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GlaxoSmithKline UK
Stockley Park West, Uxbridge, Middlesex, UB11 1BT
Telephone: +44 (0)800 221 441
Fax: +44 (0)208 990 4328
Medical Information e-mail: customercontactuk@gsk.com

Before you contact this company: often several companies will market medicines with the same active ingredient. Please check that this is the correct company before contacting them. Why?
Summary of Product Characteristics last updated on the eMC: 17/02/2012
SPC Hycamtin 0.25mg and 1 mg hard capsule

When a pharmaceutical company changes an SPC or PIL, a new version is published on the eMC. For each version, we show the dates it was published on the eMC and the reasons for change.

Updated on 17/02/2012 and displayed until Current
Reasons for adding or updating:
  • Removal of Black Triangle
Date of revision of text on the SPC:   28-Oct-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Removal of Black Triangle
Updated on 17/11/2010 and displayed until 17/02/2012
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Pregnancy and Lactation
  • Change to section 4.8 - Undesirable Effects
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 5.2 - Pharmacokinetic Properties
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   28-Oct-2010
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company
Details of SPC changes:

-          Section 4.2: safety related change (addition of information related to proactive management of  diarrhoea) and format changes

-          Section 4.3: hypersensitivity contraindication  updated to specify that contraindicated in ‘severe’ hypersensitivity cases

-          Section 4.4: safety-related change (addition of: when prescribing HYCAMTIN) and format changes

-          Section 4.5: addition of information relating to in vivo pharmacokinetic studies (No in vivo human pharmacokinetic interaction studies have been performed.)

-          Section 4.6: format changes

-          Section 4.8: safety-related changes (addition of severe bleeding, information relating to fatal cases of interstitial lung disease, potential for nausea, vomiting and diarrhoea to cause dehydration, addition of info relating to fatalities due to sepsis) and format changes

-          Section 5.1: format changes

-          Section 5.2: safety-related changes (correction of figures relating to overall recovery of administered dose after renal clearance) and format changes

-          Section 10: update to date last updated and update of EMA contact details.

Updated on 02/02/2010 and displayed until 17/11/2010
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   20-Jan-2010
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company
Section 7 - SmithKline Beecham Ltd, 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom.

Section 10 -20-January-2010
Updated on 20/01/2009 and displayed until 02/02/2010
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 6. 5 - Nature and Contents of Container
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   12-Dec-2008
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company
Section 4.2 - Hycamtin capsules may be taken with or without food (see section 5.2).

Section 4.3 -already have severe bone marrow depression prior to starting first course, as evidenced by baseline neutrophils < 1.5 x 109/l and/or a platelet count of < 100 x 109/l.

Section 6.5 - 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.

Section 10 - 12 December 2008
Updated on 18/11/2008 and displayed until 20/01/2009
Reasons for adding or updating:
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.8 - Undesirable Effects
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   30-Oct-2008
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company
Section 3 - Light yellow to greenish powder (for IV injection only).

Section 4.2 - whole section

Section 4.4 - Addition of:

Topotecan has been associated with reports of interstitial lung disease, some of which have been fatal (see section 4.8). Underlying risk factors include history of ILD, pulmonary fibrosis, lung cancer, thoracic exposure to radiation and use of pneumotoxic drugs and/or colony stimulating factors. Patients should be monitored for pulmonary symptoms indicative of interstitial lung disease (e.g. cough, fever, dyspnoea and/or hypoxia), and topotecan should be discontinued if a new diagnosis of ILD is confirmed.

Section 4.8 - Respiratory, thoracic and mediastinal disorders
Rare: interstitial lung disease

Section 10 - 30 October 2008
Updated on 29/09/2008 and displayed until 18/11/2008
Reasons for adding or updating:
  • New SPC for new product
Date of revision of text on the SPC:  
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company
None provided

Active Ingredients/Generics

 
  topotecan hydrochloride