Dimethyl fumarate EG Stada Italia: detailed information

Package leaflet: Information for the patient

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

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 pass it on to others, even if their symptoms are the same as yours, because it could be harmful.
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet

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

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

What Dimetilfumarato EG STADA ITALIA is
Dimetilfumarato EG STADA ITALIA is a medicine that contains the active substance dimethyl fumarate.
What Dimetilfumarato EG STADA ITALIA is 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 affecting the central nervous system (CNS), i.e. the brain and spinal cord. Relapsing-remitting multiple sclerosis is characterized by repeated attacks (relapses) of neurological symptoms. Symptoms vary from patient to patient, but typically include difficulty walking, feelings of imbalance, and vision problems (e.g. blurred or double vision). These symptoms may completely disappear when a relapse resolves, although some problems may persist.
How Dimetilfumarato EG STADA ITALIA works
Dimetilfumarato EG STADA ITALIA 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 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 fumarate or to any of the other ingredients of this medicine (listed in section 6).
if it is suspected that you have a rare brain infection called progressive multifocal leukoencephalopathy (PML) or if PML has been confirmed.

Warnings and precautions
Dimetilfumarato EG STADA ITALIA may affect the number of white blood cells in your blood, your kidneys, and your liver. Before starting 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 carry out these tests periodically during treatment. If your white blood cell count decreases during treatment, your doctor may consider further testing or discontinuation of therapy.
Contact your doctor before taking Dimetilfumarato EG STADA ITALIA if you have:

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

Cases of herpes zoster infection (shingles) may occur during treatment with Dimetilfumarato EG STADA ITALIA. In some cases, serious complications have occurred. Contact your doctor immediately if you suspect you have any symptoms of herpes zoster infection.
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 fluid intake, 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 are no data available in this age group.
Other medicines and Dimetilfumarato EG STADA ITALIA
Inform 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 for the treatment of 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 medicines purchased without a doctor's prescription), and medicines containing lithium;
taking this medicine together with certain types of vaccines (live vaccines) could cause you to develop an infection and should therefore be avoided. Your doctor will inform you whether other types of vaccines (non-live vaccines) should be administered.

Dimetilfumarato EG STADA ITALIA and alcohol
Consumption of beverages with high alcohol content (more than 30% alcohol by volume, e.g., spirits) in amounts greater than a small quantity (more than 50 mL) should be avoided within one hour of taking Dimetilfumarato EG STADA ITALIA, as alcohol may interact with this medicine. This could cause stomach inflammation (gastritis), particularly in individuals already prone to gastritis.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are 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 fetus when used during pregnancy. Do not use Dimetilfumarato EG STADA ITALIA during pregnancy unless you have discussed it with your doctor and the 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 you should discontinue breastfeeding or discontinue treatment with Dimetilfumarato EG STADA ITALIA. This decision will take into account the benefit of breastfeeding for your child versus the benefit of therapy for you.
Driving and using machines
This medicine is not expected to affect your ability to drive or use machinery.

3. How to take Dimetilfumarato EG STADA ITALIA

Take this medicine exactly as your doctor has instructed. If you have any doubts, consult your
doctor.
Initial dose
120 mg twice daily.
Take this initial dose for the first 7 days, then proceed to the regular dose.
Regular dose
240 mg twice daily.
Dimetilfumarato EG STADA ITALIA is for oral use.
Swallow each capsule whole with some water. Do not split, crush, dissolve, suck or
chew the capsule, as this could increase certain side effects.
Take Dimetilfumarato EG STADA ITALIA with food – this may help reduce some of the more common
side effects (listed in section 4).
If you take more Dimetilfumarato EG STADA ITALIA 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 Dimetilfumarato EG STADA ITALIA
If you forget or miss a dose, do not take a double dose to make up for the missed dose.
You may take the missed dose if at least 4 hours will elapse between doses. Otherwise, wait until your next scheduled dose.
If you have any questions about the use of 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

Dimetilfumarato EG STADA ITALIA may reduce levels of lymphocytes (a type of white blood cell). Having low levels of white blood cells 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 to 5 years of treatment, so your doctor must continue monitoring your white blood cells throughout the entire 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 immune system function.

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 more than a few days.

Therefore, if you feel that your MS is worsening or if you notice any new symptoms during treatment with Dimetilfumarato EG STADA ITALIA, 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 (redness 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 Dimetilfumarato EG STADA ITALIA and call a doctor immediately.

Other side effects

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

redness of the face or body, sensation of warmth, intense heat, burning, or itching (flushing)
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.

Consult your doctor for advice 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 intestinal lining ( gastroenteritis )
feeling unwell ( vomiting )
indigestion ( dyspepsia )
inflammation of the stomach lining ( gastritis )
gastrointestinal disorder
burning sensation
hot flush, sensation of warmth
itchy skin ( pruritus )
skin rash
pink or red spots on the skin (erythema)
hair loss (alopecia)

Side effects that may appear in blood or urine tests:

low levels of white blood cells ( lymphopenia, leukopenia ) in the blood. A reduction in white blood cell count may indicate that you are not able to fight infections adequately. If you develop a serious infection (such as pneumonia), contact your doctor immediately
presence of protein ( albumin ) in the urine
increased liver enzyme levels (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 patches with severe pain
runny nose ( rhinorrhea )

Children (aged 13 years 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, 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, talk to your doctor or pharmacist. You can 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 Dimetilfumarato EG STADA ITALIA

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister, on the bottle label and on the carton after 'Exp'. The expiry date refers to the last day of that month.
This medicine does not require any special storage temperature.
Store in the original packaging to protect the medicine from light.
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 EG STADA ITALIA contains
The active substance is dimethyl fumarate.
Dimetilfumarato EG STADA ITALIA 120 mg gastro-resistant hard capsules
Each gastro-resistant hard capsule contains 120 mg of dimethyl fumarate.
Dimetilfumarato EG STADA ITALIA 240 mg gastro-resistant hard capsules
Each gastro-resistant hard capsule contains 240 mg of dimethyl fumarate.
The other components 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), iron oxide yellow (E172).
Printing ink on the capsule: shellac, potassium hydroxide, propylene glycol (E 1520), iron oxide black (E172), strong ammonia solution.

Description of the appearance of Dimetilfumarato EG STADA ITALIA and contents of the pack
Dimetilfumarato EG STADA ITALIA 120 mg gastro-resistant hard capsules (gastro-resistant capsules):
green cap and white body, 21.4 mm capsule shell, printed with “DMF 120” in black ink on the body, containing white to off-white mini-tablets.
Dimetilfumarato EG STADA ITALIA 240 mg gastro-resistant hard capsules (gastro-resistant capsules):
green cap and green body, 23.2 mm capsule shell, printed with “DMF 240” in black ink on the body, containing white to off-white mini-tablets.
White HDPE containers of 200 ml with PP/HDPE caps and seal (PE/PET/Al/carton) and silica gel desiccant container.
Do not ingest the desiccant.
Blister packs made of OPA/Al/PVC//Al or OPA/Al/PVC//Al divisible into single doses.
Dimetilfumarato EG STADA ITALIA 120 mg gastro-resistant hard capsules
Pack sizes:
14 gastro-resistant capsules (blister pack)
14 x 1 gastro-resistant capsules (single-dose divisible blisters)
100 gastro-resistant capsules (bottle)
Dimetilfumarato EG STADA ITALIA 240 mg gastro-resistant hard capsules
Pack sizes:
56 gastro-resistant capsules (blister pack)
56 x 1 gastro-resistant capsules (single-dose divisible blisters)
168 gastro-resistant capsules (blister pack)
168 x 1 gastro-resistant capsules (single-dose divisible blisters)
100 gastro-resistant capsules (bottle)
Not all pack sizes may be marketed.
Marketing Authorization 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 authorized in the European Economic Area countries under the following
names:
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