Slinda

OC.

1 tab daily for 28 consecutive days taken every day 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. Continuously take tab, & a subsequent pack should be started immediately after finishing the previous pack, w/o a break in daily tab intake. No preceding hormonal contraceptive use (in the past mth) Start on day 1 of the woman's natural cycle (1st day of menstrual bleeding). Following 1st-trimester abortion Start immediately after abortion took place. Following delivery or 2nd-trimester abortion Start between 21 & 28 days after delivery or 2nd trimester abortion. Rule out pregnancy & use additional method of contraception for the 1st wk if contraceptive treatment is initiated later but before the menstruations have returned. Changing from combined hormonal contraceptive [combined OC (COC)], vag ring or transdermal patch Start on the day after the last active tab of previous COC or on the day of removal of vag ring or transdermal patch. 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. Use of an additional barrier method is recommended during the 1st 7 days. Changing from progestogen-only-method [progestogen-only pill (POP), inj, implant] or progestogen-releasing intrauterine system (IUS) May switch any day from another POP & start Slinda the day after, w/in 24 hr of discontinuing the previous POP; may switch from an implant or following IUS removal on the same day that the implant or IUS is removed; may switch from using an injectable contraceptive & start Slinda on the day the next inj was due to occur.

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

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 during treatment or significant increase in BP does not adequately 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. Slightly enhanced risk of stroke in women w/ HTN. Slightly increased risk of VTE (DVT, pulmonary embolism); breast cancer. Loss of bone mineral density. Occasional chloasma may occur especially in women w/ history of chloasma gravidarum. Women should be advised to consult a physician in case of mood changes & depressive symptoms, including shortly after treatment initiation. 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 signs of 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. Avoid sun or UV radiation whilst on treatment in women w/ tendency to chloasma. 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 certain lab test results including 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. 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 of sex hormones & may lead to breakthrough bleeding &/or contraceptive failure w/ other medicinal products that induce microsomal enzymes. Increased clearance (diminished contraceptive efficacy by enzyme induction) w/ barbiturates, bosentan, carbamazepine, phenytoin, primidone, rifampicin, ritonavir, nevirapine & efavirenz; & possibly also felbamate, griseofulvin, oxcarbazepine, topiramate, & products containing herbal remedy St. John's wort (Hypericum perforatum). Increased or decreased plasma conc w/ HIV PIs (eg, ritonavir, nelfinavir), NNRTIs (eg, nevirapine, efavirenz) &/or combinations w/ HCV medicinal products (eg, boceprevir, telaprevir). Increased plasma conc w/ strong or moderate CYP3A4 inhibitors eg, azole antifungals (fluconazole, itraconazole, ketoconazole, voriconazole), verapamil, macrolides (clarithromycin, erythromycin), diltiazem & grapefruit juice. May increase plasma & tissue conc of cyclosporine. May decrease plasma & tissue conc of lamotrigine.

Oral Contraceptives

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

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