ATACAND PLUS

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

CANDESARTAN CILEXETIL ; HYDROCHLOROTHIAZIDE

Available from:

Imbat Limited

ATC code:

C09DA06

INN (International Name):

CANDESARTAN CILEXETIL ; HYDROCHLOROTHIAZIDE

Dosage:

16/12.5 Milligram

Pharmaceutical form:

Tablets

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

candesartan and diuretics

Authorization status:

Authorised

Authorization date:

2009-06-19

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Atacand Plus 16/12.5mg tablets.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One Atacand Plus tablet contains 16mg candesartan cilexetil and 12.5mg
hydrochlorothiazide.
Excipients: each tablet also contains lactose monohydrate.
For a full list of excipients, see 6.1.
3 PHARMACEUTICAL FORM
Tablets
_Product imported from Italy._
Atacand Plus are peach, oval, biconvex tablets with a score on both
sides and engraved A/CS on one side and plain on
the other.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Atacand Plus is indicated for the:
Treatment of essential hypertension in adult patients whose blood
pressure is not optimally controlled with
candesartan cilexetil or hydrochlorothiazide monotherapy.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The recommended dose of Atacand Plus 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 Atacand
Plus maybe considered. Dose titration of
candesartan cilexetil is recommended when switching from
hydrochlorothiazide monotherapy. Atacand Plus may be
administered in patients whose blood pressure is not optimally
controlled with candesartan cilexetil or
hydrochlorothiazide monotherapy or Atacand Plus at lower doses.
Most of the antihypertensive effect is usually attained within 4 weeks
of initiation of treatment.
Special populations
_Elderly population_
No dose adjustment is necessary in elderly patients.
_Patients with 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).
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