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Tostran 2% Gel

Last Updated on eMC 20-Feb-2017 View document  | Kyowa Kirin 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.

Updated on 20-Feb-2017 and displayed until Current

Reasons for adding or updating:

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

Date of revision of text on the SPC: 01-Dec-2016

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

In section 4.4 (Special warnings and precaution for use): The statement 'Clotting disorders- Testosteroneshould be used with caution in patients with thrombophilia, as there have beenpost‑marketing studies and reports of thrombotic events in these patientsduring testosterone therapy' has been added.$0$0$0$0$0$0In section 10: Date of revision of the text changed from May 2016 to December 2016.$0

Updated on 11-Jul-2016 and displayed until 20-Feb-2017

Reasons for adding or updating:

  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text

Date of revision of text on the SPC: 31-May-2016

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



Marketing Authorisation Holder Name changed from ProStrakan Ltd. to Kyowa Kirin Ltd.

DATE OF REVISION OF THE TEXT changed from 19 Aug 2015 to 05 2016

Updated on 16-Oct-2015 and displayed until 11-Jul-2016

Reasons for adding or updating:

  • Change to section 3 - Pharmaceutical form
  • Change to section 4.1 - Therapeutic indications
  • 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 4.8 - Undesirable effects
  • Change to section 4.8 - Undesirable effects - how to report a side effect
  • 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: 19-Aug-2015

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Section 2 qualitative and quantitative composition

No change in content

Additional heading - Excipient(s) with known effect
'For a full list of excipients, see Section 6.1.' changed to 'For the full list of excipients see Section 6.1.'

Section 3 Pharmaceutical form

'Clear, colourless gel.', changed to 'Clear, colourless to slightly yellow gel.

Section 4.1 Therapeutic Indications

Change in wording from:

Replacement therapy with testosterone for male hypogonadism when testosterone deficiency has been confirmed by clinical symptoms and laboratory analyses (see Section 4.4).

to:

Testosterone replacement therapy for male hypogonadism when testosterone deficiency has been confirmed by clinical features and biochemical tests. (see Section 4.4).

4.2 Posology and method of administration

Minor amends to order of entries i.e. The heading 'Children' now removed and related paragraph entered under the heading  'Paediatric Population'. 'For cutaneous use' now entered under the heading 'Method of administration'.

4.3 Contraindications

Change in wording from:

'Known hypersensitivity to testosterone or any of the excipients' now reads

to:

'hypersensitivity ro the active substance(s) or to any of the excipients listed in section 6.1

Section 4.4

Following paragraphs removed;

'Oedema with or without congestive heart failure may be a serious complication in patients with pre-existing cardiac, renal or hepatic disease.  The treatment must be discontinued immediately if such complications occur.  In addition, diuretic therapy may be required.'

'The following checks should be carried out periodically: full blood count (including haemoglobin and haematocrit to detect polycythaemia), lipid profile and liver function tests.'
 
Following paragraph deleted and incorporated into revised text (see revised text inserted into section below);

'Testosterone may cause a rise in blood pressure and Tostran should be used with caution in men with hypertension.'

'ischaemic heart disease' removed from the following paragraph;

Tostran should be used with caution in patients with ischaemic heart disease, epilepsy and migraine as these conditions may be aggravated.

Revised text inserted into section as follows;

'...

 

In patients suffering from severe cardiac, hepatic, or renal insufficiency or ischaemic heart disease, treatment with testosterone may cause severe complications characterised by oedema with or without congestive cardiac failure. In such case, treatment must be stopped immediately.

 

Testosterone may cause a rise in blood pressure and Tostran should be used with caution in men with hypertension.

 

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.

 

In patients receiving long-term androgen therapy, the following laboratory parameters should also be monitored regularly: haemoglobin, and haematocrit, liver function tests and lipid profile.

 

There is limited experience on the safety and efficacy of the use of Tostran 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.

 

...'

Section 4.6 Pregnancy and  Lactation, heading only changed to, Fertility, pregnancy and lactation

Section 4.8 Undesirable effects

In Organ system Blood and lymphatic system disorders;

Wording changed from:

'Increase in haemoglobin and haematocrit'

to:

Haematocrit increased
Red blood cell count increased, Haemoglobin increased

Following wording on the reporting of suspected adverse reactions inserted;

Reporting of suspected adverse reactions

Reporting 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 yellow card scheme. Website: www.mhra.gov.uk/yellowcard

9. Date of first authorisation/renewal of the authorisation

Wording changed from:

12/12/2009

to:

Date of first authorisation: 25 October 2006
Date of latest renewal: 12 December 2009

10 Date of revision of the text

Changed from:

30/06/2010

to:

19/08/2015





Updated on 17-Dec-2010 and displayed until 16-Oct-2015

Reasons for adding or updating:

  • Change to section 10 date of revision of the text

Date of revision of text on the SPC: 30-Jun-2010

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

In Section 10 the date of revision has been changed to 30 June 2010

Updated on 10-Sep-2010 and displayed until 17-Dec-2010

Reasons for adding or updating:

  • 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
  • Change to section 6. 4 - Special Precautions for Storage
  • 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: 12-Dec-2009

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

$04.2 –information on priming the pump added$0$04.4 –addition of advice for health professionals and carers re the use of disposablegloves $0$04.8 –updated to include MedDRA frequency convention and system organ class$0$06.1 – listof excipients revised according to the European Pharmacopoeia$0$06.4 –storage precautions revised to include ‘Do not refrigerate or freeze’and ‘Store canister upright’.$0$09. and 10.– dates changed$0

Updated on 25-May-2007 and displayed until 10-Sep-2010

Reasons for adding or updating:

  • Correction of spelling/typing errors

Updated on 25-May-2007 and displayed until 25-May-2007

Reasons for adding or updating:

  • New SPC for new product

Company contact details

Kyowa Kirin Ltd

Company image
Address

Galabank Business Park, Galashiels, TD1 1QH

Medical Information e-mail
Medical Information Direct Line

+ 44 (0)1896 664 000

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?

Active ingredients

testosterone

Legal categories

POM - Prescription Only Medicine

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