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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