Dimtelzo

Leaflet accompanying the packaging: patient information

Dimtelzo, 120 mg, gastro-resistant hard capsules

Dimtelzo, 240 mg, gastro-resistant hard capsules

Dimethyl fumarate

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed to a specific person. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Dimtelzo and what is it 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 packaging and other information

1. What is Dimtelzo and what is it used for

What is Dimtelzo

Dimtelzo is a medicine that contains dimethyl fumarateas the active substance.

What is Dimtelzo used for

Dimtelzo is used to treat relapsing-remitting multiple sclerosis (MS) in
patients aged 13 and over.
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 from person to person, but usually include difficulty walking, balance problems, and vision problems (such as blurred or double vision). These symptoms may completely disappear after the relapse is over, but some problems may persist.

How does Dimtelzo work

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. Important information before taking Dimtelzo

When not to take Dimtelzo

If the patient is allergic to dimethyl fumarateor any of the other ingredients of this medicine (listed in section 6).

If the patient is suspected or confirmed to have a rare brain infection called progressive multifocal leukoencephalopathy (PML)

Progressive multifocal leukoencephalopathy, PML.

Warnings and precautions

Dimtelzo may have a negative effect on white blood cell countand kidney and liver function. Before starting treatment with Dimtelzo, the doctor will check the patient's white blood cell count and ensure that 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 additional tests or discontinuation of treatment.
Before taking Dimtelzo, the patient should consult their doctorif they have:

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

During treatment with Dimtelzo, shingles may occur. In some cases, severe complications have occurred. If the patient suspects they have 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 disease that can 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 problems called Fanconi syndrome have been reported. If the patient notices that they are urinating more, feeling thirstier, and drinking more than usual, their muscles seem weaker, they have a bone fracture, or simply feel pain, they should see their doctor as soon as possible to investigate these symptoms.

Children and adolescents

This medicine should not be given to children under 10 years of age, as there is no data available for this age group.

Dimtelzo and other medicines

The patient should tell their doctor or pharmacistabout 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 that affect the immune system, including chemotherapy, immunosuppressantsor other medicines used to treat multiple sclerosis;
• medicines that affect the kidneys, including certain antibiotics(used to treat infections), diuretics, certain types of painkillers(such as ibuprofen and similar anti-inflammatory medicines) and lithium-containing medicines;
• the use of certain vaccines (live vaccines) during treatment with Dimtelzo may lead to infection, so this should be avoided. The doctor will advise whether other types of vaccines (inactivated vaccines) can be given.

Taking Dimtelzo with alcohol

The patient should avoid consuming high-percentage alcoholic beverages (over 30% alcohol by volume, e.g., spirits) in excess of 50 ml within an hour of taking Dimtelzo, due to the risk of interaction between alcohol and this medicine, which may lead to stomach inflammation (gastritis), especially in people prone to this disease.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist.

Pregnancy

There is limited data on the use of this medicine in pregnant women. Dimtelzo should not be taken during pregnancy unless the patient has discussed it with their doctor and the use of the medicine is necessary.

Breastfeeding

It is not known whether the active substance of Dimtelzo passes into breast milk. The doctor will advise the patient whether to stop breastfeeding or stop taking Dimtelzo. The decision will be based on the assessment of the benefits of breastfeeding for the baby compared to the benefits of treatment for the patient.

Driving and using machines

Dimtelzo is not expected to affect the patient's ability to drive or use machines.

3. How to take Dimtelzo

This medicine should always be taken exactly as prescribed by the doctor. If the patient has any doubts, they should consult their 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.
Each capsule should be swallowed whole, with a glass of water. The capsules should not be divided, crushed, dissolved, sucked, or chewed, as this may increase certain side effects.
The bottles contain a desiccant. The desiccant container should not be swallowed.
Dimtelzo should be taken with food– this may help alleviate the very common side effects (listed in section 4).

Taking a higher dose of Dimtelzo than recommended

If the patient takes more capsules than recommended, they should immediately tell their doctor. Side effects similar to those described below in section 4 may occur.

Missing a dose of Dimtelzo

The patient should not take a double doseto make up for a missed dose.
A missed dose can be taken if there is a 4-hour interval before the next dose. Otherwise, the missed dose should not be taken, and the next dose should be taken at the usual time.
If the patient has any further doubts about taking this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

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

Severe 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 lead to severe disability or death. PML has been reported after 1 to 5 years of treatment, so 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. They include weakness or increased weakness on one side of the body, coordination problems, vision problems, speech or thinking problems, confusion (disorientation) or personality changes, speech problems, and communication difficulties lasting more than a few days. Therefore, if the patient experiences a worsening of multiple sclerosis symptoms or new symptoms during treatment with dimethyl fumarate, they should contact their doctor as soon as possible. They should also discuss their treatment with their partner or caregivers and inform them about their treatment. The patient may not be aware of the symptoms.

If the patient experiences any of the following symptoms, they should immediately contact their doctor

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 (paroxysmal) flushing of the face or body. However, if the 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).

→ The patient should stop taking Dimtelzo and immediately contact their doctor.

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

• flushing of the face or feeling of increased body temperature, heat, burning sensation of the skin, or itching of the skin ( paroxysmal flushing)
• diarrhea ( diarrhea)
• nausea ( nausea)
• stomach pain or cramps

→ Taking the medicine with foodwill help alleviate the above side effects.
During treatment with Dimtelzo, ketone bodies (substances normally produced in the body) are very commonly found in the urine.
The patient should discuss with their doctorhow to manage these side effects. The doctor may reduce the dose of the medicine. The patient should not reduce the dose themselves unless their doctor advises them 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 problems
• burning sensation of the skin
• hot flashes, feeling of heat
• itching of the skin ( pruritus)
• rash
• pink or red spots on the skin ( erythema)
• hair loss ( alopecia)

Side effects that may cause abnormal blood or urine test results

• low white blood cell count ( lymphopenia, leukopenia) in the blood. A low white blood cell count may indicate that the body is less able to fight infection. In case of severe infection (e.g., pneumonia), the patient should immediately contact their doctor;
• 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 sensation, itching, or pain of 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
• runny nose ( 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, such as headache, stomach pain or cramps, vomiting, sore throat, cough, and painful menstruation.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their 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.
Reporting side effects will help gather more information on the safety of this medicine.

5. How to store Dimtelzo

The medicine should be stored 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 month.
Store in the original packaging to protect from light.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Dimtelzo contains

The active substance of Dimtelzo 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, 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.
The capsule is size 0, 21.4 mm long, 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.
The capsule is size 00, 23.2 mm long, 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 with HDPE with 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 with HDPE with 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 about this medicine, the patient should contact their 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