Jastinda

Drospirenone 3 mg, ethinylestradiol 0.02 mg

OC.

1 tab daily for 28 consecutive days. Each subsequent pack is started the day after the last tab of previous pack. No preceding hormonal contraceptive use (in the past mth) Start on the 1st day of menstrual bleeding. Changing from a combined hormonal contraceptive [combined OC (COC), vag ring or transdermal patch] Start preferably on the day after the last active tab of the previous COC, but at the latest on the day following the usual tab-free or placebo tab interval of the previous COC. In case of a vag ring or transdermal patch has been used, start preferably on the day of removal, but at the latest when the next application would have been due. Changing from a progestogen-only-method (progestogen-only pill, inj, implant) or progestogen-releasing intrauterine system May switch any day from the progesterone-only pill. Following 1st-trimester abortion May start immediately. Following delivery or 2nd-trimester abortion Start at day 21-28 after delivery or 2nd-trimester abortion.

May be taken with or without food.

Hypersensitivity. Presence or risk of VTE; current VTE (on anticoagulants), history of DVT or pulmonary embolism; known hereditary or acquired predisposition for VTE [eg, APC-resistance (including Factor V Leiden), antithrombin-III, protein C or protein S deficiency]; major surgery w/ prolonged immobilization. Presence or risk of arterial thromboembolism (ATE); current or history of ATE (eg, MI) or prodromal condition (eg, angina pectoris); current or history of stroke or prodromal condition (eg, transient ischaemic attack); known hereditary or acquired predisposition for ATE (eg, hyperhomocysteinaemia & antiphospholipid-Abs); history of migraine w/ focal neurological symptoms; DM w/ vascular symptoms, severe HTN or dyslipoproteinaemia. Presence or history of liver tumours (benign or malignant). Known or suspected sex-steroid influenced malignancies (eg, of the genital organs or breasts). Undiagnosed vag bleeding. Hepatic & renal impairment. Pregnancy; cholestatic jaundice of pregnancy or jaundice w/ prior pill use.

Increased risk of arterial & venous thrombotic & thromboembolic diseases (eg, MI, stroke, DVT, pulmonary embolism & CVA) w/ age, smoking (especially in women >35 yr), +ve family history, obesity, dyslipoproteinemia, HTN, migraine, valvular heart disease, atrial fibrillation, prolonged immobilization, major or any surgery to the legs or major trauma. Discontinue use in case of suspected or confirmed thrombosis. Consider increased risk of thromboembolism in the puerperium. DM, SLE, hemolytic uremic syndrome, chronic inflammatory bowel disease (Crohn's disease or ulcerative colitis) & sickle cell disease. Discontinue immediately if w/ increase in migraine frequency or severity; pre-existing HTN, constantly elevated or significant increase in BP not responsive to antihypertensives; recurrence of cholestatic jaundice &/or cholestasis-related pruritus. Risk of cervical cancer; breast cancer; benign or malignant liver tumours. Increased risk of pancreatitis in women w/ or family history of hypertriglyceridemia. May induce or exacerbate angioedema symptoms in women w/ hereditary angioedema. Acute or chronic disturbances of liver function. Carefully observed diabetic women. Worsening of endogenous depression, epilepsy, Crohn's disease & ulcerative colitis. Avoid exposure to sun or UV radiation in women w/ tendency to chloasma. Mood changes & depressive symptoms including shortly after treatment initiation. Patients w/ rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption. Complete medical history & physical examination should be taken prior to initiation or reinstitution of treatment & repeated periodically. Do not protect against HIV infections (AIDS) & other STD. Reduced efficacy in events of missed active tab, GI disturbances during active tab taking or concomitant medication. Irregular bleeding (spotting or breakthrough bleeding) may occur. Lactation; not recommended until breast-feeding mother has completely weaned her child. Drospirenone: May slightly increase serum K levels in patients w/ mild or moderate renal impairment & concomitant use of K-sparing medicinal products.

Emotional lability, depression/depressive mood; migraine; nausea; breast pain, unscheduled uterine bleeding, genital tract bleeding.

Increased clearance of sex hormones w/ hepatic enzymes inducers [eg, phenytoin, barbiturates, primidone, carbamazepine, rifampicin, bosentan, HIV-medication (eg, ritonavir, nevirapine), oxcarbazepine, topiramate, felbamate, griseofulvin & St. John's Wort]. Enterohepatic circulation interference w/ antibiotics (eg, penicillins & tetracyclines). May increase plasma & tissue conc of ciclosporin. May decrease plasma & tissue conc of lamotrigine. Potential increase in serum K w/ AIIA, K-sparing diuretics & aldosterone antagonists. May influence certain lab test results including biochemical parameters of liver, thyroid, adrenal & renal function; plasma levels of carrier proteins (eg, corticosteroid-binding globulin & lipid/lipoprotein fractions); parameters of carbohydrate metabolism, coagulation & fibrinolysis. Drospirenone: Increased plasma renin activity & plasma aldosterone.

Oral Contraceptives

G03AA12 - drospirenone and ethinylestradiol ; Belongs to the class of progestogens and estrogens in fixed combinations. Used as systemic contraceptives.

POM