CLOMID Tablet (2020)
Βιβλιογραφική αναφορά
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Περιεχόμενα
Name of the medicinal product
Clomid 50 mg Tablets.
Qualitative and quantitative composition
Clomifene Citrate 50 mg.
Pharmaceutical form
Tablet.
Therapeutic indications
Clomid 50 mg Tablets (Clomifene Citrate BP) is indicated for the treatment of ovulatory failure in women desiring pregnancy. Clomid 50 mg Tablets is indicated only for patients in whom ovulatory dysfunction ...
Posology and method of administration
Posology Adults The recommended dose for the first course of Clomid 50 mg Tablets (Clomifene Citrate BP) is 50 mg (1 tablet) daily for 5 days. Therapy may be started at any time in the patient who has ...
Contraindications
Pregnancy See section 4.6. Liver disease Clomid 50 mg Tablets (Clomifene Citrate BP) therapy is contraindicated in patients with liver disease or a history of liver dysfunction. Hormone-Dependent Tumours ...
Special warnings and precautions for use
Warnings General Good levels of endogenous oestrogen (as estimated from vaginal smears, endometrial biopsy, assay of urinary oestrogen, or endometrial bleeding in response to progesterone) provide a favourable ...
Interaction with other medicinal products and other forms of interaction
None stated.
Pregnancy and lactation
Clomid 50 mg Tablets is not indicated during pregnancy. Although there is no evidence that Clomid 50 mg Tablets has a harmful effect on the human fetus, there is evidence that Clomid 50 mg Tablets has ...
Effects on ability to drive and use machines
Patients should be warned that visual symptoms may render such activities as driving a car or operating machinery more hazardous than usual, particularly under conditions of variable lighting (see section ...
Undesirable effects
Symptoms/Signs/Conditions Adverse effects appeared to be dose-related, occurring more frequently at the higher dose and with the longer courses of treatment used in investigational studies. At recommended ...
Overdose
Toxic effects of acute overdosage of Clomid 50 mg Tablets have not been reported but the number of overdose cases recorded is small. In the event of overdose, appropriate supportive measures should be ...
Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> ovulation stimulants, synthetic <b>ATC code:</b> G03BG02 Mechanism of action The ovulatory response to cyclic Clomid 50 mg Tablets therapy is mediated through increased ...
Pharmacokinetic properties
Orally administered <sup>14</sup>C labelled Clomifene citrate was readily absorbed when administered to humans. Cumulative excretion of the <sup>14</sup>C label by way of urine and feces averaged about ...
Preclinical safety data
Long-term carcinogenicity studies have not been performed to evaluate the carcinogenic potential of Clomid. Clomifene citrate did not induce gene mutations in bacteria (Ames test) or chromosome aberrations ...
List of excipients
Sucrose Lactose Soluble starch Maize starch Magnesium stearate Iron oxide yellow E172 Purified water
Incompatibilities
Not applicable.
Shelf life
3 years.
Special precautions for storage
Store in original container, do not store above 25°C.
Nature and contents of container
Blister pack Base: 250 micron PVC. Foil: 20 micron hard-tempered aluminium. (in cardboard cartons) <u>Pack sizes:</u> 30 and 100 tablets.
Special precautions for disposal and other handling
None.
Marketing authorization holder
Aventis Pharma Limited, 410 Thames Valley Park Drive, Reading, Berkshire, RG6 1PT, UK Trading as: Sanofi, 410 Thames Valley Park Drive, Reading, Berkshire, RG6 1PT, UK
Marketing authorization number(s)
PL 04425/5900R
Date of first authorization / renewal of the authorization
Licence renewed: 29<sup>th</sup> September 1995.
Date of revision of the text
12/02/2020
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