Iaxteran

Package Leaflet: Information for the Patient

JAXTERAN 120 mg gastro-resistant hard capsules

JAXTERAN 240 mg gastro-resistant hard capsules

Dimethyl fumarate

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

• You should keep this leaflet, so you can read it again later.
• 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 those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the package leaflet

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

1. What the medicine is and what it is used for

What the medicine is

It is a medicine containing the active substance dimethyl fumarate.

What the medicine is used for

The medicine 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 problems with walking and balance, and vision disturbances (such as blurred or double vision). These symptoms can completely disappear after a relapse, but some problems may persist.

How the medicine works

The medicine seems to prevent 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 the medicine

When not to take the medicine

• -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).

Warnings and precautions

The medicine may have a negative effect on white blood cell countand kidneyand liverfunction. Before starting treatment with the medicine, your doctor will check your white blood cell count and ensure that your kidneys and liver are working properly. These tests will be performed periodically during treatment. If your white blood cell count decreases during treatment, your doctor may consider additional tests or discontinuation of treatment.
Before taking the medicine, you should tell your doctorif you have:

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

During treatment with the medicine, shingles may occur. In some cases, severe complications have occurred. If you suspect any symptoms of shingles you should immediately inform your doctor.
If your multiple sclerosis worsens (e.g., you experience weakness or vision disturbances) or new symptoms appear, 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 lead to 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 previously taken medicines that affect the immune system.
During treatment with a medicine containing dimethyl fumarate in combination with other fumaric acid esters used to treat psoriasis (a skin disease), rare but severe kidney damage called Fanconi syndrome has been reported. If you notice that you are urinating more, feeling thirstier, and drinking more than usual, your muscles seem weaker, you have a bone fracture, or you simply feel pain, you should see your doctor as soon as possible to investigate these symptoms.

Children and adolescents

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

Medicine interactions

You should tell your doctor or pharmacistabout all medicines you are taking or have recently taken, as well as 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 the kidneys, including some antibiotics(used to treat infections), diuretics, certain painkillers(such as ibuprofen and similar anti-inflammatory medicines and over-the-counter medicines), and medicines containing lithium;
• taking certain vaccines (live vaccines) during treatment with the medicine

may increase the risk of infection, so it should be avoided. Your doctor will advise whether to administer vaccines of a different type (inactivated vaccines).

Taking the medicine with alcohol

You 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 the medicine, due to the risk of interaction between alcohol and this medicine, which may lead to stomach upset (gastritis), especially in people prone to this disease.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult your doctor or pharmacist before taking this medicine.
Pregnancy
There is limited data on the use of this medicine in pregnant women. The medicine 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 the medicine passes into breast milk. Your doctor will advise whether you should stop breastfeeding or stop taking the medicine. The decision will be made based on the assessment of the benefits of breastfeeding for the child compared to the benefits of treatment for you.

Driving and using machines

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

3. How to take the medicine

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 recommended dose should be taken.

Recommended dose:

240 mg twice a day.

The medicine 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.
The medicine should be taken with food– this will help alleviate very common side effects (listed in section 4).

Taking a higher dose of the medicine than recommended

In case of taking a higher number of capsules than recommended you should immediately tell your doctor. Side effects similar to those described below in section 4 may occur.

Missing a dose of the medicine

In case of missing a dose you should not take a double 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, you should not take the missed dose, but take the next dose at the usual time.
In case of any further doubts about taking this medicine, you should ask your doctor or pharmacist.

4. Possible side effects

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

Serious side effects

The medicine 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 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 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 disturbances, problems with thinking or memory, confusion (disorientation) or personality changes, speech disturbances, and communication problems lasting longer than a few days. Therefore, if you experience a worsening of multiple sclerosis symptoms or new symptoms while taking the medicine, 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. There may be symptoms that you are not aware of.

If you experience any of the above symptoms, you should immediately contact your 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 skin of the face or body. If the flushing of the skin 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, hypoxia);
• dizziness or loss of consciousness (hypotension), may indicate a severe allergic reaction (anaphylaxis).

You should stop taking the medicine and immediately contact your doctor.

Other side effects

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

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

Taking the medicine with food will help alleviate the above side effects.

During treatment with dimethyl fumarate, an increase in ketone body production (substances normally produced in the body) is very commonly found in urine tests.
You should ask your doctor how to deal with side effects. Your doctor may reduce the dose of the medicine. You should not reduce the dose of the medicine yourself unless your doctor advises you to do so.
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 disorders;
• burning sensation of the skin;
• hot flashes, feeling hot;
• 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 the body is less able to fight infection. In case of a severe infection (e.g., pneumonia), you should immediately contact your doctor;
• protein (albumin) in the urine;
• increased liver enzyme levels (ALT, AST) in the blood. Uncommon(may affect up to 1 in 100 people)
• allergic reactions (hypersensitivity);
• decreased platelet count.

Rare(may affect up to 1 in 1,000 people, but not more)

• liver inflammation and increased liver enzyme activity (ALT or AST together with bilirubin);

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

• shingles, with symptoms such as: blisters on the skin, burning, 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, and then 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, e.g., headache, abdominal pain or stomach cramps, vomiting, sore throat, cough, and painful menstruation.

Reporting side effects

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

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the blister, bottle label, and carton after: "EXP". The expiry date refers to the last day of the month.
There are no special storage instructions for the medicine.
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. This will help protect the environment.

6. Contents of the package and other information

What the medicine contains

The active substance of the medicine is dimethyl fumarate.
120 mg, gastro-resistant hard capsules
Each gastro-resistant hard capsule contains 120 mg of dimethyl fumarate.
240 mg, gastro-resistant hard capsules
Each gastro-resistant hard capsule contains 240 mg of dimethyl fumarate.
The other ingredients are:

• Capsule: microcrystalline cellulose, crospovidone, talc, povidone, colloidal anhydrous silica, magnesium stearate, triethyl citrate, methacrylic acid, and ethyl acrylate copolymer (1:1), titanium dioxide (E 171), triacetin.
• Coating: gelatin, titanium dioxide (E 171), brilliant blue FCF (E 133), yellow iron oxide (E 172)
• Ink: shellac, potassium hydroxide, propylene glycol (E 1520), black iron oxide (E 172), concentrated ammonia solution.

What the medicine looks like and contents of the package

120 mg gastro-resistant hard capsules: Green cap and white body, capsule shell with a diameter of 21.4 mm, with black ink printing "DMF 120" on the body containing white to off-white mini-tablets.
240 mg gastro-resistant hard capsules: Green cap and body, capsule shell with a diameter of 23.2 mm, with black ink printing "DMF 240" on the body containing white to off-white mini-tablets.
HDPE bottle with PP/HDPE cap and a desiccant in the form of silica gel.
Do not swallow the desiccant.
OPA/Aluminum/PVC//Aluminum blisters or single-dose OPA/Aluminum/PVC//Aluminum blisters.
120 mg, gastro-resistant hard capsules
Package sizes:
14 gastro-resistant hard capsules (blister)
14 x 1 gastro-resistant hard capsule (perforated single-dose blisters)
100 gastro-resistant hard capsules (bottle)
240 mg, gastro-resistant hard capsules
Package sizes:
56 gastro-resistant hard capsules (blister)
56 x 1 gastro-resistant hard capsule (perforated single-dose blisters)
168 gastro-resistant hard capsules (blister)
168 x 1 gastro-resistant hard capsule (perforated single-dose blisters)
100 gastro-resistant hard capsules (bottle)
Not all package sizes may be marketed.

Marketing authorization holder

Zentiva k.s.
U kabelovny 130
Dolní Měcholupy
102 37 Prague 10
Czech Republic

Importer

Pharmadox Healthcare Ltd.
KW20A Kordin Industrial Park
Paola PLA 3000, Malta
Adalvo Limited
Malta Life Sciences Park
Building 1, Level 4, Sir Temi Zammit Buildings
San Gwann, SGN 3000, Malta
KeVaRo GROUP Ltd
9 Tzaritza Elenora Str. Office 23
Sofia 1618 Bulgaria

This medicine is authorized in the Member States of the European Economic Area under the following names:

Bulgaria: Джакстеран
Croatia, Iceland, Poland, Czech Republic, Romania, Slovakia, Hungary:
In order to obtain more detailed information on this medicine, you should contact the local representative of the marketing authorization holder:
Zentiva Polska Sp. z o.o.
Bonifraterska 17 Street
00-203 Warsaw
tel: + 48 22 375 92 00
{logo of the marketing authorization holder}
Date of last revision of the leaflet:February 2025