Država: Velika Britanija
Jezik: engleski
Izvor: MHRA (Medicines & Healthcare Products Regulatory Agency)
Gabapentin
Rivopharm (UK) Ltd
N02BF01
Gabapentin
100mg
Oral capsule
Oral
Schedule 3 (CD No Register Exempt Safe Custody)
Valid as a prescribable product
BNF: 04080100; GTIN: 5060388650070
PACKAGE LEAFLET: INFORMATION FOR THE USER GABAPENTIN 100 MG CAPSULES, HARD GABAPENTIN 300 MG CAPSULES, HARD GABAPENTIN 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. • If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. See section 4. IN THIS LEAFLET: 1. What Gabapentin capsules are and what they are used for 2. What you need to know before you take Gabapentin capsules 3. How to take Gabapentin capsules 4. Possible side effects 5. How to store Gabapentin capsules 6. Contents of the pack and other information 1. WHAT GABAPENTIN CAPSULES ARE AND WHAT THEY ARE USED FOR Gabapentin capsules, hard (called Gabapentin capsules in the rest of this leaflet) belong to a group of medicines used to treat epilepsy and peripheral neuropathic pain (long lasting pain caused by damage to the nerves). Gabapentin capsules are 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). Your doctor will prescribe Gabapentin capsules for you to help treat your epilepsy when your current treatment is not fully controlling your condition. You should take Gabapentin capsules in addition to your current treatment unless told otherwise. Gabapentin capsules 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 legs and/or arms), such as diabetes or shingles. Pain se Pročitajte cijeli dokument
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Gabapentin 100 mg capsules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 100 mg capsule contains 100 mg gabapentin. Excipients: Each 100 mg capsule contains 16.83 mg lactose (as monohydrate). For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Hard capsules (capsules): White hard capsule, imprinted “100” and containing a 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 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 dosing range was 900 to 3600 mg/day. Therapy may be initiated by titrating the dose as described in Table Pročitajte cijeli dokument