Estelle-35

21 yellow tab each containing Ethinylestradiol 0.035 mg, cyproterone acetate 2 mg

Androgen-dependent diseases in women eg, moderate to severe acne & mild forms of hirsutism.

Starting on the 1st day of menstrual bleeding, take 1 tab at around the same time daily for 21 consecutive days, in order directed on the package.

May be taken with or without food.

Hypersensitivity. Concomitant use w/ another hormonal contraceptive. Presence or history of venous or arterial thrombotic/thromboembolic events (eg, DVT, pulmonary embolism, MI) or of a CVA; prodromi of a thrombosis (eg, transient ischaemic attack, angina pectoris), CVA; liver tumours (benign or malignant). History of migraine w/ focal neurological symptoms. DM w/ vascular symptoms, severe HTN & dyslipoproteinaemia. Hereditary or acquired predisposition for venous or arterial thrombosis, eg, activated protein C resistance, antithrombin-III-deficiency, protein C & S deficiency, hyperhomocystinaemia & antiphospholipid-Ab (anticardiolipin-Ab, lupus anticoagulant). Known or suspected sex-steroid influenced malignancies (eg, of genital organs or breasts). Undiagnosed vag bleeding. Severe hepatic disease. Known or suspected pregnancy & lactation. Jaundice or persistent itching during a previous pregnancy, Dubin Johnson syndrome. Rotor syndrome, sickle cell anaemia, existing or treated breast or endometrial cancer, disturbances of lipometabolism, a history of herpes of pregnancy, otosclerosis w/ deterioration during pregnancy. Not for use in men.

Not to be prescribed for contraception alone. Increased risk of arterial & venous thrombotic & thromboembolic diseases eg, MI, DVT, pulmonary embolism & CVA. Conditions associated w/ adverse circulatory events ie, DM, SLE, hemolytic uremic syndrome, chronic inflammatory bowel disease (Crohn's disease or ulcerative colitis) & sickle cell disease. Discontinue use if frequency or severity of migraine increases; in case of suspected thrombosis. Persistent HPV infection (most important risk factor for cervical cancer). Increased risk of pancreatitis in women w/ or history of hypertriglyceridemia. W/draw & treat HTN if sustained clinically significant HTN develops during therapy. Hereditary angioedema exogenous estrogens. Discontinue use if acute or chronic hepatic disturbance or recurrence of cholestatic jaundice (w/ 1st occurrence during pregnancy or previous sex steroid use) occurs. Chloasma may occur. Clarify the cause by a differential diagnosis, in case of hirsutism symptoms which have recently developed or increased substantially. Complete medical history & physical exam should be taken prior to initiation or reinstitution of therapy, & repeated periodically. Not for protection against HIV infection (AIDS) & other STD. Irregular bleeding may occur especially during the 1st mth of use. Renal impairment. Indicated only after menarche in childn & adolescents. Not indicated after menopause.

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

Concomitant use w/ microsomal-enzyme inducing drugs may lead to breakthrough bleeding &/or contraceptive failure. Reduced efficacy w/ enzyme-inducing antimicrobials ie, rifampicin & griseofulvin. Increased clearance w/ phenytoin, barbiturates, primidone, carbamazepine; possibly, oxcarbazepine, topiramate, felbamate & products containing St. John's wort. Potentially, plasma conc may be increased or decreased by HIV/HCV PIs & non-nucleoside reverse transcriptase inhibitors. May increase plasma & tissue conc of cyclosporins. May decrease plasma & tissue conc of lamotrigine.

Combined Sex Hormones / Acne Treatment Preparations

G03HB01 - cyproterone and estrogen ; Belongs to the class of antiandrogen preparations in combination with estrogens. Used to counter androgenic activities.

POM