Belara

Belara Contraindications

Manufacturer:

Gedeon Richter

Distributor:

Zuellig Pharma

Marketer:

Abbott
Full Prescribing Info
Contraindications
Hypersensitivity to chlormadinone acetate, ethinyl oestradiol or any of the excipients of Belara; history or current blood clots in the veins or arteries (eg, deep vein thrombosis, pulmonary embolism, heart attack, stroke); 1st stages or signs of a blood clot, inflammation of the veins or embolism eg, fleeting, stabbing pain, chest pain or feeling of tightness in the chest; immobilization for long periods of time (eg, on strict bed-rest or due to a plaster cast) or scheduled surgery (discontinue Belara at least 4 weeks before the operation); diabetes, uncontrollable blood sugar or changes in the blood vessels; high blood pressure which is difficult to control or if blood pressure rises considerably (values constantly >140/90 mmHg); blood clotting disturbance (eg, protein C deficiency); inflammation of the liver (eg, due to a virus) or from jaundice or if liver values have not yet returned to normal; itching all over the body or bile flow disorder particularly if this occurred in connection with a previous pregnancy or oestrogen treatment; increased bilirubin eg, due to an in-born excretion disorder (Dubin-Johnson or Rotor syndrome); history of or current liver tumour; severe stomachache, enlarged liver or signs of bleeding in the belly; 1st time or recurrent porphyria; history of or suspected hormone-dependent malignant tumour eg, cancer of the breast or womb; severe disorders of fat metabolism; history or current inflammation of the pancreas associated with severe increase in triglycerides; migraine or migraine accompanied by disorders of sensation, perception and/or movement (migraine accompagnee); unusually severe, frequent or long-lasting headache; sudden perception disorders (sight or hearing); movement disorders (in particular signs of paralysis); worsening of epileptic fits; severe depression; otosclerosis that became worse during previous pregnancies; absence of menstrual period for some unknown reason; endometrial hyperplasia; vaginal bleeding of unknown origin.
If one of these conditions occurs during administration of Belara, it should be discontinued immediately.
Do not take Belara or discontinue immediately if there is a serious risk or several risks of blood clotting disorders.
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