ETHINYLESTRADIOL Tablets (2016)
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Περιεχόμενα
Name of the medicinal product
Ethinylestradiol Tablets BP 1 mg.
Qualitative and quantitative composition
Ethinylestradiol 1.048 mg. For excipients see 6.1.
Pharmaceutical form
White flat bevel edged uncoated tablets. Breakline on one side and engraved Evans 1-138 on the other side. For oral administration.
Therapeutic indications
Post menopausal symptoms due to estrogen deficiency. Prevention of osteoporosis in postmenopausal women at high risk of future fractures who are intolerant of, or contraindicated for, other medicinal products ...
Posology and method of administration
Ethinylestradiol Tablets is an estrogen-only preparation of hormone replacement therapy (HRT) for oral administration. Post menopausal symptoms due to estrogen deficiency including prevention of postmenopausal ...
Contraindications
Active or recent arterial thromboembolic disease, e.g. angina, myocardial infarction. Current or previous idiopathic venous thromboembolism (deep venous thrombosis, pulmonary embolism). Known, past 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 enzymes, such as anti-convulsants (e.g. phenobarbitol, ...
Pregnancy and lactation
Ethinylestradiol Tablets are not indicated during pregnancy. If pregnancy occurs during medication with Ethinylestradiol Tablets treatment should be withdrawn immediately. The results of most epidemiological ...
Effects on ability to drive and use machines
None stated.
Undesirable effects
Breast cancer According to evidence from a large number of epidemiological studies and one randomised placebo-controlled trial, the Womens Health Initiative (WHI), the overall risk of breast cancer increases ...
Overdose
Acute overdose of ethinylestradiol may cause nausea and vomiting and may result in withdrawal bleeding in females.
Pharmacodynamic properties
The active ingredient, ethinylestradiol, is chemically and biologically identical to endogenous human oestradiol. It substitutes for the loss of estrogen production in menopausal women, and alleviates ...
Pharmacokinetic properties
Ethinylestradiol is rapidly and completely absorbed from the gut but it undergoes some first pass metabolism in the gut wall. Ethinylestradiol is rapidly distributed throughout most body tissues with the ...
Preclinical safety data
None stated.
List of excipients
Lactose monohydrate Starch maize Magnesium stearate IMS 99% Purified water
Incompatibilities
None stated.
Shelf life
Shelf life: 36 months.
Special precautions for storage
Store below 25°C.
Nature and contents of container
Pigmented polypropylene container fitted with a tamper evident closure containing 21 or 100 tablets. All pack sizes may not be marketed.
Special precautions for disposal and other handling
Not applicable.
Marketing authorization holder
UCB Pharma Ltd, 208 Bath Road, Slough, Berkshire, SL1 3WE
Marketing authorization number(s)
PL 00039/0550
Date of first authorization / renewal of the authorization
26/06/2003
Date of revision of the text
June 2016
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