Tostran 2% Gel

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

 

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

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

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

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

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

None provided