Dienille

Dienille

Manufacturer:

Eurodrug

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Dienogest 2 mg, ethinylestradiol 0.03 mg
Indications/Uses
Hormonal contraception. Mild to moderate acne in women who desire OC.
Dosage/Direction for Use
1 tab daily on 1st day of menstrual cycle for 21 consequent days followed by 7 tab-free days.
Administration
May be taken with or without food: Take at the same time each day.
Contraindications
Hypersensitivity. Presence or history of DVT, pulmonary embolism; arterial thrombosis eg, cerebrovascular event, heart attack; prodromal events eg, angina pectoris, transient ischemic attack. DM w/ vascular involvement, severe HTN & dyslipidaemia, biochemical factors indicative of hereditary or acquired venous or arterial thrombosis predisposition. Known or suspected steroid dependent genital organs or breasts tumors. Vag bleeding of unknown origin. History of migraine w/ focal neurological symptoms; pancreatitis associated w/ severe hypertriglyceridaemia. Concomitant use w/ ombitasvir/paritaprevir/ritonavir & dasabuvir. History or existing active severe liver disease; benign or malignant active liver tumor. Severe renal insufficiency or acute renal failure.
Special Precautions
Allergy w/ peanut & soya. Not for protection against HIV infections or other STD. Increased risk of venous or arterial thromboembolism; increasing age, positive family history of venous or arterial thromboembolism, obesity; dyslipoproteinaemia, HTN, valvular heart disease, atrial fibrillation, migraine, smoking; varicose veins, advanced stage phlebitis & thrombosis, existence of heart disease, blood clotting disorders. Increased risk of cervical or breast cancer. Hypertriglyceridaemia; Crohn's disease & ulcerative colitis; chloasma; hereditary angioedema; endogenous depression or epilepsy; irregular bleeding. Monitor BP & perform physical exam prior to therapy. Prolonged immobilization, major surgery or trauma, any leg surgery. Premature epiphyses closure. Concomitant use of St. John's wort, ombitasvir/paritaprevir/ritonavir & dasabuvir w/ or w/o ribavirin. Galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. Active or chronic hepatic disease. Not indicated during pregnancy. Not to be used during lactation.
Adverse Reactions
Headache; abdominal pain; breast tenderness or pain.
Drug Interactions
Increased clearance w/ hydantoin, barbiturates, primidone, carbamazepine, rifampicin. Increased liver enzyme induction w/ rifabutin, efavirenz, nevirapine, oxcarbazepine, topiramate, felbamate, ritonavir, nelfinavir, griseofulvin, St. John's wort containing-products. Reduced efficacy w/ ampicillin or tetracycline. Increased plasma & tissue conc of cyclosporin. Decreased plasma & tissue conc of lamotrigine. Increased risk of ALT elevations w/ ombitasvir/paritaprevir/ritonavir & dasabuvir w/ or w/o ribavirin. ACE inhibitors, angiontensin II receptor & aldosterone antagonists, K-sparing diuretics, NSAIDs.
MIMS Class
Oral Contraceptives / Acne Treatment Preparations
ATC Classification
G03AA16 - dienogest and ethinylestradiol ; Belongs to the class of progestogens and estrogens in fixed combinations. Used as systemic contraceptives.
Presentation/Packing
Form
Dienille FC tab
Packing/Price
21's
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