Candy 16 mg

These preparation are not used during pregnancy as they may cause fetal injury or fetal death

Name of the medicinal product

CANDY 8MG TABLETS

CANDY 16 MG TABLETS

Qualitative and quantitative composition

Each tablet contains 8 mg Candesartan Cilexetil .

Each tablet contains 16 mg Candesartan Cilexetil.

Excipient with known effect

    • 8 mg: Each tablet contains (lactose monohydrate  70mg )16 mg: Each tablet contains (lactose monohydrate 164mg )
      1. Pharmaceutical form

      Tablet.

      Candy 8mg :(White  round  biconvex tablet scored from one side )

      Candy 16 mg : (White , round, biconvex tablet scored from one side)

      1. Clinical particulars

      4.1 Therapeutic indications

      • Treatment of essential hypertension in adults.
      • Treatment of adult patients with heart failure and impaired left ventricular systolic function (left ventricular ejection fraction ≤ 40%) when Angiotensin Converting Enzyme (ACE)-inhibitors are not tolerated or as add-on therapy to ACE-inhibitors in patients with symptomatic heart failure, despite optimal therapy, when mineralocorticoid receptor antagonists are not tolerated (see sections 4.2, 4.4, 4.5 and 5.1).
      • Treatment of hypertension in children and adolescents aged 6 to <18 years.

      4.2 Posology and method of administration

Category:
Posology in hypertension
Elderly population
Renal impairment
Hepatic impairment
Black patients

Posology in hypertension

The recommended initial dose and usual maintenance dose of Candy 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. Candy may also be administered with other antihypertensive agents (see sections 4.3, 4.4, 4.5 and 5.1). Addition of hydrochlorothiazide has been shown to have an additive antihypertensive effect with various doses of Candy.

Elderly population

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. Candy is contraindicated in patients with severe hepatic impairment and/or cholestasis (see sections 4.3 and 5.2).

Black patients

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

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