Slinda

24 white active FC tab each containing Drospirenone 4 mg, 4 green placebo FC tab

Hormonal contraceptive.

1 tab daily taken at the same time of the day for 28 consecutive days (1 white active tab daily during the 1st 24 days & 1 green placebo tab daily during the 4 following days). Take the 1st tab on the 1st day of menstrual bleeding. Continuously take tab, start a new pack immediately w/o a break in daily tab intake. No preceding hormonal contraceptive use (in the past mth) Start on the 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 if contraceptive treatment is initiated later but before the menstruations have returned. Changing from a combined hormonal contraceptive (combined OC, vag ring or transdermal patch) Start on the day after the last active tab of the previously combined OC or on the day of removal of the 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 the previous combined hormonal contraceptive, but during the 1st 7 days of tab taking an additional barrier method is recommended. Changing from a progesterone-only-method (progesterone-only pill (POP), inj, implant) or from a progesterone-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/grapefruit juice.

Hypersensitivity. Active venous thromboembolic disorder, adrenal insufficiency, undiagnosed vag bleeding. Known or suspected sex-steroid sensitive malignancies. 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.

Hyperkalemia. Check serum K levels during the 1st treatment cycle in women w/ renal insufficiency & pre-treatment serum K in upper reference range & during concomitant use of K-sparing drugs. Risk of CV & cerebral events in women w/ increasing age, HTN & smoking. Risk of stroke in women w/ HTN. Discontinue treatment if symptoms of arterial or venous thromboembolic event or suspicion occurs. May affect bone mineral density. Increased risk of developing breast cancer. Consider hepatic tumour in differential diagnosis when severe upper abdominal pain, liver enlargement or signs of intra-abdominal haemorrhage occur. Ectopic pregnancy. Discontinue if jaundice develops. Carefully observe diabetic patients during the 1st mth of use. Discontinue if sustained HTN develops during use, or if a significant increase in BP does not adequately respond to antihypertensive therapy. Women w/ history of chloasma gravidarum. Avoid exposure to the sun or UV radiation in women w/ tendency to chloasma. Mood changes & depressive symptoms. Perform complete medical history & rule out pregnancy prior to initiation or reinstitution of treatment. Do not protect against HIV infections (AIDS) or any other STD. Disruption of menstrual bleeding. Discontinue treatment if pregnancy occurs. Reduced efficacy in the event of missed tab, GI disturbances or concomitant medication. May influence results of certain lab test including biochemical parameters of liver, thyroid, adrenal & renal function, serum levels of proteins, parameters of carbohydrate metabolism, & parameters of coagulation & fibrinolysis. Do not use in patients w/ rare hereditary problems of galactose intolerance, lactase deficiency or glucose-galactose malabsorption. Do not use during pregnancy. Childn & 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.

Rx