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QISMETTE is a brand name for Drospirenone, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: AND CLINICAL USE .......................................................................... 3 CONTRAINDICATIONS .............................................................................................. 3 WARNINGS AND PRECAUTIONS .............................................................................. 4…
Verbatim from this product's HC label. Tap a section to expand.
, retinal thrombosis) pulmonary embolism thrombophlebitis The following other adverse reactions also have been reported in patients receiving oral contraceptives: Nausea and vomiting, usually the most common adverse reaction, occurs in approximately 10% or fewer of patients during the first cycle.
The following other reactions, as a general rule, are seen less frequently or only occasionally: abdominal pain amenorrhea during and after treatment angioedema (exogenous estrogens may induce or exacerbate symptoms of angioedema in women with hereditary angioedema) auditory disturbances breakthrough bleeding breast changes (tenderness, enlargement, and secretion) cataracts changes in appetite change in corneal curvature (steepening) changes in libido change in menstrual flow change in weight (increase or decrease) changes in glucose tolerance or effect on peripheral insulin resistance chloasma or melasma which may persist cholestatic jaundice chorea Crohn’s disease cystitis-like syndrome mental depression Page 15 of 55 diarrhea dizziness dysmenorrhea edema endocervical hyperplasia erythema multiforme erythema nodosum gallstone formationa gastrointestinal symptoms (such as abdominal cramps and bloating) headache hemolytic uremic syndromea hemorrhagic eruption herpes gestationisa hirsutism hypersensitivity hypertriglyceridemia (increased risk of pancreatitis when using COCs) hypertension impaired renal function increase in size of uterine leiomyomata intolerance to contact lenses jaundice related to cholestatisa liver function disturbances loss of scalp hair migraine nervousness optic neuritis otosclerosis-related hearing lossa pancreatitis porphyriaa possible diminution in lactation when given immediately postpartum premenstrual-like syndrome pruritis related to cholestasisa rash (allergic) Raynaud’s phenomenon reduced tolerance to carbohydrates retinal thrombosis rhinitis spotting Sydenham’s choreaa systemic lupus erythematosusa temporary infertility after discontinuation of treatment ulcerative colitis aOccurrence or deterioration of conditions for which association with COC use is not conclusive Page 16 of 55 urticaria vaginal candidiasis vaginal discharge vaginitis Clinical Trial Adverse Drug Reactions Because clinical trials are conducted under very specific conditions the adverse reaction rates observed in the clinical trials may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Drospirenone in Canada.
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Adverse drug reaction information from clinical trials is useful for identifying drug-related adverse events and for approximating rates. 030 mg ethinyl estradiol during clinical trials, occurring in >1% of subjects and which may or may not be drug related: headache, menstrual disorder, breast pain, abdominal pain, nausea, leukorrhea, flu syndrome, acne, vaginal moniliasis, depression, diarrhea, asthenia, dysmenorrhea, back pain, infection, pharyngitis, intermenstrual bleeding, migraine, vomiting, dizziness, nervousness, vaginitis, sinusitis, cystitis, bronchitis, gastroenteritis, allergic reaction, urinary tract infection, pruritus, emotional lability, surgery, rash, upper respiratory infection.
Less Common Clinical Trial Adverse Drug Reactions Other reactions to oral contraceptives, as a general rule, are seen less frequently or only occasionally, as follows: gastrointestinal symptoms (such as abdominal cramps and bloating), breakthrough bleeding, spotting, change in menstrual flow, dysmenorrhea, amenorrhea during and after treatment, temporary infertility after discontinuation of treatment, edema, chloasma or melasma which may persist, breast changes (tenderness, enlargement, secretion), change in weight (increase or decrease), endocervical hyperplasias, possible diminution in lactation when given immediately postpartum, cholestatic jaundice, migraine, increase in size of uterine leiomyomata, rash (allergic), mental depression, reduced tolerance to carbohydrates, vaginal candidiasis, premenstrual-like syndrome, intolerance to contact lenses, change in corneal curvature (steepening), cataracts, optic neuritis, retinal thrombosis, changes in libido, chorea, changes in appetite, cystitis- like syndrome, rhinitis, headache, nervousness, dizziness, hirsutism, loss of scalp hair, erythema multiforme, erythema nodosum, hemorrhagic eruption, vaginitis, porphyria, impaired renal function, Raynaud’s phenomenon, auditory disturbances, hemolytic uremic syndrome, pancreatitis.
1 events per 100 000 woman-years. 030 mg ethinyl estradiol, but a causal relationship has not been established: pancytopenia, thrombocytopenia, arrhythmia, palpitations, tachycardia, ventricular extrasystoles, sudden hearing loss, ocular hypertension, visual disturbance, vitreous opacities, ischaemic colitis, hepatitis, hyperbilirubinemia, abnormal liver function test, decreased blood Page 17 of 55 sodium, bone pain, pain in extremity, fibroadenoma of breast, seizure, dysarthria, facial paresis, hemiparesis, hypoesthesia, syncope, anxiety, nervousness, panic reaction, breast cyst, hematometra due to cervical polyp, asthma, leukocytoclastic […]