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active substances: amlodipine besylate and valsartan; 1 tablet contains amlodipine besylate 6.94 mg in terms of amlodipine 5 mg and 80 mg of valsartan or amlodipine besylate 6.94 mg in terms of amlodipine 5 mg and 160 mg of valsartan, or amlodipine besylate 13.88 mg in terms of amlodipine 10 mg and 160 mg of valsartan;
excipients: calcium hydrogen phosphate, dihydrate; microcrystalline cellulose; croscarmellose sodium; hydroxypropylcellulose; colloidal anhydrous silica; talc; magnesium stearate; coating for coating Opadry II White (polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide (E 171)).
Essential hypertension of patients whose blood pressure is not regulated by means of monotherapy with amlodipine or valsartan.
Hypersensitivity to any component of the drug.
Severe hepatic impairment, biliary cirrhosis or cholestasis.
Severe renal impairment (glomerular filtration rate (SHHF) <30 ml / min / 1.73 m2).
Contraindicated in patients who are on dialysis.
Contraindicated for concomitant use of angiotensin receptor antagonists, including valsartan, angiotensin-converting enzyme inhibitors or aliskirenom of patients with diabetes mellitus or renal impairment (glomerular filtration rate (SHHF) <60 ml / min / 1.73 m2).
Contraindicated to pregnant women and women planning to become pregnant.
According to the Safety of amlodipine:
– Obstruction output tract of the left ventricle (eg aortic stenosis severe);
– Hemodynamically unstable heart failure after acute myocardial infarction.
Dosage & Administration
Patients whose blood pressure is not regulated mono-drugs amlodipine or valsartan may be converted to combination therapy with Difors.
The recommended dose – 1 tablet per day. Difors taken regardless of meals with water.
Patients taking valsartan and amlodipine alone could translate into Difors containing the same dose components. Before moving to fixed-dose combination recommended individual selection of doses of the individual components (ie amplodypinu and valsartan).
Daily dose – 1 tablet Difors 80 or 1 tablet Difors 160, or 1 tablet Difors XL (maximum allowable dose of the drug – 10 mg amlodipine content, 320 mg valsartan content).
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