ARBICEN 240 mg Capsules

Contents of the leaflet

1. Package Leaflet: Information for the Patient
2. Arbicen, 120 mg, Gastro-Resistant Hard Capsules
3. Arbicen, 240 mg, Gastro-Resistant Hard Capsules
   1. Read All of This Leaflet Carefully Before You Start Taking This Medicine Because It Contains Important Information for You.
   2. Contents of the Pack
4. What is Arbicen and What is it Used For
   1. What is Arbicen
   2. What is Arbicen Used For
   3. Arbicen is Used to Treat Relapsing-Remitting Multiple Sclerosis (MS) in Patients Aged 13 Years and Over.
   4. How Does Arbicen Work
5. Before You Take Arbicen
   1. When Not to Take Arbicen
   2. Warnings and Precautions
   3. Children and Adolescents
   4. Arbicen and Other Medicines
   5. Arbicen and Alcohol
   6. Pregnancy and Breast-Feeding
   7. Driving and Using Machines
6. How to Take Arbicen
   1. Initial Dose
   2. 120 mg Twice a Day.
   3. Usual Dose
   4. 240 mg Twice a Day.
   5. Taking More Than the Recommended Dose of Arbicen
   6. Forgetting to Take a Dose of Arbicen
7. Possible Side Effects
   1. Serious Side Effects
   2. If You Experience Any of the Following Symptoms, You Should Immediately Contact Your Doctor
   3. Severe Allergic Reactions
   4. You Should Stop Taking Arbicen and Immediately Contact Your Doctor.
   5. Other Side Effects
   6. Taking the Medicine with Food Will Help Reduce the Above Side Effects.
   7. Rare (May Affect Up to 1 in 1,000 People, But No More)
   8. Children (Aged 13 and Over) and Adolescents
   9. Reporting Side Effects
8. How to Store Arbicen
9. Contents of the Pack and Other Information
   1. What Arbicen Contains
   2. What Arbicen Looks Like and Contents of the Pack
   3. Marketing Authorization Holder
   4. Importer
   5. Date of Last Revision of the Leaflet: 15.04.2025

Package Leaflet: Information for the Patient

Arbicen, 120 mg, Gastro-Resistant Hard Capsules

Arbicen, 240 mg, Gastro-Resistant Hard Capsules

Dimethyl Fumarate

Read All of This Leaflet Carefully Before You Start Taking This Medicine Because It Contains Important Information for You.

• You should keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Pack

• 1. What is Arbicen and What is it Used For
• 2. Before You Take Arbicen
• 3. How to Take Arbicen
• 4. Possible Side Effects
• 5. How to Store Arbicen
• 6. Contents of the Pack and Other Information

1. What is Arbicen and What is it Used For

What is Arbicen

Arbicen is a medicine that contains the active substance dimethyl fumarate.

What is Arbicen Used For

Arbicen is Used to Treat Relapsing-Remitting Multiple Sclerosis (MS) in Patients Aged 13 Years and Over.

Multiple sclerosis is a long-term disease that affects the central nervous system (the brain and spinal cord). The relapsing-remitting form of multiple sclerosis is characterized by recurring episodes of symptoms (relapses) from the nervous system, which can include problems with walking and balance, and vision problems (such as blurred or double vision). These symptoms can completely disappear after a relapse, but some problems may remain.

How Does Arbicen Work

Arbicen seems 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. Before You Take Arbicen

When Not to Take Arbicen

• If You are Allergic to Dimethyl Fumarate or Any of the Other Ingredients of This Medicine(listed in section 6).
• If You Have a Suspected or Confirmed Rare Brain Infection Called Progressive Multifocal Leukoencephalopathy (PML).

Warnings and Precautions

Arbicen May Affect Your White Blood Cell Countand Kidney and Liver Function. Before Starting Treatment with Arbicen, Your Doctor Will Check Your White Blood Cell Count and Kidney and Liver Function. These Tests Will be Repeated Periodically During Treatment. If Your White Blood Cell Count Decreases During Treatment, Your Doctor May Consider Additional Tests or Stop Treatment.

• severe kidney disease
• severe liver disease
• stomach or intestine disease
• severe infection(such as pneumonia).

During Treatment with Arbicen, Shingles (Herpes Zoster) May Occur. In Some Cases, Serious Complications Have Occurred. If You Suspect Any Symptoms of Shingles, You Must Immediately Inform Your Doctor. If Your Multiple Sclerosis Gets Worse (for Example, You Experience Weakness or Vision Problems) or You Experience New Symptoms, 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 Cause Severe Disability or Death.

Children and Adolescents

This Medicine Must Not be Given to Children Under 10 Years of Age, as There is No Information on Its Use in This Age Group.

Arbicen and Other Medicines

Tell Your Doctor or Pharmacist About All Medicines You are Taking or Have Recently Taken, and About Any Medicines You Plan to Take, Especially:

• medicines containing fumaric acid estersused to treat psoriasis;
• medicines that Affect the Immune System, Including Chemotherapy, Immunosuppressants, or Other Medicines Used to Treat Multiple Sclerosis;
• medicines that Affect the Kidneys, Including Certain Antibiotics (Used to Treat Infections), Diuretics, Certain Pain Relievers (Such as Ibuprofen and Similar Anti-Inflammatory Medicines, as Well as Over-the-Counter Medicines), and Medicines Containing Lithium.
• the use of certain vaccines (live vaccines) during treatment with Arbicen may cause infection, so this should be avoided. Your doctor will advise whether you should receive a different type of vaccine (inactivated vaccines).

Arbicen and Alcohol

You Should Avoid Drinking More Than a Small Amount (More Than 50 mL) of High-Percentage Alcoholic Beverages (More Than 30% Alcohol by Volume, e.g., Spirits) Within an Hour of Taking Arbicen, as Alcohol May Interact with This Medicine. This May Cause Stomach Inflammation (Gastritis), Especially in People Already Prone to Gastritis.

Pregnancy and Breast-Feeding

There is Limited Information on the Use of This Medicine in Pregnant Women. This Medicine Should Not be Taken During Pregnancy, Unless You Have Discussed This with Your Doctor and the Use of the Medicine is Necessary.

Driving and Using Machines

You Should Not Expect Arbicen to Affect Your Ability to Drive or Use Machines.

3. How to Take Arbicen

This Medicine Should Always be Taken Exactly as Your Doctor Has Told You. If You are Not Sure, Ask 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.

Arbicen Should be Taken Orally. Each Capsule Should be Swallowed Whole, with Water. The Capsules Should Not be Divided, Crushed, Dissolved, Sucked, or Chewed, as This May Increase Certain Side Effects. Arbicen Should be Taken with Food- This Will Help Reduce the Very Common Side Effects (Listed in Section 4).

Taking More Than the Recommended Dose of Arbicen

If You Have Taken More Than the Recommended Number of Capsules, You Should Immediately Tell Your Doctor. Side Effects Similar to Those Described Below in Section 4 May Occur.

Forgetting to Take a Dose of Arbicen

Do Not Take a Double Dose. If You Forget a Dose, You Can Take it as Soon as You Remember, Provided That the Next Dose is Not Due Within the Next 4 Hours. Otherwise, You Should Wait Until the Next Planned Dose. If You Have Any Further Questions on the Use of This Medicine, Ask Your Doctor or Pharmacist.

4. Possible Side Effects

Like All Medicines, This Medicine Can Cause Side Effects, Although Not Everybody Gets Them.

Serious Side Effects

Arbicen May Reduce the Number of Lymphocytes (a Type of White Blood Cell). A Low White Blood Cell Count May Increase the Risk of Infections, Including a Rare Brain Infection Called Progressive Multifocal Leukoencephalopathy (PML). PML Can Cause 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 Treatment, 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 Medicines that Affect the Immune System.

If You Experience Any of the Following Symptoms, You Should Immediately Contact Your Doctor

Severe Allergic Reactions

The Frequency of Severe Allergic Reactions Cannot be Estimated from the Available Data (Frequency Not Known). Very Commonly, Sudden (Paroxysmal) Redness of the Face or Body Occurs. If the Redness of the Skin 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), may indicate a severe allergic reaction (anaphylaxis).

You Should Stop Taking Arbicen and Immediately Contact Your Doctor.

Other Side Effects

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

• redness of the skin of the face or a feeling of increased body temperature, heat, burning of the skin, or itching of the skin (paroxysmal redness of the skin)
• loose stools (diarrhea)
• nausea (nausea)
• stomach pain or cramps

Taking the Medicine with Food Will Help Reduce the Above Side Effects.

During Treatment with Dimethyl Fumarate, an Increased Production of Ketone Bodies (Substances Normally Produced in the Body) is Very Commonly Found in Urine Tests. You Should Ask Your Doctor How to Deal with These Side Effects. Your Doctor May Reduce the Dose of the Medicine. Do Not Reduce the Dose Yourself Unless Your Doctor Tells You to. 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)
• gastrointestinal disorders
• skin burning
• hot flashes, feeling of heat
• itching (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. If you have a severe infection (such as pneumonia), you should immediately contact your doctor
• protein (albumin) in the urine
• increased levels of liver enzymes (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, But No More)

• -liver inflammation and increased liver enzyme activity (ALT or AST together 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 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, 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, Such as Headache, Abdominal Pain or Stomach Cramps, Vomiting, Sore Throat, Cough, and Painful Menstruation.

Reporting Side Effects

If You Experience Any Side Effects, Including Any Not Listed in This Leaflet, You Should Tell Your Doctor or Pharmacist. You Can Also Report Side Effects Directly to the Department of Drug Monitoring of the 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. You Can Also Report Side Effects to the Marketing Authorization Holder.

5. How to Store Arbicen

Medicines Should be Kept Out of the Sight and Reach of Children. Do Not Use This Medicine After the Expiry Date Which is Stated on the Blister, Bottle Label, and Carton After “EXP”. The Expiry Date Refers to the Last Day of the Month Stated. There are No Special Storage Conditions for This Medicine. Store in the Original Package 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. These Measures Will Help Protect the Environment.

6. Contents of the Pack and Other Information

What Arbicen Contains

The Active Substance is Dimethyl Fumarate. Arbicen, 120 mg, Gastro-Resistant Hard CapsulesEach Gastro-Resistant Hard Capsule Contains 120 mg of Dimethyl Fumarate. Arbicen, 240 mg, Gastro-Resistant Hard CapsulesEach Gastro-Resistant Hard Capsule Contains 240 mg of Dimethyl Fumarate. The Other Ingredients Are:

• Capsule Content: Microcrystalline Cellulose, Crospovidone, Talc, Povidone, Colloidal Silica, Magnesium Stearate, Triethyl Citrate, Methacrylic Acid, and Ethyl Acrylate Copolymer (1:1), Hypromellose, Titanium Dioxide (E 171), Triacetin.
• Capsule Shell: Gelatin, Titanium Dioxide (E171), Brilliant Blue FCF (E133), Iron Oxide Yellow (E172).
• Capsule Printing Ink (Black): Shellac, Potassium Hydroxide, Propylene Glycol (E1520), Iron Oxide Black (E172), Ammonium Hydroxide.

What Arbicen Looks Like and Contents of the Pack

Arbicen, 120 mg, Gastro-Resistant Hard Capsules: Green Cap and White Body, Capsule Shell 21.4 mm, with “DMF 120” Printed on the Body, Containing White or Almost White Mini-Tablets. Arbicen, 240 mg, Gastro-Resistant Hard Capsules: Green Cap and Green Body, Capsule Shell 23.2 mm, with “DMF 240” Printed on the Body, Containing White or Almost White Mini-Tablets. HDPE Bottle with PP/HDPE Cap, with a Desiccant and a Silica Gel Container as a Moisture-Absorbing Agent. Do Not Swallow the Moisture-Absorbing Agent. OPA/Aluminum/PVC//Aluminum or Single-Dose OPA/Aluminum/PVC//Aluminum Blister. Arbicen, Gastro-Resistant Hard Capsules, 120 mg Pack Sizes: 14 Capsules (Blisters) 14 x 1 Capsule (Perforated Single-Dose Blisters) 100 Capsules (Bottle) Arbicen, Gastro-Resistant Hard Capsules, 240 mg Pack Sizes: 56 Capsules (Blisters) 56 x 1 Capsule (Perforated Single-Dose Blisters) 168 Capsules (Blisters) 168 Capsules (Perforated Single-Dose Blisters) 100 Capsules (Bottle) Not All Pack Sizes May be Marketed.

Marketing Authorization Holder

Egis Pharmaceuticals PLC Keresztúri út 30-38 1106 Budapest Hungary

Importer

Pharmadox Healthcare Ltd. KW20A Kordin Industrial Park Paola PLA 3000 Malta Adalvo Ltd (AMOL) Malta Life Sciences Park Building 1, Level 4, Sir Temi Zammit Buildings San Ġwann SĠN 3000 Malta KeVaRo GROUP Ltd 9, Tzaritza Elenora Str. Office 23 Sofia 1618 Bulgaria This Medicinal Product is Authorized in the Member States of the European Economic Area Under the Following Names: Iceland Arbicen 120 mg magasýruþolin hörð hylki Arbicen 240 mg magasýruþolin hörð hylki Bulgaria Arbicen 120 mg стомашно-устойчиви твърди капсули Arbicen 240 mg стомашно-устойчиви твърди капсули Czech Republic Arbicen Hungary Arbicen 120 mg gyomornedvellenálló kemény kapszula Arbicen 240 mg gyomornedvellenálló kemény kapszula Poland Arbicen Slovakia Arbicen 120 mg tvrdé gastrorezistentné kapsuly Arbicen 240 mg tvrdé gastrorezistentné kapsuly Romania Arbicen 120 mg capsule gastrorezistente Arbicen 240 mg capsule gastrorezistente Lithuania Arbicen 120 mg skrandyje neirios kietosios kapsulės Arbicen 240 mg skrandyje neirios kietosios kapsulės Latvia Arbicen 120 mg zarnās šķīstošā kapsula, cietā Arbicen 240 mg zarnās šķīstošā kapsula, cietā For More Information on This Medicinal Product, Please Contact the Local Representative of the Marketing Authorization Holder: EGIS Polska Sp. z o.o. ul. Komitetu Obrony Robotników 45D 02-146 Warsaw Tel.: +48 22 417 92 00

Date of Last Revision of the Leaflet: 15.04.2025