Država: Malezija
Jezik: engleski
Izvor: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
GABAPENTIN
VIATRIS SDN. BHD.
GABAPENTIN
100Capsule Capsules; 50Capsule Capsules
PFIZER PHARMACEUTICALS LLC
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ NEURONTIN ® CAPSULES Gabapentin (Capsule: 100 mg, 300 mg & Tablet: 600 mg) 1 WHAT IS IN THIS LEAFLET 1. What NEURONTIN is used for 2. How NEURONTIN works 3. Before you use NEURONTIN 4. How to use NEURONTIN 5. While you are using it 6. Side effects 7. Storage and Disposal of NEURONTIN 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of Revision 11. Serial Number WHAT NEURONTIN IS USED FOR NEURONTIN is used to treat epilepsy (seizures that are initially limited to certain parts of the brain, whether the seizure spreads to other parts of the brain or not) and peripheral neuropathic pain (long lasting pain caused by damage to the nerves). HOW NEURONTIN WORKS NEURONTIN 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 NEURONTIN _-_ _When you must not use it_ Do not take NEURONTIN: - If you are allergic (hypersensitive) to gabapentin or any of the other ingredients of NEURONTIN _Pregnancy and lactation_ Tell your doctor if you are pregnant or intend to become pregnant. NEURONTIN should not be taken during pregnancy, unless you are told otherwise by your doctor. Effective contraception must be used by women of child-bearing potential. Contact your doctor immediately if you become pregnant, think you might be pregnant or are planning to become pregnant while taking NEURONTIN. Do not suddenly discontinue taking this medicine as this may lead to a breakthrough seizure, which could have serious consequences for you and your baby. Gabapentin, the active substance of NEURONTIN, is passed through human milk. As the effect on the baby is unknown, caution should be exercised when gabapentin is administered to a nursing mother. Gabapentin should be used in nursing mothers only if the benefits clearly outweigh the risks. _-_ _Before you start to use it_ Inform your doctor if you have the following: -If you are about to take any prescription or non- Pročitajte cijeli dokument
CLD Title : Gabapentin (Neurontin) CLD Date : 9 March 2023 Country : Malaysia Reference Document : CDS Version 22.0 Dated 20 January 2023 Reason for change : To update section 4.4 to add a paragraph on withdrawal syndrome and woman of childbearing potential/contraception : To update section 4.6 to add a paragraph on neonatal withdrawal syndrome, pregnancy study outcome and replacement of current wording : To update section 4.8 by replacing the current withdrawal symptoms statement with the PRAC statement 1 1. NAME OF THE MEDICINAL PRODUCT NEURONTIN ® 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Gabapentin is supplied as capsules containing 100 mg, and 300 mg of active drug substance for oral administration. Gabapentin is also supplied as 600 mg tablets. Gabapentin is a white to off-white crystalline solid. It is freely soluble in water and both basic and acidic aqueous solutions. 3. PHARMACEUTICAL FORM _CAPSULE _ Gabapentin 100 mg is a hard gelatin capsule with a white opaque cap, blue printed “Neurontin 100 mg” and white opaque body, blue printed “PD”. Gabapentin 300 mg is a hard gelatin capsule with a light yellow opaque cap, grey printed with “Neurontin 300 mg” and light yellow opaque body, grey printed “PD”. _TABLET _ Gabapentin 600 mg is a white elliptical shaped, film-coated tablets with a bisecting score on both sides and debossed with ‘NT’ and ‘16’ on one side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATION _EPILEPSY _ Gabapentin is indicated as adjunctive therapy in the treatment of partial seizures with and without secondary generalization in adults and children aged 3 years and older. Safety and effectiveness for adjunctive therapy in pediatric patients younger than 3 years have not been established (see Section 4.2 POSOLOGY AND METHOD OF ADMINISTRATION: _EPILEPSY_ : _Pediatric patients aged 3 to 12 years_ ). _NEUROPATHIC PAIN _ Gabapentin is indicated for the treatment of neuropathic pain which includes diabetic neuropathy, post- herpetic neuralgia and trigeminal neuralgia Pročitajte cijeli dokument