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This leaflet is part III of a three-part “Product Monograph" published when MYLAN-GABAPENTIN was approved for sale in Canada and is designed specifically for Consumers. PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PrNEURONTIN® Gabapentin Capsules Capsules, 100 mg, 300 mg and 400 mg, oral IMPORTANT: PLEASE READ: This leaflet is part III of a three-part “Product Monograph” published when NEURONTIN was approved for sale in Canada and is designed specifically for Consumers. This leaflet is a summary and will not tell you everything about NEURONTIN. Contact your doctor or pharmacist if you have any questions about the drug. PRODUCT MONOGRAPH PrTEVA-GABAPENTIN Gabapentin Capsules 100 mg, 300 mg, and 400 mg Tablets 600 mg and 800 mg Antiepileptic Agent This leaflet is part III of a three-part "Product Monograph" published when GABAPENTIN was approved for sale in Canada and is designed specifically for Consumers. This leaflet is part III of a three-part “Product Monograph" published when Neurontin was approved for sale in Canada and is designed specifically for Consumers. This leaflet is part III of a three-part “Product Monograph" published when NEURONTIN was approved for sale in Canada and is designed specifically for Consumers. This leaflet is a summary and will not tell you everything about NEURONTIN. Contact your doctor or pharmacist if you have any questions about the drug. This document is a product monograph for Neurontin (gabapentin), an antiepileptic agent. It provides information on the approved indications, contraindications, warnings and precautions, adverse reactions, drug interactions, dosage and administration, and other details regarding the safe and effective use of the drug. The approved indication is for adjunctive therapy in the management of PRODUCT MONOGRAPH Pr NEURONTIN® Gabapentin Capsules 100 mg, 300 mg, and 400 mg Tablets 600 mg and 800 mg Antiepileptic Agent Pfizer Canada Inc. NEURONTIN oral solution contains 250 mg of gabapentin per 5 mL (50 mg per mL) and the following inactive ingredients: glycerin, xylitol, purified water, and artificial cool strawberry anise flavor. 1 NEURONTIN® (Gabapentin Capsules, 100 mg, 300 mg and 400 mg; Gabapentin Tablets, 600 mg and 800 mg), submission control 275525, Product Monograph, BGP Pharma ULC. DESCRIPTION Neurontin® (gabapentin) Capsules, Neurontin (gabapentin) Tablets, and Neurontin (gabapentin) Oral Solution are supplied as imprinted hard shell capsules containing 100 mg, 300 mg, and 400 mg of gabapentin, elliptical film-coated tablets containing 600 mg and 800 mg of gabapentin or an oral solution containing 250 mg/5 mL of gabapentin. This leaflet is part III of a three-part “Product Monograph" published when NEURONTIN was approved for sale in Canada and is designed specifically for Consumers. Adults GABAPENTIN (gabapentin) is indicated as adjunctive therapy for the management of patients with epilepsy who are not satisfactorily controlled by conventional therapy. Product description The active ingredient in NEURONTIN capsules, tablets, and oral solution is gabapentin, which has the chemical name 1- (aminomethyl)cyclohexaneacetic acid. PRODUCT MONOGRAPH Pr NEURONTIN® Gabapentin Capsules 100 mg, 300 mg, and 400 mg Tablets 600 mg and 800 mg Antiepileptic Agent Pfizer Canada ULC Date of Revision: 17,300 Trans-Canada Highway January 27, 2020 Kirkland, Quebec H9J 2M5 www.pfizer.ca Submission Control No: 232770 ®TM Warner-Lambert Company LLC Pfizer Canada ULC, Licensee ©Pfizer Canada ULC 2019 NEURONTIN® (gabapentin) Product 17 SUPPORTING PRODUCT MONOGRAPHS 1 NEURONTIN® (Capsule 100 mg, 200 mg & 300 mg; Tablet, 600 mg & 800 mg), Submission Control#275525, Product Monograph, BGP Pharma ULC. This is a quick reference drug monograph for the antiepileptic, gabapentin (Neurontin). NEURONTIN may cause you to feel dizzy or drowsy. Avoid driving, using machinery, or doing dangerous activities until you know how NEURONTIN affects you. Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines. In placebo-controlled trials of 12 weeks duration in patients not satisfactorily controlled with current antiepileptic drugs, NEURONTIN (gabapentin), when added to current antiepileptic therapy, was superior to placebo in reducing the frequency of both simple and complex partial seizures and secondarily generalized tonic-clonic seizures.
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