Levera Tablets (Generic Levetiracetam Tablets)

1. Levera Tablets (Generic Levetiracetam Tablets) © The Swiss Pharmacy

2. Levera Tablets (Generic Levetiracetam Tablets) © The Swiss Pharmacy

3. Levera Tablets (Generic Levetiracetam Tablets) Levera Tablets (Generic Levetiracetam Tablets) are used as monotherapy in the treatment of partial onset seizures with or without secondary generalisation in adults and adolescents from 16 years of age with newly diagnosed epilepsy. Levera tablets are used as adjunctive therapy in the treatment of partial onset seizures with or without secondary generalisation in adults, adolescents, children and infants from 1 month of age with epilepsy. It is also used as adjunctive therapy in the treatment of myoclonic seizures in adults and adolescents from 12 years of age with Juvenile Myoclonic Epilepsy. It is also used as adjunctive therapy in the treatment of primary generalised tonic-clonic seizures in adults and adolescents from 12 years of age with Idiopathic Generalised Epilepsy. © The Swiss Pharmacy

4. Levera Tablets (Generic Levetiracetam Tablets) Levera tablets are manufactured by Intas Pharmaceuticals Limited, India in the strengths of 250 mg, 500 mg, 750 mg and 1000 mg. © The Swiss Pharmacy

5. Levera Tablets (Generic Levetiracetam Tablets) Chemical Structure - Levetiracetam © The Swiss Pharmacy

6. Levera Tablets (Generic Levetiracetam Tablets) The active ingredient contained in Levera tablets is Levetiracetam. Each film-coated tablet contains 250 mg, 500 mg, 750 mg or 1000 mg of Levetiracetam. © The Swiss Pharmacy

7. Levera Tablets (Generic Levetiracetam Tablets) Uses of Levera 250 mg, 500 mg, 750 mg and 1000 mg Tablets: Levera (Generic Levetiracetam tablets) is used alone or together with other medicines to help control certain types of seizures (eg, partial seizures, myoclonic seizures, or tonic-clonic seizures) in the treatment of epilepsy. This medicine cannot cure epilepsy and will only work to control seizures for as long as you continue to use it. It belongs to a class of drugs known as anticonvulsants. Levetiracetam may decrease the number of seizures you have. Partial-Onset Seizures: Partial-Onset Seizures: Levetiracetam tablets are indicated for the treatment of partial-onset seizures in patients 1 month of age and older. URL : URL : https://www.theswisspharmacy.com/product_info.php?info=p9853_Levetiracetam-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9853_Levetiracetam-Tablets.html © The Swiss Pharmacy

8. Levera Tablets (Generic Levetiracetam Tablets) Uses of Levera 250 mg, 500 mg, 750 mg and 1000 mg Tablets: Myoclonic Seizures in Patients with Juvenile Myoclonic Myoclonic Seizures in Patients with Juvenile Myoclonic Epilepsy: Epilepsy: Levetiracetam tablets are indicated as adjunctive therapy for the treatment of myoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy. Primary Generalized Tonic-Clonic Seizures: Primary Generalized Tonic-Clonic Seizures: Levetiracetam tablets are indicated as adjunctive therapy for the treatment of primary generalized tonic-clonic seizures in patients 6 years of age and older with idiopathic generalized epilepsy. URL : URL : https://www.theswisspharmacy.com/product_info.php?info=p9853_Levetiracetam-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9853_Levetiracetam-Tablets.html © The Swiss Pharmacy

9. Levera Tablets (Generic Levetiracetam Tablets) Recommended Adult Dosage Levera tablets Levera tablets (Generic Levetiracetam tablets) are usually administered twice daily with or without food. The Levetiracetam dosing regimen depends on the indication, age group, dosage form (tablets), and renal function. Dosing for Partial Onset Seizures (Adults 16 Years and Older): Dosing for Partial Onset Seizures (Adults 16 Years and Older): Start treatment with a daily dose of 1000 mg/day, given as twice-daily dosing (500 mg twice daily). Additional dosing increments may be given (1000 mg/day additional every 2 weeks) to a maximum recommended daily dose of 3000 mg. URL : URL : https://www.theswisspharmacy.com/product_info.php?info=p9853_Levetiracetam-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9853_Levetiracetam-Tablets.html © The Swiss Pharmacy

10. Levera Tablets (Generic Levetiracetam Tablets) Recommended Adult Dosage Levera tablets Levera tablets (Generic Levetiracetam tablets) are usually administered twice daily with or without food. Dosing for Myoclonic Seizures in Patients 12 Years of Age and Older with Dosing for Myoclonic Seizures in Patients 12 Years of Age and Older with Juvenile Myoclonic Epilepsy: Juvenile Myoclonic Epilepsy: Treatment has to be started with a dose of 1000 mg/day, given as twice-daily dosing (500 mg twice daily). Increase the dosage by 1000 mg/day every 2 weeks to the recommended daily dose of 3000 mg. Dosing for Primary Generalized Tonic-Clonic Seizures in Adults 16 Years Dosing for Primary Generalized Tonic-Clonic Seizures in Adults 16 Years and Older: and Older: Treatment has to be started with a dose of 1000 mg/day, given as twice-daily dosing (500 mg twice daily). The dosage may be increased by 1000 mg/day every 2 weeks to the recommended daily dose of 3000mg. URL : URL : https://www.theswisspharmacy.com/product_info.php?info=p9853_Levetiracetam-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9853_Levetiracetam-Tablets.html © The Swiss Pharmacy

11. Levera Tablets (Generic Levetiracetam Tablets) Contraindications ➔Levera is contraindicated in patients with a known hypersensitivity to Levetiracetam (as angioedema and anaphylaxis have occurred) or any component of the tablet. URL : URL : https://www.theswisspharmacy.com/product_info.php?info=p9853_Levetiracetam-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9853_Levetiracetam-Tablets.html © The Swiss Pharmacy

12. Levera Tablets (Generic Levetiracetam Tablets) Storage Instructions Levera tablets (Generic Levetiracetam tablets) have to be stored at controlled room temperature i.e. from 20°C to 25°C (68°F to 77°F) with excursions permitted between 15° to 30°C (59° to 86°F). Keep this as well as all other medicines away from children and pets. URL : URL : https://www.theswisspharmacy.com/product_info.php?info=p9853_Levetiracetam-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9853_Levetiracetam-Tablets.html © The Swiss Pharmacy

13. Levera Tablets (Generic Levetiracetam Tablets) Warnings Behavioral abnormalities including psychotic symptoms, suicidal ideation, irritability, and aggressive behavior have been observed; monitor patients for psychiatric signs and symptoms. Suicidal Behavior and Ideation: Monitor patients for new or worsening depression, suicidal thoughts/behavior, and/or unusual changes in mood or behavior. Monitor for somnolence and fatigue and advise patients not to drive or operate machinery until they have gained sufficient experience on Levera (Levetiracetam Tablets). URL : URL : https://www.theswisspharmacy.com/product_info.php?info=p9853_Levetiracetam-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9853_Levetiracetam-Tablets.html © The Swiss Pharmacy

14. Levera Tablets (Generic Levetiracetam Tablets) Warnings Serious Dermatological Reactions: Discontinue Levera (Levetiracetam Tablets) at the first sign of rash unless clearly not drug related. Coordination Difficulties: Monitor for ataxia, abnormal gait, and incoordination. Advise patients to not drive or operate machinery until they have gained experience on Levera (Levetiracetam Tablets). Withdrawal Seizures: Levera (Levetiracetam Tablets) must be gradually withdrawn. URL : URL : https://www.theswisspharmacy.com/product_info.php?info=p9853_Levetiracetam-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9853_Levetiracetam-Tablets.html © The Swiss Pharmacy

15. Levera Tablets (Generic Levetiracetam Tablets) Levera Tablets and Alcohol Yes, you can drink alcohol with Levetiracetam, but it may make you feel sleepy or tired, and alcohol and hangovers can bring on seizures in some people with epilepsy. Levera (Generic Levetiracetam tablets) and alcohol both affect the central nervous system and can heighten each other’s side effects, making mild symptoms like fatigue or dizziness much more severe. Usually, people who take alcohol and Levetiracetam together experience impaired judgment and difficulty concentrating. This could make driving difficult and impair one’s ability to perform at work or school. During the first few days of taking levetiracetam, it's best to stop drinking alcohol until you see how the medicine affects you. URL : URL : https://www.theswisspharmacy.com/product_info.php?info=p9853_Levetiracetam-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9853_Levetiracetam-Tablets.html © The Swiss Pharmacy

16. Levera Tablets (Generic Levetiracetam Tablets) Possible Side Effects Most common Levetiracetam (Levera Tablets) side effects with an incidence rate of 5% or more and greater than placebo include: Adult patients: somnolence, asthenia, infection and dizziness Pediatric patients: fatigue, aggression, nasal congestion, decreased appetite, and irritability URL : URL : https://www.theswisspharmacy.com/product_info.php?info=p9853_Levetiracetam-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9853_Levetiracetam-Tablets.html © The Swiss Pharmacy

17. Levera Tablets (Generic Levetiracetam Tablets) Overdosage The highest known dose of levetiracetam received in the clinical development program was 6,000 mg/day. Other than drowsiness, there were no adverse reactions in the few known cases of overdose in clinical trials. Cases of somnolence, agitation, aggression, depressed level of consciousness, respiratory depression and coma were observed with Levetiracetam overdoses in postmarketing use. URL : URL : https://www.theswisspharmacy.com/product_info.php?info=p9853_Levetiracetam-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9853_Levetiracetam-Tablets.html © The Swiss Pharmacy

18. Levera Tablets (Generic Levetiracetam Tablets) Overdosage There is no specific antidote for overdose with Levetiracetam. If indicated, elimination of unabsorbed drug should be attempted by emesis or gastric lavage; usual precautions should be observed to maintain airway. General supportive care of the patient is indicated including monitoring of vital signs and observation of the patient's clinical status. URL : URL : https://www.theswisspharmacy.com/product_info.php?info=p9853_Levetiracetam-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9853_Levetiracetam-Tablets.html © The Swiss Pharmacy

19. Levera Tablets (Generic Levetiracetam Tablets) Levera Tablets during Pregnancy Levetiracetam (Levera Tablets) is classified by the US FDA as Pregnancy Category C . During animal studies, it was observed that Levetiracetam produced evidence of developmental toxicity at doses similar to or greater than human therapeutic doses. There are no adequate and well-controlled studies conducted in pregnant women. Levera (Levetiracetam Tablets) should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. URL : URL : https://www.theswisspharmacy.com/product_info.php?info=p9853_Levetiracetam-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9853_Levetiracetam-Tablets.html © The Swiss Pharmacy

20. Levera Tablets (Generic Levetiracetam Tablets) Levera Tablets Levera Tablets (Generic Levetiracetam Tablets) are manufactured by Intas Pharmaceuticals Limited, India. URL : URL : https://www.theswisspharmacy.com/product_info.php?info=p9853_Levetiracetam-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9853_Levetiracetam-Tablets.html © The Swiss Pharmacy