ATACAND Tablets 32 Milligram
البلد: أيرلندا
اللغة: الإنجليزية
المصدر: HPRA (Health Products Regulatory Authority)
خصائص المنتج
(SPC)
18-05-2024
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ارسل طلب
ارسل طلب
العنصر النشط:
CANDESARTAN CILEXETIL
متاح من:
AstraZeneca UK Limited
جرعة:
32 Milligram
الشكل الصيدلاني:
Tablets
تاريخ الترخيص:
2005-07-22
خصائص المنتج
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Atacand 32 mg tablets.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 32 mg candesartan cilexetil.
Each 32 mg tablet contains 163 mg lactose monohydrate.
For a full list of excipients, _see section 6.1._
3 PHARMACEUTICAL FORM
Tablet
Atacand 32 mg are round (diameter 9.5 mm), pink tablets with a score and marked A/CL on one side and marked 032
on the other side.
Atacand 32 mg tablets can be divided into equal halves.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Essential hypertension.
Treatment of patients with heart failure and impaired left ventricle systolic function (left ventricular ejection fraction
40%) as add-on therapy to ACE inhibitors or when ACE inhibitors are not tolerated _(see section 5.1 Pharmacodynamic_
_properties)._
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
_Dosage in Hypertension_
The recommended initial dose and usual maintenance dose is 8 mg once daily. The dose may be increased to 16 mg
once daily. If blood pressure is not sufficiently controlled after 4 weeks of treatment with 16 mg once daily, the dose
may be further increased to a maximum of 32 mg once daily _(see section 5.1 Pharmacodynamic properties). _If blood
pressure control is not achieved with this dose, alternative strategies should be considered.
Therapy should be adjusted according to blood pressure response. Most of the antihypertensive effect is attained within
4 weeks of initiation of treatment.
_Use in the elderly_
No initial dosage adjustment is necessary in elderly patients.
_Use in 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 also 4.4 Special warnings and
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