Dimethil fumarate Stada Azhneimittel Ag

Leaflet attached to the packaging: patient information

Dimethyl fumarate STADA Arzneimittel AG, 120 mg, gastro-resistant hard capsules

Dimethyl fumarate STADA Arzneimittel AG, 240 mg, gastro-resistant hard capsules

Dimethyl fumarate

Read the contents of this leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Dimethyl fumarate STADA Arzneimittel AG and what is it used for
• 2. Important information before taking Dimethyl fumarate STADA Arzneimittel AG
• 3. How to take Dimethyl fumarate STADA Arzneimittel AG
• 4. Possible side effects
• 5. How to store Dimethyl fumarate STADA Arzneimittel AG
• 6. Contents of the packaging and other information

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

What is Dimethyl fumarate STADA Arzneimittel AG

Dimethyl fumarate STADA Arzneimittel AG is a medicine that contains the active substance dimethyl fumarate.

What is Dimethyl fumarate STADA Arzneimittel AG used for

Dimethyl fumarate STADA Arzneimittel AG 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 (called relapses). Symptoms vary from person to person but usually include problems with walking, balance, and vision (such as blurred or double vision). These symptoms can completely disappear after a relapse, but some problems may persist.

How does Dimethyl fumarate STADA Arzneimittel AG work

Dimethyl fumarate STADA Arzneimittel AG seems to prevent the immune system from causing damage to the brain and spinal cord. It may also help slow down the progression of multiple sclerosis in the future.

2. Important information before taking Dimethyl fumarate STADA Arzneimittel AG

When not to take Dimethyl fumarate STADA Arzneimittel AG

• -if the patient is allergic to dimethyl fumarateor any of the other ingredients of this medicine (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 STADA Arzneimittel AG may have a negative effect on white blood cell countand kidney and liver function. Before starting treatment with Dimethyl fumarate STADA Arzneimittel AG, the doctor will check the white blood cell count and ensure that the kidneys and liver are functioning properly. These tests will also be performed periodically during treatment. If the white blood cell count decreases during treatment, the doctor may consider additional tests or discontinuation of treatment.
Before taking Dimethyl fumarate STADA Arzneimittel AG, discuss with your doctorif you have:

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

During treatment with Dimethyl fumarate STADA Arzneimittel AG, shingles may occur. In some cases, severe 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 disease that can lead to severe disability or death.
When taking fumaric acid esters, including dimethyl fumarate, in combination with other fumaric acid esters used to treat psoriasis (a skin disease), rare but severe kidney damage called Fanconi syndrome has been reported. If the patient notices that they are urinating more, feeling thirstier, and drinking more than usual, their muscles seem weaker, they have a fracture, or they simply feel pain, they should see their doctor as soon as possible for further examination of these symptoms.

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 STADA Arzneimittel AG and other medicines

Tell your doctor or pharmacistabout all other medicines you are taking, have recently taken, or might take, especially:

• medicines containing fumaric acid esters(fumarates) used 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(diuretics), certain types of painkillers(such as ibuprofen and other similar anti-inflammatory medicines and over-the-counter medicines) and medicines containing lithium
• the use of certain vaccines(live vaccines) during treatment with Dimethyl fumarate STADA Arzneimittel AG may cause infection, so it should be avoided. The doctor will advise whether to administer vaccines of another type (inactivated vaccines).

Dimethyl fumarate STADA Arzneimittel AG with food and alcohol

Avoid consuming high-percentage alcoholic beverages (over 30% alcohol by volume, e.g., spirits) in amounts greater than 50 mL within an hour of taking Dimethyl fumarate STADA Arzneimittel AG, due to the risk of interaction between alcohol and this medicine.
This may lead to the occurrence of gastritis (inflammation of the stomach lining), especially in people prone to this disease.

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 medicine.
Pregnancy
There is limited data on the use of this medicine in pregnant women. Dimethyl fumarate STADA Arzneimittel AG should not be taken during pregnancy unless the patient has discussed it with their doctor and the use of this medicine is necessary.
Breastfeeding
It is not known whether the active substance of Dimethyl fumarate STADA Arzneimittel AG passes into breast milk. The doctor will advise the patient whether to stop breastfeeding or stop taking Dimethyl fumarate STADA Arzneimittel AG. The decision will be made 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

It is not expected that Dimethyl fumarate STADA Arzneimittel AG will affect the ability to drive or use machines.

3. How to take Dimethyl fumarate STADA Arzneimittel AG

This medicine should always be taken as directed by the doctor. If you have any doubts, consult 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.

Method of administration

Dimethyl fumarate STADA Arzneimittel AG 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 STADA Arzneimittel AG should be taken with food– this will help alleviate the very common side effects (listed in section 4).

Taking a higher dose of Dimethyl fumarate STADA Arzneimittel AG than recommended

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

Missing a dose of Dimethyl fumarate STADA Arzneimittel AG

Do 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, do not take the missed dose, but take the next dose at the usual time.
If you have any further doubts about taking this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Dimethyl fumarate STADA Arzneimittel AG can cause side effects, although not everybody gets them.

Severe side effects

Dimethyl fumarate STADA Arzneimittel AG may decrease the number of lymphocytes, which are 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 white blood cell count in the patient 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 medicines that affect the immune system.
Symptoms of PML may resemble a relapse of multiple sclerosis. They include new weakness or worsening of weakness on one side of the body, coordination problems, vision problems, speech or thinking problems, confusion (disorientation) or personality changes, speech or communication problems lasting more than a few days.
If the patient experiences any of these symptoms while taking Dimethyl fumarate STADA Arzneimittel AG, they should contact their doctor as soon as possible. They should also discuss their treatment with their partner or caregivers and inform them about their treatment. The patient may not be aware of some symptoms.

If you experience any of the following 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 acute 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, hypoxia);
• dizziness or loss of consciousness (hypotension), this may indicate a severe allergic reaction (anaphylaxis).

Stop taking Dimethyl fumarate STADA Arzneimittel AG and contact your doctor immediately.

Other side effects

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

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

Taking the medicine 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.
Talk to your doctorabout how to deal with side effects. The doctor may reduce the dose of the medicine. Do not reduce the dose of the medicine yourself unless your doctor advises you to do so.
Common(may affect up to 1 in 10 people):

• inflammation of the lining of the intestine (gastrointestinal disorder)
• vomiting
• indigestion
• inflammation of the stomach lining (gastritis)
• stomach and intestinal problems
• burning sensation on 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 cause abnormal blood or urine test results

• low white blood cell count (lymphopenia, leukopenia). A low white blood cell count may mean that the body is less able to fight infection. In case of severe infection (e.g., pneumonia), contact your doctor immediately;
• protein in the urine (albumin);
• increased liver enzyme activity (ALT, AST) 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 (ALT or ASTtogether with bilirubin)

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

• shingles, with symptoms such as: blisters on the skin, 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, or red spots with 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 you experience any side effects, including any side effects not listed in this leaflet, tell your 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 181 C, 02-222 Warsaw
tel.: +48 22 49 21 301, fax: + 48 22 49 21 309
website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help gather more information on the safety of this medicine.

5. How to store Dimethyl fumarate STADA Arzneimittel AG

Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister or on the label of the bottle after "EXP". The expiry date refers to the last day of the month stated.
There are no special storage instructions for the 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 that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Dimethyl fumarate STADA Arzneimittel AG contains

The active substance of the medicine is dimethyl fumarate.
Dimethyl fumarate STADA Arzneimittel AG, 120 mg
Each gastro-resistant hard capsule contains 120 mg of dimethyl fumarate.
Dimethyl fumarate STADA Arzneimittel AG, 240 mg
Each gastro-resistant 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 silica anhydrous (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), iron oxide black (E 172), concentrated ammonia solution (E 527)].

What Dimethyl fumarate STADA Arzneimittel AG looks like and contents of the pack

Dimethyl fumarate STADA Arzneimittel AG, 120 mg are gastro-resistant hard capsules (21 mm), with a green cap and a white body, with black printing "DMF 120" on the body, available in blisters containing 14, 28, 56, or 168 gastro-resistant hard capsules in a carton, in perforated single-dose blisters containing 14x1, 28x1, 56x1, or 168x1 gastro-resistant hard capsules in a carton, or in a bottle containing 100 gastro-resistant hard capsules in a carton.
The bottle contains a desiccant, which should not be swallowed.
Not all pack sizes may be marketed.
Dimethyl fumarate STADA Arzneimittel AG, 240 mg are gastro-resistant hard capsules (23 mm), with a green cap and a green body, with black printing "DMF 240" on the body, available in blisters containing 14, 28, 56, 60, 168, or 180 gastro-resistant hard capsules in a carton, in perforated single-dose blisters containing 14x1, 28x1, 56x1, 60x1, 168x1, or 180x1 gastro-resistant hard capsules in a carton, or in a bottle containing 100 gastro-resistant hard capsules in a carton.
The bottle contains a desiccant, which should not be swallowed.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

STADA Arzneimittel AG
Stadastrasse 2-18
61118 Bad Vilbel

Germany

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
To obtain more detailed information on this medicine, please contact the local representative of the marketing authorization holder:
Stada Pharm Sp. z o.o.
ul. Krakowiaków 44
02-255 Warsaw
Tel. +48 22 737 79 20

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

Austria
Dimethylfumarat Aliud 120 mg magensaftresistente Hartkapseln
Dimethylfumarat Aliud 240 mg magensaftresistente Hartkapseln
Belgium
Dimethylfumaraat Eurogenerics 120 mg harde maagsapresistente capsules
Dimethylfumaraat Eurogenerics 240 mg harde maagsapresistente capsules
Croatia
Dimetilfumarat STADA 120mg želučanootporne kapsule
Dimetilfumarat STADA 240mg želučanootporne kapsule
Czech Republic
Dimethyl fumarate STADA Arzneimittel AG
Cyprus
Dimethyl fumarate Hemopharm
Denmark
Dimethyl fumarate STADA Nordic
Estonia
Dimethyl fumarate STADA ALIUD
Greece
Dimethyl fumarate / Hemopharm
Finland
Dimethyl fumarate STADA Arzneimittel AG 120 mg enterokapseli, kova
Dimethyl fumarate STADA Arzneimittel AG 240 mg enterokapseli, kova
Ireland
Dimethyl fumarate Clonmel Healthcare 120 mg hard gastro-resistant capsules
Dimethyl fumarate Clonmel Healthcare 240 mg hard gastro-resistant capsules
Iceland
Dimethyl fumarate STADA Nordic 120 mg magasýruþolin hörð hylki
Dimethyl fumarate STADA Nordic AG 240 mg magasýruþolin hörð hylki
Lithuania
Dimethyl fumarate ALIUD 120 mg skrandyje neirios kietosios kapsulės
Dimethyl fumarate ALIUD 240 mg skrandyje neirios kietosios kapsulės
Luxembourg
Dimethylfumaraat Eurogenerics 120 mg gélules gastro-résistantes
Dimethylfumaraat Eurogenerics 240 mg gélules gastro-résistantes
Latvia
Dimethyl fumarate ALIUD 120 mg zarnās šķīstošās cietās kapsulas
Dimethyl fumarate ALIUD 240 mg zarnās šķīstošās cietās kapsulas
Malta
Dimethyl fumarate Clonmel Healthcare 120 mg gastro-resistant capsules
Dimethyl fumarate Clonmel Healthcare 240 mg gastro-resistant capsules
Norway
Dimethyl fumarate STADA Nordic
Portugal
Fumarato de dimetilo Ciclum
Poland
Dimethyl fumarate STADA Arzneimittel AG
Slovenia
Dimetilfumarat STADA 120 mg gastrorezistentne trde kapsule
Dimetilfumarat STADA 240 mg gastrorezistentne trde kapsule
Slovakia
Dimetyl-fumarát STADA 120 mg tvrdé gastrorezistentné kapsuly
Dimetyl-fumarát STADA 240 mg tvrdé gastrorezistentné kapsuly
Sweden
Dimethyl fumarate STADA Nordic 120 mg enterokapslar, hårda
Dimethyl fumarate STADA Nordic 240 mg enterokapslar, hårda
Hungary
Dimetil-fumarát STADA Arzneimittel 120 mg
gyomornedv-ellenálló kemény kapszula
Dimetil-fumarát STADA Arzneimittel 240 mg
gyomornedv-ellenálló kemény kapszula

Date of last revision of the leaflet: