Novelon Lite - Tablet Drospirenone + Ethinylestradiol - 0.02 mg+3 mg 28 Tablet(s) / Box Renata Limited Introduction: Novelon Lite is a combination of two medicines used for contraception (to prevent pregnancy) and in the treatment of irregular periods. It helps to prevent release and fertilization of the egg. Novelon Lite can be taken with or without food, but take it at the same time to get the most benefit. It should be taken as your doctor's advice. You should have to start taking the pill on the day one of your menstrual cycle and continue taking it for whole month and start with new pack once the pack get finished. If you experience vomiting with in 4... Uses of Novelon Lite: Contraception Side effects of Novelon Lite: NauseaStomach painHeadacheWeight gainBreast painIrregular uterine bleeding How to use Novelon Lite: Take this medicine in the dose and duration as advised by your doctor. Swallow it as a whole. Do not chew, crush or break it. Novelon Lite may be taken with or without food, but it is better to take it at a fixed time. How Novelon Lite works: Novelon Lite is a combined oral contraceptive pill. It works by preventing the release of egg (ovulation) and affecting sperm movement in the womb to prevent its union with the egg. It also changes the lining of the womb and renders it unsuitable for pregnancy. Indication: Acne, Oral contraception, Premenstrual dysphoric disorder. Administration: May be taken with or without food. Take dose at the same time each day. Women should be instructed to take the tablets at about the same time every day, preferably after the evening meal or at bedtime. 1 tab/day for 21 days followed by 7 pill-free days before starting on a new pack or after taking 21 light yellow tablets for 21 days, then continue taking one white placebo tablet every day from the last row in the pack for next 7 days. 1 tab/day for 24 days followed by 4 pill-free days before starting on a new pack... Adult Dose: Contraception 1 active tablet (3 mg drospirenone/0.03 mg EE) PO qDay for 21 days, THEN 1 inert tablet PO qDay for 7 days 1 active tablet (3 mg drospirenone/0.02 mg EE) PO qDay for 24 days, THEN 1 inert tablet PO qDay for 4 days Premenstrual Dysphoric Disorder Symptoms of premenstrual dysphoric disorder (PMDD), but only if oral contraceptive is chosen as method of birth control 1 active tablet (3 mg drospirenone/0.02 mg EE) PO qDay for 24 days, THEN 1 inert tablet PO qDay for 4 days Hepatic impairment: Avoid use. Child Dose: Contraception 14 years: Same dosing as adult Renal Dose: Renal impairment: CrCl (ml/min) <50 Avoid use. Contraindication: Pregnancy. Undiagnosed abnormal genital bleeding. Renal insufficiency, hepatic dysfunction or tumor. Adrenal insufficiency, cholestatic jaundice of pregnancy, jaundice with prior oral contraceptive use. Major surgery with prolonged immobilisation. Heavy smoking (>15 cigarettes/day) in patients >35 y. History of or current thrombophlebitis or venous thromboembolic disorders. Active or recent (within 1 yr) arterial thromboembolic disease; cerebral vascular disease, coronary artery disease, severe hypertension, valvular heart disease with thrombogenic complications. Diabetes with vascular involvement; headache with focal neurological symptoms. Known or suspected breast carcinoma, endometrial cancer, oestrogen-dependent neoplasms. Mode of Action: Ethinylestradiol is a synthetic oestrogen while drospirenone is a progestogen with antimineralocorticoid and antiandrogenic activity. Combined oral contraceptives act by suppressing the gonadotropins. Oral contraceptives also produce changes in the cervical mucus, making it less favorable for sperm penetration even if ovulation occurs. Precaution: May increase risk of breast cancer, thromboembolism and glucose intolerance. May lead to hyperkalaemia in patients with adrenal insufficiency. May affect serum triglycerides and lipoprotein levels. May cause retinal vascular thrombosis; discontinue treatment if papilloedema or retinal vascular lesions occur. Caution when used in patients with depression, history of migraines or risk factors for coronary arterial diseases. Patients with diseases which may be worsened by fluid retention. May have dose-related risk of gall bladder disease. Increased risk of CV side effects when used in smokers, especially if they are >35 yr of age. Recommended to stop treatment 4 wk before... Side Effect: >10% Premenstrual syndrome (13.2%),Migraine/headache (10.7%) 1-10% Breast pain/discomfort/tenderness (8.3%),Menstrual irregularities (4.7%),Nausea/vomiting (4.5%),Abdominal pain/discomfort/tenderness (2.3%),Mood changes, including affect lability, depression, alteration of mood, mood swings, and irritability (2.3%) Frequency Not Defined Irregular uterine bleeding,Venous/arterial thromboembolic events, including DVT, PE, stroke, MI, intracardiac thrombosis, sagittal sinus thrombosis, intracranial venous sinus thrombosis, retinal vein thrombosis,Hypertension,Hypersensitivity,Hyperkalemia,Chloasma,Gallbladder disease,Toxic skin eruption,Uterine leiomyoma Pregnancy Category Note: Pregnancy category: X Lactation: Small amounts of steroids are excreted in breast milk; estrogens may reduce quality/quantity of milk; may be prudent to use other forms of birth control until full weaning (AAP Committee states compatible with nursing) Interaction: Increased risk of hyperkalaemia when used with ACE inhibitors, angiotensin II receptor antagonists, aldosterone antagonists, potassium salts or NSAIDs. Aminoglutethimide may increase hepatic metabolism of progestins. Increased risk of systemic acidosis when used with ammonium chloride. Serum concentrations may be reduced by aprepitant, topiramate, rifampin or protease inhibitors. Efficacy may be reduced by concurrent use of acitretin, carbamazepine, felbamate, oxcarbazepine, phenobarbital, phenytoin, topiramate, barbiturates, griseofulvin, modafinil. Oestrogens may decrease the clearance of benzodiazepines that undergo oxidative metabolism. Concurrent use may increase the serum levels of systemic corticosteroids, ciclosporin, tizanidine, voriconazole and selegiline. May affect the efficacy of coumarin derivativesl; thus...