uent urination), fatigue (tiredness) and oedema (fluid retention). For the full list of all side effects reported with Exforge HCT, see the Package Leaflet.
Exforge HCT should not be used in people who may be hypersensitive (allergic) to the active substances, to other sulfonamides, to dihydropyridine derivatives or to any of the other ingredients in Exforge HCT. It must not be used in women who are more than three months pregnant. It must also not be used in patients who have liver or bile problems (such as jaundice), severe kidney problems, anuria (a condition in which a patient cannot make or pass urine) or in patients undergoing dialysis (a blood clearance technique). Finally, Exforge HCT must not be used in patients with hypokalaemia (low blood potassium levels), hyponatraemia (low blood sodium levels) and hypercalcaemia (high blood calcium levels) that do not respond to treatment and in patients with hyperuricaemia (high blood levels of uric acid) that causes symptoms.
Why has it been approved?
The Committee for Medicinal Products for Human Use (CHMP) noted that patients already taking the three active substances would be more likely to comply with their treatment if prescribed Exforge HCT which combines the three substances in a single tablet. The main study showed the benefit of the highest strength of Exforge HCT in lowering the blood pressure. For all doses, Exforge HCT also met requirements to prove that it was comparable to the combinations of the individual active substances taken seperately. The CHMP therefore decided that Exforge HCT’s benefits are greater than its risks for the treatment of essential hypertension in adults whose blood pressure is already adequately controlled with a combination of amlodipine, valsartan and hydrochlorothiazide. The Committee recommended that Exforge HCT be given marketing authorisation.
Further information
The European Commission granted a marketing authorisation valid throughout the European Union for Exforge HCT to Novartis Europharm Limited on 16 October 2009.
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Name
Exforge HCT 5 mg/160 mg/12.5 mg film-coated tablets
Composition
Each film-coated tablet contains 5 mg of amlodipine (as amlodipine besylate), 160 mg of valsartan, and 12.5 mg of hydrochlorothiazide.
For a full list of excipients, see section 6.1.
Pharmaceutical Form
Film-coated tablet (tablet)
White, ovaloid, biconvex tablets with bevelled edge, debossed “NVR” on one side and “VCL” on the other side.
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