Candesartan HCT Sandoz 16mg12.5mg Tablet

Country: Malaysia

Bahasa: Inggeris

Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Bahan aktif:

HYDROCHLOROTHIAZIDE; CANDESARTAN CILEXETIL

Boleh didapati daripada:

SANDOZ PRODUCTS MALAYSIA SDN. BHD.

INN (Nama Antarabangsa):

HYDROCHLOROTHIAZIDE; CANDESARTAN CILEXETIL

Unit dalam pakej:

28 Tablets; 30 Tablets

Dikeluarkan oleh:

LEK PHARMACEUTICALS D.D.

Risalah maklumat

_Consumer Medication Information Leaflet (RiMUP) _
CANDESARTAN HCT SANDOZ TABLET
Candesartan cilexetil & Hydrochlorothiazide (16mg/12.5mg)
1
WHAT IS IN THIS LEAFLET:
1.
What Candesartan HCT Sandoz is
used for
2.
How
Candesartan
HCT
Sandoz
works
3.
Before you use Candesartan HCT
Sandoz
4.
How
to
use
Candesartan
HCT
Sandoz
5.
While you are using Candesartan
HCT Sandoz
6.
Side effects
7.
Storage and disposal Candesartan
HCT Sandoz
8.
Product description
9.
Manufacturer
&
Product
Registration Holder
10.
Date of revision
WHAT CANDESARTAN HCT
SANDOZ IS USED FOR
Candesartan HCT Sandoz is used for
treating hypertension (high blood
pressure), where a monotherapy is not
sufficiently effective.
HOW CANDESARTAN HCT
SANDOZ WORKS
Candesartan cilexetil is a type of
medicine called an angiotensin II
receptor antagonist, which by
blocking the effects of the hormone
angiotensin II, causes relaxation of the
blood vessels and results in a lowering
of the blood pressure.
Hydrochlorothiazide belongs to a
class of drugs called diuretics. Its
effect promotes the urinary excretion
of sodium, chloride and water and
results in a lowering of the blood
pressure
BEFORE YOU USE CANDESARTAN
HCT SANDOZ
_When you must not use it _
DO NOT TAKE CANDESARTAN HCT
SANDOZ:
•
if you are pregnant, think you might
be pregnant or considering
becoming pregnant. It may cause
serious harm or even death your
baby if used during pregnancy
•
if you are breast-feeding
•
if you are allergic to any of the
ingredients in Candesartan HCT
Sandoz or to drugs closely related
to hydrochlorothiazide
•
if you have severe liver disease
•
if you have severe kidney disease
•
if you have had gout
•
if you have had problems in the past
when taking medicines containing
candesartan cilexetil or
hydrochlorothiazide
•
if you have diabetes or impaired
kidney function and you are treated
with a blood pressure medicine
containing aliskiren.
_Before you start to use it _
Please talk to your doctor or pharmacist
before taking this medicine:
•
if you have any heart, live

Ciri produk

1
PACKAGE INSERT
1.
NAME OF THE MEDICINAL PRODUCT
Candesartan HCT Sandoz 16mg/12.5mg Tablet
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 16 mg of candesartan cilexetil and 12.5 mg of
hydrochlorothiazide.
Excipients with known effect: lactose monohydrate.
For the full list of excipients, see section 6.1 Excipients.
3.
PHARMACEUTICAL FORM
Apricot, mottled, oval biconvex tablets, scored on both sides.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Hypertension when a monotherapy is not sufficiently effective.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Dosage in hypertension
The recommended dose of Candesartan HCT Sandoz is one tablet once
daily.
Most of the antihypertensive effect is usually attained within 4 weeks
of initiation of treatment.
When clinically appropriate a direct change from monotherapy to
Candesartan HCT Sandoz may be considered.
Dose titration of candesartan cilexetil is recommended when switching
from hydrochlorothiazide monotherapy.
Administration
For oral use.
Candesartan HCT Sandoz should be taken once daily with or without
food.
Use in the elderly
No dosage adjustment is necessary in elderly patients.
Use in impaired renal function
In patients with mild to moderate renal impairment (i.e., creatinine
clearance between 30-80ml/min/1.73 m
2
BSA),
a dose titration is recommended.
Candesartan HCT Sandoz should not be used in patients with severe
renal impairment (creatinine clearance <30
ml/min/1.73 m
2
BSA).
Use in impaired hepatic function
Patients with hepatic impairment: Dose titration is recommended in
patients with mild to moderate chronic liver
disease.
Candesartan HCT Sandoz should not be used in patients with severe
hepatic impairment and/or cholestasis.
Use in children
The safety and efficacy of Candesartan HCT Sandoz have not been
established in children.
4.3 CONTRAINDICATIONS
•
Hypersensitivity to the active substances or to any of the excipients
or to sulfonamide derived active
substances. Hydrochlorothiazide is a sulfonamide derived active
substance.
•
Preg