Belara

Ethinylestradiol 0.03 mg, chlormadinone acetate 2 mg

Hormonal contraception.

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

May be taken with or without food: Take at the same every day, preferably in the evening.

Hypersensitivity. Uncontrolled DM, uncontrolled HTN or significant increase in BP; 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 or prodomal condition eg, transient ischaemic attack; history of migraine w/ focal neurological symptoms; multiple risk factors for VTE or ATE eg, DM w/ vascular symptoms, severe HTN & dyslipoproteinaemia; generalised pruritus, cholestatis. Dubin-Johnson & Rotor syndrome; bile-flow disorders; history or existing liver tumours; severe epigastric pain or lipid metabolism disorders; liver enlargement or intra-abdominal haemorrhage symptoms; porphyria; presence or history of malignant hormone-sensitive tumours; pancreatitis associated w/ severe hypertriglyceridemia; 1st time symptoms of migraine; acute visual or hearing disorder; motor disorders; increase in epileptic seizures; severe depression; otosclerosis; unexplained amenorrhea or genital bleeding; endometrial hyperplasia. Concomitant use w/ ombitasvir-/paritaprevir-/ritonavir-/dasubuvir-/ glecaprevir-/pibrentasvir-containing medicinal products. Hepatitis, jaundice, hepatic function disorders.

Not for protection against HIV infections & other STD. Not to be used after menopause. Increased risk of venous or arterial thromboembolic diseases; +ve family history of venous or arterial thromboembolism, obesity (BMI >30 kg/m²), increasing age (>35 yr), smoking, cancer, SLE, haemolytic uraemic syndrome, Crohn's disease or ulcerative colitis, sickle cell disease; HTN, migraine, DM, hyperhomocysteinaemia, valvular heart disease, atrial fibrillation, dyslipoproteinaemia; benign or malignant liver tumours. History of herpes gestationis. Hypertriglyceridaemia, pancreatitis. Epilepsy, multiple sclerosis, tetany, asthma, cardiac insufficiency, chorea minor, endometriosis, varicosis, phlebitis, blood coagulation disorders, mastopathy, uterine myoma, depression. Breakthrough bleeding & spotting. Prolonged immobilisation, major surgery or trauma, any leg or pelvis surgery. Chloasma; avoid exposure to sun or UV radiation. Perform physical & medical exam including BP measurement. Not to be taken w/ St. John's wort. Concomitant use of ombitasvir/paritaprevir/ritonavir & dasabuvir w/ or w/o ribavirin. Not to be taken by patients w/ galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. Acute or chronic hepatic function disturbances. Renal insufficiency. Not indicated during pregnancy. Not to be used during lactation. Adolescents <16 yr.

Nausea; vag discharge, dysmenorrhoea, amenorrhoea. Depressed mood, nervousness, irritability; dizziness, migraine; visual disturbance; vomiting; acne; heaviness sensation; lower abdominal pain; fatigue, oedema, increased wt; increased BP.

Increased risk of ALT elevations w/ ombitasvir/paritaprevir/ritonavir & dasabuvir w/ or w/o ribavirin. Increased clearance w/ drugs inducing microsomal enzymes. Diminished efficacy by barbiturates, bosentan, carbamazepine, barbexaclone, phenytoin, primidone, modafinil, rifampicin, rifabutin, ritonavir, nevirapine, efavirenz, felbamate, griseofulvin, oxcarbazepine, topiramate, St. John's wort. Reduced serum conc by metoclopramide, activated charcoal. Increased or decreased plasma conc w/ HIV PIs & NNRTIs. Increased serum conc w/ ascorbic acid, paracetamol, atorvastatin, fluconazole, indinavir or troleandomycin. Raised serum conc of diazepam, ciclosporin, theophylline, prednisolone. Reduced serum conc of lamotrigine, clofibrate, paracetamol, morphine, lorazepam. Altered insulin or oral antidiabetic requirements.

Oral Contraceptives

G03AA15 - chlormadinone and ethinylestradiol ; Belongs to the class of progestogens and estrogens in fixed combinations. Used as systemic contraceptives.

C