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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 this medicine, as it contains important information for you.

• You should keep this leaflet, so you can read it again later.
• 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.

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 pack 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 years and older.

Multiple sclerosis is a long-term 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 problems (such as 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 is thought to prevent the immune system from causing damage to the brain and spinal cord, which may also help to 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 you are allergic to dimethyl fumarateor 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

Dimethyl fumarate G.L. Pharma may affect your white blood cell countand kidney and liver function. Before starting treatment with Dimethyl fumarate G.L. Pharma, your doctor will check your white blood cell count and make sure 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.

• Severe kidney disease
• Severe liver disease
• Stomach or intestinal disease
• Severe infection(such as pneumonia)

During treatment with Dimethyl fumarate G.L. Pharma, you may experience shingles. In some cases, serious complications have occurred. If you suspect that you have symptoms of shingles, you should immediately tell your doctor.
If your multiple sclerosis gets worse (for example, 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

The warnings and precautions mentioned above also apply to children and adolescents. Dimethyl fumarate G.L. Pharma can be used in children and adolescents aged 13 years and older. There is no experience with the use of dimethyl fumarate in children under 10 years of age.

Dimethyl fumarate G.L. Pharma with other medicines

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, including those you have bought without a prescription, especially:

• Medicines containing fumaric acid estersused 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, including certain antibiotics(used to treat infections), diuretics, certain painkillers(such as ibuprofen and similar anti-inflammatory medicines, as well as over-the-counter medicines), and lithium;
• Live vaccines. The use of live vaccines during treatment with Dimethyl fumarate G.L. Pharma may cause infection, so it should be avoided. Your doctor will advise you whether to use a different type of vaccine (inactivated vaccines).

Dimethyl fumarate G.L. Pharma with alcohol

You should avoid consuming high-percentage alcoholic beverages (more than 30% alcohol content, e.g., spirits) in amounts exceeding 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 inflammation (gastritis), especially in people prone to this disease.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
Dimethyl fumarate G.L. Pharma should not be taken during pregnancy unless you have discussed it with your 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. Your doctor will help you decide whether to stop breastfeeding or stop taking Dimethyl fumarate G.L. Pharma. The decision will be based on the benefit of breastfeeding to the baby compared to the benefit of treatment for you.

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 unlikely that Dimethyl fumarate G.L. Pharma will affect your ability to drive and use machines.

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

Always take this medicine 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 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 to reduce the very common side effects (listed in section 4).

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

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

Missing a dose of Dimethyl fumarate G.L. Pharma

Do not take a double dose to make up for a forgotten 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, do 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, this medicine can cause side effects, although not everybody gets them.

Serious 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 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 taken medicines that affect the immune system in the past.

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 (acute) flushing of the face or body. If the 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), it may indicate a severe allergic reaction (anaphylaxis).

Stop taking Dimethyl fumarate G.L. Pharma and contact your doctor immediately.

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

• flushing of the face or a feeling of increased body temperature, heat, burning, or tingling of the skin (acute flushing)
• diarrhea
• nausea (feeling sick)
• stomach pain or cramps

Taking the medicine with food will help to reduce the side effects listed above.

During treatment with Dimethyl fumarate G.L. Pharma, ketonuria (the presence of ketones in the urine) is very commonly reported in urine tests.
Ask your doctor for advice on how to deal with side effects.Your doctor may reduce the dose of the medicine. Do not reduce the dose yourself unless your doctor advises you to do so.
Common side effects(may affect up to 1 in 10 people)

• enteritis (inflammation of the intestines)
• vomiting
• indigestion
• gastritis (inflammation of the stomach)
• gastrointestinal disorders
• burning sensation of the skin
• heat sensation - burning of the skin (flushing)
• rash
• red 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 (such as pneumonia), you should contact your doctor immediately
• protein (albumin) in the urine
• increased liver enzyme activity (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(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, tingling, 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, tingling, or red spots and severe pain
• nasal congestion (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, such as headache, stomach pain or cramps, vomiting, sore throat, cough, and painful menstruation.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse.You can also report side effects directly to the national reporting system via the contact details listed below. By reporting side effects, you can help provide more information on the safety of this medicine.

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

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the blister, bottle, and carton after “EXP”. The expiry date refers to the last day of that month.
There are no special storage instructions 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 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.
The other ingredients are:

• Capsule content: 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.
HDPE bottle with PP/HDPE cap and a desiccant container - silica gel, containing 100 capsules.
Do not swallow the desiccant.
OPA/Aluminium/PVC/Aluminium blisters or single-dose OPA/Aluminium/PVC/Aluminium 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 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

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

G.L. PHARMA POLAND Sp. z o.o.
Al. Jana Pawła II 61/313
01-031 Warsaw, Poland
Phone: 022/ 636 52 23; 636 53 02
[email protected]

Date of last revision of the leaflet: 10.06.2025