GENERIC NAME

Clomiphene citrate

PROPRIETARY NAME

ClomiGold®

DOSAGE FORM

50mg / for Tablet

COMPOSITION

Each tablet contains:
Clomiphene citrate ………..50 mg
Excipients q.s. ……………….. 1 tablet
(lactose, refined sugar, corn starch, pregelatinized corn starch, magnesium stearate, iron oxide yellow)

INFORMATION PACIENT

· Expected medicine Action: ovulation usually occurs 6-12 days after the series of Clomid
· Storage Care:. Store at room temperature (15-30 ° C) away from light and moisture.
· Shelf life: Do not use the medicine if the expiration date has expired, which can be found on the outer packaging of the product.
· Pregnancy and lactation: If you become pregnant during treatment, discontinue the medication and consult your physician. "Tell your doctor if you are breast-feeding.
· Administration of Care: "Follow the directions from your doctor, always respecting schedules, doses and duration of treatment.
· Discontinuation of treatment: "Do not stop treatment without the knowledge of your
· Adverse reactions: "Tell your doctor the appearance of unpleasant reactions. May occur: discomfort, abdominal swelling or abdominal pain, weight gain and hot flashes. There are likely to occur multiple pregnancy (eg. Twins, triplets).

TECHNICAL INFORMATION ClomiGold®

ClomiGold (clomiphene citrate) is a nonsteroidal agent with estrogenic and antiestrogenic ­properties, which can induce ovulation in some women who do not ovulate. It competes with the endogenous hypothalamic estrogen in estrogen receptors, producing increased secretion Gen. RH and LH and FSH, resulting in ovarian stimulation with subsequent maturation of the ovarian follicles and corpus luteum development. Human studies with clomiphene citrate 14C have shown that absorption is rapid and Excretion is mainly via the faeces. Approximately 50% of the administered dose was excreted after 5 days. The presence in the feces of 14C, 6 weeks after administration suggests that the drug and / or metabolites are slowly excreted by enterohepatic cycle.

INDICATIONS

Treating female infertility due to anovulation. ClomiGold is indicated only for patients with demonstrated anovulation, which falls under the conditions described in this leaflet for patients and where clomiphene citrate is not contraindicated. Other causes of infertility should be excluded or adequately treated before treatment. Good endogenous estrogen levels (estimated by vaginal discharge, endometrial biopsy, determination of urinary estrogen or endometrial bleeding in response to progesterone), are favorable prognosis for the ovulatory response induced by clomiphene citrate. However, a low level of estrogen does not prevent the success of treatment. The treatment is ineffective in patients with pituitary or primary ovarian failure and can not be replaced by other specific treatment of ovulatory failure causes such as thyroid or adrenal dysfunction. Before treatment, one should conduct a careful assessment particularly in patients with abnormal metrorrhagia, it is very important to rule out the presence of neoplastic lesions.