Dimethyl fumarate msn

Package leaflet: Information for the patient

Dimethyl fumarate MSN, 120 mg, enteric hard capsules
Dimethyl fumarate MSN, 240 mg, enteric hard capsules
Dimethylis fumaras
Read the entire leaflet before taking this medicine because it contains important information for you.

• 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 a specific individual. Do not pass it on to others. It may harm them 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 MSN is and what it is used for
2. What you need to know before taking Dimethyl fumarate MSN
3. How to take Dimethyl fumarate MSN
4. Possible side effects
5. How to store Dimethyl fumarate MSN
6. Contents of the pack and other information

1. What Dimethyl fumarate MSN is and what it is used for

What Dimethyl fumarate MSN is
Dimethyl fumarate MSN is a medicine that contains the active substance dimethyl fumarate.

What Dimethyl fumarate MSN is used for
Dimethyl fumarate MSN 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 neurological flare-ups. Symptoms vary between patients but usually include walking difficulties, loss of balance, and vision problems (e.g. blurred or double vision). These symptoms may completely resolve after a relapse, but some issues may persist.

How Dimethyl fumarate MSN works
Dimethyl fumarate MSN appears to work by suppressing 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 using Dimethyl fumarate MSN

When not to use Dimethyl fumarate MSN:

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

Warnings and precautions
Dimethyl fumarate MSN may affect the white blood cell count, the function of the kidneys,
and the liver. Before starting treatment with Dimethyl fumarate MSN, 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 MSN, 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 MSN. 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 problems called Fanconi syndrome have been reported during treatment
with dimethyl fumarate in combination with other fumaric acid esters used to treat psoriasis (a skin
disease). If the patient notices increased urination, feels thirsty and drinks more than usual, their
muscles seem weaker, a bone fracture occurs, or they simply feel pain, they should see a doctor as
soon as possible for further evaluation of 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.
Dimethyl fumarate MSN 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 to treat psoriasis;
• medicines affecting the immune system , including chemotherapeutic agents , immunosuppressive medicines , or other medicines used to treat multiple sclerosis ;
• medicines affecting the kidneys , such as certain antibiotics (used to treat infections), diuretics , certain types of painkillers (such as ibuprofen and other similar anti-inflammatory medicines, including over-the-counter medicines), and medicines containing lithium ;
• use of certain vaccines: live vaccines administered during treatment with Dimethyl fumarate MSN may lead to infection and should therefore be avoided. The doctor will advise whether inactivated (killed) vaccines should be used instead.

Dimethyl fumarate MSN and alcohol
The patient should avoid consuming high-strength alcoholic drinks (more than 30% alcohol by
volume) in quantities exceeding 50 mL within one hour of taking Dimethyl fumarate MSN, 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 or breastfeeding, suspects she may be pregnant, or is planning to have a
child, 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. Dimethyl fumarate MSN should not be used during pregnancy unless discussed with the
doctor and deemed necessary.
Breastfeeding
It is unknown whether the active ingredient of Dimethyl fumarate MSN passes into human milk.
The doctor will advise the patient whether she should discontinue breastfeeding or the use of
Dimethyl fumarate MSN. The decision will be based on an assessment of the benefits of breastfeeding
for the child compared to the benefits of treatment for the mother.
Driving and operating machinery
Dimethyl fumarate MSN is not expected to affect the ability to drive or operate machinery.
Dimethyl fumarate MSN contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per capsule; therefore, this medicine is
considered "sodium-free".

3. How to use Dimethyl fumarate MSN

This medicine should always be used 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 taken at the recommended dose.
Recommended dose: 240 mg twice daily.
Dimethyl fumarate MSN 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 effects.
Dimethyl fumarate MSN should be taken with food – this helps reduce the very common adverse effects listed in section 4.
Taking more Dimethyl fumarate MSN than recommended
If more capsules of Dimethyl fumarate MSN than recommended have been taken, you should contact your doctor immediately. Adverse effects similar to those described below in section 4 may occur.
Missing a dose of Dimethyl fumarate MSN
Do not take a double dose to make up for a missed dose.
A missed dose may be taken if at least a 4-hour interval is maintained between doses. 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 reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.

Serious adverse reactions

The medicine Dimethyl fumarate MSN may reduce the number of lymphocytes (a type of white blood cells). Low levels 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 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 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. For this reason, if you notice worsening of symptoms related to multiple sclerosis or the appearance of any new symptoms while taking Dimethyl fumarate MSN, 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 or a sensation of warmth. If sudden skin redness 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 Dimethyl fumarate MSN and contact your doctor immediately.

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

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

During treatment with Dimethyl fumarate MSN, substances called ketone bodies, which are naturally produced in the body, are very commonly detected in urine tests.
Talk to your doctor about 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
• burning sensation of the skin
• hot flushes, feeling of warmth
• itching of the skin (pruritus)
• rash
• pink or red skin patches (erythema)
• hair loss (alopecia)

Adverse reactions that may appear in blood or urine tests

• low number of white blood cells (lymphopenia, leukopenia). Reduced white blood cell count may mean the body is less able to fight infections. If you develop a serious infection (such as pneumonia), contact your doctor immediately.
• protein (albumin) in urine
• increased liver enzyme activity (AlAT, AspAT) in blood

Uncommon (may affect up to 1 in 100 people)

• allergic reactions (hypersensitivity)
• decreased platelet count

Rare (may affect up to 1 in 1,000 people)

• hepatitis and increased liver enzyme activity (AlAT or AspAT in combination with bilirubin*)

Frequency unknown (frequency cannot be estimated from available data)

• shingles, with symptoms such as 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 patches with severe pain
• nasal congestion (rhinitis)

Children (aged 13 years and older) 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, stomach pain or cramps, nausea (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, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, 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 Dimethyl fumarate MSN

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and carton after: EXP.
The expiry date refers to the last day of the stated month.
No special storage conditions are required for this medicine.
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 MSN contains
The active substance is dimethyl fumarate.
Dimethyl fumarate MSN, 120 mg: Each capsule contains 120 mg of dimethyl fumarate.
Dimethyl fumarate MSN, 240 mg: Each capsule contains 240 mg of dimethyl fumarate.
The other ingredients are:

• Capsule contents (enteric-coated micropellets): microcrystalline cellulose (E 460), sodium croscarmellose, colloidal anhydrous silica, magnesium stearate (E 470b), copolymer of methacrylic acid and methyl methacrylate (1:1), copolymer of methacrylic acid and ethyl acrylate (1:1), 30% dispersion, triethyl citrate (E 1505), talc (E 553b), sodium lauryl sulfate, polysorbate 80 (E 433).
• Capsule shell contains gelatin, titanium dioxide (E 171), FD&C Blue No. 1 (E 133), iron oxide black (E 172), and iron oxide yellow (E 172).
• Black printing ink contains shellac (E 904), iron oxide black (E 172), potassium hydroxide (E 525), and propylene glycol (E 1520).

What Dimethyl fumarate MSN looks like and contents of the pack
[120 mg]: Green-white enteric hard capsules, approximately 22 mm in diameter, printed with “M” and “120 mg”.
[240 mg]: Green enteric hard capsules, approximately 22 mm in diameter, printed with “M” and “240 mg”.
The capsules are filled with white or almost white enteric-coated micropellets.
Pack sizes:
120 mg:
PVC/PE/PVDC/Aluminium blisters containing 14 or 56 enteric hard capsules.
Perforated single-dose blisters made of PVC/PE/PVDC/Aluminium containing 14 x 1 or 56 x 1 enteric hard capsule.
240 mg:
PVC/PE/PVDC/Aluminium blisters containing 56, 168 or 196 enteric hard capsules.
Perforated single-dose blisters made of PVC/PE/PVDC/Aluminium containing 56 x 1, 168 x 1 or 196 x 1 enteric hard capsule.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer/Importer
Marketing Authorisation Holder:
MSN Labs Europe Limited
KW20A Corradino Park
Paola, PLA 3000
Malta
Tel.: (+48) 699 711 147
Manufacturer/Importer:
MSN Labs Europe Limited
KW20A Corradino Park
Paola, PLA 3000
Malta
Pharmadox Healthcare Limited
KW20A Kordin Industrial Park
Paola, PLA 3000
Malta
This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Netherlands: Dimethylfumaraat MSN 120 mg maagsapresistente harde capsules
Dimethylfumaraat MSN 240 mg maagsapresistente harde capsules
Czech Republic: Dimethyl fumarate MSN
Poland: Dimethyl fumarate MSN
Bulgaria: Диметилфумарат MSN 120 mg стомашно-устойчиви твърди капсули
Диметилфумарат MSN 240 mg стомашно-устойчиви твърди капсули
Croatia: Dimetilfumarat MSN 120 mg tvrde želučanootporne capsule
Dimetilfumarat MSN 240 mg tvrde želučanootporne kapsule
Hungary: Dimethyl fumarate MSN 120 mg gyomornedv-ellenálló kemény kapszula
Dimethyl fumarate MSN 240 mg gyomornedv-ellenálló kemény kapszula
Lithuania: Dimethyl fumarate MSN 120 mg skrandyje neirios kietosios kapsulės
Dimethyl fumarate MSN 240 mg skrandyje neirios kietosios kapsulės
Latvia: Dimethyl fumarate MSN 120 mg zarnās šķīstošās cietās kapsulas
Dimethyl fumarate MSN 240 mg zarnās šķīstošās cietās kapsulas
Estonia: Dimethyl fumarate MSN
Romania: Dimetil fumarat MSN 120 mg capsule gastrorezistente
Dimetil fumarat MSN 240 mg capsule gastrorezistente
Slovakia: Dimethyl fumarate MSN 120 mg
Dimethyl fumarate MSN 240 mg
Slovenia: Dimetilfumarat MSN 120 mg gastrorezistentne trde kapsule
Dimetilfumarat MSN 240 mg gastrorezistentne trde kapsule