Keppra 100 mg/ml oral solution

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

Keppra is used:

• on its own in patients from 16 years of age with newly diagnosed epilepsy, to treat partial onset seizures with or without secondary generalisation
• as an add-on to other antiepileptic medicines to treat: partial onset seizures with or without generalisation in patients from one month of age myoclonic seizures in patients from 12 years of age with juvenile myoclonic epilepsy, primary generalised tonic-clonic seizures in patients from 12 years of age with idiopathic generalised epilepsy

Do not take Keppra

• If you are allergic (hypersensitive) to levetiracetam or any of the other ingredients of Keppra.

Take special care with Keppra

• 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.
• If you notice an increase in seizure severity (e.g. increased number), please contact your doctor.
• A small number of people being treated with anti-epileptics such as Keppra have had thoughts of harming or killing themselves. If you have any symptoms of depression and/or suicidal ideation, please contact your doctor.

Taking other medicines

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

Taking Keppra with food and drink
You may take Keppra with or without food. As a safety precaution, do not take Keppra with alcohol.

Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking any medicine.
If you are pregnant or if you think you may be pregnant, please inform your doctor. Keppra should not be used during pregnancy unless clearly necessary. The potential risk to your unborn child is unknown. Keppra 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
Keppra may impair your ability to drive or operate any tools or machinery, as Keppra 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.

Important information about some of the ingredients of Keppra

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

Always take Keppra exactly as your doctor has told you. You should check with your doctor if you are not sure.
Keppra 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 and adolescents (from 16 years of age):

General dose: between 10 ml (1000 mg) and 30 ml (3,000 mg) each day, divided in 2 intakes per day. When you will first start taking Keppra, your doctor will prescribe you a lower dose during 2 weeks before giving you the lowest general dose.

Add-on therapy

Dose in adults and adolescents (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 (6 to 23 months), children (2 to 11 years) and adolescents (12 to 17 years) weighing less than 50 kg:

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 delivered using either the 3 ml syringe with 0.1 ml graduations or the 10 ml syringe with 0.25 ml graduations, depending on the dose.

Weight Starting dose 0.1 mlkg twice daily Maximum dose 0.3 mlkg twice daily 6 kg 0.6 ml twice daily 1.8 ml twice daily 8 kg 0.8 ml twice daily 2.4 ml twice daily 10 kg 1 ml twice daily 3 ml twice daily 15 kg 1.5 ml twice daily 4.5 ml twice daily 20 kg 2 ml twice daily 6 ml twice daily 25 kg 2.5 ml twice daily 7.5 ml twice daily From 50 kg 5 ml twice daily 15 ml twice daily

Dose in infants (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 delivered using the 1 ml syringe with 0.05 ml graduations.

Weight Starting dose 0.07 mlkg twice daily Maximum dose 0.21 mlkg twice daily 4 kg 0.3 ml twice daily 0.85 ml twice daily 5 kg 0.35 ml twice daily 1.05 ml twice daily 6 kg 0.45 ml twice daily 1.25 ml twice daily 7 kg 0.5 ml twice daily 1.5 ml twice daily

Method of administration:

Keppra oral solution may be diluted in a glass of water.

Instruction for use:

• Open the bottle: press the cap and turn it anticlockwise (figure )
• Insert the syringe adaptor into the bottle neck (figure ). Ensure it is well fixed.
• Take the syringe and put it in the adaptor opening (figure )
• Turn the bottle upside down (figure )
• Fill the syringe with a small amount of solution by pulling the piston down (figure A), then push the piston upward in order to remove any possible bubble (figure B), finally, pull the piston down to the graduation mark corresponding to the quantity in milliliters (ml) prescribed by your doctor (figure C).

• Turn the bottle the right way up. Remove the syringe from the adaptator.
• Empty the contents of the syringe in a glass of water or baby?s bottle by pushing the piston to the bottom (figure ).
• Drink the whole contents of the glass
• Wash the syringe with water (figure )
• Close the bottle with the plastic screw cap.

Duration of treatment:

• Keppra is used as a chronic treatment. You should continue Keppra 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. Should your doctor decide to stop your Keppra treatment, he/she will instruct you about the gradual withdrawal of Keppra.

If you take more Keppra than you should:

The possible side effects of an overdose of Keppra are sleepiness, agitation, aggression, decrease of alertness, inhibition of breathing and coma.
Contact your doctor if you took more Keppra than you should. Your doctor will establish the best possible treatment of 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 a forgotten dose.

If you stop taking Keppra:
If stopping treatment, as with other antiepileptic medicines, Keppra should be discontinued gradually to avoid an increase of seizures.

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

Like all medicines, Keppra can cause side effects, although not everybody gets them. Tell your doctor if you have any of the following and they worry you.

Some of the side effects like sleepiness, tiredness and dizziness may be more common at the beginning of the treatment or at dose increase. These effects should however decrease over time.

The frequency of possible side effects listed below is defined using the following convention: Very common (affects more than 1 user in 10)
Common (affects 1 to 10 users in 100)
Uncommon (affects 1 to 10 users in 1,000)
Rare (affects 1 to 10 users in 10,000)
Very rare (affects less than 1 user in 10,000)
Not known (frequency cannot be estimated from the available data)

Very common:

• somnolence (sleepiness);
• asthenia/fatigue (tiredness).

Common:

• infection, nasopharyngitis;
• decreased number of blood platelets;
• anorexia (loss of appetite), weight increase;
• agitation, depression, emotional instability/mood swings, hostility or aggression, insomnia, nervousness or irritability, personality disorders (behavioral problems), thinking abnormal (slow thinking, unable to concentrate);
• dizziness (sensation of unsteadiness), convulsion, headache, hyperkinesia (hyperactivity), ataxia (impaired coordinated movements), tremor (involuntary trembling), amnesia (loss of memory), balance disorder (equilibrium disorder), disturbance in attention (loss of concentration), memory impairment (forgetfulness);
• diplopia (double vision), vision blurred;
• vertigo (sensation of rotation);
• cough (increase of pre-existing cough);
• abdominal pain, nausea, dyspepsia (indigestion), diarrhoea, vomiting;
• rash, eczema, pruritus;
• myalgia (muscle pain);
• accidental injury.

Not known:

• decreased number of red blood cells, and/or white blood cells;
• weight loss;
• abnormal behaviour, anger, anxiety, confusion, hallucination, mental disorder, suicide, suicide attempt and suicidal ideation;
• paraesthesia (tingling);
• pancreatitis, hepatic failure, hepatitis, liver function test abnormal;
• hair loss, blistering of the skin, mouth, eyes and genital area, skin eruption.

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

Keep out of the reach and sight of children.

Do not use after the expiry date stated on the cardboard box and bottle after EXP:. The expiry date refers to the last day of the month.
Do not use after 7 months of first opening the bottle.

Due to sensitivity to light, store in the original container.

What Keppra contains

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

The other ingredients are: sodium citrate, citric acid monohydrate, methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), ammonium glycyrrhizate, glycerol (E422), maltitol liquid (E965), acesulfame potassium (E950), grape flavour, purified water.

What Keppra looks like and contents of the pack

Keppra 100 mg/ml oral solution is a clear liquid.
The 300 ml glass bottle of Keppra (for children aged 4 years and above, adolescents and adults) is packed in a cardboard box containing a graduated oral syringe of 10 ml graduated 0.25 ml per 0.25 ml and an adaptor for the syringe.
The 150 ml glass bottle of Keppra (for infants aged 6 months and above and children aged 2 to 4 years) is packed in a cardboard box containing a graduated oral syringe of 3 ml graduated 0.1 ml per 0.1 ml and an adaptor for the syringe.
The 150 ml glass bottle of Keppra (for infants aged 1 month to less than 6 months) is packed in a cardboard box containing a graduated oral syringe of 1 ml graduated 0.05 ml per 0.05 ml and an adaptor for the syringe.

Marketing Authorisation Holder and Manufacturer

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.

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

BelgiëBelgiqueBelgien UCB Pharma SANV TelTél 32 02 559 92 00 LuxembourgLuxemburg UCB Pharma SANV TélTel 32 02 559 92 00

Te. 359 0 2 962 30 49 Magyarország UCB Magyarország Kft. Tel. 36-1 391 0060

eská republika UCB s.r.o. Tel 420 221 773 411 Malta Pharmasud Ltd. Tel 356 21 37 64 36

Danmark UCB Nordic AS Tlf 45 32 46 24 00 Nederland UCB Pharma B.V. Tel. 31 076-573 11 40

Deutschland UCB Pharma GmbH Tel 49 0 2173 48 4847 Norge UCB Nordic AS Tlf 45 32 46 24 00

Eesti UCB Pharma Oy Finland Tel 358 10 234 6800 Soome Österreich UCB Pharma GmbH Tel 43 1 291 80 00

UCB .. 30 2109974000 Polska UCB Pharma Sp. z o.o. Tel. 48 22 696 99 20

España UCB Pharma, S.A. Tel 34 91 570 34 44 Portugal UCB Pharma Produtos Farmacêuticos, Lda Tel 351 21 302 5300

France UCB Pharma S.A. Tél 33 01 47 29 44 35 România UCB Pharma România S.R.L. Tel 40 21 300 29 04

Ireland UCB Pharma Ireland Ltd. Tel 353 01-46 37 395 Slovenija Medis, d.o.o. Tel 386 1 589 69 00

Ísland Vistor hf. Tel 354 535 7000 Slovenská republika UCB s.r.o., organizaná zloka Tel 421 0 2 5920 2020

Italia UCB Pharma S.p.A. Tel 39 02 300 791 SuomiFinland UCB Pharma Oy Finland PuhTel 358 10 234 6800

Lifepharma Z.A.M. Ltd 357 22 34 74 40 Sverige UCB Nordic AS Tel 46 0 40 29 49 00

Latvija UCB Pharma Oy Finland Tel 358 10 234 6800 Somija United Kingdom UCB Pharma Ltd. Tel 44 01753 534 655

Lietuva
UCB Pharma Oy Finland

Tel: + 358 10 234 6800 (Suomija)

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