Dimethyl fumarate Teva Generics

Patient Information Leaflet

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

Generic 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 others, 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, consult your doctor or pharmacist. See section 4.

Contents of this leaflet

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

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

What is Dimetilfumarato Teva Generics
Dimetilfumarato Teva Generics is a medicine that contains the active substance dimethyl fumarate.
What Dimetilfumarato Teva Generics is used for
Dimetilfumarato Teva Generics 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 characterised by repeated attacks (relapses) of neurological symptoms. 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 Teva Generics works
Dimetilfumarato Teva Generics 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 Teva Generics

Do not take Dimetilfumarato Teva Generics

• 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 diagnosed.

Warnings and precautions
Dimetilfumarato Teva Generics may affect the number of white blood cells in your blood, your kidneys, and your liver. Before starting treatment with Dimetilfumarato Teva Generics, 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 testing or discontinuation of therapy.
Talk to your doctor before taking Dimetilfumarato Teva Generics if you have:

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

Treatment with Dimetilfumarato Teva Generics may lead to cases of herpes zoster infection (shingles). In some cases, serious complications have occurred. Tell your doctor immediately if you suspect you may have any symptoms of herpes zoster infection.
If you think your MS is getting worse (for example, if you experience weakness or changes in vision) or if you notice new symptoms, contact your doctor immediately, as these could be signs 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 bone fractures or only bone pain or discomfort, 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 available data in this age group.
Other medicines and Dimetilfumarato Teva Generics
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 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 painkillers (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 Teva Generics and alcohol
Consumption of alcoholic beverages with high alcohol content (more than 30% alcohol by volume, e.g. spirits) in amounts exceeding a small quantity (more than 50 mL) should be avoided within one hour of taking Dimetilfumarato Teva Generics, 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 unborn child when used during pregnancy. Do not use Dimetilfumarato Teva Generics 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 substance of this medicine passes into breast milk. Your doctor will advise you whether you should stop breastfeeding or stop treatment with Dimetilfumarato Teva Generics. This decision will be based on evaluating the benefit of breastfeeding for your child against the benefit of the treatment for you.
Driving and using machines
This medicine is not expected to affect your ability to drive or operate machinery.

3. How to take Dimethylfumarate Teva Generics

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 proceed to the regular dose.
Regular dose: 240 mg twice daily.
Dimethylfumarate Teva Generics 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 the risk of certain side effects.
Take Dimethylfumarate Teva Generics with food – this may help reduce some of the more common side effects (listed in section 4).
If you take more Dimethylfumarate Teva Generics than you should
If you have taken too many capsules, contact your doctor immediately . You may experience side effects similar to those described in section 4 below.
If you forget to take Dimethylfumarate Teva Generics
If you miss or forget a dose, do not take a double dose .
You may take the missed dose if at least 4 hours have passed 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 everyone will experience them.

Serious side effects

Dimetilfumarato Teva Generics 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, so your doctor must continue to monitor your white blood cell counts throughout the duration of treatment. Be vigilant in observing any potential symptoms of PML, as described below. The risk of PML may be higher if you have previously taken medicines that impair 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 your MS is worsening or if you notice any new symptoms during treatment with Dimetilfumarato Teva Generics, it is very important to contact your doctor as soon as possible. Also, inform your partner or caregiver about your treatment, as they may notice symptoms you might 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 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 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 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):

• flushing (reddening of the face or body, sensation of warmth, intense heat, burning or itching)
• loose stools (diarrhea)
• feeling of imminent vomiting (nausea)
• stomach discomfort 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.
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 gastrointestinal tract walls ( gastroenteritis )
• 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 unable 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 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

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

• inflammation of the liver and increased liver enzyme levels ( ALT or AST in combination with bilirubin )

Not known (frequency cannot be estimated from the 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 infection, followed by numbness, red or itchy spots 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, vomiting, sore throat, cough and painful menstruation.

Reporting of side effects
If you experience any side effect, 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 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 stated on the blister and carton after "Exp".
The expiry date refers to the last day of that month.
This medicine does not require any special temperature conditions for storage.
Store in the original packaging, protected 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 Teva Generics contains
The active substance is dimethyl fumarate.
Dimetilfumarato Teva Generics 120 mg gastro-resistant hard capsules
Each gastro-resistant hard capsule contains 120 mg of dimethyl fumarate.
Dimetilfumarato Teva Generics 240 mg gastro-resistant hard capsules
Each gastro-resistant hard capsule contains 240 mg of dimethyl fumarate.
The other components are:

• Capsule contents: 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), iron oxide yellow (E172).
• Printing ink on the capsule: shellac, potassium hydroxide, propylene glycol (E1520), iron oxide black (E172), strong ammonia solution.

Description of the appearance of Dimetilfumarato Teva Generics and contents of the pack
Dimetilfumarato Teva Generics 120 mg gastro-resistant hard capsules (gastro-resistant capsules):
21.4 mm capsule shell, with white body and green cap, marked “DMF 120” in black ink on the body, containing mini-tablets of white to off-white colour.
Dimetilfumarato Teva Generics 240 mg gastro-resistant hard capsules (gastro-resistant capsules):
23.2 mm capsule shell, with green body and green cap, marked “DMF 240” in black ink on the body, containing mini-tablets of white to off-white colour.
Blister packs made of oPA/Alu/PVC//Alu or perforated, divisible unit-dose blisters in oPA/Alu/PVC//Alu.
Dimetilfumarato Teva Generics 120 mg gastro-resistant hard capsules
Pack sizes:
14 capsules in blister or 14 x 1 capsules in perforated, divisible unit-dose blisters
Dimetilfumarato Teva Generics 240 mg gastro-resistant hard capsules
Pack sizes:
56, 168 or 196 capsules in blister or 56 x 1, 168 x 1 or 196 x 1 capsules in perforated, divisible unit-dose blisters
Not all pack sizes may be marketed.
Marketing Authorization Holder
Teva Italia S.r.l.
Piazzale Luigi Cadorna, 4
20123 Milan, Italy
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