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ZUMENON Film-coated tablet (2019)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

Zumenon 2mg Film-coated Tablets.

Qualitative and quantitative composition

Each tablet contains 2 mg estradiol (as hemihydrate). Excipient with known effect: each tablet contains 118.2 mg lactose monohydrate. For the full list of excipients, see section 6.1.

Pharmaceutical form

Brick-red, round, biconvex, film-coated tablets imprinted with 379 on one side.

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 ...

Posology and method of administration

One tablet to be taken orally. Zumenon is an oestrogen only continuous HRT for women with or without a uterus. In women with a uterus, a progestogen should be added to Zumenon for 12-14 days each month ...

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

No interaction studies have been performed. The efficacy of oestrogens might be impaired: The metabolism of oestrogens may be increased by concomitant use of substances known to induce drug-metabolising ...

Pregnancy and lactation

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 If pregnancy occurs during medication with Zumenon, treatment should be withdrawn immediately.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

Effects on ability to drive and use machines

Zumenon does not affect the ability to drive or use machines.

Undesirable effects

Serious undesirable effects associated with the use of hormone replacement therapy are also mentioned in section 4.4 Special warnings and precautions for use. The table below reports undesirable effects, ...

Overdose

Nausea, vomiting, sleepiness, dizziness and withdrawal bleeding may occur in some women. There is no specific antidote and treatment should be symptomatic. Aforementioned information is also applicable ...

Pharmacodynamic properties

Pharmacotherapeutic group: Natural and semisynthetic oestrogens, plain ATC code: G03CA03 Oestradiol The active ingredient, synthetic 17β-oestradiol, is chemically and biologically identical to endogenous ...

Pharmacokinetic properties

Estradiol, estra-1,3,5(10)-triene-3,17ß-diol is identical to human ovarian estradiol. Absorption Absorption of estradiol is dependent on the particle size: micronized estradiol is rapidly absorbed from ...

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. ...

List of excipients

Tablets core: Lactose Hypromellose Maize starch Colloidal andydrous silica Magnesium stearate Film-coat: Hypromellose Talc Macrogol 400 Titanium dioxide E171 Iron oxide red E172 Iron oxide black E172 ...

Incompatibilities

Not applicable.

Shelf life

3 years.

Special precautions for storage

This medicinal product does not require any special storage conditions.

Nature and contents of container

The tablets are packed in blister strips of 28. The blister strips are made of PVC film with covering Aluminium foil. Each carton contains 84 tablets.

Special precautions for disposal and other handling

Medicines no longer required should not be disposed of via wastewater or household waste. Any unused product or waste material should be disposed of in accordance with local requirements.

Marketing authorization holder

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

Marketing authorization number(s)

PL 46302/0053

Date of first authorization / renewal of the authorization

14 May 1997 / 23 Mar 2006

Date of revision of the text

20<sup>th</sup> March 2019

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