Belara

Belara

Manufacturer:

Gedeon Richter

Distributor:

Pahang Pharmacy
Concise Prescribing Info
Contents
Ethinylestradiol 0.03 mg, chlormadinone acetate 2 mg
Indications/Uses
Dosage/Direction for Use
1 tab daily on the 1st day of menstruation for 21 consecutive days followed by 7 tab-free days.
Administration
May be taken with or without food: Take at the same every day, preferably in the evening.
Contraindications
Hypersensitivity. Loss of control of DM, uncontrolled HTN or significant increase in BP, generalised pruritus, cholestatis. Presence or risk of venous or arterial thromboembolism. 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 & dasabuvir. Hepatitis, jaundice, hepatic function disorders.
Special Precautions
Not for protection against HIV infections & other STD. Increased risk of venous or arterial thromboembolic diseases; positive family history of venous or arterial thromboembolism, obesity, 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; chloasma. Epilepsy, multiple sclerosis, tetany, asthma, cardiac insufficiency, chorea minor, endometriosis, varicosis, phlebitis, blood coagulation disorders, mastopathy, uterine myoma, depression. Irregular vag bleeding. Prolonged immobilisation, major surgery or trauma, any leg or pelvis surgery. Perform medical exam including BP measurement, breast, abdomen, internal & external genital organs exam, cervical smear & appropriate laboratory tests prior to therapy. Concomitant use of St. John's wort, ombitasvir/paritaprevir/ritonavir & dasabuvir w/ or w/o ribavirin. 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.
Adverse Reactions
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.
Drug Interactions
Increased risk of ALT elevatons 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.
MIMS Class
ATC Classification
G03AA15 - chlormadinone and ethinylestradiol ; Belongs to the class of progestogens and estrogens in fixed combinations. Used as systemic contraceptives.
Presentation/Packing
Form
Belara FC tab
Packing/Price
1 × 21's;3 × 21's
Register or sign in to continue
Asia's one-stop resource for medical news, clinical reference and education
Sign up for free
Already a member? Sign in