Details

---

• Manufacturer: Novartis Farma S.p.A., Italy.

• Marketing Authorisation Holder (MAL): MAL15015057ARZ.

Content

• Active Ingredients: Each tablet contains 10 mg of amlodipine (as amlodipine besylate), 160 mg of valsartan, and 12.5 mg of hydrochlorothiazide.

Indications

Exforge HCT is indicated for:

• Essential Hypertension: Treatment of high blood pressure in adults whose blood pressure is adequately controlled on the combination of amlodipine, valsartan, and hydrochlorothiazide, taken either as three single-component formulations or as a dual-component and a single-component formulation.

Instructions for Use

• Dosage: The recommended dose is one tablet daily, taken preferably in the morning.

• Administration: Swallow the tablet whole with a glass of water. Do not chew, crush, or break the tablet.

• With or Without Food: Exforge HCT can be taken with or without food.

• Maximum Dosage: The maximum recommended dose is 10 mg of amlodipine, 320 mg of valsartan, and 25 mg of hydrochlorothiazide per day.

• Renal Impairment: Use with caution in patients with severe kidney disease. Dose adjustment may be necessary.

• Hepatic Impairment: Use with caution in patients with liver disease. Dose adjustment may be necessary.

• Pregnancy and Lactation: Not recommended during pregnancy and breastfeeding.

• Storage: Store below 30°C in the original package to protect from moisture. Keep out of reach of children.