Change to section 4.4 - Special warnings and precaution for use

Change to section 10 - Date of revision of the text

Information added to the PIL

2. What you need to know before you use Decapeptyl

Warnings and precautions

• Wording amended to "...at the site of the intramuscular injection."
• For women, addition of exemestane as an example of an aromatase inhibitor
• For women, addition of a warning concerning the use of Decapeptyl for underage girls
• Rewording of the paragraph concerning osteoporosis
• For women, addition of a warning for women with submucous fibroids after the bullet point on contraceptive pill
• For men, rewording of the paragraph concerning urinary obstruction and spinal cord compression
• For men, addition of the warning concerning the change in ECG after the bullet point on arrhythmia
• For women, moving of the warning for patients with heart problem to the Breast Cancer paragraph 
• Addition of the warning concerning surgical castration and misleading diagnostic tests of gonadal functions or sex organs after the bullet point on benign tumour

Other medicines and Decapeptyl

• Addition of a warning concerning medication for blood pressure control and management

Decapeptyl contains

• Rewording of the paragraph concerning sodium to comply with EU excipient guidelines

4. Possible side effects

• Addition of angioedema and anaphylactic reaction as examples of allergic reaction
• Addition of dizziness
• Addition of swelling of the ankles, feet or fingers as uncommon side effects
• Rewording of the definition of anaphylactic shock

The following sections have been updated:

2 What you need to know before you use Decapeptyl SR

Section 2 has been updated to include the updated sodium warning. Information on the use of Decapeptyl for the treatment of endometriosis in adolescents has also been updated.

Information on the use of Decapeptyl for the treatment of endometriosis in adolescents has also been updated.

4 Possible side effects

Section 4 has been updated to include additional information on side effects in post-marketing surveillance, including information on increased bleeding risk in the case of a pituitary tumour in both the “Men” and “Women” sections.

Information on exacerbated symptoms of endometriosis during the first weeks of treatment has also been added in the “Women” sub section.

Update of the safety information for Decapeptyl

SmPC

4.2 Posology and method of administration

Section 4.2 has been updated to add a warning for patients treated for endometriosis.

Section 4.2 has been updated to add a warning on co-administration with hormone replacement therapy.

4.4 Special warnings and precautions for use

Section 4.4 has been split into a section detailing special warnings and precautions in men and in women. Information on the loss of bone mineral density in women has been added.

4.6 Fertility, pregnancy and lactation

Section 4.6 has been amended to include a new sub-heading, “Fertility”.

4.8 Undesirable effects

Information on the frequency of undesirable effects has been updated to include the frequency “not known (cannot be estimated from the available data)”.

The adverse event “pituitary apoplexy” has been added under “Endocrine disorders” with a frequency not known in the “General tolerance in men” and “General tolerance in women” sections for the 3mg and 11.25mg strengths and in the “General tolerance in men” section for the 22.5mg strength. Information on the long term use of GnRH analogues in combination with radiotherapy has also been included.

4.9 Overdose 

Section 4.9 has been updated to remove information related to animal data related to overdose.

5.3 Preclinical safety data 

Section 5.3 has been updated to include information on mutagenicity in animal studies.

7. Marketing Authorisation Holder

Ipsen have taken this opportunity to correct the MAH name from “Ipsen Pharmaceuticals Ltd” to “Ipsen Pharmaceuticals Limited”

The following sections have been changed in the PIL:

- Section 1 has been corrected by updating the wording for breast cancer indication so that the wording is exactly in alignment with approved common/RMS text.

- Section 2 has been corrected by addition of text relating to monitoring of depression during treatment within the men warning and precautions section. The women warning and precautions section has been corrected by creating a separate distinct sub-section for warnings and precautions in relation to the use of Decapeptyl SR for breast cancer with the consequential removal of these warnings and precautions from the general women warning and precautions section.

-Section 3 has been corrected by removal of text relating to the breast cancer indication from the section for men (If you stop using Decapeptyl SR) and addition of this same text into the correct section for women.

-Section 4 has been corrected by creating a separate distinct sub-section for side effects when used for breast cancer in combination with either tamoxifen or an aromatase inhibitor within the women side effects section and consequential removal of these side effects from the general women side effects section.

Section 4.4 Addition of:

Androgen deprivation therapy may prolong the QT interval.

In patients with a history of or risk factors for QT prolongation and in patients receiving concomitant medicinal products that might prolong the QT interval (see section 4.5) physicians should assess the benefit risk ratio including the potential for Torsade de pointes prior to initiating Decapeptyl 6 month

Section 4.5 Addition of:

Since androgen deprivation treatment may prolong the QT interval, the concomitant use of Decapeptyl 6 Month with medicinal products known to prolong the QT interval or medicinal products able to induce Torsade de pointes such as class IA (e.g. quinidine, disopyramide ) or class III (e.g. amiodarone, sotalol, dofetilide, ibutilide) antiarrhythmic medicinal products, methadone, moxifloxacin, antipsychotics, etc. should be carefully evaluated (see section 4.4).

Section 4.8 Addition of QT prolongation in AE table as an Adverse Event - SOC Cardiac Disorders - Frequency unknown as below:

2            Qualitative and quantitative composition

Excipients:

Sodium < 1mmol (23mg)

4.4            Special warnings and special precautions for use

This medicinal product contains less than 1mmol sodium (23mg) per dose and is considered essentially ‘sodium-free’.