FERTILAN Tablet (2020)
Βιβλιογραφική αναφορά
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Περιεχόμενα
1. Name of the medicinal product
Fertilan 50mg tablets.
2. Qualitative and quantitative composition
Each tablet contains Clomifene Citrate 50mg. <u>Excipient with known effect:</u> sucrose. Each 50 mg tablet contains 15 mg sucrose.
3. Pharmaceutical form
Tablet. White, round, flat scored tablet, with 9.5mm diameter. The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses.
4.1. Therapeutic indications
Fertilan (Clomifene citrate BP) is indicated for the treatment of ovulatory failure in women desiring pregnancy. Fertilan is indicated only for patients in whom ovulatory dysfunction is demonstrated. Other ...
4.2. Posology and method of administration
Posology Adults Only The recommended dose for the first course of Fertilan is 50mg (1 tablet) daily for 5 days. Therapy may be started at any time in the patient who has had no recent uterine bleeding. ...
4.3. Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 Pregnancy: See section 4.6 Liver disease: Fertilan therapy is contraindicated in patients with liver disease or ...
4.4. 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 ...
4.5. Interaction with other medicinal products and other forms of interaction
None stated.
4.6. Pregnancy and lactation
Pregnancy Clomifene is not indicated during pregnancy. Although there is no evidence that clomifene has a harmful effect on the human foetus, there is evidence that clomifene has a deleterious effect on ...
4.7. 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 ...
4.8. 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 ...
4.9. Overdose
Symptoms Toxic effects of acute overdosage of clomifene have not been reported but the number of overdose cases recorded is small. Management In the event of overdose, appropriate supportive measures should ...
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Ovulation stimulants, synthetic, Sex hormones and modulators of the genital system <b>ATC code:</b> G03GB02 Mechanism of action The ovulatory response to cyclic clomifene ...
5.2. 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 faeces averaged about ...
5.3. Preclinical safety data
Carcinogenicity Prolonged use of clomifene citrate may increase the risk of developing ovarian cancer. Long term toxicity studies in animals have not been performed to evaluate the carcinogenic potential ...
6.1. List of excipients
Citric acid Maize starch Crospovidone Sucrose colloidal silicon dioxide Magnesium stearate
6.2. Incompatibilities
Not applicable.
6.3. Shelf life
5 years.
6.4. Special precautions for storage
Store below 25°C in the original package.
6.5. Nature and contents of container
Blister packs of 10 and 1000 tablets are available. Not all pack sizes may be marketed.
6.6. Special precautions for disposal and other handling
No special precautions for disposal.
7. Marketing authorization holder
CODAL-SYNTO Ltd, 21 Constantinoupoleos Street, 3011 Limassol, Cyprus
8. Marketing authorization number(s)
22019
9. Date of first authorization / renewal of the authorization
06/06/2014 / 19/10/2020
10. Date of revision of the text
19/10/2020
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