Patient Information Leaflet

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

Keep this leaflet as you may need to read it again.
If you have any further questions, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm other people, even if their symptoms are the same.
If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Leaflet Contents

What JAXTERAN is and what it is used for
What you need to know before you take JAXTERAN
How to take JAXTERAN
Possible side effects
How to store JAXTERAN
Contents of the pack and other information

1. What JAXTERAN is and what it is used for

What JAXTERAN is
JAXTERAN is a medicine containing the active substance dimethyl fumarate.
What JAXTERAN is used for
JAXTERAN 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 walking and balance difficulties, and vision problems (e.g. blurred or double vision). These symptoms may completely resolve after a relapse, but some issues may persist.
How JAXTERAN works
JAXTERAN appears to suppress the immune system from causing damage to the brain and spinal cord, which may help slow the future progression of the disease.

2. Information before using the medicine

When not to take the medicine

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
The medicine may adversely affect the number of white blood cells and the function of the kidneys and liver. Before starting treatment with this medicine, 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 interrupting treatment.
Before starting to take this medicine, consult a doctor if the patient has:

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

Shingles (herpes zoster) may occur during treatment with this medicine. In some cases, severe complications have occurred. If there is suspicion of shingles in the patient, the doctor should be informed immediately.
If multiple sclerosis worsens (e.g. the patient experiences 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.
Rare but serious kidney problems called Fanconi syndrome have been reported when dimethyl fumarate-containing medicines are used in combination with other fumaric acid esters used in the treatment of psoriasis (a skin disease). If the patient notices that they are urinating more than usual, feel increased thirst and drink more than normal, their muscles seem weaker, a bone fracture occurs, or they simply feel pain, they should see a 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.
Medicines and other medicines
Tell your 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 in the treatment of psoriasis;
medicines affecting the immune system, including chemotherapeutic agents, immunosuppressive medicines, or other medicines used in the treatment of multiple sclerosis;
medicines affecting the kidneys, including certain antibiotics (used to treat infections), diuretics, certain types of painkillers (such as ibuprofen and similar anti-inflammatory medicines, including over-the-counter medicines), and medicines containing lithium;
the use of certain vaccines (live vaccines) during treatment with this medicine may lead to the development of an infection and should therefore be avoided. The doctor will advise whether inactivated vaccines should be administered instead.
Use of the medicine with alcohol
Avoid consuming high-strength alcoholic beverages (over 30% alcohol by volume, e.g. spirits) in amounts exceeding 50 mL within one hour of taking the medicine, due to the risk of interaction between alcohol and this medicine, which may lead to gastric irritation (inflammation of the gastric mucosa), especially in individuals susceptible to this condition.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor or pharmacist before using this medicine.
Pregnancy
There is limited information on the effects of this medicine on the unborn child when used during pregnancy. The medicine should not be used during pregnancy unless discussed with the doctor and deemed necessary.
Breastfeeding
It is not known whether the active substance of the medicine passes into breast milk. The doctor will advise the patient whether she should discontinue breastfeeding or the medicine. 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 using machines
No effect of the medicine on the ability to drive or operate machinery is expected.

3. How to use the medicine

This medicine should always be taken according to the doctor's instructions. If in doubt, consult
your doctor.
Initial dose:
120 mg twice daily.
This initial dose should be taken for the first 7 days, after which the medicine should be used at
the recommended dose.
Usual dose:
240 mg twice daily.
The medicine 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 medicine should be taken with food – this will help reduce the very common adverse
reactions (listed in section 4).
Taking more medicine than recommended
If more capsules than recommended have been taken, inform your doctor immediately.
Adverse effects similar to those described below in section 4 may occur.
Missing a dose
If a dose is missed, do not take a double dose.
The missed dose may be taken later, provided that there is at least a 4-hour interval before the
next dose. If it is too late to take the missed dose, do not take it, but 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 effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Serious adverse effects
The medicine may reduce the number of lymphocytes (a type of white blood cell). 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 observed between 1 and 5 years after starting treatment, therefore the physician should monitor the patient's white blood cell levels throughout the duration of treatment, and the patient should be vigilant for the symptoms described below, which may indicate PML. The risk of developing PML may be higher if the patient has previously taken medicines that impair immune system function.
Symptoms of PML may resemble a relapse of multiple sclerosis. These include new or worsening weakness on one side of the body, loss of coordination, vision problems, cognitive or memory problems, confusion (disorientation), personality changes, speech difficulties, and communication problems lasting longer than a few days. For this reason, if the patient notices worsening of symptoms related to multiple sclerosis or the appearance of any new symptoms during treatment, they should contact their doctor as soon as possible. The patient should also talk to their partner or caregivers and inform them about their treatment. Symptoms may occur that the patient may not be aware of.
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 effect is sudden (episodic) redness of the face or body. If episodic skin redness is accompanied by a red rash or hives and any of the following symptoms:

swelling of the face, lips, mouth, or tongue (angioedema);
wheezing, breathing difficulties, or shortness of breath (dyspnea, hypoxia);
dizziness or loss of consciousness (hypotension), this may indicate a severe allergic reaction (anaphylaxis). The medicine must be discontinued and medical advice sought immediately.

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

redness of the face or sensation of increased body temperature, hot flushes, skin burning, or itching (episodic skin redness)
loose stools (diarrhea)
nausea
stomach pain or cramps Taking the medicine with food may help reduce the adverse effects listed above.

During treatment with dimethyl fumarate, increased production of ketone bodies (substances normally produced in the body) is very commonly observed in urine tests. Ask your doctor how to manage adverse effects. The doctor may reduce the dose of the medicine. Do not reduce the dose yourself unless instructed by your doctor.
Common (may affect up to 1 in 10 people)

inflammation of the intestinal mucosa (gastroenteritis);
vomiting;
indigestion;
inflammation of the gastric mucosa (gastritis);
gastrointestinal disorders;
skin burning;
hot flushes, sensation of heat;
skin itching (pruritus);
rash;
pink or red skin patches (erythema);
hair loss (alopecia).

Adverse effects that may cause abnormal blood or urine test results

low levels of white blood cells (lymphopenia, leukopenia). A reduced number of white blood cells may mean the body is less able to fight infections. In case of severe infection (e.g. pneumonia), contact a doctor immediately;
protein (albumin) in the urine;
increased levels of liver enzymes (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 frequently)

hepatitis and increased activity of liver enzymes (ALT or AST together with bilirubin);

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

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 fatigue in the early stages of infection, followed by numbness, itching, red patches, and severe pain;
cold (nasopharyngitis).

Children (aged 13 years and above) and adolescents
The adverse effects listed above also apply to children and adolescents.
Some adverse effects were 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 adverse effects
If any adverse effects occur, including any symptoms not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring of Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49-21-301
Fax: +48 22 49-21-309
Website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store the medicine

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister, label of the bottle, and cardboard box after: "EXP". The expiry date refers to the last day of the stated month.
No special storage temperature requirements.
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 in use. Such measures help protect the environment.

6. Contents of the pack and other information

What the medicine contains
The active substance is dimethyl fumarate.
120 mg, hard enteric capsules
Each hard enteric capsule contains 120 mg of dimethyl fumarate.
240 mg, hard enteric capsules
Each hard enteric capsule contains 240 mg of dimethyl fumarate.
Other ingredients are:

Capsule shell: microcrystalline cellulose, crospovidone, talc, povidone, colloidal anhydrous silica, magnesium stearate, triethyl citrate, copolymer of methacrylic acid and ethyl acrylate (1:1), titanium dioxide (E 171), triacetin.
Capsule 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 ammonium hydroxide.

What the medicine looks like and contents of the pack
120 mg hard enteric capsules: green cap and white body, capsule shell with a diameter of 21.4 mm, printed in black ink "DMF 120" on the body, containing off-white to white minitablets.
240 mg hard enteric capsules: green cap and green body, capsule shell with a diameter of 23.2 mm, printed in black ink "DMF 240" on the body, containing off-white to white minitablets.
HDPE bottle with PP/HDPE screw cap with seal and desiccant in the form of silica gel.
Do not swallow the desiccant.
Blisters OPA/Aluminium/PVC//Aluminium or single-dose blisters OPA/Aluminium/PVC//Aluminium.
120 mg, hard enteric capsules
Pack sizes:
14 enteric capsules (blisters)
14 x 1 enteric capsule (perforated single-dose blisters)
100 enteric capsules (bottle)
240 mg, hard enteric capsules
Pack sizes:
56 enteric capsules (blisters)
56 x 1 enteric capsule (perforated single-dose blisters)
168 enteric capsules (blisters)
168 x 1 enteric capsule (perforated single-dose blisters)
100 enteric capsules (bottle)
Not all pack sizes may be marketed.

Marketing Authorisation 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 authorised in the European Economic Area countries under the following names:
Bulgaria: JAXTERAN
Croatia, Iceland, Poland, Czech Republic, Romania, Slovakia, Hungary:
For further information on this medicine, contact the local representative of the Marketing Authorisation Holder:
Zentiva Polska Sp. z o.o.
ul. Bonifraterska 17
00-203 Warsaw
tel: +48 22 375 92 00
{logo of the Marketing Authorisation Holder}