Leaflet: information for the user

Levetiracetam Kern Pharma 100 mg/ml oral solution EFG

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, consult your doctor or pharmacist.

-This medicine has been prescribed for you and should not be given to others, even if they have the same symptoms of the disease, 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.

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

2. What you need to know before 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 secondary 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 takeLevetiracetam 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 the instructions of your doctor who will decide if you need to adjust the dose to take.
• If you notice any decrease in your child's growth or an unexpected onset of puberty, contact your doctor.
• If you notice an increase in the severity of seizures (e.g. increase in number), contact your doctor.
• A small number of people taking antiepileptic medications such as Levetiracetam Kern Pharma 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 reacting more aggressively than normal or if you or your family and friends notice significant changes in mood or behavior.

Interaction of Levetiracetam Kern Pharma with other medications

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

Interaction ofLevetiracetam Kern Pharmawith food, drink, and alcohol

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

Pregnancy, breastfeeding, and fertility

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

Levetiracetam Kern Pharma contains parahydroxybenzoic acid methyl ester (E218), parahydroxybenzoic acid propyl ester (E216), and maltitol.

Containing parahydroxybenzoic acid methyl ester (E218) and parahydroxybenzoic acid propyl ester (E216) may cause allergic reactions (possibly delayed).

If your doctor informs you that you have intolerance to some sugars, contact your doctor before taking this medication.

Follow exactly the administration instructions for Levetiracetam Kern Pharma indicated by your doctor or pharmacist. Consult your doctor or pharmacist if you have doubts.

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

Take the oral solution according to your doctor's instructions.

Monotherapy

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

Measure the appropriate dose using the 10 ml syringe included in the packaging for patients 4 years of age and older.

Dosage:

Levetiracetam Kern Pharma is taken twice a day, divided into two equal doses, each of between 5 ml (500 mg) and 15 ml (1500 mg).

When starting to take Levetiracetam Kern Pharma, your doctor will prescribe a lower dose for two weeks before administering the lowest general dose.

Concomitant therapy

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

Measure the appropriate dose using the 10 ml syringe included in the packaging for patients 4 years of age and older.

Dosage:Levetiracetam Kern Pharma is taken twice a day, divided into two equal doses, each of between 5 ml (500 mg) and 15 ml (1500 mg).

Dosage in children 6 months of age and older:Your doctor will prescribe the most appropriate pharmaceutical form of Levetiracetam Kern Pharma based on age, weight, and dose.

For children 6 months to 4 years, measure the appropriate dose using the 3 ml syringe included in the packaging.

For children over 4 years,measure the appropriate dose using the 10 ml syringe included in the packaging.

Dosage: Levetiracetam Kern Pharma is taken twice a day, divided into two equal doses, each of between 0.1 ml (10 mg) and 0.3 ml (30 mg) per kilogram of body weight of the child (see examples of doses in the table below).

Dosage in children 6 months of age and older:

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

For infants 1 month to less than 6 months, measure the appropriate dose using the 1 ml syringe included in the packaging.

Dosage: Levetiracetam Kern Pharma is taken twice a day, divided into two equal doses, each of between 0.07 ml (7 mg) and 0.21 ml (21 mg) per kilogram of body weight of the infant (see examples of doses in the table below).

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

Administration form

After measuring the correct dose with an appropriate syringe, Levetiracetam Kern Pharma can be taken by diluting the oral solution in a glass of water or in a bottle.

Instructions for correct administration:

• Open the bottle: press the cap and unscrew in the opposite direction to the clock hands (figure 1).

• Insert the adapter into the neck of the bottle (figure 2). Make sure it is securely fixed.

• Take the syringe and insert it into the opening of the adapter (figure 3).

• Put the bottle upside down (figure 4).

• Fill the syringe with a small amount of solution by lowering the plunger (figure 5A) and then raising it to eliminate any possible bubbles (figure 5B). Lower the plunger to the graduation mark corresponding to the dose in milliliters (ml) prescribed by your doctor (figure 5C).

• Put the bottle right side up (figure 6A). Remove the syringe from the adapter (figure 6B).

• Empty the contents of the syringe into a glass of water or a bottle by lowering the plunger to the end of the syringe (figure 7).

• Drink the entire contents of the glass.

• Close the bottle with the plastic screw cap.

• Wash the syringe with water (figure 8).

Treatment duration

• Levetiracetam Kern Pharma is used as a chronic treatment. You should continue treatment with Levetiracetam Kern Pharma for the time indicated by your doctor.
• Do not stop treatment without your doctor's recommendation, as this may increase your seizures.If your doctor decides to stop your treatment with Levetiracetam Kern Pharma, they will give you instructions for the gradual withdrawal of Levetiracetam Kern Pharma.

If you take more Levetiracetam Kern Pharma than you should

The possible adverse effects of an overdose of Levetiracetam Kern Pharma are drowsiness, agitation, aggression, decreased alertness, respiratory inhibition, and coma.

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

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.

If you forget to takeLevetiracetam 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 treatment withLevetiracetam Kern Pharma

Like with other antiepileptic medications, the discontinuation of treatment with Levetiracetam Kern Pharma 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 medications, Levetiracetam Kern Pharma can produce 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)
  • flu-like symptoms and a 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 low urine output, fatigue, nausea, vomiting, confusion, and swelling of the legs, arms, or feet, as it may be a sign of sudden kidney function decline a skin rash that can form blisters and may appear as small dots (central dark spots surrounded by a lighter area, with a dark ring around the edge) (erythema multiforme)
• 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 (affects more than 1 in 10 patients)

common (affects between 1 and 10 in 100 patients)

uncommon (affects between 1 and 10 in 1,000 patients)

rare (affects between 1 and 10 in 10,000 patients)

very rare (affects less than 1 in 10,000 patients)

frequency unknown (cannot be estimated from available data)

Very common:

• nasopharyngitis;
• drowsiness (drowsiness), headache.

Common:

• anorexia (loss of appetite);
• depression, hostility or aggression, anxiety, insomnia, nervousness or irritability;
• seizures, balance disorder, dizziness (sensation of instability), lethargy, tremor (involuntary shaking);
• vertigo (sensation of rotation);
• cough;
• abdominal pain, diarrhea, dyspepsia (heavy digestion, burning, and acidity), vomiting, nausea;
• skin rash;
• asthenia/weakness (sensation of weakness).

Uncommon:

• decrease in platelet count, decrease in white blood cell count;
• weight loss, weight gain;
• suicidal attempt and suicidal thoughts, mental alterations, abnormal behavior, hallucinations, anger, confusion, emotional instability/mood changes, agitation;
• amnesia (memory loss), memory decline (forgetfulness), abnormal coordination/ataxia (coordinated movement altered), paresthesia (tingling), attention alterations (loss of concentration);
• abnormal results in liver function tests;
• hair loss, eczema, itching;
• muscle weakness, myalgia (muscle pain);
• injury.

Rare:

• infection;
• decrease in red blood cell and/or white blood cell count;
• suicide, personality disorders (behavior problems), abnormal thinking (slow thinking, difficulty concentrating);
• involuntary muscle spasms affecting the head, torso, and limbs, difficulty controlling movements, hyperkinesia (hyperactivity);
• pancreatitis (inflammation of the pancreas);
• hepatic insufficiency, hepatitis (inflammation of the liver);
• skin blisters in the mouth, eyes, and genital area, skin rash;
• decrease in sodium concentration in the blood.
• sudden decline in kidney function;
• rhabdomyolysis (muscle tissue breakdown) and associated elevated creatine phosphokinase in the blood.

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

If you consider that any of the side effects you are experiencing are severe or if you notice any side effects not mentioned in this prospectus, inform your doctor or pharmacist.

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 not listed 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 medication.

Keep this medication out of the sight and reach of children.

Store in the original packaging to protect it from light.

Do not useLevetiracetam Kern Pharmaafter the expiration date that appears on the packaging after “CAD”. The expiration date is the last day of the month indicated.

Do not use after 7 months of opening the packaging.

Medicines should not be disposed of through drains or in the trash. Deposit the packaging and medicines you no longer need at the SIGRE collection pointof the pharmacy.If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. In this way, you will help protect the environment.

Composition of Levetiracetam Kern Pharma

• The active ingredient is levetiracetam. Each milliliter of oral solution contains 100 mg of levetiracetam.
• The other components are: citrato de sodio, ácido cítrico monohidrato, parahidroxibenzoato de metilo (E218), parahidroxibenzoato de propilo (E216), glicirrizato de amonio, glicerol (E422), maltitol líquido (E965), acesulfamo K (E950), aroma de uva, agua purificada.

Appearance of the product and content of the container

Levetiracetam Kern Pharma is a transparent liquid. It is presented in a 300 ml glass bottle or a 150 ml glass bottle.

The 300 ml glass bottle of Levetiracetam Kern Pharma (for children aged 4 years and older, adolescents, and adults) is packaged in a cardboard box accompanied by a 12 ml oral syringe (graduated every 0.25 ml) and an adapter for the syringe.

The 150 ml glass bottle of Levetiracetam Kern Pharma (for infants aged 6 months and older and children aged 2 to 4 years) is packaged in a cardboard box accompanied by a 3 ml oral syringe (graduated every 0.1 ml) and an adapter for the syringe.

The 150 ml glass bottle of Levetiracetam Kern Pharma (for infants aged 1 month to less than 6 months) is packaged in a cardboard box accompanied by a 1 ml oral syringe (graduated every 0.05 ml) and an adapter for the syringe.

Holder of the marketing authorization of the marketing authorization

Kern Pharma, S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

Responsible for manufacturing

Zaklady Farmaceutyczne POLPHARMA S.A.

Oddzial Medana w Sieradzu

ul. W. Lokietka 10, 98-200 Sieradz

Poland

Last review date of this leaflet: November 2019.

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