Belara

Hormonal contraception.

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

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

Hypersensitivity. Uncontrolled DM & HTN or significant BP increase; presence or risk of VTE & arterial thromboembolism (ATE); known hereditary or acquired predisposition for VTE & ATE; major surgery w/ prolonged immobilisation; cerebrovascular disease, current or history of stroke or prodromal 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, cholestasis; Dubin-Johnson & Rotor syndrome, bile-flow disorders; meningioma or history of meningioma; 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-/sofosbuvir-/velpatasvir-/voxilaprevir-containing medicinal products. Hepatitis, jaundice, hepatic function disorders.

Discontinue use if meningioma is diagnosed or a significant BP increase. Not for protection against HIV infections & other STDs. Not to be used after menopause. 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. Benign or malignant liver tumours; depression, history of herpes gestationis & familial hypertriglyceridemia; epilepsy, multiple sclerosis, tetany, asthma, cardiac insufficiency, chorea minor, endometriosis, varicosis, phlebitis, blood coagulation disorders, mastopathy, uterine myoma; breakthrough bleeding & spotting. May induce or exacerbate symptoms of hereditary & acquired angioedema. History of chloasma gravidarum; avoid exposure to sun or UV radiation. Perform physical & medical exam including BP measurement. Not to be taken by patients w/ galactose intolerance, total lactase deficiency or glucose-galactose malabsorption. Not to be taken w/ St. John's wort-containing herbal prep. Acute or chronic hepatic function disturbances. Renal insufficiency. Not recommended 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.

ALT elevations w/ ombitasvir/paritaprevir/ritonavir & dasabuvir w/ or w/o ribavirin; glecaprevir/pibrentasvir or sofosbuvir/velpatasvir/voxilaprevir. 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-containing herbal products. Reduced serum conc by metoclopramide, activated charcoal. Increased/decreased plasma conc w/ HIV PIs, NNRTIs, HCV inhibitors. Increased serum conc w/ ascorbic acid, paracetamol, atorvastatin, fluconazole, indinavir, troleandomycin. Raised serum conc of diazepam, ciclosporin, theophylline, prednisolone. Reduced serum conc of lamotrigine, clofibrate, paracetamol, morphine, lorazepam. Altered insulin or oral antidiabetic requirements. Interference w/ lab tests results.

Oral Contraceptives

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

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