d in patients with heart failure and coronary artery disease, particularly at the maximum dose of Exforge HCT, 10 mg/320 mg/25 mg.
Elderly (age 65 years or over)
Caution, including more frequent monitoring of blood pressure, is recommended in elderly patients, particularly at the maximum dose of Exforge HCT, 10 mg/320 mg/25 mg, since available data in this patient population are limited.
Paediatric population
There is no relevant use of Exforge HCT in the paediatric population (patients below age 18 years) for the indication of essential hypertension.
Method of administration
Exforge HCT can be taken with or without food. The tablets should be swallowed whole with some water, at the same time of the day and preferably in the morning.
4.3 Contraindications
− Hypersensitivity to the active substances, to other sulfonamides, to dihydropyridine derivatives, or to any of the excipients.
− Second and third trimesters of pregnancy (see sections 4.4 and 4.6).
− Hepatic impairment, biliary cirrhosis or cholestasis.
− Severe renal impairment (GFR <30 ml/min/1.73 m2), anuria and patients undergoing dialysis.
− Refractory hypokalaemia, hyponatraemia, hypercalcaemia, and symptomatic hyperuricaemia.
4.4 Special warnings and precautions for use
Sodium- and/or volume-depleted patients
Excessive hypotension, including orthostatic hypotension, was seen in 1.7% of patients treated with the maximum dose of Exforge HCT (10 mg/320 mg/25 mg) compared to 1.8% of valsartan/hydrochlorothiazide (320 mg/25 mg) patients, 0.4% of amlodipine/valsartan (10 mg/320 mg) patients, and 0.2% of hydrochlorothiazide/amlodipine (25 mg/10 mg) patients in a controlled trial in patients with moderate to severe uncomplicated hypertension. In patients with an activated renin-angiotensin system (such as volume- and/or salt-depleted patients receiving high doses of diuretics) who are receiving angiotensin II receptor antagonists (AIIRAs), symptomatic hypotension may occur. Correction of this condition prior to administration of Exforge HCT or close medical supervision at the start of treatment is recommended.
If excessive hypotension occurs with Exforge HCT, the patient should be placed in the supine position and, if necessary, given an intravenous infusion of normal saline. Treatment can be continued once blood pressure has been stabilised.
Serum electrolyte changes
Amlodipine/valsartan/hydrochlorothiazide
In the controlled trial of Exforge HCT, the counteracting effects of valsartan 320 mg and hydrochlorothiazide 25 mg on serum potassium approximately balanced each other in many patients. In other patients, one or the other effect may be dominant. Periodic determinations of serum electrolytes to detect possible electrolyte imbalance should be performed at appropriate intervals.
Periodic determination of serum electrolytes and potassium in particular should be performed at appropriate intervals to detect possible electrolyte imbalance, especially in patients with other risk factors such as impaired renal function, treatment with other medicinal products or history of prior electrolyte imbalances.
Valsartan
Concomitant use with potassium supplements, potassium-sparing diuretics, salt substitutes containing potassium, or other medicinal products that may increase potassium levels (heparin, etc.) is not recommended. Monitoring of potassium should be undertaken as appropriate.
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