Ethinyl Estradiol + Drospirenone (21 tablet)

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This is indicated in oral contraception.

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Preparations containing estrogen/progestogen combinations should not be used in the presence of any of the conditions listed below. If any of the conditions appear for the first time during their use, the product should be stopped immediately. Thrombosis (venous or arterial) present or in history (e.g. deep venous thrombosis, pulmonary embolism, myocardial infarction, cerebrovascular accident) Presence or history of prodromi of a thrombosis (e.g.transient ischaemic attack, angina pectoris) Presence or history of migraine with focal neurological symptoms Diabetes mellitus with vascular involvement Disturbed lipometabolism The presence of a severe or multiple risk factor(s) for venous or arterial thrombosis may also constitute a contraindication Pancreatitis or a history thereof if associated with severe hypertriglyceridemia Presence or history of severe hepatic disease as long as liver function values have not returned to normal Severe renal insufficiency or acute renal failure 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 this tablet.

This is a combined oral contraceptive tablet containing the synthetic progestogen, drospirenone and the synthetic estrogen, ethinylestradiol. The contraceptive effect of this tablet is based on the interaction of various factors, the most important of which are seen as the inhibition of ovulation and the changes in cervical secretion. When this tablet is taken according to instructions, the egg cells are prevented from maturing to the point at which they can be fertilized, the cervical mucus remains thick so as to constitute a barrier to sperm and the endometrium is rendered unreceptive to implantation. As well as protection against pregnancy, estrogen/progestogen combinations have several positive properties which, next to the negative properties, can be useful in deciding on the method of birth control. The cycle is more regular and the menstruation is often less painful and bleeding is lighter.Drospirenone has antimineralocorticoid activity, counteracting estrogen related sodium retention. In combination with ethinylestradiol, drospirenone displays a favourable lipid profile with an increase in high-density lipoprotein HDL. Drospirenone exerts antiandrogenic activity and does not counteract the ethinylestradiol-related sex hormone binding globulin (SHBG) increase which is useful for binding and inactivating the endogenous androgens. Drospirenone is devoid of any androgenic, estrogenic, glucocorticoid and antiglucocorticoid activity. This in combination with the antimineralocorticoid and antiandrogenic properties, gives drospirenone a biochemical and pharmacological profile closely resembling the natural hormone progesterone.

Like other contraceptives some undesirable effects may have seen with this tablet, these include venous and arterial thromboembolic disorders. The following undesirable effects have been reported in users of COCs and whether this association is causal has not been confirmed: Nausea, abdominal pain, Vomiting, diarrhoea, Weight increased, Fluid retention, Headache, Migraine, Depressed mood, mood altered, Breast pain, breast tenderness, Libido decreased, Breast hypertrophy, Rash, urticaria. In women with hereditary angioedema exogenous estrogens may induce or exacerbate symptoms of angioedema.

The Pill and Breastfeeding: This tablet is generally not recommended for use during breast feeding. If you wish to take the Pill while breastfeeding, please seek the advice of your doctor.The Pill and Pregnancy: This tablet must not be used by women who are pregnant or who think they may be pregnant.

The clinical and epidemiological evidence for estrogen/progestogen combinations like this tablet is predominantly based on experience with COCs in general. Therefore, the following warnings related to the use of COCs apply also to the use of this tablet. Also, increased risk of arterial, venous thrombotic and thromboembolic diseases such as myocardial infarction, deep venous thrombosis, pulmonary embolism and of cerebrovascular accidents. These events occur rarely. Cervical cancer Hypertriglyceridemia Blood pressure Jaundice Erythematosus Haemolytic uraemic syndrome Sydenham's chorea Herpes gestationis Otosclerosis-related hearing loss. Hereditary angioedema Acute or chronic disturbances of liver or kidney Crohn's disease and ulcerative colitis Chloasma The Pill and other Medicines: Some medicines may stop the Pill from working properly. These include medicines used for the treatment of epilepsy (e.g. primidone, phenyton, barbiturates) and tuberculosis (e.g. rifampicin); and antibiotics (e.g. ampilicllin, tetracyclines, griseofulvin); for some other infectious diseases. Always tell the doctor, who prescribes the Pill, which medicines you are already using. Also tell other doctor/dentist who prescribes another medicine (or the dispensing pharmacist) that you use this tablet. They can tell you if you need to take additional contraceptive precautions and if so, for how long.The Pill and Ability to Drive: There are no observed effects.