Microgynon 30

Microgynon 30

levonorgestrel + ethinylestradiol

Manufacturer:

Bayer

Distributor:

DKSH
Concise Prescribing Info
Contents
Levonorgestrel 0.15 mg, ethinylestradiol 0.03 mg
Dosage/Direction for Use
1 tab daily on the 1st day of menstrual bleeding for 21 consecutive days, followed by a 7-day tab-free interval.
Contraindications
Hypersensitivity. Presence or history of venous or arterial thrombotic/thromboembolic events (eg, DVT, pulmonary embolism, MI) or CVA, prodromi of a thrombosis (eg, transient ischaemic attack, angina pectoris), benign or malignant liver tumours; history of migraine w/ focal neurological symptoms, & herpes of pregnancy; DM w/ vascular involvement; high risk of venous or arterial thrombosis; known or suspected sex steroid-influenced malignancies eg, of the genital organs or breasts; undiagnosed vag bleeding; jaundice or persistent itching during a previous pregnancy; sickle cell anemia; disturbances of lipometabolism; history of herpes of pregnancy; otosclerosis w/ deterioration during pregnancy. Concomitant use w/ direct-acting antiviral (DAA) medicinal products containing ombitasvir, paritaprevir, or dasabuvir, & combinations of these. Severe hepatic disease. Known or suspected pregnancy.
Special Precautions
Discontinue use if acute or chronic disturbances of liver function occur. Increased risk of arterial & venous thrombotic & thromboembolic diseases (eg MI, DVT, pulmonary embolism) & CVA; VTE; cervical & breast cancer, benign & malignant liver tumours; pancreatitis in women w/ hypertriglyceridemia; HTN; jaundice &/or pruritus related to cholestasis; gallstone formation, porphyria, Sydenham's chorea, herpes gestationis, otosclerosis-related hearing loss. May induce or exacerbate symptoms of angioedema in women w/ hereditary angioedema. Irregular bleeding may occur. DM, SLE, hemolytic uremic syndrome, Crohn's disease or ulcerative colitis, sickle cell disease. May reduce efficacy w/ missed doses, GI disturbances or concomitant medication. Avoid sun or UV exposure in women w/ a tendency to chloasma. May influence the results of certain laboratory tests. Renal impairment. Not recommended during lactation.
Adverse Reactions
Nausea, abdominal pain; increased wt; headache; depressed & altered mood; breast pain & tenderness.
Drug Interactions
Breakthrough bleeding &/or contraceptive failure w/ microsomal enzyme inducers. Reduced efficacy w/ rifampicin & griseofulvin. Diminished efficacy w/ phenytoin, barbiturates, primidone, carbamazepine, rifampicin, oxcarbazepine, topiramate, felbamate, griseofulvin & St. John's wort. Increased or decreased plasma conc of estrogen or progestin w/ HIV/HCV PIs & NNRTIs. May increase plasma conc of cyclosporin. May decrease plasma conc of lamotrigine.
MIMS Class
Oral Contraceptives
ATC Classification
G03AA - Progestogens and estrogens, fixed combinations ; Used as systemic contraceptives.
Presentation/Packing
Form
Microgynon 30 coated tab
Packing/Price
21's
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