Levetiracetam. 250 mg

 

WHAT LEVETIRACETAM TEVA AND WHAT IS Used

Levetiracetam Teva is an antiepileptic medicine (a medicine used to treat seizures

epilepsy).

Levetiracetam Teva is used:

 alone in patients over 16 years of age with newly diagnosed epilepsy, to treat partial-onset seizures with or without secondary generalization;

 together with other medicines to treat:

 partial seizures with or without generalization in patients over 1 month of age;

  myoclonic seizures in patients over 12 years of age with juvenile myoclonic epilepsy;

 primary generalized tonic-clonic seizures in patients over 12 years of age with idiopathic generalized epilepsy.

 BEFORE YOU TAKE LEVETIRACETAM TEVA

Do not take Levetiracetam Teva

 If you are allergic (hypersensitive) to levetiracetam or any of the other ingredients of Levetiracetam Teva

Take special care with Levetiracetam Teva

 If you have kidney problems, follow your doctor's instructions. He / she can evaluate whether it is necessary to adjust the dose.

 If you notice any slowdown or unexpected signs of puberty in your child, please call your doctor.

 If you notice an increase in seizure severity (eg increased number), please contact your doctor.

 A small number of patients who were treated with antiepileptic drugs such as Levetiracetam Teva had to samonaranyat thoughts or suicide. If you have any eproyavi of depression and / or suicidal thoughts, please call 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 Levetiracetam Teva with food and drink

Levetiracetam Teva can be taken with or without food. As a precaution, do not take Levetiracetam Teva 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.

Levetiracetam Teva should not be used during pregnancy unless clearly necessary. The potential risk to your unborn child is not known.

Studies of levetiracetam in animals have shown adverse 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 operating machinery

Levetiracetam Teva may affect the ability to drive and use machines as Levetiracetam Teva can cause drowsiness. This is more likely to occur at the beginning of treatment or after a dose increase. Do not use any tools or machines until it is established that your ability to perform such activities is not affected.

HOW TO TAKE LEVETIRACETAM TEVA

Always take Levetiracetam Teva exactly as your doctor tells you. If you're not sure, ask your doctor.

Levetiracetam Teva should be taken twice daily, morning and evening at about the same time of day.

Take the number of tablets exactly as your doctor has told you.

Monotherapy

Dose in adults and adolescents (16 years old):

Usual dose: between 1,000 and 3,000 mg per day.

When you first start taking Levetiracetam Teva, your doctor will prescribe a low dose and should not take over 2 weeks before giving you the lowest regular dose.

For example: if your daily dose is 1,000 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 1,000 and 3,000 mg per day.

For example: if your daily dose is 1,000 mg, you should take 2 tablets in the morning and 2 tablets in the evening.

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

Your doctor will predpishte most appropriate formulation of levetiracetam as age, weight and dose.

Oral solution formulation is best for infants and children under 6 years of age.

Usual dose: between 20 mg per kg body weight and 60 mg per kilogram of body weight each day.

For example: if the usual dose is 20 mg per kilogram of body weight each day, you can give your child weighing 25 kg 1 tablet in the morning and 1 tablet in the evening.

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

For infants of this age is more appropriate to use the medicine in the form of

oral solution.

Method of application:

Levetiracetam Teva Swallow the tablets with a sufficient amount of fluid (eg one glass of water).

Duration of treatment:

 Levetiracetam Teva is used as a chronic treatment. You should continue treatment with Levetiracetam Teva as long as your doctor recommends.

 Do not stop treatment without first consulting you doctor because it may precipitate seizures. If your doctor decides to stop your treatment with Levetiracetam Teva, he / she will explain how to gradually discontinue use of Levetiracetam Teva.

If you take a larger dose than Levetiracetam Teva

Possible side effects of overdose with Levetiracetam Teva include drowsiness, agitation, aggression, reduced alertness, respiratory depression and coma.

Tell your doctor if you take more tablets than necessary. Your doctor will take the best steps possible overdose.

If you forget to take Levetiracetam Teva

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 Levetiracetam Teva

Upon discontinuation of treatment, as with other antiepileptic drugs, Levetiracetam Teva intake should be discontinued gradually to avoid shortness of seizures.

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

 POSSIBLE SIDE EFFECTS

Like all medicines, Levetiracetam Teva 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 such as drowsiness, fatigue and dizziness may occur more frequently at the beginning of treatment or when the dose is increased. These effects are expected to decrease over time.

The frequency of possible side effects listed below have been determined using the following convention:

Very common (affects more than 1 patient 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 in 10,000)

Not known (frequency assessment can be made of the available

data)

Very common:

 nasopharyngitis;

 somnolence (drowsiness), headache.

Common:

 anorexia (loss of appetite);

 depression, hostility or aggression, anxiety, insomnia, nervousness or irritability;

 convulsion, balance disorder (loss of balance), dizziness (sensation of unsteadiness), lethargy, tremor (involuntary shaking);

 vertigo (feeling dizzy)

 cough;

 abdominal pain, diarrhea, dyspepsia (indigestion), vomiting, nausea;

 rash;

 asthenia / fatigue (tiredness).

Uncommon:

 decreased platelet count, low white blood cells;

 weight loss, weight gain;

 suicide attempt and suicidal thoughts, psychiatric disorders, abnormal behavior, hallucinations, anger, confusion, emotional instability / mood swings, anxiety;

 amnesia (loss of memory), memory impairment (forgetfulness), incoordination / ataxia (lack of coordination), paresthesia (tingling), disturbance in attention (loss of concentration);

 diplopia (double vision), blurred vision;

 Abnormal results in liver imaging;

 hair loss, eczema, pruritus;

 muscle weakness, myalgia (muscle pain);

 injury.

Rare:

 infection;

 reduced number of erythrocytes and / or leukocytes;

 suicide, personality disorders (behavioral problems), abnormal 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;

 blistering of the skin, mouth, eyes and genital area, skin rash.

If any of the side effects gets serious, or you notice other effects not mentioned in this

leaflet, please tell your doctor or pharmacist.

 HOW TO STORE LEVETIRACETAM TEVA

Keep out of reach of children.

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 protect the environment.

 ADDITIONAL INFORMATION

What Levetiracetam Teva

 The active substance is called levetiracetam.

One Levetiracetam Teva tablet contains 250 mg 250 mg

levetiracetam.

 The other ingredients are:

Core: maize starch, povidone, croscarmellose sodium and

magnesium stearate.

Film coating: hypromellose 6 Wed, titanium dioxide (E171), macrogol 3350,

brilliant blue FCF (E133) and indigotin (E132).