ESTROFEM Film-coated tablet (2020)
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Περιεχόμενα
1. Name of the medicinal product
Estrofem 2 mg film-coated tablets.
2. Qualitative and quantitative composition
Each film-coated tablet contains estradiol 2 mg (as estradiol hemihydrate). <u>Excipient with known effect:</u> lactose monohydrate. For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Film-coated tablets. Blue, film-coated, round biconvex tablets, engraved with NOVO 280. Diameter 6 mm.
4.1. Therapeutic indications
Hormone Replacement Therapy (HRT) for oestrogen deficiency symptoms in postmenopausal women. Prevention of osteoporosis in postmenopausal women at high risk of future fractures, who are intolerant of, ...
4.2. Posology and method of administration
Estrofem is an oestrogen-only product for hormonal replacement. Estrofem is administered orally, one tablet daily without interruption.For initiation and continuation of treatment of menopausal symptoms, ...
4.3. Contraindications
Known, past or suspected breast cancer. Known, past or suspected oestrogen-dependent malignant tumours (e.g. endometrial cancer). Undiagnosed genital bleeding. Untreated endometrial hyperplasia. Previous ...
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
The metabolism of oestrogens may be increased by concomitant use of substances known to induce drug-metabolising enzymes, specifically cytochrome P450 enzymes such as anticonvulsants (e.g. phenobarbital, ...
4.6. Pregnancy and lactation
Pregnancy Estrofem is not indicated during pregnancy. If pregnancy occurs during medication with Estrofem treatment should be withdrawn immediately. The results of most epidemiological studies to date ...
4.7. Effects on ability to drive and use machines
Estrofem has no known effect on the ability to drive and use machines.
4.8. Undesirable effects
Clinical experience In clinical trials less than 10% of the patients experienced adverse drug reactions. The most frequently reported adverse reactions are breast tenderness/breast pain, abdominal pain, ...
4.9. Overdose
Overdose may be manifested by nausea and vomiting. Treatment should be symptomatic.
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Natural and semisynthetic estrogens, plain <b>ATC code:</b> G03CA03 The active ingredient, synthetic 17β-estradiol, is chemically and biologically identical to endogenous ...
5.2. Pharmacokinetic properties
Following oral administration of 17β-estradiol in micronised form, rapid absorption from the gastrointestinal tract occurs. It undergoes extensive first-pass metabolism in the liver and other enteric organs, ...
5.3. Preclinical safety data
The toxicity profile of estradiol is well-known. There are no preclinical data of relevance to the prescriber which are additional to that already included in other sections of the SmPC.
6.1. List of excipients
<u>The tablet core contains:</u> Lactose monohydrate Maize starch Hydroxypropylcellulose Talc Magnesium stearate <u>Film coating:</u> Hypromellose Talc Titanium dioxide (E171) Macrogol 400 Indigo carmine ...
6.2. Incompatibilities
Not applicable.
6.3. Shelf life
4 years.
6.4. Special precautions for storage
Store below 25ºC. Do not refrigerate.
6.5. Nature and contents of container
1 28 tablets in a calendar dial pack. The calendar pack with 28 tablets consists of the following 3 parts: The base made of coloured, non-transparent polypropylene. The ring-shaped lid made of transparent ...
6.6. Special precautions for disposal and other handling
No special requirements.
7. Marketing authorization holder
Novo Nordisk A/S, Novo Alle, DK-2880, Bagsvaerd, Denmark
8. Marketing authorization number(s)
PA0218/050/001
9. Date of first authorization / renewal of the authorization
Date of first authorisation: 01 May 1996 Date of last renewal: 01 May 2006
10. Date of revision of the text
September 2020
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