Valsts: Īrija
Valoda: angļu
Klimata pārmaiņas: HPRA (Health Products Regulatory Authority)
Gabapentin
Aurobindo Pharma (Malta) Limited
N03AX; N03AX12
Gabapentin
400 milligram(s)
Capsule, hard
Other antiepileptics; gabapentin
Not marketed
2005-11-18
PACKAGE LEAFLET PACKAGE LEAFLET: INFORMATION FOR THE USER GABAPENTIN AUROBINDO 100 MG CAPSULES, HARD GABAPENTIN AUROBINDO 300 MG CAPSULES, HARD GABAPENTIN AUROBINDO 400 MG CAPSULES, HARD gabapentin READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. • Keep this leaflet. You may need to read it again. • If you have any further questions, ask your doctor or pharmacist. • This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. • If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET: 1. What Gabapentin Aurobindo is and what it is used for 2. What you need to know before you take Gabapentin Aurobindo 3. How to take Gabapentin Aurobindo 4. Possible side effects 5. How to store Gabapentin Aurobindo 6. Contents of the pack and other information 1. WHAT GABAPENTIN AUROBINDO IS AND WHAT IT IS USED FOR Gabapentin Aurobindo belongs to a group of medicines used to treat epilepsy and peripheral neuropathic pain (long lasting pain caused by damage to the nerves). The active substance in Gabapentin Aurobindo is gabapentin. Gabapentin Aurobindo is used to treat - Various forms of epilepsy (seizures that are initially limited to certain parts of the brain, whether the seizure spreads to other parts of the brain or not). The doctor treating you or your child 6 years of age and older will prescribe Gabapentin Aurobindo to help treat epilepsy when the current treatment is not fully controlling the condition. You or your child 6 years of age and older should take Gabapentin Aurobindo in addition to the current treatment unless told otherwise. Gabapentin Aurobindo can also be used on its own to treat adults and children over 12 years of age. - Peripheral neuropathic pain (long lasting pain caused by damage to the nerves). A variety of different diseas Izlasiet visu dokumentu
Health Products Regulatory Authority 22 February 2024 CRN00DZ31 Page 1 of 12 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Gabapentin Aurobindo 400 mg capsules, hard 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 400 mg gabapentin. Excipients of known effect: each hard capsule contains 90.0 mg lactose. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Capsule, hard. The 400 mg capsules are orange in colour and contain a white powder. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Epilepsy Gabapentin Aurobindo is indicated as adjunctive therapy in the treatment of partial seizures with and without secondary generalisation in adults and children aged 6 years and above (see section 5.1). Gabapentin Aurobindo is indicated as monotherapy in the treatment of partial seizures with and without secondary generalisation in adults and adolescents aged 12 years and above. Treatment of peripheral neuropathic pain Gabapentin Aurobindo is indicated for the treatment of peripheral neuropathic pain such as painful diabetic neuropathy and post-herpetic neuralgia in adults. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology For all indications a titration scheme for the initiation of therapy is described in Table 1, which is recommended for adults and adolescents aged 12 years and above. Dosing instructions for children under 12 years of age are provided under a separate sub-heading later in this section. TABLE 1 Dosing Chart – Initial Titration Day 1 Day 2 Day 3 300 mg once a day 300 mg two times a day 300 mg three times a day _Discontinuation of gabapentin_ In accordance with current clinical practice, if gabapentin has to be discontinued it is recommended this should be done gradually over a minimum of 1 week independent of the indication. EPILEPSY Epilepsy typically requires long-term therapy. Dosage is determined by the treating physician according to individual tolerance and efficacy. _Adults and adolescents:_ In clinical trials, the effective Izlasiet visu dokumentu