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Testogel

*
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):

    Testosterone

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

Updated on 25 June 2024

File name

ie-pl-testogel-50mg-1_0-2024-05-28.pdf

Reasons for updating

  • Change to section 4 - how to report a side effect
  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - date of revision
  • Joint PIL superseded by individual PILs

Updated on 20 October 2022

File name

ie-pl-testogel-50mg-2022-08-16.pdf

Reasons for updating

  • Change to name of manufacturer

Updated on 03 March 2021

File name

Testogel 50mg- Leaflet.pdf

Reasons for updating

  • Joint PIL superseded by individual PILs

Updated on 29 January 2021

File name

testogel-50mg Leaflet.pdf

Reasons for updating

  • Change to section 3 - how to take/use
  • Change to section 6 - date of revision

Free text change information supplied by the pharmaceutical company

To update product information (SPC, PIL and labelling) pharmaceutical form from “gel/gel in sachet” to “transdermal gel” including the product name.

Updated on 29 January 2021

File name

Testogel-50mg-SmPC.pdf

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 3 - Pharmaceutical form
  • 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

To update product information (SPC, PIL and labelling) pharmaceutical form from “gel/gel in sachet” to “transdermal gel” including the product name.

Updated on 14 December 2020

File name

testogel-50mg Leaflet.pdf

Reasons for updating

  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Updated on 11 December 2020

File name

Testogel-50mg Leaflet.pdf

Reasons for updating

  • 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 6 - date of revision

Updated on 11 December 2020

File name

ie-spc-testogel-50mg.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)

Updated on 19 December 2019

File name

ie-pl-testogel-50mg-2019-12-18 text.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions

Free text change information supplied by the pharmaceutical company

Change from "Testogel" to "this medicine" throughout the leaflet

Possible transfer of testosterone - change from "6 hours" to "at least 1 hour" before showering or bathing. Rewording of section

Updated on 19 December 2019

File name

ie-spc-testogel-50mg-2019-12-18.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 4.8 – Undesirable effects - how to report a side effect
  • Change to section 4.9 - Overdose
  • Change to section 5.2 - Pharmacokinetic properties

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

Free text change information supplied by the pharmaceutical company

Section 4.2 - reordering of text, inclusion of use in women and paediatrics

Section 4.3 - change from "Testogel" to "this medicine"

Section 4.4 - removal of "not a treatment for male sterility or impotence", rewording of insullin sensitivity, laboratory parameters and potential transfer sections. Patient should wait for 1 hour before showering and bathing (previously 1-6 hours)

Section 4.5 - diabetic medication included

Section 4.6 - Added "spermatogenesis may be reversibly suprresed with this medicine" and not indicated in breast feeding women

Section 4.8 - rearrangement of text, additional AE's

Section 4.9 - symptoms and treatment added

Section 5.2 - change from "Testogel" to "this medicine"

Updated on 20 May 2019

File name

ie-pl-testogel-50mg-bmb-2018-11-16-text.pdf

Reasons for updating

  • Change to other sources of information section

Updated on 24 September 2018

File name

ie-uk-pil-testogel-50mg-text 2018-09-24.pdf

Reasons for updating

  • Change to section 6 - marketing authorisation holder

Updated on 28 November 2017

Reasons for updating

  • New SPC for new product

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

Updated on 28 November 2017

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Correction of spelling/typing errors

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

Free text change information supplied by the pharmaceutical company

Correction to the new text included in section 4.4 on Thrombophilia, in line with the Health Authority approval

Updated on 27 November 2017

File name

PIL_7946_556.pdf

Reasons for updating

  • New PIL for new product

Updated on 27 November 2017

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions

Updated on 07 November 2017

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

Update section 4.4 in line with the PRAC recommendation on thrombophilia

Updated on 06 November 2017

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions

Updated on 10 April 2017

Reasons for updating

  • Change of distributor details

Updated on 11 August 2016

Reasons for updating

  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • 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

Section 4.3 Contraindications:$0in cases of known hypersensitivity to testosterone or to any other constituent of the gel has been changed to in cases of known hypersensitivity to the active substance or any of the excipients listed in section 6.1.$0$0$0$0$0Section 4.4 Special warnings and precautions for use:$0$0In patients suffering from severe cardiac, hepatic or renal insufficiency or ischaemic heart disease$0$0$0$0$0Testosterone may cause a rise in blood pressure and Testogel should be used with caution in patients men with hypertension.$0$0$0$0$0Added sentence: Testosterone level should be monitored at baseline and at regular intervals during treatment. Clinicians should adjust the dosage individually to ensure maintenance of eugonadal testosterone levels.$0$0$0$0$0Added sentence: There is limited experience on the safety and efficacy of the use of Testogel in patients over 65 years of age. Currently, there is no consensus about age specific testosterone reference values. However, it should be taken into account that physiologically testosterone serum levels are lower with increasing age.$0$0$0$0$0Section 4.8 Undesirable effects$0$0$0$0$0Added point Haematocrit increased, Red blood cell count increased, Haemoglobin increased to the common adverse reactions table$0$0$0$0$0Added point$0$0$0$0$0$0Reporting of suspected adverse reactions$0$0Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system: $0$0HPRA Pharmacovigilance$0$0Earlsfort Terrace $0$0IRL - Dublin 2$0$0Tel: +353 1 6764971$0$0Fax: +353 1 6762517$0$0Website: www.hpra.ie$0$0e-mail: medsafety@hpra.ie$0$0$0$0$0$0$0$0

Updated on 09 August 2016

Reasons for updating

  • Change to, or new use for medicine
  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to drug interactions
  • Change to date of revision

Updated on 08 October 2014

Reasons for updating

  • Change to section 8 - MA number
  • Change to section 9 - Date of renewal of authorisation

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

Free text change information supplied by the pharmaceutical company

This is the Irish SPC for Testogel (as opposed to the UK version) - we have just received this.$0$0$0$0As such this SPC has a PA number (rather than PL) and the date in Section 9 is different$0

Updated on 23 September 2014

Reasons for updating

  • SPC re-instated

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

Free text change information supplied by the pharmaceutical company

The supplier in Ireland has changed from Bayer Healthcare to Besins Healthcare (UK) Ltd, however this does not affect the SPC as the MA Holder remains Laboratoires BESINS INTERNATIONAL.$0$0$0$0Therefore this SPC has been reinstated and should show up on medicines.ie under the supplier profile of Besins Healthcare (UK) Ltd.$0

Updated on 23 September 2014

Reasons for updating

  • PIL re-instated

Updated on 23 November 2012

Reasons for updating

  • Correction of spelling/typing errors
  • Change of distributor for the product

Updated on 14 May 2010

Reasons for updating

  • Change to packaging
  • Change to date of revision

Updated on 28 August 2007

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to further information section
  • Change to name of manufacturer

Updated on 23 August 2007

Reasons for updating

  • 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 10 - Date of revision of the text
  • Change of distributor for the product

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

Free text change information supplied by the pharmaceutical company

Section 4.4 Special warnings and precautions for use

The sentence was changed from:

“Beside laboratory tests of the testosterone concentrations in patients on long-term androgen therapy the following laboratory parameters should be checked periodically: haemoglobin, haematocrit (to detect polycythemia), liver function tests.”

to;

“Beside laboratory tests of the testosterone concentrations in patients on long-term androgen therapy the following laboratory parameters should be checked periodically: hemoglobin, hematocrit (to detect polycythaemia), liver function tests, and determination of lipids profile.”

 

Section 4.7 Effects on ability to drive and use machines

The sentence was changed from:

“Testogel has no influence on the ability to drive or use machines.”

to;

“No studies on the effects on the ability to drive and use machines have been performed.”

 

Section 4.8 Undesirable effects

The following table has been inserted:

Organ system

Adverse reactions

 

Metabolism and nutrition disorders

Weight gain, electrolyte changes (retention of sodium, chloride, potassium, calcium, inorganic phosphate and water) during high dose and/or prolonged treatment

Musculoskeletal system

Muscle cramps

Nervous system

Nervousness, depression, hostility

Respiratory system

Sleep apnoea

Hepatobiliary disorders

In very rare cases jaundice and liver function test abnormalities

Skin and appendages

Various skin reactions may occur including acne, seborrhoea, and balding

Reproductive system and breast disorders

Libido changes, increased frequency of erections; therapy with high doses of testosterone preparations commonly reversibly interrupts or reduces spermatogenesis, thereby reducing the size of the testicles; testosterone replacement therapy of hypogonadism can in rare cases cause persistent, painful erections (priapism), prostate abnormalities, prostate cancer*, urinary obstruction

General disorders and administration site conditions

High dose or long-term administration of testosterone occasionally increases the occurrences of water retention and oedema; hypersensitivity reactions may occur.

 

Section 10 Date of Revision of the Text

The date was changed from “April 2005” to “February 2007”

Updated on 22 August 2006

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • 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

The address of the Marketing Authorisation Holder has changed from:
 
Laboratoires BESINS INTERNATIONAL
5, rue du Bourg l'Abbé
75003 Paris
France
 
to:
 
Laboratoires BESINS INTERNATIONAL
3, rue du Bourg l'Abbé
75003 Paris
France

Updated on 21 August 2006

Reasons for updating

  • Change to date of revision

Updated on 26 October 2005

Reasons for updating

  • Improved electronic presentation

Updated on 06 August 2004

Reasons for updating

  • New PIL for medicines.ie

Updated on 13 February 2004

Reasons for updating

  • Change to section 6.3 - Shelf life
  • 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 18 August 2003

Reasons for updating

  • Improved electronic presentation

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

Updated on 02 July 2003

Reasons for updating

  • Improved electronic presentation

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

Updated on 23 June 2003

Reasons for updating

  • New SPC for new product

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