Balfumon

Package leaflet: Information for the patient

Balfumon, 120 mg, hard enteric-coated capsules
Balfumon, 240 mg, hard enteric-coated capsules
Dimethyl fumarate
Please read the entire leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet for future reference.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not share it with others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any adverse reactions, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

1. What Balfumon is and what it is 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 pack and other information

1. What Balfumon is and what it is used for

What Balfumon is
Balfumon is a medicine containing the active substance dimethyl fumarate.

What Balfumon is used for
Balfumon is used in the treatment of 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 recurrent episodes of neurological symptoms (called relapses). Symptoms vary between patients but typically include walking and balance difficulties, and visual impairment (e.g. blurred or double vision). These symptoms may completely resolve after a relapse, but some problems may persist.

How Balfumon works
Balfumon appears to suppress the immune system from causing damage to the brain and spinal cord. This may also help slow the future progression of multiple sclerosis.

2. Important information before taking Balfumon

When not to take Balfumon

• if the patient is allergic to dimethyl fumarate or any of the other ingredients of this medicine (listed in section 6).
• if the patient is suspected of having or is diagnosed with a rare brain infection called progressive multifocal leukoencephalopathy (PML).

Warnings and precautions
Balfumon may adversely affect white blood cell count, kidney function, and liver function. Before starting treatment with Balfumon, the doctor will check the patient's white blood cell count and assess whether 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 performing additional tests or discontinuing treatment.

Before starting Balfumon, discuss this with your doctor if the patient has:

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

Shingles (herpes zoster) may occur during treatment with Balfumon. In some cases, severe complications have occurred. If the patient suspects any symptoms of shingles, they should inform their doctor immediately.

If multiple sclerosis worsens (e.g. the patient experiences weakness or vision disturbances) or new symptoms appear, the patient should contact their doctor immediately, as these may be symptoms of a rare brain infection called progressive multifocal leukoencephalopathy (PML). PML is a serious condition that may lead to severe disability or death.

Rare but serious kidney disorders called Fanconi syndrome have been reported with dimethyl fumarate-containing medicines used in combination with other fumaric acid esters for the treatment of psoriasis (a skin condition). If the patient notices that they are passing more urine than usual, feel increased thirst and drink more than normal, their muscles seem weaker, experience bone fractures, or simply feel pain, they should seek medical advice as soon as possible to investigate these symptoms.

Children and adolescents
This medicine should not be given to children under 10 years of age, as data in this age group are not available.

Balfumon and other medicines
Tell your doctor or pharmacist about all other medicines the patient is currently taking, has recently taken, or plans to take, especially:

• medicines containing fumaric acid esters (fumarates) used in the treatment of psoriasis;
• medicines affecting the immune system, including chemotherapeutic agents, immunosuppressive medicines, or other medicines used in the treatment of multiple sclerosis;
• medicines affecting the kidneys, including certain antibiotics (used to treat infections), diuretics, certain types of painkillers (such as ibuprofen and similar anti-inflammatory medicines, including over-the-counter products), and medicines containing lithium;
• vaccination with certain vaccines (vaccines containing live microorganisms) during treatment with Balfumon may lead to infection; therefore, such vaccinations should be avoided. Your doctor will advise whether other types of vaccines (containing inactivated microorganisms) should be administered.

Balfumon and alcohol
Avoid consuming high-strength alcoholic beverages (more than 30% alcohol by volume, e.g. spirits) in amounts exceeding 50 mL within one hour of taking Balfumon, due to the risk of interaction between alcohol and this medicine. This may lead to stomach upset (inflammation of the stomach lining), especially in individuals susceptible to this condition.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor or pharmacist before using this medicine.

Pregnancy
There are limited data on the effects of this medicine on the unborn child when used during pregnancy. Balfumon should not be taken during pregnancy unless the patient has discussed this with her doctor and treatment is considered necessary.

Breastfeeding
It is not known whether the active ingredient of Balfumon passes into human milk. The doctor will advise the patient whether she should discontinue breastfeeding or stop taking Balfumon. The decision will be based on an assessment of the benefits of breastfeeding for the child compared to the benefits of treatment for the patient.

Driving and operating machinery
No effect of Balfumon on the ability to drive or operate machinery is expected.

3. How to take Balfumon

This medicine should always be taken as directed by your doctor. If you have any doubts, you should
consult your doctor.
Initial dose
120 mg twice daily.
This initial dose should be taken for the first 7 days, after which the medicine should be continued at the
usual maintenance dose.
Usual dose
240 mg twice daily.
Balfumon should be taken orally.
Each capsule should be swallowed whole with water. The capsules must not be divided, crushed,
dissolved, sucked or chewed, as this may increase the risk of certain adverse effects.
Balfumon should be taken with food – this helps to reduce the very common adverse effects (listed in
section 4).
Taking more Balfumon than recommended
If you take more capsules than recommended, you should inform your doctor immediately.
Adverse effects similar to those described below in section 4 may occur.
Missed dose of Balfumon
Do not take a double dose to make up for a missed dose.
A missed dose may be taken later, provided that at least a 4-hour interval is maintained before the next
scheduled dose. If it is too late, the missed dose should not be taken; instead, take the next dose at the
usual time.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone gets them.

Serious adverse reactions

The medicine Balfumon may reduce the number of lymphocytes, which are a type of white blood cells. A low number of white blood cells may increase the risk of infections, including a rare brain infection called progressive multifocal leukoencephalopathy (PML). PML may lead to severe disability or death. PML has been reported from 1 year to 5 years after starting treatment. Therefore, your doctor should monitor your white blood cell count throughout the entire duration of treatment, and you should be alert to the symptoms described below, which may indicate PML.

The risk of developing PML may be higher if you have previously taken medicines that affect the immune system.

PML symptoms may resemble a relapse of multiple sclerosis. These include progressive weakness or worsening of weakness on one side of the body, loss of coordination, vision problems, changes in thinking or memory, confusion (disorientation), personality changes, speech difficulties, and communication problems lasting longer than a few days. Therefore, if during treatment with Balfumon you notice worsening of symptoms related to multiple sclerosis or the appearance of any new symptoms, you should contact your doctor as soon as possible. You should also talk to your partner or caregivers and inform them about your treatment, as symptoms may occur that you yourself may not be aware of.

If any of the symptoms listed above occur, you must contact your doctor immediately.

Serious allergic reactions

The frequency of serious allergic reactions cannot be determined from available data (frequency unknown).

A very common adverse reaction is sudden (episodic) redness of the face or body. If this episodic skin redness is accompanied by a red rash or hives and any of the following symptoms:

• swelling of the face, lips, mouth, or tongue (angioedema);
• wheezing, difficulty breathing, or shortness of breath (dyspnoea, hypoxia);
• dizziness or loss of consciousness (hypotension),

this may indicate a serious allergic reaction (anaphylaxis). You must stop taking Balfumon immediately and contact your doctor without delay.

Other adverse reactions

Very common (may occur in more than 1 in 10 people):

• redness of the face or sensation of increased body temperature, hot flushes, burning or itching of the skin (episodic skin redness);
• loose stools (diarrhoea);
• nausea;
• stomach pain or cramps.

Taking Balfumon with food may help reduce the above adverse reactions.

During treatment with Balfumon, increased production of ketone bodies (substances normally produced in the body) is very commonly observed in urine tests.

Ask your doctor how to manage adverse reactions. Your doctor may reduce the dose of the medicine. Do not reduce the dose yourself unless your doctor tells you to do so.

Common (may occur in up to 1 in 10 people):

• inflammation of the intestinal mucosa (gastroenteritis);
• vomiting;
• indigestion;
• inflammation of the stomach mucosa (gastritis);
• gastrointestinal disorders;
• skin burning;
• hot flushes, sensation of heat with skin itching (pruritus);
• rash;
• red or pink skin spots (erythema);
• hair loss (alopecia).

Adverse reactions that may cause abnormal results in blood or urine tests:

• low number of white blood cells (lymphopenia, leukopenia). A reduced number of white blood cells may mean that the body is less able to fight infections. In case of severe infection (e.g. pneumonia), contact your doctor immediately;
• protein (albumin) in the urine;
• increased liver enzyme activity (AlAT, AspAT) in blood.

Uncommon (may occur in up to 1 in 100 people):

• allergic reactions (hypersensitivity);
• reduced platelet count.

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

• liver inflammation and increased liver enzyme activity (AlAT or AspAT together with bilirubin);
• shingles, with symptoms such as: skin blisters, burning, itching, or skin pain, usually on one side of the upper body or face, and other symptoms such as fever and fatigue in the early stages of infection, followed by numbness, itching, red spots, and severe pain;
• cold (nasopharyngitis).

Children (aged 13 years and older) and adolescents

The adverse reactions listed above also apply to children and adolescents. Some adverse reactions have been reported more frequently in children and adolescents than in adults, e.g. headache, abdominal pain or stomach cramps, vomiting, sore throat, cough, and painful menstruation.

Reporting of adverse reactions

If any adverse symptoms occur, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can also be reported directly to the Department of Monitoring Adverse Drug Reactions 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

Adverse reactions may also be reported to the marketing authorisation holder.

Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Balfumon

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and cardboard
pack after "EXP". The expiry date refers to the last day of the stated month.
There are no special storage temperature requirements for this medicine.
Store in the original packaging to protect from light.
Medicines must not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer in use. This will help protect
the environment.

6. Contents of the pack 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 contents: microcrystalline cellulose (E 460), crospovidone (type A), talc (E 553b), povidone K30 (E 1201), colloidal silicon dioxide (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 printing ink: shellac, potassium hydroxide, propylene glycol (E 1520), black iron oxide (E 172), concentrated ammonium hydroxide.

What Balfumon looks like and contents of the pack
Balfumon 120 mg, hard enteric capsules
Green cap and white body, 21.4 mm capsules, printed in black with "DMF 120" on the body,
containing white or almost white enteric mini-tablets.
Balfumon 240 mg, hard enteric capsules
Green cap and green body, 23.2 mm capsules, printed in black with "DMF 240" on the body,
containing white or almost white enteric mini-tablets.
Blister packs made of OPA/Aluminium/PVC/Aluminium or single-dose perforated blister packs made of
OPA/Aluminium/PVC/Aluminium, in a cardboard box.
Balfumon 120 mg hard enteric capsules
Pack sizes containing:
14 capsules (blister packs)
14 x 1 capsule (single-dose perforated blister pack)
Balfumon 240 mg hard enteric capsules
Pack sizes containing:
56 capsules (blister packs)
56 x 1 capsule (single-dose perforated blister pack)
Not all pack sizes may be marketed.

Marketing Authorisation 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 medicinal product is authorised in 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 more detailed information on this medicine, contact the representative of the Marketing Authorisation Holder:
G.L. PHARMA POLAND Sp. z o.o.
ul. Sienna 75; 00-833 Warsaw, Poland
Tel: 022/ 636 52 23; 636 53 02
[email protected]