccines) should be administered.

Use of Dimethyl fumarate Teva with alcohol
High-strength alcoholic beverages (over 30% alcohol by volume) should be avoided in amounts exceeding 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 gastric irritation (inflammation of the gastric mucosa), 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 child, she should consult her doctor or pharmacist before using this medicine.
Pregnancy
There is limited data on the effects of this medicine on the unborn child when used during pregnancy. Dimethyl fumarate Teva should not be used during pregnancy unless the patient has discussed this with her doctor and the use of this 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. The decision will be based on an assessment of the benefits of breastfeeding for the child compared to the benefits of treatment for the patient.
Driving and operating machinery
This medicine is not expected to affect the ability to drive or operate machinery.

3. How to take Dimethyl fumarate Teva

This medicine should always be taken as instructed by your doctor. If in doubt, consult your doctor.
Initial dose
120 mg twice daily.
This initial 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 should be taken orally.
Each capsule must be swallowed whole with water. Capsules must not be divided, crushed, dissolved, sucked or chewed, as this may increase certain adverse effects.
Dimethyl fumarate Teva should be taken with food – this will help reduce the very common adverse effects listed in section 4.
Taking more Dimethyl fumarate Teva than prescribed
If you take more capsules than prescribed, you must immediately inform your doctor. Adverse effects similar to those described below in section 4 may occur.
Missing a dose of Dimethyl fumarate Teva
Do not take a double dose to make up for a missed dose.
A missed dose may be taken later, provided that a 4-hour interval is maintained before the next dose. If it is too late, do not take the missed dose; 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 effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Serious adverse effects
The medicine Dimethyl fumarate Teva may reduce the number of lymphocytes (a type of white blood cell).
Low numbers of white blood cells may increase the risk of infections, including a rare brain infection
called progressive multifocal leukoencephalopathy (PML). PML may lead to severe disability or death.
PML has been observed after 1 to 5 years of treatment; therefore, the doctor should monitor the patient's
white blood cell count throughout the entire treatment period, and the patient should pay attention to
the symptoms described below, which may indicate PML. The risk of developing PML may be higher
if the patient has previously taken medicines that affect the immune system.
Symptoms of PML may resemble a relapse of multiple sclerosis. These include: new onset of weakness
or worsening of weakness on one side of the body, disturbances in coordination, vision problems,
thinking or memory problems, confusion (disorientation), or personality changes, speech problems,
and communication difficulties lasting longer than a few days. Therefore, if the patient notices
worsening of symptoms related to multiple sclerosis or the occurrence of any new symptoms while
taking Dimethyl fumarate Teva, they should contact their doctor as soon as possible. The patient
should also talk to their partner or caregivers and inform them about their treatment. Symptoms may
occur that the patient may not be aware of.
If any of the symptoms listed above occur, contact a doctor immediately.
Serious allergic reactions
The frequency of serious allergic reactions cannot be determined from available data (frequency unknown).
A very common adverse effect is sudden ( flushing ) redness of the face or body. If flushing 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).

The patient must stop taking Dimethyl fumarate Teva and contact a doctor immediately.
Other adverse effects
Very common ( may occur in more than 1 in 10 people )

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

Taking the medicine with food may help reduce the adverse effects listed above.
During dimethyl fumarate treatment, ketone bodies (substances normally produced in the body)
are very commonly detected in urine tests.
Ask the doctor how to manage these adverse effects. The doctor may reduce the dose of the medicine.
Do not reduce the dose of the medicine on your own unless instructed by the doctor.
Common ( may occur in 1 in 10 people, but not more )

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

Adverse effects that may appear in blood or urine test results

• low number of white blood cells ( lymphopenia, leukopenia ). Reduced white blood cell count may mean the body is less able to fight infections. In case of severe infection (e.g. pneumonia), contact a doctor immediately
• protein ( albumin ) in urine
• increased liver enzyme activity ( ALAT, AspAT ) in blood

Uncommon (may occur in 1 in 100 people, but not more )

• allergic reactions (hypersensitivity )
• decreased platelet count

Rare (may occur in 1 in 1000 people, but not more )

• hepatitis and increased liver enzyme activity ( 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 weakness in the early stages of infection, followed by numbness, itching, red spots, and severe pain
• cold ( nasal congestion )

Children (aged 13 years and older) and adolescents
The adverse effects listed above also apply to children and adolescents.
Some adverse effects were 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 effects
If any adverse effects occur, including any not listed in this leaflet, tell a doctor or pharmacist.
Adverse effects 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 effects helps to provide more information on the safety of the medicine.
Adverse 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 pack and carton after:
"Expiry date (EXP)" / "EXP". The expiry date refers to the last day of the stated month.
There are no special storage temperature requirements for this medicine.
Store in the original packaging 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. Such measures help protect the environment.

6. Package Contents 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 contents: 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).
• Printing ink for capsule (black ink): shellac, potassium hydroxide, propylene glycol (E1520), black iron oxide (E172), concentrated ammonium hydroxide.

What Dimethyl fumarate Teva looks like and contents of the pack
Dimethyl fumarate Teva, 120 mg, gastro-resistant hard capsules: 21.4 mm capsules with a green cap and white body, printed in black with "DMF 120" on the body, containing white to off-white minitablets.
Dimethyl fumarate Teva, 240 mg, gastro-resistant hard capsules: 23.2 mm capsules with a green cap and green body, printed in black with "DMF 240" on the body, containing white to off-white minitablets.
Blisters OPA/Aluminium/PVC//Aluminium or single-dose blisters OPA/Aluminium/PVC//Aluminium.
Dimethyl fumarate Teva, 120 mg, gastro-resistant hard capsules
Pack sizes:
14 gastro-resistant hard capsules (blisters)
14x1 gastro-resistant hard capsules (perforated single-dose blisters)
Dimethyl fumarate Teva, 240 mg, gastro-resistant hard capsules
Pack sizes:
56 gastro-resistant hard capsules (blisters)
56x1 gastro-resistant hard capsules (perforated single-dose blisters)
Not all pack sizes may be marketed.

Marketing Authorisation 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 medicinal product is authorised 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 želudačno otporne kapsule
Dimetilfumarat Teva GmbH 240 mg tvrde želudačno otporne 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 zarnām izturīgas cietās kapsulas
Dimethyl fumarate TevaPharm 240 mg zarnām izturīgas cietās kapsulas
Lithuania: Dimethyl fumarate TevaPharm 120 mg skrandyje neširiančios kietosios kapsulės
Dimethyl fumarate TevaPharm 240 mg skrandyje neširiančios 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