(and dosage form):
Each ClomiHexal tablet contains 50 mg clomifene citrate.
A 18.8 Ovulation controlling agents.
Clomifene acts as a competitive inhibitor at oestogen receptors, blocking their activation by endogenous oestrogen. By clomifene competing with oestrogen for binding sites at the hypothalamic level, the gonadotropins, follicle stimulating hormone (FSH) and luteinising hormone secretion, is increased, which results in the maturation of the ovarian follicle and thus the development and function of the corpus luteum.
Treatment of anovulatory infertility and that due to polycystic ovaries.
Pregnancy, liver disease, history of liver dysfunction, pituitary failure, endometrial carcinoma or ovarian cysts (other than polycystic ovary), undiagnosed ,abnormal uterine bleeding.
Hypersensitivity to clomifene or any of the ingredients of this formulation.
Prolonged courses of treatment are not recommended.
Basal body temperature must be monitored throughout all treatment cycles and the patient should be carefully monitored to determine whether ovulation occurs. If the basal temperature, following Clomifene administration is biphasic and is not followed by menses, the patient should be examined carefully and should undergo a pregnancy test. This is to avoid inadvertent treatment with clomifene during early pregnancy.
The patient should be warned of the possibility of multiple births, particularly if higher doses are used.
DOSAGE AND DIRECTIONS FOR USE
During the first course - 50 mg (1 tablet daily) for 5 days, beginning on day 5 of the cycle, or any day if there is amenorrhoea.
Should ovulation appear not to have occurred, after the first course of therapy a second course of 100 mg daily (as a single dose) may be administered for 5 days.
If pregnancy does not occur after 6 courses, further courses are unlikely to be successful.
SIDE-EFFECTS AND SPECIAL PRECAUTIONS
Side effects are dose related.
Common side effects include vasomotor flushes, abdominal or pelvic discomfort or pain, ovarian enlargement, cyst formation and visual blurring.
The normal variation of ovarian size may be exaggerated, even at normal dosage. There have been rare reports of massive ovarian enlargement and rupture of a lutein cyst with resulting haemoperitoneum.
Visual side effects have been described as blurring or spots and flashes (scintillating scotomata). Ophthalmologically definable scotomata and retinal cell function changes have been reported. The administration of ClomiHexal should be discontinued if visual symptoms occur and a thorough ophthalmological evaluation should be made. No further courses of ClomiHexal should be administered.
Less frequent side effects include nausea and vomiting, increased nervous tension, depression, fatigue, dizziness or light headedness, insomnia, vertigo, headache, mastalgia, menorrhagia, intermenstrual spotting, weight gain, skin reactions such as allergic rashes and urticaria, increased urinary frequency and moderate reversible alopecia.
The formation of Hydatidiform mole has been associated with clomifene administration.
Some abnormalities of liver function may occur.
It is very important to select and evaluate each patient and to pay careful attention to dosage instructions, contra-indications and side effects.
Before starting treatment patients should be thoroughly examined to exclude liver disease, pituitary or ovarian failure and neoplasms of the endometrium.
The cause of infertility and any abnormal bleeding should be investigated. The patient must be instructed to report any abdominal or pelvic pain as this may indicate the presence or enlargement of ovarian cysts.
Since the ovaries are stimulated by the administration of clomifene, abnormal ovarian enlargement may occur.
Patients suffering from polycystic ovary disease should receive the lowest dose of clomifene, in order to prevent any further enlargement or cyst formation
If enlargement of the ovaries occur, administration of clomifene should be discontinued.
Should conception occur, during a cycle in which clomifene is administered, there is the possibility of increased incidence of multiple pregnancy. Both patients and their husbands should be advised of this possibility.
KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT
See Side effects and Special Precautions.
Treatment is symptomatic and supportive.
White, round, biconvex tablets, scored on one face.
Diameter - 9,0-9,2 mm
Height - 3,8-4,2 mm
Blisters of white opaque PVC and aluminium. 10 tablets per blister strip.
Ten blister strips per carton (100s)
One blister strip per carton (10s)
Store in a well closed container, protected from light.
Store below 25°C.
Do not remove the blister from the carton until required for use.
KEEP OUT OF REACH OF CHILDREN
NAME AND BUSINESS OF ADDRESS OF APPLICANT
Hexal Pharma (SA) (PTY) Ltd
Unit A, 10 Fangio road
DATE OF PUBLICATION OF THIS PACKAGE INSERT
08 December 2000
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