Dimtelzo

Package Leaflet: Information for the Patient

Dimtelzo, 120 mg, Gastro-Resistant Hard Capsules

Dimtelzo, 240 mg, Gastro-Resistant Hard Capsules

Dimethyl Fumarate

Read All of This Leaflet Carefully Before You Start Taking This Medicine Because It Contains Important Information for You.

• You should 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 you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Pack and Other Information

• 1. What Dimtelzo is and what it is used for
• 2. Before you take 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 the active substance dimethyl fumarate.

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

How Dimtelzo works

Dimtelzo seems to prevent the immune system from causing damage to the patient's brain and spinal cord, which may also help slow down the progression of the disease in the future.

2. Before you take Dimtelzo

When not to take Dimtelzo

If you are allergic to dimethyl fumarateor 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)

Progressive multifocal leukoencephalopathy(PML) is a rare and serious brain infection caused by a virus. If you have been diagnosed with PML, your doctor will not prescribe Dimtelzo for you.

Warnings and precautions

Dimtelzo may affect your white blood cell countand your kidneyand liverfunction. Before starting treatment with Dimtelzo, your doctor will check your white blood cell count and make sure that 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.
Before taking Dimtelzo, tell your doctor if you have:

• severe kidney disease
• severe liver disease
• stomach or intestinal disease
• severe infection(such as pneumonia).

During treatment with Dimtelzo, you may develop shingles. In some cases, serious complications have occurred. If you suspect that you have any symptoms of shingles, you must immediately inform your doctor.
If you notice that your multiple sclerosis is getting worse (e.g., you experience weakness or vision problems) or if you develop new symptoms, you should contact your doctor immediately, as these may be symptoms of PML. PML is a serious disease that can cause severe disability or death.
During treatment with a medicine containing dimethyl fumarate, used in combination with other fumaric acid esters for the treatment of psoriasis (a skin disease), rare but serious kidney problems, called Fanconi syndrome, have been reported. If you notice that you are urinating more than usual, feel thirsty, and drink more than usual, your muscles feel weak, you have a fracture, or you just feel unwell, you should contact your doctor as soon as possible to investigate these symptoms.

Children and adolescents

Dimtelzo should not be given to children under 10 years of age because there is no information on its use in this age group.

Dimtelzo and other medicines

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, or other medicines used to treat multiple sclerosis;
• medicines that affect kidney function, including certain antibiotics(used to treat infections), diuretics, certain types of painkillers(such as ibuprofen and similar anti-inflammatory medicines), and lithium;
• the use of certain vaccines (live vaccines) during treatment with Dimtelzo may cause infection, so they should be avoided. Your doctor will advise whether you can receive other types of vaccines (inactivated vaccines).

Dimtelzo and alcohol

You should avoid drinking high-percentage alcoholic beverages (more than 30% alcohol by volume, e.g., spirits) in excess of 50 ml within 1 hour of taking Dimtelzo, 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 are planning to have a baby, ask your doctor or pharmacist for advice.

Pregnancy

There is limited information on the use of this medicine in pregnant women. Dimtelzo should not be used during pregnancy unless your doctor considers it necessary.

Breastfeeding

It is not known whether the active substance of Dimtelzo passes into breast milk. Your doctor will advise whether you should stop breastfeeding or stop taking Dimtelzo. The decision will be based on the benefit of breastfeeding to your child and the benefit of treatment to you.

Driving and using machines

Dimtelzo is not expected to affect your ability to drive or use machines.

3. How to take Dimtelzo

Always take this medicine 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.

Dimtelzo should be taken orally.
Swallow each capsule wholewith water. Do not divide, crush, dissolve, suck, or chew the capsules, as this may increase the risk of certain side effects.
There is a desiccant in the bottles. Do not swallow the desiccant container.
Dimtelzo should be taken with food– this may help reduce the very common side effects (listed in section 4).

If you take more Dimtelzo than you should

If you have taken more capsules than you should, you must immediately tell your doctor. You may experience side effects similar to those described below in section 4.

If you forget to take Dimtelzo

Do not take a double doseto make up for a forgotten dose.
You can take a missed dose if you remember within 4 hours before the next dose is due. Otherwise, do not take the missed dose, but take the next dose at the usual time.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

Serious side effects

Dimtelzo may decrease 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 cause severe disability or death. PML has been reported after 1 to 5 years of treatment, so your doctor should 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 during treatment with dimethyl fumarate, you should contact your doctor as soon as possible. You should also discuss your treatment with your partner or caregivers and inform them about your treatment. You may not be aware of some symptoms.

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

Severe allergic reactions

The frequency of severe allergic reactions cannot be estimated from the available data (frequency not known).
A very common side effect is sudden (flushing) redness of the face or body. However, 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) may indicate a severe allergic reaction (anaphylaxis).

→ Stop taking Dimtelzo and contact your doctor immediately.

Other side effects

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

• redness of the skin of the face or body, feeling of warmth, heat, burning, or itching of the skin (flushing);
• loose stools (diarrhea);
• nausea (nausea);
• stomach pain or cramps

→ Taking Dimtelzo with foodwill help reduce the above side effects.
During treatment with Dimtelzo, ketone bodies (substances normally produced by the body) are very commonly found in the urine.
Talk to your doctorabout how to manage these side effects. Your doctor may reduce the dose of Dimtelzo. 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 lining of the intestine (gastroenteritis);
• vomiting
• indigestion
• inflammation of the stomach lining (gastritis);
• gastrointestinal disorders
• burning sensation of the skin
• hot flashes, feeling of warmth
• 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) in the blood. 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 contact your doctor immediately;
• protein (albumin) in the urine;
• increased liver enzyme activity (ALT, AST) in the blood

Uncommon(may affect up to 1 in 100 people)

• allergic reactions (hypersensitivity)
• decreased platelet count

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

• inflammation of the liver and increased liver enzyme activity (ALT or ASTtogether with bilirubin);
• shingles, with symptoms such as: blisters on the skin, burning, itching, or pain on the skin, 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 (13 years and older) 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, such as headache, stomach pain or cramps, vomiting, sore throat, cough, and painful menstruation.

Reporting of side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring 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 Dimtelzo

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton, blister, or bottle after EXP. The expiry date refers to the last day of that month.
Store in the original package to protect from light.
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 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 content: microcrystalline cellulose, povidone K30, crospovidone (type A), colloidal silicon dioxide, 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, ammonium hydroxide, concentrated, 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 with black printing „DMF 120”, containing white to off-white mini-tablets.
Dimtelzo, 240 mg gastro-resistant hard capsules.
Capsule size 00, length 23.2 mm, with a green, opaque cap and a green, opaque body with black printing „DMF 240”, containing white to off-white mini-tablets.
Dimtelzo, 120 mg gastro-resistant hard capsules.
Blisters or single-dose blisters, perforated, made of OPA/Aluminum/PVC/Aluminum foil in a cardboard box.
Pack sizes: 14 or 14 x 1 gastro-resistant hard capsules
Bottle (HDPE) with a PP/HDPE cap with a seal and a container with a desiccant (silica gel) in a cardboard box.
Pack size: 100 gastro-resistant hard capsules
Dimtelzo, 240 mg gastro-resistant hard capsules.
Blisters or single-dose blisters, perforated, made of OPA/Aluminum/PVC/Aluminum foil in a cardboard box.
Pack sizes: 56, 56 x 1, 168, 168 x 1, and 196 hard capsules.
Bottle (HDPE) with a PP/HDPE cap with a seal and a container with a desiccant (silica gel) in a cardboard box.
Pack size: 100 gastro-resistant hard capsules
Not all pack sizes may be marketed.

Marketing authorization holder and importer

Marketing authorization holder
Sandoz Polska Sp. z o.o.
ul. Domaniewska 50 C
02-672 Warsaw
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
To obtain more detailed information on this medicine, contact the local representative:

Poland

Sandoz Polska Sp. z o.o.
ul. Domaniewska 50 C
02-672 Warsaw
tel. 22 209 70 00

This medicinal product is authorized in the Member States of the European Economic Area 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
Date of last revision of the leaflet:06/2024
Logo of the marketing authorization holder