KEPPRA (LEVETIRACETAM)

What Keppra is and what it is used?

Keppra 250 mg film-coated tablets is an antiepileptic medicine (a medicine used to treat seizures in epilepsy).

Keppra is used:
• alone in adults and adolescents 16 years and older with newly diagnosed epilepsy, to treat partial onset seizures with or without secondary generalization.
• in addition to other anti-epileptic medicaments for the treatment of:
• partial onset seizures with or without generalization in adults, adolescents, children and infants of one or more months
• myoclonic seizures in adults and adolescents 12 years and older with juvenile myoclonic epilepsy.
• primary generalized tonic-clonic seizures in adults and adolescents 12 years and older with idiopathic generalized epilepsy.

2. What you should know before taking Keppra

Do not take Keppra
• If you are allergic (hypersensitive) to levetiracetam or any of the other ingredients of this medicine (listed in Section 6).

Warnings and Precautions
Talk to your doctor before taking Keppra.
• If you have kidney problems, follow your doctor’s instructions. Your doctor can determine whether your dose needs to be adjusted.
• If you notice any slowdown or unexpected puberty development of your child, please inform your doctor.
• If you notice an increase in seizure severity (eg increased number), please inform your doctor.
Small number of people being treated with anti-epileptics such as Keppra have had thoughts of harming or killing themselves. If you have symptoms of depression and / or suicidal thoughts, please talk to your doctor.

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

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

Pregnancy and lactation
Ask your doctor or pharmacist before taking any medicine. If you are pregnant or think you are pregnant, please inform your doctor. Keppra should be used during pregnancy unless clearly necessary. Can not completely exclude the risk of birth defects in your unborn child. Keppra has shown unwanted animal reproductive studies at doses that are much higher than those that you need to control your seizures.
Breastfeeding is not recommended during treatment. Driving and using machines
Keppra may impair your ability to drive or operate machinery, as Keppra may cause drowsiness. This is more likely at the beginning of treatment or after an increase in dose. Do not use any tools or machines until it is established that your ability to perform such activities is not affected.

3. How to take Keppra?
Always take this medicine exactly as your told your doctor or pharmacist. If you are not sure, ask your doctor or pharmacist.
Keppra must be taken twice a day, once in the morning and once in the evening, at the same time each day.
Take the number of tablets exactly as your doctor tells you.
monotherapy
Dosage in adults and adolescents (16 years and over):
Usual dose: between 1000 mg (4 tablets) and 3000 mg (12 tablets) each day.
When you first start taking Keppra, your doctor will prescribe a low dose for 2 weeks before giving you the lowest regular dose.
For example: if your daily dose is 1000 mg, you should take 2 tablets in the morning and 2 tablets in the evening.
Add-on therapy
Dosage in adults and adolescents (12-17 years) weighing 50 kg or more:
Usual dose: between 1000 mg (4 tablets) and 3000 mg (12 tablets) each day. For example: if your daily dose of 1000 mg, you should take 2 tablets in the morning and 2 tablets in the evening.
Dosage in infants (6-23 months), children (2-11 years) and adolescents (12-17 years) weighing less than 50 kg:
Your doctor will prescribe the most appropriate form of Keppra according to age, weight and dosage.
Keppra 100 mg / ml oral solution is more appropriate for infants and children under 6 years.
Usual Dose: between 20 mg per kg body weight and 60 mg per kg of body weight every day.
For example: if the usual dose is 20 mg per kg of body weight each day, you can give your child weighing 25 kg, one tablet in the morning and one tablet in the evening.

Dosage in infants (1 month to less than 6 months):
Keppra 100 mg / ml oral solution is in a form suitable for administration to infants. Method of administration:
Swallow Keppra tablets with a sufficient amount of fluid (e.g. a glass of water).

Duration of treatment:
• Keppra is used for chronic treatment. You should continue Keppra treatment for as long as advised by your doctor.
• Do not stop taking Keppra without advice from your doctor, as this could increase your seizures. If your doctor decides to stop your treatment with Keppra, he will explain how to gradually reduce your dose of Keppra.

If you take more Keppra than
Possible side effects of overdose of Keppra are sleepiness, anxiety, aggression, reduced ATTENTION, respiratory depression and coma. Tell your doctor if you take more tablets. Your doctor will take the best possible measures overdose.

If you forget to take Keppra
Tell your doctor if you miss one or more doses. Do not take a double dose to make up for a forgotten tablet.

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 medicine, ask your doctor or pharmacist.

4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Some of the side effects like sleepiness, tiredness and dizziness may occur more frequently at the beginning of treatment or when increasing the dose. These effects are expected to decrease over time.

Very common: may affect more than 1 in 10 patients
• nasopharyngitis;
• somnolence (sleepiness), headache. Common: may affect 1 to 10 users in 100
• anorexia (loss of appetite);
• depression, hostility or aggression, anxiety, insomnia, nervousness or irritability;
• convulsion, narushenda in balance (loss of balance), dizziness (sensation of unsteadiness), lethargy, tremor (involuntary shaking);
• vertigo (feelings of dizziness);
• cough;
• abdominal pain, diarrhea, dyspepsia (indigestion), nausea, vomiting;
• rash;
• asthenia / fatigue (tiredness).

Uncommon: may affect 1 to 10 of 1000 patients
• reduced number of platelets, decreased leukocyte;
• weight loss, weight gain;
• suicide attempt and suicidal thoughts, psychiatric disorders, abnormal behavior, hallucinations, anger, confusion, panic attacks, emotional instability/mood swings, anxiety;
• amnesia (loss of memory), memory impairment (forgetfulness), abnormal coordination / ataxia (uncoordinated movements), paraesthesia (tingling), disturbance in attention (loss of concentration);
• diplopia (double vision), blurred vision;
• deviation of the normal values of the results of an examination of the liver;
• hair loss, eczema, pruritus;
• muscle weakness, myalgia (muscle pain);
• injury.

Rare: may affect 1 to 10 of 10,000 patients
• infection;
• a reduced number of all types of blood cells;
• suicide, personality disorders (behavioral problems), change in thinking (slow thinking, inability to concentrate);
• uncontrollable muscle spasms affecting the head, body and limbs, difficulty in controlling movements, hyperkinesia (hyperactivity);
• pancreatitis;
• hepatic failure, hepatitis;
• skin rash, which may be in the form of blisters and looks like small targets (central dark spots surrounded by paler areas 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 more severe, which causes flaking of the skin for more than 30% of the body surface (toxic epidermal necrolysis).
If you get any side effects, tell your doctor or pharmacist.
This includes all listed in this leaflet.

5. How to store Keppra?
Keep out of reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after “EXP”.
The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of medications in wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. Contents of the pack and other information
What does Keppra?

The active substance is levetiracetam. Each tablet contains 250 mg levetiracetam. Other ingredients are:

Core: croscarmellose sodium, macrogol 6000, silica colloidal anhydrous, magnesium stearate

Film coating: Opadry 85F20694 (Polyvinyl alcohol-partially hydrolyzed, titanium dioxide (E 171), macrogol 3350, talc, indigo carmine aluminum lake (E 132)).

The film-coated tablets are blue, oblong, scored and debossed with the code “ucb” and “250” on one side.
Cartons contain 20, 30, 50, 60, 100 x 1, 100 tablets and multipack containing 200 (2 packs of 100) film-coated tablets. Package with 100 x 1 tablets are available as aluminum / PVC perforated unit dose blisters. All other packages are available as standard aluminum / PVC blisters. Not all pack sizes may be marketed.