What is Dafiro HCT?
Dafiro HCT is a medicine containing three active substances, amlodipine, valsartan and hydrochlorothiazide, available as tablets containing amlodipine, valsartan and hydrochlorothiazide in the following doses: 5/160 / 12.5 mg, 10/160 / 12.5 mg, 5 / 160/25 mg, 10/160/25 mg and 10/320/25 mg.
What is Dafiro HCT used for?
Dafiro HCT is used to treat essential hypertension (high blood pressure) in adults whose blood pressure is already adequately controlled with a combination of amlodipine, valsartan and hydrochlorothiazide. The term "essential" indicates that hypertension has no cause. obvious.
The medicine can only be obtained with a prescription.
How is Dafiro HCT used?
One Dafiro HCT tablet should be taken orally, at the same time and preferably in the morning. The dose of Dafiro HCT to be used is similar to the doses of the three individually taken active substances that the patient was taking previously. The daily dose of Dafiro HCT should not exceed 10 mg of amlodipine, 320 mg of valsartan and 25 mg of hydrochlorothiazide.
How does Dafiro HCT work?
The three active substances in Dafiro HCT are antihypertensive medicines already marketed in the European Union (EU).
"Amlodipine is a" calcium channel blocker ", which means it blocks particular channels on the cell surface, called calcium channels, which normally allow calcium ions to enter the cells. When calcium ions enter the muscle cells of the vascular walls, cause a contraction. By reducing the flow of calcium into the cells, amlodipine inhibits the contraction of cells, promoting relaxation and widening of blood vessels and thus lowering blood pressure.
Valsartan is an "angiotensin II receptor antagonist", which means that it blocks the action of a hormone in the body called angiotensin II, which is a powerful vasoconstrictor (a substance that constricts blood vessels). Normally angiotensin II binds, valsartan blocks the effect of the hormone, allowing blood vessels to dilate and lower blood pressure.
Hydrochlorothiazide is a diuretic. It works by increasing urine output, reducing the volume of fluid in the blood and lowering blood pressure.
The combination of the three active substances has an additional effect, reducing blood pressure to a greater extent than the three medicines taken alone. By lowering blood pressure, the risks associated with high blood pressure, such as that of have a stroke.
How has Dafiro HCT been studied?
Since the combination of the three active ingredients has been on the market for several years, the manufacturer has presented studies showing that the tablet containing the three ingredients is absorbed into the body in the same way as the separate tablets.
In addition, one main study was performed in 2 271 patients with moderate to severe hypertension with the strongest dose of Dafiro HCT (320 mg of valsartan, 10 mg of amlodipine and 25 mg of hydrochlorothiazide). Patients were given Dafiro HCT or one of three combinations containing only two active substances for eight weeks. The main measure of effectiveness was the reduction in blood pressure.
What benefit has Dafiro HCT shown during the studies?
Treatment with the higher dose of Dafiro HCT was more effective in treating hypertension than combinations containing any two of the active substances. The mean decrease in blood pressure was approximately 39.7 / 24.7 mmHg in patients. who took Dafiro HCT compared with 32 / 19.7 mmHg, 33.5 / 21.5 mmHg and 31.5 / 19.5 mmHg in patients who took the combinations valsartan / hydrochlorothiazide, valsartan / amlodipine and hydrochlorothiazide / amlodipine respectively .
What is the risk associated with Dafiro HCT?
The most common side effects seen with Dafiro HCT (seen between 1 and 10 out of 100 patients) are hypokalaemia (low blood potassium levels), dizziness, headache, hypotension (low blood pressure), dyspepsia (heartburn), pollakiuria (frequent need for
urinating), tiredness and edema (fluid retention). For the full list of side effects
detected with Dafiro HCT, see the package leaflet.
Dafiro HCT should not be taken by people who may be hypersensitive (allergic) to
active ingredients, other sulfonamides, dihydropyridine derivatives or any ingredient in Dafiro
HCT. It must not be used in women who are more than three months pregnant. It should also not be used in patients with liver or bile problems (such as jaundice), severe kidney problems, anuria (a condition in which the patient cannot produce or pass urine) or in patients undergoing dialysis (a technique of blood purification). Finally, Dafiro HCT should not be used in patients with hypokalaemia (low blood potassium levels), hyponatremia (low blood sodium levels) and hypercalcaemia (high blood calcium levels) who are unresponsive to treatment and in patients with hyperuricaemia (high levels of uric acid in the blood) which causes symptoms.
Why has Dafiro HCT been approved?
The Committee for Medicinal Products for Human Use (CHMP) noted that patients already taking the three active substances are more likely to adjust to treatment if they are prescribed Dafiro HCT which combines the three active substances in a single tablet. The main study demonstrated the benefits of the higher dose of Dafiro HCT in lowering blood pressure. For all doses, Dafiro HCT was also shown to be comparable to combinations of the active substances taken separately. The CHMP therefore decided that the benefits of Dafiro HCT 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 Dafiro HCT be given marketing authorization.
More information about Dafiro HCT
On November 4, 2009, the European Commission granted Novartis Europharm Limited a "Marketing Authorization" for Dafiro HCT, valid throughout the European Union.
For the full version of the Dafiro HCT EPAR, click here.
Last update of this summary: 08-2009.
The information on Dafiro HCT published on this page may be out of date or incomplete. For a correct use of this information, see the Disclaimer and useful information page.
