Fumatyl

Package leaflet: Information for the patient

Fumatyl, 120 mg, hard enteric capsules
Fumatyl, 240 mg, hard enteric capsules
Dimethyl fumarate
Please read carefully the entire leaflet before taking this medicine, as it contains
important information for the patient.

• Keep this leaflet so that you can read it again if necessary.
• 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. The medicine may harm another person, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

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

1. What Fumatyl is and what it is used for

What Fumatyl is
Fumatyl is a medicine containing the active substance dimethyl fumarate.
What Fumatyl is used for
Fumatyl is used in the treatment of relapsing-remitting multiple sclerosis
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 worsening of neurological symptoms (called relapses).
Symptoms vary between patients but usually include walking and balance difficulties
and visual impairment (e.g., blurred or double vision). These symptoms may completely resolve
after a relapse, but some problems may persist.
How Fumatyl works
Fumatyl appears to suppress the immune system from causing damage
to the brain and spinal cord, which may also help slow the future progression of multiple sclerosis.

2. Important information before using Fumatyl

When not to take Fumatyl

• if the patient is allergic to dimethyl fumarate or to any of the other ingredients of this medicine (listed in section 6).
• if progressive multifocal leukoencephalopathy (PML) is suspected or has been confirmed. PML is a rare brain infection.

Warnings and precautions
Fumatyl may adversely affect the number of white blood cells, as well as the function of the kidneys and liver. Before starting treatment with Fumatyl, 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 Fumatyl, discuss with the doctor if the patient has:

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

Shingles (herpes zoster) may occur during treatment with Fumatyl. 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.
Rare but serious kidney dysfunction (Fanconi syndrome) has been reported during treatment with dimethyl fumarate in combination with other fumaric acid esters used in the treatment of psoriasis (a skin disease). If the patient notices that they are passing more urine, feel increased thirst and drink more than usual, their muscles seem weaker, experience bone fractures or simply feel pain, they should seek medical advice as soon as possible to investigate these symptoms.
Children and adolescents
This medicine should not be given to children under 10 years of age, as data in this age group are not available.
Fumatyl and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take, particularly:

• medicines containing fumaric acid esters used in the treatment of psoriasis;
• medicines affecting the immune system, including chemotherapeutic 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 similar anti-inflammatory medicines, including over-the-counter products), and medicines containing lithium;
• administration of certain vaccines (live organism vaccines) during treatment with Fumatyl may lead to infection; therefore, such vaccination should be avoided. The doctor will advise whether alternative vaccines (inactivated organism vaccines) should be given.

Fumatyl and alcohol
High-strength alcoholic beverages (over 30% alcohol by volume) exceeding 50 ml should be avoided within one hour of taking Fumatyl, due to the risk of interaction between alcohol and this medicine, which may lead to gastric irritation (inflammation of the stomach mucosa), especially in individuals susceptible to this condition.
Pregnancy and breastfeeding
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor or pharmacist before using this medicine.
Pregnancy
There is limited information on the effects of this medicine on the unborn child when used during pregnancy. Fumatyl should not be used during pregnancy unless the patient has discussed this with her doctor and use of the medicine is considered necessary.
Breastfeeding
It is not known whether the active substance of Fumatyl passes into breast milk. The doctor will advise the patient whether she should discontinue breastfeeding or stop taking Fumatyl. 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
No effect of Fumatyl on the ability to drive or operate machinery is expected.
Fumatyl contains sodium
Fumatyl contains less than 1 mmol ( 23 mg) of sodium per capsule, meaning the medicine is considered "sodium-free".

3. How to take Fumatyl

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 medicine should be continued
at the recommended dose.
Usually recommended dose
240 mg twice daily.
Fumatyl 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.
Fumatyl should be taken with food – this helps to reduce the very common adverse reactions
(listed in section 4).
Taking more Fumatyl 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 Fumatyl
Do not take a double dose to make up for a missed dose.
A missed dose may be taken later, provided that a 4-hour interval is maintained before the next dose.
If it is too late, the missed dose should not be taken; instead, take the next dose at the usual time.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Serious adverse effects
Fumatyl 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 treatment period, 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.
PML symptoms may resemble a relapse of multiple sclerosis. These include new or worsening weakness on one side of the body, loss of coordination, vision problems, problems with thinking or memory, confusion (disorientation), personality changes, speech difficulties, and communication problems lasting longer than a few days.
For this reason, if you notice worsening of symptoms related to multiple sclerosis or the appearance of any new symptoms while taking Fumatyl, 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 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 effect 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) .

• • Stop taking Fumatyl immediately and contact your doctor without delay

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

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

During treatment with Fumatyl, ketone bodies (substances normally produced in the body) are very frequently detected in urine tests.
Talk to your doctor about how to manage adverse 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 adverse effects
May occur in no more than 1 out of 10 people:

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

Adverse effects 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 the body is less able to fight infections. If you develop a severe infection (e.g., pneumonia), contact your doctor immediately;
• protein (albumin) in urine;
• increased liver enzyme activity (AlAT, AspAT) in blood.

Uncommon adverse effects
May occur in no more than 1 out of 100 people:

• allergic reactions (hypersensitivity)
• decreased platelet count

Rare
May occur in no more than 1 out of 1,000 people:

• hepatitis and increased liver enzyme activity (AlAT or AspAT together with bilirubin)

Frequency unknown
Frequency cannot be estimated from available data

• 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 weakness in the early stages of infection, followed by numbness, itching, or red spots with severe accompanying pain
• cold (nasopharyngitis)

Children (aged 13 years and older) and adolescents
The adverse effects listed above also apply to children and adolescents.
Some adverse 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 of adverse effects
If any adverse effects occur, including any not listed in this leaflet, tell your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring of Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Fumatyl

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and the cardboard
pack. The expiry date refers to the last day of the specified month.
No special storage conditions apply.
Medicines must not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer required. This will help protect
the environment.

6. Contents of the packaging and other information

What Fumatyl contains
Active substance:
Dimethyl fumarate.

Fumatyl 120 mg: each capsule contains 120 mg of dimethyl fumarate.
Fumatyl 240 mg: each capsule contains 240 mg of dimethyl fumarate.

Other ingredients:

• Capsule contents (enteric-coated mini-tablets): silicified microcrystalline cellulose (microcrystalline cellulose, colloidal anhydrous silica), methacrylic acid and ethyl acrylate copolymer (1:1) dispersion 30%, talc, sodium croscarmellose, colloidal anhydrous silica, methacrylic acid and methyl methacrylate copolymer (1:1), triethyl citrate, magnesium stearate.
• Capsule shell: gelatin, purified water, titanium dioxide (E 171), brilliant blue FCF (E 133), yellow iron oxide (E 172), black iron oxide (E 172).
• Printing ink for capsule ( Black ink ): shellac, black iron oxide (E 172), propylene glycol, potassium hydroxide.

What Fumatyl looks like and contents of the pack
Fumatyl 120 mg, hard enteric capsules
Hard gelatin capsules of size “0” with a green cap and white body, printed in black with “HR1” on the body, containing white or almost white, round, biconvex, coated mini-tablets, smooth on both sides, available in packs containing 14 capsules. Capsule dimensions approximately 21.3 x 7.5 mm.
Available pack sizes:
Cardboard box containing 14 hard enteric capsules.
PVC/PE/PVDC/Aluminium blisters in a cardboard box.

Fumatyl 240 mg, hard enteric capsules
Hard gelatin capsules of size “0” with a green cap and body, printed in black with “HR2” on the body, containing white or almost white, round, biconvex, coated mini-tablets, smooth on both sides, available in packs containing 56 capsules. Capsule dimensions approximately 21.3 x 7.5 mm.
Available pack sizes:
Cardboard box containing 56 hard enteric capsules.
PVC/PE/PVDC/Aluminium blisters in a cardboard box.

Marketing Authorisation Holder
Biofarm Sp. z o.o.
ul. Wałbrzyska 13
60-198 Poznań
tel.: +48 61 66 51 500
e-mail: [email protected]

Importer
Laboratori Fundació DAU
C/ C, 12-14 Pol. Ind. Zona Franca,
08040, Barcelona
Spain