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 Abbott Corporation has recently taken over the pharmaceutical business of the Solvay Company. As a result the names of the former Solvay affiliate companies are being changed.
4.2 Posology and method of administration
Added statement:
Femoston 2/10 is not recommended for the use in children below the age of 18 due to insufficient data on safety and efficacy.
4.3 Contraindications
Known hypersensitivity to the active substances or to any of the excipients;
· Known or suspected progesterone dependant neoplasma;
· Known or suspected pregnancy.
Deleted statement:
· Known hypersensitivity to the active substances or to any of the excipients;
4.5 Interaction with other medicinal products and other forms of interaction
No interaction studies have been performed.
Femoston 2/10 can be administrated irrespective of food intake.
4.7 Effect on ability to drive and use machines
Amended from: Femoston does not affect the ability to drive or use machines.
Amended to: Femoston has no or negiligible influence on the ability to drive and use machines.
4.8 Undesirable Effects
Added asterix in Vascular disorder
Vascular disorders
Hypertension,Peripheral vascular disease,Varicose vein,
Venous thromboembolism*
Stroke
* see below for further information
Other adverse reactions have been reported in association with estrogen/progestagen treatment:
Added:
- Increase in size of pregestogen dependant neoplasma (e.g. meningioma), (see section 4.3)
Double Asterix added:
- Estrogen-dependent neoplasms benign and malignant, e.g. endometrial cancer.**
4.9 Overdose
No case of overdose has been reported for Femoston 2/10.
5.3 Preclinical safety data
Deleted:
Supraphysiologically high doses (prolonged overdoses) of estradiol have been associated with the induction of tumours in estrogen‑dependent target organs for all rodent species tested. The changes observed with dydrogesterone in animal toxicity studies are characteristic for progesterone‑like compounds. In-vitro and in-vivo data gave no indications of mutagenic effects of dydrogesterone. In long-term studies, doses administered to rats and mice were sufficient to produce hormone-mediated changes, but did not provide tumorogenic potential.
There are no preclinical safety data which could be relevant to the presciber and shich are not already included in other relevant sections of the SPC.