Tablets "Diane-35" are used in the treatment of moderate and severe androgen-dependent acne (which is accompanied / not accompanied by seborrhea) and / or hirsutism in women of reproductive age. "Diane-35" should be used only in case of ineffectiveness of local therapy or systemic antibiotic therapy for the treatment of acne. Since Diane-35 is also a hormonal contraceptive, this preparation should not be used in combination with other hormonal contraceptives.
One film-coated tablet contains active ingredients):
Excipients: lactose monohydrate, corn starch, povidone 25000, magnesium stearate, sucrose, povidone 700000, macrogol 6000, calcium carbonate, talc, 85% glycerin, titanium dioxide (E 171), yellow iron oxide dye (E 172), montan glycol wax .
Medicines containing combinations of estrogens/progestogens should not be used in the presence of at least one of the diseases listed below (if any of these diseases occurs for the first time during the use of these medicines, they should be stopped immediately):
Diane-35 should not be used to treat men.
The preparation "Diane-35" is contraindicated when used simultaneously with preparations containing ombitasvir / paritaprevir / ritonavir and dasabuvir.
For oral use.
Tablets should be taken daily according to the order indicated on the package, at about the same time, with a small amount of liquid. The preparation is taken one tablet per day for 21 days in a row. Taking tablets from each subsequent package should be started after the end of the 7-day break in taking the preparation, during which menstrual-like bleeding usually occurs, which usually begins on the 2-3rd day after taking the last tablet and can continue until the start of taking the tablets from new packaging.
Contraceptive protection begins on the first day of taking the pills and continues, including during the 7-day break in taking the preparation. Therefore, it is necessary to stop the simultaneous use of hormonal contraceptives.
Children
The preparation is indicated for use as prescribed by a doctor only after the onset of stable menstruation.
Drivers
In patients taking Diane-35, there was no effect on the ability to drive a car or work with mechanisms.
Data on overdose in humans are not available. Based on the general data collected with the use of COCs, overdose symptoms may include nausea, vomiting and vaginal bleeding. Vaginal bleeding can occur in girls even before menarche in case of inadvertent/accidental use of the preparation. There is no antidote, treatment is symptomatic.
Adverse reactions that were observed most often and associated with the use of the preparation "Diane-35" are nausea, abdominal pain, weight gain, headache, depression, depressed mood, mood changes, soreness of the mammary glands, a feeling of their tension. They occur in ≥ 1% to ˂ 10% of all users. For all women who use Diane-35, there is an increased risk of developing thromboembolism.
Store at a temperature not exceeding 30 ° C, out of the reach of children.
Shelf life - 5 years.
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