When a pharmaceutical company changes an SPC or PIL, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.
The only change is to section 2 'Qualitative and Quantitative Composition' as follows:
Each film-coated 2mg tablet contains lactose 36.8mg as lactose monohydrate
SmPC changes for Trisequens
Gelatine Substitution
PREVIOUS WORDING
NEW WORDING
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Excipients: Each tablet contains approximately 38mg lactose monohydrate.
Excipients: Each tablet contains approximately 37mg lactose monohydrate.
4.4 Special warnings and precautions for use
Ovarian cancer
Use of estrogen alone and estrogen plus progestogen therapies for at least 5 or 10 years has been associated with an increased risk of ovarian cancer in some epidemiological studies.
Use of oestrogen alone and oestrogen plus progestogen therapies for at least 5 or 10 years has been associated with an increased risk of ovarian cancer in some epidemiological studies.
4.5 Interaction with other medicinal products and other forms of interaction
Ritonavir and nelfinavir, although known as strong inhibitors, by contrast exhibit inducing properties when used concomitantly with steroid hormones. Herbal preparations containing St John’s wort (Hypericum perforatum) may induce the metabolism of oestrogens and progestogens.
Ritonavir and nelfinavir, although known as strong inhibitors, by contrast exhibit inducing properties when used concomitantly with steroid hormones. Herbal preparations containing St John’s Wort (Hypericum perforatum) may induce the metabolism of oestrogens and progestogens.
4.8 Undesirable effects
Breast cancer
The WHI trial estimated that after 5.6 years of follow-up of women between the ages of 50 and 79 years, an additional 8 cases of invasive breast cancer would be due to oestrogen-progestogen combined HRT (CEE + MPA) per 10,000 women years. According to calculations from the trial data, it is estimated that:
• For 1000 women in the placebo group,
- about 16 cases of invasive breast cancer would be diagnosed in 5 years.
• For 1000 women who used oestrogen + progestogen combined HRT (CEE + MPA), the number of additional cases would be
- between 0 and 9 (best estimate = 4) for 5 years’ use.
• For 1000 women in the placebo group: About 16 cases of invasive breast cancer would be diagnosed in 5 years.
• For 1000 women who used oestrogen + progestogen combined HRT (CEE + MPA), the number of additional cases would be between 0 and 9 (best estimate = 4) for 5 years’ use.
6.1 List of Excipients
Gelatin
Blue tablets: Indigotin E132
Hydroxypropylcellulose
Blue tablets: Indigo carmine E132
9. DATE OF FIRST AUTHORISATION/RENEWAL OF AUTHORISATION
Date of first authorisation: 21st May 1977
Date of last renewal: 21st May 2007
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 21 May 1977
Date of last renewal: 21 May 2007
10. DATE OF REVISION OF THE TEXT
October 2009
July 2010