DIMETILFUMARATO 120 mg Enteric-Coated Hard Capsule

Содержание инструкции

1. Dimetilfumarato EG STADA ITALIA 120 mg hard gastro-resistant capsules, 240 mg hard gastro-resistant capsules
   1. What is Dimetilfumarato EG STADA ITALIA and what it is used for
   2. What you need to know before taking Dimetilfumarato EG STADA ITALIA
   3. How to take Dimetilfumarato EG STADA ITALIA
   4. Possible side effects
   5. How to store Dimetilfumarato EG STADA ITALIA
   6. Package contents and other information

Dimetilfumarato EG STADA ITALIA 120 mg hard gastro-resistant capsules, 240 mg hard gastro-resistant capsules

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

1. What is Dimetilfumarato EG STADA ITALIA and what it is used for

What is Dimetilfumarato EG STADA ITALIA
Dimetilfumarato EG STADA ITALIA is a medicine that contains the active ingredient dimetilfumarate.
What is Dimetilfumarato EG STADA ITALIA used for
Dimetilfumarato EG STADA ITALIA is used to treat relapsing-remitting multiple sclerosis (MS) 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 affecting the nervous system. Symptoms vary from patient to patient, but typically
include difficulty walking, a feeling of imbalance and vision problems (e.g. blurred or
double vision). These symptoms may disappear completely when the relapse resolves, but some problems
may remain.

How Dimetilfumarato EG STADA ITALIA works
It appears that Dimetilfumarato EG STADA ITALIA works by preventing the body's defense system from
damaging the brain and spinal cord. This may also help to delay future worsening
of MS.

2. What you need to know before taking Dimetilfumarato EG STADA ITALIA

Do not take Dimetilfumarato EG STADA ITALIA

• 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 EG STADA ITALIA can affect the number of white blood cellsin your blood, your kidneysand your

liver. Before you start taking Dimetilfumarato EG STADA ITALIA, your doctor will perform a
blood test to count your white blood cells and will check that your kidneys and liver
are functioning 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 stopping therapy.

Talk to your doctorbefore taking Dimetilfumarato EG STADA ITALIA if you have:

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

Cases of herpes zoster infection (shingles) can occur with treatment with Dimetilfumarato EG STADA ITALIA. In some cases, serious complications have occurred. Tell your doctor
immediately if you suspect you have any symptoms of herpes zoster infection.
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, your muscles are weaker, or in case of fracture or just pain, contact your doctor as soon as
possible so that further investigations can be carried out.

Children and adolescents
Do not give this medicine to children under 10 years of age because there is no data available in this
age group.

Other medicines and Dimetilfumarato EG STADA ITALIA
Tell your doctor or pharmacistif you are taking, have recently taken or might take any
other medicines, in particular:

• 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 for the treatment of MS;
• medicines that affect the kidneys, including some antibiotics(used to treat infections), diuretics, certain types of pain relievers(such as ibuprofen and other similar anti-inflammatory drugs and over-the-counter medicines) and medicines that contain lithium;
• taking this medicine with certain types of vaccines (live vaccines) could cause you to become infected and should therefore be avoided. Your doctor will tell you if other types of vaccines (non-live vaccines) should be given.

Dimetilfumarato EG STADA ITALIA with 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 EG
STADA ITALIA, because alcohol can interact with this medicine. This could cause
stomach inflammation (gastritis), especially 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 with breast
milk, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
There is limited information about the effects of this medicine on the fetus if used during pregnancy.
Do not use Dimetilfumarato EG STADA ITALIA if you are pregnant unless you have discussed this with
your doctor and if this medicine is clearly necessary for you.
Breastfeeding
It is not known whether the active ingredient of this medicine passes into breast milk. Your doctor will advise you whether to
stop breastfeeding or stop treatment with Dimetilfumarato EG STADA
ITALIA. This involves assessing the benefit of breastfeeding for your baby versus the
benefit of therapy for you.

Driving and operating machinery
This medicine is not expected to affect your ability to drive and operate machinery.

3. How to take Dimetilfumarato EG STADA ITALIA

Take this medicine following exactly the instructions of your doctor. If you have 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 EG STADA ITALIA is for oral use.

Swallow each capsule whole, with a little water. You must not divide, crush, dissolve, suck or
chew the capsule, because this could increase some undesirable effects.

Take Dimetilfumarato EG STADA ITALIA with food– this may help to reduce some more common undesirable effects
(listed in paragraph 4).

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

If you forget to take Dimetilfumarato EG STADA ITALIA
If you forget or miss a dose, do not take a double doseto make up for a missed 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.
manifest.

Serious side effects
Dimetilfumarato EG STADA ITALIA may reduce the levels of lymphocytes (a type of white blood cell). Having 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 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. Be careful to closely 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 while on therapy with
Dimetilfumarato EG STADA ITALIA, it is very important that you see your doctor as soon as possible. Also
inform your partner or anyone who assists you 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
the flushing is accompanied by a red or hives rash and you 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 Dimetilfumarato EG STADA ITALIA and 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)
• loose stools (diarrhea)
• feeling unwell (nausea)
• stomach pain or stomach cramps Taking the medicine with food may help reduce the above side effects.

The presence of substances called ketones, which are produced naturally by the body, is very
commonly revealed in urine tests during the intake of dimethyl fumarate.
Ask your doctor for 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 lining of the stomach ( gastritis)
• gastrointestinal illness
• burning sensation
• hot flash, feeling of heat
• itchy skin ( pruritus)
• 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, leucopenia) in the blood. A decrease in the number of white blood cells in the blood may indicate that you are unable to fight off an infection adequately. If you have a serious infection (such as pneumonia), see your doctor immediately
• proteins ( 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 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 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 the infection, followed by numbness, red or itchy spots with severe pain
• runny nose ( rhinorrhea)

Children (13 years of age and over) 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
compared to adults, for example headache, stomach pain or stomach cramps, feeling unwell (vomiting), sore
throat, cough and painful periods.

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 EG STADA ITALIA

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, on the label of the bottle and
on the carton after 'Exp'. The expiry date refers to the last day of that month.
This medicine does not require any particular storage temperature.
Store in the original package to protect the medicine from light.
Do not dispose of any medicine in 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 EG STADA ITALIA contains
The active ingredient is dimethyl fumarate.

Dimetilfumarato EG STADA ITALIA 120 mg hard gastro-resistant capsules
Each hard gastro-resistant capsule contains 120 mg of dimethyl fumarate.

Dimetilfumarato EG STADA ITALIA 240 mg hard gastro-resistant capsules
Each hard gastro-resistant capsule contains 240 mg of dimethyl fumarate.
The other ingredients are:

• Capsule content: microcrystalline cellulose (E 460), crospovidone, talc (E 553b), povidone K30 (E 1201), anhydrous colloidal silica (E 551), magnesium stearate (E 470b), triethyl citrate, methacrylic acid - ethyl acrylate copolymer (1:1), hypromellose, titanium dioxide (E 171), triacetin.
• Capsule shell: gelatin, titanium dioxide (E171), brilliant blue FCF (E133), yellow iron oxide (E172).
• Printing ink on the capsule: shellac, potassium hydroxide, propylene glycol (E 1520), black iron oxide (E172), strong ammonia solution.

Description of the appearance of Dimetilfumarato EG STADA ITALIA and package contents
Dimetilfumarato EG STADA ITALIA 120 mg hard gastro-resistant capsules (gastro-resistant capsules):
green cap and white body, capsule shell of 21.4 mm, with “DMF 120” printed in black ink on the body containing white to off-white mini-tablets.
Dimetilfumarato EG STADA ITALIA 240 mg hard gastro-resistant capsules (gastro-resistant capsules):
green cap and body, capsule shell of 23.2 mm, with “DMF 240” printed in black ink on the body containing white to off-white mini-tablets.
White HDPE containers of 200 ml with PP/HDPE caps with a seal (PE/PET/Al/cardboard) and a silica gel desiccant container.
Do not ingest the desiccant.
OPA/Al/PVC//Al or OPA/Al/PVC//Al divisible unit-dose blisters.
Dimetilfumarato EG STADA ITALIA 120 mg hard gastro-resistant capsules
Packs:
14 gastro-resistant capsules (blister)
14 x 1 gastro-resistant capsules (divisible unit-dose blisters)
100 gastro-resistant capsules (bottle)
Dimetilfumarato EG STADA ITALIA 240 mg hard gastro-resistant capsules
Packs:
56 gastro-resistant capsules (blister)
56 x 1 gastro-resistant capsules (divisible unit-dose blisters)
168 gastro-resistant capsules (blister)
168 x 1 gastro-resistant capsules (divisible unit-dose blisters)
100 gastro-resistant capsules (bottle)
Not all pack sizes may be marketed.

Marketing Authorisation Holder
EG S.p.A.,
Via Pavia 6,
20136 Milano

Manufacturers
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 medicinal product is authorised in the Member States of the European Economic Area with the following
denominations:
IS Dimethyl fumarate STADAPHARM
DE Dimethylfumarat STADA 120/240 mg magensaftresistente Hartkapseln
ES Fumarato de dimetilo STADAFARMA 120/240 mg cápsulas duras gastrorresistentes EFG
FR DIMETHYL FUMARATE STADA 120/240 mg, gélule gastro-résistante
IT Dimetilfumarato EG STADA ITALIA