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Warnings: Reasons for immediate Discontinuation of Medication: Occurrence for the first time of migrainous headaches or more frequent occurrence of unusually severe headaches; sudden perceptual disorders (eg: disturbances of vision or hearing); first symptoms of thrombophlebitis or thromboembolism; a feeling of pain and tightness in the chest; pending operations (6 weeks beforehand) and immobilization eg, following accidents. In all these cases, there may be an increased risk of thrombosis.
Further reasons for discontinuation are: Onset of jaundice; onset of hepatitis; generalized pruritus; increase in epileptic seizures; significant rise in blood pressure; pregnancy.
Precaution: Before starting treatment, a thorough general medical (including blood pressure measurement, urine test for sugar, and, if necessary, special liver tests) and gynaecological examination (including the breasts and cytological smear of the cervix) should be carried out to detect any diseases requiring treatment or any risks. Control examinations are recommended at about 6-monthly intervals during the use of Giane 35.
The family case history should be carefully noted. Disturbances of the clotting system must be ruled out if any members of the family have suffered from thromboembolic diseases (eg, deep vein thrombosis, stroke, myocardial infarction) already at a young age. Pregnancy must be excluded.
During treatment, ovulation will not take place, thus preventing a possible conception. The simultaneous use of hormonal or other contraceptives is therefore unnecessary.
Women suffering from diabetes, hypertension, varicose veins, otosclerosis, multiple sclerosis, epilepsy, porphyria, tetany, chorea minor and women with a history of phlebitis or with a tendency to diabetes should be closely supervised.
In rare cases, benign and, in even rarer cases, malignant liver tumours leading in isolated cases to life-threatening intra-abdominal haemorrhage have been observed after the use of hormonal substances eg. Those contained in Giane 35. If severe upper abdominal complaints, liver enlargement or signs of intra-abdominal haemorrhage occur, a liver tumour should be included in the differential-diagnostic considerations.
According to the present state of knowledge, an association between the use of progestogen-estrogen combinations and an increased risk of venous and arterial thromboembolic diseases cannot be ruled out.
The relative risk of arterial thromboses (eg, stroke, myocardial infarction) appears to increase further when heavy smoking, increasing age and the use of combined oral contraceptives coincide.
Giane 35 is not for use in men.
Circulatory Disorders: Epidemiological studies have suggested an association between the use of COCs and an increased risk of arterial and venous thrombotic and thromboembolic diseases eg, myocardial infarction, deep venous thrombosis, pulmonary embolism and of cerebrovascular accidents. These events occur rarely.
The risk of venous thromboembolism (VTE) is highest during the 1st year of use. The increased risk is present after initially starting a COC or restarting (following a 4-week or greater pill-free interval) the same or a different COC. Data from a large, prospective 3-armed cohort study suggest that this increased risk is mainly present during the first 3 months.
Overall, the risk for VTE in users of low estrogen dose (<50 mcg ethinylestradiol) COCs is 2- to 3-fold higher than for non-users of COCs who are not pregnant and remains lower than the risk associated with pregnancy and delivery.
Venous thromboembolism may be fatal in 1-2% of the cases. Venous thromboembolism manifesting as deep venous thrombosis (DVT) and/or pulmonary embolism may occur during the use of all COCs.
Extremely rarely, thrombosis has been reported to occur in other blood vessels eg, hepatic, mesenteric, renal, cerebral or retinal veins and arteries in COC users. There is no consensus as to whether the occurrence of these events is associated with the use of COCs.
Symptoms of DVT can include: Unilateral swelling of the leg or along a vein in the leg; pain or tenderness in the leg which may be felt only when standing or walking; increased warmth in the affected leg; red or discolored skin on the leg.
Symptoms of pulmonary embolism (PE) can include: Sudden onset of unexplained shortness of breath or rapid breathing; sudden coughing which may bring up blood; sharp chest pain which may increase with deep breathing; sense of anxiety; severe lightheadedness or dizziness; rapid or irregular heartbeat. Some of these symptoms (eg, shortness of breath, coughing) are nonspecific and might be misinterpreted as more common or less severe events (eg, respiratory tract infections).
An arterial thromboembolic event can include cerebrovascular accident, vascular occlusion or myocardial infarction (MI).
Symptoms of a cerebrovascular accident can include: Sudden numbness or weakness of the face, arm or leg, especially on 1 side of the body; sudden confusion, trouble speaking or understanding; sudden trouble seeing in one or both eyes; sudden trouble walking, dizziness, loss of balance or coordination, sudden, severe or prolonged headache with no known cause; loss of consciousness or fainting with or without seizure.
Other signs of vascular occlusion can include: Sudden pain, swelling and slight blue discoloration of an extremity; acute abdomen.
Symptoms of MI can include: Pain, discomfort, pressure, heaviness, sensation of squeezing or fullness in the chest, arm or below the breastbone; discomfort radiating to the back, jaw, throat, arm, stomach; fullness, indigestion or choking feeling; sweating, nausea, vomiting or dizziness; extreme weakness, anxiety or shortness of breath; rapid or irregular heartbeats. Arterial thromboembolic events may be fatal.
The risk of venous or arterial thrombotic/thromboembolic events, or of a cerebrovascular accident increases with: Age; obesity (body mass index >30 kg/m2; a positive family history (ie, venous or arterial thromboembolism in a sibling or parent at a relatively early age). If hereditary predisposition is known or suspected, the woman should be referred to a specialist for advice before deciding about any COC use; prolonged immobilization, major surgery, any surgery to the legs or major trauma. In these situations, it is advisable to discontinue COC use (in the case of elective surgery, at least 4 weeks in advance) and not to resume until 2 weeks after complete remobilization; smoking (with heavier smoking and increasing age, the risk further increases especially in women >35 years); dyslipoproteinemia; hypertension; migraine; valvular heart disease; atrial fibrillation.
There is no consensus about the possible role of varicose veins and superficial thrombophlebitis in venous thromboembolism.
The increased risk of thromboembolism in the puerperium must be considered (for information on pregnancy and lactation, see Use in Pregnancy and Use in Lactation under Use in Pregnancy & Lactation).
Other medical conditions which have been associated with adverse circulatory events include diabetes mellitus, polycystic ovary syndrome, systemic lupus erythematosus, hemolytic uremic syndrome, chronic inflammatory bowel disease (Crohn's disease or ulcerative colitis) and sickle cell disease.
An increase in frequency or severity of migraine during COC use (which may be prodromal of a cerebrovascular event) may be a reason for immediate discontinuation of the COC.
Biochemical factors that may be indicative of hereditary or acquired predisposition for venous or arterial thrombosis include activated protein C (APC) resistance, hyperhomocysteinemia, antithrombin-III deficiency, protein C deficiency, protein S deficiency, antiphospholipid antibodies (anticardiolipin antibodies, lupus anticoagulant).
When considering risk/benefit, the physician should take into account that adequate treatment of a condition may reduce the associated risk of thrombosis and that the risk associated with pregnancy is higher than that associated with low-dose COCs (<0.05 mg ethinylestradiol).
Warning for Cyproterone acetate: Direct hepatic toxicity, including jaundice, hepatitis and hepatic failure, which has been fatal in some cases, has been reported in patients treated with 100mg or more of cyproterone acetate. Most reported cases are in men with prostatic cancer. Toxicity is dose-related and develops, usually, several months after treatment has begun. Liver function tests should be performed pre-treatment and whenever any symptoms or signs suggestive of hepatotoxicity occur. If hepatotoxicity is confirmed, cyproterone acetate should normally be withdrawn, unless the hepatotoxicity can be explained by another cause, e.g. metastatic disease, in which case cyproterone acetate should be continued only if the perceived benefit outweighs the risk.
