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sanofi-aventis
1 Onslow Street, Guildford, Surrey, GU1 4YS, UK
Telephone: +44 (0)1483 505 515
Fax: +44 (0)1483 535 432
Medical Information e-mail: uk-medicalinformation@sanofi-aventis.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: 27/05/2011
SPC Danol 100mg Capsules, Danol 200mg Capsules

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 27/05/2011 and displayed until Current
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.6 - Pregnancy and Lactation
  • Change to section 4.7 - Effects on Ability to Drive and Use Machines
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 5.3 - Preclinical Safety Data
  • Change to section 6.1 - List of Excipients
  • Change to section 6.2 - Incompatibilities
  • Change to section 6. 3 - Shelf Life
  • Change to section 6. 5 - Nature and Contents of Container
  • Change to section 6. 6 - Instructions for use, handling and disposal
  • 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:   15-May-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Section 2: updates so that the quantity of lactose monohydrate is also provided

 

Section 3 updated so that the size, colour, appearance of the capsules is now specified.

 

Section 4.3: Hypersensitivity to danazol or to any of the excipients added as a contraindication

 

Section 4.4- reformatted so that headings 4.4.1 and 4.4.2 are now removed.

 

Section 4.6: sub heading changed to read Fertility, pregnancy and lactation. No other changes

 

Section 4.7- text changed from No special warning is felt necessary, to Danol has no or negligible influence on the ability to drive and use machines.

 

Section 5.1- following text added: Pharmacotherapeutic group: sex hormones and modulators of the genital system, antigonadotropins and similar agents, ATC code: G03XA01 and section 5.3 has had slight reformatting and correction of typos.

Section 6.1- E numbers added for excipients where appropriate. Shellac and shellac glaze replaced with S-1-27794 Opacode Black,  also addition of Industrial methylated spirit 74 OP. Following section also added:

 

TekPrint SW-9008 Black Ink

Shellac

Dehydrated alcohol

Isopropyl alcohol

Butyl alcohol

Propylene glycol

Purified water

Strong ammonia solution

Potassium hydroxide

Black iron oxide (E172)

 

Section 6.3- changed from 60 months to 5 years

 

Section 6.6- text changed to ‘ no special requirements’.

 

Section 9- details amended to: Date of First Authorisation: 10 June 1974. Date of Latest Renewal: 2 April 2002, previsouly read 28th October 1993

 

Section 10- date changed to 15th May 2011

 
Updated on 13/01/2011 and displayed until 27/05/2011
Reasons for adding or updating:
  • Change to section 8 - MARKETING AUTHORISATION NUMBER(S)
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   30-Dec-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Change of MA number
Updated on 15/11/2010 and displayed until 13/01/2011
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable Effects
Date of revision of text on the SPC:   25-Oct-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 4.8 - section reformatted in line with CDS
Updated on 22/09/2010 and displayed until 15/11/2010
Reasons for adding or updating:
  • 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:   07-Jul-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 9 date of first authorisation same for both strengths
Section 10 different dates of revision for the two strengths
Updated on 03/08/2010 and displayed until 22/09/2010
Reasons for adding or updating:
  • Change to section 9 - Date of first Authorisation/renewal of the Authorisation
  • Change to section 10 date of revision of the text
  • Change to section 7 - Marketing Authorisation Holder
  • Change to section 8 - MARKETING AUTHORISATION NUMBER(S)
Date of revision of text on the SPC:   07-Jul-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
The name of the MAH for Danol 100mg has changed, requiring change to MAH contact details, PL number, date of autorisation and date of revision of text
Updated on 02/07/2010 and displayed until 03/08/2010
Reasons for adding or updating:
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   05-May-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 4.5 - The following text has been added:

 

Statins: The risk of myopathy and rhabdomyolysis is increased by concomitant administration of danazol with statins metabolised by CYP3A 4 such as simvastatin, atorvastatin and lovastatin.


Section 10: New date of revision
Updated on 05/01/2009 and displayed until 02/07/2010
Reasons for adding or updating:
  • Change to section 6.1 - List of Excipients
  • Correction of spelling/typing errors
Date of revision of text on the SPC:   01-Jul-2007
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 6.1

Information has not changed. Typographical errors have been amended
Updated on 03/08/2007 and displayed until 05/01/2009
Reasons for adding or updating:
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
Date of revision of text on the SPC:   07/2007
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Addition to special warnings:
 
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Updated on 19/09/2006 and displayed until 03/08/2007
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder
Date of revision of text on the SPC:   04/2006
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 7 (Marketing Authorisation Holder): Change to MA Holder's address
Updated on 15/05/2006 and displayed until 19/09/2006
Reasons for adding or updating:
  • Change from BAN to rINN
Date of revision of text on the SPC:   25/4/06
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 4.5 - BANs to INNs (phenobarbital, ciclosporin)
Section 4.8 - BANs to INNs (levothyroxine)
Updated on 17/09/2004 and displayed until 15/05/2006
Reasons for adding or updating:
  • Change to section 3 - pharmaceutical form
  • Change to section 10 (date of (partial) revision of the text
Updated on 11/09/2003 and displayed until 17/09/2004
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 6.1 - List of Excipients
Updated on 26/09/2002 and displayed until 11/09/2003
Reasons for adding or updating:
  • Change to section 4.4 - Special Warnings and Precautions for Use
  • Change to section 4.8 - Undesirable Effects
Updated on 15/07/2002 and displayed until 26/09/2002
Reasons for adding or updating:
  • Change to section 4.4 - Special Warnings and Precautions for Use
  • Change to section 4.5 - Interactions with other Medicaments and other forms of Interaction
  • Change to section 4.8 - Undesirable Effects
  • Change to section 4.9 - Overdose
  • Correction of spelling/typing errors
Updated on 26/08/2001 and displayed until 15/07/2002
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder

Active Ingredients/Generics

 
  danazol