IRSATIM 75

COMPOSITION: Each film-coated tablet contains:

- Active ingredient: Irbesartan 75 mg

- Excipients: Copovidone, Lactose, Microcrystalline cellulose 101, Sodium croscarmellose, Magnesium stearate, Opadry white, Purified water q.s. one tablet.

INDICATIONS:

-     Hypertension: It may be used alone or in combination with other antihypertensive agents.

-     Nephropathy in Type 2 Diabetic Patients: It is indicated for the treatment of diabetic nephropathy with an elevated serum creatinine and proteinuria in patients with type 2 diabetes and hypertension, reduces the rate of progression of nephropathy in this population.

DOSAGE AND ADMINISTRATION:

Hypertension: The recommended initial dose is 150 mg once daily. Patients requiring further reduction in blood pressure should be titrated to 300 mg once daily. A low dose of a diuretic (hydrochlorothiazide) may be added, if blood pressure is not controlled by Irbesartan alone. No dosage adjustment is necessary in elderly patients, or in patients with hepatic impairment or renal impairment.

Nephropathy in Type 2 Diabetic Patients: The recommended target maintenance dose is 300 mg once daily. There are no data on the clinical effects of lower doses of Irbesartan on diabetic nephropathy.

A lower initial dose of Irbesartan (75 mg) is recommended in patients with depletion of intravascular volume or salt (eg, patients treated vigorously with diuretics or on hemodialysis).

CONTRAINDICATIONS:

• Hypersensitivity to any of its ingredient(s).

PRECAUTIONS:

• Renal function should be monitored in patients on long-term treatment with Irbesartan.
• The drug is not recommended for use in pregnancy or lactating women.
• Do not use for children under 6 years old since not enough studies have been made until now on these

PRESENTATION:

Blister of 10 film-coated tablets. Box of 3 blisters.

Keep out of reach of children

Read the package insert carefully before use

Ask your doctor for further information

Use upon doctor’s prescription only

Manufactured and distributed by: AMPHARCO U.S.A PJSC

Nhon Trach 3 I.P., Nhon Trach, Dong Nai.

Tel: 02513 566 202    -     Fax: 02513 566 203