Belara Adverse Reactions

Clinical studies with Belara have shown that the most frequent side- effects (> 20%) were breakthrough bleeding, spotting, headache and breast pain. Irregular bleeding usually decreases with continuation of the intake of Belara.
The following side-effects have been reported after administration of Belara in a clinical study with 1629 women. (See Table 4.)

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In addition, the following adverse reactions associated with ethinylestradiol and chlormadinone acetate have been reported in post-marketing use: asthenia, and other allergic skin reactions not related to immune system disorders.
Description of selected adverse reactions: The following side-effects have also been reported with administration of combined hormonal contraceptives including 0.030 mg ethinylestradiol and 2 mg chlormadinone acetate: An increased risk of arterial and venous thrombotic and thrombo-embolic events, including myocardial infarction, stroke, transient ischemic attacks, venous thrombosis and pulmonary embolism has been observed in women using CHCs, which are discussed in more detail in Precautions.
An increased risk of biliary tract diseases has been reported in some studies on the long-term administration of CHCs.
In rare cases benign, and even more rarely, malignant liver tumours have been observed after the administration of hormonal contraceptives, that led to life-threatening intra-abdominal haemorrhage (see Precautions).
Aggravation of chronic inflammatory bowel disease (Crohn's disease, ulcerative colitis; see also Precautions).
For other serious side-effects such as cancer of the cervix or of the breast see Precautions.
Interactions: Breakthrough bleeding and/or contraceptive failure may result from interactions of other drugs (enzyme inducers) (see Interactions).
Reporting of suspected adverse reactions: Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the National Centre for Adverse Drug Reaction Monitoring by calling Tel: 03-78835550, or visiting the website npra.moh.gov.my (Public-> Reporting Medicinal Problems/Side Effects/AEFI/Vaccine Safety).