Uses of Orbas Plus 20/12.5: - Hypertension (high blood pressure) Hypertension, Diabetic nephropathy Hypersensitivity to olmesartan medoxomil, hydrochlorothiazide or to other sulfonamide-derived drugs. Severe hepatic & renal impairment (CrCl <30 mL/min); cholestasis & biliary obstructive disorders; refractory hypokalemia; hypercalcemia; hyponatraemia, symptomatic hyperuricaemia; anuria. Concomitant use w/ aliskiren in patients w/ DM or renal impairment (GFR <60 mL/min/1.73 m2). Pregnancy (2nd & 3rd trimester) & lactation.

How to use Hydrochlorothiazide + Olmesartan Medoxomil: 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. Hydrochlorothiazide + Olmesartan Medoxomil may be taken with or without food, but it is better to take it at a fixed time. Administration: May be taken with or without food. Adult Dose: Hypertension Initial: 20 mg/12.5 mg PO qDay May increase to 40 mg/25 mg after 2 weeks Hepatic Impairment Dose adjustment not necessary Child Dose: Safety and efficacy not established Renal Dose: Renal Impairment CrCl <30 mL/min: Not recommended

Olmesartan medoxomil: Increased risk of hypotension, hyperkalemia & changes in renal function w/ aliskiren. May result in deterioration of renal function w/ NSAIDs. May attenuate the antihypertensive effect of angiotensin II receptor antagonists. Reduces systemic exposure & peak plasma conc w/ colosevelam HCl. Hydrochlorothiazide: Potentiation of orthostatic hypotension w/ alcohol, barbiturates or narcotics. Antidiabetic drugs. Potentiation effect w/ other antihypertensives. Reduced absorption w/ cholestyramine & colestipol resins. Intensified electrolyte depletion w/ corticosteroid, ACTH. Decreased response to pressor amines (eg norepinephrine). Increased responsiveness to skeletal muscle relaxants (eg tubocurarine). Reduce the renal clearance of lithium.

Hypersensitivity to olmesartan medoxomil, hydrochlorothiazide or to other sulfonamide-derived drugs. Severe hepatic & renal impairment (CrCl <30 mL/min); cholestasis & biliary obstructive disorders; refractory hypokalemia; hypercalcemia; hyponatraemia, symptomatic hyperuricaemia; anuria. Concomitant use w/ aliskiren in patients w/ DM or renal impairment (GFR <60 mL/min/1.73 m2). Pregnancy (2nd & 3rd trimester) & lactation.

Common - Nausea - Taste change - Upset stomach - Diarrhea - Headache - Dizziness - Weakness - Electrolyte imbalance - Glucose intolerance - Increased blood lipid level - Increased blood uric acid - Decreased blood pressure 1-10% Olmesartan Dizziness (3%),Headache (1%),Fatigue,Diarrhea (1%),Hyperglycemia (1%),Hypertriglyceridemia (1%),Back pain (1%),Bronchitis (1%),Flu-like symptoms (1%),Pharyngitis (1%),Rhinitis (1%),Sinusitis (1%),URI (1%) Frequency Not Defined Chest pain,Peripheral edema,Rash,Hyperuricemia,Dizziness,Hyperlipidemia,Diarrhea,Hyperuricemia,Hematuria,Hyperglycemia,Upper respiratory infections,Increased transaminases,Gastroenteritis,Dyspepsia,Arthralgia,Arthritis,Myalgia,Back pain,Increased CPK,Hydrochlorothiazide,Anorexia,Epigastric distress,Hypotension,Orthostatic hypotension,Photosensitivity,Anaphylaxis,Anemia,Confusion,Erythema multiforme,Stevens-Johnson syndrome,Exfoliative dermatitis including toxic epidermal necrolysis,Dizziness,Hypokalemia and/or hypomagnesemia,Hyperuricemia,Headache Potentially Fatal: Acute renal failure.

Precaution: Drugs that act on renin-angiotensin system can cause fetal injury and death when used in 2nd and 3rd trimesters of pregnancy. Olmesartan medoxomil should be discontinued as soon as possible once pregnancy is detected. Symptomatic hypotension may occur in patients who are volume- and/or salt-depleted. May be associated with oliguria, progressive azotaemia, and acute renal failure (rare). Patients with bilateral or unilateral renal artery stenosis may have increased risk of severe hypotension and renal insufficiency. Caution in renal impairment; monitor serum creatinine and potassium levels periodically. Avoid use in severe renal impairment (CrCl< 20 mL/min) and severe hepatic impairment. Caution in patients with aortic or mitral valve stenosis, obstructive hypertrophic cardiomyopathy. Patients with primary aldosteronism may not respond to angiotensin receptor antagonist. Not recommended in lactation. Lactation: discontinue drug or do not nurse

Hydrochlorothiazide inhibits the reabsorption of Na and chloride in the distal tubules causing increased excretion of Na and water K and hydrogen ions. Olmesartan is a selective and competitive angiotensin II Type 1 (AT1) receptor antagonist that blocks the vasoconstrictor and aldosterone-secreting effects of angiotensin II. As a result, olmesartan relaxes blood vessels, hence lowering BP and increases blood supply and oxygen to the heart.

Pregnancy Category: C (1st trimester); D (2nd & 3rd trimesters)