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GABAPENTIN (gabapentin) is indicated as adjunctive therapy for the management of patients with epilepsy who are not satisfactorily controlled by conventional therapy. 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. Search the Drug Product Database (DPD) to find drugs authorized for sale by Health Canada. The DPD is updated nightly and includes: availability of the drug in Canada ; product monograph (PM) for human drugs ; labels for animal drugs; Generic drug manufacturers must update their PM to ensure it aligns with the Canadian Reference Product. NEURONTIN® (gabapentin) Product Monograph Page 17 of 29 ACTION AND CLINICAL PHARMACOLOGY Mechanism of Action Neurontin (gabapentin) readily enters the brain and prevents seizures in a number of animal models of epilepsy. 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). Information on drug and health products authorized by Health Canada. Skip to main content GABAPENTIN: 300 MG The Product Monograph is a scientific document 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. TEVA-GABAPENTIN (gabapentin) is indicated as adjunctive therapy for the management of patients with epilepsy who are not satisfactorily controlled by conventional therapy. 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. GABAPENTIN (Gabapentin Tablets) Page 8 of 37 600 mg tablets: GABAPENTIN 600 mg tablets are white to off white, oval shaped, biconvex, film coated tablets, debossed with ‘G’ and ‘A’ separated by score line on one face and score line on the other. PRODUCT MONOGRAPH PrNEURONTIN® Gabapentin Capsules 100 mg, 300 mg, and 400 mg Tablets 600 mg and 800 mg Antiepileptic Agent May 5, 2020 Date of Revision: ©Upjohn Canada ULC,2020 Upjohn Canada ULC, Licensee ®Warner-Lambert CompanyLLC Submission Control No.: 237475 H9J 2M5 Kirkland, Quebec 17300Trans-Canada Highway UpjohnCanadaULC NEURONTIN (gabapentin) belongs to the family of medicines called antiepileptic drugs and is used for treating epilepsy (seizures). What it does: NEURONTIN has been prescribed for you by your doctor to reduce your number of seizures. When it should not be used: Do not use NEURONTIN if you are allergic to it or any of the PRODUCT MONOGRAPH Pr Gabapentin Gabapentin Tablets, House Standard 600 mg and 800 mg Antiepileptic Agent JAMP Pharma Corporation 1310 rue Nobel Boucherville, Quebec Tell your doctor immediately if you experience increased side effects such as drowsiness or slowed breathing while taking GABAPENTIN with an opioid or other sedatives and tranquilizers. The dose of these drugs or GABAPENTIN may need to be adjusted. Avoid alcoholic drinks while taking GABAPENTIN. RIVA-GABAPENTIN (gabapentine) est indiqué comme traitement adjuvant chez les patients dont l’état épileptique n’est pas stabilisé de façon satisfaisante par la thérapeutique classique. 1.1 Enfants Enfants (< 18 ans) : D’après les données soumises à Santé Canada et examinées par l’organisme, NEURONTIN (gabapentin) Page 1 of 36 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 Submission Control No.: 274395 NEURONTIN® (gabapentin) Product Monograph Page 1 of 29 PRODUCT MONOGRAPH Pr NEURONTIN® Gabapentin Capsules 100 mg, 300 mg, and 400 mg Tablets 600 mg and 800 mg Antiepileptic Agent Pfizer Canada Inc. 17, 300 Trans-Canada Highway Kirkland, Quebec H9J 2M5 www.pfizer.ca Date of Revision: February 22, 2018 Submission Control No: 211678 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. 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. women. Gabapentin should only be used during pregnancy if the potential benefit to the mother outweighs the potential risk to the fetus. Nursing Women: Gabapentin is excreted in human milk. Because the effect on the nursing infant is unknown, caution should be exercised when gabapentin is administered to a nursing mother.
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