Država: Malezija
Jezik: engleski
Izvor: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
GABAPENTIN
PFIZER (MALAYSIA) SDN. BHD.
GABAPENTIN
50Capsule Capsules; 100Capsule Capsules; 100Capsule Capsules
PFIZER PHARMACEUTICALS LLC
Pfizer Confidential _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ NEURONTIN ® Gabapentin (Capsule: 100 mg, 300 mg, 400 mg & Tablet: 600 mg) 1 PLD TITLE : NEURONTIN PLD DATE : 14 May 2019 COUNTRY : Malaysia REFERENCE DOCUMENT : Malaysia LPD dated 5 January 2018 REASON FOR CHANGE : To update PRH address : To add serial number Pfizer Confidential _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ NEURONTIN ® Gabapentin (Capsule: 100 mg, 300 mg, 400 mg & Tablet: 600 mg) 2 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 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 Pročitajte cijeli dokument
P fize r Confide ntia l - 1 - LP D T it le : G ABAP EN T I N LPD Date : 172905 MayAugust J anuary 2016782 15 July Mar c h 20165 Country : Malay s ia Referenc e : CD S version1Ve r s io n 1796.0 dated Dated 01 0716 June J anMar c h 201520167 Reas on :: Sinc e tw o major health authorities (US and EU) have now requested the addition of “hyponatremia” as an ADR in gabapentin produc t labeling, an RMC review of this safety topic w as c onduc ted, inc luding disc ussion at PVMAC on 25- Mar-2015. T h e P VMAC rec ommendation w as to add hyponatremia as an ADR in sec tion 4.8 of the CDS. Consequently the Gabapentin CDS is being revised to add “hyponatremia” in sec tion 4.8 under the post - marketing experienc e sec tion. Addition of anaphylaxis w arning (inc luding symptoms of angioedema) in sec tion 4.4 of the Gabapentin CDS Addition of the ADR anaphylaxis in sec tion 4.8 of the Gabapentin CDS (under the post -marketing experienc e sec tion) Also, moved the loc ation of the existing DRESS w arning in sec tion 4.4 to be positioned up higher to reflec t higher c linic al signific anc e of this w arning. • Addition of mandatory s tatement for Ep ilep t ic s in sec tion 4.4 as per Malays ia D rug Registration Guidanc e Doc ument - S p ec if ic Lab ellin g Requirement (s ubs tanc e s pecific ) • Addition of anaphylaxis w arning (inc luding symptoms of angioedema) in sec tion 4.4 of the Gabapentin CDS • Addition of the ADR anaphylaxis in sec tion 4.8 of the Gabapentin CDS (under the post marketing experienc e sec tion) • Also, moved the loc ation of the existing DRES S w arning in sec tion 4.4 to be positioned up higher to reflec t higher c linic al signific anc e of this w arning. • Addition of mandatory statement for Epileptic s in sec tion 4.4 as per Malaysia Drug Registration Guidanc e Doc ument - Spec ific Labelling Requirement (s ubs tanc e specific ) • HA request to update PI ac c ordingly w ith referenc e to PRAC's recommendation on respiratory depression. EMA has c onc luded gabapentin c an c aus Pročitajte cijeli dokument