Dimethyl fumarate stada

Package leaflet: Information for the patient

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

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for you personally. Do not pass it on to others. It may harm someone else, even if their symptoms are the same.
• 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 STADA is and what it is used for
2. What you need to know before taking Dimethyl fumarate STADA
3. How to take Dimethyl fumarate STADA
4. Possible side effects
5. How to store Dimethyl fumarate STADA
6. Contents of the pack and other information

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

What Dimethyl fumarate STADA is
Dimethyl fumarate STADA is a medicine containing dimethyl fumarate.
What Dimethyl fumarate STADA is used for
Dimethyl fumarate STADA 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 individuals but usually include problems with walking and balance, 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 STADA works
Dimethyl fumarate STADA 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 STADA

When not to take Dimethyl fumarate STADA:

• 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 STADA may adversely affect the number of white blood cells and the function of the kidneys and liver. Before starting treatment with Dimethyl fumarate STADA, the doctor will check the patient's white blood cell count and assess whether the kidneys and liver are functioning properly. These tests will also 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 Dimethyl fumarate STADA, consult a doctor if the patient has:

• 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 STADA. In some cases, severe complications have been reported. If there is any suspicion of shingles in the patient, the doctor should be informed immediately.

If multiple sclerosis worsens (e.g. the patient experiences weakness or vision disturbances) or new symptoms appear, the patient should contact the 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 problems (Fanconi syndrome) have been reported during treatment with medicines containing dimethyl fumarate in combination with other fumaric acid esters used in the treatment of psoriasis (a skin disease). If the patient notices increased urination, feels more thirsty and drinks more than usual, muscles seem weaker, bone fractures occur, or the patient simply feels pain, they should contact the doctor as soon as possible for further evaluation of these symptoms.

Children and adolescents

The above warnings and precautions also apply to children. Dimethyl fumarate STADA may be used in children and adolescents aged 13 years and older. Data in children under 10 years of age are not available.

Dimethyl fumarate STADA and other medicines

Tell the doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take, especially:

• medicines containing fumaric acid esters (fumarates) used in the treatment of psoriasis;
• medicines affecting the immune system, including other medicines used to treat multiple sclerosis, such as fingolimod, natalizumab, teriflunomide, alemtuzumab, ocrelizumab or cladribine, and certain medicines commonly used in cancer treatment (rituximab or mitoxantrone);
• medicines affecting the kidneys, including certain antibiotics (used to treat infections), diuretics, certain types of painkillers (such as ibuprofen and similar anti-inflammatory medicines, including over-the-counter products), and medicines containing lithium;
• administration of certain vaccines (vaccines containing live microorganisms) during treatment with Dimethyl fumarate STADA may lead to infection; therefore, such vaccines should be avoided. The doctor will advise whether other types of vaccines (vaccines containing inactivated microorganisms) should be given.

Taking Dimethyl fumarate STADA with food and alcohol

Avoid consuming high-concentration alcoholic beverages (over 30% alcohol by volume) in amounts exceeding 50 ml within one hour of taking Dimethyl fumarate STADA, 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, breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor or pharmacist before using this medicine.

Pregnancy

Dimethyl fumarate STADA should not be taken during pregnancy unless discussed with the doctor.

Breastfeeding

It is unknown whether the active substance of Dimethyl fumarate STADA passes into human breast milk. Dimethyl fumarate STADA should not be taken during breastfeeding. The doctor will help the patient decide whether to discontinue breastfeeding or the administration of Dimethyl fumarate STADA. 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 using machines

The effect of Dimethyl fumarate STADA on the ability to drive and use machines is unknown.

No effect of Dimethyl fumarate STADA on the ability to drive and use machines is expected.

3. How to take Dimethyl fumarate STADA

This medicine should always be taken exactly as instructed 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 medicine should be taken at the recommended dose.
Usual dose
240 mg twice daily.
Method of administration
Dimethyl fumarate STADA should be taken orally.
Each capsule must be swallowed whole with water. Do not divide, crush, dissolve, suck or chew the capsules, as this may increase the risk of certain adverse effects.
Dimethyl fumarate STADA should be taken with food – this helps to reduce the very common adverse effects listed in section 4.
Taking more Dimethyl fumarate STADA than recommended
If you take more capsules than recommended, you must inform your doctor immediately. Adverse effects similar to those described below in section 4 may occur.
Missing a dose of Dimethyl fumarate STADA
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 reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.

Serious adverse reactions
Dimethyl fumarate STADA may reduce the number of lymphocytes, a type of white blood cells.
Low levels of white blood cells 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 duration of treatment, 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.

The 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, changes in thinking or memory, confusion (disorientation), personality changes, speech difficulties, and communication problems lasting longer than a few days. For this reason, if you notice worsening of symptoms related to multiple sclerosis or any new symptoms while taking Dimethyl fumarate STADA, 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.

Severe allergic reactions
The frequency of severe allergic reactions cannot be determined from available data (unknown).

A very common adverse reaction 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 severe allergic reaction (anaphylaxis) . You must stop taking Dimethyl fumarate STADA and contact your doctor immediately.

Very common adverse reactions
These reactions may occur in more than 1 in 10 people:

• redness of the skin of the face or sensation of increased body temperature, warmth, 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 reactions listed above.

During treatment with Dimethyl fumarate STADA, increased production of ketone bodies (substances normally produced in the body) is very commonly observed in urine tests. Ask your doctor how to manage adverse reactions. Your doctor may reduce the dose of the medicine. Do not reduce the dose yourself unless instructed by your doctor.

Common adverse reactions
May occur in 1 in 10 people, but not more frequently:

• inflammation of the intestinal mucosa ( gastroenteritis )
• vomiting
• indigestion
• inflammation of the stomach mucosa ( 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 reactions that may cause abnormal blood or urine test results:

• 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. In case of severe infection (e.g. pneumonia), contact your doctor immediately;
• protein ( albumin ) in the urine;
• increased liver enzyme activity ( AlAT, AspAT ) in blood.

Uncommon adverse reactions
May occur in 1 in 100 people, but not more frequently:

• allergic reactions (hypersensitivity)
• decreased number of platelets

Unknown
(frequency cannot be determined from available data)

• hepatitis and increased liver enzyme activity ( AlAT or AspAT together with bilirubin )
• shingles, with symptoms such as: skin blisters, burning, itching, or painful skin, 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, red spots, and severe pain
• cold ( rhinitis )

Children (aged 13 years and older) 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 symptoms not listed in this leaflet, you should inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181 C, 02-222 Warsaw
Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.

Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Dimethyl fumarate STADA

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the cardboard box,
blister pack, or on the bottle label after "EXP". The expiry date refers to the last day of the specified 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. This will help protect the environment.

6. Contents of the packaging and other information

What the medicine Dimethyl fumarate STADA contains
The active substance is dimethyl fumarate.
Dimethyl fumarate STADA, 120 mg
Each enteric hard capsule contains 120 mg of dimethyl fumarate.
Dimethyl fumarate STADA, 240 mg
Each enteric hard capsule contains 240 mg of dimethyl fumarate.

Other ingredients are:
Capsule contents: microcrystalline cellulose (E 460), crospovidone (E 1202), talc (E 553b),
povidone (E 1201), colloidal anhydrous silica (E 551), magnesium stearate (E 470B), triethyl citrate (E 1505),
methacrylic acid and ethyl acrylate copolymer (1:1), hypromellose (E 464), titanium dioxide (E 171),
triacetin (E 1518)
Capsule shell: gelatin, titanium dioxide (E 171), brilliant blue FCF (E 133), yellow iron oxide (E 172),
black ink (shellac (E 904), potassium hydroxide (E 525), propylene glycol (E 1520), black iron oxide (E 172),
concentrated ammonium hydroxide (E 527))

What Dimethyl fumarate STADA looks like and contents of the pack
Dimethyl fumarate STADA, 120 mg are enteric hard capsules (21 mm) with a green cap and white body, printed in black with “DMF 120” on the body. They are available in blister packs containing 14, 28, 56 or 168 enteric hard capsules, in perforated unit-dose blisters containing 14x1, 28x1, 56x1 or 168x1 enteric hard capsules, or in a bottle containing 100 enteric hard capsules.
Not all pack sizes may be marketed.

Dimethyl fumarate STADA, 240 mg are enteric hard capsules (23 mm) with a green cap and body, printed in black with “DMF 240” on the body. They are available in blister packs containing 14, 28, 56, 60, 168 or 180 enteric hard capsules, in perforated unit-dose blisters containing 14x1, 28x1, 56x1, 60x1, 168x1 or 180x1 enteric hard capsules, or in a bottle containing 100 enteric hard capsules.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
STADA Arzneimittel AG
Stadastrasse 2-18
61118 Bad Vilbel
Germany
For further information, please contact the local representative of the Marketing Authorisation Holder:
Stada Pharm Sp. z o.o.
ul. Krakowiaków 44
02-255 Warsaw
Tel. +48 22 737 79 20

Manufacturer/Importer:
STADA Arzneimittel AG
Stadastrasse 2-18
61118 Bad Vilbel
Germany
STADA Arzneimittel GmbH
Muthgasse 36/2
1190 Vienna
Austria
Clonmel Healthcare Ltd.
Waterford Road
Clonmel, Tipperary
E91 D768
Ireland
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 Sofia 1618
Bulgaria

This medicine is authorised in the European Economic Area member states under the following names:
Sweden Dimethyl fumarate STADA 120 mg enterokapslar, hårda
Dimethyl fumarate STADA 240 mg enterokapslar, hårda
Austria Dimethylfumarat STADA 120 mg magensaftresistente Hartkapseln
Dimethylfumarat STADA 240 mg magensaftresistente Hartkapseln
Belgium Dimethyl Fumarate Eurogenerics 120mg harde maagsapresistente capsules
Dimethyl Fumarate Eurogenerics 240mg harde maagsapresistente capsules
Czech Republic Dimethyl fumarate STADA
Cyprus Dimethyl fumarate / STADA
Denmark Dimethyl fumarate STADA
Estonia Dimethyl fumarate STADA
Greece Dimethyl fumarate/Hemopharm 120 mg γαστροανθεκτικά σκληρά καψάκια
Dimethyl fumarate/Hemopharm 240 mg γαστροανθεκτικά σκληρά καψάκια
Finland Dimethyl fumarate STADA 120 mg enterokapseli, kova
Dimethyl fumarate STADA 240 mg enterokapseli, kova
Hungary DIMETIL-FUMARÁT STADA 120 MG GYOMORNEDV-ELLENÁLLÓ KEMÉNY KAPSZULA
DIMETIL-FUMARÁT STADA 240 MG GYOMORNEDV-ELLENÁLLÓ KEMÉNY KAPSZULA
Croatia Dimetilfumarat STADA 120mg želučanootporne kapsule
Dimetilfumarat STADA 240mg želučanootporne kapsule
Ireland Dimethyl fumarate Clonmel 120 mg hard gastro-resistant capsules
Dimethyl fumarate Clonmel 240 mg hard gastro-resistant capsules
Iceland Dimethyl fumarate STADA 120 mg magasýruþolin hörð hylki
Dimethyl fumarate STADA 240 mg magasýruþolin hörð hylki
Lithuania Dimethyl fumarate STADA 120 mg skrandyje neirios kietosios kapsulės
Dimethyl fumarate STADA 240 mg skrandyje neirios kietosios kapsulės
Luxembourg Dimethyl Fumarate Eurogenerics 120mg gélules gastro-résistantes
Dimethyl Fumarate Eurogenerics 240mg gélules gastro-résistantes
Latvia Dimethyl fumarate STADA 120 mg zarnās šķīstošās cietās kapsulas
Dimethyl fumarate STADA 240 mg zarnās šķīstošās cietās kapsulas
Malta Dimethyl fumarate Clonmel 120 mg gastro-resistant capsules
Dimethyl fumarate Clonmel 240 mg gastro-resistant capsules
Norway Dimethyl fumarate STADA
Portugal Fumarato de dimetilo
Poland Dimethyl fumarate STADA
Slovenia Dimetilfumarat STADA 120 mg gastrorezistentne kapsule
Dimetilfumarat STADA 240 mg gastrorezistentne kapsule
Slovakia Dimetyl-fumarát STADA 120 mg tvrdé gastrorezistentné kapsuly
Dimetyl-fumarát STADA 240 mg tvrdé gastrorezistentné kapsuly