Source: Web Search Revision Year: 2010 Publisher: Pfizer Healthcare Ireland, 9 Riverwalk, National Digital Park, Citywest Business Campus, Dublin 24, Ireland
Hormonal contraception.
To achieve maximum contraceptive effectiveness, Microval must be taken exactly as directed. One tablet is taken every day at the same time, preferably after the evening meal or at bedtime so that the interval between tablets is always about 24 hours. The tablets should be taken with no interruption, whether bleeding occurs or not. Each subsequent pack is started on the day after the previous pack is finished. Contraceptive efficacy may be reduced if a tablet is taken more than 3 hours late.
During the first cycle additional non-hormonal contraceptive precautions should be taken for the first 14 days.
The tablets are started on the first day of menstruation and taken daily without interruption for as long as contraception is desired. They should be taken at the same time each day, preferably after the evening meal or at bedtime so that the interval between tablets is always about 24 hours. Protection may be reduced when the interval increases beyond 27 hours.
During the first cycle additional contraceptive non-hormonal precautions should be taken for the first 14 days.
Tablet-taking should start on the day of an implant removal or, if using an injection, the day the next injection would be due. In addition, a non-hormonal back-up method of birth control should be used for the first 14 days.
Women who change from a combined oral contraceptive to Microval should stop taking the previous product, leave seven clear days and take the first Microval tablet on the eighth day, then continue to take 1 tablet daily. Additional non-hormonal contraceptive precautions should be taken until the fourteenth tablet has been taken.
In women who are breast-feeding tablet taking may start six weeks after delivery. A non-hormonal back-up method of birth control should be used for the last 14 days.
Tablet-taking may start immediately. A non-hormonal back-up method of birth control should be used for the first 14 days.
When oral contraceptives are administered in the immediate post-partum/post-miscarriage period, the increased risk of thromboembolic disease must be considered.
Irregular spotting or bleeding may occur with a proportion of women initially but menstrual regularity is usually reestablished after the first few cycles. Those patients whose menstrual patterns do not become reasonably regular after three to four cycles or who have prolonged bleeding or amenorrhea lasting for two months should be instructed to return for advice.
If a tablet is not taken at the usual time it should be taken as soon as possible and the next tablet taken at the usual time. If the interval between tablets is more than 27 hours protection may be impaired. The patient should take one tablet as soon as she remembers and thereafter one tablet daily as before but should use additional contraceptive measures until the tablets have been taken regularly for 14 days. If a tablet is missed, the patient should take 1 tablet daily as before but should use additional non-hormonal contraceptive measures until the tablets have been taken regularly for 14 days. In addition, if three or more tablets have been missed, the possibility of pregnancy should be considered before tablet-taking is resumed.
If vomiting occurs shortly after a tablet has been taken contraceptive protection can be maintained by taking another tablet, provided that it is taken within three hours of the normal time. The last tablet in the pack may be used for this purpose. If repeated vomiting or diarrhoea endanger absorption additional non-hormonal contraceptive precautions should be used for 14 days after the symptoms have disappeared.
Other methods of contraception should be considered if the gastro-intestinal disorder is likely to be prolonged.
Breakthrough bleeding and spotting are sometimes encountered, primarily during the first three months of use, and usually cease spontaneously. The woman, therefore, should continue to use Microval even if irregular bleeding occurs. Should break-through bleeding persist or recur, appropriate diagnostic measures to exclude an organic cause should be taken.
This also applies in the case of spotting which occurs at irregular intervals in several consecutive cycles or which occurs for the first time after prolonged use of Microval.
If one withdrawal bleed is missed and Microval has not been taken according to directions, or if two consecutive withdrawal bleeds are missed, tablet-taking should be discontinued until the possibility of pregnancy is excluded. In addition, a non-hormonal back-up method of contraception should be used.
Overdosage may cause nausea, vomiting, breast tenderness, dizziness, somnolence and withdrawal bleeding in females. Treatment of overdose, if necessary, is directed to the symptoms.
3 years.
Do not store above 25°C. Store in the original package.
Primary container: Polyvinylchloride (PVC)/Aluminium foil blister pack.
Secondary container: Cardboard carton.
Presentation: Each blister pack contains 35 tablets.
Carton contains 1 blister.
No special requirements.
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