Dimethil fumarate Stada Azhneimittel Ag

Package Leaflet: Information for the Patient

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 Package Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.

• Keep this package leaflet, as you may need to read it again.
• In case of any doubts, consult your doctor or pharmacist.
• This medication has been prescribed specifically for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this package leaflet, inform your doctor or pharmacist. See section 4.

Table of Contents of the Package 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 pack 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 medication containing 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 above.

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 gait and balance disturbances and vision impairment (e.g., blurred or double vision). These symptoms may completely resolve after a relapse, but some problems may persist.

How does Dimethyl Fumarate STADA Arzneimittel AG work

Dimethyl Fumarate STADA Arzneimittel AG appears to inhibit the immune system from causing damage to the brain and spinal cord. It may also contribute to slowing 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 you are allergic to dimethyl fumarateor any of the other ingredients of this medication (listed in section 6).
• -if you are 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, your doctor will check your white blood cell count and ensure that your kidneys and liver are functioning properly. These tests will also be performed periodically during treatment. If your white blood cell count decreases during treatment, your 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 been reported. If you suspect any symptoms of shingles, inform your doctor immediately.
If your multiple sclerosis worsens (e.g., you experience weakness or vision disturbances) or new symptoms appear, you should contact your 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 disorders called Fanconi syndrome have been reported. If you notice that you are urinating more, feeling thirstier, and drinking more than usual, your muscles seem weaker, you have a bone fracture, or you simply feel pain, you should see your 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 STADA Arzneimittel AG and other medications

Tell your doctor or pharmacistabout all other medications you are currently taking or have recently taken, as well as any medications you 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 kidney function, including certain antibiotics(used to treat infections), diuretics(diuretics), certain types of painkillers(such as ibuprofen and other similar anti-inflammatory medications and over-the-counter medications) and medications containing lithium
• the use of certain vaccines(live vaccines) during treatment with Dimethyl Fumarate STADA Arzneimittel AG may lead to infection, so it should be avoided. Your doctor will advise whether to administer other types of vaccines (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 medication.
This may lead to the occurrence of gastritis (inflammation of the stomach lining), especially in individuals prone to this disease.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before taking this medication.
Pregnancy
There is limited data on the effects of this medication on the unborn child. Dimethyl Fumarate STADA Arzneimittel AG should not be taken during pregnancy unless you have discussed it with your doctor and the use of this medication is necessary.
Breastfeeding
It is not known whether the active substance of Dimethyl Fumarate STADA Arzneimittel AG passes into breast milk. Your doctor will advise whether to stop breastfeeding or stop taking Dimethyl Fumarate STADA Arzneimittel AG. The decision will be based on the assessment of the benefits of breastfeeding for the child versus the benefits of treatment for the patient.

Driving and using machines

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

3. How to take Dimethyl Fumarate STADA Arzneimittel AG

Always take this medication exactly as your doctor has told you. If you are unsure, 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.
Swallow each capsule whole, with water. Do not divide, crush, dissolve, suck, or chew the capsules, as this may increase certain side effects.
Take Dimethyl Fumarate STADA Arzneimittel AG with food– this will help alleviate very common side effects (listed in section 4).

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

In case of taking a higher number of 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.
In case of any further doubts about taking this medication, consult your doctor or pharmacist.

4. Possible side effects

Like all medications, 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, 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 your doctor should monitor your white blood cell count throughout the treatment period, and you should be aware of the symptoms described below, which may indicate PML. The risk of PML may be higher if you have 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 disturbances, changes in thinking or memory, confusion (disorientation), or personality changes, speech difficulties, and communication problems lasting more than a few days.
Therefore, if you experience worsening of multiple sclerosis symptoms or new symptoms while taking Dimethyl Fumarate STADA Arzneimittel AG, you should contact your doctor immediately. You should also discuss your treatment with your partner or caregivers and inform them about your treatment. You may not be aware of certain 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 (paroxysmal) flushing of the skin of the face or body. If the 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 of the face or a feeling of increased body temperature, heat, burning, or itching of the skin (paroxysmal flushing)
• diarrhea (diarrhea)
• nausea (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.
Discuss with your doctorhow to manage side effects. Your doctor may reduce the dose of the medication. Do not reduce the dose yourself unless your doctor advises you to do so.
Common(may affect up to 1 in 10 people):

• inflammation of the intestinal lining (gastrointestinal disorder)
• vomiting
• indigestion
• inflammation of the stomach lining (gastritis)
• gastrointestinal disturbances
• burning sensation of the skin
• hot flashes
• itching of the skin (pruritus)
• rash
• pink or red spots on the skin (erythema)
• hair loss (alopecia)

Side effects that may affect laboratory test results

• low white blood cell count (lymphopenia, leukopenia). A low white blood cell count may indicate that the body is less able to fight infection. In case of severe infection (e.g., pneumonia), contact your doctor immediately;
• protein (albumin) in the urine;
• 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 1000 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
• cold ( rhinitis)

Children (aged 13 and above) 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, e.g., headache, abdominal pain or stomach cramps, vomiting, sore throat, cough, and painful menstruation.

Reporting side effects

If you experience any side effects, including those not listed in this package leaflet, inform 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.
By reporting side effects, you can help provide more information on the safety of this medication.

5. How to store Dimethyl Fumarate STADA Arzneimittel AG

Keep the medication out of sight and reach of children.
Do not use this medication after the expiration date stated on the carton and blister or on the label of the bottle after "EXP". The expiration date refers to the last day of the month stated.
There are no special storage instructions for the medication.
Store in the original packaging to protect from light.
Medications should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medications that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Dimethyl Fumarate STADA Arzneimittel AG contains

The active substance of the medication 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 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), 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 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 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 medication, 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 medication 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 package leaflet: