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Merck Sharp & Dohme Limited
Hertford Road, Hoddesdon, Hertfordshire, EN11 9BU
Telephone: +44 (0)1992 467 272
Fax: +44 (0)1992 479 292
Medical Information e-mail: medicalinformationuk@merck.com

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?
Summary of Product Characteristics last updated on the eMC: 15/03/2012
SPC Restandol Testocaps 40 mg capsule, soft

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 15/03/2012 and displayed until Current
Reasons for adding or updating:
  • 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 10 date of revision of the text
Date of revision of text on the SPC:   29-Feb-2012
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
in section 4.4 Special Warnings and Precautions for use:

In patients with Ppre-existing cardiac, renal or hepatic disease androgen treatment may cause complications charecterized by oedema with or without congestive heart failure. In such case, treatment must be stopped immediately. Patients after myocardial infarction, cardiac, hepatic or renal insufficiency, hypertension, epilepsy, or migraine should be monitored due to the risk of deterioration or reoccurrence.  since oedema with or without congestive heart failure may result from androgen treatment.  In addition to discontinuation of the drug, diuretic therapy may be required.

 

in section 4.5 Contraindications:

The concurrent administration of testosterone with ACTH or corticosteroids may enhance oedema formation: thus these active substances should be administered cautiously, particularly in patients with cardiac or hepatic disease or in patients predisposed to oedema.

Laboratory test interactions: Androgens may decrease levels of thyroxine-binding globulin resulting in decreased total T4 serum levels and increased resin uptake of T3 and T4. free thyroid hormone levels remain unchanged, however, and there is no clinical evidence of thyroid dysfunction.
Updated on 12/10/2011 and displayed until 15/03/2012
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for Use
Date of revision of text on the SPC:   04-Oct-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 4.4: A warning for the excipient Sunset Yellow has been added. It already appears in the Patient Information Leaflet.
Updated on 27/09/2011 and displayed until 12/10/2011
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:   16-Aug-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


The following points have been added to the beginning of Section 4.4 , Special warnings and precautions for use:

 

Physicians should consider patients receiving Restandol Testocaps for monitoring before the start of treatment, at quarterly intervals for the first 12 months and yearly thereafter for the following parameters:

• digital rectal examination (DRE) of the prostate and PSA in men over the age of 45 years, to exclude prostate cancer (see section 4.3)

• hematocrit and hemoglobin to exclude polycythemia. In case of severe polycythemia, treatment with Restandol Testocaps should be stopped or the dosage should be lowered.
Updated on 17/02/2010 and displayed until 27/09/2011
Reasons for adding or updating:
  • Change to section 4.6 - Pregnancy and Lactation
  • Change to section 4.8 - Undesirable Effects
Date of revision of text on the SPC:   29-Jan-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Change details

 

Section  4.6

Heading title changed from Pregnancy & Lactation to Fertility, Pregnancy and Lactation

 


Section 4.8 Undesirable effects

 

Addition of following text:

 

In a few patients diarrhoea and abdominal pain or discomfort have been reported during use of Restandol Testocaps.
Updated on 29/02/2008 and displayed until 17/02/2010
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 4. Clinical Particulars
  • Change to section 5 - Pharmacological Properties
  • Change to section 6.1 - List of Excipients
  • Change to section 6.2 - Incompatibilities
  • Change to section 6. 3 - Shelf Life
  • Change to section 6. 4 - Special Precautions for Storage
  • Change to section 6. 5 - Nature and Contents of Container
  • Change to section 6. 6 - Instructions for use, handling and disposal
  • 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:   09/2007
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Due to the extensive change to the SPC please follow the link below:
 
 
Updated on 30/09/2002 and displayed until 29/02/2008
Reasons for adding or updating:
  • Change to section 1 - trade name
Updated on 08/04/2002 and displayed until 30/09/2002
Reasons for adding or updating:
  • Change to section 10 (date of (partial) revision of the text

Active Ingredients/Generics

 
  testosterone undecanoate