FEMOSTON 1/10 TABLET [SIN11896P]

Product Info

FEMOSTON 1/10 TABLET

[SIN11896P]

4.1 Therapeutic Indications

For continuous combined HRT regimen: Femoston® Conti 1/5
Hormone Replacement Therapy (HRT) for oestrogen deficiency symptoms in postmenopausal women with a uterus, at least 12 months since last menses.

Prevention of osteoporosis in postmenopausal women with a uterus, at high risk of future fractures who are intolerant of, or contraindicated for, other medicinal products approved for the prevention of osteoporosis.

For continuous sequential HRT regimen: Femoston® 1/10
Hormone Replacement Therapy (HRT) for oestrogen deficiency symptoms in postmenopausal women at least 6 months since last menses.

Prevention of osteoporosis in postmenopausal women at high risk of future fractures who are intolerant of, or contraindicated for, other medicinal products approved for the prevention of osteoporosis.

For continuous sequential HRT regimen: Femoston® 2/10
Hormone Replacement Therapy (HRT) for oestrogen deficiency symptoms in postmenopausal women at least 6 months since last menses.

All Formulations
Elderly population
The experience in treating women older than 65 years is limited.

4.2 Posology and method of administration

For oral use

Femoston® Conti 1/5: Continuous combined
Femoston® should be taken continuously without a break between packs.

The oestrogen and the progestogen are given every day without interruption.
One tablet to be taken daily for a 28 day cycle.

Femoston® conti is intended to prevent stimulation of the endometrium in postmenopausal women, usually resulting in amenorrhoea.
Before initiating treatment, pregnancy must be excluded.

Changing from other HRT:
Patients changing from a continuous combined preparation may start therapy at any time. Patients changing from another continuous sequential or cyclical preparation should complete the 28 day cycle and then change to Femoston®.

Femoston® conti should be used only in postmenopausal women more than 12 months after menopause. If the menopausal status is not known (e.g. because of previous use of sequential HRT or oral combination contraceptives) the endogenous estrogen may still be high. This could result in unpredictable bleeding.

If a dose has been forgotten, it should be taken as soon as possible. If more than 12 hours have elapsed, treatment should be continued with the next tablet without taking the forgotten tablet. The likelihood of breakthrough bleeding or spotting may be increased.

Femoston® may be taken irrespective of food intake.

Femoston® 1/10: Continuous sequential
Femoston® should be taken continuously without a break between packs.

The oestrogen is dosed continuously. The progestogen is added for the last 14 days of every 28 day cycle, in a sequential manner.

For initiation and continuation of treatment of postmenopausal symptoms, the lowest effective dose for the shortest duration (see also section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information) should be used.

1. Treatment of postmenopausal symptoms
   In general, sequential combined treatment should start with Femoston® 1/10. Depending on the clinical response, the dosage can afterwards be adjusted to individual need. If the complaints linked to estrogen deficiency are not ameliorated, the dosage can be increased by using Femoston® 2/10.

2. Osteoporosis prevention
   Hormone replacement therapy for the prevention of postmenopausal osteoporosis must take into account the expected effects on bone mass, which are dose-related (see section 5.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information) and the individual tolerability of treatment.

Treatment commences with one white tablet daily for the first 14 days followed by one grey tablet daily for the next 14 days, as directed on the 28 days calendar pack.

Changing from other HRT:
Patients changing from a continuous combined preparation may start therapy at any time. Patients changing from another continuous sequential or cyclical preparation should complete the 28 day cycle and then change to Femoston®.

If a dose has been forgotten, it should be taken as soon as possible. If more than 12 hours have elapsed, treatment should be continued with the next tablet without taking the forgotten tablet. The likelihood of breakthrough bleeding or spotting may be increased.

Femoston® may be taken irrespective of food intake.

Femoston® 2/10: Continuous sequential
Femoston® should be taken continuously without a break between packs.
The oestrogen is dosed continuously. The progestogen is added for the last 14 days of every 28 day cycle, in a sequential manner.

Treatment commences with one brick red tablet daily for the first 14 days followed by one yellow tablet daily for the next 14 days, as directed on the 28 day calendar pack.

Changing from other HRT:
Patients changing from a continuous combined preparation may start therapy at any time. Patients changing from another continuous sequential or cyclical preparation should complete the 28 day cycle and then change to Femoston®.

If a dose has been forgotten, it should be taken as soon as possible. If more than 12 hours have elapsed, treatment should be continued with the next tablet without taking the forgotten tablet. The likelihood of breakthrough bleeding or spotting may be increased.

Femoston® may be taken irrespective of food intake.

Paediatric population:
There is no relevant indication for the use of Femoston® in the paediatric population.

4.3 Contraindications

• Known past or suspected breast cancer

• Known or suspected oestrogen-dependent malignant tumours (e.g. endometrial cancer)

• Known or suspected progestogen-dependent neoplasms (e.g. meningioma)

• Undiagnosed genital bleeding

• Untreated endometrial hyperplasia

• Previous or current venous thromboembolism (deep venous thrombosis, pulmonary embolism)

• Known thrombophilic disorders (e.g. protein C, protein S or antithrombin deficiency, see section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information)

• Active or recent arterial thromboembolic disease (e.g. angina, myocardial infarction)

• Acute liver disease, or a history of liver disease, as long as the liver function tests have failed to return to normal

• Porphyria

• Known hypersensitivity to the active substances or to any of the excipients