Levetiracetam Teva 100 mg/ml Oral Solution

PACKAGE LEAFLET: INFORMATION FOR THE USER

Read all of this leaflet carefully before you or your child 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. See section 4.

1    What Levetiracetam Teva 100 mg/ml oral solution is and what it is used for

2    What you need to know before you take Levetiracetam Teva 100 mg/ml oral solution

3    How to take Levetiracetam Teva 100 mg/ml oral solution

4    Possible side effects

5    How to store Levetiracetam Teva 100mg/ml oral solution

6    Contents of the pack and other information

OWhat Levetiracetam Teva 100 mg/ml Oral Solution is and what it is used for

Levetiracetam Teva 100 mg/ml oral solution is an antiepileptic medicine (a medicine used to treat seizures in epilepsy).

Levetiracetam Teva is 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).

parahydroxybenzoate (E216) which may cause allergic reactions (possibly delayed).

Levetiracetam Teva oral solution 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.

©How to take Levetiracetam Teva 100 mg/ml Oral Solution

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

Take the oral solution following your doctor's instructions.

Levetiracetam Teva must be taken twice a day, once in the morning and once in the evening, at about the same time each day.

Monotherapy

Dose in adults and adolescents (From 16 years of age): General dose: between 10 ml (1,000 mg) and 30 ml (3,000 mg) each day, divided in 2 intakes per day. When you first start taking Levetiracetam Teva, your doctor will prescribe you a lower dose for 2 weeks before giving you the lowest general dose. Add-on therapy

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

General dose: between 10 ml (1,000 mg) and 30 ml (3,000 mg) each day, divided in 2 intakes per day. Dose in infants aged 1 month to 23 months, children aged 2 to 11 years and adolescents aged 12 to 17

pharmaceutical form of Levetiracetam according to the age, weight and dose.

Oral solution is a formulation more appropriate to infants and children under the age of 6 years and to children and adolescent (from 6 to 17 years)

allow accurate dosage.

General dose: between 0.2 ml (20 mg) and 0.6 ml (60 mg) per kg bodyweight each day, divided in 2 intakes per day. The exact quantity of oral solution formulation should be measured using the syringe (provided in the cardboard box) and then emptying the contents of the syringe into either a glass of water or baby's bottle.

3

What you need to know before you take Levetiracetam Teva 100 mg/ml Oral Solution

Do not take Levetiracetam Teva

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 this

medicine:

•    if you suffer from kidney problems, follow your doctor's instructions. He/she may decide if your dose should be adjusted.

•    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 Levetiracetam Teva have had thoughts of harming or killing themselves. If you have any symptoms of depression and/or suicidal ideation, please contact your doctor.

Children and adolescents

Children 25 kg or less should start the treatment with Levetiracetam Teva 100 mg/ml oral solution Dose in children and adolescents 50 kg or more is the same as in adults

Dose in infants aged 1 month to less than 6 months:

General dose: between 0.14 ml (14 mg) and 0.42 ml (42 mg) per kg bodyweight each day, divided in 2 intakes per day. The exact quantity of oral solution formulation should be measured using the syringe provided in the cardboard box and then emptying the contents of the syringe into either a glass of water or baby's bottle.

• Levetriacetam Teva is not indicated in children and adolescents below 16 years on its own (monotherapy).

Other medicines and Levetiracetam Teva

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

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

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. Levetiracetam Teva should not be used during pregnancy unless clearly necessary. A risk of birth defects for your unborn child cannot be completely excluded. Levetiracetam Teva has shown unwanted reproductive effects in animal studies at dose levels higher than you would need to control your seizures. Breast-feeding is not recommended during treatment Driving and using machines

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

Levetiracetam Teva 100 mg/ml oral solution contains methyl parahydroxybenzoate, propyl parahydroxybenzoate and maltitol

Levetiracetam Teva oral solution includes methyl parahydroxybenzoate (E218) and propyl

Method of administration:

Levetiracetam Teva oral solution may be diluted in a glass of water or baby's bottle. You may take Levetiracetam with or without food.

Instructions for use:

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

•    Insert the syringe adaptor into the bottle neck (figure 2). Ensure it is well fixed.

•    Take the syringe and put it in the adaptor opening (figure 2).

•    Turn the bottle upside down (figure 3).

•    Fill the syringe with a small amount of solution by pulling the piston down (figure 4), then push the piston upward in order to remove any possible bubbles (figure 5). Pull the piston down to the graduation mark corresponding to the quantity in millilitres (ml) prescribed by your doctor (figure 6).