APO-CANDESARTAN HCTZ 16/12.5

Krajina: Nový Zéland

Jazyk: angličtina

Zdroj: Medsafe (Medicines Safety Authority)

Aktívna zložka:

Candesartan cilexetil 16mg;  ; Hydrochlorothiazide 12.5mg

Dostupné z:

Arrotex Pharmaceuticals (NZ) Limited

Forma lieku:

Tablet

Zloženie:

Active: Candesartan cilexetil 16mg   Hydrochlorothiazide 12.5mg Excipient: Carmellose calcium Hyprolose Lactose monohydrate Macrogol 8000 Magnesium stearate Maize starch Pigment blend PB-24880 pink

Typ predpisu:

Prescription

Terapeutické indikácie:

APO-CANDESARTAN HCTZ is indicated for the treatment of hypertension. Treatment should not be initiated with these fixed dose combinations.

Prehľad produktov:

Package - Contents - Shelf Life: Blister pack, Alu-Alu blister in cardboard carton - 7 tablets - 24 months from date of manufacture stored at or below 25°C - Blister pack, Alu-Alu blister in cadboard carton - 30 tablets - 24 months from date of manufacture stored at or below 25°C

Dátum Autorizácia:

2022-06-23

Súhrn charakteristických

1
NEW ZEALAND DATA SHEET
1
PRODUCT NAME
APO-CANDESARTAN HCTZ 16/12.5
APO-CANDESARTAN HCTZ 32/12.5
APO-CANDESARTAN HCTZ 32/25
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each
tablet
contains
16
mg
or
32
mg
candesartan
cilexetil
and
12.5
mg
or
25
mg
hydrochlorothiazide as the active ingredient.
EXCIPIENTS WITH KNOWN EFFECT
Sugars as lactose monohydrate.
For the full list of excipients see section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
CANDESARTAN HCTZ 16/12.5 TABLETS
Light pink, oval shape, biconvex, uncoated, mottled tablets debossed
with ‘L3’ and ’02’ on
either side of breakline on one side and break line on other side
CANDESARTAN HCTZ 32/12.5 MG TABLET
Light yellow, oval biconvex uncoated mottled tablets debossed with
'L3' & '04' on either side of
break line on one side & break line on one other side
CANDESARTAN HCTZ 32/25 MG TABLET
Light pink, oval biconvex uncoated mottled tablets debossed with 'L3'
& '04' on either side of
break line on one side & break line on one other side
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Candesartan HCTZ is indicated for the treatment of hypertension.
Treatment should not be
initiated with these fixed dose combinations.
4.2
DOSE AND METHOD OF ADMINISTRATION
APO- candesartan HCTZ are intended for oral administration.
DOSAGE
The dose of Candesartan HCTZ must be determined by careful titration
of the dose of each of
the individual components.
The recommended dose is 1 tablet once daily. Candesartan HCTZ may be
taken with or
without food. The tablets should not be divided.
Candesartan HCTZ 16/12.5 may be administered in patients whose blood
pressure is not
optimally controlled with hydrochlorothiazide alone or candesartan 16
mg monotherapy.
2
Candesartan HCTZ 32/12.5 or 32/25 may be administered in patients
whose blood pressure
is not optimally controlled with hydrochlorothiazide alone or
candesartan 32 mg monotherapy,
or
at
a
lower
dose
of
Candesartan
HCTZ.
Dose
titration
of
candesartan
cilexetil
is
recommended when adding on to hydrochlorothiazide monotherapy