CANDESARTAN TEVA PHARMA 4 Milligram Tablets

Pays: Irlande

Langue: anglais

Source: HPRA (Health Products Regulatory Authority)

Ingrédients actifs:

CANDESARTAN CILEXETIL

Disponible depuis:

Teva Pharma B.V.

DCI (Dénomination commune internationale):

CANDESARTAN CILEXETIL

Dosage:

4 Milligram

forme pharmaceutique:

Tablets

Type d'ordonnance:

Product subject to prescription which may be renewed (B)

Statut de autorisation:

Withdrawn

Date de l'autorisation:

2014-06-26

Notice patient

PRODUCT
:
AMENDS:
APPROVAL:
SENIOR ARTWORK CO-ORDINATO
R
• SUBJECT TO REG. AGENCY APPROVAL
• APPROVED BY REG. DEPT. FOR PRINT 
DESIGN DEPARTMENT
 Harlow
Signed
Signed
27226
CANDESARTAN T
EVA PHARMA 
4/8/16/32MG T
ABS ALL TEI (BLU) 
V2
27-2-13
148x600mm
5
12-03-14
TB
KA
Leafl
 et
CUTTER GUIDE
PMS PROCESS BLACK
PMS GREEN
INDESIGN CS6
Last amend:
X
SUPPLIER INSTRUCTIONS 
Artwork, text and content must NOT be altered. The only exceptions to
this are: bleeds, 
chokes, spreads or other adjustments required for print reproduction
purposes only
. If you have any diffi
 culties 
please contact the T
eva Artwork T
eam. W
e
 must receive a copy of the 3rd Party V
endors Proof before fi
 nal 
approval can be made. 
Body: Univers 55 Roman/

65 Bold/ 55 Oblique 10pts
Subhead: Univers 65 Bld 11pts
Header: Univers 65 Bld 14pts
CANDESARTAN 
TEVA PHARMA 
4 MG, 8 MG, 16 MG & 
32 MG TABLETS
CANDESARTAN CILEXETIL
PACKAGE LEAFLET: INFORMATION 
FOR THE USER
READ ALL OF THIS LEAFL ET CAREFULLY 
BEFORE YOU START TAKING THIS MEDICINE 
BECAUSE IT CONTAINS IMPORTANT 
INFORMATION FOR YOU.
•  
Keep this leafl et. You may need to 
read it again.
•  
If you have any further questions, 
ask your doctor or pharmacist.
•  
This medicine has been prescribed 
for you only. Do not pass it on to 
others. It may harm them, even if 
their signs of illness are the same 
as yours.
•  
If you get any side effects, talk to 
your doctor or pharmacist. This 
includes any possible side effects 
not listed in this leafl et.
 WHAT IS IN THIS LEAFLET: 
 1.    WHAT CANDESARTAN TEVA PHARMA 
IS AND WHAT IT IS USED FOR
 2.    WHAT YOU NEED TO KNOW BEFORE 
YOU TAKE CANDESARTAN TEVA 
PHARMA
 3.    HOW TO TAKE CANDESARTAN TEVA 
PHARMA
4.   POSSIBLE SIDE EFFECTS
5.  
HOW TO STORE CANDESARTAN TEVA 
PHARMA
6.  
CONTENTS OF THE PACK AND OTHER 
INFORMATION
     WHAT CANDESARTAN TEVA 
PHARMA IS AND WHAT IT IS 
USED FOR
The name of your medicine is 
Candesartan Teva Pharma. The 
active ingredie

Résumé des caractéristiques du produit

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Candesartan Teva Pharma 4 mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 4 mg candesartan cilexetil.
Excipient with known effect:
95.1 mg lactose monohydrate/tablet.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet.
Candesartan Teva Pharma 4 mg tablets are white, round biconvex tablets, marked _CC _on one face and _04 _on the other
face and are scored on both faces.
The tablet can be divided into equal halves.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Candesartan Teva Pharma is indicated for the:
Treatment of essential hypertension in adults.
Treatment of adult patients with heart failure and impaired left ventricular systolic function (left ventricular
ejection fraction
40%) as add-on therapy to Angiotensin Converting Enzyme (ACE) inhibitors or when ACE
inhibitors are not tolerated (see section 5.1).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology in Hypertension
The recommended initial dose and usual maintenance dose of Candesartan Teva Pharma is 8 mg once daily. Most of
the antihypertensive effect is attained within 4 weeks. In some patients whose blood pressure is not adequately
controlled, the dose can be increased to 16 mg once daily and to a maximum of 32 mg once daily. Therapy should be
adjusted according to blood pressure response. Candesartan Teva Pharma may also be administered with other
antihypertensive agents. Addition of hydrochlorothiazide has been shown to have an additive antihypertensive effect
with various doses of Candesartan Teva Pharma.
_Elderly population_
No initial dose adjustment is necessary in elderly patients.
_Patients with intravascular volume depletion_
An initial dose of 4 mg may be considered in patients at