DIMETILFUMARATO 120 mg Enteric-Coated Hard Capsule

Содержание инструкции

1. Dimetilfumarato Teva Generics 120 mg hard gastro-resistant capsules, 240 mg hard gastro-resistant capsules
   1. What is Dimetilfumarato Teva Generics and what it is used for
   2. What you need to know before taking Dimetilfumarato Teva Generics
   3. How to take Dimetilfumarato Teva Generics
   4. Possible side effects
   5. How to store Dimetilfumarato Teva Generics
   6. Contents of the pack and other information

Dimetilfumarato Teva Generics 120 mg hard gastro-resistant capsules, 240 mg hard gastro-resistant capsules

Generic medicine

Read this leaflet carefully before you start taking this medicine as 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 Teva Generics is and what it is used for
• 2. What you need to know before you take Dimetilfumarato Teva Generics
• 3. How to take Dimetilfumarato Teva Generics
• 4. Possible side effects
• 5. How to store Dimetilfumarato Teva Generics
• 6. Contents of the pack and other information

1. What is Dimetilfumarato Teva Generics and what it is used for

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

What is Dimetilfumarato Teva Generics used for
Dimetilfumarato Teva Generics 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. The symptoms vary from patient to patient,
but generally include difficulty walking, a feeling of imbalance and visual impairment
(e.g. blurred or double vision). These symptoms may disappear completely when the relapse
resolves, but some problems may remain.

How does Dimetilfumarato Teva Generics work
It appears that Dimetilfumarato Teva Generics 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 Teva Generics

Do not take Dimetilfumarato Teva Generics

• 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 Teva Generics can affect the number of white blood cellsin the blood, the kidneysand the

liver. Before starting to take Dimetilfumarato Teva Generics, 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 discontinuation of therapy.

Talk to your doctorbefore taking Dimetilfumarato Teva Generics 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)

With treatment with Dimetilfumarato Teva Generics, cases of herpes zoster infection (shingles) can occur.
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 because these could 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 your muscles are weaker, or in case of bone fracture or just pain
or discomfort, 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 Teva Generics
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;
• medicinesthataffecttheimmunesystem, including chemotherapy, 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 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 administered.

Dimetilfumarato Teva Generics 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 Teva Generics, 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 with breast
milk, 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 when used during
pregnancy. Do not use Dimetilfumarato Teva Generics 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 this medicine passes into breast milk. Your doctor will advise you if
you should stop breastfeeding or treatment with Dimetilfumarato Teva Generics. 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 Teva Generics

Take this medicine following exactly the instructions of your doctor. If you have any doubts, ask 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 Teva Generics 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 Teva Generics with food– this may help to reduce some more common undesirable effects
(listed in paragraph 4).

If you take more Dimetilfumarato Teva Generics than 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 Teva Generics
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.
li manifestino.

Serious side effects
Dimetilfumarato Teva Generics can reduce the levels of lymphocytes (a type of white blood cell). Prolonged
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 1-5 years of treatment, so the doctor
must continue to monitor white blood cell levels 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 functionality 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 think that
your MS is getting worse or if you notice any new symptoms while taking Dimetilfumarato
Teva Generics, it is very important that you contact your doctor as soon as possible. Also, tell your
partner or caregiver about your treatment. Symptoms may develop 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 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 be a serious allergic reaction ( anaphylaxis)
• - Stop taking Dimetilfumarato Teva Generics 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, heat, burning or itching ( flushing)
• loose stools (diarrhea)
• feeling of impending vomiting (nausea)
• stomach pain or stomach cramps
• - Taking the medicine with foodmay help reduce the aforementioned side effects.

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

Contact 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 gastrointestinal walls ( gastroenteritis)
• vomiting
• indigestion ( dyspepsia)
• inflammation of the stomach ( gastritis)
• gastrointestinal illness
• burning sensation
• hot flashes, 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 reduction 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), contact 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

Rare(may affect up to 1 in 1000 people):

• inflammation of the liver and increased levels of liver enzymes ( ALT or AST incombination with bilirubin)
• Not known(frequency cannot be estimated based on available data):
• 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, such as headache, stomach pain or cramps, vomiting, sore throat,
cough and painful periods.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet. You can also report side effects directly through the national reporting system reported at the address 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 Teva Generics

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 on the carton after “Scad”.
The expiry date refers to the last day of that month.
This medicine does not require special temperature conditions for storage.
Store in the original package protected from light.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how
to eliminate medicines that you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Dimetilfumarato Teva Generics contains
The active ingredient is dimethyl fumarate.

Dimetilfumarato Teva Generics 120 mg hard gastro-resistant capsules
Each hard gastro-resistant capsule contains 120 mg of dimethyl fumarate.

Dimetilfumarato Teva Generics 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, crospovidone, talc, povidone, anhydrous colloidal silica, magnesium stearate, triethyl citrate, methacrylic acid/ethyl acrylate copolymer (1:1), hypromellose, titanium dioxide (E171), 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 (E1520), black iron oxide (E172), strong ammonia solution.

Description of the appearance of Dimetilfumarato Teva Generics and contents of the pack
Dimetilfumarato Teva Generics 120 mg hard gastro-resistant capsules (gastro-resistant capsules):
capsule shell of 21.4 mm, with a white body and a green cap and the inscription “DMF 120” printed in
black ink on the body, containing mini-tablets ranging in colour from white to off-white.
Dimetilfumarato Teva Generics 240 mg hard gastro-resistant capsules (gastro-resistant capsules):
capsule shell of 23.2 mm, with a green body and a green cap and the inscription “DMF 240” printed in black
ink on the body, containing mini-tablets ranging in colour from white to off-white.
Blisters in oPA/Alu/PVC//Alu or divisible unit-dose perforated blisters in oPA/Alu/PVC//Alu.
Dimetilfumarato Teva Generics 120 mg hard gastro-resistant capsules
Packs:
14 capsules in blisters or 14 x 1 capsules in divisible unit-dose perforated blisters
Dimetilfumarato Teva Generics 240 mg hard gastro-resistant capsules
Packs:
56, 168 or 196 capsules in blisters or 56 x 1, 168 x 1 or 196 x 1 capsules in divisible unit-dose perforated
blisters
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Teva Italia S.r.l.
Piazzale Luigi Cadorna, 4
20123 Milano

Manufacturer
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
Pharmadox Healthcare Ltd.
KW20A Kordin Industrial Park,
Paola PLA 3000, Malta
Teva Operations Poland Sp. Z.o.o
ul. Mogilska 80,
Kraków 31-546, Poland