Dimethil Fumarate Gedeon Rihter

Leaflet accompanying the packaging: patient information

Dimethyl Fumarate Gedeon Richter, 120 mg, gastro-resistant hard capsules

Dimethyl Fumarate Gedeon Richter, 240 mg, gastro-resistant hard capsules

Dimethyl fumarate

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• 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, please inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What is Dimethyl Fumarate Gedeon Richter and what is it used for

What is Dimethyl Fumarate Gedeon Richter

Dimethyl Fumarate Gedeon Richter is a medicine that contains the active substance dimethyl fumarate.

What is Dimethyl Fumarate Gedeon Richter used for

Dimethyl Fumarate Gedeon Richter 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. Relapsing-remitting multiple sclerosis is characterized by recurring, periodic exacerbations of neurological symptoms (called relapses). Symptoms vary among patients but usually include gait and balance disturbances and vision impairment (e.g., blurred or double vision). These symptoms may completely resolve after a relapse, but some problems may persist.

How Dimethyl Fumarate Gedeon Richter works

Dimethyl Fumarate Gedeon Richter appears to inhibit the immune system from causing damage to the brain and spinal cord. This may also help slow down the progression of multiple sclerosis in the future.

2. Important information before taking Dimethyl Fumarate Gedeon Richter

When not to take Dimethyl Fumarate Gedeon Richter

• -if you are allergic to dimethyl fumarateor any of the other ingredients of this medicine (listed in section 6).
• -if you suspect or have been diagnosed with a rare brain infection called progressive multifocal leukoencephalopathy (PML).

Warnings and precautions

Dimethyl Fumarate Gedeon Richter may have a negative effect on white blood cell countand kidney and liver function. Before starting treatment with Dimethyl Fumarate Gedeon Richter, 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 Dimethyl Fumarate Gedeon Richter, discuss with your doctorif you have:

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

During treatment with Dimethyl Fumarate Gedeon Richter, shingles (herpes zoster) may occur. In some cases, severe complications have occurred. 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, you should contact your doctor immediately, as these may be symptoms of a rare brain infection called PML. PML is a serious disease that can lead to severe disability or death.
During treatment with a medicine containing dimethyl fumarate in combination with other fumaric acid esters used to treat psoriasis (a skin disease), rare but serious kidney disorders called Fanconi syndrome have been reported. If you notice that you are urinating more, feel thirstier, and drink more than usual, your muscles seem weaker, you have a fracture, or you simply feel unwell, you should see your doctor as soon as possible to investigate these symptoms.

Children and adolescents

This medicine should not be given to children under 13 years of age, as there is limited data available for this age group.

Dimethyl Fumarate Gedeon Richter and other medicines

Tell your doctor or pharmacistabout all 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 the kidneys, including certain antibiotics(used to treat infections), diuretics(diuretics), some types of painkillers(such as ibuprofen and other similar anti-inflammatory medicines and over-the-counter medicines), and lithium;
• the use of certain vaccines ( vaccines containing live microorganisms) during treatment with Dimethyl Fumarate Gedeon Richter may lead to infection, so it should be avoided. Your doctor will advise whether to administer other types of vaccines ( vaccines containing killed microorganisms).

Dimethyl Fumarate Gedeon Richter with alcohol

Avoid consuming high-percentage alcoholic beverages (over 30% alcohol by volume, e.g., spirits) in excess of 50 mL within 1 hour of taking Dimethyl Fumarate Gedeon Richter, due to the risk of interaction between alcohol and this medicine. This may lead to stomach upset ( gastritis), especially in people prone to this disease.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
There is limited data on the use of this medicine in pregnant women. Dimethyl Fumarate Gedeon Richter should not be used during pregnancy unless your doctor has discussed it with you and the use of the medicine is necessary.
Breastfeeding
It is not known whether the active substance of Dimethyl Fumarate Gedeon Richter passes into human milk. Your doctor will advise whether to stop breastfeeding or stop taking Dimethyl Fumarate Gedeon Richter. The decision will be based on the assessment of the benefit to the baby from breastfeeding compared to the benefit to the patient from treatment.

Driving and using machines

Dimethyl Fumarate Gedeon Richter is unlikely to affect your ability to drive or use machines.

Dimethyl Fumarate Gedeon Richter contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per capsule, which is considered to be "sodium-free".

3. How to take Dimethyl Fumarate Gedeon Richter

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 Gedeon Richter should be taken orally.
Swallow each capsule whole, with water. The capsules should not be divided, crushed, dissolved, sucked, or chewed, as this may increase certain side effects.
Dimethyl Fumarate Gedeon Richter should be taken with food– this will help alleviate very common side effects (listed in section 4).

Taking a higher dose of Dimethyl Fumarate Gedeon Richter than recommended

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

Missing a dose of Dimethyl Fumarate Gedeon Richter

Do not take a double doseto 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. Otherwise, wait until the planned time for the next dose.
If you have any further questions on the use of 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.

Severe side effects

Dimethyl fumarate 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 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 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 disturbances; vision disturbances, changes in thinking or memory; confusion (disorientation) or personality changes, or speech and communication difficulties lasting more than a few days. Therefore, if you experience a worsening of your multiple sclerosis symptoms or the development of new symptoms while taking Dimethyl Fumarate Gedeon Richter, you should contact your doctor as soon as possible. You should also discuss your treatment with your partner or caregivers and inform them about your treatment. You may not be aware of the symptoms.

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 of the skin of the face or body ( flushing). 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, hypoxia)
• dizziness or loss of consciousness ( hypotension)

it may indicate a severe allergic reaction ( anaphylaxis).

• - Stop taking Dimethyl Fumarate Gedeon Richter and contact your doctor immediately

Other side effects

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

• flushing of the skin of the face or a feeling of increased body temperature, heat, burning of the skin, or itching of the skin ( flushing)
• diarrhea ( diarrhea)
• nausea ( nausea)
• stomach pain or cramps
• - Taking the medicine with foodwill help alleviate the above side effects

During treatment with dimethyl fumarate, increased production of ketone bodies (substances normally produced in the body) is very commonly found in urine tests.
Ask your doctorhow 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(may affect up to 1 in 10 people):

• inflammation of the lining of the intestines ( gastrointestinal disorder)
• vomiting
• indigestion
• inflammation of the stomach lining ( gastritis)
• gastrointestinal disturbances
• burning sensation of the skin
• hot flashes, feeling of heat
• itching of the skin ( 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 in the blood ( 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), 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(frequency cannot be estimated from the available data):

• liver inflammation and increased liver enzyme activity ( ALT or ASTtogether with bilirubin)
• shingles, with symptoms such as: blisters on the skin, burning, itching, or pain on the skin, usually on one side of the upper body or face, and other symptoms, such as fever and weakness in the early stages of infection, followed by numbness, itching, or red spots with 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, e.g., 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 leaflet, please 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,
Aleje 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 medicine.

5. How to store Dimethyl Fumarate Gedeon Richter

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 carton and blister after "EXP". The expiry date refers to the last day of that month.
Do not store above 30°C.
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 Gedeon Richter contains

The active substance is dimethyl fumarate.
Dimethyl Fumarate Gedeon Richter, 120 mg: each capsule contains 120 mg of dimethyl fumarate.
Dimethyl Fumarate Gedeon Richter, 240 mg: each capsule contains 240 mg of dimethyl fumarate.
Other ingredientsare croscarmellose sodium, siliconized microcrystalline cellulose (microcrystalline cellulose, colloidal anhydrous silica), colloidal anhydrous silica, magnesium stearate, methacrylic acid and methyl methacrylate copolymer (1:1), triethyl citrate, methacrylic acid and ethyl acrylate copolymer (1:1) dispersion 30%, micronized talc, simethicone, gelatin, titanium dioxide (E171), yellow iron oxide (E172), brilliant blue FCF (E133), shellac, black iron oxide (E172), propylene glycol (E1520), and concentrated ammonia solution (E 527).

What Dimethyl Fumarate Gedeon Richter looks like and contents of the pack

Dimethyl Fumarate Gedeon Richter, 120 mg, gastro-resistant hard capsules are opaque, dark green ( "cap" ) - white ( "body" ), with black printing "120". The capsule size is No. 1 (length approximately 19.4 mm). The capsule contents are white microtablets.
Dimethyl Fumarate Gedeon Richter, 240 mg, gastro-resistant hard capsules are opaque, dark green ( "cap and body" ), with black printing "240". The capsule size is No. 00 (length approximately 23.3 mm). The capsule contents are white microtablets.
The capsules are packaged in white, opaque PVC/PE/PVDC/Aluminum blister packs.
The blisters are packaged in a folded cardboard box.
Pack sizes:
Dimethyl Fumarate Gedeon Richter, 120 mg, gastro-resistant hard capsules
Cardboard box containing 14 gastro-resistant hard capsules.
Dimethyl Fumarate Gedeon Richter, 240 mg, gastro-resistant hard capsules
Cardboard box containing 56 or 168 gastro-resistant hard capsules.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Gedeon Richter Polska Sp. z o.o.
ul. Ks. J. Poniatowskiego 5
05-825 Grodzisk Mazowiecki
Poland

Manufacturer:

Gedeon Richter Polska Sp. z o.o.
ul. Ks. J. Poniatowskiego 5
05-825 Grodzisk Mazowiecki
Poland
Gedeon Richter Plc.
1103 Budapest
Gyömrői út 19-21
Hungary

This medicine is authorized in the Member States of the European Economic Area under the following names:

Bulgaria
Диметилфумарат Гедеон Рихтер 120 mg, 240 mg, стомашно-устойчиви твърди капсули
Czech Republic Dimethyl Fumarate Gedeon Richter
Estonia
Dimethyl Fumarate Gedeon Richter
Lithuania
Dimethyl Fumarate Gedeon Richter 120 mg, 240 mg skrandyje neirios kietosios kapsulės
Latvia
Dimethyl Fumarate Gedeon Richter 120 mg, 240 mg zarnās šķīstošās cietās kapsulas
Poland
Dimethyl Fumarate Gedeon Richter
Romania
Dimetil fumarat Gedeon Richter 120 mg, 240 mg capsule gastrorezistente
Slovakia
Dimethyl Fumarate Gedeon Richter 120 mg, 240 mg tvrdé gastrorezistentné kapsuly
Hungary
Dimethyl Fumarate Gedeon Richter 120 mg, 240 mg gyomornedv-ellenálló kemény kapszula
To obtain more detailed information on this medicine, please contact:
Gedeon Richter Polska Sp. z o.o.
Medical Department
ul. Ks. J. Poniatowskiego 5
05-825 Grodzisk Mazowiecki
tel.: +48 (22) 755 96 48
[email protected]

Date of last revision of the leaflet: December 2024