DIMETHYL 120 mg Capsules

Contents of the leaflet

1. Leaflet included in the packaging: patient information
2. Balfumon, 120 mg, gastro-resistant hard capsules
3. Balfumon, 240 mg, gastro-resistant hard capsules
   1. Table of contents of the leaflet
4. What is Balfumon and what is it used for
   1. What is Balfumon
   2. What is Balfumon used for
   3. Balfumon is used to treat relapsing-remitting multiple sclerosis (MS) in patients aged 13 and over.
   4. How Balfumon works
5. Important information before taking Balfumon
   1. When not to take Balfumon
   2. Warnings and precautions
   3. Children and adolescents
   4. Balfumon and other medicines
   5. Balfumon and alcohol
   6. Pregnancy and breastfeeding
   7. Driving and using machines
6. How to take Balfumon
   1. Initial dose
   2. 120 mg twice a day.
   3. Usual dose
   4. 240 mg twice a day.
   5. Taking more Balfumon than prescribed
   6. Missing a dose of Balfumon
7. Possible side effects
   1. Severe side effects
   2. Anaphylaxis
   3. Other side effects
   4. Children (aged 13 and over) and adolescents
   5. Reporting side effects
8. How to store Balfumon
9. Contents of the packaging and other information
   1. What Balfumon contains
   2. What Balfumon looks like and contents of the pack
   3. Marketing authorization holder
   4. Importer
   5. This medicine is authorized in the Member States of the European Economic Area under the following names:
   6. For further information about this medicine, contact the marketing authorization holder:
   7. Date of last revision of the leaflet: 10.06.2025

Leaflet included in the packaging: patient information

Balfumon, 120 mg, gastro-resistant hard capsules

Balfumon, 240 mg, gastro-resistant hard capsules

Dimethyl fumarate
You should carefully read the contents of this leaflet before taking this medicine, as it contains important information for you.

• You should keep this leaflet, so you can read it again later if you need to.
• 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 symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What is Balfumon and what is it used for

What is Balfumon

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

What is Balfumon used for

Balfumon 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). The symptoms vary from person to person, but usually include problems with walking, balance, and vision (such as blurred or double vision). These symptoms can completely disappear after a relapse, but some problems may persist.

How Balfumon works

Balfumon appears to prevent the immune system from causing damage to the brain and spinal cord. This may also slow down the progression of multiple sclerosis in the future.

2. Important information before taking Balfumon

When not to take Balfumon

• If you are allergic to dimethyl fumarate or any of the other ingredients of this medicine (listed in section 6).
• If you have a rare brain infection called progressive multifocal leukoencephalopathy (PML).

Warnings and precautions

Balfumon may have a negative effect on white blood cell countand kidney and liver function. Before starting treatment with Balfumon, your doctor will check your white blood cell count and ensure that your kidneys and liver are working properly. 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.

You should discuss this with your doctorif you have:

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

During treatment with Balfumon, you may experience shingles. In some cases, severe complications have occurred. If you suspect that you have any symptoms of shingles, you should inform your doctor immediately. If your multiple sclerosis worsens (e.g., you experience weakness or vision problems) or you develop 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 should not be given to children under 10 years of age, as there is no data available for this age group.

Balfumon and other medicines

You should tell your doctor or pharmacist about all other medicines you are taking, or have recently taken, and about any medicines you plan to take, especially:

• medicines containing fumaric acid esters (fumarates) used to treat psoriasis
• medicines that affect the immune system, including chemotherapy, immunosuppressants, or other medicines used to treat multiple sclerosis
• medicines that affect kidney function, including certain antibiotics (used to treat infections), diuretics, certain types of painkillers (such as ibuprofen and similar anti-inflammatory medicines), and medicines containing lithium
• live vaccines (containing live microorganisms). Your doctor will advise you whether to use a different type of vaccine (containing killed microorganisms).

Balfumon and alcohol

You should avoid consuming high-percentage alcoholic beverages (more than 30% alcohol by volume, e.g., spirits) in excess of 50 mL within 1 hour of taking Balfumon, due to the risk of interaction between alcohol and this medicine. This may lead to stomach upset (gastritis), especially in people prone to this condition.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, you should consult your doctor or pharmacist before taking this medicine.

Pregnancy

There is limited data on the use of this medicine in pregnant women. Balfumon should not be taken during pregnancy unless your doctor considers it necessary.

Breastfeeding

It is not known whether the active substance of Balfumon passes into breast milk. Your doctor will advise you whether to stop breastfeeding or stop taking Balfumon. The decision will be based on the benefits of breastfeeding for the baby compared to the benefits of treatment for you.

Driving and using machines

You should not expect Balfumon to affect your ability to drive or use machines.

3. How to take Balfumon

This medicine should always be taken exactly as your doctor has instructed.If you are unsure, 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.

Balfumon 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.

Balfumon should be taken with food- this will help to reduce the very common side effects (listed in section 4).

Taking more Balfumon than prescribed

If you have taken more capsules than prescribed, you should tell your doctor immediately.Side effects may occur, similar to those described below in section 4.

Missing a dose of Balfumon

You should not take a double dose to 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, you should not take the missed dose, but take the next dose at the usual time.

If you have any further questions about taking this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Balfumon can cause side effects, although not everybody gets them.

Severe side effects

Balfumon 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 cause 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 developing PML may be higher if you have taken medicines that affect the immune system in the past.

Symptoms of PML can be similar to those of a relapse of multiple sclerosis. They include:

• weakness or increased weakness on one side of the body
• coordination problems
• vision problems
• problems with thinking or memory
• confusion or personality changes
• speech problems or difficulty communicating

If you experience any of these symptoms, you should contact your doctor immediately.

Anaphylaxis

The frequency of anaphylaxis cannot be estimated from the available data (frequency not known).

A very common side effect is sudden (acute) flushing 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)
• dizziness or loss of consciousness (syncope)

You should stop taking Balfumon and contact your doctor immediately.

Other side effects

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

• flushing of the skin on the face or a feeling of warmth (flushing)
• diarrhea
• nausea
• stomach pain or cramps

Taking Balfumon with food will help to reduce these side effects.

During treatment with Balfumon, very common findings in urine tests include increased production of ketone bodies (substances normally produced by the body).

You should ask your doctor for advice on how to manage side effects.Your doctor may reduce the dose of Balfumon. You should not reduce the dose yourself unless your doctor advises you to do so.

Common(may affect up to 1 in 10 people)

• gastroenteritis (inflammation of the stomach and intestines)
• vomiting
• indigestion
• gastritis (inflammation of the stomach lining)
• gastrointestinal disorders
• burning sensation of the skin
• hot flashes, feeling of warmth - burning sensation of the skin
• rash
• red or purple spots on the skin (erythema)
• hair loss (alopecia)

Side effects that may affect the results of blood or urine tests

• low white blood cell count (lymphopenia, leukopenia). A low white blood cell count may mean that your body is less able to fight infection. If you have a severe infection (e.g., pneumonia), you should contact your doctor immediately
• 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

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

• liver inflammation and increased liver enzyme activity (ALT or AST together with bilirubin)
• shingles with symptoms such as: blisters on the skin, burning sensation, itching, or pain on the skin, usually on one side of the upper part of the body or face, and other symptoms such as fever and weakness in the early stages of infection, followed by itching, burning sensation, or red spots and severe pain
• runny nose (rhinitis)

Children (aged 13 and over) and adolescents

The side effects listed above 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 stomach cramps, vomiting, sore throat, cough, and painful menstruation.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should tell your doctor, pharmacist, or nurse.You can also report side effects directly to the national reporting system:

Department for Monitoring of Adverse Reactions to Medicinal Products

Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych

Al. Jerozolimskie 181C

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 Balfumon

The medicine should be stored out of sight and reach of children.

Do not use this medicine after the expiry date stated on the blister and carton 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 that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Balfumon contains

The active substance is dimethyl fumarate.

Balfumon, 120 mg - Each capsule contains 120 mg of dimethyl fumarate.

Balfumon, 240 mg - Each capsule contains 240 mg of dimethyl fumarate.

The other ingredients are:

• Capsule content: microcrystalline cellulose (E 460), crospovidone (type A), talc (E 553b), povidone K30 (E 1201), colloidal silica, anhydrous (E 551), magnesium stearate (E 470b), triethyl citrate, methacrylic acid, and ethyl acrylate copolymer (1:1), hypromellose, titanium dioxide (E 171), triacetin
• Capsule shell: gelatin, titanium dioxide (E 171), brilliant blue FCF (E 133), yellow iron oxide (E 172)
• Black ink: shellac, potassium hydroxide, propylene glycol (E 1520), black iron oxide (E 172), ammonium hydroxide

What Balfumon looks like and contents of the pack

Balfumon 120 mg, gastro-resistant hard capsules

Green cap and white body, 21.4 mm capsules, with black printing "DMF 120" on the body, containing white or almost white gastro-resistant mini-tablets.

Balfumon 240 mg, gastro-resistant hard capsules

Green cap and body, 23.2 mm capsules, with black printing "DMF 240" on the body, containing white or almost white gastro-resistant mini-tablets.

Blisters of OPA/Aluminum/PVC/Aluminum or single-dose blisters of OPA/Aluminum/PVC/Aluminum in a carton box.

Balfumon, 120 mg gastro-resistant hard capsules

Packaging containing:

• 14 capsules (blisters)
• 14 x 1 capsule (single-dose blister)

Balfumon, 240 mg gastro-resistant hard capsules

Packaging containing:

• 56 capsules (blisters)
• 56 x 1 capsule (single-dose blister)

Not all pack sizes may be marketed.

Marketing authorization holder

G.L. Pharma GmbH

Schlossplatz 1

8502 Lannach

Austria

Importer

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:

Austria: Balfumon 120/240 mg magensaftresistente Hartkapseln

Iceland: Balfumon 120/240 mg Magasýruþolið hart hylki

Poland: Balfumon

For further information about this medicine, contact the marketing authorization holder:

G.L. PHARMA POLAND Sp. z o.o.

ul. Sienna 75; 00-833 Warsaw, Poland

Phone: 022/ 636 52 23; 636 53 02

[email protected]

Date of last revision of the leaflet: 10.06.2025