
Please review Product Information before prescribing.
The Product Information can be accessed at besins-healthcare.com.au/PI or telephone 1800 BESINS (237 467).
Minimum Product Information Slinda (drospirenone 4 mg) Indication: Contraception Contraindications: active venous thromboembolic disorder; presence or history of severe hepatic disease with abnormal liver function values; severe renal insufficiency or acute renal failure; known or suspected sex-steroid sensitive malignancies; undiagnosed vaginal bleeding; hypersensitivity to active substance or any excipients. Clinically significant precautions: a complete medical history should be taken and pregnancy excluded, patients should be counselled that contraceptives do not protect against HIV or STIs; efficacy can be reduced with missed pills and gastrointestinal disturbances; hyperkalaemia (monitor serum potassium levels in patients presenting with renal insufficiency and pre-treatment potassium in upper reference range); risk of stroke and VTE may be slightly increased with progestogen-only preparations; discontinue Slinda with pregnancy, symptoms of thrombosis, jaundice, sustained hypertension; consider discontinuation with prolonged immobilisation; decreased estradiol levels may affect bone metabolism; breast cancer risk may be similar to that associated with COC use; rare cases of liver tumours with hormonal contraceptive use; new amenorrhea or abdominal pain may indicate ectopic pregnancy; monitor for altered insulin and glucose tolerance in diabetic patients, mood and depressive symptoms; changes in menstrual bleeding and chloasma may occur. Clinically significant interactions: enzyme-inducing drugs can lead to contraceptive failure and/or breakthrough bleeding, patients on long-term treatment are advised not to use Slinda; certain medications increase clearance of contraceptive hormones (e.g. barbiturates, bosentan, carbamazepine, phenytoin, rifampicin); HIV/HCV medications can alter progestin concentrations; CYP3A4 enzyme inhibitors such as azole antifungals, verapamil, macrolides, diltiazem and grapefruit juice can increase plasma progestogen concentrations; Slinda may affect cytochrome P450 metabolism of other active substances (e.g. cyclosporine, lamotrigine); monitor for hyperkalaemia with use of potassium-sparing medicines. Very common and common adverse effects: acne, changes in menstrual bleeding (metrorrhagia, vaginal haemorrhage, dysmenorrhea, menstruation irregular), headache, breast pain, libido and mood changes, nausea, abdominal pain, weight increased (see full PI). Dosage and method of use: tablets must be taken orally the same time each day without a break in daily tablet intake; 7 days of uninterrupted tablet intake is required to attain adequate contraception; contraceptive protection is not reduced if a patient is less than 24 hours late in tablet intake; management of missed tablets (more than 24 hours late) is dependent on stage of menstrual cycle (see full PI); consider additional contraceptive measures with gastrointestinal disturbances.
Slinda® is a registered trademark of Chemo Research S.L. Besins Healthcare Australia Pty Ltd. ABN 68 164 882 062. Suite 5.02, 12 Help St, Chatswood, NSW 2067. For medical information call 1800 BESINS (237 467). www.besins-healthcare.com.au