The need to unify instructions for the use of appropriate drugs has been identified.
Instructions for the use of the reference medication registered in the Russian Federation have been revised, the latest update in 2016. These instructions are available on the GRLS portal.
According to the current information, indications for the use of topiramate in the dosage form of the capsule are as follows:
"Epilepsy
- as a monotherapy in adults and children older than 2 years with epilepsy (including patients with newly diagnosed epilepsy);
- as part of complex therapy in adults and children over 2 years with partial or generalized tonic-clonic seizures, as well as for the treatment of seizures in the background of the Lennox-Gasgo syndrome.
Migraine
- prevention of migraine attacks in adults. The use of topiramate for the treatment of acute migraine attacks has not been studied. "
Section "Contraindications for use":
"Hypersensitivity to any of the components of the drug;
- children under 2 years.
The use of topiramate for the prevention of migraine attacks is contraindicated during pregnancy, as well as in women with preserved reproductive potential, who do not use reliable methods of contraception. "
For topiramate preparations, in the dosage form of the tablet, there are additional age limits in children (children under 3 years) with epilepsy:
- as a monotherapy in adults and children older than 3 years with epilepsy (including patients with newly diagnosed epilepsy);
- as part of complex therapy in adults and children older than 3 years with partial or generalized tonic-clonic seizures, as well as for the treatment of seizures in the background of the Lennox-Gastaut syndrome.
The use of migraine in adults:
- prevention of migraine attacks in adults. The use of topiramate for the treatment of acute migraine attacks has not been studied.
Section "Contraindications for use":
"Hypersensitivity to any of the components of the drug;
- children under 3 years.
The use of topiramate for the prevention of migraine attacks is contraindicated during pregnancy, as well as in women with preserved reproductive potential, who do not use reliable methods of contraception. "
See section "Contraindications to the use of" all forms of medicinal drugs topiramate should be supplemented with information about the excipients with a proven effect on the body, if any, contained in the finished product, including lactose, sucrose, etc.
The information in the sections "Pregnancy and Breastfeeding", "Side Effects", "Precautionary Measures", etc., significantly expanded.
In the civil turnover of the Russian Federation there are medicinal preparations of topiramate, the instructions for their use contain information that does not correspond to the current information on the clinical experience of the clinical use of topiramate in the indicated dosage forms.
We consider it advisable to give instructions on the use of topiramate preparations, in accordance with the current information on the clinical experience.