Testogel
- Name:
Testogel
- Company:
Besins Healthcare (UK) Ltd
- Active Ingredients:
- Legal Category:
Product subject to medical prescription which may not be renewed (A)
Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 14/12/20

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Besins Healthcare (UK) Ltd
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Company Products
Medicine Name | Active Ingredients |
---|---|
Medicine Name IMVAGGIS 0.03 mg pessary | Active Ingredients Estriol |
Medicine Name Testogel | Active Ingredients Testosterone |
Medicine Name Testogel 16.2mg/g Gel | Active Ingredients Testosterone |
Medicine Name Utrogestan® Vaginal 200 mg Vaginal Capsules, soft | Active Ingredients Progesterone |
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 14 December 2020 PIL
Reasons for updating
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 11 December 2020 PIL
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 SPC
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 PIL
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 SPC
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 PIL
Reasons for updating
- Change to other sources of information section
Updated on 24 September 2018 PIL
Reasons for updating
- Change to section 6 - marketing authorisation holder
Updated on 28 November 2017 SPC
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 SPC
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
Updated on 27 November 2017 PIL
Reasons for updating
- New PIL for new product
Updated on 27 November 2017 PIL
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
Updated on 7 November 2017 SPC
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
Updated on 6 November 2017 PIL
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
Updated on 10 April 2017 PIL
Reasons for updating
- Change of distributor details
Updated on 11 August 2016 SPC
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
Updated on 9 August 2016 PIL
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 8 October 2014 SPC
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
Updated on 23 September 2014 PIL
Reasons for updating
- PIL re-instated
Updated on 23 September 2014 SPC
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
Updated on 23 November 2012 PIL
Reasons for updating
- Correction of spelling/typing errors
- Change of distributor for the product
Updated on 14 May 2010 PIL
Reasons for updating
- Change to packaging
- Change to date of revision
Updated on 28 August 2007 PIL
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 SPC
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 SPC
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
Updated on 21 August 2006 PIL
Reasons for updating
- Change to date of revision
Updated on 26 October 2005 PIL
Reasons for updating
- Improved electronic presentation
Updated on 6 August 2004 PIL
Reasons for updating
- New PIL for medicines.ie
Updated on 13 February 2004 SPC
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 SPC
Reasons for updating
- Improved electronic presentation
Legal category: Product subject to medical prescription which may not be renewed (A)
Updated on 2 July 2003 SPC
Reasons for updating
- Improved electronic presentation
Legal category: Product subject to medical prescription which may not be renewed (A)
Updated on 23 June 2003 SPC
Reasons for updating
- New SPC for new product
Legal category: Product subject to medical prescription which may not be renewed (A)