Details

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• Manufacturer: Siegfried Barbera, S.L.

• Marketing Authorisation Holder (MAL): MAL20081727ARZ.

Content

• Active Ingredients: Each tablet contains 5 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.

• Renal Impairment: No dosage adjustment is required for patients with mild to moderate renal impairment. Monitoring of potassium levels and creatinine is advised in moderate renal impairment.

• Hepatic Impairment: Exforge HCT is contraindicated in patients with severe hepatic impairment. Caution should be exercised when administering Exforge HCT to patients with hepatic impairment or biliary obstructive disorders.

• Elderly: Caution is required when increasing the dosage in elderly patients.

• Storage: Store below 25°C in the original package to protect from moisture. Keep out of reach of children.