देश: आयरलैंड
भाषा: अंग्रेज़ी
स्रोत: HPRA (Health Products Regulatory Authority)
GABAPENTIN
Teva Pharma B.V.
GABAPENTIN
800 Milligram
Film Coated Tablet
Product subject to prescription which may be renewed (B)
Authorised
0000-00-00
PRODUCT: AMENDS: APPROVAL: SENIOR ARTWORK CO-ORDINATOR • SUBJECT TO REG. AGENCY APPROVAL • APPROVED BY REG. DEPT. FOR PRINT GABAPENTIN TEVA 600 & 800 MG FC TABS ALL TUK V2 16843 14-5-10 GC 3 15/2/12 GP 280X190 MM ILLUSTRATOR CS3 LEAFLET Univers ALL 8pts body Header: 12pts Subhead: 10pts SUPPLIER INSTRUCTIONS Artwork, text and content must NOT be altered. The only exceptions to this are: bleeds, chokes, spreads or other adjustments required for print reproduction purposes only. If you have any difficulties please contact the Teva Artwork Team. We must receive a copy of the 3rd Party Vendors Proof before final approval can be made. DESIGN DEPARTMENT Harlow Date Signed Date Signed CUTTERGUIDE (not for Print) BLACK PMS GREEN GABAPENTIN TEVA 600 MG FILM-COATED TABLETS GABAPENTIN TEVA 800 MG FILM-COATED TABLETS GABAPENTIN PACKAGE LEAFLET: INFORMATION FOR THE USER READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE. • 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. IN THIS LEAFLET: 1. WHAT GABAPENTIN TEVA IS AND WHAT IT IS USED FOR 2. BEFORE YOU TAKE GABAPENTIN TEVA 3. HOW TO TAKE GABAPENTIN TEVA 4. POSSIBLE SIDE EFFECTS 5. HOW TO STORE GABAPENTIN TEVA 6. FURTHER INFORMATION WHAT GABAPENTIN TEVA IS AND WHAT IT IS USED FOR Gabapentin Teva 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 ingredient in Gabapentin Teva is gabapentin. Gabapentin Teva is used to treat: • various forms of epilepsy (seizures that are initially limited to पूरा दस्तावेज़ पढ़ें
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Gabapentin Teva 800 mg Film-coated Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 800 mg film-coated tablet contains 800 mg of gabapentin. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet White to off-white, oval shaped, bevelled edged, film-coated tablet. On one side engraved “7174”, and on the other side engraved “93”. 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 For oral use. Gabapentin can be given with or without food and should be swallowed whole with sufficient fluid-intake (e.g. a glass of water). 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 _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. Table 1 DOSING CHART - INITIAL TITRATION Day l Day 2 Day पूरा दस्तावेज़ पढ़ें