Details

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

• Marketing Authorisation Holder (MAL): MAL20081727ARZ.

Content

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

Indications

Exforge is indicated for:

• Essential Hypertension: Treatment of high blood pressure in adults whose blood pressure is not adequately controlled with amlodipine 10 mg or valsartan 160 mg alone, or with Exforge 5 mg/160 mg.

Instructions for Use

• Dosage: The recommended dose is one tablet daily.

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

• With or Without Food: Exforge 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 is contraindicated in patients with severe hepatic impairment. Caution should be exercised when administering Exforge 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.