Keppra 100 mg/ml oral solution

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Keppra 100 mg/ml oral solution

Levetiracetam

Read this entire leaflet carefully before you or your child 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 only and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

1. What Keppra is and what it is used for
2. What you need to know before taking Keppra
3. How to take Keppra
4. Possible side effects
5. How to store Keppra
6. Contents of the pack and other information

1. What Keppra is and what it is used for

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

Keppra is used:

• as monotherapy in adults and adolescents 16 years of age or older with newly diagnosed epilepsy to treat a form of epilepsy. Epilepsy is a condition in which patients have seizures. Levetiracetam is used for the type of epilepsy in which seizures initially affect only one side of the brain but may then spread to broader areas on both sides of the brain (partial-onset seizures with or without secondary generalization). Your doctor has prescribed levetiracetam to reduce the number of seizures.
• in combination with other antiepileptic medicines to treat:
• partial-onset seizures with or without secondary generalization in adults, adolescents, children, and infants from 1 month of age.
• myoclonic seizures (brief, shock-like jerks of a muscle or group of muscles) in adults and adolescents from 12 years of age with juvenile myoclonic epilepsy.
• primary generalized tonic-clonic seizures (major seizures, including loss of consciousness) in adults and adolescents from 12 years of age with idiopathic generalized epilepsy (a type of epilepsy thought to have a genetic cause).

2. What you need to know before taking Keppra

Do not take Keppra

• If you are allergic to levetiracetam, to pyrrolidone derivatives, or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor before starting Keppra

• If you have kidney problems, follow your doctor's instructions, as they will decide whether your dose needs to be adjusted.
• If you notice any growth delay in your child or unexpected development of puberty, contact your doctor.
• A small number of people taking antiepileptic medicines such as Keppra have had thoughts of harming themselves or of suicide. If you experience any symptoms of depression and/or suicidal thoughts, contact your doctor.
• If you have a personal or family history of irregular heartbeat (visible on electrocardiogram), or if you have a disease and/or are taking treatment(s) that may make you prone to cardiac arrhythmias or electrolyte imbalances.

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

• Abnormal thoughts, feeling irritable, or reacting more aggressively than usual, or if you or your family and friends notice significant changes in mood or behaviour.
• Worsening of epilepsy:

Rarely, epileptic seizures may worsen or occur more frequently, especially during the first month after starting treatment or increasing the dose.

In a very rare form of early-onset epilepsy (epilepsy associated with SCN8A mutations) causing multiple seizure types and loss of skills, you may notice that seizures persist or worsen during treatment.

If you experience any of these new symptoms while taking Keppra, seek medical advice as soon as possible.

Children and adolescents

• Treatment with Keppra alone (monotherapy) is not indicated in children and adolescents under 16 years of age.

Taking Keppra with other medicines

Inform your doctor or pharmacist if you are using, have recently used, or might need to use any other medicines.

Do not take macrogol (a medicine used as a laxative) within one hour before or one hour after taking levetiracetam, as it could reduce its effect.

Pregnancy and breastfeeding

If you are pregnant, breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor before using this medicine. Levetiracetam may only be used during pregnancy if, after careful evaluation, your doctor considers it necessary.

Do not stop your treatment without first discussing it with your doctor.

The risk of birth defects for the baby cannot be completely ruled out. Two studies do not suggest an increased risk of autism or intellectual disability in children born to mothers treated with levetiracetam during pregnancy. However, available data on the impact of levetiracetam on infant neurological development are limited.

Breastfeeding is not recommended during treatment.

Driving and using machines

Keppra 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. You should not drive or use machinery until you are certain that your ability to perform these activities is not impaired.

Keppra contains methyl parahydroxybenzoate, propyl parahydroxybenzoate, and maltitol

Keppra 100 mg/ml oral solution contains methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216), which may cause allergic reactions (possibly delayed).

Keppra oral solution also contains maltitol. If your doctor has informed you that you have an intolerance to certain sugars, consult your doctor before taking this medicine.

Keppra contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per ml; therefore, it is essentially “sodium-free”.

3. How to take Keppra

Follow exactly the instructions for administering this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

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

Take the oral solution as directed by your doctor.

Monotherapy (from 16 years of age)

Adults (≥18 years) and adolescents (from 16 years of age):

For patients from 4 years of age, measure the appropriate dose using the 10 ml syringe provided in the package.

Recommended dose: Keppra is taken twice daily in two equal doses, with each individual dose ranging from 5 ml (500 mg) to 15 ml (1,500 mg).

When you first start taking Keppra, your doctor will prescribe a lower dose for two weeks before increasing to the lowest daily dose.

Concomitant therapy

Doses in adults and adolescents (12 to 17 years of age):

For patients from 4 years of age, measure the appropriate dose using the 10 ml syringe provided in the package.

Recommended dose: Keppra is taken twice daily in two equal doses, with each individual dose ranging from 5 ml (500 mg) to 15 ml (1,500 mg).

Doses in children from 6 months of age:

Your doctor will prescribe the most appropriate pharmaceutical form of Keppra depending on the child's age, weight, and required dose.

For children from 6 months to 4 years of age, measure the appropriate dose using the 5 ml syringe provided in the package.

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

Recommended dose: Keppra is taken twice daily in two equal doses, with each individual dose ranging from 0.1 ml (10 mg) to 0.3 ml (30 mg) per kg of the child's body weight (see the following table for dose examples).

Doses in children from 6 months of age:

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

For infants from 1 month to less than 6 months of age, measure the appropriate dose using the 1 ml syringe provided in the package.

Recommended dose: Keppra is taken twice daily, in two equal doses, with each individual dose ranging between 0.07 ml (7 mg) and 0.21 ml (21 mg) per kg of the infant's body weight (see examples of dosing in the table below).

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

Administration method:

After measuring the correct dose with the appropriate syringe, Keppra oral solution may be diluted in a glass of water or in a feeding bottle. You may take Keppra with or without food. A bitter taste may be noticed after oral administration of levetiracetam.

Instructions on how to use the syringe:

• Open the bottle: press down on the cap and unscrew it counterclockwise (Figure 1)

• Follow these steps the first time you take Keppra:

• Separate the oral dosing adapter from the oral syringe (Figure 2).

• Place the adapter onto the top of the bottle (Figure 3). Make sure it is securely attached. There is no need to remove the adapter after use.

• Follow these steps each time you take Keppra:

• Attach the oral syringe into the opening of the adapter (Figure 4).

• Turn the bottle upside down (Figure 5).

• Hold the bottle upside down with one hand and use the other hand to fill the oral syringe.

• Pull the plunger down to draw a small amount of solution into the oral syringe (Figure 5A).

• Then, push the plunger up to expel any possible air bubbles (Figure 5B).

• Pull the plunger down to the graduation mark on the oral syringe corresponding to the dose in milliliters (mL) prescribed by your doctor (Figure 5C). The plunger may rise slightly within the barrel during the first administration. Therefore, ensure the plunger remains in position until the syringe is disconnected from the bottle.

• Turn 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 into a feeding bottle by pushing the plunger down to the end of the syringe (Figure 7).

Duration of treatment:

• Keppra is used as a chronic treatment. You should continue Keppra treatment for the duration indicated by your doctor.
• Do not stop your treatment without your doctor's recommendation, as your seizures may increase.

If you take more Keppra than you should

Possible adverse effects of an overdose of Keppra include 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 determine the most appropriate treatment for the overdose.

If you forget to take Keppra:

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

Do not take a double dose to make up for missed doses.

If you stop taking Keppra:

Discontinuation of Keppra treatment should be done gradually to avoid an increase in seizures. If your doctor decides to stop your Keppra treatment, they will provide you with instructions for the gradual withdrawal of Keppra.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, Keppra can cause adverse effects, although not everyone experiences them.

Contact your doctor immediately, or go to the nearest hospital emergency department if you experience:

• weakness, dizziness or difficulty breathing, as these may be signs of a severe allergic (anaphylactic) reaction
• 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, an increase in a type of white blood cells (eosinophilia), enlarged lymph nodes and involvement of other organs in the body (Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS))
• symptoms such as low urine output, tiredness, nausea, vomiting, confusion and swelling of legs, ankles or feet, as this may be a sign of sudden decrease in kidney function
• a skin rash that may blister and may appear as small targets (dark central spots surrounded by a paler area, with a dark ring around the edge) (erythema multiforme)
• 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 over more than 30% of the body surface (toxic epidermal necrolysis)
• signs of serious mental changes or if someone around you notices signs of confusion, somnolence (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 most frequently reported adverse effects are nasopharyngitis, somnolence (drowsiness), headache, fatigue and dizziness. Adverse effects such as drowsiness, feeling weak and dizziness may be more common when treatment is started or when the dose is increased. However, these adverse effects should decrease over time.

Very common: may affect more than 1 in 10 people

• nasopharyngitis;
• somnolence (drowsiness), headache.

Common: may affect up to 1 in 10 people

• anorexia (loss of appetite);
• depression, hostility or aggression, anxiety, insomnia, restlessness or irritability;
• seizures, balance disorder, dizziness (feeling of unsteadiness), lethargy (lack of energy and enthusiasm), tremor (involuntary shaking);
• vertigo (spinning sensation);
• cough;
• abdominal pain, diarrhoea, dyspepsia (indigestion, heartburn and acid reflux), vomiting, nausea;
• skin rash;
• asthenia/fatigue (feeling of weakness).

Uncommon: may affect up to 1 in 100 people

• decreased number of platelets, decreased white blood cells;
• weight loss, weight gain;
• suicide attempt and suicidal thoughts, mental disturbances, abnormal behaviour, hallucinations, anger, confusion, panic attacks, emotional instability/mood swings, agitation;
• amnesia (memory loss), memory impairment (memory problems), abnormal coordination/ataxia (impaired coordination of movement), paresthesia (tingling), attention disorders (loss of concentration);
• diplopia (double vision), blurred vision;
• elevated/abnormal results in liver function tests;
• hair loss, eczema, itching;
• muscle weakness, myalgia (muscle pain);
• injury.

Rare: may affect up to 1 in 1,000 people

• infection;
• decrease in all types of blood cells;
• severe allergic reactions (DRESS, anaphylactic reaction (serious and severe allergic reaction), angioedema (swelling of face, lips, tongue and throat));
• decreased concentration of sodium in the blood;
• suicide, personality disorders (behavioural problems), abnormal thinking (slow thinking, difficulty concentrating);
• delirium;
• encephalopathy (see subsection “Contact your doctor immediately” for a detailed description of symptoms);
• epileptic seizures may worsen or occur more frequently;
• uncontrolled muscle spasms affecting the head, trunk and limbs, difficulty controlling movements, hyperkinesia (hyperactivity);
• change in heart rhythm (electrocardiogram);
• pancreatitis (inflammation of the pancreas);
• liver failure, hepatitis (inflammation of the liver);
• sudden decrease in kidney function;
• skin rash, which may lead to blisters that may appear as small targets (dark central spots surrounded by a paler area, with a dark ring around the edge) (erythema multiforme), widespread rash with blisters and peeling of the skin, especially around the mouth, nose, eyes and genitals (Stevens-Johnson syndrome) and a more severe form causing peeling of the skin over more than 30% of the body surface (toxic epidermal necrolysis);
• rhabdomyolysis (breakdown of muscle tissue) and associated increase in blood creatine phosphokinase. Prevalence is significantly higher in Japanese patients compared to non-Japanese patients;
• limping or difficulty walking;
• combination of fever, muscle rigidity, unstable blood pressure and heart rate, confusion, decreased level of consciousness (may be signs of a disorder called neuroleptic malignant syndrome). Prevalence is significantly higher in Japanese patients compared to non-Japanese patients.

Very rare: may affect up to 1 in 10,000 people

• unwanted, repeated thoughts or urges to do something over and over again (obsessive-compulsive disorder).

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through the national reporting system included in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Keppra Storage

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

Do not use this medicine after the expiry date stated on the carton and on the bottle after EXP.

The expiry date refers to the last day of the month indicated.

Do not use more than 7 months after opening the container.

Store in the original bottle to protect from light.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Keppra

The active substance is levetiracetam. Each ml contains 100 mg of levetiracetam.

The other components are: sodium citrate, citric acid monohydrate, methyl 4-hydroxybenzoate (E218), propyl 4-hydroxybenzoate (E216), ammonium glycyrrhizinate, glycerol (E422), liquid maltitol (E965), potassium acesulfame (E950), grape flavour, purified water.

Appearance of the product and contents of the pack

Keppra 100 mg/ml oral solution is a clear liquid.

The 300 ml glass bottle of Keppra (for children from 4 years of age, adolescents and adults) is packaged in a cardboard box, together with a 10 ml oral dosing syringe (graduated every 0.25 ml) and a syringe adapter.

The 150 ml glass bottle of Keppra (for infants and young children from 6 months to less than 4 years of age) is packaged in a cardboard box, together with a 5 ml oral dosing syringe (graduated every 0.1 ml from 0.3 ml to 5 ml and every 0.25 ml from 0.25 ml to 5 ml) and a syringe adapter.

The 150 ml glass bottle of Keppra (for infants from 1 month to less than 6 months of age) is packaged in a cardboard box, together with a 1 ml oral dosing syringe (graduated every 0.05 ml) and a syringe adapter.

Marketing Authorisation Holder

UCB Pharma SA, Allée de la Recherche 60, B-1070 Brussels, Belgium.

Manufacturer

NextPharma SAS, 17 Route de Meulan, F-78520 Limay, France

or UCB Pharma SA, Chemin du Foriest, B-1420 Braine-l’Alleud, Belgium

Further information on this medicinal product is available upon request to the local representative of the Marketing Authorisation Holder.

Date of the most recent review of this leaflet:

Other sources of information

Detailed information on this medicine is available on the website of the European Medicines Agency: https://www.ema.europa.eu.