দেশ: আয়ার্লণ্ড
ভাষা: ইংরেজি
সূত্র: HPRA (Health Products Regulatory Authority)
Gabapentin
McDermott Laboratories Ltd., T/A Gerard Laboratories
N03AX; N03AX12
Gabapentin
100 milligram(s)
Capsule, hard
Product subject to prescription which may be renewed (B)
Other antiepileptics; gabapentin
Marketed
2005-11-18
PAGE 1 OF 10 PACKAGE LEAFLET PAGE 2 OF 10 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 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 is and what it is used for 2. What you need to know before you take Gabapentin 3. How to take Gabapentin 4. Possible side effects 5. How to store Gabapentin 6. Contents of the pack and other information 1. WHAT GABAPENTIN IS AND WHAT IT IS USED FOR Gabapentin 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 is gabapentin. EPILEPSY: Gabapentin 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 for you to help treat your epilepsy when your current treatment is not fully controlling your condition. You should take Gabapentin in addition to your current treatment unless told otherwise. Gabapentin can also be used on its own to treat adults and children over 12 years of age. PERIPHERAL NEUROPATHIC PAIN: Gabapentin is used to treat 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 h সম্পূর্ণ নথি পড়ুন
Health Products Regulatory Authority 03 December 2020 CRN009ZQQ Page 1 of 12 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Gabapentin 100 mg capsules, hard 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 100 mg gabapentin. Excipients of known effect: each hard capsule contains 22.5 mg lactose anhydrous. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Capsule, hard. The 100 mg capsules are white in colour and contain a white 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 generalisation 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 3 300 mg once a day300 mg two times a day300 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 donegraduallyover a minimum of 1 week independent of the indication. Epilepsy Epilepsy typically requires long-term therapy. Dosage is determined bythetreatingphysician according to individual tolerance and efficacy. Health Products Regulatory Authority 03 December 2020 CRN009ZQQ Page 2 of 12 Adults and adolescents: In clinical tri সম্পূর্ণ নথি পড়ুন