Last Updated on eMC 15-12-2016 View medicine  | Merck Sharp & Dohme Limited 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.

Reasons for adding or updating:

  • Change to section 4.4 - Special warnings and precautions for use

Date of revision of text on the SPC:01-12-2016

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



Following an Article 31 referral, the marketing authorization holders of medicinal products containing testosterone were requested by the PRAC to reflect and discuss the findings on the cardiovascular risk, report on venous thromboembolism (VTEs) and discuss the possible mechanism(s) of VTE in the forthcoming PSURs.

 

After review by the PRAC of the data provided, it recommended that the prescribing information for these products be updated to include a warning of thrombotic events in patients with thrombophilia.  

The SPC for Restandol has been updated accordingly:

 4.4  Special warnings and precautions for use

The addition of the following warning:
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.’

 

 

Reasons for adding or updating:

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects - how to report a side effect

Date of revision of text on the SPC:23-03-2015

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



The following changes are the result of a European Article 31 referral, due to concerns over cardiovascular risks associated with testosterone therapy. This evaluated the impact of the risk for cardiovascular events on the benefit-risk of testosterone-containing medicinal products in its approved indications. 

4.1 Therapeutic indications – updated to include text regarding confirmation of the diagnosis by both clinical features and biochemical testing.

4.4 Special warnings and precautions for use – updated to include the already well-known cardiovascular, safety information.

4.8 Undesirable effects -  added well-documented blood system adverse reactions, which may contribute to cardiovascular risk.

Reasons for adding or 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 - Fertility, pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • 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
  • Change to section 5.3 - Preclinical safety data

Date of revision of text on the SPC:08-01-2015

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



The changes made to the SmPC are as follows:

 

·        Section 4.2 Posology and method of administration: Aligned with QRD and paediatric guidance extended “Pre-pubertal children treated with Restandol Testocaps should be treated with caution (see section 4.4).

·        Section 4.3 Contraindications: reworded text in line with EU approved Core Safety Profile (CSP) and aligned with CCDS text “carcinoma of the prostate or breast (see section 4.4)”.

·        Section 4.4 Special warnings and precautions for use: Extended wording for Direct Rectal Examination and PSA monitoring in men, updated text with paragraphs about, Tumour, Pre-existing conditions, Diabetes Mellitus, Anticoagulant and Sleep Apnea, added guidance for (mis)use in sports and paediatrics.

·        Section 4.5 Interaction with other medicinal products and other forms of interaction : Extended monitoring requirements for patients using anti-diabetic medicine and anticoagulants, added guidance regarding use of ACTH/Corticosteroids and added sentence – “to be taken with normal meal to ensure absorption”.

·        Section 4.6 Fertility, pregnancy and lactation and fertility: Pregnancy and lactation guidance changed to include Restandol Testocaps is not indicated in women. Fertility guidance for men added

·        Section 4.8 Undesirable effects: Introduction of Medra Table, addition of undesirable effects in paediatric population, Reporting of suspected adverse reactions paragraph added.

·        Section 4.9 Overdose: added sentence “The acute toxicity of testosterone is low” .

·        Section 5.2 Pharmacokinetic properties: Sentence “Testosterone, oestradiol….” Deleted from paragraph Elimination.

·        Section 5.3 Preclinical safety data: added “experimental data in rodents and use of androgens in different species…” Alignment of section with Headquarter CCDS text of Sustanon, Testosterone and Deca-Durabolin.

Reasons for adding or 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

Date of revision of text on the SPC:04-12-2013

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

The Marketing Authorisation has been transferred from Organon Laboratories Limited to Merck Sharp & Dohme Limited following a company merger.
 New details are below

7             MARKETING AUTHORISATION HOLDER

Merck Sharp & Dohme Limited

Hertford Road

Hoddesdon

Hertfordshire

EN11 9BU

UK

 

8             MARKETING AUTHORISATION NUMBER(S)

 

PL  00025/0595

 

10           DATE OF REVISION OF THE TEXT

 

29 November 2013

Reasons for adding or updating:

  • Change to section 4.2 - Posology and method of administration

Date of revision of text on the SPC:24-08-2012

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



The words 'and adolescents' have been added to Section 4.2 Posology and method of administration as follows:

 Children

Safety and efficacy has not been determined in children and adolescents.

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:29-02-2012

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.

Reasons for adding or updating:

  • Change to section 4.4 - Special warnings and precautions for Use

Date of revision of text on the SPC:04-10-2011

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.

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:16-08-2011

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.

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:29-01-2010

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.

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:01-09-2007

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:
 
 

Reasons for adding or updating:

  • Change to section 1 - trade name

Reasons for adding or updating:

  • Change to section 10 (date of (partial) revision of the text