Presentation and Status in Health Basket
3 X 21
First treatment cycle: 1 tablet daily for 21 days, starting on the first day of the menstrual cycle.
Contraceptive protection begins immediately.
Subsequent cycles: Tablet taking from the next pack of Gynera is continued after a 7-day interval, beginning on the same day of the week as the first pack.
Changing from 21-day combined oral contraceptives: The first tablet of Gynera should be taken on the first day immediately after the end of the previous oral contraceptive course. Additional contraceptive precautions are not required.
Changing from a combined Every Day pill (28 day tablets): Gynera should be started after taking the last active tablet from the Every Day Pill pack. The first
Gynera tablet is taken the next day. Additional contraceptive precautions are not then required.
Changing from a progestogen-only pill (POP): The first tablet of Gynera should be taken on the first day of bleeding, even if a POP has already been taken on that day. Additional contraceptive precautions are not then required. The remaining progestogen-only pills should be discarded.
Post-partum and post-abortum use: After pregnancy, oral contraception can be started 21 days after a vaginal delivery, provided that the patient is fully ambulant and there are no puerperal complications. Additional contraceptive precautions will be required for the first 7 days of tablet taking. Since the first post-partum ovulation may precede the first bleeding, another method of
contraception should be used in the interval between childbirth and the first course of tablets. After a first-trimester abortion, oral contraception may be started immediately in which case no additional contraceptive precautions are required.
Special circumstances requiring additional contraception
Incorrect administration: A single delayed tablet should be taken as soon as possible, and if this can be done within 12 hours of the correct time, contraceptive protection is maintained. With longer delays, additional contraception is needed. Only the most recently delayed tablet should be taken,
earlier missed tablets being omitted, and additional non-hormonal methods of contraception (except the rhythm or temperature methods) should be used for the next 7 days, while the next 7 tablets are being taken. Additionally, therefore, if tablet(s) have been missed during the last 7 days of a pack, there should be no break before the next pack is started. In this situation, a withdrawal bleed should not be expected until the end of the second pack. Some breakthrough bleeding may occur on tablet taking days but this is not clinically significant. If the patient does not have a withdrawal bleed during the tablet-free interval following the end of the second pack, the possibility of pregnancy must be ruled out before starting the next pack.
Gastro-intestinal upset: Vomiting or diarrhoea may reduce the efficacy of oral contraceptives by preventing full absorption. If vomiting or diarrhoea occurs within 4 hours of taking Gynera tablettaking from the current pack should be continued. Additional non-hormonal methods of contraception (except the rhythm or temperature methods) should be used during the gastrointestinal
upset and for 7 days following the upset. If these 7 days overrun the end of a pack, the next pack should be started without a break. In this situation, a withdrawal bleed should not be expected until the end of the second pack. If the patient does not have a withdrawal bleed during the tablet-free interval following the end of the second pack, the possibility of pregnancy must be ruled
out before starting the next pack. Other methods of contraception should be considered if the gastrointestinal disorder is likely to be prolonged.
Children: Not applicable.
Elderly: Not applicable.
Hypersensitivity to any of the components. Pregnancy. Severe disturbances of liver function, jaundice or persistent itching during a previous pregnancy, Dubin-Johnson syndrome, Rotor syndrome, previous or existing liver tumours. Current or past confirmed venous thromboembolism (VTE), family history of idiopathic VTE and other known risk factors for VTE. Existing or previous arterial thrombotic or embolic processes; conditions which predispose to them, e.g. disorders of the clotting processes, valvular heart disease and atrial fibrillation. Sickle cell anaemia. Mammary or endometrial carcinoma, or a history of these conditions. Severe diabetes mellitus with vascular changes. Disorders of lipid metabolism. History of herpes gestationis. Deterioration of otosclerosis during pregnancy. Undiagnosed abnormal vaginal bleeding.
See prescribing information for full details.
Users of combined oral contraceptives experience, more often than non-users, venous thromboembolism, arterial thrombosis, including cerebral and myocardial infarction, and subarachnoid hemorrhage. Full recovery from such disorders does not always occur, and it should be realized that in a few cases they are fatal. How often these disorders occur in users of the modern low-dose pills is not known, they may occur less often than with older pills. Smoking, obesity, varicose veins, cardiovascular diseases, diabetes and migraine. The use of combined oral contraceptives by women in the older age group, especially those who are cigarette smokers, should be discouraged and alternative methods uses. Risks of ovarian, endometrial, cervical and breast cancer in women using combined oral contraceptives. Chronic diseases may occasionally deteriorate during the use of combined oral contraceptives. Examination of the pelvic organs, breasts and blood pressure should precede the prescribing of any combined oral contraceptive, and should be repeated regularly. A history of severe depressive states, varicose veins, diabetes, hypertension, epilepsy, otosclerosis, multiple sclerosis, porphyria, tetany, disturbed liver function, gallstones, cardiovascular diseases, renal diseases, chloasma, uterine fibroids, asthma, the wearing of contact lenses, any diseases that is prone to worsen during pregnancy, chorea minor, a history of phlebitis or a tendency to diabetes. See prescribing information for full details.
Nausea, vomiting, headaches, breast tension, changed body weight or libido, depressive moods, chloasma, gastric upsets. Reduction of menstrual flow, missed menstruation, intermenstrual bleeding. May accelerate erythrocyte sedimentation in the absence of any disease.
See prescribing information for full details.
Rifampicin, griseofulvin, barbiturates, phenytoin, primidone, carbamazepine. Tetracyclines, ampillicin, coumarin anticoagulants. Bile acids, danazol, oral hypoglycemics, insulin. Theophylline, cyclosporin. S
ee prescribing information for full details.
Pregnancy and Lactation
Pregnancy: Gynera is not indicated during pregnancy. If pregnancy occurs during treatment with Gynera, further intake must be stopped. However, extensive epidemiological studies have revealed neither an increased risk of birth defects in children born to women who used COCs prior to pregnancy, nor a tertatogenic effect when COCs were taken inadvertently during early pregnancy.
The increased risk of VTE during the postpartum period should be considered when re-starting Gynera.
Lactation: The use of Gynera during lactation may lead to a reduction in the volume of milk produced and to a change in its composition. Minute amounts of the active substances are excreted with the milk.
These amounts may affect the child particularly in the first 6 weeks post-partum. Mothers who are breast-feeding may be advised instead to use another method of contraception.
Overdosage may cause nausea, vomiting and, in females, withdrawal bleeding.
There are no specific antidotes and treatment should be symptomatic.