desogestrel + ethinylestradiol


Gedeon Richter


Full Prescribing Info
Ethinylestradiol, desogestrel.
Each tablet contains ethinylestradiol 0.02 mg and desogestrel 0.15 mg.
Oral contraception, functional bleeding disorders, dysmenorrhoea and premenstrual syndrome.
Dosage/Direction for Use
1 tab daily starting on the 1st day of menstruation without interruption for 21 days, then 7 tablet-free days.
Pregnancy, nursing, vaginal bleeding of unknown origin, liver-function disorders, bile secretion and outflow disorders (eg, Dubin-Johnson, Rotor's syndrome, gestational cholestatis, pruritus and jaundice in the course of previous pregnancy), predisposition to vascular obstructive disorders (eg, heavy smoking, particularly >35 years of age, sickle-cell anaemia, varicosity, phlebitis in the medical history, myocardial infarction, cerebrovascular disorders, lipid metabolism disorders, severe hypertension alone/or complicated by diseases of the vascular wall, diabetes), history of gestational herpes, otosclerosis, malignancies, 6 weeks before elective surgery, long-term bedridden states (eg, accidents). Its administration can only be recommended with increased medical supervision: In case of multiple sclerosis, porphyria, tetania and epilepsy.
To avoid health injury, the presence of risk factors should be excluded (particularly considering vascular injury eg, diabetes, hypertension, cardiovascular disorders, history of thrombotic disorders, etc). In the course of hormonal contraception, gynaecological examination is recommended at yearly intervals. Smoking (particularly >35 years) increases the hazard of thromboembolic disorders. In diabetes, the contraceptives may alter the patient's oral antidiabetic and/or insulin requirement.
Special Precautions
Important Complications: Obstructive vascular diseases (thrombosis, embolism, myocardial infarction, cerebral blood vessel injury).
There is an increased risk in case of heavy smoking, diabetes mellitus, hypertension, lipid metabolism disorders, obesity, varicosity, cardiovascular diseases, in case of a history of vascular obstructive diseases.
Drug intake should immediately be terminated in the following cases: Sudden increase of blood pressure, diabetes becomes unstable, development of liver disease, thrombotic processes or suspected vascular injury, unusually severe and/or migraine-like headache, heavy thoracic or abdominal pain, visual disturbance, paraesthesias, jaundice or itching all over the body, skin rash, and if pregnancy is suspected.
Adverse Reactions
Gastric complaints, nausea, body weight and libido changes, tension of the breasts, contact lens intolerance, breakthrough bleeding, subdepression-like mood disorders, skin pigmentation and headache.
Drug Interactions
Certain drugs eg, barbiturates, certain antiepileptics (hydantoins, carbamazepine, primidone, barbexaclone), ampicillin and rifampicin may reduce the contraceptive effect of Novynette.
MIMS Class
ATC Classification
G03AA09 - desogestrel and ethinylestradiol ; Belongs to the class of progestogens and estrogens in fixed combinations. Used as systemic contraceptives.
Tab (film-coated) x 21's.
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