FEMODENE ED| • | Thrombosis (venous or arterial) present or in history (eg deep venous thrombosis, pulmonary embolism, myocardial infarction, cerebrovascular accident). |
| • | Presence or history of prodromi of a thrombosis (eg transient ischaemic attack, angina pectoris). |
| • | Diabetes mellitus with vascular involvement. |
| • | The presence of a multiple risk factor(s) for venous or arterial thrombosis (such as eg hypertension, a family history of thromboembolic events, prolonged immobilisation –see further risk factors for thromboembolism under “Warnings - Circulatory disorders”below) may also constitute a contra-indication. |
| • | Presence or history of hepatic disease as long as liver function values have not returned to normal. |
| • | Presence or history of liver tumours (benign or malignant). |
| • | Known or suspected malignant conditions of the genital organs or the breasts, if sex steroid-influenced. |
| • | Undiagnosed vaginal bleeding. |
| • | Known or suspected pregnancy. |
| • | Hypersensitivity to any of the components of Femodene ED. |
| • | age; |
| • | smoking (with heavier smoking and increasing age the risk further increases, especially in women over 35 years of age); |
| • | a positive family history (ie venous or arterial thromboembolism ever in a sibling or parent at a relatively early age). If a hereditary predisposition is suspected, the woman should be referred to a specialist for advice before deciding about any combined oral contraceptive use; |
| • | obesity (body mass index over 30 kg/m²); |
| • | dyslipoproteinaemia; |
| • | hypertension; |
| • | valvular heart disease; |
| • | atrial fibrillation; |
| • | prolonged immobilisation, major surgery, any surgery to the legs, or major trauma. In these situations it is advisable to discontinue combined oral contraceptive use (in the case of elective surgery at least four weeks in advance) and not to resume until two weeks after complete remobilisation. |
| • | Women with hypertriglyceridaemia, or a family history thereof, may be at an increased risk of pancreatitis when using combined oral contraceptives. |
| • | Small increases in blood pressure have been reported in many women taking combined oral contraceptives; clinically relevant increases may occur. If a sustained clinically significant hypertension develops during the use of a combined oral contraceptive then it is prudent for the physician to withdraw the combined oral contraceptive and treat the hypertension. Where considered appropriate, combined oral contraceptive use may be resumed if normotensive values can be achieved with antihypertensive therapy. |
| • | The following conditions have been reported to occur or deteriorate with combined oral contraceptive use: jaundice and/or pruritus related to cholestasis; gallstone formation; porphyria; systemic lupus erythematosus; haemolytic uraemic syndrome; Sydenham’s chorea; herpes gestationis; otosclerosis-related hearing loss. |
| • | Acute or chronic disturbances of liver function may necessitate the discontinuation of combined oral contraceptive use until markers of liver function return to normal. Recurrence of cholestatic jaundice which occurred first during pregnancy or previous use of sex steroids necessitates the discontinuation of combined oral contraceptives. |
| • | Although combined oral contraceptives may have an effect on peripheral insulin resistance and glucose tolerance, there is no evidence for a need to alter the therapeutic regimen in diabetics using combined oral contraceptives. However, diabetic women should be carefully observed while taking combined oral contraceptives. |
| • | Crohn’s disease and ulcerative colitis have been associated with combined oral contraceptive use. |
| • | Chloasma may occasionally occur, especially in women with a history of chloasma gravidarum. Women with a tendency to chloasma should avoid exposure to the sun or ultraviolet radiation whilst taking combined oral contraceptives. |
| • | Respiratory: Asthma may deteriorate in women using combined oral contraceptives. |
| • | Tablet-taking must never be discontinued for longer than 7 days. |
| • | 7 days of uninterrupted active tablet-taking are required to attain adequate suppression of the hypothalamic-pituitary-ovarian-axis. |
| Extra contraceptive precautions When you need extra contraceptive precautions, either: - don’t have sex; or - use a cap plus spermicide, or a condom. Don’t use the rhythm or temperature methods as extra contraceptive precautions. This is because oral contraceptives disrupt the usual menstrual cycle changes such as changes in temperature and cervical mucus. |
| The 7 day rule If: - you are more than 12 hours late in taking a tablet; or - you have vomiting; or - your doctor advises you to follow the 7 day rule because you are taking certain medicines; continue to take your tablets as usual. However, take extra contraceptive precautions during the next 7 days, BUT - if these days run beyond the end of the small white active tablets in your pack - the 7 large white inactive tablets must NOT be taken (ie discard the current pack after taking the last small tablet on “FR”). Start a new pack the next day with the “SA”tablet from the silver section. You can now continue pill taking as before. Read the section “Extra contraceptive precautions”carefully. Do not leave a gap between packs. Your menstrual period will occur after you have completed the second pack. If the period does not occur, consult your doctor before resuming the next pack. |