Apo-Candesartan

Country: New Zealand

Lingwa: Ingliż

Sors: Medsafe (Medicines Safety Authority)

Ingredjent attiv:

Candesartan cilexetil 16mg;  

Disponibbli minn:

Apotex NZ Ltd

INN (Isem Internazzjonali):

Candesartan cilexetil 16 mg

Dożaġġ:

16 mg

Għamla farmaċewtika:

Tablet

Kompożizzjoni:

Active: Candesartan cilexetil 16mg   Excipient: Carmellose calcium Hyprolose Iron oxide red Lactose monohydrate Magnesium stearate Maize starch Purified water Triacetin

Unitajiet fil-pakkett:

Blister pack, PVC/PVdC/Al, 7 tablets

Klassi:

Prescription

Tip ta 'preskrizzjoni:

Prescription

Manifatturat minn:

Apotex Pharmachem India Pvt. Ltd.

Indikazzjonijiet terapewtiċi:

Treatment of hypertension.

Sommarju tal-prodott:

Package - Contents - Shelf Life: Blister pack, PVC/PVdC/Al - 7 tablets - 24 months from date of manufacture stored at or below 30°C - Blister pack, PVC/PVdC/Al - 28 tablets - 24 months from date of manufacture stored at or below 30°C - Blister pack, PVC/PVdC/Al - 30 tablets - 24 months from date of manufacture stored at or below 30°C - Bottle, plastic, HDPE - 28 tablets - 24 months from date of manufacture stored at or below 30°C - Bottle, plastic, HDPE - 30 tablets - 24 months from date of manufacture stored at or below 30°C - Bottle, plastic, HDPE - 100 tablets - 24 months from date of manufacture stored at or below 30°C

Data ta 'l-awtorizzazzjoni:

2012-12-10

Karatteristiċi tal-prodott

NEW ZEALAND DATA SHEET
APO-CANDESARTAN
CANDESARTAN CILEXETIL 4 MG, 8 MG, 16 MG AND 32 MG TABLETS
Please refer to Medsafe website (
www.medsafe.govt.nz
) for the most recent datasheet
Page 1
PRESENTATION
APO-CANDESARTAN Tablets 4 mg: White to off white coloured, round shaped, biconvex tablets,
engraved “APO” on one side and “CA” scored “4” on the other side.
APO-CANDESARTAN Tablets 8 mg: Pink to light pink coloured, round shaped, biconvex tablets,
engraved “APO” on one side and “CA” bisect “8” on the other side.
APO-CANDESARTAN Tablets 16 mg: Pink to light pink coloured, round shaped, biconvex
tablets, engraved “APO” on one side and “CA” bisect “16” on the other side.
APO-CANDESARTAN Tablets 32 mg: Pink to light pink coloured, round shaped, biconvex
tablets, engraved “APO” on one side and “CA” bisect “32” on the other side.
Do not halve tablet. Dose equivalence when the tablet is divided has not been established.
INDICATIONS
Hypertension.
Treatment of patients with heart failure and left ventricular systolic dysfunction. Treatment with
APO-CANDESARTAN reduces mortality, reduces hospitalisation due to heart failure, and
improves symptoms.
DOSAGE AND ADMINISTRATION
DOSAGE IN HYPERTENSION
The recommended initial and maintenance dose of candesartan is 8 mg once daily. The dose
may be increased to 16 mg once daily. In patients who require further blood pressure reduction,
the dose may be increased to 32 mg once daily.
Therapy should be adjusted according to blood pressure response. The maximal antihypertensive
effect is attained within 4 weeks after initiation of treatment.
In patients with less than optimal blood pressure reduction on candesartan combination with a
thiazide diuretic is recommended.
USE IN THE ELDERLY
No initial dosage�