Dimethyl fumarate Abdi

Patient Information Leaflet: Information for the User

Dimetilfumarato Abdi 120 mg gastro-resistant hard capsules, 240 mg gastro-resistant hard capsules

Dimethyl fumarate
Equivalent medicine
Please read this leaflet carefully before taking this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Dimetilfumarato Abdi is and what it is used for

What Dimetilfumarato Abdi is
Dimetilfumarato Abdi is a medicine that contains the active substance dimethyl fumarate.
What Dimetilfumarato Abdi is used for
Dimetilfumarato Abdi is used to treat relapsing-remitting multiple sclerosis (MS)
in patients aged 13 years and older.
Multiple sclerosis is a chronic disease affecting the central nervous system (CNS), that is, the brain and spinal cord. Relapsing-remitting multiple sclerosis is characterized by repeated attacks (relapses) of symptoms affecting the nervous system. Symptoms vary from patient to patient, but generally include difficulty walking, feelings of imbalance, and vision problems (e.g. blurred or double vision). These symptoms may completely disappear when a relapse resolves, but some problems may persist.
How Dimetilfumarato Abdi works
Dimetilfumarato Abdi appears to work by preventing the body's immune system from damaging the brain and spinal cord. This may also help delay future worsening of the disease.

2. What you need to know before taking Dimetilfumarato Abdi

Do not take Dimetilfumarato Abdi

• if you are allergic to dimethyl fumarate or to any of the other ingredients of this medicine (listed in section 6).
• if you are suspected to have a rare brain infection called progressive multifocal leukoencephalopathy (PML) or if PML has been confirmed.

Warnings and precautions
Dimetilfumarato Abdi may affect the number of white blood cells in your blood, your kidneys, and your liver.
Before starting Dimetilfumarato Abdi, your doctor will perform a blood test to check your white blood cell count and to ensure that your kidneys and liver are functioning properly. Your doctor will carry out regular tests during treatment. If your white blood cell count decreases during treatment, your doctor may consider further investigations or discontinuation of therapy.
Contact your doctor before taking Dimetilfumarato Abdi if you have:

• a severe kidney disease
• a severe liver disease
• a stomach or intestinal disorder
• a serious infection (such as pneumonia)

Cases of herpes zoster infection (shingles) may occur during treatment with Dimetilfumarato Abdi. In some cases, serious complications have occurred. Inform your doctor immediately if you suspect you have any symptoms of shingles.
If you think your MS is worsening (for example, if you experience weakness or changes in vision) or if you notice new symptoms, contact your doctor immediately, as these could be symptoms of a rare brain infection called PML. PML is a serious condition that may lead to severe disability or death.
With a medicine containing dimethyl fumarate in combination with other fumaric acid esters, used for the treatment of psoriasis (a skin disease), a rare but serious kidney disorder called Fanconi syndrome has been observed. If you notice increased urination, increased thirst and drinking more than usual, muscle weakness, or experience fractures or even pain, contact your doctor as soon as possible so that appropriate investigations can be carried out.
Children and adolescents
Do not give this medicine to children under 10 years of age, as there is no data available for this age group.
Other medicines and Dimetilfumarato Abdi
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, especially:

• medicines containing fumaric acid esters (fumarates) used to treat psoriasis
• medicines that affect the immune system, including chemotherapeutic agents, immunosuppressants, or other medicines used to treat MS
• medicines that affect the kidneys, including certain antibiotics (used to treat infections), diuretics, some types of analgesics (such as ibuprofen and other similar anti-inflammatory medicines and over-the-counter medicines), and medicines containing lithium
• taking Dimetilfumarato Abdi together with certain types of vaccines ( live vaccines ) could cause you to develop an infection and should therefore be avoided. Your doctor will advise you whether other types of vaccines (non-live vaccines) should be administered.

Dimetilfumarato Abdi and alcohol
Consumption of alcoholic beverages with high alcohol content (more than 30% alcohol by volume, e.g. spirits) in amounts larger than a small quantity (more than 50 mL) should be avoided within one hour of taking Dimetilfumarato Abdi, as alcohol may interact with this medicine. This could cause stomach inflammation ( gastritis ), particularly in people who are already prone to gastritis.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
There is limited information on the effects of this medicine on the unborn child when used during pregnancy. Do not use Dimetilfumarato Abdi during pregnancy unless you have discussed this with your doctor and the medicine is clearly needed.
Breastfeeding
It is not known whether the active substance of Dimetilfumarato Abdi passes into breast milk. Your doctor will advise you whether you should stop breastfeeding or stop treatment with Dimetilfumarato Abdi. This decision will be based on weighing the benefit of breastfeeding for your child against the benefit of therapy for you.
Driving and using machines
Dimetilfumarato Abdi is not expected to affect your ability to drive or use machinery.
Dimetilfumarato Abdi contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per capsule, i.e. essentially 'sodium-free'.

3. How to take Dimethylfumarate Abdi

Take this medicine exactly as your doctor has told you. If you have any doubts, consult your doctor.
Starting dose: 120 mg twice daily.
Take this starting dose for the first 7 days, then switch to the regular dose.
Regular dose: 240 mg twice daily.
Dimethylfumarate Abdi is for oral use.
Swallow each capsule whole with some water. Do not split, crush, dissolve, suck or chew the capsule, as this may increase certain side effects.
Take Dimethylfumarate Abdi with food – this may help reduce some of the more common side effects (listed in section 4).
If you take more Dimethylfumarate Abdi than you should
If you have taken too many capsules, contact your doctor immediately. You may experience side effects similar to those described below in section 4.
If you forget to take Dimethylfumarate Abdi
If you forget or miss a dose, do not take a double dose.
You may take the missed dose if at least 4 hours remain between doses. Otherwise, wait until your next scheduled dose.
If you have any doubts about how to use this medicine, consult 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

Dimethyl fumarate Abdi may reduce levels of lymphocytes (a type of white blood cell). Persistently low levels of white blood cells may increase the risk of infections, including the risk of a rare brain infection called progressive multifocal leukoencephalopathy (PML). PML can lead to severe disability or death. PML has occurred after 1 to 5 years of treatment; therefore, your doctor must continue to monitor your white blood cell counts throughout the duration of treatment. Pay close attention to any potential symptoms of PML, as described below. The risk of PML may be higher if you have previously taken medicines that impair the function of the immune system.

Symptoms of PML may resemble those of a multiple sclerosis relapse. Symptoms may include the onset or worsening of weakness on one side of the body; clumsiness; changes in vision, thinking, or memory; confusion or personality changes; or difficulty with language and communication lasting longer than a few days.

Therefore, if you feel your MS is worsening or if you notice any new symptoms during treatment with Dimethyl fumarate Abdi, it is very important to contact your doctor as soon as possible. Also inform your partner or caregiver about your treatment, as symptoms may arise that you might not notice yourself.

• If you experience any of these symptoms, call your doctor immediately

Severe allergic reactions
The frequency of severe allergic reactions cannot be determined from the available data (not known).

Flushing (reddening of the face or body) is a very common side effect. However, if flushing is accompanied by a red skin rash or hives and you have any of the following symptoms:

• swelling of the face, lips, mouth, or tongue (angioedema)
• shortness of breath, difficulty breathing, or breathlessness (dyspnea, hypoxia)
• dizziness or loss of consciousness (hypotension)

this may indicate a severe allergic reaction (anaphylaxis).

• Stop taking Dimethyl fumarate Abdi and call a doctor immediately

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

• flushing (reddening of the face or body, sensation of warmth, intense heat, burning, or itching)
• loose stools (diarrhea)
• feeling unwell (nausea)
• stomach ache or stomach cramps

Taking the medicine with food may help reduce the above-mentioned side effects.

The presence of substances called ketones, which are naturally produced by the body, is very commonly detected in urine tests during treatment with Dimethyl fumarate Abdi.
Contact your doctor for advice on managing these side effects. Your doctor may reduce your dose. Do not reduce the dose unless your doctor tells you to do so.

Common (may affect up to 1 in 10 people)

• inflammation of the intestinal lining (gastroenteritis)
• feeling unwell (vomiting)
• indigestion (dyspepsia)
• inflammation of the stomach (gastritis)
• gastrointestinal disorder
• burning sensation
• hot flush, feeling of warmth
• itching
• skin rash
• pink or red spots on the skin (erythema)
• hair loss (alopecia)

Side effects that may be detected in blood or urine tests:

• low levels of white blood cells (lymphopenia, leukopenia) in the blood. A reduced number of white blood cells may mean you are less able to fight infections adequately. If you develop a serious infection (such as pneumonia), contact your doctor immediately.
• protein (albumin) in the urine
• increased levels of liver enzymes (alanine aminotransferase, ALT, and aspartate aminotransferase, AST) in the blood

Uncommon (may affect up to 1 in 100 people)

• allergic reactions (hypersensitivity)
• reduced platelet count in the blood

Not known (frequency cannot be determined from the available data)

• inflammation of the liver and increased liver enzyme levels (ALT or AST in combination with bilirubin)
• herpes zoster infection (shingles) with symptoms such as blisters, burning, itching, or skin pain, usually on one side of the torso or face, and other symptoms such as fever and weakness in the early stages of infection, followed by numbness, red or itchy spots with severe pain
• runny nose (rhinorrhea)

Children (aged 13 years and older) and adolescents
The above-mentioned 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 ache or stomach cramps, feeling unwell (vomiting), sore throat, cough, and painful menstruation.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. You may also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Dimethylfumarate Abdi

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and the carton after "Exp". The expiry date refers to the last day of that month.
Do not store above 30°C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Dimetilfumarato Abdi contains
The active substance is dimethyl fumarate.
Dimethyl fumarate 120 mg: Each capsule contains 120 mg of dimethyl fumarate.
Dimethyl fumarate 240 mg: Each capsule contains 240 mg of dimethyl fumarate.
The other components are: microcrystalline cellulose, sodium croscarmellose, talc, silicified microcrystalline cellulose, colloidal silicon dioxide, magnesium stearate, triethyl citrate, methacrylic acid – methyl methacrylate copolymer (1:1), methacrylic acid – ethyl acrylate copolymer (1:1) 30% dispersion, sodium lauryl sulfate, polysorbate 80, gelatin (bovine gelatin), titanium dioxide (E171), brilliant blue FCF (E133), iron oxide yellow (E172), iron oxide black (E172), shellac (E904), propylene glycol (E1520), ammonium hydroxide 28% (E527).

Description of the appearance of Dimetilfumarato Abdi and package contents
Dimetilfumarato Abdi 120 mg gastro-resistant hard capsules contain enteric-coated white to almost white mini-tablets in a hard gelatin capsule with an opaque white body and an opaque light green cap, with an external diameter of approximately 7.6 mm and a total length of 21.7 mm when closed, printed with “120 mg”, and available in packages containing 14, 28 or 56 capsules.
Dimetilfumarato Abdi 240 mg gastro-resistant hard capsules contain enteric-coated white to almost white mini-tablets in a hard gelatin capsule with an opaque light green body and an opaque light green cap, with an external diameter of approximately 7.6 mm and a total length of 21.7 mm when closed, printed with “240 mg”, and available in packages containing 56, 168 or 196 capsules.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Abdi Farma GmbH
Donnersbergstraße 4
64646 Heppenheim, Germany

Manufacturer
Flavine Pharma France
3 Voie D'Allemagne,
13127 Vitrolles, France
Interpharma Services Ltd.
Bul Cherni Vrah 43 A
1407 Sofia
Bulgaria

This medicinal product is authorised in the European Economic Area countries under the following names:
Czech Republic: Dimethyl Fumarate Abdi
Germany: Dimethylfumarat Abdi
Italy: Dimetilfumarato Abdi
Netherlands: Dimethylfumaraat Abdi