Dimethyl fumarate gedeon richter

Package leaflet: Information for the patient

Dimethyl Fumarate Gedeon Richter, 120 mg, hard enteric capsules
Dimethyl Fumarate Gedeon Richter, 240 mg, hard enteric capsules
Dimethylis fumaras
Please read carefully the entire leaflet before taking this medicine, as it contains
important information for the patient.

• Keep this leaflet for future reference.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

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

What Dimethyl Fumarate Gedeon Richter is
Dimethyl Fumarate Gedeon Richter is a medicine containing the active substance dimethyl fumarate.
What Dimethyl Fumarate Gedeon Richter is 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 episodes of neurological symptoms (called relapses). Symptoms vary among patients but usually include walking and balance difficulties, 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 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 Dimethyl Fumarate Gedeon Richter

When not to take Dimethyl Fumarate Gedeon Richter

• 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 or has been diagnosed with a rare brain infection called progressive multifocal leukoencephalopathy (PML).

Warnings and precautions
Dimethyl Fumarate Gedeon Richter may have an adverse effect on the number of white blood cells, as well as on the function of the kidneys and liver. Before starting treatment with Dimethyl Fumarate Gedeon Richter, 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 treatment with Dimethyl Fumarate Gedeon Richter, the patient should discuss this with the doctor if they have:

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

Herpes zoster (shingles) may occur during treatment with Dimethyl Fumarate Gedeon Richter. In some cases, severe complications have occurred. If the patient suspects any symptoms of shingles, they should immediately inform their doctor.
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 PML. PML is a serious condition that may lead to severe disability or death.
Rare but serious kidney dysfunction known as Fanconi syndrome has been reported during use of dimethyl fumarate in combination with other fumaric acid esters used in the treatment of psoriasis (a skin disease). If the patient notices increased urination, increased thirst and fluid intake, muscle weakness, bone fractures, or unexplained pain, they should seek medical advice as soon as possible for further evaluation of these symptoms.

Children and adolescents
This medicine should not be given to children under 13 years of age, as data in this age group are limited.

Dimethyl Fumarate Gedeon Richter and other medicines
The patient should tell their doctor or pharmacist about 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 in the treatment of psoriasis;
• medicines affecting the immune system, including chemotherapy 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 other similar anti-inflammatory medicines, including over-the-counter products), and medicines containing lithium;
• administration of certain vaccines ( live organism vaccines ) while taking Dimethyl Fumarate Gedeon Richter may lead to infection; therefore, such vaccination should be avoided. The doctor will advise whether alternative vaccines ( inactivated organism vaccines ) should be administered.

Dimethyl Fumarate Gedeon Richter and alcohol
High-strength alcoholic beverages (over 30% alcohol by volume, e.g. spirits) should be avoided in amounts exceeding 50 mL within one hour of taking Dimethyl Fumarate Gedeon Richter due to the risk of interaction between alcohol and this medicine. This may lead to gastric irritation ( gastritis ), especially in individuals susceptible to this condition.

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

Pregnancy
There is limited data on the effects of this medicine on the unborn child when used during pregnancy. Dimethyl Fumarate Gedeon Richter should not be used during pregnancy unless the patient has discussed this with her doctor and use is considered 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 she should discontinue breastfeeding or discontinue/abstain from therapy with Dimethyl Fumarate Gedeon Richter. The decision will be based on an assessment of the benefits of breastfeeding for the child versus the benefits of treatment for the mother.

Driving and using machines
Dimethyl Fumarate Gedeon Richter is not expected to affect the ability to drive or operate machinery.

Dimethyl Fumarate Gedeon Richter contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per capsule, meaning the medicine is considered "sodium-free".

3. How to take Dimethyl Fumarate Gedeon Richter
This medicine should always be taken as prescribed by the doctor. If in doubt, consult the doctor.

Initial dose: 120 mg twice daily.
This initial dose should be taken for the first 7 days, after which the medicine should be taken at the recommended dose.

Recommended dose: 240 mg twice daily.
Dimethyl Fumarate Gedeon Richter should be taken orally.

Each capsule must be swallowed whole with water. Capsules must not be divided, crushed, dissolved, sucked, or chewed, as this may increase the occurrence of certain adverse effects.

Dimethyl Fumarate Gedeon Richter should be taken with food – this will help reduce the very common adverse effects (listed in section 4).

Taking more than the recommended dose of Dimethyl Fumarate Gedeon Richter
If more capsules than recommended are taken, the patient should immediately inform their doctor. Adverse 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 dose to make up for a missed dose.
A missed dose may be taken later, provided there is at least a 4-hour interval before the next scheduled dose. Otherwise, the patient should wait until the next scheduled dose.

If the patient has any further questions about the use of this medicine, they should consult their doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Serious adverse reactions
Dimethyl fumarate may reduce the number of lymphocytes, which are a type of white blood cell. A low
number of white blood cells may 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; therefore, your doctor should monitor
your white blood cell count throughout the entire duration of treatment, and you should be aware of
the symptoms described below, which may indicate PML. The risk of developing PML may be
higher if you have previously taken medicines that impair immune system function.
Symptoms of PML may resemble a relapse of multiple sclerosis. These include new or worsening
weakness on one side of the body; loss of coordination; vision, thinking or memory problems;
confusion (disorientation) or personality changes; or speech and communication difficulties lasting
longer than a few days. Therefore, if you notice worsening of symptoms related to multiple sclerosis
or the appearance of any new symptoms while taking Dimethyl Fumarate Gedeon Richter, you should
contact your doctor as soon as possible. You should also talk to your partner or caregivers and inform
them about your treatment. Symptoms may occur that you yourself may not be aware of.
 If any of the symptoms listed above occur, 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 redness of the face or body (flushing). If flushing 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).

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

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

• redness of the face or sensation of increased body temperature, hot flushes, burning or itching of the skin (flushing)

• loose stools (diarrhoea)

• nausea

• stomach pain or cramps

• • Taking the medicine with food may help reduce the adverse reactions listed above

During dimethyl fumarate treatment, 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 advises you to do so.
Common (may affect up to 1 in 10 people):

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

Adverse reactions that may cause abnormal blood or urine test results:

• low number of white blood cells in blood (lymphopenia, leukopenia). A reduced number of white blood cells may mean that the body is less able to fight infections. If you develop a serious infection (e.g. pneumonia), contact your doctor immediately
• protein (albumin) in urine
• increased liver enzyme activity (ALT, AST) in blood

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

• allergic reactions (hypersensitivity)
• decreased number of platelets

Frequency unknown (frequency cannot be estimated from available data):

• hepatitis and increased liver enzyme activity (ALT or AST 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 or red spots with severe pain
• cold (rhinitis)

Children (aged 13 years and above) 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 reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can 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 can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps 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 stated on the carton and blister pack after
"Expiry date (EXP)". The expiry date refers to the last day of the stated month.
Do not store above 30°C.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This 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.
The other ingredients are sodium croscarmellose, silicified 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 ammonium hydroxide (E527).

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 and white body, with black print "120". Capsule size No. 1 (approximately 19.4 mm in length). 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 print "240". Capsule size No. 00 (approximately 23.3 mm in length). The capsule contents are white microtablets.
The capsules are packed in white, opaque calendar blisters made of PVC/PE/PVDC/Aluminium foil.
The blisters are packed into a cardboard carton.

Pack sizes:
Dimethyl Fumarate Gedeon Richter, 120 mg, gastro-resistant hard capsules
Carton box containing 14 gastro-resistant hard capsules.
Dimethyl Fumarate Gedeon Richter, 240 mg, gastro-resistant hard capsules
Carton box containing 56 or 168 gastro-resistant hard capsules.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation 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 medicinal product is authorised in 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

For further information about this medicinal product, 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]