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ESTRADOT Transdermal patch (2019)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

Estradot 25 micrograms/24 hours, transdermal patch.

Qualitative and quantitative composition

2.5 cm² patch containing 0.39 mg estradiol (as hemihydrate) with a release rate 25 micrograms estradiol per 24 hours. For the full list of excipients, see section 6.1.

Pharmaceutical form

Transdermal patch. Rectangular patch with rounded corners, comprising a pressure-sensitive adhesive layer containing estradiol, with a translucent polymeric backing on one side and a protective liner on ...

Therapeutic indications

Hormone replacement therapy (HRT) for oestrogen deficiency symptoms in postmenopausal women. The experience treating women older than 65 years is limited.

Posology and method of administration

Dosage The transdermal patch is applied twice weekly, i.e. every three to four days. Oestrogen deficiency symptoms Estradot is available in five strengths: 25, 37.5, 50, 75 and 100. For initiation and ...

Contraindications

Known, past or suspected breast cancer. Known or suspected oestrogen-dependent malignant tumours (e.g. endometrial cancer). Undiagnosed genital bleeding. Untreated endometrial hyperplasia. Previous or ...

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 ...

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 ...

Pregnancy and lactation

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 If pregnancy occurs during medication with Estradot, treatment should be withdrawn immediately.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

Effects on ability to drive and use machines

Estradot has no or negligible influence on the ability to drive and use machines.

Undesirable effects

Mild erythema at the patch application site was the most reported undesirable effect (16.6%). The erythema was observed after removing the patch by peeling from the skin at the application site. Mild pruritus ...

Overdose

Acute overdose is unlikely due to the method of administration. The most common symptoms of overdose in clinical use are breast tenderness and/or vaginal bleeding. If such symptoms occur, a reduction in ...

Pharmacodynamic properties

Pharmacotherapeutic group: Oestrogens ATC code: G03CA03 The active substance in Estradot, synthetic 17β-estradiol, is chemically and biologically identical to endogenous human estradiol. It substitutes ...

Pharmacokinetic properties

Absorption Transdermal administration of estradiol achieves therapeutic plasma concentrations using a lower total dose of estradiol than required with oral administration, whereas plasma levels of estrone ...

Preclinical safety data

The toxicity profile of estradiol has been well established. Long-term continuous administration of natural and synthetic estrogens in certain animal species increases the frequency of carcinomas of the ...

List of excipients

Adhesive matrix: Acrylic adhesive Silicone adhesive Oleyl alcohol Dipropylene glycol Povidone (E1201) Backing layer: Ethylene/vinyl acetate copolymer Vinylidene chloride/methyl acrylate copolymer laminate ...

Incompatibilities

Not applicable.

Shelf life

2 years.

Special precautions for storage

Do not refrigerate or freeze. Store in the original pouch and carton.

Nature and contents of container

Each Estradot patch is individually sealed in an aluminium laminate sachet. Sachets may be provided in cartons of 2, 8, 24 and 26. Not all pack sizes may be marketed.

Special precautions for disposal and other handling

Used transdermal patches should be folded in half with the adhesive side inwards, and discarded safely and out of the reach and sight of children. Any used or unused transdermal patches should be disposed ...

Marketing authorization holder

Novartis Pharmaceuticals UK Limited, Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR

Marketing authorization number(s)

PL 00101/0703

Date of first authorization / renewal of the authorization

16 September 2004 / 31 July 2006

Date of revision of the text

02 April 2019

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