Tostran 2% Gel *
Pharmacy Only: Prescription

  • Company:

    Kyowa Kirin International plc
  • Status:

    No Recent Update
  • Legal Category:

    Product subject to medical prescription which may be renewed (B)
  • Active Ingredient(s):

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

Updated on 07 February 2020

File name

pl-ie-clean_1581078438.pdf

Reasons for updating

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

Free text change information supplied by the pharmaceutical company

Addition to Section 2. Warnings and precautions

Under 'Tell your doctor before treatment if you: - have or ever had blood clotting problems' the addition of the following bulleted text

- factors that increase your risk for blood clots in a vein: previous blood clots in a vein; smoking; obesity; cancer; immobility; if one of your immediate family has had a blood clot in the leg, lung or other organ at a young age (e.g. below the age of about 50); or as you get older.
How to recognise a blood clot: painful swelling of one leg or sudden change in colour of the skin e.g. turning pale, red or blue, sudden breathlessness, sudden unexplained cough which may bring up blood; or sudden chest pain, severe light headedness or dizziness, severe pain in your stomach, sudden loss of vision. Seek urgent medical attention if you experience one of these symptoms.

Date of revision of the text

Change from: 02/2019; to: 12/2019

 

Updated on 07 February 2020

File name

spc-ie-clean_1581076758.pdf

Reasons for updating

  • 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 be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 4.4.  Special warnings and precautions for use

statement under the section clotting disorders expanded to include risk of VTE

Changed from:

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

Changed to:

Testosterone should be used with caution in patients with thrombophilia or risk factors for venous thromboembolism (VTE), as there have been post-marketing studies and reports of thrombotic events (e.g. deep-vein thrombosis, pulmonary embolism, ocular thrombosis) in these patients during testosterone therapy.  In thrombophilic patients, VTE cases have been reported even under anticoagulation treatment, therefore continuing testosterone treatment after first thrombotic event should be carefully evaluated. In case of treatment continuation, further measures should be taken to minimise the individual VTE risk.

Section 10  Date of Revision of the Text

Changed from:

February 2019

Changed to:

December 2019

Updated on 06 June 2019

File name

Test 2 Gel - SPC - IE - Clean_1559838442.pdf

Reasons for updating

  • Other

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 21 February 2019

File name

Test Gel - PIL - IE - Clean_1550681017.pdf

Reasons for updating

  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - date of revision

Updated on 20 February 2019

File name

Test 2% Gel - SPC - IE - Clean_1550670277.pdf

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - Marketing authorisation number(s)
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 7 (Marketing Authorisation Holder)- updated to Kyowa Kirin Holdings B.V., Bloemlaan 2, 2132NP Hoofddorp, The Netherlands

Section 8- Marketing Authorisation Number updated to PA2288/001/004

Section 10- Date of revision updated to Feb 2019

Updated on 28 February 2017

File name

PIL_16555_364.pdf

Reasons for updating

  • New PIL for new product

Updated on 28 February 2017

Reasons for updating

  • New SPC for new product

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 28 February 2017

Reasons for updating

  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

In section 10, Date of revision of the text has been changed from December 2016 to February 2017

Updated on 28 February 2017

Reasons for updating

  • Change to section 6 - date of revision

Updated on 20 February 2017

Reasons for updating

  • 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 be renewed (B)

Free text change information supplied by the pharmaceutical company

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

Updated on 17 February 2017

Reasons for updating

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

Updated on 28 October 2016

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 be renewed (B)

Free text change information supplied by the pharmaceutical company

In section 7 (Marketing Authorisation Holder)- Name change from ProStrakan to Kyowa Kirin$0In section 10- Date of revision of the text changed from Aug 2015 to May 2016$0

Updated on 26 October 2016

Reasons for updating

  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - date of revision

Updated on 17 December 2015

Reasons for updating

  • New SPC for medicines.ie

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

None provided

Updated on 16 December 2015

Reasons for updating

  • New PIL for medicines.ie