Concise Prescribing Info
Dosage/Direction for Use
1 tab daily for 28 consecutive days taken at the same time of the day. 1 white active tab daily during the first 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 a combined hormonal contraceptive, vag ring or transdermal patch Start on the day after the last active tab of previous combined oral contraceptive or on the day of removal of her 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 first 7 days. Changing from a progestogen-only-method pill (POP), inj, implant or from a progestogen-releasing intrauterine system May switch any day from other POP & start Slinda the day after, within 24 hr or discontinuing previous POP.
May be taken with or without food: Take at approx the same time each day.
Hypersensitivity. Active venous thromboembolic disorder. 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. Known or suspected sex-steroid sensitive malignancies. Undiagnosed vag bleeding.
Special Precautions
Discontinue in case of prolonged immobilization due to surgery or illness if jaundice, sustained HTN develops; acute & chronic disturbances of liver function occur. Risk of CV & cerebral events in women w/ increasing age, HTN & smoking. Increased risk of stroke in women w/ HTN. Slightly increased risk of venous thromboembolism (DVT, pulmonary embolism). Discontinue treatment in symptoms or suspicion of arterial or venous thrombotic event. 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. May affect bone mineral density. Increased risk of breast cancer. Consider hepatic tumour in cases of severe upper abdominal pain, liver enlargement or signs of intra-abdominal haemorrhage. Ectopic pregnancy. Carefully observe diabetic patients during the 1st mth of use. Women w/ a history of chloasma gravidarum. Avoid exposure to the sun or UV radiation during treatment in women w/ a tendency to chloasma. Mood changes & depressive symptoms. Not to be taken by patients w/ rare hereditary problems of galactose intolerance, lactase deficiency or glucose-galactose malabsorption. Perform complete medical history & rule out pregnancy prior to initiation or reinstitution of treatment. Measure BP & perform physical exam. May disrupt menstrual bleeding pattern. Consider another contraceptive method if bleeding is very frequent & irregular. May influence results of certain laboratory tests eg, parameters of liver, thyroid, adrenal & renal function, carbohydrate metabolism, & coagulation & fibrinolysis, serum levels of (carrier) proteins. Discontinue treatment if pregnancy occurs. Lactation. Pre-menarche adolescents.
Adverse Reactions
Libido disorder, mood disturbances; headache; nausea, abdominal pain; acne; breast discomfort, metrorrhagia, vag haemorrhage, dysmenorrhea, irregular menstruation; increased wt.
Drug Interactions
Concomitant use w/ drugs that induce microsomal enzymes. Increased clearance w/ 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.
MIMS Class
ATC Classification
G03AC10 - drospirenone ; Belongs to the class of progestogens. Used as systemic contraceptives.
Slinda film-coated tab 4 mg
1 × 28's
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