Diane-35

Treatment of moderate to severe acne due to androgen sensitivity (w/ or w/o seborrhoea) &/or hirsutism in women of childbearing age. Hormonal contraceptive for women requiring treatment for androgen-dependent conditions.

1 tab daily for 21 consecutive days. Start each subsequent pack after a 7-day tab-free interval.

May be taken with or without food.

Hypersensitivity. Concomitant use w/ another hormonal contraceptive; medicinal products containing ombitasvir/paritaprevir/ritonavir plus dasabuvir or medicinal products containing glecaprevir/pibrentasvir or sofosbuvir/velpatasvir/voxilaprevir. Existing or previous venous thrombosis (eg, DVT, pulmonary embolism). Personal or family medical history of known, idiopathic VTE. Existing or previous arterial thrombosis (eg, MI) or previous disorders (eg, angina pectoris, transient ischemic attack). Existing or previous CVA. Presence of severe or multiple risk factors for venous or arterial thrombosis eg, DM w/ vascular symptoms, severe HTN, severe dyslipoproteinaemia. Inherited or acquired predisposition for venous or arterial thrombosis eg, activated protein C resistance, antithrombin III deficiency, protein C deficiency, protein S deficiency, hyperhomocysteinaemia, antiphospholipid Abs (anticardiolipin Abs, lupus anticoagulant). Sickle cell anaemia. Undiagnosed vag bleeding. History of migraine w/ focal neurological symptoms. Known or suspected sex-steroid influenced malignancies (eg, of genital organs or breasts). Presence or history of meningioma. Presence or history of liver tumors (benign or malignant). Severe hepatic disorders (also disorders of the excretory system eg, Dubin-Johnson & Rotor syndrome) as long as liver function values have not returned to normal. History of idiopathic jaundice of pregnancy, severe pruritus of pregnancy or herpes gestationis, otosclerosis worsening in previous pregnancies. Pregnancy & lactation. Women w/ thrombophlebitis, thromboembolic disorders, or history of these conditions. Smokers. Not for use in men.

Should be used only after failure of topical therapy or systemic antibiotic treatments for acne therapy. Should not be used in women solely for contraception. May only be used after menarche. Not indicated after menopause. Increased risk of VTE; arterial (MI, transient ischemic attack) thromboembolism; thromboembolism in the puerperium. Increased frequency or severity of migraine can be a reason for immediate discontinuation. Risk of cervical cancer, breast cancer, liver tumors, or meningiomas; Crohn's disease & ulcerative colitis; depressed mood & depression; chloasma, especially in women w/ history of chloasma gravidarum. Increased risk of pancreatitis in women w/ hypertriglyceridaemia or +ve family history thereof. Discontinue if persistent, clinically relevant HTN develops during use. May precipitate or exacerbate symptoms of hereditary & acquired angioedema. Acute or chronic liver dysfunction may necessitate discontinuation of use until liver function values have normalised. Diabetic patients must be carefully monitored during treatment. Contraceptive efficacy may be reduced in the event of missed tab, GI disturbances, or certain concomitant medication. Irregular bleeding (spotting or breakthrough bleeding) may occur, especially during the 1st few mth of use. Should not be taken by patients w/ rare hereditary problems of galactose or fructose intolerance, lactase deficiency, glucose-galactose malabsorption, or sucrase-isomaltase deficiency.

Nausea, abdominal pain; increased wt; headache; depressive/altered mood; breast pain/tenderness, intermenstrual bleeding.

Co-administration w/ active substances that induce microsomal enzymes may increase clearance of sex hormones & lead to breakthrough bleeding &/or contraceptive failure. Increased clearance & reduced effectiveness w/ enzyme inducers eg, barbiturates, rifampicin, antiepileptic drugs (eg, barbexaclone, carbamazepine, phenytoin, primidone), & possibly also oxcarbazepine, topiramate, felbamate, griseofulvin & products containing St. John's wort. Increased or decreased plasma conc of oestrogen or progestogen w/ HIV/HCV PIs & NNRTIs. Increased plasma conc of oestrogens or progestogens or both w/ potent CYP3A4 inhibitors. Increased plasma conc of ethinylestradiol w/ etoricoxib. Increased plasma levels & tissue conc of cyclosporine. Decreased plasma levels & tissue conc of lamotrigine. Requirement for antidiabetics can change as a result of the effect on glucose tolerance. Inhibited clearance of CYP1A2 substrates, thereby leading to slight (eg, theophylline) or moderate (eg, tizanidine) rise in plasma conc thereof. ALT elevations w/ medicinal products containing ombitasvir/paritaprevir/ritonavir & dasabuvir w/ or w/o ribavirin; glecaprevir/pibrentasvir or sofosbuvir/velpatasvir/voxilaprevir. May influence results of certain lab tests, including biochemical parameters of hepatic, thyroid, adrenal & renal function, as well as plasma levels of (carrier) proteins eg, corticosteroid-binding globulin & lipid/lipoprotein fractions, parameters of carbohydrate metabolism, blood coagulation & fibrinolysis.

Acne Treatment Preparations / Oral Contraceptives

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

P₁S₁S₃