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PREMARIN Coated tablet (2016)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

Premarin 0.625 mg Coated Tablets.

Qualitative and quantitative composition

Each tablet contains 0.625 mg conjugated estrogens. Excipients with known effect: Each tablet contains lactose monohydrate 54.1 mg and sucrose 45 mg. For the full list of excipients, see section 6.1. ...

Pharmaceutical form

Coated Tablet. Maroon oval biconvex sugar-coated tablet marked with 0.625 in white ink.

Therapeutic indications

Hormone replacement therapy for estrogen deficiency symptoms in postmenopausal women. Prevention of osteoporosis in postmenopausal women at high risk of future fractures who are intolerant of, or contraindicated ...

Posology and method of administration

Adults Premarin is an estrogen only HRT. Treatment of Postmenopausal Symptoms Premarin 0.3-1.25mg daily is the usual starting dose for women without a uterus. Continuous administration is recommended. ...

Contraindications

Known, suspected or history of breast cancer Known or suspected estrogen-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 estrogens may be increased by concomitant use of substances known to induce drug-metabolising enzymes, specifically cytochrome P450 3A4 (CYP3A4) enzymes. Therefore, inducers or inhibitors ...

Fertility, pregnancy and lactation

Pregnancy Premarin is not indicated during pregnancy. For women with a uterus If pregnancy occurs during medication with Premarin treatment should be withdrawn immediately. The results of most epidemiological ...

Effects on ability to drive and use machines

No studies on the effect of ability to drive or use machines have been performed.

Undesirable effects

See also section 4.4. Adverse drug reactions (ADRs) The adverse reactions listed in the table are based on post-marketing spontaneous (reporting rate), clinical trials and class-effects. Common ADRs (>1/100, ...

Overdose

Symptoms of overdosage of estrogen-containing products in adults and children may include nausea, vomiting, breast tenderness, dizziness, abdominal pain, drowsiness/ fatigue and withdrawal bleeding may ...

Pharmacodynamic properties

ATC Code: G03C A57 Conjugated Estrogens The active ingredients are primarily the sulfate esters of estrone, equilin sulfates, 17α-estradiol and 17β-estradiol. These substitute for the loss of estrogen ...

Pharmacokinetic properties

Absorption Conjugated estrogens are soluble in water and are well absorbed from the gastrointestinal tract after release from the drug formulation. Premarin tablets release conjugated estrogens slowly ...

Preclinical safety data

Long-term continuous administration of natural and synthetic estrogens in certain animal species increases the frequency of carcinoma of the breast, cervix, vagina and liver.

List of excipients

Compressed Tablet Cores: Lactose Monohydrate (Spray Dried) Microcrystalline Cellulose Hypromellose 2208, K100M (100,000cps) Magnesium Stearate Tablet Coating: Filler Coat: Sucrose Microcrystalline Cellulose ...

Incompatibilities

Not applicable.

Shelf life

2 years.

Special precautions for storage

Do not store above 25°C.

Nature and contents of container

Blister pack consisting of a PVC/Aclar/PVC and a hard tempered aluminium foil lid containing 28 tablets. One carton pack contains 3 blisters. Securitainers containing 100 tablets. PVC/Aluminium foil blisters ...

Special precautions for disposal and other handling

Not applicable.

Marketing authorization holder

Pfizer Limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, United Kingdom

Marketing authorization number(s)

PL 00057/1285

Date of first authorization / renewal of the authorization

21 July 2011

Date of revision of the text

08/2016

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