LEVETIRACETAM KERN PHARMA 1000 mg FILM-COATED TABLETS

2. What you need to know before you take Levetiracetam Kern Pharma

Do not take Levetiracetam Kern Pharma

• if you are allergic (hypersensitive) to levetiracetam or any of the other ingredients of Levetiracetam Kern Pharma.

Warnings and precautions

• a small number of people taking antiepileptics such as levetiracetam have had thoughts of harming themselves or suicidal thoughts. If you have any symptoms of depression and/or suicidal thoughts, contact your doctor.

Tell your doctor or pharmacist if any of the following side effects gets worse or lasts more than a few days:

• abnormal thoughts, feeling irritable or behaving more aggressively than usual or if you or your family and friends notice significant changes in mood or behaviour.

Taking other medicines

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including those obtained without a prescription.

Taking Levetiracetam Kern Pharma with food and drink

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

Pregnancy and breast-feeding

Ask your doctor or pharmacist for advice before taking any medicine.

If you are pregnant or think you may be pregnant, inform your doctor.

Levetiracetam Kern Pharma should not be used during pregnancy unless clearly necessary. The risk to the baby is unknown. In animal studies, levetiracetam has shown undesirable effects on reproduction at doses higher than those that you may need to control your seizures.

Breast-feeding is not recommended during treatment with Levetiracetam Kern Pharma.

Driving and using machines

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

3. How to take Levetiracetam Kern Pharma

Follow exactly the instructions given to you by your doctor for taking Levetiracetam Kern Pharma. Consult your doctor if you are unsure.

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

Take the number of tablets advised by your doctor.

Monotherapy

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

General dose: between 1000 mg and 3000 mg each day.

When you first start taking levetiracetam, your doctor will prescribe you a lower doseduring two weeks before giving you the lowest general dose.

For example: for a daily dose of 2000 mg, you should take 1 tablet in the morning and 1 tablet in the evening.

Concomitant therapy

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

General dose: between 1000 mg and 3000 mg each day.

For example: for a daily dose of 2000 mg, you should take 1 tablet in the morning and 1 tablet in the evening.

Dosage in infants (from 6 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 according to the age, weight and dose.

Levetiracetam 100 mg/ml oral solution is a more appropriate formulation for infants and children under 6 years.

General dose: between 20 mg per kg of body weight and 60 mg per kg of body weight each day.

Dosage in infants (from 1 month to less than 6 months):

Levetiracetam 100 mg/ml oral solution is a more appropriate formulation for infants under 6 months.

Method of administration:

Swallow Levetiracetam Kern Pharma tablets with a sufficient amount of liquid (e.g. a glass of water).

Duration of treatment:

• Levetiracetam is used as a chronic treatment. You should continue to take Levetiracetam for as long as your doctor has told you.
• Do not stop your treatment without the advice of your doctor, as this may increase your seizures. If your doctor decides to stop your treatment with levetiracetam, he/she will tell you how to gradually reduce the dose.

If you take more Levetiracetam Kern Pharma than you should

In case of overdose or accidental intake, consult your doctor or pharmacist immediately or call the Toxicological Information Service on +34 91 562 04 20, indicating the medicine and the amount taken.

Possible side effects of an overdose of levetiracetam are somnolence, agitation, aggression, decreased alertness, inhibition of breathing and coma.

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

If you forget to take Levetiracetam Kern Pharma

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 Kern Pharma

As with other antiepileptics, discontinuation of Levetiracetam should be done gradually to avoid an increase in seizures.

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 Kern Pharma can cause side effects, although not everybody gets them.

Tell your doctor if you have any of the following side effects and they worry you.

Some of the side effects such as somnolence, asthenia and dizziness may be more frequent at the start of treatment or when the dose is increased. However, these side effects should decrease over time.

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 oedema)
• 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 enlarged lymph nodes (Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS))
• symptoms such as decreased urine output, tiredness, nausea, vomiting, confusion and swelling of the legs, arms or feet, as these may be signs of sudden decrease in kidney function
• a skin rash which may form blisters and may look like targets (central dark spot surrounded by a paler area, with a dark ring on the edge) (erythema multiforme)

• a widespread rash with blisters and peeling of the skin, particularly 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 serious mental changes or if someone around you notices signs of confusion, somnolence (drowsiness), amnesia (loss of memory), memory impairment (forgetfulness), abnormal behaviour or other neurological signs including involuntary or uncontrolled movements. These may be symptoms of encephalopathy

The frequency of possible side effects listed below is defined as:

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

common (may affect up to 1 in 10 people)

uncommon (may affect up to 1 in 100 people)

rare (may affect up to 1 in 1,000 people)

very rare (may affect up to 1 in 10,000 people)

frequency not known (cannot be estimated from the available data)

Very common:

• somnolence (feeling drowsy);
• asthenia/fatigue (feeling weak).

Common:

• infection, nasopharyngitis;
• decrease in the number of platelets;
• anorexia (loss of appetite), weight increase;
• agitation, depression, emotional instability/mood changes, hostility or aggression, insomnia, nervousness or irritability, personality disorders (behavioural problems), abnormal thinking (slow thinking, difficulty concentrating);
• dizziness (feeling unsteady), convulsions, headache, hyperkinesia (hyperactivity), ataxia (altered coordination), tremor (involuntary trembling), amnesia (loss of memory), balance disorder, attention disorders (loss of concentration), memory impairment (forgetfulness);
• diplopia (double vision), blurred vision;
• vertigo (feeling of spinning);
• cough (increase in pre-existing cough);
• abdominal pain, nausea, dyspepsia (indigestion, heartburn and acid), diarrhoea, vomiting;
• skin rash, eczema, itching;
• myalgia (muscle pain);
• accidental injury.

Rare:

• decrease in sodium levels in the blood;
• sudden decrease in kidney function;
• rhabdomyolysis (breakdown of muscle tissue) and increased creatine phosphokinase in the blood.

The prevalence is significantly higher in Japanese patients compared to non-Japanese patients.

Frequency not known:

• decrease in red blood cells and/or white blood cells;
• weight loss;
• abnormal behaviour, anger, anxiety, confusion, hallucinations, mental disorders, suicide, attempted suicide and suicidal thoughts;
• paraesthesia (tingling), difficulty controlling movements, uncontrolled muscle spasms affecting the head, torso and limbs;
• pancreatitis (inflammation of the pancreas), liver failure, hepatitis (inflammation of the liver), abnormal liver function tests;
• hair loss, blisters on the skin, in the mouth, eyes and genital area, skin rash.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Medicines Monitoring 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 Kern Pharma

Keep out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and blister 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 further information

Composition of Levetiracetam Kern Pharma 1000 mg film-coated tablets

• The active substance is Levetiracetam. Each film-coated tablet contains 1000 mg of Levetiracetam.
• The other ingredients are:

Core of the tablet: croscarmellose sodium, colloidal anhydrous silica, magnesium stearate.

Coating: Opadry 85F18422 (partially hydrolysed polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc).

Appearance and packaging

The film-coated tablets are white, oval and scored on one side. The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses.

The packs contain 30 or 60 film-coated tablets.

Levetiracetam Kern Pharma is also available in 250 mg film-coated tablets in packs of 60 tablets and 500 mg film-coated tablets in packs of 60 and 100 tablets.

Not all pack sizes may be marketed.

Marketing authorisation holder

Kern Pharma, S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

Manufacturer

NOUCOR HEALTH, S.A.

Av. Camí Reial, 51-57

08184-Palau-solità i Plegamans

(Barcelona-Spain)

Date of last revision of this leaflet: October 2019

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) www.aemps.gob.es