LEVETIRACETAM KERN PHARMA 100 mg/ml ORAL SOLUTION

Introduction

Package Leaflet: Information for the User

Levetiracetam Kern Pharma 100 mg/ml Oral Solution EFG

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.

Contents of the pack:

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 other 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 adults and adolescents 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 adults, adolescents and children from 1 month of age.
• myoclonic seizures in adults and adolescents from 12 years of age with juvenile myoclonic epilepsy.

primary generalised tonic-clonic seizures in adults and adolescents from 12 years of age with idiopathic generalised epilepsy.

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

Do not takeLevetiracetam 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 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 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 Kern Pharma 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 serious or lasts longer than a few days:

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

Interaction of Levetiracetam Kern Pharma with other medicines

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

Interaction ofLevetiracetam Kern Pharmawith food, drink and alcohol

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

Pregnancy, breast-feeding and fertility

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

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

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 the reproductive system 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 Kern Pharma 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 such activities is not affected.

Levetiracetam Kern Pharma contains methylparahydroxybenzoate (E218), propylparahydroxybenzoate (E216) and maltitol.

Since it contains methylparahydroxybenzoate (E218) and propylparahydroxybenzoate (E216), it may cause allergic reactions (possibly delayed).

If your doctor tells you that you have an intolerance to some sugars, contact your doctor before taking this medicine.

3. How to take Levetiracetam Kern Pharma

Follow exactly the instructions of administration of Levetiracetam Kern Pharma given by your doctor or pharmacist. Ask your doctor or pharmacist if you have any doubts.

Levetiracetam Kern Pharma must be taken twice a day, once in the morning and once in the evening, approximately at the same time every day.

Take the oral solution as instructed by your doctor.

Monotherapy

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

Measure the appropriate dose using the 10 ml syringe provided in the pack for patients from 4 years of age onwards.

General dose:

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

When starting treatment with Levetiracetam Kern Pharma, your doctor will prescribe a lower dosefor two weeks before giving you the lowest general dose.

Concomitant therapy

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

Measure the appropriate dose using the 10 ml syringe provided in the pack for patients from 4 years of age onwards.

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

Dose in children from 6 months of age onwards:Your doctor will prescribe the most appropriate pharmaceutical form of Levetiracetam Kern Pharma according to the age, weight and dose.

For children from 6 months to 4 years, measure the appropriate dose using the 3 ml syringe provided in the pack.

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

General dose: Levetiracetam Kern Pharma is taken twice a day, divided into two equal doses, each of 0.1 ml (10 mg) to 0.3 ml (30 mg) per kg of the child's body weight (see examples of doses in the table below).

Dose in children from 6 months of age onwards:

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

For infants from 1 month to less than 6 months, measure the appropriate dose using the 1 mlsyringe provided in the pack.

General dose: Levetiracetam Kern Pharma is taken twice a day, divided into two equal doses, each of 0.07 ml (7 mg) to 0.21 ml (21 mg) per kg of the infant's body weight (see examples of doses in the table below).

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

Method of administration

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 baby bottle.

Instructions for correct administration:

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

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

• Take the syringe and insert it into the adapter opening (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 upright (figure 6A). Remove the syringe from the adapter (figure 6B).

• Empty the contents of the syringe into a glass of water or a baby bottle, 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).

Duration of treatment

• 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 your treatment without your doctor's recommendation, as your seizures may increase. If your doctor decides to stop your treatment with Levetiracetam Kern Pharma, he/she will give you instructions for gradual withdrawal of Levetiracetam Kern Pharma.

If you take more Levetiracetam Kern Pharma than you should

Possible side effects of an overdose of Levetiracetam Kern Pharma are drowsiness, agitation, aggression, decreased alertness, respiratory depression 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, telephone 91 562 04 20, indicating the medicine and the amount ingested.

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 Kern Pharma 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 get any of the following side effects and it worries 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 (Quincke's edema)
  • 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 central spots 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 that causes 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 uncontrolled or involuntary 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 people)

common (affects between 1 and 10 in 100 people)

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

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

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

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

Very common:

• nasopharyngitis;
• drowsiness (feeling of sleep), headache.

Common:

• anorexia (loss of appetite);
• depression, hostility or aggression, anxiety, insomnia, nervousness or irritability;
• seizures, balance disorder, dizziness (feeling of instability), lethargy, tremor (involuntary tremor);
• vertigo (feeling of rotation);
• cough;
• abdominal pain, diarrhoea, dyspepsia (indigestion, heartburn and acidity), vomiting, nausea;
• skin rash;
• asthenia/fatigue (feeling of weakness).

Uncommon:

• decrease in platelet count, decrease in white blood cells;
• weight loss, weight gain;
• suicidal thoughts and attempts, mental disorders, abnormal behaviour, hallucinations, anger, confusion, emotional instability/mood changes, agitation;
• amnesia (memory loss), memory impairment (lack of memory), abnormal coordination/ataxia (altered movement coordination), paraesthesia (tingling), attention disorders (loss of concentration);
• abnormal liver function tests;
• hair loss, eczema, itching;
• muscle weakness, myalgia (muscle pain);
• injury.

Rare:

• infection;
• decrease in red and/or white blood cells;
• suicide, personality disorders (behavioural problems), abnormal thinking (slow thinking, difficulty concentrating);
• uncontrolled muscle spasms that affect the head, torso and limbs, difficulty controlling movements, hyperkinesia (hyperactivity);
• pancreatitis (inflammation of the pancreas);
• liver failure, hepatitis (inflammation of the liver);
• blisters on the skin, in the mouth, eyes and genital area, skin rash;
• 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.

If you think any of the side effects you are experiencing are serious, or if you notice any side effects not listed in this leaflet, tell your doctor or pharmacist.

Reporting of side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly through 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 this medication out of sight and reach of children.

Store in the original packaging to protect it from light.

Do not use Levetiracetam Kern Pharma after the expiration date shown on the packaging after "CAD". The expiration date is the last day of the indicated month.

Do not use after 7 months of opening the packaging.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and unused medicines at the SIGRE Point of the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and unused medicines. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Levetiracetam Kern Pharma

• The active ingredient is levetiracetam. Each ml of oral solution contains 100 mg of levetiracetam.
• The other components are: sodium citrate, citric acid monohydrate, methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), ammonium glycyrrhizate, glycerol (E422), liquid maltitol (E965), acesulfame K (E950), grape flavor, purified water.

Appearance of the Product and Package Contents

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

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

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

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

Marketing Authorization Holder

Kern Pharma, S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

Manufacturer

Zaklady Farmaceutyczne POLPHARMA S.A.

Oddzial Medana w Sieradzu

ul. W. Lokietka 10, 98-200 Sieradz

Poland

Date of the Last Revision of this Leaflet: November 2019.

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/