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.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed to a specific person. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any not listed in this leaflet, they should tell their 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 packaging 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 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). 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 does Dimethyl Fumarate Gedeon Richter work

Dimethyl Fumarate Gedeon Richter appears to prevent 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 the patient is allergic to dimethyl fumarateor any of the other ingredients of this medicine (listed in section 6).
• -if the patient is suspected or confirmed to have 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, 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 Gedeon Richter, the patient should discuss with their doctorif they 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, serious complications have occurred. If the patient suspects they have shingles, they should immediately inform their doctor.
If multiple sclerosis worsens (e.g. the patient experiences weakness or vision problems) or new symptoms appear, the patient should contact their 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 damage called Fanconi syndrome has been reported. If the patient notices that they are urinating more, feeling thirstier, and drinking more than usual, their muscles seem weaker, they have broken a bone, or are simply feeling unwell, they should see their 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 on this age group.

Dimethyl Fumarate Gedeon Richter and other medicines

The patient should tell their doctor or pharmacistabout all medicines they are taking, have recently taken, or might 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), certain types of painkillers(such as ibuprofen and other similar anti-inflammatory medicines, including those available without a prescription), and lithium;
• the use of certain vaccines(live vaccines) while taking Dimethyl Fumarate Gedeon Richter may cause infection, so this should be avoided. The doctor will advise whether other types of vaccines (inactivated vaccines) can be given.

Dimethyl Fumarate Gedeon Richter and alcohol

The patient should avoid consuming high-percentage alcoholic beverages (over 30% alcohol by volume, e.g. spirits) in excess of 50 mL within an 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 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
There is limited data on the use of this medicine in pregnant women. Dimethyl Fumarate Gedeon Richter should not be used during pregnancy unless the patient has discussed it with their doctor 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. The doctor will advise the patient whether to stop breastfeeding or stop taking Dimethyl Fumarate Gedeon Richter. 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 patient should not expect Dimethyl Fumarate Gedeon Richter to affect their 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 means it is essentially 'sodium-free'.

3. How to take Dimethyl Fumarate Gedeon Richter

This medicine should always be taken exactly as prescribed by the doctor. In case of doubt, the patient 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 Gedeon Richter 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 Gedeon Richter 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 Gedeon Richter than recommended

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

Missing a dose of Dimethyl Fumarate Gedeon Richter

The patient should 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, the patient should wait until the planned time for the next dose.
In case of any further doubts about taking this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Dimethyl Fumarate Gedeon Richter 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 the doctor should monitor the patient's white blood cell count throughout treatment, and the patient should be aware of the symptoms described below, which may indicate PML. The risk of 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 problems, thinking, or memory problems; confusion (disorientation) or personality changes, or speech and communication difficulties lasting more than a few days. Therefore, if the patient experiences a worsening of multiple sclerosis symptoms or new symptoms while taking Dimethyl Fumarate Gedeon Richter, they should contact their doctor as soon as possible. They should also discuss their treatment with their partner or caregivers and inform them about their treatment. The patient may not be aware of the symptoms.
 If any of the above symptoms occur, the patient should immediately contact their doctor

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 on 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).
The patient should stop taking Dimethyl Fumarate Gedeon Richter and immediately contact their doctor

Other side effects

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

• flushing of the skin on the face or body, feeling of warmth, burning sensation, or itching (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.
The patient should ask their doctorhow to deal with side effects. The doctor may reduce the dose of the medicine. The patient should not reduce the dose of the medicine themselves unless their doctor advises them 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 disorders
• burning sensation of the skin
• hot flashes, feeling of warmth
• itching (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 case of a severe infection (e.g. pneumonia), the patient should immediately contact their doctor
• 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):

• 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 skin pain, 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, stomach pain or cramps, vomiting, sore throat, cough, and painful menstruation.

Reporting side effects

If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring, 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.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Dimethyl Fumarate Gedeon Richter

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after "Expiry date" (EXP). The expiry date refers to the last day of the month.
Do not store above 30°C.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines they no longer use. This will help protect the environment.

6. Contents of the packaging and other information

What Dimethyl Fumarate Gedeon Richter contains

The active substance of Dimethyl Fumarate Gedeon Richter 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 calendars.
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, the patient should 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
lekalert@grodzisk.rgnet.org

Date of last revision of the leaflet: December 2024