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, +ve 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; DM, SLE, haemolytic uraemic syndrome, 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. Not to be taken by patients w/ galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. Active or chronic hepatic disease. Discontinue use if jaundice due to pregnancy or use of steroids occurs or cholestatic pruritus develops. 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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