LEVETIRACETAM KERN PHARMA 250 mg FILM-COATED TABLETS

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 you may need to control your seizures.

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

Driving and using machines

Levetiracetam 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 machines until it is established that your ability to perform these 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, at approximately the same time each day.

Take the number of tablets prescribed by your doctor.

Monotherapy

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

General dose: between 1,000 mg (4 tablets) and 3,000 mg (12 tablets) per day.

When starting levetiracetam, your doctor will prescribe a lower dosefor two weeks before giving you the lowest general dose.

For example: for a daily dose of 1,000 mg, you should take 2 tablets in the morning and 2 tablets in the evening.

Concomitant therapy

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

General dose: between 1,000 mg (4 tablets) and 3,000 mg (12 tablets) per day.

For example: for a daily dose of 1,000 mg, you should take 2 tablets in the morning and 2 tablets 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 suitable pharmaceutical form of levetiracetam according to age, weight and dose.

Levetiracetam 100 mg/ml oral solution is a more suitable presentation 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 per day.

For example: for a general dose of 20 mg per kg of body weight per day, you should give the child of 25 kg of weight 1 tablet in the morning and 1 tablet in the evening.

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

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

Method of administration:

Swallow the 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 treatment with Levetiracetam for as long as your doctor has told you.
• Do not stop treatment without your doctor's advice, as your seizures may increase. If your doctor decides to stop your treatment with levetiracetam, he/she will give you instructions for gradual withdrawal of levetiracetam.

If you take more Levetiracetam Kern Pharma than you should

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

The possible side effects of an overdose of levetiracetam are drowsiness, 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 possible 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 antiepileptic medicines, stopping treatment with 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 drowsiness, weakness and dizziness may be more frequent when starting treatment or increasing the dose. However, these side effects should decrease over time.

Tell your doctor immediately, or go to the emergency 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 (angioedema)
• 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 low urine output, fatigue, nausea, vomiting, confusion and swelling of legs, arms or feet, as it may be a sign of sudden decrease in kidney function

• a skin rash that may form blisters and may appear as small targets (dark spots in the centre surrounded by a paler area, with a dark ring around the edge) (erythema multiforme)

• a widespread rash with blisters and peeling of the skin, especially around the mouth, nose, eyes and genitals (Stevens-Johnson syndrome)
• a more severe form causing peeling of the skin on more than 30% of the body surface

(toxic epidermal necrolysis)

• signs of serious mental changes or if someone around you notices signs of confusion, drowsiness (drowsiness), amnesia (memory loss), memory impairment (forgetfulness), abnormal behaviour or other neurological signs including involuntary or uncontrolled movements. These may be symptoms of encephalopathy.

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

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:

• drowsiness (feeling sleepy);
• asthenia/fatigue (feeling weak).

Common:

• infection, nasopharyngitis;
• decrease in platelet count;
• anorexia (loss of appetite), weight gain;
• 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), seizures, headache, hyperkinesia (hyperactivity), ataxia (altered movement coordination), tremor (involuntary tremor), amnesia (memory loss), balance disorder, attention disorders (loss of concentration), memory impairment (memory loss);
• diplopia (double vision), blurred vision;
• vertigo (feeling of rotation);
• cough (increase in pre-existing cough);
• abdominal pain, nausea, dyspepsia (indigestion, heartburn and acidity), 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 changes, 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 test results;
• 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 Pharmacovigilance System for Human Use Medicines: 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 is the last day of the month stated.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Place the empty packaging and any unused medicinal product in the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of the packaging and unused medicinal products. This will help protect the environment.

6. Contents of the pack and further information

Composition of Levetiracetam Kern Pharma 250 mg film-coated tablets

• The active substance is Levetiracetam. Each film-coated tablet contains 250 mg of levetiracetam.
• The other ingredients are:

Tablet core: croscarmellose sodium, colloidal anhydrous silica, magnesium stearate.

Film coating: Opadry 85F20694 (partially hydrolysed polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc, aluminium lake of indigo carmine (E132)).

Appearance and packaging

The film-coated tablets are blue, 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 60 film-coated tablets.

Levetiracetam Kern Pharma is also available in 500 mg film-coated tablets in packs of 60 and 100 tablets and 1,000 mg tablets in packs of 30 and 60 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 updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) www.aemps.gob.es