Testogel 16.2mg/g Gel *
Pharmacy Only: Prescription

  • Company:

    Besins Healthcare (UK) Ltd
  • Status:

    No Recent Update
  • Legal Category:

    Product subject to medical prescription which may not be renewed (A)
  • Active Ingredient(s):

    *Additional information is available within the SPC or upon request to the company

When a pharmaceutical company changes any document, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.

Updated on 07 June 2021

File name

testogel-16.2mg- PIL_1623085803.pdf

Reasons for updating

  • Change to Section 1 - what the product is
  • Change to section 2 - what you need to know - contraindications
  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 3 - overdose, missed or forgotten doses
  • Change to section 4 - possible side effects
  • Change to section 6 - what the product contains
  • Change to section 6 - date of revision

Updated on 07 June 2021

File name

testogel-16.2mg -SmPC_1623085248.pdf

Reasons for 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 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 29 January 2021

File name

Testogel-16.2mg- SmPC_1611948286.pdf

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

PRAC recommendation to revise and update safety precautionary warning content on SPCs and Patient Information Leaflets for Testosterone. The updates relate to “Clotting disorders / VTE” and flammability warning wording for excipient, ethanol.

Updated on 29 January 2021

File name

Testogel-16.2mg- leaflet_1597866976.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - driving and using machines
  • Change to section 6 - date of revision

Free text change information supplied by the pharmaceutical company

PRAC recommendation to revise and update safety precautionary warning content on SPCs and Patient Information Leaflets for Testosterone. The updates relate to “Clotting disorders / VTE” and flammability warning wording for excipient, ethanol.

Updated on 19 August 2020

File name

Testogel-16.2mg- leaflet_1597866976.pdf

Reasons for updating

  • New PIL for new product

Free text change information supplied by the pharmaceutical company

Changes notified are as follows:

  • Change in details of the local representative for the UK (distributor) from 1st Floor, 28 Poland Street, London, W1F 8QN to Lion Court, 25 Procter Street Holborn, London, WC1V 6NY
  • Update date of revision

Updated on 27 July 2018

File name

ie-spc-testogel-16.2mg-2018-06-24_1532688475.pdf

Reasons for updating

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

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

PRAC (PSUSA/00002908/201512) – Thrombosis risk; addition to SmPC section 4.4 the following warning:

Testosterone should be used with caution in patients with thrombophilia, as there have been post-marketing reports of thrombotic events in these patients during testosterone therapy.”

Updated on 27 February 2018

Reasons for updating

  • New SPC for new product

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 26 February 2018

File name

PIL_17421_571.pdf

Reasons for updating

  • New PIL for new product