Dimethil fumarate Msn

Package Leaflet: Information for the Patient

Dimethyl Fumarate MSN, 120 mg, Gastro-Resistant Hard Capsules

Dimethyl Fumarate MSN, 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, you may need to read it again.
• In case of any doubts, consult your doctor or pharmacist.
• This medication has been prescribed for a specific person. Do not pass it on to others. The medication may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any not listed in this Package Leaflet, they should inform their doctor or pharmacist. See section 4.

Package Leaflet Contents:

• 1. What is Dimethyl Fumarate MSN and what is it used for
• 2. Important information before taking Dimethyl Fumarate MSN
• 3. How to take Dimethyl Fumarate MSN
• 4. Possible side effects
• 5. How to store Dimethyl Fumarate MSN
• 6. Contents of the pack and other information

1. What is Dimethyl Fumarate MSN and what is it used for

What is Dimethyl Fumarate MSN

Dimethyl Fumarate MSN is a medication containing the active substance dimethyl fumarate.

What is Dimethyl Fumarate MSN used for

Dimethyl Fumarate MSN 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, periodic worsening of neurological symptoms. Symptoms vary among patients but usually include walking difficulties, 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 Dimethyl Fumarate MSN works

Dimethyl Fumarate MSN appears to work by preventing the immune system from causing damage to the brain and spinal cord. This may also help slow down the progression of multiple sclerosis in the future.

2. Important information before taking Dimethyl Fumarate MSN

When not to take Dimethyl Fumarate MSN:

• If the patient is allergic to dimethyl fumarateor any of the other ingredients of this medication (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 MSN may affect white blood cell count, kidney function, and liver function. Before starting treatment with Dimethyl Fumarate MSN, the doctor will check the patient's white blood cell count and ensure that the kidneys and liver are functioning properly. These tests will be performed periodically during treatment. If the patient's white blood cell count decreases during treatment, the doctor may consider additional tests or discontinuation of treatment.
Before starting Dimethyl Fumarate MSN, the patient should discuss with their doctor if they have:

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

During treatment with Dimethyl Fumarate MSN, shingles (herpes zoster) may occur. In some cases, severe complications have occurred. If the patient suspects any symptoms of shingles, such as blisters, burning, itching, or pain on one side of the body or face, 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 PML. PML is a serious disease that can lead to severe disability or death.
During treatment with a medication containing dimethyl fumarate in combination with other fumaric acid esters used to treat psoriasis (a skin disease), rare but severe kidney dysfunction called Fanconi syndrome has been reported. If the patient notices that they are urinating more, feeling thirsty, and drinking more than usual, their muscles seem weaker, they experience a bone fracture, or simply feel pain, they should consult their doctor as soon as possible to investigate these symptoms.

Children and adolescents

This medication should not be given to children under 10 years of age, as data for this age group are not available.

Dimethyl Fumarate MSN and other medications

The patient should inform their doctor or pharmacistabout all medications they are currently taking or have recently taken, as well as any medications they plan to take, especially:

• medications containing fumaric acid esters(fumarates) used to treat psoriasis;
• medications that affect the immune system, including chemotherapy, immunosuppressive medications, or other medications used to treat multiple sclerosis;
• medications that affect the kidneys, such as certain antibiotics(used to treat infections), diuretics, certain types of pain medications(such as ibuprofen and other similar anti-inflammatory medications, including over-the-counter medications), and medications containing lithium;
• the use of certain vaccines(live vaccines) during treatment with Dimethyl Fumarate MSN may lead to infection, so they should be avoided. The doctor will advise whether other types of vaccines (inactivated vaccines) can be administered.

Dimethyl Fumarate MSN and alcohol

The patient should avoid consuming high-percentage alcoholic beverages (over 30% alcohol by volume) (more than 50 mL) within an hour of taking Dimethyl Fumarate MSN, due to the risk of interaction between alcohol and this medication. This may lead to stomach upset (gastritis), especially in individuals 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 medication.
Pregnancy
There is limited data on the use of this medication in pregnant women. Dimethyl Fumarate MSN should not be taken during pregnancy unless the patient has discussed it with their doctor and the use of the medication is necessary.
Breastfeeding
It is not known whether the active substance of Dimethyl Fumarate MSN passes into human milk. The doctor will advise the patient whether to stop breastfeeding or stop taking Dimethyl Fumarate MSN. The decision will be based on the assessment of the benefit to the baby from breastfeeding compared to the benefit to the patient from treatment.

Driving and using machines

Dimethyl Fumarate MSN is not expected to affect the ability to drive or use machines.

Dimethyl Fumarate MSN contains sodium

This medication contains less than 1 mmol (23 mg) of sodium per capsule, which means it is essentially "sodium-free".

3. How to take Dimethyl Fumarate MSN

This medication should always be taken exactly as prescribed by the doctor. In case of doubts, the patient should consult their 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.

Dimethyl Fumarate MSN 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 MSN should be taken with food– this will help alleviate very common side effects (listed in section 4).

Taking more than the recommended dose of Dimethyl Fumarate MSN

In case of taking more than the recommended number of Dimethyl Fumarate MSN capsules, the patient should immediately contact their doctor. Side effects similar to those described below in section 4 may occur.

Missing a dose of Dimethyl Fumarate MSN

The patient should not take a double doseto make up for a missed dose.
A missed dose can be taken if there is at least a 4-hour interval between doses. If it is too late, the patient should not take the missed dose but take the next dose at the usual time.
In case of further doubts about taking this medication, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medications, Dimethyl Fumarate MSN can cause side effects, although not everybody gets them.

Severe side effects

Dimethyl Fumarate MSN 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 the doctor should monitor the patient's white blood cell count 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 medications that affect the immune system.
Symptoms of PML may resemble those of a relapse of multiple sclerosis. They include weakness or worsening weakness on one side of the body, coordination problems, vision problems, difficulties with thinking or memory, confusion (disorientation) or personality changes, speech difficulties, and communication problems lasting more than a few days. Therefore, if the patient experiences worsening symptoms of multiple sclerosis or new symptoms while taking Dimethyl Fumarate MSN, 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.

• In case of any of the above symptoms, the patient should immediately contact their doctor

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 flushing of the face or body. If sudden 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)

it may indicate a severe allergic reaction (anaphylaxis).

The patient should stop taking Dimethyl Fumarate MSN and immediately contact their doctor

Other side effects

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

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

During treatment with Dimethyl Fumarate MSN, substances called ketone bodies are very commonly detected in urine tests, which are naturally produced in the body.
The patient should discuss with their doctorhow to manage side effects. The doctor may reduce the dose of the medication. The patient should not reduce the dose of the medication unless their doctor advises them to do so.
Common(may affect up to 1 in 10 people)

• inflammation of the lining of the intestines (gastroenteritis)
• vomiting
• indigestion
• inflammation of the stomach lining (gastritis)
• stomach and intestinal problems
• burning sensation on 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 appear in blood or urine tests

• low white blood cell count (lymphopenia, leukopenia). A decreased white blood cell count may indicate that the body is less able to fight infection. In case of severe infection (such as pneumonia), the patient should immediately contact their doctor.
• 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 1,000 people)

• inflammation of the liver and increased liver enzyme activity (ALT or ASTin combination with bilirubin)

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

• shingles, with symptoms such as blisters, burning, itching, or pain on the 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, followed by numbness, itching, or red spots with severe pain
• runny nose (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, such as headache, stomach pain or cramps, nausea (vomiting), sore throat, cough, and painful menstruation.

Reporting side effects

If the patient experiences any side effects, including any not listed in this Package Leaflet, they should inform their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 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 to gather more information on the safety of this medication.

5. How to store Dimethyl Fumarate MSN

The medication should be stored out of sight and reach of children.
Do not use this medication after the expiry date stated on the blister and carton after: EXP.
The expiry date refers to the last day of the month.
There are no special precautions for storing the medication.
Medications should not be disposed of via wastewater or household waste. The patient should ask their 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 MSN contains

The active substance of Dimethyl Fumarate MSN is dimethyl fumarate.
Dimethyl Fumarate MSN, 120 mg: Each capsule contains 120 mg of dimethyl fumarate.
Dimethyl Fumarate MSN, 240 mg: Each capsule contains 240 mg of dimethyl fumarate.

Other ingredients are:

• Capsule contents (enteric-coated microtablets): microcrystalline cellulose (E 460), sodium croscarmellose, colloidal silicon dioxide, magnesium stearate (E 470b), methacrylic acid and methyl methacrylate copolymer (1:1), methacrylic acid and ethyl acrylate copolymer (1:1), 30% dispersion, triethyl citrate (E 1505), talc (E 553b), sodium lauryl sulfate, polysorbate 80 (E 433).
• Capsule shell contains gelatin, titanium dioxide (E 171), brilliant blue FCF (E 133), iron oxide black (E 172), and iron oxide yellow (E 172).
• Black ink for printing contains shellac (E 904), iron oxide black (E 172), potassium hydroxide (E 525), and propylene glycol (E 1520).

What Dimethyl Fumarate MSN looks like and contents of the pack

[120 mg]: Green and white gastro-resistant hard capsules, approximately 22 mm in diameter, with the imprint "M" and "120 mg".
[240 mg]: Green gastro-resistant hard capsules, approximately 22 mm in diameter, with the imprint "M" and "240 mg".
The capsules are filled with white or off-white enteric-coated microtablets.
Pack sizes:
120 mg:
PVC/PE/PVDC/Aluminum blisters containing 14 or 56 gastro-resistant hard capsules.
Perforated unit dose blisters of PVC/PE/PVDC/Aluminum containing 14 x 1 or 56 x 1 gastro-resistant hard capsules.
240 mg:
PVC/PE/PVDC/Aluminum blisters containing 56, 168, or 196 gastro-resistant hard capsules.
Perforated unit dose blisters of PVC/PE/PVDC/Aluminum containing 56 x 1, 168 x 1, or 196 x 1 gastro-resistant hard capsules.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer/importer

Marketing authorization holder:

MSN Labs Europe Limited
KW20A Corradino Park
Paola, PLA 3000
Malta
tel.: (+48) 699 711 147

Manufacturer/Importer:

MSN Labs Europe Limited
KW20A Corradino Park
Paola, PLA 3000
Malta
Pharmadox Healthcare Limited
KW20A Kordin Industrial Park
Paola, PLA 3000
Malta

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

Netherlands:
Dimethylfumaraat MSN 120 mg maagsapresistente harde capsules
Dimethylfumaraat MSN 240 mg maagsapresistente harde capsules
Czech Republic:
Dimethyl fumarate MSN
Poland:
Dimethyl fumarate MSN
Bulgaria:
Диметилфумарат MSN 120 mg стомашно-устойчиви твърди капсули
Диметилфумарат MSN 240 mg стомашно-устойчиви твърди капсули
Croatia:
Dimetilfumarat MSN 120 mg tvrde želučanootporne kapsule
Dimetilfumarat MSN 240 mg tvrde želučanootporne kapsule
Hungary:
Dimethyl fumarate MSN 120 mg gyomornedv-ellenálló kemény kapszula
Dimethyl fumarate MSN 240 mg gyomornedv-ellenálló kemény kapszula
Lithuania:
Dimethyl fumarate MSN 120 mg skrandyje neirios kietosios kapsulės
Dimethyl fumarate MSN 240 mg skrandyje neirios kietosios kapsulės
Latvia:
Dimethyl fumarate MSN 120 mg zarnās šķīstošās cietās kapsulas
Dimethyl fumarate MSN 240 mg zarnās šķīstošās cietās kapsulas
Estonia:
Dimethyl fumarate MSN
Romania:
Dimetil fumarat MSN 120 mg capsule gastrorezistente
Dimetil fumarat MSN 240 mg capsule gastrorezistente
Slovakia:
Dimethyl fumarate MSN 120 mg
Dimethyl fumarate MSN 240 mg
Slovenia:
Dimetilfumarat MSN 120 mg gastrorezistentne trde kapsule
Dimetilfumarat MSN 240 mg gastrorezistentne trde kapsule

Date of last revision of the Package Leaflet: 03/2025