DISICAR^®40

COMPOSITION: Each film-coated tablet contains:

Telmisartan..................................................................... 40 mg

Excipients: Lactose, Microcrystalline cellulose, Sodium starch glycolate, Talc, Magnesium stearate, Sorbitol, Opadry II whiteq.s. 1 tablet.

INDICATIONS:

• Hypertension: Telmisartan may be used alone or in combination with other antihypertensive
• Telmisartan is indicated for reduction of the risk of myocardial infarction, stroke, or death from cardiovascular causes in patient 55 years of age or older at high risk of developing major cardiovascular events who are unable to take ACE inhibitors.

DOSAGE AND ADMINISTRATION:

Hypertension

Dosage must be individualized. The usual starting dose is 40 mg once a day. Blood pressure response is dose-related over the range of 20 to 80 mg.

In patients with mild to moderate impaired hepatic function, dose should not exceed 40 mg once daily.

No initial dosage adjustment is necessary for elderly patients or patients with renal impairment, including those onhemodialysis. Patients ondialysismaydeveloporthostatichypotension;their blood pressure should be closely monitored.

Telmisartan tablets may be administered with other anti-hypertensive agents.

Cardiovascular Risk Reduction

The recommended dose of telmisartan tablets is 80 mg once a day.

Telmisartan tablets may be administered with or without food.

CONTRAINDICATIONS:

• Hypersensitivity to any of its ingredient(s).
• Pregnant women.
• Nursing mothers.
• Severe renal impairment.
• Severe hepatic impairment.

WARNINGS AND PRECAUTIONS:

Consider periodic determinations of kalemia, especially in elderly and impaired renal function patients.

Patients suffering from aortic or mitral stenosis, or obstructive hypertrophic cardiomyopathy.

Patients with severe congestive heart failure.

In patients with an activated renin-angiotensin system, such as volume- or salt-depleted patients (e.g., those being treated with high doses of diuretics), symptomatic hypotension may occur after initiation of therapy with telmisartan. Either correct this condition prior to administration of telmisartan, or start treatment under close medical supervision with a reduced dose.

Impaired hepatic function: as the majority of telmisartan is eliminated by biliary excretion, patients with biliary obstructive disorders or hepatic insufficiency can be expected to have reduced clearance. DISICAR tablets (telmisartan) should be used with caution in patients with biliary obstructive disorders or hepatic insufficiency. Initiate telmisartan at low doses and titrate slowly in these patients.

Renal artery stenosis.

Mild and moderate renal impairment

Pregnancy

Due to caution,telmisartan is not recommended during the first trimester of pregnancy. Drugs that act directly on the renin-angiotensin system can cause fetal and neonatal morbidity and death when administered to pregnant women, therefore telmisartan is contraindicated during the second and third trimester of pregnancy. When pregnancy is detected, discontinue drug as soon as possible.

Nursing Mother

It is not known whether telmisartan is excreted in human milk, decide whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

PRESENTATION:

Blister of 10 tablets. Box of 3blisters.

Keep out of reach of children.

Carefully read the instructions before use.

Ask your doctor for further information.

Use upon doctor’s prescription only

Manufactured and Distributed by: AMPHARCO U.S.A PHARMACEUTICAL JOINT-STOCK COMPANY          

NhonTrach 3 Industrial Park, HiepPhuoc ward, NhonTrach district, Dong Nai province.

Tel: 02513 566 202    -     Fax: 02513 566 203