|1.||Pregnancy, known or suspected.|
|2.||Acute or chronic disturbances of liver function (including Dubin-Johnson syndrome, Rotor syndrome), current or previous history of liver tumours, recurrent cholestatic jaundice or severe pruritus during a previous pregnancy.|
|3.||Current or previous history of known or suspected sex steroid dependent neoplasias, (eg existing or treated cancer of the breast or endometrium).|
|4.||Current or previous history of arterial or venous thrombotic or embolic processes and conditions which predispose to them (eg defects of the coagulation system, valvular heart disease, atrial fibrillation), severe migraine or cerebrovascular insufficiency.|
|5.||Undiagnosed vaginal bleeding.|
|6.||Disorders of lipometabolism.|
|8.||Severe diabetes with vascular changes.|
|9.||History of herpes gestationis.|
|10.||Otosclerosis with deterioration during pregnancy.|
|11.||Hypersensitivity to any of the components of Melodene.|
|Extra contraceptive precautions|
When you need extra contraceptive precautions, either:
- dont have sex; or
- use a cap plus spermicide, or a condom.
Dont 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|
- you are more than 12 hours late in taking a tablet; or
- you have vomiting or diarrhoea; 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 white active tablets in your pack - the 7 pink non-hormonal tablets must NOT be taken. Start the next pack on the white active tablets on the corresponding day in the silver section (following the direction of the arrows), as soon as you have finished the white active tablets of the present pack. Read the section Extra contraceptive precautionscarefully.
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.
|1.||Thromboembolic disorders and other vascular problems:|
There is evidence of an association between the use of combined oral contraceptives and an increased risk of venous and arterial thromboembolic diseases such as myocardial infarction, stroke, pulmonary embolism, thrombophlebitis, and retinal thrombosis. Full recovery from these disorders does not always occur, and it should be realised that in a few cases they are fatal. The physician should therefore be alert to the earliest manifestations of these disorders. Should any of these occur or be suspected, oral contraceptives should be discontinued immediately.
|The risk of arterial thrombosis (eg stroke, myocardial infarction) associated with combined oral contraceptives increases with age and with heavy smoking. For this reason, women over 35 years of age who use oral contraceptives should be strongly advised not to smoke.|
|Certain disease states such as hypertension, hyperlipidemia, obesity, and diabetes mellitus may increase the observed risk of thromboembolic events associated with oral contraceptive use. The suitability of using oral contraceptives in these disease states should be weighed against the risk associated with the condition, and should be discussed with the patient before she decides to take an oral contraceptive.|
|2.||Carcinoma of the breasts: |
The evidence linking combined oral contraceptives and breast cancer remains inconclusive. The results of epidemiological studies have revealed that overall there is no increased risk of breast cancer in women who had ever used oral contraceptives. The results of some studies suggesting a possible increased risk in certain subgroups of women remain conflicting.
|3.||Hepatic neoplasia: |
In rare cases, benign liver tumours, and even more rarely, malignant liver tumours have been reported in users of oral contraceptives. In isolated cases, these tumours have led to life-threatening intra-abdominal haemorrhages. A hepatic tumour should be considered in the differential diagnosis when severe upper abdominal pain, liver enlargement, or signs of intra-abdominal haemorrhage occur in women taking oral contraceptives.
|4.||Gallbladder disease: |
Earlier studies reported an increased risk of surgically confirmed gallbladder disease in users of estrogens and oral contraceptives. However, more recent studies have shown that the relative risk of developing gallbladder disease may be minimal.
|5.||Lipid and carbohydrate metabolism: |
Changes in serum triglyceride, cholesterol and lipoprotein levels have been reported in users of oral contraceptives. Oral contraceptives may also cause a decrease in glucose tolerance.
|6.||Elevated blood pressure:|
An increase in blood pressure has been reported in women taking oral contraceptives. Elevated blood pressure usually returns to normal after discontinuing oral contraceptives.
|7.||Bleeding irregularities: |
Breakthrough bleeding and spotting are sometimes encountered, primarily during the first three months of use, and usually cease spontaneously. The woman, therefore, should continue to take Melodene, even if irregular bleeding occurs. Should breakthrough bleeding persist or recur, appropriate diagnostic measures to exclude an organic cause are indicated and may include curettage. The same applies in the case of spotting which occurs at irregular intervals in several consecutive cycles or which occurs for the first time after long term use of Melodene.
|After discontinuation of oral contraceptives, some women may experience amenorrhoea or oligomenorrhoea, especially when these conditions existed prior to use. Women with these pre-existing menstrual patterns should be informed of this possibility. |
Occasionally, withdrawal bleeding may not occur during the 7 day pink non-hormonal tablet taking period. Pregnancy must be ruled out before use of the preparation is continued.
|8.||Use during pregnancy: |
Pregnancy must be excluded before starting Melodene. If pregnancy occurs during use of Melodene, the preparation is to be withdrawn immediately.
|9.||Use during lactation:|
|Minute amounts of the components of oral contraceptives have been identified in the milk of nursing mothers. Additionally, oral contraceptives given in the post-partum period may interfere with lactation by decreasing the volume of milk produced and by changing the composition of the breast milk.|
|1.||Occurrence for the first time of migrainous headaches or more frequent occurrence of unusually severe headaches.|
|2.||Acute disturbances of vision, hearing or other perceptual disorders.|
|3.||First symptoms of thrombophlebitis or thromboembolism (eg unusual pains in or swelling of the legs, stabbing pains on breathing or coughing for no apparent reason).|
|4.||A feeling of pain or tightness in the chest.|
|5.||Pending operations (six weeks beforehand), immobilisation (eg following accidents). In all these cases there may be an increased risk of thrombosis.|
|6.||Onset of severe clinical depression.|
|7.||Severe upper abdominal pain or liver enlargement.|