Daylina

OC. Moderate acne vulgaris in women who use OC. Symptomatic treatment of premenstrual dysphoric disorder in women.

1 tab daily for 28 days.

May be taken with or without food.

Hypersensitivity to drospirenone, ethinylestradiol, peanut or soya. Presence or risk of VTE & arterial thromboembolism (ATE); known hereditary or acquired predisposition for VTE & ATE; major surgery w/ prolonged immobilisation; cerebrovascular disease, current stroke, history of stroke or prodromal condition eg, transient ischaemic attack; history of migraine w/ focal neurological symptoms; severe or multiple risk factor(s) for arterial thrombosis eg, DM w/ vascular symptoms, severe HTN & dyslipoproteinaemia; presence or history of benign or malignant liver tumours; known or suspected sex steroid-influenced malignancies of genital organs or breasts; undiagnosed vag bleeding. Concomitant use w/ ombitasvir-/paritaprevir-/ritonavir- & dasubuvir-, glecaprevir-/pibrentasvir- or sofosbuvir-/velpatasvir-/voxilaprevir-containing medicinal products. Severe hepatic disease & renal insufficiency; acute renal failure.

Hypersensitivity to peanut or soya. Discontinue use if VTE or ATE is suspected or confirmed. Not for protection against HIV infections & other STDs. Not to be used after menopause. Circulatory disorders; VTE or ATE; symptoms of VTE/ATE eg, DVT, pulmonary embolism; CVA; MI. Risk factors for VTE eg, obesity (BMI >30 kg/m²), prolonged immobilisation, major surgery, any legs or pelvis surgery, neurosurgery or major trauma, +ve family history, cancer, SLE, haemolytic uraemic syndrome, chronic inflammatory bowel disease (Crohn's disease or ulcerative colitis), sickle cell disease, increasing age. Risk factors for ATE eg, smoking, HTN, migraine, DM, hyperhomocysteinaemia, valvular heart disease, atrial fibrillation, dyslipoproteinaemia. Tumours; hypertriglyceridemia; jaundice &/or cholestasis-related pruritus; gallstones; porphyria; Sydenham's chorea; herpes gestationis; otosclerosis-related hearing loss; hereditary & acquired angioedema; endogenous depression, epilepsy; GI disturbances. Irregular or w/drawal bleeding. History of chloasma gravidarum; avoid exposure to sun or UV radiation. May cause allergic reaction due to sunset yellow. Monitor serum K during therapy in patients w/ renal insufficiency during concomitant use of K-sparing medicinal products. Regularly measure BP & perform physical exam prior to therapy. Not to be taken by patients w/ galactose intolerance, total lactase deficiency or glucose-galactose malabsorption. Ensure adequate alternative contraception w/ concomitant anticoagulant therapy eg, coumarins. Acute or chronic liver function disturbances. Not to be used during pregnancy. Not recommended during lactation.

Emotional lability; headache; nausea; breast pain, metrorrhagia, amenorrhea.

ALT elevations w/ ombitasvir-/paritaprevir-/ritonavir- & dasubuvir-containing medicinal products w/ or w/o ribavirin; glecaprevir/pibrentasvir, sofosbuvir/velpatasvir/voxilaprevir. Increased clearance w/ drugs inducing microsomal enzymes, barbiturates, bosentan, carbamazepine, phenytoin, primidone, rifampicin, HIV medication (ritonavir, nevirapine, efavirenz), felbamate, griseofulvin, oxacarbazepine, topiramate, St. John's wort-containing products. Increased/decreased plasma conc w/ HIV PIs, NNRTIs, HCV inhibitors. Increased plasma conc w/ strong CYP3A4 inhibitors, etoricoxib. Increased plasma & tissue conc of ciclosporin. Decreased plasma & tissue conc of lamotrigine. Increased plasma conc of theophylline, tizanidine. Interference w/ lab test results.

Oral Contraceptives / Acne Treatment Preparations

G03AA12 - drospirenone and ethinylestradiol ; Belongs to the class of progestogens and estrogens in fixed combinations. Used as systemic contraceptives.

C