Mercilon

Desogestrel 0.15 mg, ethinylestradiol 0.02 mg

Contraception.

1 tab daily for 21 consecutive days. Each subsequent strip is started after a 7-day tab-free interval.

May be taken with or without food.

Hypersensitivity. Presence or risk of VTE; arterial thromboembolism. Presence or history of pancreatitis associated w/ severe hypertriglyceridaemia; severe hepatic disease as long as liver function values have not returned to normal; liver tumours (benign or malignant). Known or suspected sex steroid-influenced malignancies. Endometrial hyperplasia. Undiagnosed vag bleeding. Concomitant use w/ medicinal products containing ombitasvir/paritaprevir/ritonavir & dasabuvir.

Increased risk of VTE; arterial thromboembolism (MI); CVA (eg, transient ischaemic attack, stroke). Risk of developing cervical cancer in HPV-infected women during long-term use. Slightly increased relative risk of developing breast cancer. Rare reports of benign & malignant liver tumours. ALT elevations in HCV patients treated w/ medicinal products containing ombitasvir/paritaprevir/ritonavir & dasabuvir, w/ or w/o ribavirin. Increased risk of pancreatitis in women w/ hypertriglyceridaemia or family history thereof. Reports of small increases in BP. Consider discontinuation in case of acute or chronic disturbances of liver function until markers return to normal. Monitor diabetic women during use. Associated w/ Crohn's disease & ulcerative colitis. Chloasma may occasionally occur, especially in women w/ history of chloasma gravidarum; avoid exposure to sun or UV radiation during use. Risk of depressed mood & depression. Perform complete medical history (including family history) & rule out pregnancy prior to initiation or reinstitution of Mercilon. Advise women that hormonal contraceptives do not protect against HIV infections (AIDS) & other sexually transmissible diseases. Irregular bleeding (spotting or breakthrough) may occur, especially during the 1st mth of use. Reduced efficacy in case of missed tab, GI disturbances, concomitant medications that decrease plasma conc of ethinylestradiol &/or etonogestrel. Do not use w/ herbal prep containing St. John's wort. Rare hereditary problems of galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption. May influence results of certain lab tests, including biochemical parameters of liver, thyroid, adrenal & renal function, plasma levels of (carrier) proteins, eg, corticosteroid-binding globulin, lipid/lipoprotein fractions & parameters of carbohydrate metabolism, coagulation & fibrinolysis. Not indicated during pregnancy. Consider increased risk of VTE during postpartum period when restarting Mercilon. Not recommended until nursing mother has completely weaned her child. Safety & efficacy in adolescents <18 yr have not been studied.

Depressed & altered mood; headache; nausea, abdominal pain; breast pain & tenderness; increased wt.

Increased clearance w/ phenytoin, phenobarb, primidone, bosentan, carbamazepine, rifampicin, some HIV PIs (eg, ritonavir) & NNRTIs (eg, efavirenz, nevirapine), & possibly oxcarbazepine, topiramate, rifabutin, felbamate, griseofulvin, St. John's wort. Increased/decreased plasma conc w/ combinations of HIV PIs (eg, nelfinavir) & NNRTIs (eg, nevirapine), &/or combinations w/ HCV medicinal products (eg, boceprevir, telaprevir). Increased serum conc w/ strong (eg, ketoconazole, itraconazole, clarithromycin) or moderate (eg, fluconazole, diltiazem, erythromycin) CYP3A4 inhibitors. Increased plasma conc of ethinylestradiol w/ etoricoxib. Increased plasma & tissue conc of ciclosporin. Decreased plasma & tissue conc of lamotrigine. Weak increases in plasma conc of theophylline. Moderate increases in plasma conc of tizanidine.

Oral Contraceptives

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

NP