Balfumon

Leaflet included in the packaging: patient information

Dimethyl fumarate G.L. Pharma, 120 mg gastro-resistant hard capsules
Dimethyl fumarate G.L. Pharma, 240 mg gastro-resistant hard capsules
Dimethyl fumarate
You should carefully read the contents of this leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so you can read it again if you need to.
• If you have any further questions, you should ask your doctor or pharmacist.
• This medicine has been prescribed to you by a doctor. Do not pass it on to others. The medicine may harm them, even if their symptoms are the same as yours.
• If the patient experiences any undesirable effects, including any undesirable effects not mentioned in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What is Dimethyl fumarate G.L. Pharma and what is it used for

What is Dimethyl fumarate G.L. Pharma

Dimethyl fumarate G.L. Pharma is a medicine that contains the active substance dimethyl fumarate.

What is Dimethyl fumarate G.L. Pharma used for

Dimethyl fumarate G.L. Pharma 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 and balance, and vision disturbances (e.g., blurred or double vision). These symptoms can completely disappear after a relapse, but some problems may persist.

How does Dimethyl fumarate G.L. Pharma work

Dimethyl fumarate G.L. Pharma 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 Dimethyl fumarate G.L. Pharma

When not to take Dimethyl fumarate G.L. Pharma:

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

Warnings and precautions

Dimethyl fumarate G.L. Pharma may have a negative effect on white blood cell countand kidney and liver function. Before starting treatment with Dimethyl fumarate G.L. Pharma, 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 discontinuation of treatment.
Before taking Dimethyl fumarate G.L. Pharma, the patient should consult their doctorif they have:

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

During treatment with Dimethyl fumarate G.L. Pharma, shingles (herpes zoster) may occur. In some cases, severe complications have been reported. If the patient suspects they have 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 disease that can lead to severe disability or death.
When taking a medicine containing dimethyl fumaratein combination with other fumaric acid esters used to treat psoriasis (a skin disease), rare but severe kidney damage (Fanconi syndrome) has been reported. If the patient notices they are urinating more, feeling thirstier, and drinking more than usual, their muscles seem weaker, they have a bone fracture, or they simply feel pain, they should consult their doctor as soon as possibleto investigate these symptoms.

Children and adolescents

The warnings and precautions mentioned above also apply to children. Dimethyl fumarate G.L. Pharma can be used in children and adolescents aged 13 and over. There is no data available for children under 10 years of age.

Dimethyl fumarate G.L. Pharma and other medicines

The patient should inform their doctor or pharmacistabout all medicines they are currently taking or have recently taken, as well as any medicines they plan to take, especially:

• medicines containing fumaric acid esters(fumarates) used to treat psoriasis;
• medicines that affect the immune system, including other medicines used to treat multiple sclerosis, such as fingolimod, natalizumab, teriflunomide, alemtuzumab, ocrelizumab, or cladribine, and some medicines commonly used to treat cancer (rituximab or mitoxantrone);
• medicines that affect kidney function, includingcertain 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 lithium;
• the use of certain vaccines (live vaccines)during treatment with Dimethyl fumarate G.L. Pharma may cause infection, so it should be avoided. The doctor will advise whether to administer a different type of vaccine (inactivated vaccines).

Taking Dimethyl fumarate G.L. Pharma with alcohol

The patient should avoid consuming high-percentage alcoholic beverages(over 30% alcohol content, e.g., spirits) in excess of 50 ml within one hour of taking Dimethyl fumarate G.L. Pharma, due to the risk of interaction between alcohol and this medicine, which may lead to stomach upset (gastritis), especially in people prone to this condition.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a baby, they should consult their doctor or pharmacist before taking this medicine.
Pregnancy
Dimethyl fumarate G.L. Pharma 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 Dimethyl fumarate G.L. Pharma passes into breast milk.
Dimethyl fumarate G.L. Pharma should not be taken during breastfeeding.The doctor will help the patient decide whether to stop breastfeeding or taking Dimethyl fumarate G.L. Pharma. The decision will be based on the assessment of the benefits of breastfeeding for the baby compared to the benefits of treatment for the patient.

Driving and using machines

The effect of Dimethyl fumarate G.L. Pharma on the ability to drive and use machines is not known.It is not expected that Dimethyl fumarate G.L. Pharma will affect the ability to drive and use machines.

3. How to take Dimethyl fumarate G.L. Pharma

This medicine should always be taken exactly as prescribed by the doctor.If the patient has any doubts, they should consult their doctor.

Initial dose

120 mg twice a day.

This initial dose should be taken for the first 7 days, and then the recommended dose should be taken.

Recommended dose

240 mg twice a day.

Dimethyl fumarate G.L. Pharma 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.
Dimethyl fumarate G.L. Pharma should be taken with food– this will help alleviate the very common side effects (listed in section 4).

Taking a higher dose of Dimethyl fumarate G.L. Pharma than recommended

If the patient takes more capsules than recommended, they should inform their doctor immediately.Side effects similar to those described below in section 4 may occur.

Missing a dose of Dimethyl fumarate G.L. Pharma

The patient should not take a double doseto make up for a missed dose.
The missed dose can be taken later, provided that a 4-hour interval is maintained before the next dose. If it is too late, the patient should not take the missed dose but take the next dose at the usual time.
If the patient has any further doubts about taking this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Dimethyl fumarate G.L. Pharma can cause side effects, although not everybody gets them.

Severe side effects

Dimethyl fumarate G.L. Pharma may lower 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 the doctor should 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 developing PML may be higher if the patient has previously taken medicines that affect the immune system.
Symptoms of PML may resemble a relapse of multiple sclerosis.They include weakness or increased weakness on one side of the body, coordination problems, vision disturbances, problems with thinking or memory, confusion (disorientation), or personality changes, speech disturbances, and communication problems lasting more than a few days. Therefore, if the patient experiences a worsening of multiple sclerosis symptoms or new symptoms while taking Dimethyl fumarate G.L. Pharma, they should contact their doctor immediately. They should also discuss their treatment with their partner or caregivers and inform them about their treatment. The patient may not be aware of some symptoms.

If the patient experiences any of the following symptoms, they should contact their doctor immediately

Severe allergic reactions

The frequency of severe allergic reactions cannot be estimated from the available data.
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);
• breathing difficulties or shortness of breath (dyspnea);
• dizziness or loss of consciousness (syncope), this may indicate a severe allergic reaction (anaphylaxis).

The patient should stop taking Dimethyl fumarate G.L. Pharma and contact their doctor immediately.

Very common side effects(may affect up to 1 in 10 people)

• redness of the face or a feeling of elevated body temperature, heat, burning sensation, or itching of the skin (flushing)
• diarrhea
• nausea
• stomach pain or cramps

Taking the medicine with food will help alleviate the above side effects.

During treatment with Dimethyl fumarate G.L. Pharma, ketone bodies (substances normally produced in the body) are often found in the urine.
The patient should ask their doctor how to manage side effects.The doctor may reduce the dose of the medicine. The patient should not reduce the dose of the medicine themselves unless the doctor advises them to do so.
Common side effects(may affect up to 1 in 10 people)

• inflammation of the lining of the intestines (non-ulcerative colitis)
• vomiting
• indigestion
• inflammation of the lining of the stomach (non-ulcerative gastritis)
• gastrointestinal disorders
• burning sensation of the skin
• heat waves, feeling of heat - burning sensation of the skin
• rash
• red or red-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 the body is less able to fight infection. In the event of a severe infection (e.g., pneumonia), the patient should contact their doctor immediately
• protein (albumin) in the urine
• increased activity of liver enzymes (ALT, AST) in the blood

Uncommon side effects(may affect up to 1 in 100 people)

• allergic reactions (hypersensitivity)
• decreased platelet count

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

• inflammation of the liver 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 of 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 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, stomach pain, or stomach cramps, vomiting, sore throat, cough, and painful menstruation.

Reporting side effects

If the patient experiences any side effects, including any side effects not mentioned in this leaflet, they should inform their doctor, pharmacist, or nurse.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, more information can be gathered on the safety of this medicine.

5. How to store Dimethyl fumarate G.L. Pharma

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, bottle, 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.The patient should ask their 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 Dimethyl fumarate G.L. Pharma contains

The active substance is dimethyl fumarate.
Dimethyl fumarate G.L. Pharma, 120 mg- Each capsule contains 120 mg of dimethyl fumarate.
Dimethyl fumarate G.L. Pharma, 240 mg- Each capsule contains 240 mg of dimethyl fumarate.
Other ingredients are:

• capsule contents: microcrystalline cellulose, crospovidone, talc, povidone, colloidal silicon dioxide, magnesium stearate, 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 Dimethyl fumarate G.L. Pharma looks like and contents of the pack

Dimethyl fumarate G.L. Pharma 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.
Dimethyl fumarate G.L. Pharma 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.
Bottle with HDPE with a PP/HDPE cap and a desiccant container- silica gel, containing 100 capsules.
Do not swallow the desiccant.
OPA/Aluminum/PVC/Aluminum blisters or single-dose blisters
Dimethyl fumarate G.L. Pharma, 120 mg gastro-resistant hard capsules
Packaging containing:

• 14 capsules (blister)
• 14 x 1 capsule (perforated single-dose blister)
• 100 capsules (bottle)
• Dimethyl fumarate G.L. Pharma, 240 mg gastro-resistant hard capsules
• Packaging containing:
• 56 capsules (blister)
• 56 x 1 capsule (perforated single-dose blister)
• 168 capsules (blister)
• 168 x 1 capsule (perforated single-dose blister)
• 100 capsules (bottle)
• 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

To obtain more detailed information about this medicine, the patient should contact the representative of the marketing authorization holder:

G.L. PHARMA POLAND Sp. z o.o.
Al. Jana Pawła II 61/313
01-031 Warsaw, Poland
Tel: 022/ 636 52 23; 636 53 02
biuro@gl-pharma.pl

Date of last revision of the leaflet: 10.06.2025