Meliane/Meliane ED

Meliane/Meliane ED Special Precautions

ethinylestradiol + gestodene


Bayer HealthCare Pharma


Full Prescribing Info
Special Precautions
Medical Examination/Consultation: A complete medical history and physical examination should be taken prior to the initiation or reinstitution of COC use, guided by the contraindications (see Contraindications) and warnings (see Warnings), and should be repeated at least annually during the use of COCs. Periodic medical assessment is also of importance because contraindications (eg, a transient ischemic attack, etc) or risk factors (eg, a family history of venous or arterial thrombosis) may appear for the 1st time during the use of a COC. The frequency and nature of these assessments should be adapted to the individual woman but should generally include special reference to blood pressure, breasts, abdomen and pelvic organs, including cervical cytology and relevant laboratory tests.
Women should be advised that oral contraceptives do not protect against HIV infections (AIDS) and other sexually transmissible diseases.
Reduced Efficacy: The efficacy of COCs may be reduced in the event of missed tablets (see Management of Missed Tablets under Dosage & Administration), vomiting (see Advice in Case of Vomiting under Dosage & Administration) or concomitant medication (see Interactions).
Reduced Cycle Control: With all COCs, irregular bleeding (spotting or breakthrough bleeding) may occur, especially during the 1st months of use. Therefore, the evaluation of any irregular bleeding is only meaningful after an adaptation interval of about 3 cycles.
If bleeding irregularities persist or occur after previously regular cycles, then nonhormonal causes should be considered and adequate diagnostic measures are indicated to exclude malignancy or pregnancy. These may include curettage.
In some women, withdrawal bleeding may not occur during the tablet-free interval. If the COC has been taken according to the directions described under Dosage & Administration, it is unlikely that the woman is pregnant. However, if the COC has not been taken according to these directions prior to the 1st missed withdrawal bleed or if 2 withdrawal bleeds are missed, pregnancy must be ruled out before COC use is continued.
Effects on the Ability to Drive or Operate Machinery: No observed effects.
Use in pregnancy & lactation: Extensive epidemiological studies have revealed neither an increased risk of birth defects in children born to women who used COCs prior to pregnancy, nor a teratogenic effect when COCs were taken inadvertently during early pregnancy. (See also Contraindications.)
Lactation may be influenced by COCs as they may reduce the quantity and change the composition of breast milk, therefore, the use of COCs should generally not be recommended until the nursing mother has completely weaned her child. Small amounts of the contraceptive steroids and/or their metabolites may be excreted with the milk but there is no evidence that this adversely affects infant health.
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