UTROGESTAN Capsule (2019)
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Περιεχόμενα
Name of the medicinal product
UTROGESTAN 100MG CAPSULES.
Qualitative and quantitative composition
Each capsule contains 100 mg micronised progesterone. Excipients with known effect: Soya lecithin. For a full list of excipients, see Section 6.1.
Pharmaceutical form
Capsules, soft. White.
Therapeutic indications
Utrogestan is indicated for adjunctive use with estrogen in post-menopausal women with an intact uterus, as hormone replacement therapy (HRT).
Posology and method of administration
Posology In women receiving estrogen replacement therapy there is an increased risk of endometrial cancer which can be countered by progesterone administration. The recommended dose is 200 mg daily at ...
Contraindications
When used in conjunction with estrogens, Utrogestan should not be used in patients with any of the following conditions: Known hypersensitivity to the active substances or to any of the excipients listed ...
Special warnings and precautions for use
Warnings 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 ...
Interaction with other medicinal products and other forms of interaction
Enzyme inducers Drugs known to induce the hepatic CYP450-3A4 such as barbiturates, anti-epileptic agents (phenytoin, carbamazepine), rifampicin, phenylbutazone, bromcriptine, spironolactone, griseofulvin, ...
Fertility, pregnancy and lactation
Pregnancy If pregnancy occurs during medication, Utrogestan 100mg Capsules should be withdrawn immediately. Clinically, data on a large number of exposed pregnancies indicate no adverse effects of progesterone ...
Effects on ability to drive and use machines
This medicine may cause drowsiness or dizziness; therefore care should be taken when driving or using machines.
Undesirable effects
Summary of the safety profile The reporting rate of adverse drug reactions with Utrogestan Oral and Vaginal formulations was calculated as 1.43/1,000 patient years corresponding to approximately 1.5 spontaneously ...
Overdose
Symptoms High doses of progesterone may cause drowsiness, dizziness, somnolence, or fatigue. Treatment Treatment of overdosage consists of discontinuation of Utrogestan together with institution of appropriate ...
Pharmacodynamic properties
Pharmacotherapeutic group: Sex hormones and modulators of the genital system; Progestogens; Pregnen-(4) derivatives ATC code: G03DA04 Mechanism of action Progesterone is a natural progestogen, the main ...
Pharmacokinetic properties
Absorption Micronised progesterone is absorbed by the digestive tract. Pharmacokinetic studies conducted in healthy volunteers have shown that after oral administration of 2 capsules (200mg), plasma progesterone ...
Preclinical safety data
Nonclinical data revealed no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, toxicity to reproduction and development. ...
List of excipients
Sunflower oil, refined Soya lecithin Gelatin Glycerol Titanium dioxide Purified water
Incompatibilities
Not applicable.
Shelf life
3 years.
Special precautions for storage
No special precautions for storage.
Nature and contents of container
The product is supplied in PVC/Aluminium blisters contained in cartons. Pack size: 30 capsules.
Special precautions for disposal and other handling
Any unused product or waste material should be disposed of in accordance with local requirements.
Marketing authorization holder
Besins Healthcare, Avenue Louise 287, B-1050 Brussels, Belgium
Marketing authorization number(s)
PL 28397/0003
Date of first authorization / renewal of the authorization
Date of first authorisation: 10/01/2003 Date of renewal: 27/03/2009
Date of revision of the text
4 April 2019
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