Genlev 100 mg/ml Oral Solution – patient leaflet, side effects, dosage

1. What Genlev is and what it is used for

Genlev contains the active ingredient levetiracetam, is an antiepileptic medicine which is used to treat various forms of epilepsy (seizures that are initially limited to certain parts of the brain, whether the seizure spreads to other parts of the brain or not). Genlev can be used:

• on its own in adults and adolescents from 16 years of age with newly diagnosed epilepsy, to treat a certain form of epilepsy. Epilepsy is a condition where the patients have repeated fits (seizures). Levetiracetam is used for the epilepsy form in which the fits initially affect only one side of the brain, but could thereafter extend to larger areas on both sides of the brain (partial onset seizure with or without secondary generalisation). Levetiracetam has been given to you by your doctor to reduce the number of fits.

• as an add-on to other antiepileptic medicines to treat:

  • partial onset seizures with or without generalisation in adults, adolescents, children

    and infants from one month of age

  • myoclonic seizures (short, shock-like jerks of a muscle or group of muscles) in

    adults and adolescents from 12 years of age with juvenile myoclonic epilepsy

  • primary generalised tonic-clonic seizures (major fits, including loss of

    consciousness) in adults and adolescents from 12 years of age with idiopathic generalised epilepsy (the type of epilepsy that is thought to have a genetic cause).

2. What you need to know before you take Genlev

Do not take Genlev:

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

Warnings and precautions

Talk to your doctor or pharmacist before taking Genlev

• if you suffer kidney problems, as your doctor may need to adjust your dose.
• if you notice any slow down in the growth or unexpected puberty development of your child, please contact your doctor.
• A small number of people being treated with anti-epileptics such as Genlev have had thoughts of harming or killing themselves. If you have any symptoms of depression and/or suicidal ideation, immediately contact your doctor.
• If you have a family or medical history of irregular heart rhythm (visible on an electrocardiogram), or if you have a disease and/or take a treatment that make(s) you prone to heartbeat irregularities or salt imbalances.

Tell your doctor or pharmacist if any of the following side effects gets serious or last longer than a few days:

• Abnormal thoughts, feeling irritable or reacting more aggressivekly than usually, or if you or your family and friends notice important changes in mood or behaviour.

• Aggravation of epilepsy

  Your seizures may rarely become worse or happen more often, mainly during the first month after the start of the treatment or increase of the dose. If you experience any of these new symptoms while taking Genlev, see a doctor as soon as possible Children and adolescents

Genlev is not indicated in children and adolescents below 16 years on it’s own (monotherapy). Other medicines and Genlev

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, even medicines bought without a prescription.

Do not take macrogol (a drug used as laxative) for one hour before and one hour after taking levetiracetam as this may results in a reduction of its effect.

If you are taking Methotrexate (used for arthritis or immune diseases), Genlev can cause methotrexate to stay in your blood for a longer period of time and at higher levels than normal. This can potentially be toxic, and your doctor will monitor your blood for levels of the two drugs.

Genlev with food and drink

Genlev can be taken with or without food.

Fertility, pregnancy and breast-feeding

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine. Genlev can be used during pregnancy, only if after careful assessment it is considered necessary by your doctor. You should not stop your treatment without discussing this with your doctor. A risk of birth defects for your unborn child cannot be completely excluded. Breast-feeding is not recommended during treatment or while breast-feeding unless you are told otherwise by your doctor.

Driving and using machines

Genlev may impair your ability to drive or operate any tools or machinery, as it may make you feel sleepy. It may cause dizziness, drowsiness and tiredness. This is more likely at the beginning of treatment or after an increase in the dose. You should not drive or use machinery until it is established that your ability to perform such activities is not affected.

Genlev contains methyl parahydroxybenzoate, propyl parahydroxybenzoate and maltitol

Genlev contains methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216) which may cause allergic reactions (possibly delayed). It also contains maltitol. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product

3. How to take Genlev

Always take Genlev exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Your doctor will determine what dose is appropriate for you. If you have the impression that the effect of Genlev is too strong or too weak, talk to your doctor or pharmacist as dose changes need to be made gradually.

Genlev must be taken twice a day, once in the morning and once in the evening, at about the same time each day. Take the oral solution following your doctor’s instructions.

Monotherapy

Dose in adults (≥18 years) and adolescents (from 16 years of age):

Measure the appropriate dosage using the 10 ml syringe included in the package for patients 4 years and above.

General dose: Genlev is taken twice daily, in two equally divided doses,each individual dose being measured between 5 ml (500 mg) and 15 ml (1500 mg). When you will first start taking Genlev, your doctor will prescribe you a lower dose for two weeks before giving you the lowest general dose.

Children and adolescents under 16 years of age

Genlev is not recommended for use as a monotherapy in this age group. Add-on therapy

Dose in adults and adolescents (12 to 17 years) weighing 50 kg or more:

Measure the appropriate dosage using the 10 ml syringe included in the package for patients of 4 years and above.

General dose: Genlev is taken twice daily, in two equally divided doses, each individual dose being measured between 5 ml (500 mg) and 15 ml (1500 mg).

Dose in children 6 months and older:

Your doctor will prescribe the most appropriate pharmaceutical form of Genlev according to the age, weight and dose.

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

For children above 4 years, measure the appropriate dosage using the 10 ml syringe included in the package.

General dose: Genlev is taken twice daily, in two equally divided doses, each individual dose being measured between 0.1 ml (10 mg) and 0.3 ml (30 mg), per kg body weight of the child (see table below for dose examples)

Dose in children 6 months and older:

Dose in infants (1 month to less than 6 months)

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

General dose: Genlev is taken twice daily, in two equally divided doses, each individual dose being measured between 0.07 ml (7 mg) and 0.21 ml (21 mg), per kg bodyweight of infant.(see table below for dose example).

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

Method of administration:

After measuring the correct dose with an appropriate syringe, Genlev may be diluted in a glass of water or baby's bottle. You may take Genlev with or without food. After oral administration the bitter taste of levetiracetam may be experienced.

Instructions for use:

Open the bottle, press the cap and turn it anticlockwise (figure 1).

Separate the adaptor from the

syringe (figure 2).

Insert the adaptor into the bottle

neck (figure 3).

Ensure it is well fixed.

Take the syringe and put it in the

adaptor opening (figure 4).

Turn the bottle upside down

(figure 5).

Fill the syringe with a small amount of solution by pulling the piston down (figure 5A), then push the piston upward in order to remove any possible bubbles (figure 5B). Pull the piston down to the graduation mark corresponding to the quantity in millilitres (ml) prescribed by your doctor (figure 5C).

Turn the bottle the right way

up (figure 6A).

Remove the syringe from the

adaptor (figure 6B).

Empty the contents of the syringe in a glass of

water or baby’s bottle by pushing the piston to

the bottom of the syringe (figure 7).

Drink the whole contents of the glass / baby’s bottle.

Close the bottle with the plastic screw cap.

Wash the syringe with water only (figure 8).

Duration of treatment:

• Genlev is used as a chronic treatment. You should continue Genlev treatment for as long as your doctor has told you.
• Do not stop your treatment without your doctor’s advice as this could increase your seizures.

If you take more Genlev than you should

Call your doctor or go to the nearest hospital emergency unit immediately. Take this leaflet and the remaining medicine with you so that the doctor knows what you have taken. The symptoms of an overdose can include sleepiness, agitation, aggression, loss of consciousness, reduced alertness, breathing problems and coma.

If you forget to take Genlev

If you forget to take a dose, take it as soon as you remember unless it is time for your next dose. Do not take a double dose to make up for a forgotten dose.

If you stop taking Genlev

Do not stop taking Genlev unless your doctor tells you to. If your treatment is stopped it should be done gradually. If you stop taking Genlev suddenly or before your doctor tells you, there is an increased risk of seizures.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Tell your doctor immediately or go to your nearest emergency department, if you experience:

• weakness, feel light-headed or dizzy or have difficulty breathing, as these may be signs of a serious allergic (anaphylactic) reaction
• swelling of the face, lips, tongue or throat (Quinche’s oedema)
• flu-like symptoms and a rash on the face followed by an extended rash with a high temperature, increased levels of liver enzymes seen 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 volume, tiredness, nausea, vomiting, confusion and swelling in the legs, ankles or feet, as this may be a sign of sudden decrease of kidney function
• skin rash, which may form blisters and looks like small targets (central dark spots surrounded by a paler area, with a dark ring around the edge) (erythema multiforme)
• a widespread rash with blisters and peeling skin, particularly around the mouth, nose, eyes and genitals (Stevens-Johnson syndrome)
• a more severe form of rash causing skin peeling in 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 (sleepiness), amnesia (loss of memory), memory impairment (forgetfulness), abnormal behaviour or other neurological signs including involuntary or uncontrolled movements. These could be symptoms of an encephalopathy. The most frequently reported side effects are nasopharyngitis, somnolence (sleepiness), headache, fatigue and dizziness. At the beginning of the treatment or at dose increase side effects like sleepiness, tiredness and dizziness may be more common. These effects should however decrease over time.

Very common side effects (may affect more than 1 in 10 people)

• somnolence (sleepiness), headache
• nasopharyngitis

Common side effects (may affect up to 1 in 10 people)

• anorexia (loss of appetite)
• depression, hostility, aggression, anxiety, insomnia, nervousness or irritability
• convulsions, balance disorder (equilibrium disorder), dizziness (sensation of unsteadiness), lethargy (lack of energy and enthusiasm), tremor (involuntary trembling)
• vertigo

• cough

  • abdominal pain, diarrhoea, dyspepsia (indigestion), vomiting, nausea
  • rash
  • asthenia, fatigue (tiredness)

Uncommon side effects (may affect up to 1 in 100 people)

• decreased number of blood platelets, decreased number of white blood cells
• weight decrease, weight increase
• attempts or thoughts of suicide, mental disorder, abnormal behaviour, hallucinations, anger, confusion, panic attacks, emotional instability/mood swings, agitation
• amnesia (loss of memory), memory impairment (forgetfulness), abnormal coordination/ataxia (impaired coordinated movements), paraesthesia (tingling), disturbance in attention (loss of concentration)
• diplopia (double vision) or blurred vision
• elevated/abnormal values in a liver function test
• hair loss, eczema, itching
• muscle weakness, myalgia (muscle pain)
• injury

Rare side effects (may affect up to 1 in 1000 people)

• infection
• decreased number of all blood cell types
• severe allergic reactions (DRESS, anaphylactic reaction [severe and important allergic reaction], Quincke’s oedema [swelling of the face, lips, tongue and throat])
• decreased blood sodium concentration
• suicide, personality disorder (behavioural problems), abnormal thinking (slow thinking, unable to concentrate)
• delirium
• encephalopathy (see sub-section “Tell your doctor immediately” for a detailed description of symptoms)
• seizures may become worse or happen more often
• uncontrollable muscle spasms affecting the head, torso and limbs, difficulty in controlling movements, hyperkinesia (hyperactivity)
• change of the heart rhythm (Electrocardiogram)
• inflammation of the pancreas
• liver failure or inflammation of the liver
• sudden decrease in kidney function
• rhabdomyolysis (breakdown of muscle tissue) and associated blood creatinine phosphokinase increase. Prevalence is significantly higher in Japanese patients when compared to non-Japanese patients
• limp or difficulty walking
• skin rash, which may form blisters and looks like small targets (central dark spots surrounded by a paler area, with a dark ring around the edge) (erythema multiforme), a widespread rash with blisters and peeling skin, particularly around the mouth, nose, eyes and genitals (Stevens-Johnson syndrome), and a more severe form causing skin peeling in more than 30% of the body surface (toxic epidermal necrolysis)
• combination of fever, muscle stiffness, unstable blood pressure and heart rate, confusion, low level of consciousness (may be signs of a disorder called neuroleptic malignant syndrome). Prevalence is significantly higher in Japanese patients when compared to non-Japanese patients

Very rare (may affect up to 1 in 10000 people)

• repeated unwanted thoughts or sensations or the urge to do something over and over again (Obsessive Compulsive Disorder).

Reporting of side effects

If you get 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 Yellow Card Scheme at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Genlev

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

Do not use this medicine after the expiry date which is stated on the bottle. The expiry date refers to the last day of that month.

This medicinal product does not require any special temperature storage conditions. Store in the original container in order to protect from light.

Do not use this medicine 7 months after you first opened the bottle.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Genlev contains

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

The other ingredients are maltitol liquid, glycerol, methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), citric acid monohydrate, sodium citrate, ammonium glycyrrhizate, acesulfame potassium, grape flavouring, purified water.

What Genlev looks like and contents of the pack

Genlev 100 mg/ml Oral Solution is a clear, colourless, grape flavoured liquid. The 300 ml glass bottle of Genlev (for children aged 4 years and above, adolescents and adults) is packed in a cardboard box containing a 10 ml oral syringe (graduated every 0.25 ml) and an adaptor for the syringe.

The 150 ml glass bottle of Genlev (for infants and young children aged from 6 months to less than 4 years) is packed in a cardboard box containing a 3 ml oral syringe (graduated every 0.1 ml) and an adaptor for the syringe.

The 150 ml glass bottle of Genlev (for infants aged 1 month to less than 6 months) is packed in a cardboard box containing a 1 ml oral syringe (graduated every 0.05 ml) and an adaptor for the syringe.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Activase Pharmaceuticals Limited, 11 Boumpoulinas, 3rd Floor, P.C. 1060 Nicosia, Cyprus

Manufacturer

Pharmadox Healthcare Limited, KW20A Kordin Industrial Park, Paola, PLA 3000, Malta

For any information about this medicine, please contact the Marketing Authorisation Holder.

This leaflet was last revised in 06/2023.

A0146/O/PIL/A5