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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: 17/11/2010
SPC Hycamtin 1mg and 4mg powder for concentrate for solution for infusion

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 17/11/2010 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.5 - 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 9 - Date of first Authorisation/renewal of the Authorisation
  • 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):   NO

Free-text change information supplied by the pharmaceutical company


Details of SPC changes

-          Section 4.1: format changes

-          Section 4.2: format changes

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

-          Section 4.5: format changes

-          Section 4.6: format changes

-          Section 4.8: safety-related changes (addition of pancytopenia, severe bleeding, and additional information regarding ILD and sepsis) and format changes

-          Section 5.1: format changes

-          Section 5.2: format changes

-          Section 9: 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):   NO

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 4.3 - Contraindications
  • 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):   NO

Free-text change information supplied by the pharmaceutical company
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 10 - 12 December 2008
Updated on 17/11/2008 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):   NO

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 07/08/2008 and displayed until 17/11/2008
Reasons for adding or updating:
  • SPC Retired pending re-submission
  • 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 5.3 - Preclinical Safety Data
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   18-Mar-2008
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Section 4.2: minor changes to the wording on paediatrics

Section 4.3: pregnancy contraindication removed (but this is not meant to imply you can use it during pregnancy - see updates to section 4.6)

Section 4.4: minor wording changes mainly relating to myelosupression and sepsis

Section 4.5: very minor wording changes

Section 4.6: addition of wording re contraception. Update to wording on pregnancy. Addition of a statement on pre-clinical findings re fertility.

Section 4.8: minor update to wording and order of the listed AEs

Section 5.1: Changes plus additional information on trials in SCLC. Note that "Active Symptom Control" (ASC) now reads "Best Supportive Care" (BSC).

Section 5.2: minor updates

Section 5.3: addition of a statement regarding findings in rats regarding fertility.

Section 10: date updated
Updated on 28/06/2007 and displayed until 07/08/2008
Reasons for adding or updating:
  • 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:   06/2007
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 6.5: Changed 4mg presentation from 5ml to 17ml type I flint glass vials
Section 10: Now 21/06/2007
Updated on 19/03/2007 and displayed until 28/06/2007
Reasons for adding or updating:
  • 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:   03/2007
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

For further information, please contact GlaxoSmithKline on +44 (0)800 221 441
Updated on 01/03/2007 and displayed until 19/03/2007
Reasons for adding or updating:
  • Change in co-marketing arrangement
Date of revision of text on the SPC:   11/2006
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Change to co-marketing arrangment from Merck Pharmaceuticals to GlaxoSmithKline UK
Updated on 04/12/2006 and displayed until 01/03/2007
Reasons for adding or updating:
  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.8 - Undesirable Effects
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 5.2 - Pharmacokinetic Properties
Date of revision of text on the SPC:   11/2006
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Information on use in paediatrics affecting sections 4.2, 5.1 and 5.2.
 
New cervical cancer indication: Topotecan is now approved for the treatment, in combination with cisplatin, of patients with carcinoma of the cervix recurrent after radiotherapy and for patients with Stage IV-B disease. Patients with prior exposure to cisplatin require a sustained treatment free interval to justify treatment with the combination. SPC sections 4.1, 4.2, 4.5, 4.8, 5.1 and 5.2 have been amended
Updated on 13/02/2006 and displayed until 04/12/2006
Reasons for adding or updating:
  • Correction of spelling/typing errors
Updated on 09/02/2006 and displayed until 13/02/2006
Reasons for adding or updating:
  • Change to section 4.1 - Therapeutic Indications
  • Change to section 4.8 - Undesirable Effects
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 10 (date of (partial) revision of the text
Updated on 29/09/2004 and displayed until 09/02/2006
Reasons for adding or updating:
  • New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC

Active Ingredients/Generics

 
  topotecan hydrochloride