Promifen Tablets (Generic Clomiphene Citrate Tablets)

1. Promifen Tablets (Generic Clomiphene Citrate Tablets) © The Swiss Pharmacy

2. Promifen Tablets (Generic Clomiphene Citrate Tablets) Promifen (Generic Clomiphene Citrate Tablets) is used for the treatment of ovulatory failure in women desiring pregnancy. Promifen 50 mg Tablets is indicated only for patients in whom ovulatory dysfunction is demonstrated. Good levels of endogenous oestrogen provide a favourable prognosis for ovulatory response induced by Promifen. Promifen therapy is ineffective in patients with primary pituitary or primary ovarian failure. © The Swiss Pharmacy

3. Promifen Tablets (Generic Clomiphene Citrate Tablets) Promifen Tablets are manufactured by Alpha Pharma Healthcare Private limited, India in the strength of 50 mg. © The Swiss Pharmacy

4. Promifen Tablets (Generic Clomiphene Citrate Tablets) Chemical Structure © The Swiss Pharmacy

5. Promifen Tablets (Generic Clomiphene Citrate Tablets) The active ingredient present in Promifen tablets is Clomiphene Citrate. Each Promifen tablet contains 50 mg of Clomiphene. © The Swiss Pharmacy

6. Promifen Tablets (Generic Clomiphene Citrate Tablets) Uses of Promifen 50 mg Tablets: Promifen (Generic Clomiphene Citrate Tablets) is used as a fertility medicine in some women who are unable to become pregnant. It works by stimulating an increase in the amount of hormones that support the growth and release of a mature egg (ovulation). This medication is not recommended for women whose ovaries no longer make eggs properly (primary pituitary or ovarian failure). Those patients most likely to achieve success with clomiphene therapy include patients with polycystic ovary syndrome, amenorrhea-galactorrhea syndrome, psychogenic amenorrhea, post-oral-contraceptive amenorrhea, and certain cases of secondary amenorrhea of undetermined etiology. Clomiphene may also be used for other conditions in both females and males as determined by your doctor. © The Swiss Pharmacy

7. Promifen Tablets (Generic Clomiphene Citrate Tablets) Recommended Adult Dosage The recommended dose for the first course of Promifen Tablets tablet) daily for 5 days. Therapy may be started at any time in the patient who has had no recent uterine bleeding. If progestin-induced bleeding is planned, or if spontaneous uterine bleeding occurs before therapy, the regimen of 50mg 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 occurred after the first course of therapy, a second course of 100mg daily (two 50mg 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 100mg/day for 5 days should not be undertaken. Promifen Tablets is 50 mg (1 URL: https://www.theswisspharmacy.com/product_info.php?info=p9947_Promifen-Tablets.html © The Swiss Pharmacy

8. Promifen Tablets (Generic Clomiphene Citrate Tablets) Contraindications ➔Promifen tablets are contraindicated in patients with a known hypersensitivity to or any component of the tablet. ➔Promifen tablets should not be administered during pregnancy ➔Promifen therapy is contraindicated in patients with liver disease or a history of liver dysfunction. ➔Promifen is contraindicated in patients with hormone-dependent tumours or in patients with abnormal uterine bleeding of undetermined origin. ➔Promifen 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. URL: https://www.theswisspharmacy.com/product_info.php?info=p9947_Promifen-Tablets.html © The Swiss Pharmacy

9. Promifen Tablets (Generic Clomiphene Citrate Tablets) Storage Instructions Promifen Tablets (Generic Clomiphene Citrate Tablets) have to be stored at controlled room temperature i.e. from 20°C to 25°C (68°F to 77°F) with excursions permitted between 15° to 30°C (59° to 86°F). Keep this as well as all other medicines away from children and pets. URL: https://www.theswisspharmacy.com/product_info.php?info=p9947_Promifen-Tablets.html © The Swiss Pharmacy

10. Promifen Tablets (Generic Clomiphene Citrate Tablets) Warnings Pregnancy: Promifen is not indicated during pregnancy. Although there is no evidence that Promifen Tablets (Clomiphene Citrate Tablets) has a harmful effect on the human foetus, there is evidence that Promifen has a deleterious effect on rat and rabbit foetuses when given in high doses to the pregnant animal. Promifen should not be administered during pregnancy. To avoid inadvertent Promifen administration during early pregnancy, appropriate tests should be utilised during each treatment cycle to determine whether ovulation occurs. The patient should have a pregnancy test before the next course of Promifen tablets therapy. URL: https://www.theswisspharmacy.com/product_info.php?info=p9947_Promifen-Tablets.html © The Swiss Pharmacy

11. Promifen Tablets (Generic Clomiphene Citrate Tablets) Warnings Liver disease: Promifen (Clomiphene Citrate) therapy is contraindicated in patients with active liver disease, a history of liver dysfunction or a family or personal history of disorders of bilirubin metabolism. Ovarian dysgenesis: Promifen is contraindicated in patients with ovarian dysgenesis, menopause or any state in which a response could not be expected. Abnormal uterine bleeding: Promifen is contraindicated in patients with hormone-dependent tumours or in patients with abnormal uterine bleeding of undetermined origin. Ovarian cyst: Promifen 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. © The Swiss Pharmacy

12. Promifen Tablets (Generic Clomiphene Citrate Tablets) Possible Side Effects The Common Clomiphene Citrate (Promifen tablets) side effects with a frequency of 1% or higher reported during clinical trials are: Central nervous system disorders: Common: Nervousness and insomnia, headache, dizziness and lightheadedness Visual disorders: Common: Visual symptoms (blurred vision, lights, floaters, waves, unspecified visual complaints, photophobia, diplopia, scotomata, phosphene) Vascular disorders: Very common: Vaso-motor flushes Gastrointestinal disorders: Common: Nausea and vomiting URL: https://www.theswisspharmacy.com/product_info.php?info=p9947_Promifen-Tablets.html © The Swiss Pharmacy

13. Promifen Tablets (Generic Clomiphene Citrate Tablets) Possible Side Effects The Common Clomiphene Citrate (Promifen tablets) side effects with a frequency of 1% or higher reported during clinical trials are: Reproductive system and breast disorders: Very common: Ovarian enlargement Common: Breast discomfort, abnormal uterine bleeding (intermenstrual spotting, menorrhagia) Body as a Whole: Common: Abdominal-pelvic discomfort/distension/bloating (may resemble ovulatory (mittelschmerz) or premenstrual phenomena or that due to ovarian enlargement). This is not a complete list of side effects. URL: https://www.theswisspharmacy.com/product_info.php?info=p9947_Promifen-Tablets.html © The Swiss Pharmacy

14. Promifen Tablets (Generic Clomiphene Citrate Tablets) Overdosage Toxic effects accompanying acute overdosage of Clomiphene Citrate (Promifen tablets) have not been reported. Signs and symptoms of overdosage as a result of the use of more than the recommended dose during Clomiphene Citrate tablets therapy include nausea, vomiting, vasomotor flushes, visual blurring, spots or flashes, scotomata, ovarian enlargement with pelvic or abdominal pain. URL: https://www.theswisspharmacy.com/product_info.php?info=p9947_Promifen-Tablets.html © The Swiss Pharmacy

15. Promifen Tablets (Generic Clomiphene Citrate Tablets) Overdosage Treatment In the event of overdose, appropriate supportive measures should be employed in addition to gastrointestinal decontamination.It is not known if Clomiphene Citrate is dialyzable. URL: https://www.theswisspharmacy.com/product_info.php?info=p9947_Promifen-Tablets.html © The Swiss Pharmacy

16. Promifen Tablets (Generic Clomiphene Citrate Tablets) Promifen Tablets During Pregnancy Clomiphene Citrate (Promifen tablets) has been classified by the US FDA as Pregnancy Category X. Clomiphene Citrate use in pregnant women is contraindicated, as Clomiphene Citrate does not offer benefit in this population. Available human data do not suggest an increased risk for congenital anomalies above the background population risk when used as indicated. However, animal reproductive toxicology studies showed increased embryo-fetal loss and structural malformations in offspring. If this medicine is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential risks to the fetus. URL: https://www.theswisspharmacy.com/product_info.php?info=p9947_Promifen-Tablets.html © The Swiss Pharmacy

17. Promifen Tablets (Generic Clomiphene Citrate Tablets) Promifen tablets Promifen tablets (Generic Clomiphene Citrate Tablets) are manufactured by Alpha Pharma Healthcare Private limited, India. URL: https://www.theswisspharmacy.com/product_info.php?info=p9947_Promifen-Tablets.html © The Swiss Pharmacy