Exluton Special Precautions

Medical examination/consultation: Before prescription, a thorough case history should be taken and a thorough gynaecological examination is recommended to exclude pregnancy. Bleeding disturbances, such as oligomenorrhoea and amenorrhoea should be investigated before prescription. The interval between check-ups depends on the circumstances in each individual case. If the prescribed product may conceivably influence latent or manifest disease (see Warnings), the control examinations should be timed accordingly. Despite the fact that Lynestrenol (Exluton) is taken regularly, bleeding disturbances may occur (see Changes in vaginal bleeding pattern as follows). If bleeding is very frequent and irregular, another contraceptive method should be considered. If the symptoms persist, an organic cause should be ruled out. Management of amenorrhoea during treatment depends on whether or not the tablets have been taken in accordance with the instructions and may include a pregnancy test. The treatment should be stopped if a pregnancy occurs.
Women should be advised that Lynestrenol (Exluton) does not protect against HIV (AIDS) and other sexually transmitted diseases.
Reduced efficacy: The efficacy of progestogen-only pills may be reduced in the event of missed tablets (see Management of missed tablets under Dosage & Administration), gastro-intestinal disturbances (see Advice in case of gastro-intestinal disturbances under Dosage & Administration) or concomitant medication (see Interactions).
Changes in vaginal bleeding pattern: During the use of a progestogen-only contraceptive, vaginal bleeding may become more frequent or of longer duration in some women, whereas in others bleeding may become incidental or be totally absent. These changes are often a reason for the woman to reject the method or to be non-compliant. Acceptance of bleeding pattern can be improved by offering women who have chosen to use Lynestrenol (Exluton) careful counselling on this point.
Evaluation of vaginal bleeding should be done on an ad hoc basis and may include examination to exclude malignancy or pregnancy (see Medical examination/consultation previously).
Follicular development: With all low-dose hormonal contraceptives, follicular development occurs and occasionally the follicle may continue to grow beyond the size it would attain in a normal cycle. Generally, these enlarged follicles disappear spontaneously. Often, they are asymptomatic; in some cases they are associated with mild abdominal pain. They rarely require surgical intervention.
Effects on ability to drive and use machines: On the basis of the pharmacodynamic profile, Lynestrenol (Exluton) is expected to have no or negligible influence on the ability to drive and use machines.