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Bristol-Myers Squibb Holdings Limited
Bristol-Myers Squibb House, Uxbridge Business Park, Sanderson Road, Uxbridge, Middlesex, UB8 1DH , UK
Telephone: +44 (0)1895 52 3000
Fax: +44 (0)1895 52 3010
Medical Information Direct Line: +1 800 749 749
Medical Information e-mail: medical.information@bms.com
Medical Information Fax: +44 (0)1895 523 677

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: 28/11/2011
SPC Megace 160 mg Tablets

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 28/11/2011 and displayed until Current
Reasons for adding or updating:
  • Change to section 6. 4 - Special Precautions for Storage
  • Change to section 10 date of revision of the text
  • Addition of Legal Category
Date of revision of text on the SPC:   21-Oct-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 6.4: Addition of text: Store in the original package in order to protect from moisture.

Section 10: Change to 21 October 2011.

Addition of Legal category: POM
Updated on 07/06/2011 and displayed until 28/11/2011
Reasons for adding or updating:
  • Change to section 4.9 - Overdose
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   20-May-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 4.9 update in line with Company Core Data Sheet

Following text added:

Reports of overdose have also been received in the postmarketing setting. Signs and symptoms reported in the context of overdose included diarrhoea, nausea, abdominal pain, shortness of breath, cough, unsteady gait, listlessness, and chest pain. There is no specific antidote for overdose with Megace. In case of overdose, appropriate supportive measures should be taken.
Updated on 08/12/2010 and displayed until 07/06/2011
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 6.1 - List of Excipients
  • Change to section 6.2 - Incompatibilities
  • Change to section 6. 6 - Instructions for use, handling and disposal
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   22-Nov-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
SPC is revised in line with QRD Template

Section 2: Lactose content included, reference to Section 6.1 for excipients

Section 3: Tablet description included

Section 6.1: Colloidal silicone dioxide changed to Colloidal anhydrous silica

Section 6.2: 'None stated' changed to 'Not applicable'

Section 6.6: 'None' changed to 'No special requirements'
Updated on 21/04/2010 and displayed until 08/12/2010
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 10 date of revision of the text
Date of revision of text on the SPC:   23-Mar-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 4.1 - Removal of the endometrial cancer indication.
Section 4.2 - Removal of the reference to the posology for the endometrial cancer indication.
Updated on 08/07/2009 and displayed until 21/04/2010
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   09-Jun-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 4.4:  Addition of lactose warning.
Updated on 21/09/2007 and displayed until 08/07/2009
Reasons for adding or updating:
  • Change to separate SPCs covering individual presentations
Date of revision of text on the SPC:   09/2007
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
 
Change to separate SPC covering remaining 160mg strength due to discontinuation of the 40mg tablets
Updated on 14/09/2005 and displayed until 21/09/2007
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder
  • Change to section 10 (date of (partial) revision of the text
Updated on 23/09/2002 and displayed until 14/09/2005
Reasons for adding or updating:
  • Change to section 6. 4 - Special Precautions for Storage
  • Change to section 9 - Date of Renewal of Authorisation
Updated on 16/09/2002 and displayed until 23/09/2002
Reasons for adding or updating:
  • Change to section 9 - Date of Renewal of Authorisation
  • Change to section 6. 4 - Special Precautions for Storage
Updated on 20/08/2001 and displayed until 16/09/2002
Reasons for adding or updating:
  • Transferred from eMC version 1
Updated on 06/09/1999 and displayed until 20/08/2001
Reasons for adding or updating:
  • No reasons supplied

Active Ingredients/Generics

 
  megestrol acetate