ARBICEN 120 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 the Package Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.
   2. Table of Contents of the Package Leaflet
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 Older.
   4. How Arbicen Works
5. Important Information Before Taking Arbicen
   1. When Not to Take Arbicen
   2. Warnings and Precautions
   3. Children and Adolescents
   4. Arbicen and Other Medications
   5. Using Arbicen with Alcohol
   6. Pregnancy and Breastfeeding
   7. Driving and Operating 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. Missing a Dose of Arbicen
7. Possible Side Effects
   1. Serious Side Effects
   2. If You Experience Any of the Following Symptoms, Contact Your Doctor Immediately
   3. Severe Allergic Reactions
   4. Stop Taking Arbicen and Contact Your Doctor Immediately.
   5. Other Side Effects
   6. Taking the Medication with Food Will Help Alleviate the Above Side Effects.
   7. Rare (may affect up to 1 in 1,000 people, but not more often)
   8. Children (Aged 13 and Older) and Adolescents
   9. Reporting Side Effects
8. How to Store Arbicen
9. Contents of the Package and Other Information
   1. What Arbicen Contains
   2. Appearance of Arbicen and Package Contents
   3. Marketing Authorization Holder
   4. Importer
   5. Date of Last Revision of the Package 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 the Package Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.

• Keep this package leaflet, as 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. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this package leaflet, inform your doctor or pharmacist. See section 4.

Table of Contents of the Package Leaflet

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

1. What is Arbicen and What is it Used For

What is Arbicen

Arbicen is a medication containing 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 Older.

Multiple sclerosis is a chronic disease that damages the central nervous system (CNS), including the brain and spinal cord. The relapsing-remitting form of multiple sclerosis is characterized by recurring episodes of neurological symptoms (called relapses). Symptoms vary from person to person but usually include problems with walking and balance, as well as vision disturbances (e.g., blurred or double vision). These symptoms can completely resolve after a relapse, but some problems may persist.

How Arbicen Works

Arbicen 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 Arbicen

When Not to Take Arbicen

• If you are allergic to dimethyl fumarateor any of the other ingredients of this medication (listed in section 6).
• If you suspect or have been diagnosed with a 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 ensure that your kidneys and liver are functioning properly. These tests will be performed periodically during treatment. If your white blood cell count decreases during treatment, your doctor may consider additional tests or discontinuation of treatment. Before taking Arbicen, inform your doctor if you have:

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

During treatment with Arbicen, shingles (herpes zoster) may occur. In some cases, severe complications have been reported. If you suspect any symptoms of shingles, inform your doctor immediately. If your multiple sclerosis worsens (e.g., you experience weakness or vision disturbances) or you develop new symptoms, contact your doctor promptly, 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. PML has been reported after 1 to 5 years of treatment with dimethyl fumarate, so your doctor will 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 medications that affect the immune system. Symptoms of PML may resemble those of a multiple sclerosis relapse. Symptoms may include weakness or increased weakness on one side of the body, coordination problems, vision disturbances, problems with thinking or memory, confusion or personality changes, speech difficulties, or communication problems lasting more than a few days. Therefore, if you experience worsening of your multiple sclerosis symptoms or new symptoms while taking Arbicen, contact your doctor promptly. You should also discuss your treatment with your partner or caregivers and inform them about your treatment. You may not be aware of some symptoms.

Children and Adolescents

Do not give this medication to children under 10 years of age, as there is no data available for this age group.

Arbicen and Other Medications

Tell your doctor or pharmacistabout all medications you are currently taking or have recently taken, as well as any medications you plan to take, especially:

• medications containing fumaric acid esters(fumarates) used to treat psoriasis;
• medications that affect the immune system, including chemotherapeutic agents, immunosuppressive medications, or other medications used to treat multiple sclerosis;
• medications that affect kidney function, including certain antibiotics (used to treat infections), diuretics, certain pain relievers (such as ibuprofen and similar anti-inflammatory medications, as well as over-the-counter medications), and medications containing lithium.
• the use of certain live vaccines during treatment with Arbicen may lead to infection, so it should be avoided. Your doctor will advise on whether to administer other types of vaccines (inactivated vaccines).

Using Arbicen with Alcohol

Avoid consuming more than a small amount (more than 50 mL) of high-percentage alcoholic beverages (over 30% alcohol by volume, e.g., spirits) within an hour of taking Arbicen, as alcohol may interact with this medication. This may cause stomach inflammation (gastritis), especially in individuals already prone to stomach inflammation.

Pregnancy and Breastfeeding

There is limited data on the use of this medication during pregnancy. This medication should not be taken during pregnancy unless the patient has discussed it with their doctor and the use of the medication is necessary. Pregnancy: Arbicen 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 this medication passes into breast milk. Your doctor will advise whether to stop breastfeeding or discontinue Arbicen. The decision will be made based on the assessment of the benefits of breastfeeding for the child compared to the benefits of treatment for the patient.

Driving and Operating Machines

Do not expect Arbicen to affect your ability to drive or operate machines.

3. How to Take Arbicen

Always take this medication exactly as your doctor has told you. 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, followed by the usual dose.

Usual Dose

240 mg twice a day.

Arbicen should be taken orally. Swallow each capsule whole, with water. Do not divide, crush, dissolve, suck, or chew the capsules, as this may increase certain side effects. Take Arbicen with food- this will help alleviate very common side effects (listed in section 4).

Taking More Than the Recommended Dose of Arbicen

If you have taken more capsules than recommended, inform your doctor immediately. Side effects similar to those described in section 4 may occur.

Missing a Dose of Arbicen

Do not take a double dose. If you miss a dose, take it as soon as possible, maintaining a 4-hour interval before the next dose. Otherwise, wait until the scheduled time for the next dose. If you have any further doubts about taking the medication, consult your doctor or pharmacist.

4. Possible Side Effects

Like all medications, Arbicen can cause side effects, although not everybody gets them.

Serious Side Effects

Arbicen 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 your doctor will 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 medications that affect the immune system. Symptoms of PML may resemble those of a multiple sclerosis relapse. Symptoms may include weakness or increased weakness on one side of the body, coordination problems, vision disturbances, problems with thinking or memory, confusion or personality changes, speech difficulties, or communication problems lasting more than a few days. Therefore, if you experience worsening of your multiple sclerosis symptoms or new symptoms while taking Arbicen, contact your doctor promptly. You should also discuss your treatment with your partner or caregivers and inform them about your treatment. You 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 (frequency not known). 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 or hypoxia)
• dizziness or loss of consciousness (hypotension), this may indicate a severe allergic reaction (anaphylaxis).

Stop Taking Arbicen and Contact Your Doctor Immediately.

Other Side Effects

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

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

Taking the Medication with Food Will Help Alleviate the Above Side Effects.

During treatment with dimethyl fumarate, an increase in ketone bodies (substances normally produced in the body) in the urine is very commonly observed. Ask your doctor how to manage these side effects. Your doctor may reduce the dose of the medication. Do not reduce the dose of the medication yourself unless advised by your doctor. 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
• burning sensation on the skin
• 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 indicate 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 levels (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 not more often)

• -liver inflammation and increased liver enzyme activity (ALT or AST simultaneously 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, usually on one side of the upper body or face, as well as 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 Older) and Adolescents

The side effects listed above also apply to children and adolescents. The occurrence of some side effects has 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 those not listed in this package leaflet, inform your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety 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. 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 medication.

5. How to Store Arbicen

Keep the medication out of sight and reach of children. Do not use this medication after the expiration date stated on the blister, bottle label, and carton after "EXP". The expiration date refers to the last day of the month stated. There are no special precautions for storing this medication at a specific temperature. Store in the original package to protect from light. Medications should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medications that are no longer needed. This will help protect the environment.

6. Contents of the Package and Other Information

What Arbicen Contains

The active substance of Arbicen 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 contents: microcrystalline cellulose, crospovidone, talc, povidone, colloidal anhydrous 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), yellow iron oxide (E172).
• Capsule imprint (black ink): shellac, potassium hydroxide, propylene glycol (E1520), black iron oxide (E172), ammonium hydroxide.

Appearance of Arbicen and Package Contents

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 off-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 off-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 blisters or single-dose OPA/Aluminum/PVC/Aluminum blisters. Arbicen, Gastro-Resistant Hard Capsules, 120 mg Package sizes: 14 capsules (blister) 14 x 1 capsule (perforated single-dose blisters) 100 capsules (bottle) Arbicen, Gastro-Resistant Hard Capsules, 240 mg Package sizes: 56 capsules (blister) 56 x 1 capsule (perforated single-dose blisters) 168 capsules (blister) 168 capsules (perforated single-dose blisters) 100 capsules (bottle) Not all package 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 medication is authorized for marketing 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 detailed information on this medication, 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 Package Leaflet: 15.04.2025