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GABAPENTIN Product Monograph Page 3 of 32 Pr GABAPENTIN Gabapentin Capsules, House Standard 100 mg, 300 mg, and 400 mg PART I: HEALTH PROFESSIONAL INFORMATION SUMMARY PRODUCT INFORMATION Route of Administration Dosage Form / Strength All Non-medicinal Ingredients Oral Capsules / 100 mg, 300 mg, and 400 mg Corn Starch, Lactose Anhydrous, and Talc. PRODUCT MONOGRAPH PrAPO-GABAPENTIN Gabapentin Capsules Apotex Standard 100 mg, 300 mg and 400 mg Gabapentin Tablets USP 600 mg and 800 mg Antiepileptic Agent APOTEX INC. DATE OF REVISION: 150 Signet Drive April 5, 2018 Toronto, Ontario M9L 1T9 Submission Control No: 214592 NEURONTIN (gabapentin) –Product Monograph Page 3of 29 PrNEURONTIN® (gabapentin) PART I: HEALTH PROFESSIONAL INFORMATION SUMMARY PRODUCT INFORMATION Route of Administration Dosage Form / Strength Nonmedicinal Ingredients Oral Capsules 100 mg, 300 mg, and 400 mg Corn starch, lactose, and talc. Capsule shells may contain: FD&CBlue No. 2 TEVA-GABAPENTIN (gabapentin) Page 1 of 41 PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PrTEVA-GABAPENTIN Gabapentin Capsules Capsules, 100 mg, 300 mg, and 400 mg, Oral Gabapentin Tablets Tablets, 600 mg and 800 mg, Oral Teva Standard NEURONTIN® (gabapentin) Product Monograph Page 6 of 29 treatment. Patients should be instructed to discontinue gabapentin and seek immediate medical care should they experience signs or symptoms of anaphylaxis. Neurologic Gabapentin treatment has been associated with dizziness and somnolence, which could increase Neurontin was evaluated for the management of postherpetic neuralgia (PHN) in 2 randomized, double-blind, placebo-controlled, multicenter studies; N=563 patients in the intent-to-treat (ITT) Gabapentin has been shown in vitro to interfere with activity of the α2δ subunit of voltage-activated calcium channels, a receptor involved in neuronal synaptogenesis. The clinical significance of these findings is unknown. NEURONTIN® (gabapentin) Product Monograph Page 25 of 29 NEURONTIN (gabapentin) is indicated as adjunctive therapy for the management of patients with epilepsy who are not satisfactorily controlled by conventional therapy. 1.1 Pediatrics NEURONTIN (gabapentin) Page 1 of 38 PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PrNEURONTIN® Gabapentin Capsules Capsules, 100 mg, 300 mg and 400 mg, oral Gabapentin Tablets Tablets, 600 mg and 800 mg, oral Antiepileptic Agent BGP Pharma ULC 85 Advance Road Etobicoke (Ontario) Canada M8Z 2S6 Date of Initial Approval: GABAPENTIN (gabapentin) Page 1 of 40 PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PrGABAPENTIN Gabapentin Capsules Capsules, 100 mg, 300 mg, and 400 mg, Oral Teva Standard Antiepileptic Agent Teva Canada Limited 30 Novopharm Court, Toronto, Ontario PRODUCT MONOGRAPH Pr MYLAN-GABAPENTIN (Gabapentin Capsules) 100 mg, 300 mg, and 400 mg (Gabapentin Tablets, USP) 600 mg and 800 mg ANTIEPILEPTIC AGENT Mylan Pharmaceuticals ULC 85 Advance Road, Etobicoke, ON M8Z 2S6 Submission Control No.: 202563 Date of Revision: February 14, 2017 TEVA-GABAPENTIN (gabapentin) is indicated as adjunctive therapy for the management of patients with epilepsy who are not satisfactorily controlled by conventional therapy. Systematic studies in geriatric patients have not been conducted. (See WARNINGS AND PRECAUTIONS, Special Populations). 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 Gabapentin is structurally related to the neurotransmitter GABA (gamma-aminobutyric acid) but it does not modify GABA A or GABA B binding. It is also not metabolically converted into GABA or a GABA agonist and it is not an inhibitor of GABA uptake or degradation. Information about the product including what the product is used for, dosage, warnings, proper use and side effects. This summary will not tell you everything about the product. Contact your healthcare professional if you have any questions about the product. The Product Monograph is a scientific document that describes the properties, claims, indications and conditions of use of the product and contains any other information that may be required for optimal, safe and effective use. NEURONTIN belongs to the family of medicines called antiepileptic drugs. It works by acting on the brain to help decrease the number of seizures you may have. What are the ingredients in NEURONTIN? Medicinal ingredients: Gabapentin. Non-medicinal ingredients: NEURONTIN Capsules: Corn starch, lactose, and talc, Capsule shells may contain: FD&C GABAPENTIN Product Monograph Page 3 of 32 PrGABAPENTIN Gabapentin Capsules, House Standard 100 mg, 300 mg and 400 mg PART I: HEALTH PROFESSIONAL INFORMATION SUMMARY PRODUCT INFORMATION Route of Administration Dosage Form / Strength All Non-medicinal Ingredients Oral Capsules: 100 mg, 300 mg, and 400 mg Corn Starch, Lactose Anhydrous, and Talc. Neurontin® (gabapentin) capsules, Neurontin® (gabapentin) tablets, and Neurontin® (gabapentin) oral solution are supplied as imprinted hard shell capsules containing 100 mg, 300 mg, and Gabapentin Page 1 of 28 PRODUCT MONOGRAPH Pr Gabapentin Gabapentin Tablets, House Standard 600 mg and 800 mg Antiepileptic Agent JAMP Pharma Corporation 1310 rue Nobel Boucherville, Quebec J4B 5H3 Control# 256895

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