FINIL 16mg Tablet

Land: Malaysia

Sprache: Englisch

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

Wirkstoff:

CANDESARTAN CILEXETIL

Verfügbar ab:

MEDISPEC (M) SDN.BHD

INN (Internationale Bezeichnung):

CANDESARTAN CILEXETIL

Einheiten im Paket:

10x10 Tablets

Hergestellt von:

Unison Laboratories Co. Ltd.

Gebrauchsinformation

_ _
_ _
_ _
_ _
_ _
_ _
_ _
_ _
_ _
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
FINIL 16MG TABLET
Candesartan cilexetil (16 mg) 1
WHAT IS IN THIS LEAFLET
1.
What Finil 16 is used for
2.
How Finil 16 works
3.
Before you use Finil 16
4.
How to use Finil 16
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of Finil 16
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT FINIL 16 IS USED FOR
Finil 16 can be used to:
•
Treat high blood pressure
•
Treat heart failure patients with
reduced heart muscle function
when Angiotensin Converting
Enzyme (ACE) inhibitors cannot be
used or in addition to ACE-
inhibitors.
HOW FINIL 16 WORKS
Finil 16 contains the active
ingredient, Candesartan cilexetil.
This belongs to a group of medicines
called angiotensin II receptor
antagonists. It works by making your
blood vessels relax and widen. This
helps to lower your blood pressure. It
also makes it easier for your heart to
pump blood to all parts of your body.
BEFORE YOU USE FINIL 16
_- When you must not use it _
•
If you are allergic (hypersensitive)
to Candesartan cilexetil or any of
the other ingredients of this
medicine (listed in
_Ingredients). _
•
If you are more than 3 months
pregnant
_ _
•
If you have severe liver disease or
biliary obstruction (a problem with
the drainage of the bile from the
gall bladder).
_ _
•
If the patient is a child under 1
year of age.
_ _
•
If you have diabetes or impaired
kidney function and you are treated
with a blood pressure lowering
medicine containing Aliskiren.
_ _
_Pregnancy and lactation _
Do not take Finil 16 if you are
pregnant, trying to get pregnant or
think you may be pregnant.
Do not take Finil 16 if you are breast-
feeding. Ask your doctor or
pharmacist for advice before taking
any medicine.
_- Before you start to use it _
Talk to your doctor or pharmacist
before taking Finil 16.
•
If you have heart, liver or kidney
problems or on dialysis.
•
If you have recently had a kidney
transplant.
•
If you hav

Fachinformation

-1-
-2-
-3-
The pharmacokinetics of Candesartan cilexetil have not been
investigated in pediatric patients < 1 year
of age.
INDICATION**:
•
Treatment of 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
.
DOSAGE AND ADMINISTRATION**:
Oral
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
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 Warning and precaution).
_USE IN IMPAIRED RENAL FUNCTION_
No initial dosage adjustment is necessary in patients with mild to
moderate renal impairment (i.e creatinine
clearance 30-80 mL/min/1.73 m
2
BSA). In patients with severe renal impairment (i.e. creatinine
clearance
< 30 mL/min/1.73 m
2
BSA), the clinical experience is limited and a lower initial dose of 4
mg should
be considered.
_USE IN IMPAIRED HEPATIC FUNCTION_
Patient with hepatic impairment: Dose titration is recommended in
patients with mild to moderate
chronic liver disease, and a lower initial dose of 4 mg should be
considered. Finil 16 should not be used
in patients with severe hepatic impairment and/or cholestasis (see
Contraindication).
_CONCOMITANT THERAPY_
Addition of a thiazi