Dimtruzic

Leaflet accompanying the packaging: information for

the patient

Dimtruzic, 120 mg, gastro-resistant hard capsules

Dimtruzic, 240 mg, gastro-resistant hard capsules

Dimethyl fumarate

You should carefully read the contents of this leaflet before taking the medicine, as it contains important information for you.

• You should keep this leaflet, so you can read it again if you need to.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

Contents of the pack

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

1. What Dimtruzic is and what it is used for

What Dimtruzic is

Dimtruzic is a medicine that contains the active substance dimethyl fumarate.

What Dimtruzic is used for

Dimtruzic is used to treat relapsing-remitting multiple sclerosis (MS) in patients aged 13 and over.

Multiple sclerosis is a long-term disease that damages the central nervous system (the brain and spinal cord). The relapsing-remitting form of multiple sclerosis is characterized by recurring episodes of symptoms (relapses) that can include problems with walking and balance, and vision problems (such as blurred or double vision). These symptoms can completely disappear after a relapse, but some problems may remain.

How Dimtruzic works

Dimtruzic seems to stop the immune system from causing damage to the brain and spinal cord, which may also help slow down the progression of the disease in the future.

2. Important information before taking Dimtruzic

When not to take Dimtruzic

• If you are allergic to dimethyl fumarate or any of the other ingredients of this medicine(listed in section 6).
• If you suspect or have been diagnosed with a rare brain infection called progressive multifocal leukoencephalopathy (PML).

Warnings and precautions

Dimtruzic may affect your white blood cell countand your kidneyand liverfunction. Before starting treatment with Dimtruzic, your doctor will check your white blood cell count and make sure your kidneys and liver are working properly. These tests will be repeated periodically during treatment. If your white blood cell count decreases during treatment, your doctor may consider additional tests or stop treatment.

You must tell your doctorif you have:

• severe kidney disease
• severe liver disease
• stomach or intestinal disease
• severe infection(such as pneumonia). During treatment with Dimtruzic, shingles (herpes zoster) may occur. In some cases, serious complications have occurred. If you suspect you have any symptoms of shingles you must immediately inform your doctor.

If your multiple sclerosis gets worse (e.g., you experience weakness or vision problems) or you develop new symptoms, you should contact your doctor immediately, as these may be symptoms of a rare brain infection called PML. PML is a serious disease that can cause severe disability or death.

Children and adolescents

This medicine should not be given to children under 10 years of age, as there is no information on its use in this age group.

Dimtruzic and other medicines

You must tell your doctor or pharmacistabout all medicines you are taking or have recently taken, and about any medicines you plan to take, especially:

• medicines containing fumaric acid esters(fumarates) used to treat psoriasis
• medicines that affect the immune system, including chemotherapy, immunosuppressants, and other medicines used to treat multiple sclerosis
• medicines that affect the kidneys, including some antibiotics(used to treat infections), diuretics, certain painkillers(such as ibuprofen and similar anti-inflammatory medicines, including those available without a prescription), and medicines containing lithium
• The use of certain vaccines (live vaccines)during treatment with Dimtruzic may cause infection, so it should be avoided. Your doctor will advise whether you can receive other types of vaccines (inactivated vaccines).

Taking Dimtruzic with alcohol

You should avoid drinking high-percentage alcoholic beverages (over 30% alcohol by volume, e.g., spirits) in amounts greater than 50 ml within one hour of taking Dimtruzic, due to the risk of interaction between alcohol and this medicine, which may lead to stomach upset (gastritis), especially in people prone to this condition.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, you must consult your doctor or pharmacist before taking this medicine.

Pregnancy

There is limited information on the use of this medicine in pregnant women. Dimtruzic should not be taken during pregnancy unless you have discussed it with your doctor and the use of the medicine is necessary.

Breastfeeding

It is not known whether the active substance of Dimtruzic passes into breast milk. Your doctor will advise whether you should stop breastfeeding or stop taking Dimtruzic.

The decision will be based on the assessment of the benefit of breastfeeding to the baby compared to the benefit of treatment for you.

Driving and using machines

You should not expect Dimtruzic to affect your ability to drive or use machines.

Dimtruzic contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per capsule, which is considered to be "sodium-free".

3. How to take Dimtruzic

This medicine should always be taken exactly as your doctor has told you. If you are not sure, ask your doctor.

Initial dose: 120 mg twice a day.

This initial dose should be taken for the first 7 days, and then the usual dose should be taken.

Usual dose: 240 mg twice a day.

Dimtruzic should be taken orally.

Each capsule should be swallowed whole, with water. The capsules should not be divided, crushed, dissolved, sucked, or chewed, as this may increase certain side effects.

Dimtruzic should be taken with food- this will help to reduce the very common side effects (listed in section 4).

Taking more Dimtruzic than prescribed

If you have taken more capsules than prescribed you must immediately tell your doctor. Side effects may occur that are similar to those described below in section 4.

Missing a dose of Dimtruzic

Do not take a double doseto make up for a missed dose.

A missed dose can be taken later, provided that a 4-hour interval is maintained before the next dose. If it is too late, do not take the missed dose, but take the next dose at the usual time.

If you have any further questions about taking this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Dimtruzic can cause side effects, although not everybody gets them.

Severe side effects

Dimtruzic may lower the number of lymphocytes, a type of white blood cell. A low white blood cell count can 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, so your doctor will monitor your white blood cell count throughout treatment, and you should be aware of the symptoms described below, which may indicate PML. The risk of PML may be higher if you have taken medicines that affect the immune system in the past.

Symptoms of PML can be similar to those of a relapse of multiple sclerosis. They include weakness or increased weakness on one side of the body, coordination problems, vision problems, problems with thinking or memory, confusion (disorientation) or personality changes, speech problems, and communication difficulties lasting more than a few days. Therefore, if you experience worsening of your multiple sclerosis symptoms or new symptoms while taking Dimtruzic, you should contact your doctor immediately. You should also discuss your treatment with your partner or caregivers and inform them about your treatment. There may be symptoms that you are not aware of.

If you experience any of the following symptoms, you must immediately contact your doctor

Severe allergic reactions

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

A very common side effect is sudden (flushing) redness of the face or body. If flushing is accompanied by a red rash or hives andany of the following symptoms:

• swelling of the face, lips, mouth, or tongue (angioedema)
• wheezing, difficulty breathing, or shortness of breath (dyspnea)
• dizziness or loss of consciousness (hypotension)

it may indicate a severe allergic reaction (anaphylaxis).

You must stop taking Dimtruzic and immediately contact your doctor

Other side effects

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

• redness of the face or a feeling of warmth or heat (flushing)
• diarrhea
• nausea
• stomach pain or cramps

→ Taking the medicine with foodwill help to reduce the above side effects

During treatment with Dimtruzic, increased production of ketone bodies (substances normally produced by the body) is very commonly found in urine tests.

You should ask your doctorhow to deal with these side effects. Your doctor may reduce the dose of the medicine. You should not reduce the dose yourself unless your doctor advises you to.

Common(may affect up to 1 in 10 people)

• inflammation of the lining of the intestines (gastroenteritis)
• vomiting
• indigestion
• inflammation of the stomach lining (gastritis)
• gastrointestinal problems
• burning sensation of the skin
• hot flashes
• itching of the skin (pruritus)
• rash
• pink or red spots on the skin (erythema)
• hair loss (alopecia)
• Side effects that may affect the results of blood or urine tests
• low white blood cell count (lymphopenia, leukopenia). A low white blood cell count may mean that your body is less able to fight infection. If you have a severe infection (e.g., pneumonia), you should immediately contact your doctor;
• protein (albumin) in the urine
• increased liver enzyme activity (ALT, AST) in the blood

Uncommon

• allergic reactions (hypersensitivity)
• decreased platelet count
• Unknown(frequency cannot be estimated from the available data)
• inflammation of the liver and increased liver enzyme activity (ALT or AST together with bilirubin)
• shingles, with symptoms such as blisters on the skin, burning, itching, or 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 and severe pain
• cold (rhinitis)

Children (aged 13 and over) and adolescents

The above side effects also apply to children and adolescents. Some side effects have been reported more frequently in children and adolescents than in adults, e.g., headache, stomach pain or cramps, vomiting, sore throat, cough, and painful menstruation.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department for Monitoring of Adverse Reactions to Medicinal Products 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 authorization holder.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Dimtruzic

Keep this medicine out of the sight and reach of children.

Do not store above 30°C.

Do not use this medicine after the expiry date stated on the carton and blister.

The expiry date refers to the last day of that month.

The inscription on the packaging after the abbreviation EXP means the expiry date, and after the abbreviation Lot/LOT means the batch number.

Medicines should 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 pack and other information

What Dimtruzic contains

The active substance of Dimtruzic is dimethyl fumarate.

Dimtruzic 120 mg

Each gastro-resistant hard capsule contains 120 mg of dimethyl fumarate.

Dimtruzic 240 mg

Each gastro-resistant hard capsule contains 240 mg of dimethyl fumarate.

The other ingredients are:

capsule filling: croscarmellose sodium, colloidal anhydrous silica, sodium stearyl fumarate, methacrylic acid and methyl methacrylate copolymer (1:1), methacrylic acid and ethyl acrylate copolymer (1:1), dispersion 30%, talc, triethyl citrate, polysorbate 80, glycerol monostearate 40-55; capsule: gelatin, titanium dioxide (E 171), yellow iron oxide (E 172), brilliant blue FCF (E 133); capsule imprint: shellac, propylene glycol (E 1520), black iron oxide (E 172), concentrated ammonia solution 28%.

What Dimtruzic looks like and contents of the pack

Dimtruzic 120 mg gastro-resistant hard capsules.

Hard, gelatin capsules, white body, light green cap, with imprint on the body "120 mg", length approximately 19.4 mm and width approximately 8.53 mm.

Dimtruzic 240 mg gastro-resistant hard capsules.

Hard, gelatin capsules, light green, with imprint on the body "240 mg", length approximately 23.3 mm and width approximately 8.53 mm.

Dimtruzic is packaged in blisters or calendar blisters or perforated single-dose blisters made of Al/PVC/PVDC foil.

Dimtruzic, 120 mg, gastro-resistant hard capsules

Blisters of 14 gastro-resistant hard capsules

Calendar blisters - 14 gastro-resistant hard capsules

Perforated single-dose blisters 14 x 1 gastro-resistant hard capsule

Dimtruzic, 240 mg, gastro-resistant hard capsules

Blisters of 56 gastro-resistant hard capsules

Calendar blisters - 56 gastro-resistant hard capsules

Perforated single-dose blisters 56 x 1 gastro-resistant hard capsule

Perforated single-dose blisters 168 x 1 gastro-resistant hard capsule

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Sandoz GmbH

Biochemiestrasse 10

6250 Kundl

Austria

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 product is authorized in the Member States of the European Economic Area under the following names

Austria

Dimtruzic 120 mg magensaftresistente Hartkapseln

Dimtruzic 240 mg magensaftresistente Hartkapseln

Belgium

Dimtruzic 120 mg harde maagsapresistente capsules

Dimtruzic 240 mg harde maagsapresistente capsules

Bulgaria

DIMTRUZIC 120 mg gastro-resistant hard capsule

DIMTRUZIC 240 mg gastro-resistant hard capsule

Croatia

Dimtruzic 120 mg tvrde želučanootporne kapsule

Dimtruzic 240 mg tvrde želučanootporne kapsule

Cyprus

DIMTRUZIC

Czech Republic

DIMTRUZIC

Estonia

DIMTRUZIC

Germany

DIMTRUZIC 120 mg magensaftresistente Hartkapseln

DIMTRUZIC 240 mg magensaftresistente Hartkapseln

Greece

DIMTRUZIC 120 mg γαστροανθεκτικά σκληρά καψάκια

DIMTRUZIC 240 mg γαστροανθεκτικά σκληρά καψάκια

France

DIMTRUZIC 120 mg, gélule gastrorésistante

DIMTRUZIC 240 mg, gélule gastrorésistante

Italy

DIMTRUZIC

Latvia

Dimtruzic 120 mg zarnās šķīstošās cietās kapsulas

Dimtruzic 240 mg zarnās šķīstošās cietās kapsulas

Lithuania

Dimtruzic 120 mg skrandyje neirios kietosios kapsulės

Dimtruzic 240 mg skrandyje neirios kietosios kapsulės

Malta

DIMTRUZIC 120 mg gastro-resistant hard capsule

DIMTRUZIC 240 mg gastro-resistant hard capsule

Poland

Dimtruzic

Romania

Dimtruzic 120 mg Capsule gastrorezistente

Dimtruzic 240 mg Capsule gastrorezistente

Slovakia

DIMTRUZIC 120 mg

DIMTRUZIC 240 mg

Slovenia

DIMTRUZIC 120 mg gastrorezistentne trde kapsule

DIMTRUZIC 240 mg gastrorezistentne trde kapsule

For more information about this medicine, please contact

Sandoz Polska Sp. z o.o.

ul. Domaniewska 50 C

02-672 Warsaw

tel. 22 209 70 00

Date of last revision of the leaflet:06/2024

(logo of the marketing authorization holder)