HYCAMTIN Hard capsule Ref.[8588] Active ingredients: Topotecan

Source: European Medicines Agency (EU) Revision Year: 2018 Publisher: Novartis Europharm Limited, Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland

Product name and form

HYCAMTIN 0.25 mg hard capsules

HYCAMTIN 1 mg hard capsules

Pharmaceutical Form
Hard capsule. HYCAMTIN 0.25 mg hard capsules: The capsules are opaque, white to yellowish white and imprinted with “HYCAMTIN” and “0.25 mg”. HYCAMTIN 1 mg hard capsules: The capsules are opaque, pink and imprinted with “HYCAMTIN” and “1 mg”.

Qualitative and quantitative composition

HYCAMTIN 0.25 mg hard capsules: Each capsule contains 0.25 mg of topotecan (as hydrochloride).

HYCAMTIN 1 mg hard capsules: Each capsule contains 1 mg of topotecan (as hydrochloride).

For the full list of excipients, see section 6.1.

Active Ingredient	Description
Topotecan	Topotecan involves the inhibition of topoisomerase-I, an enzyme intimately involved in DNA replication.

List of Excipients
HYCAMTIN 0.25 mg hard capsules Capsule contents: Hydrogenated vegetable oil Glyceryl monostearate Capsule shell: Gelatin Titanium dioxide (E171) Sealing band: Gelatin Black ink: Black iron oxide (E172) Shellac Anhydrous ethanol – see leaflet for further information Propylene glycol Isopropyl alcohol Butanol Concentrated ammonia solution Potassium hydroxide HYCAMTIN 1 mg hard capsules Capsule contents: Hydrogenated vegetable oil Glyceryl monostearate Capsule shell: Gelatin Titanium dioxide (E171) Red iron oxide (E172) Sealing band: Gelatin Black ink: Black iron oxide (E172) Shellac Anhydrous ethanol – see leaflet for further information Propylene glycol Isopropyl alcohol Butanol Concentrated ammonia solution Potassium hydroxide

Pack sizes and marketing

White polyvinyl chloride / polychlorotrifluoroethylene blister sealed with aluminium / Polyethylenterephtalate (PET) / paper foil lidding. The blisters are sealed with a peel-push child resistant opening feature.

Each blister contains 10 capsules.

Marketing authorization holder

Novartis Europharm Limited, Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland

Marketing authorization dates and numbers

HYCAMTIN 0.25 mg hard capsules: EU/1/96/027/006
HYCAMTIN 1 mg hard capsules: EU/1/96/027/007

Date of first authorisation: 12 November 1996
Date of latest renewal: 20 November 2006

Drugs

Drug	Countries
HYCAMTIN	Austria, Australia, Brazil, Cyprus, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Japan, Lithuania, Netherlands, Poland, Romania, Singapore, Turkey, United Kingdom, United States, South Africa

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