CANDESARTAN AND HYDROCHLOROTHIAZIDE

Posology in hypertension The recommended dose of Candesartan and Hydrochlorothiazide Tablets is one tablet once daily. Dose titration with the individual components (candesartan cilexetil and hydrochlorothiazide) is recommended. When clinically appropriate a direct change from monotherapy to Candesartan and Hydrochlorothiazide Tablets may be considered.

Dose titration of candesartan cilexetil is recommended when switching from hydrochlorothiazide monotherapy. Candesartan and Hydrochlorothiazide Tablets may be administered in patients whose blood pressure is not optimally controlled with candesartan cilexetil or hydrochlorothiazide monotherapy or Candesartan and Hydrochlorothiazide Tablets at lower doses.

Most of the antihypertensive effect is usually attained within 4 weeks of initiation of treatment. Special populations Elderly No dose adjustment is necessary in elderly patients. Intravascular volume depletion Dose titration of candesartan cilexetil is recommended in patients at risk for hypotension, such as patients with possible volume depletion (an initial dose of candesartan cilexetil of 4 mg may be considered in these patients).

73 m2 Body Surface Area (BSA)) a dose titration is recommended. 3). 3). Paediatric population The safety and efficacy of Candesartan and Hydrochlorothiazide Tablets in children aged between birth and 18 years have not been established.

No data are available. Method of administration Oral use. Candesartan and Hydrochlorothiazide Tablets can be taken with or without food. The bioavailability of candesartan is not affected by food. There is no clinically significant interaction between hydrochlorothiazide and food.

In controlled clinical studies with candesartan cilexetil/hydrochlorothiazide adverse reactions were mild and transient. 3%). In clinical trials with candesartan cilexetil/hydrochlorothiazide, adverse reactions were limited to those that were reported previously with candesartan cilexetil and/or hydrochlorothiazide.

The table below presents adverse reactions with candesartan cilexetil from clinical trials and post marketing experience. In a pooled analysis of clinical trial data of hypertensive patients, adverse reactions with candesartan cilexetil were defined based on an incidence of adverse events with candesartan cilexetil at least 1% higher than the incidence seen with placebo.

8 are: 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) and not known (cannot be estimated from the available data). 4) The table below presents adverse reactions with hydrochlorothiazide monotherapy usually with doses of 25 mg or higher.

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. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

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, Candesartan and Hydrochlorothiazide Tablets should be withdrawn and appropriate treatment given. Hydrochlorothiazide should not be administered to patients who previously experienced ARDS following hydrochlorothiazide intake Dual blockade of the renin-angiotensin-aldosterone system (RAAS) There is evidence that the concomitant use of ACE-inhibitors, angiotensin II receptor blockers or aliskiren increases the risk of hypotension, hyperkalaemia and decreased renal function (including acute renal failure).

1). If dual blockade therapy is considered absolutely necessary, this should only occur under specialist supervision and subject to frequent close monitoring of renal function, electrolytes and blood pressure. ACE-inhibitors and angiotensin II receptor blockers should not be used concomitantly in patients with diabetic nephropathy.

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, Candesartan and Hydrochlorothiazide tablets should be discontinued and appropriate monitoring should be initiated until complete resolution of symptoms has occurred.

3). Kidney transplantation There is limited clinical evidence regarding Candesartan and Hydrochlorothiazide tablets use in patients who have undergone kidney transplantation. Renal artery stenosis Medicinal products that affect the renin-angiotensin-aldosterone system, including angiotensin II receptor antagonists (AIIRAs), may increase blood urea and serum creatinine in patients with bilateral renal artery stenosis or stenosis of the artery to a solitary kidney.

Intravascular volume depletion In patients with intravascular volume and/or sodium depletion symptomatic hypotension may occur, as described for other agents acting on the renin- angiotensin-aldosterone system. Therefore, the use of Candesartan and Hydrochlorothiazide Tablets is not recommended until this condition has been corrected.

Anaesthesia and surgery Hypotension may occur during anaesthesia and surgery in patients treated with AIIRAs due to blockade of the renin-angiotensin system. Very rarely, hypotension may be severe such that it may warrant the use of intravenous fluids and/or vasopressors.

Hepatic impairment 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. There is no clinical experience with Candesartan and Hydrochlorothiazide Tablets in patients with hepatic impairment.

Aortic and mitral valve stenosis (obstructive hypertrophic cardiomyopathy) As with other vasodilators, special caution is indicated in patients suffering from haemodynamically relevant aortic or mitral valve stenosis, or obstructive hypertrophic cardiomyopathy.

Primary hyperaldosteronism Patients with primary hyperaldosteronism generally will not respond to antihypertensive agents acting through inhibition of the renin-angiotensin- aldosterone system. Therefore the use of Candesartan and Hydrochlorothiazide Tablets is not recommended in this population.

Electrolyte imbalance Periodic determination of serum electrolytes should be performed at appropriate intervals. Thiazides, including hydrochlorothiazide, can cause fluid or electrolyte imbalance (hypercalcaemia, hypokalaemia, hyponatraemia, hypomagnesaemia and hypochloraemic alkalosis).

Thiazide diuretics may decrease the urinary calcium excretion and may cause intermittent and slightly increased serum calcium concentrations. Marked hypercalcaemia may be a sign of hidden hyperparathyroidism. Thiazides should be discontinued before carrying out tests for parathyroid function.

Hydrochlorothiazide dose-dependently increases urinary potassium excretion which may result in hypokalaemia. This effect of hydrochlorothiazide seems to be less evident when combined with candesartan cilexetil. The risk for hypokalaemia may be increased in patients with cirrhosis of the liver, in patients experiencing brisk diuresis, in patients with an inadequate oral intake of electrolytes and in patients receiving concomitant therapy with corticosteroids or adrenocorticotropic hormone (ACTH).

Treatment with candesartan cilexetil may cause hyperkalaemia, especially in the presence of heart failure and/or renal impairment. g. heparin sodium, co-trimoxazole also known as trimethoprim/sulfamethoxazole) may lead to increases in serum potassium.

Monitoring of potassium should be undertaken as appropriate. Thiazides have been shown to increase the urinary excretion of magnesium, which may result in hypomagnesaemia. Metabolic and endocrine effects Treatment with a thiazide diuretic may […]

1 or to sulfonamide derived active substances. Hydrochlorothiazide is a sulfonamide derived active substance. 73 m2 BSA). Severe hepatic impairment and/or cholestasis. Refractory hypokalaemia and hypercalcaemia. Gout. 1).