国家: 爱尔兰
语言: 英文
来源: HPRA (Health Products Regulatory Authority)
Gabapentin
PCO Manufacturing Ltd.
N03AX12
Gabapentin
800 milligram(s)
Film-coated tablet
gabapentin
2019-10-18
_ _ _ _ PACKAGE LEAFLET: INFORMATION FOR THE USER NEURONTIN ® 100 MG, 300 MG & 400 MG HARD CAPSULES 600 MG & 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 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 Neurontin is and what it is used for 2. What you need to know before you take Neurontin 3. How to take Neurontin 4. Possible side effects 5. How to store Neurontin 6. Contents of the pack and other information 1. WHAT NEURONTIN IS AND WHAT IT IS USED FOR Neurontin 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 Neurontin is gabapentin. NEURONTIN 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). The doctor treating you or your child 6 years of age and older will prescribe Neurontin to help treat epilepsy when the current treatment is not fully controlling the condition. You or your child 6 years of age and older should take Neurontin in addition to the current treatment unless told otherwise. Neurontin 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, 阅读完整的文件
Health Products Regulatory Authority 18 October 2019 CRN0098X5 Page 1 of 2 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Neurontin 800 mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 800 mg gabapentin. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet _Product imported from Spain _ White, elliptical film-coated tablet with a bisecting score on both sides and debossed with 'NT' and '26' on one side. The tablet can be divided into equal doses. 4 CLINICAL PARTICULARS As per PA0822/015/005 5 PHARMACOLOGICAL PROPERTIES As per PA0822/015/005 6 PHARMACEUTICAL PARTICULARS 6.1 LIST OF EXCIPIENTS Poloxamer 407 (ethylene oxide and propylene oxide) Copovidone Maize starch Magnesium stearate _Film-coating _ Opadry white YS-1-18111 (hydroxypropylcellulose, talc) _Polishing agent _ Candelilla wax 6.2 INCOMPATIBILITIES Not applicable. 6.3 SHELF LIFE The shelf life expiry date of this product shall be the date shown on the blister and outer package of the product on the market in the country of origin. 6.4 SPECIAL PRECAUTIONS FOR STORAGE Do not store above 25 °C. Health Products Regulatory Authority 18 October 2019 CRN0098X5 Page 2 of 2 6.5 NATURE AND CONTENTS OF CONTAINER PVC/PE/PVDC/aluminium foil blister packs or PVC/PVDC/aluminium foil blister packs. Supplied in packs of 90 or 100 film-coated tablets. Not all pack sizes may be marketed. 6.6 SPECIAL PRECAUTIONS FOR DISPOSAL No special requirements. 7 PARALLEL PRODUCT AUTHORISATION HOLDER PCO Manufacturing Ltd. Unit 10, Ashbourne Business Park Rath Ashbourne Co. Meath Ireland 8 PARALLEL PRODUCT AUTHORISATION NUMBER PPA0465/097/005 9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 18 th October 2019 10 DATE OF REVISION OF THE TEXT 阅读完整的文件