Страна: Мальта
Язык: английский
Источник: Medicines Authority
GABAPENTIN
Aurobindo Pharma (Malta) Limited Vault 14, Level 2, Valletta Waterfront, Floriana FRN 1913, Malta
N03AX12
GABAPENTIN 100 mg
HARD CAPSULE
GABAPENTIN 100 mg
POM
ANTIEPILEPTICS
Authorised
2016-10-17
PACKAGE LEAFLET: INFORMATION FOR THE USER GABAPENTIN AUROBINDO 100 MG CAPSULES, HARD GABAPENTIN AUROBINDO 300 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 diseases can cause peripheral neuropathic pain (primarily occurring in the l Прочитать полный документ
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Gabapentin Aurobindo 100 mg capsules, hard Gabapentin Aurobindo 300 mg capsules, hard 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each hard capsule contains 100 mg gabapentin. Each hard capsule contains 300 mg gabapentin. For the full list of excipients, see section 6.1 3. PHARMACEUTICAL FORM Capsule, hard Gabapentin Aurobindo 100 mg capsules, hard: White / White size ‘3’ hard gelatin capsules imprinted with ‘D’ on white cap and ‘02’ on white body with black edible ink, filled with white to off-white crystalline powder.. Gabapentin Aurobindo 300 mg capsules, hard: Yellow / Yellow size ‘1’ hard gelatin capsules imprinted with ‘D’ on yellow cap and ‘03’ on yellow body with black edible ink, filled with white to off-white crystalline powder. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Epilepsy Gabapentin is indicated as adjunctive therapy in the treatment of partial seizures with and without secondary generalization in adults and children aged 6 years and above (see section 5.1). Gabapentin is indicated as monotherapy in the treatment of partial seizures with and without secondary generalization in adults and adolescents aged 12 years and above. Treatment of peripheral neuropathic pain Gabapentin 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 – 300 mg once a day Day 2 – 300 mg two times a day Day 3 - 300 mg three times a day Discontinuation of gabapentin In accordance with current clinical practice, if gabapentin has to be discontinued it is rec Прочитать полный документ