What is Levetiracetam Ratiopharm?
Levetiracetam ratiopharm is a medicine containing the active substance levetiracetam, available as oblong tablets (250 mg, 500 mg, 750 mg and 1 000 mg) and as an oral suspension (100 mg / ml).
Levetiracetam ratiopharm is a 'generic medicine' which means a medicine similar to a 'reference medicine' already authorized in the European Union (Keppra).
What is Levetiracetam Ratiopharm used for?
Levetiracetam ratiopharm as monotherapy (alone) is indicated for the treatment of partial onset seizures with or without secondary generalization in patients from 16 years of age with newly diagnosed epilepsy. This type of epilepsy, due to excessive electrical activity in one area of the brain, is characterized by symptoms such as sudden spasmodic movements of a part of the body, changes in hearing, smell or vision, numbness or sudden fears. secondary generalization subsequently arises when hyperactivity spreads throughout the brain.
Levetiracetam ratiopharm is also indicated as add-on therapy to other antiepileptic medicinal products in the treatment of:
- partial onset seizures with or without secondary generalization in patients from one month of age;
- myoclonic seizures (short and sudden spasms of a muscle or group of muscles) in patients from 12 years of age with juvenile myoclonic epilepsy;
- primary generalized tonic-clonic seizures (major seizures, which include loss of consciousness) in patients from 12 years of age with idiopathic generalized epilepsy (the type of epilepsy believed to be of genetic origin).
How is Levetiracetam Ratiopharm used?
As monotherapy, the recommended starting dose of Levetiracetam ratiopharm is 250 mg twice a day, which can be increased after two weeks to 500 mg twice a day. Based on the patient's response, the dosage may be further increased every two weeks, up to a maximum dose of 1,500 mg twice daily.
When Levetiracetam ratiopharm is combined with another antiepileptic therapy, in patients over 12 years of age, weighing at least 50 kg, the starting dose is 500 mg twice a day. The daily dose can be increased up to 1,500 mg twice a day. In patients between six months and 17 years of age, who weigh less than 50 kg, the starting dose is 10 mg per kilogram of body weight twice a day; this dose can be increased up to 30 mg / kg twice daily. The use of the oral solution is recommended at the start of therapy in children under six years of age or weighing less than 25 kg. In infants aged one to six months, the starting dose is 7 mg / kg twice daily in oral solution The daily dose can be increased up to 21 mg / kg twice daily.
Dosage should be decreased in patients with impaired renal function (e.g. elderly patients).
Levetiracetam ratiopharm tablets should be swallowed with liquid. The oral solution can be diluted in a glass of water before taking.
How does Levetiracetam Ratiopharm work?
The active substance in Levetiracetam ratiopharm, levetiracetam, is an anti-epileptic medicine. Epilepsy is due to excessive electrical activity in the brain. The precise modes of action of levetiracetam are not yet fully known; the principle seems to interfere with a protein (the 2A protein of the synaptic vesicle) which is found in the space between the nerves and intervenes in the release of chemical transmitters coming from the nerve cells. This allows Levetiracetam ratiopharm to stabilize the electrical activity in the brain and prevent seizures.
How has Levetiracetam Ratiopharm been studied?
Since Levetiracetam ratiopharm is a generic medicine, the studies conducted were limited to verifying its bioequivalence with the reference medicine, Keppra. Two drugs are bioequivalent if, once released into the body, they produce the same levels of active ingredient.
What are the benefits and risks of Levetiracetam Ratiopharm?
Because Levetiracetam ratiopharm is a generic medicine and is bioequivalent to the reference medicine, the benefits and risks associated with it are considered to be the same as the reference medicine.
Why has Levetiracetam Ratiopharm been approved?
The CHMP (Committee for Medicinal Products for Human Use) concluded that, in line with EU requirements, Levetiracetam ratiopharm has been shown to be qualitatively comparable and bioequivalent to Keppra.Therefore, the CHMP considered that, like Keppra, the benefits outweigh the identified risks and recommended the granting of a marketing authorization for the medicine.
More information about Levetiracetam Ratiopharm
On 26 August 2011, the European Commission issued a "Marketing Authorization" for Levetiracetam ratiopharm, valid throughout the European Union.
For more information about Levetiracetam ratiopharm therapy, read the package leaflet (included with the EPAR) or contact your doctor or pharmacist.
The full EPAR version of the reference medicine can also be found on the Agency's website.
Last update of this summary: 06-2011.
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