Fumarate dimethyl adamed

Package leaflet: information for the patient

Fumaran Dimetylu Adamed, 120 mg, enteric hard capsules
Fumaran Dimetylu Adamed, 240 mg, enteric hard capsules
Dimethylis fumaras
Please read the entire leaflet carefully before taking this medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• 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. This medicine may harm other people, 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 Fumaran Dimetylu Adamed is and what it is used for
2. Important information before taking Fumaran Dimetylu Adamed
3. How to take Fumaran Dimetylu Adamed
4. Possible side effects
5. How to store Fumaran Dimetylu Adamed
6. Contents of the pack and other information

1. What Fumaran Dimetylu Adamed is and what it is used for

What Fumaran Dimetylu Adamed is
Fumaran Dimetylu Adamed is a medicine containing dimethyl fumarate.
What Fumaran Dimetylu Adamed is used for
Fumaran Dimetylu Adamed is used in the treatment of relapsing-remitting multiple sclerosis ( sclerosis multiplex , 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 between individual patients but usually include walking and balance difficulties, as well as vision impairment (e.g. blurred or double vision). These symptoms may completely resolve after a relapse, but some problems may persist.
How Fumaran Dimetylu Adamed works
Fumaran Dimetylu Adamed appears to suppress the immune system from causing damage to the brain and spinal cord, which may also help slow the future progression of the disease.

2. Important information before using Fumaran Dimetylu Adamed

When not to take Fumaran Dimetylu Adamed:

• if the patient is allergic to dimethyl fumarate or to 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
Fumaran Dimetylu Adamed may adversely affect the number of white blood cells and the function of the kidneys and liver. Before starting treatment with Fumaran Dimetylu Adamed, 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 Fumaran Dimetylu Adamed, the patient should discuss with the doctor if they have:

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

Shingles (herpes zoster) may occur during treatment with Fumaran Dimetylu Adamed. In some cases, serious 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 progressive multifocal leukoencephalopathy (PML). PML is a serious condition that may lead to severe disability or death.
During treatment with dimethyl fumarate-containing medicines in combination with other fumaric acid esters used in the treatment of psoriasis (a skin disease), rare but serious kidney disorders (Fanconi syndrome) have been reported. If the patient notices increased urination, feels unusually thirsty and drinks more than usual, experiences muscle weakness, bone fractures, or general pain, they should seek medical advice as soon as possible for further evaluation of these symptoms.
Children and adolescents
The above warnings and precautions also apply to children. Fumaran Dimetylu Adamed may be used in children and adolescents aged 13 years and older. Data in children below 10 years of age are not available.
Fumaran Dimetylu Adamed and other medicines
The patient should inform 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 other medicines used in the treatment of multiple sclerosis , such as fingolimod, natalizumab, teriflunomide, alemtuzumab, ocrelizumab or cladribine, and certain medicines commonly used in cancer treatment (rituximab or mitoxantrone);
• medicines affecting the kidneys , including certain antibiotics (used to treat infections), diuretics , certain types of painkillers (such as ibuprofen and similar anti-inflammatory medicines, including over-the-counter products), and medicines containing lithium ;
• use of certain vaccines ( vaccines containing live microorganisms )

during treatment with Fumaran Dimetylu Adamed may lead to infection; therefore, such vaccines should be avoided. The doctor will advise whether other types of vaccines ( vaccines containing inactivated microorganisms ) should be administered.
Taking Fumaran Dimetylu Adamed with food and alcohol
The patient should avoid consuming high-strength alcoholic beverages (over 30% alcohol by volume) in amounts exceeding 50 ml within one hour after taking Fumaran Dimetylu Adamed, due to the risk of interaction between alcohol and this medicine, which may cause gastric irritation (inflammation of the stomach lining), especially in individuals susceptible to this condition.
Pregnancy and breastfeeding
If the patient is pregnant, breastfeeding, thinks she may be pregnant, or is planning to have a baby, she should consult her doctor or pharmacist before using this medicine.
Pregnancy
Fumaran Dimetylu Adamed should not be taken during pregnancy unless discussed with the doctor.
Breastfeeding
It is unknown whether the active substance of Fumaran Dimetylu Adamed passes into human milk. Fumaran Dimetylu Adamed should not be taken during breastfeeding. The doctor will help the patient decide whether to discontinue breastfeeding or the use of Fumaran Dimetylu Adamed. The decision will be based on an assessment of the benefits of breastfeeding for the child compared to the benefits of treatment for the patient.
Driving and using machines
The effect of Fumaran Dimetylu Adamed on the ability to drive and operate machinery is unknown.
No effect of Fumaran Dimetylu Adamed on the ability to drive and operate machinery is expected.
Fumaran Dimetylu Adamed contains sodium
The medicine contains less than 1 mmol (23 mg) of sodium per capsule, meaning that the medicine is considered "sodium-free".

3. How to take Fumaran Dimetylu Adamed

This medicine should always be taken exactly as prescribed by your doctor. If in doubt,
consult your doctor.
Initial dose
120 mg twice daily.
This initial dose should be taken for the first 7 days, after which the usual maintenance dose should be taken.
Usual maintenance dose
240 mg twice daily.
Fumaran Dimetylu Adamed 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 risk of certain adverse reactions.
Fumaran Dimetylu Adamed should be taken with food – this helps to reduce the very common
adverse reactions (listed in section 4).
Taking more Fumaran Dimetylu Adamed than prescribed
If you take more capsules than prescribed, you must inform your doctor immediately.
Adverse reactions similar to those described below in section 4 may occur.
Missing a dose of Fumaran Dimetylu Adamed
Do not take a double dose to make up for a missed dose.
A missed dose may be taken if at least 4 hours remain before the next scheduled dose. If it is too late,
do not take the missed dose. In any other case, take the next dose at the usual time.
If you have any further doubts about the use of this medicine, consult your 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
Fumaran Dimetylu Adamed may reduce the number of lymphocytes (a type of white blood cells). 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 pay attention to the symptoms described below, which may indicate PML.
The risk of developing 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. These include new or worsening weakness on one side of the body, coordination problems, vision disturbances, changes in thinking or memory, confusion (disorientation), personality changes, speech difficulties, and communication problems lasting longer than a few days. Therefore, if you notice worsening of symptoms related to multiple sclerosis or any new symptoms while taking Fumaran Dimetylu Adamed, 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 (unknown).
A very common adverse reaction is sudden ( flushing ) redness of the face or body. 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 (dyspnea, hypoxia);

• dizziness or loss of consciousness (hypotension), this may indicate a serious allergic reaction (anaphylaxis).

• You must stop taking Fumaran Dimetylu Adamed and contact your doctor immediately

Very common adverse reactions:
These may occur in more than 1 out of 10 people:

• redness of the face or sensation of increased body temperature, hot flushes, burning or itching of the skin ( flushing )
• loose stools (diarrhea)
• nausea (nausea)
• stomach pain or cramps
• Taking the medicine with food may help reduce the above-mentioned adverse reactions

During treatment with Fumaran Dimetylu Adamed, ketone bodies (substances normally produced in the body) are very commonly detected 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 adverse reactions
May occur in 1 out of 10 people, but not more frequently:

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

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

• low number of white blood cells ( lymphopenia, leukopenia ). A reduced number of white blood cells may mean that the body is less able to fight infections. In case of severe infection (e.g. pneumonia), contact your doctor immediately;
• protein ( albumin ) in urine;
• increased liver enzyme activity ( AlAT, AspAT ) in blood.

Uncommon adverse reactions
May occur in 1 out of 100 people, but not more frequently:

• allergic reactions (hypersensitivity)
• decreased number of platelets

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

• hepatitis and increased liver enzyme activity (AlAT or AspAT 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, red patches, and severe pain
• cold (nasopharyngitis)

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 symptoms 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 authorization holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Fumaran Dimetylu Adamed

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister pack and carton following "EXP".
The expiry date refers to the last day of the stated month.
No special requirements for the storage conditions of this medicine.
Medicines should 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 packaging and other information

What Fumaran Dimetylu Adamed contains
The active substance in this medicinal product is dimethyl fumarate.
Fumaran Dimetylu Adamed, 120 mg: each capsule contains 120 mg of dimethyl fumarate.
Fumaran Dimetylu Adamed, 240 mg: each capsule contains 240 mg of dimethyl fumarate.

Other ingredients are:
Capsule contains (enteric mini-tablets): microcrystalline cellulose, sodium croscarmellose,
talc, colloidal anhydrous silica, magnesium stearate, triethyl citrate, methacrylic acid and methyl methacrylate copolymer (1:1), methacrylic acid and ethyl acrylate copolymer (1:1), 30% dispersion.

Capsule shell: gelatin, titanium dioxide (E171), brilliant blue FCF (E133), yellow iron oxide (E172), black iron oxide (E172).

Capsule print (black ink): shellac (20% esterified), propylene glycol (E1520), black iron oxide (E172).

What Fumaran Dimetylu Adamed looks like and contents of the pack
Fumaran Dimetylu Adamed, 120 mg: enteric hard capsules, size length: 21.4±0.4 mm, width: 7.4±0.4 mm, with a white, opaque body and light green, opaque cap, printed with “120” in black ink on the body, containing mini-tablets.

Fumaran Dimetylu Adamed, 240 mg: enteric hard capsules, size length: 21.4±0.4 mm, width: 7.4±0.4 mm, with a light green, opaque body and light green, opaque cap, printed with “240” in black ink on the body, containing mini-tablets.

Pack sizes:
Enteric hard capsules, 120 mg: 14 capsules.
Enteric hard capsules, 240 mg: 56 or 168 capsules.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów
tel. 22 732 77 00

Manufacturer
Adamed Pharma S.A.
ul. Marszałka Józefa Piłsudskiego 5
95-200 Pabianice

This medicine is authorised for marketing in the Member States of the European Economic Area under the following names: