Dafiro HCT

Posology The recommended dose of Dafiro HCT is one tablet per day, to be taken preferably in the morning. Before switching to Dafiro HCT patients should be controlled on stable doses of the monocomponents taken at the same time. The dose of Dafiro HCT should be based on the doses of the individual components of the combination at the time of switching.

The maximum recommended dose of Dafiro HCT is 10 mg/320 mg/25 mg. 2). 2). 3). 2). Amlodipine dose recommendations have not been established in patients with mild to moderate hepatic impairment. 1) with hepatic impairment to Dafiro HCT, the lowest available dose of the amlodipine component should be used.

Heart failure and coronary artery disease There is limited experience with the use of Dafiro HCT, particulary at the maximum dose, in patients with heart failure and coronary artery disease. Caution is advised in patients with heart failure and coronary artery disease, particularly at the maximum dose of Dafiro HCT, 10 mg/320 mg/25 mg.

4 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 Dafiro HCT, 10 mg/320 mg/25 mg, since available data in this patient population are limited.

1) to Dafiro HCT, the lowest available dose of the amlodipine component should be used. Paediatric population There is no relevant use of Dafiro HCT in the paediatric population (patients below age 18 years) for the indication of essential hypertension.

Method of administration Oral use. Dafiro 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.

The safety profile of Dafiro HCT presented below is based on clinical studies performed with Dafiro HCT and the known safety profile of the individual components amlodipine, valsartan and hydrochlorothiazide. Summary of the safety profile The safety of Dafiro HCT has been evaluated at its maximum dose of 10 mg/320 mg/25 mg in one controlled short-term (8 weeks) clinical study with 2,271 patients, 582 of whom received valsartan in combination with amlodipine and hydrochlorothiazide.

Adverse reactions were generally mild and transient in nature and only infrequently required discontinuation of therapy. 7%). In the 8-week controlled clinical study, no significant new or unexpected adverse reactions were observed with triple therapy treatment compared to the known effects of the monotherapy or dual therapy components.

In the 8-week controlled clinical study, changes in laboratory parameters observed with the combination of Dafiro HCT were minor and consistent with the pharmacological mechanism of action of the monotherapy agents. The presence of valsartan in the triple combination attenuated the hypokalaemic effect of hydrochlorothiazide.

Tabulated list of adverse reactions The following adverse reactions, listed by MedDRA System Organ Class and frequency, concern Dafiro HCT (amlodipine/valsartan/HCT) and amlodipine, valsartan and HCT individually. Very common: ≥1/10; common: ≥1/100 to <1/10; uncommon: ≥1/1,000 to <1/100; rare: ≥1/10,000 to <1/1,000; very rare: <1/10,000, not known (cannot be estimated from the available data).

4) -- -- -- Very rare Respiratory distress, pulmonary oedema, pneumonitis -- -- -- Very rare Rhinitis -- Uncommon -- -- Throat irritation Uncommon -- -- -- 16 Gastrointestinal disorders Abdominal discomfort, abdominal pain upper Uncommon Common Uncommon Rare Breath odour Uncommon -- -- -- Change of bowel habit -- Uncommon -- -- Constipation -- -- -- Rare Decreased appetite -- -- -- Common Diarrhoea Uncommon Uncommon -- Rare Dry mouth Uncommon Uncommon -- -- Dyspepsia Common Uncommon -- -- Gastritis -- Very rare -- -- Gingival hyperplasia -- Very rare -- -- Nausea Uncommon Common -- Common Pancreatitis -- Very rare -- Very rare Vomiting Uncommon Uncommon -- Common Intestinal angioedema -- -- Very rare -- Hepatobiliary disorders Liver function test abnormal, including blood bilirubin increase -- Very rare** Not known -- Hepatitis -- Very rare -- -- Intrahepatic cholestasis, jaundice -- Very rare -- Rare Skin and subcutaneous tissue disorders Alopecia -- Uncommon -- Angioedema -- Very rare Not known -- Dermatitis bullous -- -- Not known -- Cutaneous lupus erythematosus-like reactions, reactivation of cutaneous lupus erythematosus -- -- -- Very rare Erythema multiforme -- Very rare -- Not known Exanthema -- Uncommon -- -- Hyperhidrosis Uncommon Uncommon -- -- Photosensitivity reaction* -- Very rare -- Rare Pruritus Uncommon Uncommon Not known -- Purpura -- Uncommon -- Rare Rash -- Uncommon Not known Common Skin discoloration -- Uncommon -- -- Urticaria and other forms of rash -- Very rare -- Common Vasculitis necrotising and toxic epidermal necrolysis -- Not known -- Very rare Exfoliative dermatitis -- Very […]

The safety and efficacy of amlodipine in hypertensive crisis have not been established. 2% of hydrochlorothiazide/amlodipine (25 mg/10 mg) patients in a controlled trial in patients with moderate to severe uncomplicated hypertension.

In sodium-depleted and/or volume-depleted patients, such as those receiving high doses of diuretics, symptomatic hypotension may occur after initiation of treatment with Dafiro HCT. Dafiro HCT should be used only after correction of any pre-existing sodium and/or volume depletion.

If excessive hypotension occurs with Dafiro 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.

5 Serum electrolyte changes Amlodipine/valsartan/hydrochlorothiazide In the controlled trial of Dafiro 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.

) is not recommended. Monitoring of potassium should be undertaken as appropriate. Hydrochlorothiazide Treatment with Dafiro HCT should only start after correction of hypokalaemia and any coexisting hypomagnesaemia. Thiazide diuretics can precipitate new onset hypokalaemia or exacerbate pre- existing hypokalaemia.

Thiazide diuretics should be administered with caution in patients with conditions involving enhanced potassium loss, for example salt-losing nephropathies and prerenal (cardiogenic) impairment of kidney function. If hypokalaemia develops during hydrochlorothiazide therapy, Dafiro HCT should be discontinued until stable correction of the potassium balance.

1. 6). − Hepatic impairment, biliary cirrhosis or cholestasis. 73 m2), anuria and patients undergoing dialysis. 1). − Refractory hypokalaemia, hyponatraemia, hypercalcaemia, and symptomatic hyperuricaemia. − Severe hypotension. − Shock (including cardiogenic shock).

g. hypertrophic obstructive cardiomyopathy and high grade aortic stenosis). − Haemodynamically unstable heart failure after acute myocardial infarction.