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LEVEBIL-500
Product Composition
Packaging Details
Product Description
LEVEBIL-500 Tablets – Levetiracetam 500 mg
LEVEBIL-500 Tablets by Amcare Pharmaceuticals contain Levetiracetam IP 500 mg in a film-coated tablet formulation. Levetiracetam is an antiepileptic medicine prescribed for the management of specific seizure disorders.
It is used for conditions including partial-onset seizures and, depending on age and diagnosis, myoclonic seizures associated with juvenile myoclonic epilepsy and primary generalized tonic-clonic seizures.
LEVEBIL-500 Tablets Composition
| Ingredient | Quantity per Tablet |
|---|---|
| Levetiracetam IP | 500 mg |
| Excipients | q.s. |
Dosage form: Film-coated tablet
Strength: 500 mg
Product Details
| Product Information | Details |
|---|---|
| Brand Name | LEVEBIL-500 |
| Generic Name | Levetiracetam |
| Strength | 500 mg |
| Dosage Form | Film-Coated Tablet |
| Route | Oral |
| Pack Size | 10 × 10 Tablets |
| Therapeutic Category | Antiepileptic / Anticonvulsant |
| Company | Amcare Pharmaceuticals |
What is LEVEBIL-500 Used For?
LEVEBIL-500 is a prescription antiepileptic medicine used to help control certain types of seizures.
Depending on the patient’s age and diagnosis, levetiracetam is indicated for:
1. Partial-Onset Seizures
Levetiracetam is used for the treatment of partial-onset seizures in patients with epilepsy. Current prescribing information includes patients from 1 month of age, with dosage depending on age, weight and formulation.
2. Myoclonic Seizures
It is used as adjunctive therapy for myoclonic seizures in juvenile myoclonic epilepsy in patients aged 12 years and older.
3. Primary Generalized Tonic-Clonic Seizures
Levetiracetam is also used as adjunctive therapy for primary generalized tonic-clonic seizures in appropriate patients with idiopathic generalized epilepsy.
Important: The exact indication and treatment plan should be determined by a neurologist or other qualified healthcare professional.
How Does LEVEBIL-500 Work?
Levetiracetam is an antiepileptic medicine that helps reduce abnormal electrical activity associated with seizures.
Its precise mechanism is not completely understood, but levetiracetam binds to the synaptic vesicle protein SV2A, which is believed to contribute to its anticonvulsant activity.
The medicine is used to help reduce the occurrence of seizures rather than providing immediate treatment for every seizure episode.
LEVEBIL-500 for Epilepsy
Epilepsy is a neurological disorder characterized by a tendency to have recurrent seizures.
Levetiracetam can be used either alone or as adjunctive therapy depending on the seizure type and clinical circumstances. Current prescribing information lists partial-onset seizures as well as certain generalized seizure types among its indications.
Treatment is generally individualized according to:
- Seizure type
- Age
- Body weight
- Kidney function
- Other medicines being taken
- Clinical response
- Tolerability
Dosage and Administration
The appropriate dose of LEVEBIL-500 must be determined by the prescribing physician.
For adults and adolescents 16 years and older with partial-onset seizures, one current prescribing label specifies an initial dose of 500 mg twice daily, with subsequent adjustment according to response and tolerability.
However, the dose varies according to:
- Type of seizure
- Patient age
- Body weight
- Kidney function
- Other medicines
- Individual response
Important
Do not use 500 mg twice daily as a universal dosage recommendation for every patient.
The 500 mg strength of the tablet does not mean every patient should take one tablet twice daily.
Patients with impaired renal function may require dosage adjustment.
How to Take LEVEBIL-500
- Take the tablet exactly as prescribed.
- It may generally be taken with or without food.
- Swallow the film-coated tablet whole with water.
- Do not chew or crush the tablet.
- Try to take doses at approximately the same times every day.
- Do not change the dose without medical advice.
Missed Dose
If a dose is forgotten, take it when remembered unless it is nearly time for the next dose.
Do not take two doses together to compensate for a missed dose.
Do Not Stop LEVEBIL-500 Suddenly
Levetiracetam should generally not be stopped abruptly without medical advice.
Suddenly stopping an antiepileptic medicine can increase the risk of seizures. If treatment needs to be discontinued, the physician will determine an appropriate reduction schedule.
Side Effects of LEVEBIL-500
Like other medicines, levetiracetam can cause side effects.
Common Side Effects
Possible side effects include:
- Sleepiness
- Drowsiness
- Dizziness
- Headache
- Tiredness
- Nausea
- Vomiting
- Tremor
- Agitation
- Irritability
- Aggressive behaviour
- Difficulty with coordination or movement
These are among the reported adverse effects of levetiracetam.
Behavioural and Mood Changes
Levetiracetam can cause behavioural or mood-related changes in some patients, including irritability, agitation or aggression.
Patients or caregivers should inform their doctor if significant mood or behavioural changes develop.
Serious Side Effects
Rare but serious reactions can occur.
Seek urgent medical attention for symptoms such as:
- Difficulty breathing
- Swelling of the face, lips, tongue or throat
- Severe skin rash
- Blistering or peeling skin
- Severe allergic reaction
- Significant psychiatric or behavioural changes
Serious skin reactions and severe allergic reactions have been reported with levetiracetam.
Precautions and Warnings
Before starting LEVEBIL-500, inform your doctor if you have:
- Kidney disease
- A history of depression
- Significant mood or behavioural problems
- Previous allergic reaction to levetiracetam
- Other neurological conditions
- Other medicines for epilepsy
Kidney Function
Levetiracetam is substantially eliminated through the kidneys, and dosage adjustment may be required in patients with impaired renal function.
LEVEBIL-500 and Driving
Levetiracetam can cause sleepiness, dizziness or reduced alertness.
If these effects occur, avoid:
- Driving
- Operating machinery
- Working at heights
- Other activities requiring full alertness
The NHS specifically advises avoiding driving or cycling if levetiracetam causes tiredness, sleepiness or dizziness.
LEVEBIL-500 and Alcohol
Alcohol may increase sleepiness and other central nervous system effects associated with levetiracetam.
It is therefore advisable to discuss alcohol consumption with the prescribing physician, particularly when treatment is newly started or the dose has been changed.
Drug Interactions
Always tell your doctor about all prescription medicines, OTC medicines, herbal products and supplements.
Some medicines and supplements may require particular consideration with levetiracetam.
The NHS specifically advises informing a healthcare professional about other medicines and notes potential concerns with medicines such as macrogol and methotrexate, as well as the herbal supplement St John’s wort.
Important
Do not start or stop another medicine or supplement without checking with your doctor or pharmacist.
LEVEBIL-500 During Pregnancy
If you are pregnant, planning pregnancy or think you may be pregnant, discuss levetiracetam treatment with your doctor.
Do not stop levetiracetam suddenly during pregnancy, because uncontrolled seizures can also carry risks.
The prescribing physician should assess the benefits and risks and determine the appropriate treatment plan.
LEVEBIL-500 During Breastfeeding
Levetiracetam can be used in some breastfeeding patients under medical supervision.
Discuss breastfeeding with your doctor before starting or changing treatment.
LEVEBIL-500 for Children
Levetiracetam is used in pediatric patients for certain seizure disorders, but pediatric dosing is generally based on:
- Age
- Body weight
- Seizure type
- Kidney function
- Clinical response
Current prescribing information includes weight-based dosing for children and recommends appropriate pediatric formulations for younger/smaller children.
Do not calculate a child’s dose from the adult 500 mg tablet strength without medical instruction.
Key Features of LEVEBIL-500
1. Levetiracetam 500 mg
Each film-coated tablet contains 500 mg Levetiracetam IP.
2. Antiepileptic Medicine
Designed for physician-directed management of specific seizure disorders.
3. Film-Coated Tablet
Convenient oral dosage form.
4. Multiple Seizure-Type Applications
Levetiracetam has established indications covering partial-onset seizures and certain generalized seizure types.
5. 10 × 10 Tablet Pack
The supplied artwork shows a 10 × 10 tablet pack.
Why Choose LEVEBIL-500 by Amcare Pharmaceuticals?
LEVEBIL-500 Tablets provide:
- Levetiracetam IP
- 500 mg strength
- Film-coated tablet
- Oral administration
- 10 × 10 tablet pack
- Prescription antiepileptic formulation
The medicine should be used according to the patient’s diagnosis and the prescribing physician’s instructions.
