Volina

Volina Adverse Reactions

ethinylestradiol + drospirenone

Manufacturer:

Gedeon Richter

Distributor:

Pahang Pharmacy
Full Prescribing Info
Adverse Reactions
For serious undesirable effects in COC users see Precautions.
The following adverse drug reactions have been reported during use of drospirenone/ethinylestradiol (3 mg/0.03 mg). (See Table 3.)

Click on icon to see table/diagram/image

Description of selected adverse reactions: 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.
The following serious adverse events have been reported in women using COCs, which are discussed in Precautions: Venous thromboembolic disorders; Arterial thromboembolic disorders; Hypertension; Liver tumours; Occurrence or deterioration of conditions for which association with COC use is not conclusive: Crohn's disease, ulcerative colitis, epilepsy, uterine myoma, porphyria, systemic lupus erythematosus, herpes gestationis, Sydenham's chorea, haemolytic uraemic syndrome, cholestatic jaundice; Chloasma; Acute or chronic disturbances of liver function may necessitate the discontinuation of COC use until markers of liver function return to normal; In women with hereditary angioedema exogenous estrogens may induce or exacerbate symptoms of angioedema.
The frequency of diagnosis of breast cancer is very slightly increased among COC users. As breast cancer is rare in women under 40 years of age the excess number is small in relation to the overall risk of breast cancer. Causation with COC use is unknown. For further information, see Contraindications and Precautions.
Interactions: Breakthrough bleeding and/or contraceptive failure may result from interactions of other drugs (enzyme inducers) with oral contraceptives (see Interactions).
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