LEVETIRACETAM TECNIGEN 500 mg FILM-COATED TABLETS

2. What you need to know before you take Levetiracetam TecniGen

Do not take Levetiracetam TecniGen

• if you are allergic to levetiracetam or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Tell your doctor, pharmacist, or nurse before starting treatment with Levetiracetam TecniGen:

• If you have kidney problems, follow your doctor's instructions. He will decide if you need to adjust the dose.
• If you notice any decrease in your child's growth or an unexpected delay in puberty, contact your doctor.
• A small number of people taking antiepileptics such as Levetiracetam TecniGen have had thoughts of harming themselves or committing suicide. If you have any symptoms of depression and/or suicidal thoughts, contact your doctor.

Children and adolescents

• Monotherapy with Levetiracetam TecniGen is not indicated for children and adolescents below 16 years.

Tell your doctor or pharmacist if any of the following side effects get serious or last longer than a few days:

• Abnormal thoughts, feeling irritable or reacting more aggressively than usual, or if you, your family, or friends notice significant changes in mood or behavior.

Taking Levetiracetam TecniGen with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Do not take Macrogol (a medicine used as a laxative) for one hour before and one hour after taking levetiracetam, as it may lose its effect.

Taking Levetiracetam TecniGen with food, drinks, and alcohol

You can take Levetiracetam TecniGen with or without food. As a precautionary measure, do not take Levetiracetam TecniGen with alcohol.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Levetiracetam TecniGen should not be used during pregnancy unless clearly necessary. It cannot be excluded that the risk of birth defects for the fetus is higher than for the general population. In animal studies, levetiracetam has shown undesirable effects on reproductive physiology at doses higher than you may need to control your seizures.

Breastfeeding is not recommended during treatment with Levetiracetam TecniGen.

Driving and using machines

Levetiracetam TecniGen may affect your ability to drive or use tools or machines, as it may cause drowsiness. This is more likely at the start of treatment or when the dose is increased. You should not drive or use machinery until it is established that your ability to perform such activities is not affected.

3. How to take Levetiracetam TecniGen

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Levetiracetam TecniGen should be taken twice daily, once in the morning and once in the evening, at approximately the same time each day.

Take the number of tablets as instructed by your doctor.

Monotherapy

• Dose in adults and adolescents (from 16 years of age):

General dose: between 1,000 mg (2 tablets) and 3,000 mg (6 tablets) each day.

When you first start taking Levetiracetam TecniGen, your doctor will prescribe you a lower dose for 2 weeks before giving you the lowest general dose.

Example: if your daily dose is 2,000 mg, you should take 2 tablets of 500 mg in the morning and 2 tablets of 500 mg in the evening.

Concomitant therapy

• Dose in adults and adolescents (from 12 to 17 years) weighing 50 kg or more:

General dose: between 1,000 mg (2 tablets) and 3,000 mg (6 tablets) each day.

Example: if your daily dose is 1,000 mg, you should take 1 tablet of 500 mg in the morning and 1 tablet of 500 mg in the evening.

• Dose in infants (from 1 month to 23 months), children (from 2 to 11 years), and adolescents (from 12 to 17 years) weighing less than 50 kg:

Your doctor will prescribe the most appropriate pharmaceutical form of Levetiracetam TecniGen according to the age, weight, and dose.

The most suitable formulation for infants and children under 6 years is an oral solution, and for children and adolescents (from 6 to 17 years) weighing less than 50 kg when tablets do not allow the dose to be adjusted.

Method of administration:

Swallow Levetiracetam TecniGen tablets with a sufficient amount of liquid (e.g., a glass of water). You can take Levetiracetam with or without food.

Duration of treatment

• Levetiracetam TecniGen is used as chronic treatment. You should continue with the treatment with Levetiracetam TecniGen for as long as your doctor has told you.
• Do not stop your treatment without the advice of your doctor, as your seizures may get worse.

If you take more Levetiracetam TecniGen than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medicine and the amount taken.

Possible side effects of an overdose of Levetiracetam TecniGen are drowsiness, agitation, aggression, decreased alertness, respiratory depression, and coma.

Contact your doctor if you have taken more Levetiracetam TecniGen than you should. Your doctor will establish the best treatment for the overdose.

If you forget to take Levetiracetam TecniGen

Contact your doctor if you have missed one or more doses.

Do not take a double dose to make up for forgotten doses.

If you stop taking Levetiracetam TecniGen

Stopping treatment with Levetiracetam TecniGen should be done gradually to avoid an increase in seizures.

If your doctor decides to stop the treatment with Levetiracetam TecniGen, he/she will give you instructions for the gradual withdrawal of Levetiracetam TecniGen.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Levetiracetam TecniGen can cause side effects, although not everybody gets them.

Tell your doctor immediately, or go to the casualty department of your nearest hospital if you experience:

• weakness, dizziness, or difficulty breathing, as these may be signs of a severe allergic reaction (anaphylaxis)
• swelling of the face, lips, tongue, or throat (Quincke's edema)
• flu-like symptoms and rash on the face followed by a prolonged rash with high temperature, elevated liver enzymes in blood tests, and an increase in a type of white blood cells (eosinophilia) and swollen lymph nodes (Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS))
• symptoms such as low urine output, tiredness, nausea, vomiting, confusion, and swelling of the legs, arms, or feet, as it may be a sign of sudden decrease in kidney function
• a skin rash that may form blisters and looks like the "bull's-eye" rash (erythema multiforme)
• a widespread rash with blisters and skin peeling, especially around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome)
• a more severe form causing skin peeling over more than 30% of the body surface (toxic epidermal necrolysis)
• signs of mental changes or if someone around you notices signs of confusion, drowsiness (drowsiness), amnesia (memory loss), memory impairment (forgetfulness), abnormal coordination/ataxia (altered movement coordination), paresthesia (tingling), attention disturbances (loss of concentration); these may be symptoms of encephalopathy.

The most frequently reported side effects are nasopharyngitis, somnolence (feeling drowsy), headache, fatigue (feeling weak), and dizziness. These latter side effects may be more frequent at the start of treatment or when the dose is increased. However, these side effects should decrease over time.

Very common(affects more than 1 in 10 people)

• nasopharyngitis;
• somnolence (feeling drowsy), headache.

Common(affects between 1 and 10 in 100 people)

• anorexia (loss of appetite);
• depression, hostility or aggression, anxiety, insomnia, nervousness or irritability;
• seizures, balance disorder, dizziness (feeling unsteady), lethargy (lack of energy and enthusiasm), tremor (involuntary shaking);
• vertigo (feeling of spinning);
• cough;
• abdominal pain, diarrhea, dyspepsia (indigestion), vomiting, nausea;
• skin rash;
• asthenia/fatigue (feeling weak).

Uncommon(affects between 1 and 10 in 1,000 people)

• decrease in the number of platelets, decrease in white blood cells;
• weight loss, weight gain;
• suicidal attempt and suicidal thoughts, mental disorders, abnormal behavior, hallucinations, anger, confusion, panic attack, emotional instability/mood changes, agitation;
• amnesia (memory loss), memory impairment (forgetfulness), abnormal coordination/ataxia (altered movement coordination), paresthesia (tingling), attention disturbances (loss of concentration);
• diplopia (double vision), blurred vision;
• elevated liver enzymes;
• hair loss, eczema, itching;
• muscle weakness, myalgia (muscle pain);
• injury.
• possible symptoms of rhabdomyolysis (muscle tissue breakdown) and increased creatine phosphokinase in the blood. The prevalence is significantly higher in Japanese patients compared to non-Japanese patients.

Rare(affects between 1 and 10 in 10,000 people)

• infection;
• decrease in all types of blood cells;
• severe allergic reactions (DRESS, anaphylactic reaction, Quincke's edema);
• decrease in sodium levels in the blood;
• suicide, personality disorders (behavioral problems), abnormal thinking (slow thinking, difficulty concentrating);
• muscle spasms that cannot be controlled, affecting the head, torso, and limbs, difficulty controlling movements, hyperkinesia (hyperactivity);
• pancreatitis (inflammation of the pancreas);
• liver failure, hepatitis (inflammation of the liver);
• skin rash that may form blisters and looks like the "bull's-eye" rash (erythema multiforme), a widespread rash with blisters and skin peeling, especially around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome), and a more severe form causing skin peeling over more than 30% of the body surface (toxic epidermal necrolysis).
• sudden decrease in kidney function.

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Medicines Information System for Human Use: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Levetiracetam TecniGen

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 label or carton after EXP. The expiry date refers to the last day of the month shown.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

Composition of Levetiracetam TecniGen

• The active substance is levetiracetam. Each tablet contains 500 mg of levetiracetam.
• The other ingredients are:
• Core of the tablet: anhydrous colloidal silica, magnesium stearate, maize starch, povidone, talc.
• Coating: Opadry 85F32004 (polyvinyl alcohol, titanium dioxide (E171), macrogol 4000, talc, yellow iron oxide (E172)).

Appearance and packaging of the product

Levetiracetam TecniGen 500 mg film-coated tablets are yellow, oval, and film-coated.

The carton box contains 20, 30, and 60 film-coated tablets.

Not all pack sizes may be marketed.

Other presentations:

• Levetiracetam TecniGen 250 mg film-coated tablets EFG
• Levetiracetam TecniGen 750 mg film-coated tablets EFG
• Levetiracetam TecniGen 1000 mg film-coated tablets EFG
• Levetiracetam TecniGen 100 mg/ml oral solution EFG

Marketing Authorisation Holder and Manufacturers

Marketing Authorisation Holder

Tecnimede España Industria Farmacéutica, S.A.

Avda. de Bruselas, 13, 3º D. Edificio América. Polígono Arroyo de la Vega,

28108 Alcobendas (Madrid) SPAIN

Email: [email protected]

Manufacturers

Atlantic Pharma – Produções Farmacêuticas, S.A.

Rua da Tapada Grande, n.º 2; Abrunheira, 2710-089 Sintra, Portugal

Or

Medinfar Manufacturing, S.A.

Parque Industrial Armando Martins Tavares

Rua Outeiro da Armada, 5, Condeixa-a-Nova

3150-194 Sebal

Portugal

Date of last revision of this leaflet:May 2016

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/