REPITEND 500 mg. 30 tablets

WHAT REPITEND AND WHAT IT IS USED
Repitend is an antiepileptic medicine (a medicine used to treat seizures in epilepsy).

Repitend used:
alone in patients 16 years of age with newly diagnosed epilepsy, to treat partial onset seizures with or without secondary generalization;
in addition to other antiepileptic medicines to treat:
partial onset seizures with or without generalization in patients from 1 month of age;
myoclonic seizures in patients from 12 years of age with juvenile myoclonic epilepsy;
primary generalized tonic-clonic seizures in patients from 12 years of age with idiopathic generalized epilepsy.
2. BEFORE YOU TAKE REPITEND
Do not take Repitend
If you are allergic (hypersensitive) to levetiracetam or any of the other ingredients of Repitend.
Take special care with Repitend
If you have kidney problems, follow your doctor's instructions. He / she may decide if your dose should be adjusted;
If you notice any slowdown or unexpected puberty development of your child, please tell your doctor;
If you notice an increase in seizure severity (eg increased number), please tell your doctor;
Small number of people being treated with antiepileptics such as Repitend have had thoughts of harming or killing themselves. If you have 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 Repitend with food and drink
You may take Repitend with or without food. As a precaution, do not take Repitend alcohol.

Pregnancy and lactation
Ask your doctor or pharmacist before taking any medicine. If you are pregnant or think you may be pregnant, please inform your doctor. Repitend should not be used during pregnancy unless clearly necessary. The potential risk to your unborn child is not known. Studies with levetiracetam in animals have shown adverse reproductive effects, but at doses which are significantly higher than those that you need to control your seizures. Breastfeeding is not recommended during treatment.

Driving and using machines
Repitend can affect your ability to drive or operate any tools or machines since Repitend can cause drowsiness. This is more likely at the beginning of treatment or after dose escalation. You should not drive or use any tools or machines until it is established that your ability to perform such activities is not affected.

Important information about some of the ingredients of Repitend
Repitend 750 mg contains Sunset Yellow FCF (E110), which can cause allergic reactions.

3. HOW TO TAKE Repitend
Always take Repitend exactly as prescribed by your doctor. If you are not sure, ask your doctor.
Repitend should be taken twice daily, once in the morning and once in the evening, at the same time each day.
Take the number of tablets as directed by your doctor.

Monotherapy
Dosage in adults and adolescents (16 years old):
Usual Dose: between 1000 mg (2 tablets of 500 mg) and 3,000 mg (6 tablets of 500 mg) daily.
When you start taking first Repitend, your doctor will prescribe a lower dose for 2 weeks before giving you the lowest general dose.
For example: if your daily dose is 1,000 mg, you must take 1 tablet (500 mg) in the morning and 1 tablet in the evening.

Add-on therapy
Dosage in adults and adolescents (12 to 17 years) weighing 50 kg or more:
Usual Dose: between 1000 mg (2 tablets of 500 mg) and 3,000 mg (6 tablets of 500 mg) daily.
For example: if your daily dose is 1,000 mg, you must take 1 tablet (500 mg) in the morning and 1 tablet in the evening.

Dosage in infants (6-23 months), children (2-11 years) and adolescents (12-17 years) weighing less than 50 kg:
Usual Dose: 20 mg per kg body weight and 60 mg per kg body weight every day.
The dose should preferably be administered as an oral solution with a syringe of 3 ml or 10 ml, depending on the dose.
Your doctor will prescribe the most appropriate form of Repitend according to the weight and dosage.
For example: if the usual dose is 20 mg per kg bodyweight each day, you must give your child weighing 25 kg, 1 tablet of 250 mg in the morning and 1 tablet in the evening or 2,5 ml in the morning and evening 2,5ml.

Dosage in infants (1 month to less than 6 months):
Repitend 100 mg / ml oral solution is more appropriate for use in infants.

Method of administration:
Swallow the tablets Repitend with sufficient liquid (eg a glass of water).

Duration of treatment:
Repitend be used as a chronic treatment. You should take Repitend as long as advised by your doctor;
Do not stop taking Repitend without advice from your doctor, as this could increase your seizures. If your doctor decides to stop your treatment with Repitend, he / she will explain how to gradually stop taking Repitend.
If you take more dose Repitend
Possible side effects of overdose Repitend are drowsiness, anxiety, aggression, attention deficit, respiratory depression and coma.
Tell your doctor if you take more dose Repitend. Your doctor will take the best possible treatment of overdose.

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

If you stop taking Repitend
If stopping treatment, as with other antiepileptic drugs, taking Repitend 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.

4. POSSIBLE SIDE EFFECTS
Like all medicines Repitend can cause side effects, although not everybody gets them.
Tell your doctor if you develop 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 treatment or when increasing the dose. These effects are expected to decrease over time.

The frequency of possible side effects listed below is defined as follows:
Very common (affects more than 1 in 10 patients);
Common (affects 1 to 10 patients in 100);
Uncommon (affects 1 to 10 of 1000 patients);
Rare (affects 1 to 10 of 10,000 patients);
Very rare (affects less than 1 in 10,000 patients);
Not known (from the available data can not be estimated).
Very common:
somnolence (sleepiness);
asthenia / fatigue (tiredness).
Common:
infection, nasopharyngitis;
reduce the number of platelets;
anorexia (loss of appetite), weight increase;
anxiety, depression, emotional lability / mood swings, hostility or aggression, insomnia, nervousness or irritability, personality disorders (behavioral problems), mental status changes (slow thinking, unable to concentrate);
dizziness (sensation of unsteadiness), convulsion, headache, hyperkinesia (hyperactivity), ataxia (impaired coordinated movements), tremor (involuntary trembling), amnesia (loss of memory), disturbance in balance, disturbance in attention (loss of concentration) , memory impairment (forgetfulness);
diplopia (double vision), blurred vision;
vertigo (sensation);
cough (increase of pre-existing cough);
abdominal pain, nausea, dyspepsia (indigestion), diarrhea, vomiting;
rash, eczema, pruritus;
myalgia (muscle pain);
accidental injury.
Not known:
reduction in red and / or white blood cells;
weight loss;
abnormal behavior, anger, anxiety, confusion, hallucination, mental disorder, suicide, suicide attempt and suicidal thoughts;
paraesthesia (tingling);
inflammation of the pancreas, liver failure, hepatitis (inflammation of liver) test abnormal liver function;
hair loss, blistering of the skin, mouth, eyes and genital area, skin rash.
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.

5. HOW TO STORE Repitend
Keep out of the reach and sight of children. Do not store above 30 ° C.
Do not use after the expiry date stated on the carton and blister after "EXP". The expiry date refers to the last day of that month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. FURTHER INFORMATION
What Repitend
The active substance is called levetiracetam. Each tablet contains 250 mg, 500 mg, 750 mg or 1000 mg levetiracetam.

Excipients:
Core: Macrogol 3350, croscarmellose sodium, talc, magnesium stearate.

Film-coated tablets 250 mg: Opadry type II 85F20694 son: polyvinyl alcohol, macrogol 3350, titanium dioxide (E171), talc, indigo carmine aluminum lake (E132).