TECNOVULA 50MG 20 TAB; clomiphen, hormonal agents .
ACTIVE-INGREDIENT OF TECNOVULA 50MG 20 TAB
Each tablet contains: Clomifene Citrate 50 mg.
INDICATION OF TECNOVULA 50MG 20 TAB
Tecnovula 50 mg tablets (Clomifene Citrate BP) is indicated for the treatment of ovulatory failure in women desiring pregnancy . Tecnovula 50 mg tablets is indicated only for patients in whom ovulatory dysfunction is demonstrated. Other causes of infertility must be excluded or adequately treated before giving Tecnovula 50 mg tablets.
DOSAGE OF TECNOVULA 50MG 20 TAB
Follow all directions given to you by your pharmacist or doctor carefully . They may differ from the information contained in this leaflet
Ask your pharmacist or doctor for help if you do not understand the instructions on the box .
The recommended dose is : –
Route of administration: Oral . Adults Only: The recommended dose for the first course of Tecnovula 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 had no recent uterine bleeding.
If progesin-induced bleeding is planned, or if spontaneous uterine bleeding occurs before therapy, the regimen of 50 mg daily for 5 days should be started on or about the fifth day of the cycle. When ovulation occurs at this dosage, there is no advantage to increasing the dose in subsequent cycles of treatment. If ovulation appears not to have occured after the first course of therapy, a second course of 100 mg daily (two 50 mg tablets given as a single daily dose) for 5 days should be given.
This course may be started as early as 30 days after the previous one. Increase of the dosage or duration of therapy beyond 100 mg/day for 5 days should not be undertaken. The majority of patients who are going to respond will respond to the first course of therapy, and 3 courses should constitute an adequate therapeutic trial. If ovulatory menses have not yet occured, the diagnosis should be re-evaluated. Treatment beyond this is not recommended in the patient who does not exhibit evidence of ovulation.
Long-term cyclic therapy. Not recommended. The relative safety of long-term cyclic therapy has not been conclusively demonstrated and, since the majority of patients will ovulate following 3 courses, long-term cyclic therapy is not recommended, i.e. beyond a total of about 6 cycles (including 3 ovulatory cycles). Special Populations: Special care with lower dosage or duration of treatment is particularly recommended if unusual sensitivity to pituitary gonadotrophin is suspected, such as in patients with polycystic ovary syndrome.
OVER-DOSAGE OF TECNOVULA 50MG 20 TAB
Toxic effects of acute overdosage of Tecnovula 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 employed.
CONTRA-INDICATION OF TECNOVULA 50MG 20 TAB
Pregnancy: Liver disease: Tecnovula 50 mg tablets (Clomifene Citrate BP) therapy is contraindicated in patients with liver disease or a history of liver dysfunction. Abnormal uterine bleeding: Tecnovula 50 mg tablets is contraindicated in patients with hormone-dependent tumours or in patients with abnormal uterine bleeding of undetermined origin. Ovarian cyst: Tecnovula 50 mg tablets should not be given in the presence of an ovarian cyst, except polycystic ovary, since further enlargement of the cyst may occur. Patients should be evaluated for the presence of ovarian cyst prior to each course of treatment.
STORAGE OF TECNOVULA 50MG 20 TAB
Store in original container, do not store above 30 °C.
PACK OF TECNOVULA 50MG 20 TAB
Carton box containing (AL/PVC) 2 strips each of 10 tablets with insert leaflet.
TECNOVULA 50MG 20 TAB MANUFACTURED BY
Technopharma Egypt New Borg Elarab – Alexandria, Egypt