NOVOFEM Film-coated tablet (2020)

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Περιεχόμενα

1. Name of the medicinal product

Novofem film-coated tablets.

2. Qualitative and quantitative composition

One red film-coated tablet contains: Estradiol 1 mg (as estradiol hemihydrate). One white film-coated tablet contains: Estradiol 1 mg (as estradiol hemihydrate) and norethisterone acetate ...

3. Pharmaceutical form

Film-coated tablets. Red film-coated, biconvex tablets engraved with NOVO 282. Diameter: 6 mm. White film-coated, biconvex tablets engraved with NOVO 283. Diameter: 6 mm.

4.1. Therapeutic indications

Hormone Replacement Therapy (HRT) for oestrogen deficiency symptoms in postmenopausal women with at least 6 months since last menses. Prevention of osteoporosis in postmenopausal women at high risk of ...

4.2. Posology and method of administration

Novofem is a continuous sequential HRT product for oral use. The oestrogen is dosed continuously. The progestagen is added for 12 days of every 28 day cycle, in a sequential manner. One tablet is taken ...

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 and progestagens may be increased by concomitant use of substances known to induce drug-metabolising enzymes, specifically cytochrome P450 enzymes, such as anticonvulsants ...

4.6. Pregnancy and lactation

Pregnancy Novofem is not indicated during pregnancy. If pregnancy occurs during medication with Novofem, treatment should be withdrawn immediately. Clinically, data on a limited number of exposed pregnancies ...

4.7. Effects on ability to drive and use machines

Novofem has no known effect on the ability to drive or use machines.

4.8. Undesirable effects

Clinical experience The most frequently reported adverse events during treatment in clinical trials conducted with an HRT product similar to Novofem were breast tenderness and headache (reported in ≥10% ...

4.9. Overdose

Symptoms of over dosage with oral oestrogens are breast tenderness, nausea, vomiting and/or metrorrhagia. Overdosage of progestagens may lead to a depressive mood, fatigue, acne and hirsutism. Treatment ...

5.1. Pharmacodynamic properties

Pharmacotherapeutic group: Progestagens and oestrogens, sequential preparations ATC code: G03FB05 Estradiol: The active ingredient, synthetic 17β-estradiol, is chemically and biologically ...

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

Animal studies with estradiol and norethisterone acetate have shown oestrogenic and progestagenic effects as expected. Both compounds induced adverse effects in preclinical reproductive toxicity studies, ...

6.1. List of excipients

Both the white and the red tablets contain: Lactose monohydrate Maize starch Hydroxypropylcellulose Talc Magnesium stearate Film-coating: White film-coated tablet: Hypromellose, triacetin ...

6.2. Incompatibilities

Not applicable.

6.3. Shelf life

3 years.

6.4. Special precautions for storage

Do not store above 25°C. Do not refrigerate. Keep the container in the outer carton in order to protect it from light.

6.5. Nature and contents of container

1 28 tablets or 3 28 tablets in calendar dial packs. The calendar dial pack with 28 tablets consists of the following 3 parts: The base made of coloured non-transparent polypropylene. The ring-shaped ...

6.6. Special precautions for disposal and other handling

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

7. Marketing authorization holder

Marketing Authorisation Holder: Novo Nordisk Limited, 3 City Place, Beehive Ring Road, Gatwick, West Sussex, RH6 0PA

8. Marketing authorization number(s)

PL 03132/0141

9. Date of first authorization / renewal of the authorization

16/11/2006

10. Date of revision of the text

09/2020

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