Dimethil fumarate Stada

Leaflet accompanying the packaging: patient information

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

Dimethyl fumarate STADA, 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 and what is it used for
• 2. Important information before taking Dimethyl fumarate STADA
• 3. How to take Dimethyl fumarate STADA
• 4. Possible side effects
• 5. How to store Dimethyl fumarate STADA
• 6. Package contents and other information

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

What is Dimethyl fumarate STADA

Dimethyl fumarate STADA is a medicine that contains dimethyl fumarate.

What is Dimethyl fumarate STADA used for

Dimethyl fumarate STADA 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 walking and balance problems and vision disturbances (e.g., blurred or double vision). These symptoms may completely disappear after a relapse, but some problems may persist.

How does Dimethyl fumarate STADA work

Dimethyl fumarate STADA appears to prevent the immune system from causing damage to the brain and spinal cord, which may also help slow down the progression of the disease in the future.

2. Important information before taking Dimethyl fumarate STADA

When not to take Dimethyl fumarate STADA:

• -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 may have a negative effect on white blood cell countand kidney and liver function. Before starting treatment with Dimethyl fumarate STADA, 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, consult 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, shingles (herpes zoster) may occur. In some cases, serious 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 disease that can lead to severe disability or death.
When taking a medicine containing dimethyl fumarate in combination with other fumaric acid esters used to treat psoriasis (a skin disease), rare but serious kidney problems (Fanconi syndrome) have 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 bone fracture, or they simply feel pain, they should see their doctor as soon as possible for further examination of these symptoms.

Children and adolescents

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

Dimethyl fumarate STADA and other medicines

Tell your doctor or pharmacistabout all 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 other medicines used to treat multiple sclerosis, such as fingolimod, natalizumab, teriflunomide, alemtuzumab, ocrelizumab, or cladribine, and some medicines commonly used to treat cancer (rituximab or mitoxantrone);
• medicines that affect the kidneys, including some antibiotics(used to treat infections), diuretics(diuretics), certain painkillers(such as ibuprofen and 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 may cause infection, so this should be avoided. The doctor will advise whether other types of vaccines ( killed vaccines) can be given.

Taking Dimethyl fumarate STADA with food and drink

Avoid consuming high-percentage alcoholic beverages (over 30% alcohol by volume) in excess of 50 ml within an hour of taking Dimethyl fumarate STADA, due to the risk of interaction between alcohol and this medicine, which may lead to stomach upset (gastritis), especially in people prone to this condition.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a baby, they should consult their doctor or pharmacist before taking this medicine.
Pregnancy
Dimethyl fumarate STADA should not be taken during pregnancy unless the patient has discussed it with their doctor.
Breastfeeding
It is not known whether the active substance of Dimethyl fumarate STADA passes into human milk. Dimethyl fumarate STADA should not be taken during breastfeeding. The doctor will help the patient decide whether to stop breastfeeding or stop taking Dimethyl fumarate STADA. The decision will be based on the assessment of the benefit of breastfeeding to the baby compared to the benefit of treatment to the patient.

Driving and using machines

The effect of Dimethyl fumarate STADA on the ability to drive and use machines is not known.
It is not expected that Dimethyl fumarate STADA will affect the ability to drive and use machines.

3. How to take Dimethyl fumarate STADA

This medicine should always be taken exactly as prescribed by your doctor. 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 recommended dose should be taken.

Recommended dose

240 mg twice a day.

Method of administration

Dimethyl fumarate STADA 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 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 than recommended

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

Missing a dose of Dimethyl fumarate STADA

A double dose should not be takento 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, the missed dose should not be taken, and the next dose should be taken 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 can cause side effects, although not everybody gets them.

Severe side effects

Dimethyl fumarate STADA may lower 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 therapy, so the doctor should monitor the white blood cell count throughout treatment, 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 weakness or increased weakness on one side of the body, coordination problems, vision problems, changes in thinking or memory, confusion (disorientation), or personality changes, speech problems, and communication difficulties lasting more than a few days. For this reason, if the patient experiences worsening of multiple sclerosis symptoms or new symptoms while taking Dimethyl fumarate STADA, they should contact their doctor immediately. 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 (unknown).
A very common side effect is sudden ( flushing) redness of the face or body. If 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 and contact your doctor immediately.

Very common side effects

These symptoms may occur in more than 1 in 10 people:

• redness of the face or a feeling of increased body temperature, heat, burning of the skin, or itching of the skin ( flushing)
• diarrhea
• nausea
• stomach pain or cramps Taking the medicine with foodwill help alleviate the above side effects.

During treatment with Dimethyl fumarate STADA, an increase in ketone bodies (substances normally produced in the body) is very commonly found in urine tests.
Ask your doctor 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 side effects

May occur in up to 1 in 10 people:

• inflammation of the lining of the intestine ( gastroenteritis)
• vomiting
• indigestion
• inflammation of the stomach lining ( gastritis)
• gastrointestinal problems
• burning sensation of the skin
• hot flashes, feeling hot
• 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 ( albumin) in the urine;
• increased liver enzyme activity ( ALT, AST) in the blood.

Uncommon side effects

May occur in up to 1 in 100 people:

• allergic reactions (hypersensitivity)
• decreased platelet count

Unknown

(frequency cannot be estimated from the available data)

• liver inflammation and increased liver enzyme activity ( ALT or ASTtogether with bilirubin)
• shingles, with symptoms such as: blisters on the skin, burning, itching, or painful skin, usually on one side of the upper body or face, and other symptoms, such as fever and weakness in the early stages of infection, and then numbness, itching, or red spots and 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, e.g., 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, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Al. Jerozolimskie 181 C, 02-222 Warsaw
Phone: +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 medicine.

5. How to store Dimethyl fumarate STADA

Keep this medicine out of the 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 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. Package contents and other information

What Dimethyl fumarate STADA contains

The active substance is dimethyl fumarate.
Dimethyl fumarate STADA, 120 mg
Each gastro-resistant hard capsule contains 120 mg of dimethyl fumarate.
Dimethyl fumarate STADA, 240 mg
Each gastro-resistant hard capsule contains 240 mg of dimethyl fumarate.
The 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 ammonia solution (E 527))

What Dimethyl fumarate STADA looks like and contents of the pack

Dimethyl fumarate STADA, 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, perforated unit dose blisters containing 14x1, 28x1, 56x1, or 168x1 gastro-resistant hard capsules, or in a bottle containing 100 gastro-resistant hard capsules.
Not all pack sizes may be marketed.
Dimethyl fumarate STADA, 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, perforated unit dose blisters containing 14x1, 28x1, 56x1, 60x1, 168x1, or 180x1 gastro-resistant hard capsules, or in a bottle containing 100 gastro-resistant hard capsules.
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
To obtain more detailed information, contact the representative of the marketing authorization holder:
Stada Pharm Sp. z o.o.
ul. Krakowiaków 44
02-255 Warsaw
Phone: +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 authorized in the Member States of the European Economic Area under the following names:

Sweden
Dimethyl fumarate STADA 120 mg enteric-coated hard capsules
Dimethyl fumarate STADA 240 mg enteric-coated hard capsules
Austria
Dimethylfumarat STADA 120 mg gastro-resistant hard capsules
Dimethylfumarat STADA 240 mg gastro-resistant hard capsules
Belgium
Dimethylfumaraat EG 120 mg hard gastro-resistant capsules
Dimethylfumaraat EG 240 mg hard gastro-resistant capsules
Czech Republic
Dimethyl fumarate STADA
Cyprus
Dimethyl fumarate / STADA
Denmark
Dimethyl fumarate STADA
Estonia
Dimethyl fumarate STADA
Greece
Dimethyl fumarate / STADA
Finland
Dimethyl fumarate STADA 120 mg enteric-coated capsules, hard
Dimethyl fumarate STADA 240 mg enteric-coated capsules, hard
Hungary
DIMETIL-FUMARÁT STADA 120 MG GASTRO-RESISTANT HARD CAPSULES
DIMETIL-FUMARÁT STADA 240 MG GASTRO-RESISTANT HARD CAPSULES
Croatia
Dimetilfumarat STADA 120mg gastro-resistant capsules
Dimetilfumarat STADA 240mg gastro-resistant capsules
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 enteric-coated hard capsules
Dimethyl fumarate STADA 240 mg enteric-coated hard capsules
Lithuania
Dimethyl fumarate STADA 120 mg gastro-resistant hard capsules
Dimethyl fumarate STADA 240 mg gastro-resistant hard capsules
Luxembourg
Dimethylfumaraat EG 120 mg gastro-resistant capsules
Dimethylfumaraat EG 240 mg gastro-resistant capsules
Latvia
Dimethyl fumarate STADA 120 mg gastro-resistant hard capsules
Dimethyl fumarate STADA 240 mg gastro-resistant hard capsules
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 gastro-resistant capsules
Dimetilfumarat STADA 240 mg gastro-resistant capsules
Slovakia
Dimetyl-fumarát STADA 120 mg hard gastro-resistant capsules
Dimetyl-fumarát STADA 240 mg hard gastro-resistant capsules

Date of last revision of the leaflet: