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Femodene is prescribed for Oral contraception. The contraceptive effect of Femodene is based on the interaction of various factors, the most important of which are seen as the inhibition of ovulation and the changes in the cervical secretion. When FEMODENE is taken according to instructions, the egg cells are prevented from maturing to the point at which they can be fertilised, the cervical mucus remains thick so as to constitute a barrier to sperm, and the endometrium is rendered unreceptive to implantation.


In the event of aggravation, exacerbation or first appearance of any of the following conditions or risk factors, the woman should contact her physician. Epidemiological studies have suggested an association between the use of COCs and an increased risk of arterial and venous thrombotic and thromboembolic diseases such as myocardial infarction, stroke, deep venous thrombosis, and pulmonary embolism. These events occur rarely. Venous thromboembolism (VTE), manifesting as deep venous thrombosis and/or pulmonary embolism, may occur during the use of all COCs. Other medical conditions which have been associated with adverse circulatory events include diabetes mellitus, systemic lupus erythematosus, haemolytic uraemic syndrome, chronic Inflammatory Bowel Disease (Crohn's Disease or Ulcerative Colitis) and sickle cell disease. An increase in frequency or severity of headaches during COC use, in particular the onset of migraine which may be prodromal of a cerebrovascular event, may be a reason for immediate discontinuation of the COC. An increased risk of cervical cancer in long-term users of COCs has been reported in some epidemiological studies, but there continues to be controversy about the extent to which this finding is attributable to the confounding effects of sexual behaviour and other factors such as human papilloma virus (HPV). Women with hypertriglyceridaemia, or a family history thereof, may be at an increased risk of pancreatitis when using COCs. Crohn's Disease and Ulcerative Colitis have been associated with COC use. Chloasma may occasionally occur, especially in women with a history of chloasma gravidarum. Women should be advised that preparations like Femodene do not protect against HIV infection (AIDS) and other sexually transmissible diseases. With estrogen/progestogen combinations, irregular bleeding (spotting or breakthrough bleeding) may occur, especially during the first months of use. Therefore, the evaluation of any irregular bleeding is only meaningful after an adaptation interval of about three cycles.
The administration of Femodene is contraindicated during pregnancy. If pregnancy occurs during treatment with Femodene , further intake should be stopped. Lactation may be influenced by COCs as they may reduce the quantity and change the composition of breast milk. Drug interactions which result in an increased clearance of sex hormones can lead to breakthrough bleeding and oral contraceptive failure. Interactions can occur with drugs that induce microsomal enzymes which can result in increased clearance of sex hormones (e.g. phenotoin, barbiturates, primidone, carbamazepine, rifampicin and possibly also oxcarbazepine, topiramate , felbamate, ritonavir and products containing St John's wort). Some clinical reports suggest the enterohepatic circulation of estrogens may decrease when certain antibiotic agents are given, which may reduce ethinylestradiol concentrations (penicillins and tetracyclines). Femodene may interfere with the metabolism of other drug affecting the respective plasma and tissue concentrations (e.g. cyclosporin).

Side Effects

The following side effects have been reported in users of COCs such as Femodene: Breast tenderness, pain, enlargement, secretion; headache; migraine; changes in libido; depressive mood/mood changes; contact lens intolerance; nausea; vomiting; changes in vaginal secretion; various skin disorders (e.g. rash, erythema nodosum, erythema multiforme); fluid retention; change in body weight; hypersensitivity reaction.


There have been no reports of serious deleterious effects from overdose. Symptoms that may occur in this case are nausea, vomiting and, in young girls, slight vaginal bleeding.

Intake Guidelines

Femodene is to be taken regularly in order to achieve the therapeutic efficacy and the required contraceptive protection. Tablets must be taken in the order directed on the package every day at about the same time with some liquid as needed. Tablet taking is continuous. Each subsequent pack is started after completing the pack, following the directional arrows. A withdrawal bleed usually occurs while taking the 7 non-hormonal tablets. This usually starts on day 2 - 3 after the last hormonal tablet is taken. In case if missed dose is more than 12 hours late in taking any hormonal tablet, contraceptive protection may be reduced. There is a particularly high risk of pregnancy if tablets are missed just before or immediately after taking the non-hormonal tablets. If tablets are missed in the first week of taking hormonal tablets following the non-hormonal tablets and intercourse took place in the preceding 7 days, the possibility of pregnancy should be considered. Do not store above 25C Store all drugs properly and keep them out of reach of children.
(c) 2017