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Belara

Belara Special Precautions

Manufacturer:

Gedeon Richter

Distributor:

Zuellig Pharma

Marketer:

Abbott
Full Prescribing Info
Special Precautions
Belara should be taken only under certain conditions and with special care for the following cases: Heart and kidney diseases, migraine, epilepsy, asthma because these may be affected by the possible accumulation of fluid; history of phlebitis; marked tendency towards varicose veins (varicosis); multiple sclerosis; St. Vitus' dance (chorea minor); muscle cramps (tetany); diabetes mellitus and a tendency towards it; history of liver disease; disorders of fat metabolism; considerable overweight; raised blood pressure; endometriosis; myomatous uterus; mastopathy; otosclerosis.
Use in Pregnancy: Belara is not indicated during pregnancy. Discontinue immediately if a patient becomes pregnant while taking Belara. However, previous use of Belara does not justify an abortion. Chlormadinone acetate has exhibited embryolethal effects in rabbits, rats and mice. Moreover, teratogenicity was observed at embryotoxic doses in rabbits and already at lowest dose tested (1 mg/kg/day). The significance of these findings for human administration is unclear.
Use in Lactation: Milk production may be reduced and its quality affected with the use of Belara. Very small amounts of the active substances pass into the milk. Oral contraceptives eg, Belara should only be taken after breastfeeding has been stopped.
In general, however, contraception is only indicated if breastfeeding for a long time because usually, the patient will not have a cycle during a short period of breastfeeding. If possible, nonhormonal methods of contraception should be used until the baby has been fully weaned.
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