Australia - English - Department of Health (Therapeutic Goods Administration)

medis pharma pty ltd - topiramate, quantity: 50 mg - tablet, film coated - excipient ingredients: microcrystalline cellulose; lactose monohydrate; magnesium stearate; pregelatinised maize starch; sodium starch glycollate; colloidal anhydrous silica; titanium dioxide; hypromellose; polysorbate 80; iron oxide yellow; macrogol 400; propylene glycol; butan-1-ol; isopropyl alcohol; strong ammonia solution; iron oxide black; ethanol; shellac; sulfuric acid; purified water; industrial methylated spirit; ammonia - epilepsy. adults and children 2 years and over: as monotherapy in patients with newly diagnosed epilepsy;. for conversion to monotherapy in patients with epilepsy;as add-on therapy in partial onset seizures (with or without secondary generalised seizures), primary generalised tonic-clonic seizures or drop attacks associated with lennox-gastaut syndrome.. migraine. prophylaxis of migraine headache in adults.

New Zealand - English - Medsafe (Medicines Safety Authority)

actavis new zealand limited - topiramate 25mg - capsule - 25 mg - active: topiramate 25mg excipient: aniseed ethanol gelatin magnesium stearate opadry white 85f18378 povidone purified water saccharin sodium sugar spheres tekprint black sw-9008 titanium dioxide - arrow - topiramate is indicated in adults and children 2 years and over: - as monotherapy in patients with newly diagnosed epilepsy - for conversion to monotherapy in patients with epilepsy - as add-on therapy in partial onset seizures, generalised tonic-clonic seizures or seizures associated with lennox-gastaut syndrome.

New Zealand - English - Medsafe (Medicines Safety Authority)

actavis new zealand limited - topiramate 50mg - capsule - 50 mg - active: topiramate 50mg excipient: aniseed ethanol gelatin magnesium stearate opadry white 85f18378 povidone purified water saccharin sodium sugar spheres tekprint black sw-9008 titanium dioxide - arrow - topiramate is indicated in adults and children 2 years and over: - as monotherapy in patients with newly diagnosed epilepsy - for conversion to monotherapy in patients with epilepsy - as add-on therapy in partial onset seizures, generalised tonic-clonic seizures or seizures associated with lennox-gastaut syndrome.

United States - English - NLM (National Library of Medicine)

direct rx - topiramate (unii: 0h73wjj391) (topiramate - unii:0h73wjj391) - topiramate 50 mg - 1.1 monotherapy epilepsy topiramate tablets are indicated as initial monotherapy in patients 2 years of age and older with partial onset or primary generalized tonic-clonic seizures. safety and effectiveness in patients who were converted to monotherapy from a previous regimen of other anticonvulsant drugs have not been established in controlled trials [see clinical studies ( 14.1)]. 1.2 adjunctive therapy epilepsy topiramate tablets are indicated as adjunctive therapy for adults and pediatric patients ages 2 to 16 years with partial onset seizures or primary generalized tonic-clonic seizures, and in patients  2 years of age and older with seizures associated with lennox-gastaut syndrome [see clinical studies ( 14.2)]. none. 8.1 pregnancy pregnancy category d. [see warnings and precautions ( 5.6)] topiramate can cause fetal harm when administered to a pregnant woman. data from pregnancy registries indicate that infants exposed to topiramate in utero have an increased risk f

United States - English - NLM (National Library of Medicine)

direct rx - topiramate (unii: 0h73wjj391) (topiramate - unii:0h73wjj391) - topiramate 25 mg - indications and usagemonotherapy epilepsy topiramate tablets are indicated as initial monotherapy in patients 10 years of age and older with partial onset or primary generalized tonic-clonic seizures. effectiveness was demonstrated in a controlled trial in patients with epilepsy who had no more than 2 seizures in the 3 months prior to enrollment. safety and effectiveness in patients who were converted to monotherapy from a previous regimen of other anticonvulsant drugs have not been established in controlled trials. adjunctive therapy epilepsy topiramate tablets are indicated as adjunctive therapy for adults and pediatric patients ages 2 to 16 years with partial onset seizures, or primary generalized tonic-clonic seizures, and in patients 2 years of age and older with seizures associated with lennox-gastaut syndrome. topiramate tablets are contraindicated in patients with a history of hypersensitivity to any component of this product. the abuse and dependence potential of topiramate has not been evaluated in

United States - English - NLM (National Library of Medicine)

proficient rx lp - topiramate (unii: 0h73wjj391) (topiramate - unii:0h73wjj391) - topiramate 50 mg - monotherapy epilepsy topiramate tablets are indicated as initial monotherapy in patients 10 years of age and older with partial onset or primary generalized tonic-clonic seizures. effectiveness was demonstrated in a controlled trial in patients with epilepsy who had no more than 2 seizures in the 3 months prior to enrollment. safety and effectiveness in patients who were converted to monotherapy from a previous regimen of other anticonvulsant drugs have not been established in controlled trials. adjunctive therapy epilepsy topiramate tablets are indicated as adjunctive therapy for adults and pediatric patients ages 2 to 16 years with partial onset seizures, or primary generalized tonic-clonic seizures, and in patients 2 years of age and older with seizures associated with lennox-gastaut syndrome. topiramate is contraindicated in patients with a history of hypersensitivity to any component of this product. the abuse and dependence potential of topiramate has not been evaluated in human studies.

United States - English - NLM (National Library of Medicine)

aidarex pharmaceuticals llc - topiramate (unii: 0h73wjj391) (topiramate - unii:0h73wjj391) - topiramate 50 mg - monotherapy epilepsy topiramate tablets are indicated as initial monotherapy in patients 10 years of age and older with partial onset or primary generalized tonic-clonic seizures. effectiveness was demonstrated in a controlled trial in patients with epilepsy who had no more than 2 seizures in the 3 months prior to enrollment. safety and effectiveness in patients who were converted to monotherapy from a previous regimen of other anticonvulsant drugs have not been established in controlled trials. adjunctive therapy epilepsy topiramate tablets are indicated as adjunctive therapy for adults and pediatric patients ages 2 to 16 years with partial onset seizures, or primary generalized tonic-clonic seizures, and in patients 2 years of age and older with seizures associated with lennox-gastaut syndrome. topiramate is contraindicated in patients with a history of hypersensitivity to any component of this product. the abuse and dependence potential of topiramate has not been evaluated in human studies.

Australia - English - Department of Health (Therapeutic Goods Administration)

sandoz pty ltd - topiramate -

Australia - English - Department of Health (Therapeutic Goods Administration)

sandoz pty ltd - topiramate -

Australia - English - Department of Health (Therapeutic Goods Administration)

sandoz pty ltd - topiramate -