Gveza

Gveza

ethinylestradiol + drospirenone

Manufacturer:

NaariEsta

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Drospirenone 3 mg, ethinylestradiol 0.03 mg
Dosage/Direction for Use
1 tab daily for 21 consecutive days. Each subsequent pack is started after a 7-day tab-free interval. No preceding hormonal contraceptive use (in the past mth) Start on the 1st day of menstrual bleeding. Changing from a combined hormonal contraceptive [combined oral contraceptive (COC), vag ring or transdermal patch] Start preferably on the day after the last active tab of the previous COC, but at the latest on the day following the usual tab-free or placebo tab interval of the previous COC. In case a vag ring or transdermal patch has been used, start treatment preferably on the day of removal, but at the latest when the next application would have been due. Changing from a progestogen-only method (progestogen-only pill, inj, implant) or progestogen-releasing intrauterine system (IUS) May switch any day from progestogen-only pill. Following 1st-trimester abortion May start immediately. Following delivery or 2nd-trimester abortion Start at day 21-28 after delivery or 2nd trimester abortion.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity. Presence or risk of VTE; current VTE (on anticoagulants) or history of DVT or pulmonary embolism; known hereditary or acquired predisposition for VTE [eg, APC-resistance (including Factor V Leiden); antithrombin III, protein C & protein S deficiency]; major surgery w/ prolonged immobilization. Presence or risk of arterial thromboembolism (ATE); current or history of ATE (eg, MI) or prodromal condition (eg, angina pectoris); current or history of stroke or prodromal condition (eg, transient ischaemic attack); known hereditary or acquired predisposition for ATE (eg, hyperhomocysteinaemia & antiphospholipid-Abs); history of migraine w/ focal neurological symptoms; DM w/ vascular symptoms, severe HTN or dyslipoproteinaemia. Pancreatitis or history thereof, if associated w/ severe hypertriglyceridaemia. Presence or history of severe hepatic disease as long as liver function values have not returned to normal. Presence or history of liver tumours (benign or malignant). Known or suspected sex-steroid influenced malignancies (eg, of the genital organs or breasts). Undiagnosed vag bleeding. Cholestatic jaundice or jaundice w/ prior pill use. Renal impairment. Pregnancy.
Special Precautions
Increased risk of arterial & venous thrombotic & thromboembolic diseases (eg, MI, DVT, pulmonary embolism & CVA) w/ age, obesity, +ve family history, prolonged immobilization, major or any surgery to the legs or major trauma, smoking (especially in women >35 yr), dyslipoproteinemia, HTN, migraine, valvular heart disease & atrial fibrillation. Discontinue use in case of suspected or confirmed thrombosis. Increased risk of thromboembolism in the puerperium. DM, SLE, haemolytic uraemic syndrome & chronic inflammatory bowel disease (Crohn's disease or ulcerative colitis) & sickle cell disease. Increased frequency or severity of migraine during use may be a reason for immediate discontinuation. Risk of cervical cancer; breast cancer; benign or malignant liver tumours. Consider hepatic tumour in the differential diagnosis when severe upper abdominal pain, liver enlargement or signs of intraabdominal haemorrhage occur. May slightly increase serum K levels in patients w/ mild or moderate renal impairment & concomitant use of K-sparing medicinal products. Increased risk of pancreatitis in women w/ or family history of hypertriglyceridaemia. W/draw COC in pre-existing HTN, constantly elevated BP values or a significant increase in BP do not adequately respond to antihypertensive treatment. Possible jaundice &/or pruritus related to cholestasis; gallstones; porphyria; SLE; haemolytic uraemic syndrome; Sydenham's chorea; herpes gestationis; otosclerosis-related hearing loss. May induce or exacerbate symptoms in women w/ hereditary angioedema. Acute or chronic disturbances of liver function. Recurrence of cholestatic jaundice &/or cholestasis-related pruritus which previously occurred during pregnancy or previous use of sex steroids. Carefully observe diabetic women particularly in the early stage of use. Possible worsening of endogenous depression, epilepsy, Crohn's disease & ulcerative colitis. Possible chloasma especially in women w/ history of chloasma gravidarum; avoid exposure to sun or UV radiation. Depressed mood & depression. Patients w/ rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption who are on a lactose-free diet. Take a complete medical history & physical exam prior to initiation or reinstitution of use; repeat periodically. Advise women that OCs do not protect against HIV (AIDS) & other STD. Efficacy may be reduced in the event of missed tab, GI disturbances or concomitant medication. Irregular bleeding may occur. Consider non-hormonal causes & exclude malignancy or pregnancy if bleeding irregularities persist or occur after previously regular cycles. Lactation; not recommended until breast-feeding mother has completely weaned her child. Childn & adolescents; only indicated after menarche. Elderly; not indicated after menopause.
Adverse Reactions
Emotional lability, depression/depressive mood, decrease & loss of libido; migraine; nausea; breast pain, unscheduled uterine bleeding, genital tract bleeding.
Drug Interactions
Increased clearance of sex hormones w/ hepatic enzyme inducers [eg, phenytoin, barbiturates, primidone, carbamazepine, rifampicin, bosentan & HIV medication (eg, ritonavir, nevirapine) & possibly oxcarbazepine, topiramate, felbamate, griseofulvin & products containing St. John's Wort]. Contraceptive failure w/ antibiotics (eg, penicillins & tetracyclines). May increase plasma & tissue conc of ciclosporin. May decrease plasma & tissue conc of lamotrigine. Potential increase in serum K w/ AIIA, K-sparing diuretics & aldosterone antagonists. May influence certain lab test results including 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. Drospirenone: Increased plasma renin activity & plasma aldosterone.
MIMS Class
Oral Contraceptives
ATC Classification
G03AA12 - drospirenone and ethinylestradiol ; Belongs to the class of progestogens and estrogens in fixed combinations. Used as systemic contraceptives.
Presentation/Packing
Form
Gveza FC tab
Packing/Price
1 × 21's
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