VALSARTAN HYDROCHLOROTHIAZIDE

5mg and Valsartan/Hydrochlorothiazide 160mg/25mg is one film-coated tablet once daily. Dose titration with the individual components is recommended. In each case, up- titration of individual components to the next dose should be followed in order to reduce the risk of hypotension and other adverse events.

When clinically appropriate direct change from monotherapy to the fixed combination may be considered in patients whose blood pressure is not adequately controlled on valsartan or hydrochlorothiazide monotherapy, provided the recommended dose titration sequence for the individual components is followed.

5mg Film-coated Tablets should be evaluated after initiating therapy and if blood pressure remains uncontrolled, the dose may be increased by increasing either one of the components to a maximum dose of Valsartan/Hydrochlorothiazide 320mg/25mg.

The antihypertensive effect is substantially present within 2 weeks. In most patients, maximal effects are observed within 4 weeks. However, in some patients, 4-8 weeks treatment may be required. This should be taken into account during dose-titration.

Special populations Renal impairment No dose adjustment is required for patients with mild to moderate renal impairment (Glomerular Filtration Rate (GFR) ≥ 30 ml/min). 2). 3). 3). 4). No adjustment of the hydrochlorothiazide dose is required for patients with mild to moderate hepatic impairment.

2). Elderly No dose adjustment is required in elderly patients. 5mg Film-coated Tablets is not recommended for use in children below the age of 18 years due to a lack of data on safety and efficacy. 5mg Film-coated Tablets can be taken with or without food and should be administered with water.

Adverse drug reactions reported in clinical trials and laboratory findings occurring more frequently with valsartan plus hydrochlorothiazide versus placebo and individual postmarketing reports are presented below according to system organ class.

Adverse drug reactions known to occur with each component given individually but which have not been seen in clinical trials may occur during treatment with valsartan/hydrochlorothiazide. Adverse drug reactions Adverse drug reactions are ranked by frequency, the most frequent first, using the following convention: 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).

Within each frequency grouping, adverse reactions are ranked in order of decreasing seriousness. Table 1. 5mg Film-coated Tablets as well, even if not observed in clinical trials or during postmarketing period. Table 2. Frequency of adverse reactions with valsartan Blood and lymphatic system disorders Not known Decrease in haemoglobin, decrease in haematocrit, thrombocytopenia Immune system disorders Not known Other hypersensitivity/allergic reactions including serum sickness Metabolism and nutrition disorders Not known Increase of serum potassium, hyponatraemia Ear and labyrinth disorders Uncommon Vertigo Vascular disorders Not known Vasculitis Gastrointestinal disorders Uncommon Abdominal pain Very rare Intestinal angioedema Hepatobiliary disorders Not known Elevation of liver function values Skin and subcutaneous tissue disorders Not known Angioedema, rash, dermatitis bullous, pruritus Renal and urinary disorders Not known Renal failure Table 3.

5mg Film-coated Tablets. 1). Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.

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) is not recommended. Monitoring of potassium should be undertaken as appropriate. Hydrochlorothiazide Hypokalaemia has been reported under treatment with thiazide diuretics, including hydrochlorothiazide. Frequent monitoring of serum potassium is recommended.

Treatment with thiazide diuretics, including hydrochlorothiazide, has been associated with hyponatraemia and hypochloraemic alkalosis. Thiazides, including hydrochlorothiazide, increase the urinary excretion of magnesium, which may result in hypomagnesaemia.

Calcium excretion is decreased by thiazide diuretics. This may result in hypercalcaemia. As for any patient receiving diuretic therapy, periodic determination of serum electrolytes should be performed at appropriate intervals. Sodium and/or volume-depleted patients Patients receiving thiazide diuretics, including hydrochlorothiazide, should be observed for clinical signs of fluid or electrolyte imbalance.

5mg Film-coated Tablets. g. patients with severe congestive heart failure), treatment with angiotensin converting enzyme inhibitors has been associated with oliguria and/or progressive azotaemia, and in rare cases with acute renal failure and/or death.

5mg Film-coated Tablets in patients with severe chronic heart failure has not been established. Hence it cannot be excluded that because of the inhibition of the renin-angiotensin-aldosterone system the application of Valartan HCT as well may be associated with impairment of the renal function.

Valartan HCT should not be used in these patients. 5mg Film-coated Tablets should not be used to treat hypertension in patients with unilateral or bilateral renal artery stenosis or stenosis of the artery to a solitary kidney, since blood urea and serum creatinine may increase in such patients.

5mg Film-coated Tablets as their renin-angiotensin system is not activated. Aortic and mitral valve stenosis, hypertrophic obstructive cardiomyopathy As with all other vasodilators, special caution is indicated in patients suffering from aortic or mitral stenosis, or hypertrophic obstructive cardiomyopathy (HOCM).

2). 5mg Film-coated Tablets is used in patients with renal impairment. 5). Kidney transplantation There is currently no experience on the safe use of valsartan/hydrochlorothiazide in patients who have recently undergone kidney transplantation.

2). Thiazides should be used with caution in patients with impaired hepatic function or progressive liver disease, since minor alterations of fluid and electrolyte balance may precipitate hepatic coma. Acute Respiratory Toxicity Very rare severe cases of acute respiratory toxicity, including acute respiratory distress syndrome (ARDS) have been reported after taking hydrochlorothiazide.

Pulmonary oedema typically develops within minutes to hours after hydrochlorothiazide intake. At the onset, symptoms include dyspnoea, fever, pulmonary deterioration and hypotension. If diagnosis of ARDS is suspected, Valsartan/Hydrochlorothiazide should be withdrawn and appropriate treatment given, Hydrochlorothiazide should not be administered to patients who previously experienced ARDS following hydrochlorothiazide intake.

8). These patients presented with abdominal pain, nausea, vomiting and diarrhoea. Symptoms resolved after discontinuation of angiotensin II receptor antagonists. If intestinal angioedema is diagnosed, Valsartan should be discontinued and appropriate monitoring should be initiated until complete resolution of symptoms has occurred.

History of angioedema Angioedema, including swelling of the larynx and glottis, causing airway obstruction and/or swelling of the face, lips, pharynx, and/or tongue has been reported in patients treated with valsartan; some of these patients previously experienced angioedema with other drugs including ACE inhibitors.

Valsartan/Hydrochlorothiazide should be immediately discontinued in patients who develop angioedema, and Valsartan/Hydrochlorothiazide […]

1. 6). - Severe hepatic impairment, biliary cirrhosis and cholestasis. - Severe renal impairment (creatinine clearance <30 ml/min), anuria. - Refractory hypokalaemia, hyponatraemia, hypercalcaemia, and symptomatic hyperuricaemia. 1).