CANDESARTAN CILEXETIL Tablet Ref.[51457] Active ingredients: Candesartan

Posology in Hypertension

The recommended initial dose and usual maintenance dose of Candesartan Cilexetil is 8 mg once daily. Most of the antihypertensive effect is attained within 4 weeks. In some patients whose blood pressure is not adequately controlled, the dose can be increased to 16 mg once daily and to a maximum of 32 mg once daily. Therapy should be adjusted according to blood pressure response.

Candesartan Cilexetil may also be administered with other antihypertensive agents. Addition of hydrochlorothiazide has been shown to have an additive antihypertensive effect with various doses of Candesartan cilexetil.

Elderly

No initial dose adjustment is necessary in elderly patients.

Patients with intravascular volume depletion

An initial dose of 4 mg may be considered in patients at risk for hypotension, such as patients with possible volume depletion (see section 4.4).

Renal impairment

The starting dose is 4 mg in patients with renal impairment, including patients on haemodialysis. The dose should be titrated according to response. There is limited experience in patients with very severe or end-stage renal impairment (Clcreatinine <15 ml/min) (see section 4.4).

Hepatic impairment

An initial dose of 4 mg once daily is recommended in patients with mild to moderate hepatic impairment. The dose may be adjusted according to response. Candesartan cilexetil is contraindicated in patients with severe hepatic impairment and/or cholestasis (see sections 4.3 and 5.2).

Black patients

The antihypertensive effect of candesartan is less pronounced in black patients than in non-black patients. Consequently, uptitration of Candesartan cilexetil and concomitant therapy may be more frequently needed for blood pressure control in black patients than in non-black patients (see section 5.1).

Paediatric Population

Children and adolescents aged 6 to <18 years

The recommended starting dose is 4 mg once daily.

• For patients weighing <50 kg: In patients whose blood pressure is not adequately controlled, the dose can be increased to a maximum of 8 mg once daily.
• For patients weighing ≥50 kg: In patients whose blood pressure is not adequately controlled, the dose can be increased to 8 mg once daily and then to 16 mg once daily if needed (see section 5.1).

Doses above 32 mg have not been studied in paediatric patients.

Most of the antihypertensive effect is attained within 4 weeks.

For children with possible intravascular volume depletion (e.g., patients treated with diuretics, particularly those with impaired renal function), Candesartan Cilexetil treatment should be initiated under close medical supervision and a lower starting dose than the general starting dose above should be considered (see section 4.4).

Candesartan Cilexetil has not been studied in children with glomerular filtration rate less than 30 ml/min/1.73m² (see section 4.4).

Black paediatric patients

The antihypertensive effect of candesartan is less pronounced in black patients than in nonblack patients. (see section 5.1).

Children aged below 1 year to <6 years

• The safety and efficacy in children aged 1 to <6 years of age has not been established. Currently available data are described in section 5.1 but no recommendation on a posology can be made.
• Candesartan Cilexetil is contraindicated in children aged below 1 year (see section 4.3).

Posology in Heart Failure

The usual recommended initial dose of Candesartan cilexetil is 4 mg once daily. Up-titration to the target dose of 32 mg once daily (maximum dose) or the highest tolerated dose is done by doubling the dose at intervals of at least 2 weeks (see section 4.4). Evaluation of patients with heart failure should always comprise assessment of renal function including monitoring of serum creatinine and potassium. Candesartan Cilexetil can be administered with other heart failure treatment, including ACE-inhibitors, beta-blockers, diuretics and digitalis or a combination of these medicinal products. Candesartan Cilexetil may be co-administered with an ACE-inhibitor in patients with symptomatic heart failure despite optimal standard heart failure therapy when mineralocorticoid receptor antagonists are not tolerated. The combination of an ACE-inhibitor, a potassium-sparing diuretic and Candesartan Cilexetil is not recommended and should be considered only after careful evaluation of the potential benefits and risks (see Sections 4.4, 4.8 and 5.1).

Special patient populations

No initial dose adjustment is necessary for elderly patients or in patients with intravascular volume depletion or renal impairment or mild to moderate hepatic impairment.

Paediatric Population

The safety and efficacy of Candesartan cilexetil in children aged between birth and 18 years have not been established in the treatment of heart failure. No data are available.

Method of administration

Oral use.

Candesartan cilexetil should be taken once daily with or without food.

The bioavailability of candesartan is not affected by food.

Symptoms

Based on pharmacological considerations, the main manifestation of an overdose is likely to be symptomatic hypotension and dizziness. In individual case reports of overdose (of up to 672 mg candesartan cilexetil) in an adult patient recovery was uneventful.

Management

If symptomatic hypotension should occur, symptomatic treatment should be instituted and vital signs monitored. The patient should be placed supine with the legs elevated. If this is not sufficient, plasma volume should be increased by infusion of, for example, isotonic saline solution. Sympathomimetic medicinal products may be administered if the abovementioned measures are not sufficient.

Candesartan is not removed by haemodialysis.

2 years.

Store below 30°C.

Candesartan Cilexetil tablets are available in PVC/PVdC – Aluminium foil blister pack and HDPE container pack with polypropylene closure.

Pack sizes:

Blister pack: 7, 28, 30, 56, 90, 98 & 500 tablets.

HDPE pack: 30, 90 & 500 tablets.

Not all pack sizes may be marketed.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.