Kraj: Malezja
Język: angielski
Źródło: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
GABAPENTIN
PFIZER (MALAYSIA) SDN. BHD.
GABAPENTIN
100Capsule Capsules; 50Capsule 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 Przeczytaj cały dokument
Pfizer Confidential - 1 - LPD Title : GABAPENTIN LPD Date : 05 January 201 8 Country : Malaysia Reference : CDS Version 1 9.0 Dated 16 March 201 7 Reason : • Addition of anaphylaxis warning (including symptoms of angioedema) in section 4.4 of the Gabapentin CDS • Addition of the ADR anaphylaxis in section 4.8 of the Gabapentin CDS (under the post marketing experience section) • Also, moved the location of the existing DRES S warning in section 4.4 to be positioned up higher to reflect higher clinical significance of this warning. • Addition of mandatory statement for Epileptics in section 4.4 as per Malaysia Drug Registration Guidance Document - Specific Labelling Requirement (substance specific) • HA request to update PI accordingly with reference to PRAC's recommendation on respiratory depression. EMA has concluded gabapentin can cause respiratory depression without concomitant opioid use. • Add "gabapentin crosses the human pla centa" in pregnancy section 4.6 and addition of a statement in section 4.6 regarding "congenital malformations and adverse developmental outcomes have been reported with gabapentin use" and "no definitive conclusions can be made as to whether gabapentin is causally associated with an increased risk of congenital malformations or other adverse developmental outcomes when taken during pregnancy. The risk of birth defects is increased by a factor of 2 -3 in the offspring of mothers treated with an antiepileptic medicinal product; revision of a statement in section 4.6 to state that "studies in animals have shown reproductive toxicity (see 5.3). The potential risk for humans is unknown. Gabapentin should be used during pregnancy only if the potential benefit to t he mother clearly outweighs the potential risk to the fetus. • Addition of the post -marketing ADR agitation. Minor edit in section 5.3: the word "doses" was meant to be "does" which means "female rabbits". The labeling team is revising this word to "female r abbits" for more clarity. 1. NAME OF THE MEDICINAL PRODUCT Przeczytaj cały dokument