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Drug Details

FEMULEN

• Drug Class Description
  Progestogens.
• Generic Name
  Etynodiol [ethynodiol]
• Presentation
  White tablet inscribed "SEARLE" on both sides.
• Description
  Each tablet contains 500 micrograms etynodiol diacetate
• Indications
  

  Oral contraception.

• Adult Dosage
  

  Starting on the first day of menstruation, one pill every day without a break in medication for as long as contraception is required. Additional contraceptive precautions (such as a condom) should be used for the first 7 days of the first pack. Pills should be taken at the same time each day.

  Missed Pills

  If a pill is missed within 3 hours of the correct dosage time then the missed pill should be taken as soon as possible; this will ensure that contraceptive protection is maintained. If a pill is taken 3 or more hours late it is recommended that the woman takes the last missed pill as soon as possible and then continues to take the rest of the pills in the normal manner. However, to provide continued contraceptive protection it is recommended that an alternative method of contraception, such as a condom, is used for the next 7 days.

  Changing from another oral contraceptive

  In order to ensure that contraception is maintained it is advised that the first pill is taken on the day immediately after the patient has finished the previous pack.

  Use after childbirth, miscarriage or abortion

  The first pill should be taken on the 21st day after childbirth. This will ensure the patient is protected immediately. If there is any delay in taking the first pill, contraception may not be established until 7 days after the first pill has been taken. In these circumstances women should be advised that extra contraceptive methods will be necessary.

  After a miscarriage or abortion patients can take the first pill on the next day; in this way they will be protected immediately.

  Vomiting or diarrhoea

  Gastrointestinal upsets, such as vomiting and diarrhoea, may interfere with the absorption of the pill leading to a reduction in contraceptive efficacy. Women should continue to take Femulen, but they should also be advised to use another contraceptive method during the period of gastrointestinal upset and for the next 7 days.

• Contra Indications
  

  The contraindications for progestogen-only oral contraceptives are:

  (i) Known, suspected, or a past history of breast, genital or hormone dependent cancer;

  (ii) Acute or severe chronic liver diseases including past or present liver tumours, Dubin-Johnson or Rotor syndrome;

  (iii) Active liver disease;

  (iv) History during pregnancy of idiopathic jaundice or severe pruritus;

  (v) Disorders of lipid metabolism;

  (vi) Undiagnosed abnormal vaginal bleeding;

  (vii) Known or suspected pregnancy;

  (viii) Hypersensitivity to any component.

  Combined oestrogen/progestogen preparations have been associated with an increase in the risk of thromboembolic and thrombotic disease. Risk has been reported to be related to both oestrogenic and progestogenic activity. In the absence of long term epidemiological studies with progestogen-only oral contraceptives, it is required that the existence, or history of thrombophlebitis, thromboembolic disorders, cerebral vascular disease, myocardial infarction, angina, coronary artery disease, or a haemoglobinopathy be described as a contraindication to Femulen as it is to oestrogen containing oral contraceptives.

• Special Precautions
  

  Assessment of women prior to starting oral contraceptives (and at regular intervals thereafter) should include a personal and family medical history of each woman. Physical examination should be guided by this and by the contraindications and warnings for this product. The frequency and nature of these assessments should be based upon relevant guidelines and should be adapted to the individual woman, but should include measurement of blood pressure and, if judged appropriate by the clinician, breast, abdominal and pelvic examination including cervical cytology.

  Femulen should be discontinued if there is a gradual or sudden, partial or complete loss of vision or any evidence of ocular changes, onset or aggravation of migraine or development of headache of a new kind which is recurrent, persistent or severe, suspicion of thrombosis or infarction, significant rise in blood pressure or if jaundice occurs.

  Malignant hepatic tumours have been reported on rare occasions in long-term users of contraceptives. Benign hepatic tumours have also been associated with oral contraceptive usage. A hepatic tumour should be considered in the differential diagnosis when upper abdominal pain, enlarged liver or signs of intra-abdominal haemorrhage occur.

  Progestogen-only oral contraceptives may offer less protection against ectopic pregnancy, than against intrauterine pregnancy.

  Femulen should be discontinued at least 4 weeks before elective surgery or during periods of prolonged immobilisation. It would be reasonable to resume Femulen two weeks after surgery provided the woman is ambulant. However, every woman, should be considered individually with regard to the nature of the operation, the extent of immobilisation, the presence of additional risk factors and the chance of unwanted conception.

  Caution should be exercised where there is the possibility of an interaction between a pre-existing disorder and a known or suspected side effect. The use of Femulen in women suffering from epilepsy, or with a history of migraine or cardiac or renal dysfunction may result in exacerbation of these disorders because of fluid retention. Caution should also be observed in women who wear contact lenses, women with impaired carbohydrate tolerance, depression, gallstones, a past history of liver disease, varicose veins, hypertension, asthma or any disease that is prone to worsen during pregnancy (eg. multiple sclerosis, porphyria, tetany and otosclerosis). Progestogen-only oral contraceptives may offer less protection against ectopic pregnancy, than against intrauterine pregnancy.

  A meta-analysis from 54 epidemiological studies reported that there is a slightly increased relative risk of having breast cancer diagnosed in women who are currently using oral contraceptives (OC). The observed pattern of increased risk may be due to an earlier diagnosis of breast cancer in OC users, the biological effects of OCs or a combination of both. The additional breast cancers diagnosed in current users of OCs or in women who have used OCs in the last ten years are more likely to be localised to the breast than those in women who never used OCs.

  Breast cancer is rare among women under 40 years of age whether or not they take OCs. Whilst the background risk increases with age, the excess number of breast cancer diagnoses in current and recent progesterone-only pill (POP) users is small in relation to the overall risk of breast cancer, possibly of similar magnitude to that associated with combined OCs. However, for POPs, the evidence is based on much smaller populations of users and so is less conclusive than that for combined OCs.

  The most important risk factor for breast cancer in POP users is the age women discontinue the POP; the older the age at stopping, the more breast cancers are diagnosed. Duration of use is less important and the excess risk gradually disappears during the course of the 10 years after stopping POP use, such that by 10 years there appears to be no excess.

  The evidence suggests that compared with never-users, among 10,000 women who use POPs for up to 5 years but stop by age 20, there would be much less than 1 extra case of breast cancer diagnosed up to 10 years afterwards. For those stopping by age 30 after 5 years use of the POP, there would be an estimated 2-3 extra cases (additional to the 44 cases of breast cancer per 10,000 women in this age group never exposed to oral contraceptives). For those stopping by age 40 after 5 years use, there would be an estimated 10 extra cases diagnosed up to 10 years afterwards (additional to the 160 cases of breast cancer per 10,000 never-exposed women in this age group).

  It is important to inform patients that users of all contraceptive pills appear to have a small increase in the risk of being diagnosed with breast cancer, compared with non-users of oral contraceptives, but this has to be weighed against the known benefits.

• Interactions
  

  Drug Interactions

  The herbal remedy St John's wort (Hypericum perforatum) should not be taken concomitantly with this medicine as this could potentially lead to a loss of contraceptive effect.

  Some drugs may modify the metabolism of Femulen reducing its effectiveness; these include certain sedatives, antibiotics, anti-epileptic and anti-arthritic drugs. During the time such agents are used concurrently, it is advised that mechanical contraceptives also be used.

• Adverse Drug Reactions
  

  Clinical investigations with Femulen indicate that side effects are infrequent and tend to decrease with time. Known or suspected side effects of progestogen-only oral contraceptives include gastrointestinal disorders such as nausea and vomiting, skin disorders including chloasma, breast changes, ocular changes, headache, migraine and depression, appetite and weight changes, changes in libido, increase in size of uterine myofibromata, and changes in carbohydrate, lipid or vitamin metabolism. Rarely dizziness, hirsutism and colitis have been reported in users of progestogen-only oral contraceptive.

  The use of oral contraceptives has also been associated with a possible increased incidence of gallbladder disease.

  Tests of endocrine, hepatic and thyroid function, as well as coagulation tests may be affected by Femulen.

  Menstrual pattern: Women taking Femulen for the first time should be informed that they may initially experience menstrual irregularity. This may include amenorrhoea, prolonged bleeding and/or spotting but such irregularity tends to decrease with time. If a woman misses two consecutive periods, pregnancy should be ruled out before continuing the contraceptive regimen.