DIMETILFUMARATO 120 mg Enteric-Coated Hard Capsule

Зміст інструкції

1. Dimetilfumarato Abdi 120 mg hard gastro-resistant capsules, 240 mg hard gastro-resistant capsules
   1. What is Dimetilfumarato Abdi 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. Package contents and other information

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

Dimetilfumarato

Generic medicine

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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell 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 you take 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 is Dimetilfumarato Abdi and what it is used for

What is Dimetilfumarato Abdi
Dimetilfumarato Abdi is a medicine that contains the active ingredient dimethyl fumarate.

What is Dimetilfumarato Abdi used for
Dimetilfumarato Abdi is used to treat relapsing-remitting multiple sclerosis (RRMS)
in patients aged 13 years and older.
Multiple sclerosis is a chronic disease that affects the central nervous system (CNS), that is, the
brain and spinal cord. Relapsing-remitting multiple sclerosis is characterized by repeated attacks
(relapses) of symptoms that affect the nervous system. Symptoms vary from patient to
patient, but generally include difficulty walking, a feeling of imbalance and difficulty
with vision (e.g. blurred or double vision). These symptoms may disappear completely when
the relapse resolves, but some problems may remain.

How does Dimetilfumarato Abdi work
It appears that Dimetilfumarato Abdi works by preventing the body's defense system from damaging the
brain and spinal cord. This may also help to 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 fumarateor to any of the other ingredients of this medicine (listed in section 6).
• if you suspect you have a rare brain infection called progressive multifocal leukoencephalopathy (PML)or if the diagnosis of PML has been confirmed.

Warnings and precautions
Dimetilfumarato Abdi can affect the number of white blood cells in the blood, the kidneysand the liver.
Before you start taking Dimetilfumarato Abdi, your doctor will perform a blood test to
count your white blood cells and will check that your kidneys and liver are working
properly. Your doctor will perform the tests periodically during treatment. If the
number of your white blood cells decreases during treatment, your doctor may consider
further tests or discontinuation of therapy.

Talk to your doctorbefore taking Dimetilfumarato Abdi if you have:

• a serious illness of the kidneys
• a serious illness of the liver
• an illness of the stomachor intestine
• a serious infection(such as pneumonia)

With treatment with Dimetilfumarato Abdi, cases of herpes zoster infection
(shingles) can occur. In some cases, serious complications have occurred. Tell your doctor
immediatelyif you suspect you have any symptoms of shingles.
If you believe that 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 may be
symptoms of a rare brain infection called PML. PML is a serious condition that can
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 that you urinate more frequently, if you are
more thirsty and drink more than usual, if muscles are weaker, or in case of fracture or just pain,
contact your doctor as soon as possible so that further investigations can be undertaken.

Children and adolescents
Do not give this medicine to children under 10 years of age because data are not available in
this age group.

Other medicines and Dimetilfumarato Abdi
Tell your doctor or pharmacistif you are taking, have recently taken or might take
any other medicines, especially:

• medicines that contain fumaric acid esters(fumarates) used for the treatment of psoriasis
• medicines that affect the immune system, including chemotherapeutic agents, immunosuppressantsor other medicines used to treat MS;
• medicines that affect the kidneys, includingsome antibiotics(used to treat infections), diuretics, certain types of painkillers(such as ibuprofen and other similar anti-inflammatory drugs and over-the-counter medicines) and medicines that contain lithium;
• taking Dimetilfumarato Abdi with certain types of vaccines (live vaccines) could cause you to develop an infection and should therefore be avoided. Your doctor will tell you if other types of vaccines (non-live vaccines) should be administered.

Dimetilfumarato Abdiwith alcohol
Consumption of beverages with a high alcohol content (more than 30% alcohol by volume, e.g. spirits) greater
than a small amount (more than 50 mL) should be avoided within one hour of taking
Dimetilfumarato Abdi, because alcohol can interact with this medicine. This could cause
inflammation of the stomach (gastritis), particularly in people already prone to gastritis.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant, are planning to become pregnant or are breastfeeding,
ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
There is limited information on the effects of this medicine on the unborn child if used during
pregnancy. Do not use Dimetilfumarato Abdi if you are pregnant unless you have discussed
this with your doctor and this medicine is clearly necessary for you.
Breastfeeding
It is not known whether the active ingredient of Dimetilfumarato Abdi passes into breast milk. Your doctor will
advise you whether to stop breastfeeding or the treatment with Dimetilfumarato
Abdi. This involves assessing the benefit of breastfeeding for your baby versus the
benefit of therapy for you.

Driving and using machines
It is not expected that Dimetilfumarato Abdi will affect your ability to drive and operate
machinery.

Dimetilfumarato Abdicontains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per capsule, i.e. essentially ‘sodium-free’.

3. How to take Dimetilfumarato Abdi

Take this medicine following exactly the instructions of your doctor. If you have any doubts, consult your
doctor.

Initial dose: 120 mg twice a day.
Take this initial dose for the first 7 days, and then take the regular dose.

Regular dose: 240 mg twice a day.
Dimetilfumarato Abdi is for oral use.

Swallow each capsule wholewith a little water. You must not divide, crush, dissolve,
suck or chew the capsule, because this could increase some undesirable effects.
Take Dimetilfumarato Abdiwith food– this may help to reduce some more
common undesirable effects (listed in paragraph 4).

If you take more Dimetilfumarato Abdithan you should
If you have taken too many capsules, seek immediate medical advice. You may experience undesirable
effects similar to those described below in paragraph 4.

If you forget to take Dimetilfumarato Abdi
If you forget or miss a dose, do not take a double dose.
You can take the missed dose if at least 4 hours have passed between doses. Otherwise wait until the
next scheduled dose.
If you have any further questions on the use of this medicine, 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
Dimethyl fumarate Abdi can reduce the levels of lymphocytes (a type of white blood cell). Persistently low white blood cell levels can increase the risk of infections, including the risk of a rare brain infection called progressive multifocal leukoencephalopathy (PML). PML can cause
severe disability or death. PML has occurred after 1-5 years of treatment, so the doctor
must continue to monitor white blood cell counts throughout the duration of treatment. Pay attention to
carefully observe any potential symptom of PML, as described below. The risk of PML
may be higher if you have previously taken medicines that compromise the function of
the immune system.
The symptoms of PML can be similar to those of a relapse of multiple sclerosis. Symptoms
may include the onset or worsening of weakness on one side of the body;
clumsiness; changes in vision, thinking, or memory; or confusion or changes in
personality or difficulty with speech and communication lasting more than a few days.
Therefore, if you believe that your MS is worsening or if you notice any new symptoms during therapy
with Dimethyl fumarate Abdi, it is very important that you see your doctor as soon as possible. Also
inform your partner or caregiver about your treatment. Symptoms may occur that you
may not be aware of.

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

Serious allergic reactions
The frequency of serious allergic reactions cannot be defined based on available data (not
known).
Facial or body flushing is a very common side effect. However, if
flushing is accompanied by a red or urticaria rash andyou have
any of these symptoms:

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

this may represent a serious allergic reaction ( anaphylaxis).

• Stop taking Dimethyl fumarate Abdiand call a doctor immediately

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

• facial or body flushing, feeling of warmth, intense heat, burning or itching ( flushing)
• soft stools ( diarrhea)
• feeling unwell ( nausea)
• stomach pain or stomach cramps
• Taking the medicine with foodmay help reduce the above side effects

The presence of substances called ketones, which are produced naturally by the body, is commonly revealed
in urine tests during the intake of Dimethyl fumarate Abdi.

See your doctorfor information on how to manage 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 lining of the intestine ( gastroenteritis)
• feeling unwell ( vomiting)
• indigestion ( dyspepsia)
• inflammation of the stomach ( gastritis)
• gastrointestinal illness
• burning sensation
• hot flash, feeling of heat
• itching
• skin rash
• pink or red spots on the skin ( erythema)
• hair loss ( alopecia)

Side effects that may emerge from blood or urine tests

• low levels of white blood cells ( lymphocytopenia, leukopenia) in the blood. A decrease in the number of white blood cells in the blood may indicate that you are unable to fight an infection adequately. If you have a serious infection (such as pneumonia), see your doctor immediately
• protein ( albumin) in the urine
• increased levels of liver enzymes (alanine-aminotransferase, ALTand aspartate- aminotransferase, AST) in the blood

Uncommon(may affect up to 1 in 100 people)

• allergic reactions ( hypersensitivity)
• reduction of platelets in the blood

Not known(frequency cannot be estimated based on available data)

• inflammation of the liver and increased levels of liver enzymes ( ALT or AST incombination 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 the infection, followed by numbness, red or itchy spots with severe pain
• runny nose ( rhinorrhea)

Children (13 years of age and older) and adolescents
The side effects listed above also apply to children and adolescents.
Some side effects have been reported more frequently in children and adolescents
than in adults, for example headache, stomach pain or stomach cramps, feeling unwell
(vomiting), sore throat, cough and painful menstruation.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. You can also report side effects directly through 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 Dimetilfumarato Abdi

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 blister and the package after
“Exp”. The expiry date refers to the last day of that month.
Do not store at a temperature above 30°C.
Do not dispose of any medicine in waste water 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 ingredientis dimethyl fumarate.
Dimetilfumarato 120 mg: Each capsule contains 120 mg of dimethyl fumarate.
Dimetilfumarato 240 mg: Each capsule contains 240 mg of dimethyl fumarate.

Other ingredientsare: 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), yellow iron oxide (E172), black iron oxide (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 are minicompresses with enteric coating from white to almost white 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 closed length of 21.7 mm, imprinted with “120 mg” and are available in packs containing 14, 28 or 56 capsules.
Dimetilfumarato Abdi 240 mg gastro-resistant hard capsules are minicompresses with enteric coating from white to almost white 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 closed length of 21.7 mm, imprinted with “240 mg” and are available in packs containing 56, 168 or 196 capsules.
Not all pack sizes may be marketed.

Marketing Authorisation 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 Member States of the European Economic Area under the
following denominations:
Czech Republic: Dimethyl Fumarate Abdi
Germany: Dimethylfumarat Abdi
Italy: Dimetilfumarato Abdi
Netherlands: Dimethylfumaraat Abdi