Dimtelzo

Package leaflet: Information for the patient

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

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please 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 side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Leaflet contents

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

1. What Dimtelzo is and what it is used for

What Dimtelzo is
Dimtelzo is a medicine that contains dimethyl fumarate as its active substance.
What Dimtelzo is used for
Dimtelzo 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 episodes of neurological symptoms (called relapses). Symptoms vary between individuals, 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 Dimtelzo works
Dimtelzo appears to suppress the immune system from causing damage to the patient's brain and spinal cord, which may also help slow the progression of the disease in the future.

2. Important information before taking Dimtelzo

When not to take Dimtelzo
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 is diagnosed with a rare brain infection
called progressive multifocal leukoencephalopathy (PML).

Warnings and precautions
Dimtelzo may adversely affect the white blood cell count as well as the function of the kidneys and
liver. Before starting treatment with Dimtelzo, 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 Dimtelzo, consult a doctor if the patient has:

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

Herpes zoster (shingles) may occur during treatment with Dimtelzo. In some cases, serious complications have occurred. If the patient suspects any symptoms of shingles, the doctor should be informed immediately.
If the patient feels that multiple sclerosis is worsening (e.g. weakness or vision disturbances) or new symptoms appear, the patient should contact the 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.

During treatment with a medicine containing dimethyl fumarate in combination with other fumaric acid esters used to treat psoriasis (a skin disease), rare but serious kidney dysfunction called Fanconi syndrome has been reported. If the patient notices increased urination, feels more thirsty and drinks more than usual, experiences muscle weakness, bone fractures, or general pain, they should contact their 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.

Dimtelzo with other medicines
Tell the 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, 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, 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;
• vaccination with live vaccines (vaccines containing live microorganisms) during treatment with Dimtelzo may lead to infection; therefore, such vaccinations should be avoided. The doctor will advise whether other types of vaccines (containing inactivated microorganisms) should be administered.

Taking Dimtelzo with alcohol
Avoid consuming high-strength alcoholic beverages (over 30% alcohol by volume, e.g. spirits) in amounts exceeding 50 ml within one hour after taking Dimtelzo, due to the risk of interaction between alcohol and this medicine, which may lead to 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 a doctor or pharmacist.

Pregnancy
There is limited data on the effects of this medicine on the unborn child when used during pregnancy. Dimtelzo should not be taken during pregnancy unless the patient has discussed this with her doctor and treatment is considered necessary.

Breastfeeding
It is not known whether the active ingredient of Dimtelzo passes into human milk. The doctor will advise the patient whether she should discontinue breastfeeding or stop taking Dimtelzo. 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 operating machinery
Dimtelzo is not expected to affect the ability to drive or operate machinery.

3. How to take Dimtelzo

This medicine should always be taken exactly as prescribed by your doctor. If in doubt, 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 continued at the usual maintenance dose.
Usual maintenance dose: 240 mg twice daily.
Dimtelzo 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.
The bottles contain a drying agent. Do not swallow the container with the drying agent.
Dimtelzo should be taken with food – this may help reduce the very common adverse effects (listed in section 4).
Taking more Dimtelzo than prescribed
If you take more capsules than recommended, you must immediately inform your doctor. Adverse effects similar to those described below in section 4 may occur.
Missing a dose of Dimtelzo
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, 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 will experience them.

Serious adverse reactions

Dimtelzo 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 from 1 year to 5 years after starting treatment; therefore, the doctor should monitor the patient's white blood cell count throughout the treatment period, and the patient should be aware of the symptoms described below, which may indicate PML. The risk of PML may be higher if the patient has 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 problems, and communication difficulties lasting longer than a few days. Therefore, if during treatment with dimethyl fumarate the patient notices worsening of symptoms related to multiple sclerosis or the appearance of any new symptoms, they should contact their doctor immediately. It is also advisable to talk to a partner or caregivers and inform them about the treatment, as symptoms may occur of which the patient may not be aware.

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

Severe allergic reactions

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

A very common adverse reaction is sudden (flushing) redness of the face or body. However, 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 severe allergic reaction (anaphylaxis).

→ Stop taking Dimtelzo immediately and contact a doctor immediately.

Other adverse reactions

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

• redness of the skin on the face or a sensation of increased body temperature, warmth, 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 adverse reactions listed above.

During treatment with Dimtelzo, the presence of ketone bodies (substances normally produced in the body) is very commonly detected in urine tests.

Discuss with your doctor how to manage these adverse reactions. The doctor may reduce the dose of the medicine. Do not reduce the dose yourself unless instructed by the 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 warmth
• itching of the skin (pruritus)
• rash
• pink or red spots on the skin (erythema)
• hair loss (alopecia)

Adverse reactions 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 a serious infection occurs (e.g. pneumonia), contact a 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

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 pain of the skin, usually on one side of the upper body or face, and other symptoms such as fever and malaise in the early stages of infection, followed by numbness, itching, red spots, and severe pain
• nasal inflammation (rhinitis)

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 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 safe use of the medicine.

5. How to store the medicine Dimtelzo

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton, blister, or bottle
after: EXP. The expiry date refers to the last day of the stated month.
Store in the original packaging to protect from light.
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 Dimtelzo contains
The active substance is dimethyl fumarate.
Dimtelzo 120 mg: each capsule contains 120 mg of dimethyl fumarate.
Dimtelzo 240 mg: each capsule contains 240 mg of dimethyl fumarate.
The other ingredients are:
Capsule contents: microcrystalline cellulose, povidone-K30, crospovidone (type A), colloidal anhydrous silica, magnesium stearate, hypromellose, triacetin, talc, methacrylic acid and ethyl acrylate copolymer (1:1), titanium dioxide (E 171), triethyl citrate; capsule shell: gelatin, titanium dioxide (E 171), yellow iron oxide (E 172), brilliant blue FCF (E 133), ink: shellac, propylene glycol, concentrated ammonium hydroxide, potassium hydroxide, black iron oxide (E 172).

What Dimtelzo looks like and contents of the pack
Dimtelzo 120 mg gastro-resistant hard capsules.
Capsule size 0, length 21.4 mm, with a green, opaque cap and a white, opaque body, printed in black with "DMF 120", containing white to off-white minitablets.
Dimtelzo 240 mg gastro-resistant hard capsules.
Capsule size 00, length 23.2 mm, with a green, opaque cap and a green, opaque body, printed in black with "DMF 240", containing white to off-white minitablets.
Dimtelzo 120 mg gastro-resistant hard capsules.
Blister packs or single-dose perforated blisters made of OPA/Aluminium/PVC/Aluminium foil in a cardboard box.
Pack sizes: 14 or 14 x 1 gastro-resistant hard capsules.
HDPE bottle with PP/HDPE screw cap, seal, and container containing a desiccant (silica gel) in a cardboard box.
Pack size: 100 gastro-resistant hard capsules.
Dimtelzo 240 mg gastro-resistant hard capsules.
Blister packs or single-dose perforated blisters made of OPA/Aluminium/PVC/Aluminium foil in a cardboard box.
Pack sizes: 56, 56 x 1, 168, 168 x 1, and 196 hard capsules.
HDPE bottle with PP/HDPE screw cap, seal, and container containing a desiccant (silica gel) in a cardboard box.
Pack size: 100 gastro-resistant hard capsules.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Importer
Marketing Authorisation Holder
Sandoz Polska Sp. z o.o.
ul. Domaniewska 50 C
02-672 Warsaw, Poland
Importer
Pharmadox Healthcare Limited
Kw20a Kordin Industrial Park
PLA 3000 Paola, Malta
Adalvo Limited
Malta Life Sciences Park, Building 1, Level 4
Sir Temi Zammit Buildings
SGN 3000 San Gwann, Malta
Lek Pharmaceuticals d.d.
Verovskova Ulica 57
1526 Ljubljana, Slovenia
For further information about this medicinal product, please contact the local representative:
Poland
Sandoz Polska Sp. z o.o.
ul. Domaniewska 50 C
02-672 Warsaw, Poland
Tel: 22 209 70 00

This medicinal product is authorised for marketing in the European Economic Area (EEA) under the following names:
Austria Dimtelzo 120 mg magensaftresistente Hartkapseln
Dimtelzo 240 mg magensaftresistente Hartkapseln
Belgium Dimtelzo 120 mg harde maagsapresistente capsules
Dimtelzo 240 mg harde maagsapresistente capsules
Bulgaria Dimtelzo 120 mg gastro-resistant hard capsules
Dimtelzo 240 mg gastro-resistant hard capsules
Croatia Dimtelzo 120 mg tvrde želučanootporne kapsule
Dimtelzo 240 mg tvrde želučanootporne kapsule
Czech Republic Dimtelzo 120 mg enterosolventní tvrdé tobolky
Dimtelzo 240 mg enterosolventní tvrdé tobolky
Estonia Dimtelzo 120 mg gastroresistentsed kõvakapslid
Dimtelzo 240 mg gastroresistentsed kõvakapslid
Germany Dimtelzo 120 mg magensaftresistente Hartkapseln
Dimtelzo 240 mg magensaftresistente Hartkapseln
Latvia Dimtelzo 120 mg zarnās šķīstošās cietās kapsulas
Dimtelzo 240 mg zarnās šķīstošās cietās kapsulas
Lithuania Dimtelzo 120 mg skrandyje neirios kietosios kapsulės
Dimtelzo 240 mg skrandyje neirios kietosios kapsulės
Poland Dimtelzo
Romania Dimtelzo 120 mg Capsule gastrorezistente
Dimtelzo 240 mg Capsule gastrorezistente
Slovakia Dimtelzo 120 mg
Dimtelzo 240 mg
Slovenia Dimtelzo 120 mg gastroresistentne trde kapsule
Dimtelzo 240 mg gastroresistentne trde kapsule

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