Zinnia P

OC & recognised gynaecological indications.

1st treatment cycle: 1 tab daily starting on 1st day of menstrual cycle for 28 days (take 21 active tab followed by 7 inert tab). Subsequent cycle: Immediately start next pack w/o break.

Hypersensitivity. Presence or risk of VTE: current VTE (on anticoagulants) or history thereof (eg, DVT or pulmonary embolism); known hereditary or acquired predisposition for VTE eg, APC-resistance (including Factor V Leiden), antithrombin-III, proteins C & S deficiency; major surgery w/ prolonged immobilisation; multiple risk factors. Presence or risk of arterial thromboembolism (ATE): current ATE, history of ATE (eg, MI) or prodromal condition (eg, angina pectoris); cerebrovascular disease eg, current stroke, history of stroke or prodromal condition (eg, transient ischaemic attack); known hereditary or acquired predisposition for ATE eg, hyperhomocysteinaemia & anti-phospholipid Abs (anticardiolipin-Abs, lupus anticoagulant); history of migraine w/ focal neurological symptoms; multiple risk factors or 1 serious risk factor eg, DM w/ vascular symptoms, severe HTN & dyslipoproteinaemia. Current or history of breast cancer. Presence or history of severe hepatic disease eg, active viral hepatitis & severe cirrhosis; liver tumours (benign or malignant). Concomitant use w/ medicinal products containing ombitasvir/paritaprevir/ritonavir, dasabuvir, glecaprevir/pibrentasvir & ofosbuvir/velpatasvir/voxilaprevir.

Discontinue use in case of 1st time occurrence or exacerbation of migraines or unusually frequent or severe headaches; sudden vision or hearing disturbances or other perceptual disorders; 1st signs of thrombosis or blood clots & feeling of chest pain & tightness; at least 4 wk prior to elective major operation (eg, abdominal, orthopaedic), any surgery to the legs, medical treatment for varicose veins or prolonged immobilisation (eg, after accidents or surgery); onset of jaundice, hepatitis, itching of whole body; significant rise in BP; severe upper abdominal pain or liver enlargement; clear exacerbation of conditions deteriorating during OC or pregnancy (eg, potential increase in risk of gallstone formation & worsening of existing disease; SLE; herpes gestationis; otosclerosis-related hearing loss; sickle cell anaemia; renal dysfunction; hereditary angioedema). Increased risk of VTE & ATE. Take complete medical including family history & rule out pregnancy prior to initiation or reinstitution of treatment. Measure BP & perform physical exam. Not for protection against HIV infections (AIDS) & other STDs. Investigate for undiagnosed vag bleeding suspicious for underlying conditions. Conditions requiring strict medical supervision eg, DM w/ mild vascular disease, nephropathy, retinopathy or neuropathy; adequately controlled HTN; porphyria; obesity; migraine; CV diseases. Risks of ovarian, endometrial, cervical, breast & liver cancer. Certain chronic diseases may deteriorate during treatment. Increased risk of pancreatitis in women w/ hypertriglyceridemia or a family history thereof. Increased risk of arterial disease in women w/ hyperlipidemia; diabetics May induce or exacerbate symptoms of hereditary & acquired angioedema. Acute or chronic disturbances of liver function. Depressed mood & depression. Chloasma may occur. Avoid sun or UV radiation exposure. Menstrual changes eg, reduced menstrual flow, missed menstruation & intermenstrual bleeding. Efficacy of COCs may be reduced in event of missed tab, vomiting or diarrhoea, or concomitant medication. Not to be taken by patients w/ galactose intolerance, Lapp lactase or sucrase-isomaltase deficiency, fructose intolerance or glucose-galactose malabsorption. Not indicated during pregnancy. Lactation.

Nausea, abdominal pain; increased wt; headache; depressed & altered mood; breast pain & tenderness.

Increased clearance & potential breakthrough bleeding &/or contraceptive failure w/ enzyme inducers eg, anticonvulsants [eg, barbiturates (including phenobarb), primidone, phenytoin, carbamazepine, oxcarbazepine, topiramate], antibiotics/antifungals (eg, griseofulvin, rifampicin), St. John's wort, antiretroviral agents (eg, ritonavir, nelfinavir, nevirapine). Increased plasma conc w/ strong & moderate CYP3A4 inhibitors eg, azole antifungals (eg, itraconazole, voriconazole, fluconazole) & macrolides (eg, erythromycin); etoricoxib. May increase plasma & tissue conc of cyclosporin, tizanidine, theophylline. May decrease plasma conc & tissue conc of lamotrigine. May increase risk of ALT elevations w/ medicinal products containing ombitasvir/paritaprevir/ritonavir, dasabuvir w/ or w/o ribavirin, glecaprevir/pibrentasvir & sofosbuvir/velpatasvir/voxilaprevir. May influence results of certain lab tests eg, 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.

Oral Contraceptives

G03AA07 - levonorgestrel and ethinylestradiol ; Belongs to the class of progestogens and estrogens in fixed combinations. Used as systemic contraceptives.

Rx