Last Updated on eMC 12-12-2017 View medicine  | Besins Healthcare (UK) Ltd Contact details

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.

Reasons for adding or updating:

  • Change to section 4.4 - Special warnings and precautions for use

Date of revision of text on the SPC:31-08-2017

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

update section 4.4 in line with the PRAC recommendations on thrombophilia

Reasons for adding or updating:

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.6 - Fertility, pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.8 - Undesirable effects - how to report a side effect
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 10 - Date of revision of the text

Date of revision of text on the SPC:02-05-2016

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Section 2: For the full list of excipients,see section 6.1.$0$0$0Section 4.3: in cases of knownhypersensitivity to the active substance or any of the excipients listed insection 6.1.$0$0$0$0$0In patients suffering from severecardiac, hepatic or renal insufficiency or ischaemic heart disease, treatmentwith testosterone may cause severe complications characterised by oedema withor without congestive cardiac failure. In such case, treatment must be stoppedimmediately. In addition, diuretic therapy may be required.$0$0$0$0$0Testosterone may cause a rise inblood pressure and Testogel should be used with caution in men withhypertension.$0$0$0Testosterone level should bemonitored at baseline and at regular intervals during treatment. Cliniciansshould adjust the dosage individually to ensure maintenance of eugonadaltestosterone levels.$0$0Beside laboratory tests of thetestosterone concentrations in patients receiving long-term androgen therapythe following laboratory parameters should also be monitored regularly: haemoglobin,haematocrit (to detect polycythaemia), liver function tests, and lipid profile.$0$0There islimited experience on the safety and efficacy of the use of Testogel inpatients over 65 years of age. Currently, there is no consensus about agespecific testosterone reference values. However, it should be taken intoaccount that physiologically testosterone serum levels are lower with increasingage.$0$0Section 4.6 Fertility, pregnancy andlactation$0$0Changes in laboratory tests (polycythaemia, lipids),Haematocrit increased, Red blood cell countincreased, Haemoglobin increased$0$0Reportingof suspected adverse reactions$0$0Reporting suspected adverse reactions afterauthorisation of the medicinal product is important. It allows continuedmonitoring of the benefit/risk balance of the medicinal product. Healthcareprofessionals are asked to report any suspected adverse reactions via theYellow Card Scheme.$0$0$0$0Website: www.mhra.gov.uk/yellowcard$0$0Section 6.6 Special precautions fordisposal$0$0Section 10: May 2015$0$0$0$0$0$0$0$0$0$0$0$0

Reasons for adding or updating:

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.7 - Effects on Ability to Drive and Use Machines
  • Change to section 4.8 - Undesirable Effects
  • 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:01-11-2007

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Section 2: Qualitative & Quantative composition - addition of text " For a full list of excipients" has been inserted
Section 4.4: Special Warnings & precautions for use:  - determination of lipids profile has been added 
Section 4.7: Effects on ability to drive and use machines: The text has been amended to read "No studies on the effects on the ability to drive and use machines have been performed."
Section 4.8 Undersirable effects: The format has changed to tabular rather than paragraphs, also addition of some organ system classes and their common adverse reactions.  
Section 9: Date of first authorisation / Renewal of the authorisation: - This has been updated from 3 March 2003 to 4 November 2006
Section 10: Date of Revision of the text: Updated from 5 February 2004 to 4 November 2006
  

Reasons for adding or updating:

  • Removal of Black Triangle

Reasons for adding or updating:

  • Change to section 6. 3 - Shelf Life
  • Change to section 10 (date of (partial) revision of the text

Reasons for adding or updating:

  • New SPC for new product