FEMOSTON Film-coated tablet (2020)

Βιβλιογραφική αναφορά

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Περιεχόμενα

1. Name of the medicinal product

Femoston 1/10mg film-coated tablets.

2. Qualitative and quantitative composition

Each tablet contains 1mg oestradiol (as hemihydrate) or a combination of 1mg oestradiol (as hemihydrate) and 10mg dydrogesterone. Excipient with known effect: lactose monohydrate. For the full list ...

3. Pharmaceutical form

Film-coated tablets. Oestradiol only tablets: Round, biconvex, white film-coated tablets with inscription 379. Oestradiol/dydrogesterone combination tablets: Round, biconvex, grey film-coated ...

4.1. Therapeutic indications

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 ...

4.2. Posology and method of administration

Femoston 1/10 and Femoston 2/10, are continuous sequential hormone replacement therapies. For initiation and continuation of treatment of postmenopausal symptoms, the lowest effective dose for the shortest ...

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 ...

4.4. Special warnings and precautions for use

For the treatment of postmenopausal symptoms, HRT should only be initiated for symptoms that adversely affect quality of life. In all cases, a careful appraisal of the risks and benefits should be undertaken ...

4.5. Interaction with other medicinal products and other forms of interaction

No interaction studies have been performed. The efficacy of oestrogens and progestogens might be impaired: The metabolism of oestrogens and progestogens may be increased by concomitant use of substances ...

4.6. Pregnancy and lactation

Pregnancy Femoston is not indicated during pregnancy. If pregnancy occurs during medication with Femoston, treatment should be withdrawn immediately. The results of most epidemiological studies to date ...

4.7. Effects on ability to drive and use machines

Femoston does not affect the ability to drive and use machines.

4.8. Undesirable effects

The most commonly reported adverse drug reactions of patients treated with oestradiol/dydrogesterone in clinical trials are headache, abdominal pain, breast pain/tenderness and back pain. The following ...

4.9. Overdose

Both oestradiol and dydrogesterone are substances with low toxicity. Symptoms such as nausea, vomiting, breast tenderness, dizziness, abdominal pain, drowsiness/fatigue, and withdrawal bleeding could occur ...

5.1. Pharmacodynamic properties

The ATC code is G03FB08. (Oestrogens: urogenital system and sex hormones) Sequential hormone replacement therapy (combined oestradiol and dydrogesterone). Oestradiol The active ingredient, synthetic 17β-oestradiol, ...

5.2. Pharmacokinetic properties

Oestradiol Absorption Absorption of oestradiol is dependent on the particle size: micronized oestradiol is readily absorbed from the gastrointestinal tract. The following table provides the mean steady ...

5.3. Preclinical safety data

There are no preclinical safety data of relevance to the prescriber in the target population that are additional to those already included in other sections of the Summary of Product Characteristics (SmPC). ...

6.1. List of excipients

Oestradiol only tablets: Lactose, Hypromellose Maize starch Colloidal anhydrous silica Magnesium stearate Opadry Y-l-7000 white: Hypromellose Polyethylene glycol 400 Titanium dioxide (E171) ...

6.2. Incompatibilities

Not applicable.

6.3. Shelf life

3 years.

6.4. Special precautions for storage

This medicinal product does not require any special storage conditions.

6.5. Nature and contents of container

PVC film with a covering aluminium foil. Blister packs: 28 film-coated tablets 84 film-coated tablets Not all pack sizes may be marketed.

6.6. Special precautions for disposal and other handling

This medicinal product may pose a risk to the aquatic environment. Medicines no longer required should not be disposed of via wastewater or household waste. Any unused product or waste material should ...

7. Marketing authorization holder

Mylan Products Ltd., 20 Station Close, Potters Bar, Herts, EN6 1TL, United Kingdom

8. Marketing authorization number(s)

PL 46302/0035

9. Date of first authorization / renewal of the authorization

27/09/1995

10. Date of revision of the text

November 2020

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