Regulon

Ethinylestradiol 0.03 mg, desogestrel 0.15 mg

OC.

1 tab daily for 21 days followed by 7 tab-free days.

May be taken with or without food.

Hypersensitivity. 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; multiple risk factor(s) for VTE & ATE eg, DM w/ vascular symptoms, severe HTN & dyslipoproteinaemia; presence or history of benign or malignant liver tumours, pancreatitis associated w/ severe hypertriglyceridaemia; known or suspected sex steroid-influenced malignancies of genital organs or breasts; undiagnosed vag bleeding; endometrial hyperplasia. Concomitant use w/ ombitasvir-/paritaprevir-/ritonavir-/dasubuvir-, glecaprevir-/pibrentasvir-, sofosbuvir-/velpatasvir-/voxilaprevir-containing medicinal products. Severe hepatic disease. Known or suspected pregnancy.

Not for protection against HIV infections & other STDs. 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; depression; hypertriglyceridaemia, jaundice &/or cholestasis-related pruritus; gallstone formation; porphyria; Sydenham's chorea; herpes gestationis; otosclerosis-related hearing loss; GI disturbances; irregular bleeding. May induce or exacerbate symptoms of hereditary & acquired angioedema. History of chloasma gravidarum; avoid exposure to sun or UV radiation. Perform medical & physical exam including BP measurement prior to therapy. Not to be taken by patients w/ galactose intolerance, total lactase deficiency or glucose-galactose malabsorption. Not to be used w/ St. John's wort-containing herbal prep. Acute or chronic hepatic function disturbances. Not indicated during pregnancy. Not recommended during lactation. Adolescents <18 yr.

Irregular menstruation. Depressed & altered mood, nervousness; headache, dizziness; nausea, abdominal pain; acne; breast pain & tenderness, amenorrhea, dysmenorrhea, premenstrual syndrome; increased wt.

ALT elevations w/ ombitasvir/paritaprevir/ritonavir & dasabuvir w/ or w/o ribavirin; glecaprevir/pibrentasvir; sofosbuvir/velpatasvir/voxilaprevir. Increased clearance w/ drugs inducing microsomal enzymes. Diminished efficacy by barbiturates, bosentan, carbamazepine, phenytoin, primidone, rifampicin, ritonavir, nevirapine, efavirenz, felbamate, griseofulvin, oxcarbazepine, topiramate, rifabutin, St. John's wort-containing products. Increased/decreased plasma conc w/ HIV PIs, NNRTIs, HCV inhibitors. Increased serum conc w/ strong (eg, ketoconazole, itraconazole, clarithromycin) or moderate (eg, fluconazole, diltiazem, erythromycin) CYP3A4 inhibitors. Increased plasma conc w/ etoricoxib. Inhibited metabolism of ciclosporin. Induced metabolism of lamotrigine. Increased plasma conc of theophylline. Enhanced BP-lowering effect of tizanidine. Reduction of free thyroxine & increased TSH w/ l-thyroxine. Interference w/ lab tests results.

Oral Contraceptives

G03AA09 - desogestrel and ethinylestradiol ; Belongs to the class of progestogens and estrogens in fixed combinations. Used as systemic contraceptives.

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