Šalis: Malaizija
kalba: anglų
Šaltinis: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
GABAPENTIN
LABORATORIES TORRENT (MALAYSIA) SDN. BHD.
GABAPENTIN
30capsule Capsules; 100capsule Capsules
TORRENT PHARMACEUTICAL LIMITED
GABATOR CAPSULES Gabapentin (300mg, 400 mg) _ _ _ _ 1 _ _ _ CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ WHAT IS IN THIS LEAFLET 1. What is Gabator used for 2. How Gabator works 3. Before you use Gabator 4. How to use Gabator 5. While you are using it 6. Side effects 7. Storage and Disposal of Gabator 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision 11. Serial Number WHAT GABATOR IS USED FOR EPILEPSY : Gabapentin is indicated as adjunctive therapy in the treatment of partial seizures with and without secondary generalization in adults and children age 3 years and above. Safety and effectiveness for adjunctive therapy in paediatric patients below the age of 3 years have not been established. NEUROPATHIC PAIN (COMPLEX, CHRONIC PAIN STATE THAT USUALLY IS ACCOMPANIED BY TISSUE INJURY) : Gabapentin is indicated for the treatment of neuropathic pain which includes diabetic neuropathy (nerve damage that can occur if you have diabetes), post-herpetic neuralgia (persistent nerve pain and shingles (painful rash) that can occur as a result of herpes zoster virus (commonly known as chicken pox virus)) and trigeminal neuralgia (chronic, severe facial pain) in adults’ age 18 years and above. Safety and effectiveness in patients below the age of 18 years have not been established. HOW GABATOR WORKS Gabator belongs to a group of medicines used to treat epilepsy and peripheral neuropathic pain (long lasting pain caused by damage to the nerves). BEFORE YOU USE GABATOR - _When you must not use it _ Do not take Gabator: • If you are allergic (hypersensitive) to Gabapentin or to any of the other ingredients of Gabator. _Pregnancy and lactation_ _ _ Tell your doctor if you are pregnant or intend to become pregnant. Gabator should not be taken during pregnancy, unless you are told otherwise by your doctor. Contact your doctor immediately if you become pregnant, think you might be pregnant or are planning to become pregnant while taking Gabator. Do not suddenly discontinue taking this m Perskaitykite visą dokumentą
Proposed Prescribing Information For the use of a Registered Medical Practitioner or a Hospital or a Laboratory GABATOR CAPSULES 300MG/ GABATOR CAPSULES 400MG GABAPENTIN CAPSULES 300 MG / GABAPENTIN CAPSULES 400 MG BRAND OR PRODUCT NAME GABATOR CAPSULES 300mg/ GABATOR CAPSULES 400mg NAME AND STRENGTH OF ACTIVE SUBSTANCE(S) GABATOR CAPSULES 300mg Each hard Gelatin Capsule contains Gabapentin USP……..300 mg Excipients……………q.s Approved colours used in the capsule shell GABATOR CAPSULES 400mg Each hard Gelatin Capsule contains Gabapentin USP ……..400 mg Excipients…………….q.s Approved colours used in the capsule shell PRODUCT DESCRIPTION GABATOR CAPSULES 300mg: Yellow/Yellow coloured, size ‘1’, capsules printed with ‘300’ in black colour on the cap and Torrent logo (Square emblem only) in black colour on the body of capsule shell containing white to off-white powder GABATOR CAPSULES 400mg: Orange/Orange coloured, size ‘0’, capsules printed with ‘400’ in black colour on the cap and Torrent logo (Square emblem only) in black colour on the body of capsule shell containing white to offwhite powder DOSAGE FORM Hard Gelatin Capsule PHARMACODYNAMICS / PHARMACOKINETICS PHARMACODYNAMICS Pharmacotherapeutic groups: Other antiepileptics ATC code: N03AX12 Mechanism of action Gabapentin readily enters the brain and prevents seizures in a number of animal models of epilepsy. Gabapentin does not possess affinity for either GABAA or GABAB receptor nor does it alter the metabolism of GABA. It does not bind to other neurotransmitter receptors of the brain and does not interact with sodium channels. Gabapentin binds with high affinity to the α2δ (alpha-2-delta) subunit of voltage-gated calcium channels and it is proposed that binding to the α2δ subunit may be involved in gabapentin's anti-seizure effects in animals. Broad panel screening does not suggest any other drug targets other than α2δ. Evidence from several pre-clinical models inform that the pharmacological activity of gabapentin may Perskaitykite visą dokumentą