Dimethyl fumarate sandoz

Package leaflet: Information for the patient

Dimethyl fumarate Sandoz, 120 mg, hard enteric-coated capsules
Dimethyl fumarate Sandoz, 240 mg, hard enteric-coated capsules
Dimethyl fumarate
Please read all of this leaflet carefully 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 someone else even if their symptoms are the same as yours.
• If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of contents

1. What Dimethyl fumarate Sandoz is and what it is used for
2. What you need to know before taking Dimethyl fumarate Sandoz
3. How to take Dimethyl fumarate Sandoz
4. Possible side effects
5. How to store Dimethyl fumarate Sandoz
6. Contents of the pack and other information

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

What Dimethyl fumarate Sandoz is
Dimethyl fumarate Sandoz is a medicine containing dimethyl fumarate as the active substance.
What Dimethyl fumarate Sandoz is used for
Dimethyl fumarate Sandoz 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 repeated episodes of neurological symptoms (called relapses). Symptoms vary between patients but usually include difficulty walking, balance problems, and vision problems (e.g. blurred or double vision). These symptoms may completely resolve after a relapse ends, but some problems may persist.
How Dimethyl fumarate Sandoz works
Dimethyl fumarate Sandoz appears to suppress the immune system from causing damage to the patient's brain and spinal cord, which may also help slow the future progression of the disease.

2. Important information before taking Dimethyl fumarate Sandoz

When not to take Dimethyl fumarate Sandoz

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

Warnings and precautions

Dimethyl fumarate Sandoz may adversely affect the white blood cell count and the function of the kidneys and liver. Before starting treatment with Dimethyl fumarate Sandoz, 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 interrupting treatment.

Before starting Dimethyl fumarate Sandoz, 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).

Shingles (herpes zoster) may occur during treatment with Dimethyl fumarate Sandoz. In some cases, severe complications have occurred. If the patient suspects any symptoms of shingles, they should immediately inform their doctor.

If the patient feels that their multiple sclerosis is worsening (e.g. weakness or vision problems) or new symptoms appear, they 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 in patients treated with dimethyl fumarate in combination with other fumaric acid esters used for the treatment of psoriasis (a skin disease). If the patient notices that they are passing more urine than usual, feels increased thirst and drinks more than normal, feels muscle weakness, experiences bone fractures, or has 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 Sandoz and other medicines

The patient should tell their doctor or pharmacist about any medicines they are currently taking, have recently taken, or plan to take, especially:

• medicines containing fumaric acid esters (fumarates) used to treat psoriasis;
• medicines affecting the immune system, including chemotherapeutic agents, immunosuppressants, or other medicines used to treat multiple sclerosis;
• medicines affecting the kidneys, including certain antibiotics (used to treat infections), diuretics (water pills), certain types of painkillers (such as ibuprofen and similar anti-inflammatory medicines, including over-the-counter products), and medicines containing lithium;
• the use of certain vaccines (live vaccines) during treatment with Dimethyl fumarate Sandoz may lead to infection and should therefore be avoided. The doctor will advise whether alternative vaccines (containing inactivated organisms) should be administered.

Dimethyl fumarate Sandoz and alcohol

The patient should avoid consuming high-strength alcoholic beverages (over 30% alcohol by volume, e.g. spirits) in quantities exceeding 50 mL within one hour of taking Dimethyl fumarate Sandoz, 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

There is limited information on the effects of this medicine on the unborn child when used during pregnancy. Dimethyl fumarate Sandoz should not be used during pregnancy unless discussed with the doctor and considered necessary.

Breastfeeding

It is not known whether the active substance of Dimethyl fumarate Sandoz passes into human milk. The doctor will advise the patient whether she should discontinue breastfeeding or stop taking Dimethyl fumarate Sandoz. 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 Dimethyl fumarate Sandoz on the ability to drive or operate machinery is expected.

Dimethyl fumarate Sandoz contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per hard gastro-resistant capsule; therefore, this medicine is considered "sodium-free".

3. How to take Dimethyl fumarate Sandoz

This medicine should always be taken exactly as directed by your doctor. If you have any doubts,
consult your doctor.
Starting dose: 120 mg twice daily.
This starting dose should be taken for the first 7 days, after which the medicine should be used at the
usual maintenance dose.
Usual maintenance dose: 240 mg twice daily.
Dimethyl fumarate Sandoz 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.
Dimethyl fumarate Sandoz should be taken with food – this may help reduce the occurrence of
very common adverse reactions (listed in section 4).
Taking more Dimethyl fumarate Sandoz 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 Dimethyl fumarate Sandoz
Do not take a double dose to make up for a missed dose.
A missed dose may be taken provided there is at least a 4-hour interval before the next scheduled dose.
Otherwise, do not take the missed dose; instead, take the next dose at the usual time.
If you have any further questions about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.

Serious side effects

Dimethyl fumarate Sandoz 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 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 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, problems with coordination, 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 Sandoz, you should contact your doctor as soon as possible. You should also talk to your partner or caregivers and inform them about your treatment, as they may notice symptoms you are not aware of.

If any of the symptoms listed above occur, contact your doctor immediately.

Severe allergic reactions

The frequency of severe allergic reactions cannot be determined from the available data (frequency unknown).

A very common side effect is sudden (episodic) redness of the face or body. However, if episodic 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 (dyspnoea, hypoxia);
• dizziness or loss of consciousness (hypotension)

this may indicate a severe allergic reaction (anaphylaxis).

• You must stop taking Dimethyl fumarate Sandoz and contact your doctor immediately.

Other side effects

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

• redness of the face or sensation of increased body temperature, warmth, burning or itching of the skin (flushing)
• loose stools (diarrhoea)
• nausea
• stomach pain or cramps

Taking the medicine with food may help reduce the side effects listed above.

During treatment with Dimethyl fumarate Sandoz, the presence of ketone bodies (substances normally produced in the body) in urine is very commonly observed.

You should discuss with your doctor how to manage these side effects. Your doctor may reduce the dose of the medicine. Do not reduce the dose yourself unless instructed by your doctor.

Common (may affect up to 1 in 10 people)

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

Side effects that may cause abnormal blood or urine test results

• low number of white blood cells (lymphopenia, leukopenia) in blood. A reduced number of white blood cells may mean 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 activity of liver enzymes (AlAT, AspAT) in blood

Uncommon (may affect up to 1 in 100 people)

• allergic reactions (hypersensitivity)
• decreased number of platelets

Frequency not known (frequency cannot be estimated from the available data)

• hepatitis and increased activity of liver enzymes (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 spots and severe pain
• nasal congestion (rhinitis)

Children (aged 13 years and above) and adolescents

The side effects listed above also apply to children and adolescents. Some side 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 side effects

If any side effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Side effects 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.

Side effects can also be reported to the marketing authorisation holder.

Reporting side effects helps provide more information on the safety of the medicine.

5. How to store Dimethyl fumarate Sandoz

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.
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 no longer required. These measures help protect the environment.

6. Contents of the pack and other information

What Dimethyl fumarate Sandoz contains
The active substance is dimethyl fumarate.
Dimethyl fumarate Sandoz 120 mg: each capsule contains 120 mg of dimethyl fumarate.
Dimethyl fumarate Sandoz 240 mg: each capsule contains 240 mg of dimethyl fumarate.
Other ingredients are: capsule contents: sodium croscarmellose (E 468), colloidal anhydrous silica (E 551), sodium stearyl fumarate (E 470A), copolymer of methacrylic acid and methyl methacrylate (1:1), copolymer of methacrylic acid and ethyl acrylate (1:1), 30% dispersion, talc (E 553B), triethyl citrate (E 1505), polysorbate 80 (E 443), glycerol monostearate 40-55; capsule shell: gelatine (E 441), titanium dioxide (E 171), iron oxide yellow (E 172), brilliant blue FCF (E 133); printing ink on capsule: shellac (20% esterified) 45% ethanolic solution (E904), iron oxide black (E 172), propylene glycol (E 1520), ammonium hydroxide 28%.

What Dimethyl fumarate Sandoz looks like and contents of the pack
Enteric hard capsules (enteric hard capsules)
Dimethyl fumarate Sandoz 120 mg, enteric hard capsules.
Enteric hard capsule with white body and light green cap, printed with "120 mg" on the body, approximately 19 mm in length and approximately 9 mm in width.
Dimethyl fumarate Sandoz 240 mg, enteric hard capsules.
Enteric hard capsule, light green in colour, printed with "240 mg" on the body, approximately 23 mm in length and approximately 9 mm in width.
Dimethyl fumarate Sandoz is packed in blisters or calendar blisters or single-dose perforated blisters made of Aluminium/PVC/PVDC foil, in a cardboard box.
Dimethyl fumarate Sandoz 120 mg, enteric hard capsules
Blisters – 14 enteric hard capsules.
Calendar blisters – 14 enteric hard capsules.
Single-dose perforated blisters – 14 x 1 enteric hard capsule.
Dimethyl fumarate Sandoz 240 mg, enteric hard capsules
Blisters – 56 enteric hard capsules.
Calendar blisters – 56 enteric hard capsules.
Single-dose perforated blisters – 56 x 1 enteric hard capsule or 168 x 1 enteric hard capsule.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Sandoz Polska Sp. z o.o.
ul. Domaniewska 50 C
02-672 Warsaw
tel. 22 209 70 00
Manufacturer
LEK farmacevtska družba d.d.
Verovškova ulica 57
1526 Ljubljana, Slovenia
Zakłady Farmaceutyczne Polpharma S.A.
ul. Metalowca 2
39-460 Nowa Dęba

This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Austria Dimethylfumarat Sandoz 120 mg – magensaftresistente Hartkapseln;
Dimethylfumarat Sandoz 240 mg – magensaftresistente Hartkapseln
Belgium Dimethyl fumarate Sandoz 120 mg harde maagsapresistente capsules/gélules gastrorésistantes/magensaftresistente Hartkapseln;
Dimethyl fumarate Sandoz 240 mg harde maagsapresistente capsules/gélules gastrorésistantes/magensaftresistente Hartkapseln
Bulgaria Dimethyl fumarate Sandoz 120 mg gastro-resistant hard capsule;
Dimethyl fumarate Sandoz 240 mg gastro-resistant hard capsule
Croatia Dimetilfumarat Sandoz 120 mg tvrde želučanootporne kapsule;
Dimetilfumarat Sandoz 240 mg tvrde želučanootporne kapsule
Cyprus Dimethyl fumarate/EBEWE 120 mg γαστροανθεκτικό καψάκιο, σκληρό;
Dimethyl fumarate/EBEWE 240 mg γαστροανθεκτικό καψάκιο, σκληρό
Czech Republic Dimethyl fumarate Sandoz
Estonia Dimethyl fumarate Sandoz
France DIMETHYL FUMARATE SANDOZ 120 mg, gélule gastro-résistante;
DIMETHYL FUMARATE SANDOZ 240 mg, gélule gastro-résistante
Greece Dimethyl fumarate/EBEWE
Lithuania Dimethyl fumarate Sandoz 120 mg skrandyje neirios kietosios kapsulės;
Dimethyl fumarate Sandoz 240 mg skrandyje neirios kietosios kapsulės
Latvia Dimethyl fumarate Sandoz 120 mg zarnās šķīstošās cietās kapsulas;
Dimethyl fumarate Sandoz 240 mg zarnās šķīstošās cietās kapsulas
Malta DIMETHYL FUMARATE SANDOZ 120mg gastro-resistant hard capsules;
DIMETHYL FUMARATE SANDOZ 240mg gastro-resistant hard capsules
Germany Dimethylfumarat - 1 A Pharma 120 mg magensaftresistente Hartkapseln;
Dimethylfumarat - 1 A Pharma 240 mg magensaftresistente Hartkapseln
Poland Dimethyl fumarate Sandoz
Romania Dimetil fumarat Sandoz 120 mg capsule gastrorezistente;
Dimetil fumarat Sandoz 240 mg capsule gastrorezistente
Slovakia Dimetyl-fumarát Sandoz 120 mg;
Dimetyl-fumarát Sandoz 240 mg
Slovenia Dimetilfumarat Sandoz 120 mg gastrorezistentne trde kapsule;
Dimetilfumarat Sandoz 240 mg gastrorezistentne trde kapsule
Italy Dimetilfumarato Sandoz
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