Zinnia P Adverse Reactions

Summary of the safety profile: The most commonly reported adverse reactions with Levonorgestrel 150 mcg and Ethinylestradiol 30 mcg Tablets with Inert Tablets are nausea, abdominal pain, increased weight, headache, depressed mood, altered mood, breast pain, breast tenderness. They occur in ≥1% of users.
Serious adverse reactions are arterial and venous thromboembolism.
The following adverse events have been reported during use of ethinylestradiol/levonorgestrel: 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; Strokes (e.g. transient ischemic attack, ischemic stroke, haemorrhagic stroke); Hypertension; Liver tumours (benign and malignant); Exogenous oestrogens may induce or exacerbate symptoms of hereditary and acquired 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'.
Conditions reported to deteriorate with pregnancy or previous COC use: Jaundice and/or pruritus related to cholestasis; gallstone formation; systemic lupus erythematosus; herpes gestationis; otosclerosis-related hearing loss; sickle cell anaemia; renal dysfunction; hereditary angioedema; porphyria; cervical cancer.
Changes in glucose tolerance or effect on peripheral insulin resistance have been reported in women using COCs (see Precautions).
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 Yellow Card Scheme.