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Prior to the initiation or reinstitution of Synfonia, a complete medical history (including family history) should be taken and pregnancy must be ruled out. Blood pressure should be measured and a physical examination should be performed, guided by the contraindications (see Contraindications) and warnings (see Warnings). The woman should also be instructed to carefully read the user leaflet and to adhere to the advice given.
Women should be advised that oral contraceptives do not protect against HIV infections (AIDS) and other sexually transmitted diseases.
Use of combined oral contraceptives is associated with an increased risk of several conditions including thromboembolism, stroke, myocardial infarction, liver tumor, gallbladder disease, visual disturbances and hypertension. Cigarette smoking increases the risk of serious adverse cardiovascular effects during oral contraceptive use. The risk increases with age and with heavy smoking (15 or more cigarettes daily) and is markedly greater in women older than 35 years of age. Women who are receiving combined oral contraceptives should be strongly advised not to smoke. Women older than 35 years of age who smoke, and women with ischemic heart disease or a history of this disease, should not use combined oral contraceptives.
If any of the conditions/risk factors mentioned previously is present, the benefits of combined oral contraceptives use should be weighed against the possible risks for each individual woman and discussed with the woman before she decides to start using it. In the event of aggravation, exacerbation or first appearance of any of these conditions or risk factors, the woman should contact her physician. The physician should then decide on whether combined oral contraceptives use should be discontinued.
The use of any combined oral contraceptive carries an increased risk of venous thromboembolism (VTE) compared with no use. Should any of the following symptoms of venous or arterial thrombotic/thromboembolic events or of a cerebrovascular accident occur, the product should be stopped and immediately contact the physician: unusual unilateral leg pain and/or swelling; sudden severe pain in the chest, whether or not it radiates to the left arm; sudden breathlessness; sudden onset of coughing; any unusual, severe, prolonged headache; sudden partial or complete loss of vision; diplopia; slurred speech or aphasia; vertigo; collapse with or without focal seizure; weakness or very marked numbness suddenly affecting one side or one part of the body; 'acute' abdomen.
The pill and cancer: Breast cancer has been diagnosed slightly more often in women who use the pill than in women of the same age who do not use the pill. This slight increase in the numbers of breast cancer diagnoses gradually disappears during the course of the 10 years after stopping use of the pill. It is not known whether the difference is caused by the pill. It may be that the women were examined more often, so that the breast cancer was noticed earlier.
In rare cases benign liver tumors and even more rarely, malignant liver tumors have been reported in users of the pill. These tumors may lead to internal bleeding. Contact a doctor immediately if patient has severe pain in her abdomen.
The most important risk factor for cervical cancer is persistent human papilloma virus infection. Some studies have indicated that long-term use of the pill may further contribute to this increased risk but there continues to be controversy about the extent to which this finding is attributable toother factors, e.g., cervical screening and sexual behavior including use of barrier contraceptives.
Effects on ability to drive and use machines: No studies on the effects on the ability to drive and use machines have been performed.
No effects on ability to drive and use machines have been observed in users of COCs.
