Држава: Велика Британија
Језик: Енглески
Извор: MHRA (Medicines & Healthcare Products Regulatory Agency)
Gabapentin
Alliance Healthcare (Distribution) Ltd
N02BF01
Gabapentin
100mg
Oral capsule
Oral
Schedule 3 (CD No Register Exempt Safe Custody)
Valid as a prescribable product
BNF: 04080100
121XXXX 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET: 1. What Gabapentin Noumed is and what it is used for 2. What you need to know before taking Gabapentin Noumed 3. How to take Gabapentin Noumed 4. Possible side effects 5. How to store Gabapentin Noumed 6. Contents of the pack and other information 1. WHAT GABAPENTIN NOUMED IS AND WHAT IT IS USED FOR Gabapentin Noumed 100mg, 300mg or 400mg Capsules (called gabapentin throughout this leaflet) belongs to a group of medicines used to treat epilepsy and peripheral neuropathic pain (long lasting pain caused by damage to the nerves) GABAPENTIN NOUMED 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). Your doctor will prescribe Gabapentin Noumed for you to help treat your epilepsy when your current treatment is not fully controlling your condition. You should take Gabapentin Noumed in addition to your current treatment unless told otherwise. Gabapentin Noumed 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 sensations may be described as hot, burning, throbbing, shooting, stabbing, sharp, cramping, aching, tingling, numbness, pins and needles etc. 2. WHAT YOU Прочитајте комплетан документ
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Gabapentin Medreich 100mg Capsules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 100mg hard capsule contains 100mg of gabapentin. Excipient with known effect: Each 100mg hard capsule contains 16.83 mg of lactose. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM ‘Capsule, hard’. Size ‘3’ white/white hard gelatin capsule marked ‘MG 100’ 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 generalisation 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 300mg once a day 300mg two times a day 300mg 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 1 or Прочитајте комплетан документ