EVOREL Patch (2020)

Βιβλιογραφική αναφορά

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Περιεχόμενα

1. Name of the medicinal product

Evorel 25 Patch, Evorel 50 Patch, Evorel 75 Patch and Evorel 100 Patch.

2. Qualitative and quantitative composition

Evorel 25: 1.6 mg estradiol/patch. Evorel 50: 3.2 mg estradiol/patch. Evorel 75: 4.8 mg estradiol/patch. Evorel 100: 6.4 mg estradiol/patch.

3. Pharmaceutical form

Evorel is a square shaped, transparent, self-adhesive transdermal delivery system (patch) of 0.2 mm thickness for application to the skin surface. It consists of a monolayered adhesive matrix throughout ...

4.1. Therapeutic indications

Hormone Replacement Therapy (HRT) for oestrogen deficiency symptoms in peri- and post-menopausal women. Evorel 50, 75 and 100 only: Prevention of osteoporosis in post-menopausal women at high risk ...

4.2. Posology and method of administration

Adults Evorel is an oestrogen-only HRT patch applied to the skin twice weekly. For initiation and continuation of treatment of menopausal symptoms, the lowest effective dose for the shortest duration (see ...

4.3. Contraindications

Known, current or past or suspected breast cancer Known or suspected oestrogen-dependent malignant tumours (eg endometrial cancer) or pre-malignant tumours (e.g. untreated atypical endometrial hyperplasia) ...

4.4. Special warnings and precautions for use

For the treatment of menopausal 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 progestogens) 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 Evorel is not indicated during pregnancy. If pregnancy occurs during use of Evorel, treatment should be withdrawn immediately. There are no clinical data on exposed pregnancies. Studies in animals ...

4.7. Effects on ability to drive and use machines

In normal use, Evorel would not be expected to have any effect on the ability to drive or use machinery.

4.8. Undesirable effects

The safety of Evorel was evaluated in 2584 subjects who participated in 15 clinical trials and received at least one administration of Evorel. Subjects were also asked about application site signs and ...

4.9. Overdose

By virtue of the mode of administration of Evorel, overdosage is unlikely, but effects can if necessary be reversed by removal of the patch. The most commonly observed symptoms of overdose with oestrogen ...

5.1. Pharmacodynamic properties

ATC code: G03CA03 Estradiol hemihydrate The active ingredient, synthetic estradiol, is chemically and biologically identical to endogenous human estradiol. It substitutes for the loss of oestrogen ...

5.2. Pharmacokinetic properties

The estradiol hemihydrate of the patch is taken up through the skin as estradiol. Estradiol is metabolised primarily in the liver to estrone, which has weak estrogenic activity. Estrone is either conjugated ...

5.3. Preclinical safety data

Preclinical effects were observed at exposures considered sufficiently in excess of the maximum human exposure, or were related to an exaggerated pharmacological effect, or were related to differences ...

6.1. List of excipients

Adhesive acrylic polymer (Duro-Tak 387-2287) Guar gum (meyprogat 90) Hostaphan MN19 (polyester film removed before application)

6.2. Incompatibilities

None known.

6.3. Shelf life

24 months for the product as packed for sale.

6.4. Special precautions for storage

Do not store above 25°C. Evorel should be kept away from children and pets.

6.5. Nature and contents of container

Each Evorel patch size is presented in a sealed protective pouch. The pouches are packed in a cardboard carton.

6.6. Special precautions for disposal and other handling

None.

7. Marketing authorization holder

Theramex HQ UK LTD, Sloane Square House, 1 Holbein Place, London SW1W 8NS UK

8. Marketing authorization number(s)

Evorel 25 PL 49105/0005 Evorel 50 PL 49105/0006 Evorel 75 PL 49105/0007 Evorel 100 PL 49105/0008

9. Date of first authorization / renewal of the authorization

1 November 1995

10. Date of revision of the text

11 September 2020

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