Hormone replacement therapy for women with intact uterus: Treatment of menopause-associated hot flashes and vulvar/vaginal atrophy, Treatment of moderate to severe vasomotor symptoms associated with the menopause,Treatment of moderate to severe symptoms of vulvar and vaginal atrophy associated with the
menopause. When prescribing solely for the treatment of symptoms of vulvar and vaginal atrophy,
topical vaginal products should be considered
This contains two active ingredients- Ethinylestradiol and Drospirenone. Ethinylestradiol is a synthetic version of estrogen and Drospirenone is a synthetic form of progesterone. The hormonal components of this preparation inhibit ovulation by suppressing gonadotropin release. Secondary mechanisms, which may contribute to the effectiveness of this tablet as a contraceptive, include changes in the cervical mucus (which increase the difficulty of sperm penetration) and changes in the endometrium (which reduce the likelihood of implantation).
Drospirenone has antimineralocorticoid activity, counteracting estrogen-related sodium retention. In combination with Ethinyloestradiol, Drospirenone displays a favorable lipid profile with an increase in high-density lipoprotein HDL. Drospirenone exerts antiandrogenic activity and does not counteract the ethinyloestradiol-related sex hormone-binding globulin increase which is useful for binding and inactivating the endogenous androgens.
1 tablet PO daily
Use the lowest dose that will control symptoms
Interactions between ethinylestradiol and other drugs may lead to decreased or increased ethinylestradiol concentrations, respectively. Decreased ethinylestradiol serum concentrations may cause an increased incidence of breakthrough bleeding and menstrual irregularities and may possibly reduce efficacy of the oral contraceptive. Example of substances that may decrease serum ethinylestradiol concentrations include rifampicin, phenytoin, primidone, rifabutin, dexamethasone, griseofulvin, topiramate, some protease inhibitors, modafinil, ritonavir and barbiturates. Certain antibiotics including ampicillin, other penicillins and tetracyclines may reduce the efficacy of oral contraceptives. During concomitant use of this tablet & other drugs that may lead to decreased ethinylestradiol serum concentrations, it is recommended that a non hormonal back-up method of contraception to be used in addition to the regular intake of this tablet.
Renal Impairment: Do not administer
Hepatic Impairment: Do not administer
Breast pain (19%),
Upper respiratory infection (19%),
Abdominal pain (11 %),
Edema 1-1 0%,
Peripheral edema,
Headache,
Accidental injury, back pain, pain in extremity,
Endometrial disorder,
Leukorrhea,
Vaginal hemorrhage,
Abdominal enlargement ,
Flu syndrome,
sinusitis
Contraindicated in Pregnancy
Lactation is not recommended
Symptoms of oral contraceptive overdose may include nausea, vomiting, breast tenderness, dizziness, abdominal pain, drowsiness/fatigue; withdrawal bleeding may occur in females. There is no specific antidote and further treatment of overdose, if necessary, is directed to the symptoms.
Do not store above 30°C. Keep away from light and out of the reach of children.
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