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 a Doctor or Pharmacist.
• This Medication has been Prescribed Specifically for You. Do not Pass it on to Others. The Medication may Harm them, even if their Symptoms are the Same as Yours.
• If the Patient Experiences any Undesirable Effects, Including those not Listed in this Package Leaflet, they Should Inform their Doctor or Pharmacist. See Section 4.

Package Leaflet Contents:

• 1. What Dimethyl Fumarate MSN is and what it is Used for
• 2. Important Information Before Taking Dimethyl Fumarate MSN
• 3. How to Take Dimethyl Fumarate MSN
• 4. Possible Undesirable Effects
• 5. How to Store Dimethyl Fumarate MSN
• 6. Package Contents and Other Information

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

What Dimethyl Fumarate MSN is

Dimethyl Fumarate MSN is a Medication Containing the Active Substance Dimethyl Fumarate.

What Dimethyl Fumarate MSN is Used for

Dimethyl Fumarate MSN 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, Periodic Exacerbations of Neurological Symptoms. Symptoms Vary Among Patients but Typically Include Walking Difficulties, Balance Problems, and Vision Disturbances (e.g., Blurred or Double Vision). These Symptoms may Completely Disappear after an Exacerbation, but some Problems may Persist.

How Dimethyl Fumarate MSN Works

Dimethyl Fumarate MSN Appears to Work by Inhibiting the Immune System from Causing Damage to the Brain and Spinal Cord. This may also Contribute to Slowing 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 Discontinue Treatment.

• Severe Kidney Disease
• Severe Liver Disease
• Stomach or Intestinal Disease
• Severe Infection(e.g., Pneumonia)

During Treatment with Dimethyl Fumarate MSN, Shingles may Occur. In some Cases, Severe Complications have been Reported. If the Patient Suspects any Symptoms of Shingles, they Should Immediately Inform their Doctor.

Children and Adolescents

This Medication Should not be Given to Children Under 10 Years of Age, as there is Limited Data Available for this Age Group.

Dimethyl Fumarate MSN and Other Medications

Tell the Doctor or Pharmacistabout all Medications the Patient is Currently Taking or has Recently Taken, Including those Planned to be Taken, Especially:

• Medications Containing Fumaric Acid Esters(Fumarates) Used to Treat Psoriasis;
• Immunosuppressant Medications, Including Chemotherapyor Other Medications Used to Treat Multiple Sclerosis;
• Medications Affecting Kidney Function, such as Certain Antibiotics(Used to Treat Infections), Diuretics, Certain Types of Pain Relief Medications(e.g., Ibuprofen and Similar Anti-Inflammatory Medications), and Medications Containing Lithium;
• Using Certain Vaccines(Live Vaccines) During Treatment with Dimethyl Fumarate MSN may Cause Infection, so they Should be Avoided. The Doctor will Advise on Whether to Use a Different Type of Vaccine (Inactivated Vaccines).

Dimethyl Fumarate MSN and Alcohol

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 Gastritis (Inflammation of the Stomach Lining), 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 Child, they Should Consult a Doctor or Pharmacist Before Taking this Medication.

Driving and Operating Machinery

Dimethyl Fumarate MSN is not Expected to Affect the Ability to Drive or Operate Machinery.

Dimethyl Fumarate MSN Contains Sodium

This Medication Contains Less than 1 mmol (23 mg) of Sodium per Capsule, which means it is Considered "Sodium-Free".

3. How to Take Dimethyl Fumarate MSN

This Medication Should Always be Taken as Directed by the Doctor. In Case of Doubts, Consult a Doctor.

Initial Dose: 120 mg Twice a Day.

This Initial Dose Should be Taken for the First 7 Days, Followed by the Recommended Dose.

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. Capsules Should not be Divided, Crushed, Dissolved, Sucked, or Chewed, as this may Increase Certain Undesirable Effects.

Dimethyl Fumarate MSN Should be Taken with Food– this will Help to Reduce Very Common Undesirable 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, Immediately Consult a Doctor. Undesirable Effects Similar to those Described Below in Section 4 may Occur.

Missing a Dose of Dimethyl Fumarate MSN

Do 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, Do not Take the Missed Dose, but Take the Next Dose at the Usual Time.

In Case of Further Doubts About Taking this Medication, Consult a Doctor or Pharmacist.

4. Possible Undesirable Effects

Like all Medications, Dimethyl Fumarate MSN can Cause Undesirable Effects, although not Everyone will Experience them.

Severe Undesirable Effects

Dimethyl Fumarate MSN may Reduce the Number of Lymphocytes (a Type of White Blood Cell). A Low White Blood Cell Count can Increase the Risk of Infections, Including the Rare Brain Infection Called Progressive Multifocal Leukoencephalopathy (PML). PML can Lead to Severe Disability or Death. PML has been Reported to Occur Between 1 Year and 5 Years of Treatment, so the Doctor will 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 Sudden Weakness or Increased Weakness on one Side of the Body, Coordination Problems, Vision Disturbances, Changes in Thinking or Memory, Confusion (Disorientation) or Personality Changes, Speech Disturbances, and Communication Difficulties Lasting More than a Few Days. Therefore, if the Patient Experiences any Exacerbation of Multiple Sclerosis Symptoms or New Symptoms During Treatment with Dimethyl Fumarate MSN, they Should Immediately Consult a Doctor.

• In Case of any of these Symptoms, Immediately Consult a Doctor

Severe Allergic Reactions

The Frequency of Severe Allergic Reactions Cannot be Determined from the Available Data (Frequency Unknown).

A Very Common Undesirable Effect is Sudden Redness of the Face or Body. If this Redness 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).

Stop Taking Dimethyl Fumarate MSN and Immediately Consult a Doctor

Other Undesirable Effects

Very Common(May Affect More than 1 in 10 People)

• Sudden Redness of the Face or a Feeling of Increased Body Temperature, Heat, Burning, or Itching of the Skin
• Diarrhea
• Nausea
• Stomach Pain or Cramps
• Taking the Medication with Foodwill Help to Reduce the Above Undesirable 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.

Consult a Doctorabout how to Manage Undesirable Effects. The Doctor may Reduce the Dose of the Medication. Do not Reduce the Dose of the Medication unless the Doctor Advises to do so.

Common(May Affect up to 1 in 10 People)

• Gastroenteritis (Gastrointestinal Inflammation)
• Vomiting
• Indigestion
• Gastritis (Inflammation of the Stomach Lining)
• Gastrointestinal Disorders
• Burning Sensation of the Skin
• Hot Flashes, Feeling of Heat
• Itching of the Skin (Pruritus)
• Rash
• Pink or Red Spots on the Skin (Erythema)
• Hair Loss (Alopecia)

Undesirable Effects that may Appear in Blood or Urine Test Results

• Low White Blood Cell Count (Lymphopenia, Leukopenia). A Reduced White Blood Cell Count may Indicate that the Body is Less Able to Fight Infection. In Case of Severe Infection (such as Pneumonia), Immediately Consult a Doctor.
• Protein (Albumin) in Urine
• Increased Liver Enzyme Activity (ALT, AST) in 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)

• Hepatitis and Increased Liver Enzyme Activity (ALT or ASTin Combination with Bilirubin)

Frequency Unknown(Frequency Cannot be Estimated from the Available Data)

• Shingles, with Symptoms such as Blisters, Burning, Itching, or Pain of 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
• Rhinitis (Rhinitis)

Children (Aged 13 and Above) and Adolescents

The Above Undesirable Effects also Apply to Children and Adolescents.

Certain Undesirable 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 Undesirable Effects

If any Undesirable Effects Occur, Including those not Listed in this Package Leaflet, Inform a Doctor, Pharmacist, or Nurse. Undesirable Effects can be Reported Directly to the Department of Adverse Reaction Monitoring 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

Undesirable Effects can also be Reported to the Marketing Authorization Holder.

Reporting Undesirable Effects will Help to Gather More Information on the Safety of this Medication.

5. How to Store Dimethyl Fumarate MSN

Store the Medication in a Place that is Inaccessible to Children.

Do not Use this Medication after the Expiration Date Stated on the Blister Pack and Carton: EXP.

The Expiration Date Refers to the Last Day of the Specified Month.

There are no Special Precautions for Storing the Medication.

Medications Should not be Disposed of via Wastewater or Household Waste. Ask a Pharmacist how to Dispose of Medications that are no Longer Needed. This will Help to Protect the Environment.

6. Package Contents 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 Carboxymethylcellulose, Colloidal Silica, 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), Black Iron Oxide (E 172), and Yellow Iron Oxide (E 172).
• Black Ink for Printing Contains Shellac (E 904), Black Iron Oxide (E 172), Potassium Hydroxide (E 525), and Propylene Glycol (E 1520).

What Dimethyl Fumarate MSN Looks Like and Package Contents

[120 mg]: Green-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.

Package Sizes:

120 mg:

Blisters of PVC/PE/PVDC/Aluminum 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:

Blisters of PVC/PE/PVDC/Aluminum 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 Package 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 for Marketing in the Member States of the European Economic Area Under the Following Names:

Netherlands:

Dimethylfumarate MSN 120 mg maagsapresistente harde capsules

Dimethylfumarate 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