ประเทศ: ไอร์แลนด์
ภาษา: อังกฤษ
แหล่งที่มา: HPRA (Health Products Regulatory Authority)
GABAPENTIN
Pfizer Healthcare Ireland
GABAPENTIN
300 Milligram
Capsules Hard
Product subject to prescription which may be renewed (B)
Authorised
0000-00-00
dNN 016 Work share SPC 4.4 update abuse and dependence QRD & CDS update Page 1 of 9 2014-0005403 PACKAGE LEAFLET: INFORMATION FOR THE USER GABAPENTIN PFIZER 100 MG CAPSULES, HARD GABAPENTIN PFIZER 300 MG CAPSULES, HARD GABAPENTIN PFIZER 400 MG CAPSULES, HARD GABAPENTIN PFIZER 600 MG FILM-COATED TABLETS GABAPENTIN PFIZER 800 MG FILM-COATED TABLETS 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 symptoms 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 Pfizer is and what it is used for 2. What you need to know before you take Gabapentin Pfizer 3. How to take Gabapentin Pfizer 4. Possible side effects 5. How to store Gabapentin Pfizer 6. Contents of the pack and other information _ _ 1. WHAT GABAPENTIN PFIZER IS AND WHAT IS IT USED FOR Gabapentin Pfizer 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 Pfizer is gabapentin. GABAPENTIN PFIZER 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 Pfizer for you to help treat your epilepsy when your current treatment is not fully อ่านเอกสารฉบับเต็ม
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Gabapentin Pfizer 300 mg capsules, hard 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule, hard contains 300 mg of gabapentin. Excipients with known effect: Each 300 mg capsule, hard includes 41 mg lactose per capsule. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Capsule, hard Gabapentin Pfizer 300 mg capsules, hard: White to off-white powder in a size #1 (19.4 mm length with a diameter body/cap of 6.63 mm/6.91 mm), hard gelatin capsule with a yellow opaque body and cap. Capsule is imprinted with G and 5027 in blue ink. 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 IRISH MEDICINES BOARD ________________________________________________________________________________________ อ่านเอกสารฉบับเต็ม