LEVETIRACETAM KERN PHARMA 500 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Levetiracetam Kern Pharma 500 mg film-coated tablets EFG

Levetiracetam

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information:

1. What is Levetiracetam Kern Pharma and what is it used for
2. What you need to know before you take Levetiracetam Kern Pharma
3. How to take Levetiracetam Kern Pharma
4. Possible side effects
5. Storage of Levetiracetam Kern Pharma
6. Contents of the pack and further information

1. What is Levetiracetam Kern Pharma and what is it used for

Levetiracetam Kern Pharma is an antiepileptic medicine (a medicine used to treat seizures in epilepsy).

Levetiracetam Kern Pharma is used:

• on its own (without other antiepileptic medicines) in patients from 16 years of age with newly diagnosed epilepsy to treat partial onset seizures with or without secondary generalisation,
• with other antiepileptic medicines to treat:

• partial onset seizures with or without secondary generalisation in patients from 1 month of age,
• myoclonic seizures in patients from 12 years of age with juvenile myoclonic epilepsy,
• primary generalised tonic-clonic seizures in patients from 12 years of age with idiopathic generalised epilepsy.

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

• If you have kidney problems, follow your doctor's instructions, who 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.
• If you notice an increase in seizure severity (e.g. increase in the number of seizures), contact your doctor.
• A small number of people taking antiepileptics, such as levetiracetam, have had thoughts of harming themselves or suicide. 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 get worse or last 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 your 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 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. Ask 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 that your doctor has told you to take.

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) per day.

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

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

Concomitant therapy

Dose in adults and adolescents (from 12 to 17 years) with a weight of 50 kg or more:

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

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

Dose in infants (from 6 to 23 months), children (from 2 to 11 years) and adolescents (from 12 to 17 years) with a weight below 50 kg:

Your doctor will prescribe the most appropriate 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.

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

If you take more Levetiracetam Kern Pharma than you should

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

Possible side effects of an overdose of levetiracetam are drowsiness, agitation, aggression, decreased alertness, respiratory inhibition, 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, the discontinuation of 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 you start treatment or increase 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 this 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 skin peeling, especially around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome)

• a more severe form that causes skin peeling on more than 30% of the body surface (toxic epidermal necrolysis)
• signs of severe 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:

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;
• 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 (lack of memory);
• double vision, blurred vision;
• vertigo (feeling of spinning);
• cough (increase in pre-existing cough);
• abdominal pain, nausea, dyspepsia (indigestion, heartburn, and acid reflux), 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 (muscle tissue breakdown) 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 that affect 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 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 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 500 mg film-coated tablets

• The active substance is Levetiracetam. Each film-coated tablet contains 500 mg of Levetiracetam.
• The other ingredients are:

Core of the tablet: croscarmellose sodium, colloidal anhydrous silica, magnesium stearate. Film coating: Opadry 85F32004 (partially hydrolysed polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc, yellow iron oxide (E172).

Appearance and packaging

The film-coated tablets are yellow, oval, scored on one side. The score line is to facilitate breaking and swallowing but not to divide into equal doses.

The packs contain 60, 100, or 500 film-coated tablets.

Levetiracetam Kern Pharma is also available in 250 mg film-coated tablets in packs of 60 tablets and 1,000 mg film-coated 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