Leaflet: Information for the User

Levetiracetam Kern Pharma 250 mg Film-Coated Tablets

Levetiracetam

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

−Keep this leaflet, as you may need to read it again.

−If you have any questions, ask your doctor or pharmacist.

−This medicine has been prescribed for you, and you should not give it to others even if they have the same symptoms as you, as it may harm them.

−If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1.What Levetiracetam Kern Pharma is andwhat it is used for

2.What you need to know before you start taking 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 additional information

Levetiracetam Kern Pharma is an antiepileptic medication (a medication for the treatment of seizures in epilepsy).

Levetiracetam Kern Pharma is used:

• alone (without the need for another antiepileptic medication) in patients aged 16 years or older with recently diagnosed epilepsy to treat partial onset seizures with or without secondary generalization,
• in conjunction with other antiepileptic medications to treat:

• partial onset seizures with or without generalization in patients aged 1 month or older,
• myoclonic seizures in patients 12 years or older with juvenile myoclonic epilepsy,
• primary generalized tonic-clonic seizures in patients aged 12 years or older with idiopathic generalized epilepsy.

Do not take Levetiracetam Kern Pharma

• If you are allergic (hypersensitive) to levetiracetam or to any of the other components 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 your dose.
• If you notice any decrease in your child's growth or an unexpected development of puberty, contact your doctor.
• If you notice an increase in the severity of seizures (e.g. an increase in frequency), contact your doctor.
• A small number of people taking antiepileptic medications such as levetiracetam have had thoughts of self-harm or suicide. If you have any symptoms of depression and/or suicidal thoughts, contact your doctor.

Inform your doctor or pharmacist if any of the following adverse effects worsen or last more than a few days:

• Abnormal thoughts, feeling of irritability, or if you or your family and friends notice significant changes in mood or behavior.

Taking other medications

Inform your doctor or pharmacistif you are using or have recently used other medications, including those purchased without a prescription.

Taking Levetiracetam Kern Pharma with food and beverages

You can take Levetiracetam Kern Pharma with or without meals. As a precaution, do not take Levetiracetam Kern Pharma with alcohol.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medication.

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

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

Breastfeeding is not recommended during treatment.

Driving and operating machinery

Levetiracetam may affect your ability to drive or operate tools or machinery, as it may cause drowsiness. This is more likely at the beginning of treatment or when the dose is increased. Do not drive or operate machinery until it is confirmed that your ability to perform these activities is not affected.

Follow exactly the administration instructions of Levetiracetam Kern Pharma as indicated by your doctor. Consult your doctor if you have any doubts.

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

Take the number of tablets prescribed by your doctor.

Monotherapy

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

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

When starting to take levetiracetam, your doctor will prescribe alower dosefor two weeks before administering the general lowest dosage.

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

Concomitant therapy

Dosage in adults and adolescents (12 to 17 years old) with a weight of50 kg or more:

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

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

Dosage in infants (6 to 23 months), children (2 to 11 years), and adolescents (12 to 17 years) with a weight less than 50 kg:

Your doctor will prescribe the most appropriate pharmaceutical form of levetiracetam based on age, weight, and dosage.

Levetiracetam 100 mg/ml oral solution is a more suitable presentation for infants and children under 6 years old.

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

For example: for a general dosage of 20 mg per kg of body weight per day, you should give the child weighing25 kg1 tablet in the morning and 1 tablet at night.

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

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

Administration form:

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

Treatment duration:

• Levetiracetam is used as a chronic treatment. You should continue with thetreatment with Levetiracetam for the time indicated by your doctor.
• Do not stop your treatment without your doctor's recommendation, as it may increase your seizures.If your doctor decides to stop your treatment with levetiracetam, they 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, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

The possible adverse effects of a levetiracetam overdose 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 forgot to take Levetiracetam Kern Pharma

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

Do not take a double dose to compensate for the missed doses.

If you interrupt the treatment with Levetiracetam Kern Pharma

Like with other antiepileptic medications, the termination of treatment with levetiracetam should be done gradually to avoid an increase in seizures.

If you have any other doubts about the use of this product, ask your doctor or pharmacist.

Like all medicines, Levetiracetam Kern Pharma may have side effects, although not everyone will experience them.

Inform your doctor if you have any of the following side effects and they concern you.

Some 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.

Inform your doctor immediately, or go to the emergency service of your nearest hospital if you experience:

• weakness, dizziness, or difficulty breathing, as these may be signs of a severe allergic reaction (anaphylactic)

• swelling of the face, lips, tongue, or throat (Quincke's edema)

• symptoms of flu and rash on the face followed by a prolonged rash with elevated temperature, elevated liver enzymes in blood tests, and an increase in a type of white blood cell (eosinophilia) and enlarged lymph nodes (drug reaction with eosinophilia and systemic symptoms (DRESS))

• symptoms such as decreased urine output, fatigue, nausea, vomiting, confusion, and swelling of legs, arms, or feet, as it may be a sign of sudden kidney function decline

• a skin rash that may form blisters and may appear as small dots (central dark spots surrounded by a lighter area, with a dark ring around the edge)

• a generalized 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 decline (forgetfulness), abnormal behavior, 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 patients)

common (may affect between 1 and 10 in 100 patients)

uncommon (may affect between 1 and 10 in 1,000 patients)

rare (may affect between 1 and 10 in 10,000 patients)

very rare (may affect fewer than 1 in 10,000 patients)

frequency not known (cannot be estimated from available data)

Very common:

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

Common:

• infection, nasopharyngitis;
• decreased platelet count;
• anorexia (loss of appetite), weight gain;
• agitation, depression, emotional instability/mood changes, hostility or aggression, insomnia, nervousness or irritability, personality disorders (behavioral problems), abnormal thinking (slow thinking, difficulty concentrating);
• dizziness (feeling unsteady), seizures, headache, hyperkinesia (hyperactivity), ataxia (coordinated movement altered), tremor (involuntary shaking), amnesia (memory loss), balance disorder, attention disorder (loss of concentration), memory decline (forgetfulness);
• diplopia (double vision), blurred vision;
• vertigo (feeling of rotation);
• increased cough (existing cough);
• abdominal pain, nausea, dyspepsia (heavy digestion, burning, and acidity), diarrhea, vomiting;
• skin rash, eczema, itching;
• muscle pain;
• accidental injury.

Rare:

• decreased sodium concentration in blood;
• sudden decline in kidney function;
• rhabdomyolysis (muscle tissue breakdown) and associated elevated creatine phosphokinase in blood.

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

Frequency not known:

• decreased red and/or white blood cells;
• weight loss;
• abnormal behavior, anger, anxiety, confusion, hallucinations, mental changes, suicide, attempted suicide, and suicidal thoughts;
• paresthesia (tingling), difficulty controlling movements, intractable muscle spasms affecting the head, torso, and limbs;
• pancreatitis (pancreas inflammation), liver insufficiency, hepatitis (liver inflammation), abnormal liver function test results;
• hair loss, skin blisters on the skin, in the mouth, eyes, and genital area, skin rash.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep out of reach and sight of children.

Do not use this medicine after the expiry date that appears on the carton and in the blister after CAD.

The expiry date is the last day of the month indicated.

This medicine does not require special conditions for conservation.

Medicines should not be thrown down the drains or in the trash. Dispose of the packaging and medicines you no longer need at the SIGRE collection point of the pharmacy.If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need.By doing so, you will help protect the environment.

Composition of Levetiracetam Kern Pharma 250 mg film-coated tablets

-The active ingredient is Levetiracetam. Each film-coated tablet contains 250 mg of levetiracetam.

-The other components are:

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

Film-coating: Opadry 85F20694 (partially hydrolyzed polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc, aluminum lacquer with indigo carmine (E132)).

Appearance of the product and content of the packaging

The film-coated tablets are blue, oval in shape, and scored on one side. The score serves to break and facilitate swallowing but not to divide into equal doses.

The packaging contains 60 film-coated tablets.

Levetiracetam Kern Pharma is also available in film-coated tablets of 500 mg in packaging of 60 and 100 tablets and of 1,000 mg in packaging of 30 and 60 tablets..

Only some package sizes may be commercially available.

Marketing authorization holder

Kern Pharma, S.L.

Venus, 72 - Pol. Ind.Colón II

08228 Terrassa - Barcelona

Spain

Responsible for manufacturing

NOUCOR HEALTH, S.A.

Av. Camí Reial, 51-57

08184-Palau-solità i Plegamans

(Barcelona-Spain)

Last review date of this leaflet: October 2019

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)www.aemps.gob.es