Belara

Belara Contraindications

Manufacturer:

Gedeon Richter

Distributor:

Pahang Pharmacy
Full Prescribing Info
Contraindications
Combined hormonal contraceptives (CHCs) should not be used in the following conditions. Belara should be discontinued immediately if one of these conditions occurs during administration: Uncontrolled of diabetes mellitus.
Uncontrolled hypertension or a significant increase in blood pressure (values constantly above 140/90 mmHg).
Presence or risk of venous thromboembolism (VTE): Venous thromboembolism - current VTE (on anticoagulants) or history of (e.g. deep venous thrombosis [DVT] or pulmonary embolism [PE]); Known hereditary or acquired predisposition for venous thromboembolism, such as APC-resistance, (including Factor V Leiden mutation), antithrombin-III-deficiency, protein C deficiency, protein S deficiency; Major surgery with prolonged immobilisation (see Precautions); A high risk of venous thromboembolism due to the presence of multiple risk factors (see Precautions).
Presence or risk of arterial thromboembolism (ATE): Arterial thromboembolism - current arterial thromboembolism, history of arterial thromboembolism (e.g. myocardial infarction) or prodromal condition (e.g. angina pectoris); Cerebrovascular disease: current stroke, history of stroke or prodromal condition (e.g. transient ischaemic attack, TIA); Known hereditary or acquired predisposition for arterial thromboembolism, such as hyperhomocysteinaemia and antiphospholipid-antibodies (anticardiolipin-antibodies, lupus anticoagulant); History of migraine with focal neurological symptoms; A high risk of arterial thromboembolism due to multiple risk factors (see Precautions) or to the presence of one serious risk factor such as: diabetes mellitus with vascular symptoms; severe hypertension; severe dyslipoproteinaemia.
Hepatitis, jaundice, liver function disorders until liver function values have returned to normal.
Generalised pruritus, cholestasis, in particular during a previous pregnancy or estrogen therapy.
Dubin-Johnson syndrome, Rotor syndrome, bile-flow disorders.
A history of, or existing, liver tumours.
Severe epigastric pain, enlargement of the liver, or symptoms of intra-abdominal haemorrhage (see Adverse Reactions).
First occurrence or recurrence of porphyria (all three forms, in particular acquired porphyria).
Presence, or a history, of malignant hormone-sensitive tumours, e.g. of the breast or uterus.
Severe disorders of lipid metabolism.
Presence or history of such pancreatitis, if associated with severe hypertriglyceridemia.
First-time symptoms occurrence of migrainous headache or more frequent occurrence of unusually severe headache.
Acute sensory disorders, e.g. visual or hearing disorders.
Motor disorders (particularly paresis).
Increase of the frequency of epileptic seizures.
Severe depression.
Otosclerosis deteriorating during previous pregnancies.
Inexplicable amenorrhoea.
Endometrial hyperplasia.
Unexplained genital bleeding.
Hypersensitivity to the active substances or to any of the excipients listed in Description.
One severe risk factor or multiple risk factors for venous or arterial thrombosis may constitute a contraindication (see Precautions).
Belara is contraindicated for concomitant use with the medicinal products containing ombitasvir/paritaprevir/ritonavir and dasabuvir or medicinal products containing glecaprevir/pibrentasvir (see Precautions and Interactions).
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