Slinda

Drospirenone

OC.

1 tab daily for 28 consecutive days taken at the same time of the day. 1 white active tab daily during the 1st 24 days & 1 green inactive tab daily during the following 4 days. Take the 1st tab on 1st day of menstrual bleeding. Following 1st-trimester abortion Take tab immediately after abortion took place. Following delivery or 2nd-trimester abortion Start between 21 & 28 days after delivery or 2nd trimester abortion. Changing from combined OC, vag ring or transdermal patch Start on the day after the last active tab of previous combined OC or on the day of removal of vag ring or transdermal patch. Patient may also start at the latest on the day following the usual tab-free, ring-free, patch-free or placebo tab interval of previous combined hormonal contraceptive. It is recommended to take an additional barrier method during the 1st 7 days. Changing from progestogen-only pill (POP), inj, implant or progestogen-releasing intrauterine system May switch any day from other POP & start Slinda the day after, within 24 hr of discontinuing previous POP.

May be taken with or without food: Take at approx the same time each day.

Hypersensitivity. Active venous thromboembolic disorder. Known or suspected sex-steroid sensitive malignancies. Undiagnosed vag bleeding. Presence or history of severe hepatic disease as long as liver function values have not returned to normal. Severe renal insufficiency or acute renal failure.

Discontinue treatment if there are symptoms of arterial or venous thrombotic event or suspicion; jaundice develops; acute or chronic disturbances of liver function occur. Consider discontinuation in case of prolonged immobilization due to surgery or illness if sustained HTN develops or BP increase does not respond to antihypertensive therapy. Not for protection against HIV infections (AIDS) & other STD. Risk of CV & cerebral events in women w/ increasing age, HTN & smoking. Increased risk of stroke in women w/ HTN. Slightly increased risk of VTE (DVT, pulmonary embolism); breast cancer. Loss of bone mineral density. Chloasma especially in women w/ history of chloasma gravidarum. Depression. Disruption of menstrual bleeding pattern. Patients w/ personal or family history of VTE, obesity, prolonged immobilization, major surgery or trauma. Reduced efficacy in case of missed tab, GI disturbances or concomitant medication. Check serum K levels during 1st treatment cycle in women presenting w/ renal insufficiency & pre-treatment serum K in the upper reference range, & during concomitant use of K sparing medicinal products. Consider in the differential diagnosis hepatic tumor when severe upper abdominal pain, liver enlargement or intra-abdominal hemorrhage occur; ectopic pregnancy if patient presents amenorrhoea or abdominal pain. Carefully observe diabetic patients during 1st mth of use; diabetic patient w/ vascular involvement. Perform complete medical including family history & rule out pregnancy prior to initiation or reinstitution of treatment. Measure BP & perform physical exam. Consider another contraceptive method if bleeding is very frequent & irregular. May influence lab test results eg, biochemical parameters of liver, thyroid, adrenal & renal function, serum levels of (carrier) proteins eg, corticosteroid binding globulin & lipid/lipoprotein fractions, parameters of carbohydrate metabolism, coagulation & fibrinolysis. Not to be taken by patients w/ rare hereditary problems of galactose intolerance, lactase deficiency or glucose-galactose malabsorption. Hepatic impairment. Discontinue treatment if pregnancy occurs. Not indicated in pre-menarche adolescents.

Libido disorder, mood disturbances; headache; nausea, abdominal pain; acne; breast discomfort, metrorrhagia, vag haemorrhage, dysmenorrhea, irregular menstruation; increased wt.

Increased clearance w/ other medicinal products that induce microsomal enzymes; barbiturates, bosentan, carbamazepine, phenytoin, primidone, rifampicin, HIV medication (eg, ritonavir, nevirapine, efavirenz), & possibly felbamate, griseofulvin, oxcarbazepine, topiramate, St. John's Wort (Hypericum perforatum). Increased or decreased plasma conc w/ HIV PIs (eg, ritonavir, nelfinavir), NNRTIs (eg, nevirapine, efavirenz) &/or combinations with HCV medicinal products (eg, boceprevir, telaprevir). Increased plasma conc w/ strong or moderate CYP3A4 inhibitors eg, azole antifungals (eg, fluconazole, itraconazole, ketoconazole, voriconazole), verapamil, macrolides (eg, clarithromycin, erythromycin), diltiazem & grapefruit juice. May increase plasma conc of cyclosporine. May decrease plasma conc of lamotrigine.

Oral Contraceptives

G03AC10 - drospirenone ; Belongs to the class of progestogens. Used as systemic contraceptives.

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