Dimethyl fumarate stada arzneimittel ag

Package leaflet: Information for the patient

Dimethyl fumarate STADA Arzneimittel AG, 120 mg, enteric hard capsules
Dimethyl fumarate STADA Arzneimittel AG, 240 mg, enteric hard capsules
Dimethylis fumaras
Please read 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. 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.

Leaflet contents

1. What Dimethyl fumarate STADA Arzneimittel AG is and what it is used for
2. What you need to know 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 Dimethyl fumarate STADA Arzneimittel AG is and what it is used for

What Dimethyl fumarate STADA Arzneimittel AG is
Dimethyl fumarate STADA Arzneimittel AG is a medicine containing the active substance dimethyl fumarate.

What Dimethyl fumarate STADA Arzneimittel AG is used for
Dimethyl fumarate STADA Arzneimittel AG 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 episodes of neurological symptoms (called relapses).
Symptoms vary between patients but usually include walking and balance difficulties, and vision problems (e.g. blurred or double vision). These symptoms may completely resolve after a relapse, but some problems may persist.

How Dimethyl fumarate STADA Arzneimittel AG works
Dimethyl fumarate STADA Arzneimittel AG appears to prevent the immune system from damaging the brain and spinal cord. It may also help slow the future progression of multiple sclerosis.

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 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 Arzneimittel AG 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
STADA Arzneimittel AG, the doctor will check the number of white blood cells and will assess whether the kidneys and liver
are functioning properly. These tests will also be performed periodically during treatment. If the number of white blood cells
decreases during treatment, the doctor may consider performing additional tests or discontinuing treatment.
Before starting treatment with Dimethyl fumarate STADA Arzneimittel AG, 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 STADA Arzneimittel AG.
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 disturbances) 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 illness that may lead to severe disability or death.
Rare but serious kidney dysfunction called Fanconi syndrome has been reported during treatment with dimethyl fumarate in combination with other fumaric acid esters used to treat psoriasis (a skin disease). If the patient notices increased urination, feels more thirsty and drinks more than usual, their muscles seem weaker, bone fractures occur, or they simply feel pain, they should consult a 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 STADA Arzneimittel AG and other medicines
The patient should tell their doctor or pharmacist about any other medicines they are currently taking, have recently taken, or 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 medicines), and medicines containing lithium;
• administration of certain vaccines (vaccines containing live microorganisms) during treatment with Dimethyl fumarate STADA Arzneimittel AG may lead to the development of infection and should therefore be avoided. The doctor will advise whether other types of vaccines (vaccines containing inactivated microorganisms) should be given.

Dimethyl fumarate STADA Arzneimittel AG with food and alcohol
The patient should avoid consuming high-concentration alcoholic beverages (over 30% alcohol by volume, e.g. spirits) in amounts exceeding 50 mL within one hour of taking Dimethyl fumarate STADA Arzneimittel AG, 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, breastfeeding, thinks 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 STADA Arzneimittel AG 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 Dimethyl fumarate STADA Arzneimittel AG passes into human milk. The doctor will advise the patient whether she should discontinue breastfeeding or discontinue/abstain from taking Dimethyl fumarate STADA Arzneimittel AG. The decision will be based on an assessment of the benefit of breastfeeding for the child versus the benefit of treatment for the patient.
Driving and using machines
Dimethyl fumarate STADA Arzneimittel AG is not expected to affect the ability to drive or operate machinery.

3. How to take Dimethyl fumarate STADA Arzneimittel AG

This medicine should always be taken as directed by the physician. If in doubt, consult the
physician.
Initial dose
120 mg twice daily.
This initial dose should be taken for the first 7 days, after which the medicine should be used at the
usual maintenance dose.
Usual maintenance dose
240 mg twice daily.
Method of administration
Dimethyl fumarate STADA Arzneimittel AG 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 the risk of certain adverse reactions.
Dimethyl fumarate STADA Arzneimittel AG should be taken with food – this helps to reduce
the very common adverse reactions (listed in section 4).
Taking more than the recommended dose of Dimethyl fumarate STADA Arzneimittel AG
If more capsules than recommended have been taken, inform the physician immediately.
Adverse reactions may occur similar to those described below in section 4.
Missed dose of Dimethyl fumarate STADA Arzneimittel AG
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 there are any further doubts about the use of this medicine, consult the physician or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.

Serious side effects

The medicine Dimethyl fumarate STADA Arzneimittel AG may reduce the number of lymphocytes, which are a type of white blood cells. A low number 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 be vigilant for 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 or worsening weakness on one side of the body, impaired coordination, vision problems, changes in thinking or memory, confusion (disorientation), personality changes, speech difficulties, and communication problems lasting longer than a few days.

For this reason, if the patient notices worsening of symptoms related to multiple sclerosis or the occurrence of any new symptoms while taking Dimethyl fumarate STADA Arzneimittel AG, they should contact their doctor as soon as possible. It is also advisable to talk to a partner or caregivers and inform them about the treatment, as symptoms may occur of which the patient may not be aware.

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 side effect is sudden (paroxysmal) redness of the face or body. If paroxysmal 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 (dyspnea, hypoxia);
• dizziness or loss of consciousness (hypotension),

this may indicate a serious allergic reaction (anaphylaxis). The medicine Dimethyl fumarate STADA Arzneimittel AG must be discontinued immediately and a doctor must be contacted immediately.

Other side effects

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

• redness or flushing of the face or a sensation of warmth, burning, or itching of the skin (flushing)
• loose stools (diarrhea)
• nausea
• stomach pain or cramps

Taking the medicine with food may help reduce the above side effects.

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 side effects. Your doctor may reduce the dose of the medicine. Do not reduce the dose yourself unless instructed by your doctor.

Common (may affect up to 1 in 10 people):

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

Side effects 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 the body is less able to fight infections. In case of severe infection (e.g. pneumonia), contact a doctor immediately;
• protein (albumin) in the urine;
• increased liver enzyme activity (AlAT, AspAT) in 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):

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

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

• shingles, with symptoms such as skin blisters, burning, itching, or 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 patches accompanied by severe pain
• cold (nasopharyngitis)

Children (aged 13 years and older) and adolescents

The side effects listed above also apply to children and adolescents. Some side effects have been reported more frequently in children and adolescents than in adults, for example: headache, abdominal pain or stomach cramps, vomiting, sore throat, cough, and painful menstruation.

Reporting of side effects

If any side effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring Adverse Drug Reactions at 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 helps provide more information on the safety of this medicine.

5. How to store Dimethyl fumarate STADA Arzneimittel AG

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the cardboard box,
blisters, or on the bottle label after "EXP". The expiry date refers to the last day of the stated month.
There are no special requirements regarding the storage temperature of 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 will help protect the environment.

6. Contents of the pack and other information

What Dimethyl fumarate STADA Arzneimittel AG contains
The active substance is dimethyl fumarate.
Dimethyl fumarate STADA Arzneimittel AG, 120 mg
Each enteric hard capsule contains 120 mg of dimethyl fumarate.
Dimethyl fumarate STADA Arzneimittel AG, 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), iron oxide yellow (E 172),
black ink [shellac (E 904), potassium hydroxide (E 525), propylene glycol (E 1520), iron oxide black (E 172),
concentrated ammonium hydroxide (E 527)].

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

Dimethyl fumarate STADA Arzneimittel AG, 240 mg are enteric hard capsules (23 mm) with a green cap and body, marked 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 a cardboard box, in perforated unit-dose blisters containing 14x1, 28x1, 56x1, 60x1, 168x1 or 180x1 enteric hard capsules in a cardboard box, or in a bottle containing 100 enteric hard capsules in a cardboard box.
The bottle contains a desiccant which must not be swallowed.
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

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

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
Stada Pharm Sp. z o.o.
ul. Krakowiaków 44
02-255 Warszawa
Tel. +48 22 737 79 20

This medicinal product is authorised in 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/STADA 120 mg γαστροανθεκτικά σκληρά καψάκια
Dimethyl fumarate/STADA 240 mg γαστροανθεκτικά σκληρά καψάκια
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