CANDESARTAN TEVA 4 Milligram Tablets

Nchi: Ayalandi

Lugha: Kiingereza

Chanzo: HPRA (Health Products Regulatory Authority)

Viambatanisho vya kazi:

CANDESARTAN CILEXETIL

Inapatikana kutoka:

Teva Pharma B.V.

ATC kanuni:

C09CA06

INN (Jina la Kimataifa):

CANDESARTAN CILEXETIL

Kipimo:

4 Milligram

Dawa fomu:

Tablets

Dawa ya aina:

Product subject to prescription which may be renewed (B)

Eneo la matibabu:

Angiotensin II antagonists, plain

Idhini hali ya:

Authorised

Idhini ya tarehe:

2011-12-21

Taarifa za kipeperushi

Teva Pharmaceuticals Europe 

MODULE 1.3.1 

PATIENT INFORMATION LEAFLET TEXT 

PACKAGE LEAFLET: INFORMATION FOR THE USER 

CANDESARTAN TEVA 4 MG TABLETS 
Candesartan cilexetil 

READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS 
IMPORTANT INFORMATION FOR YOU. 
- 
Keep this leaflet. 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 of the side
effects, talk to your doctor or pharmacist. This
includes any possible 
side effects not listed in this leaflet. See section 4. 

WHAT IS IN THIS LEAFLET 

1. 
What Candesartan Teva is and what it is used for 
2. 
What you need to know before you take Candesartan Teva 
3. 
How to take Candesartan Teva 
4. 
Possible side effects 
5. 
How to store Candesartan Teva 
6. 
Contents of the pack and other information 

1. 
WHAT CANDESARTAN TEVA IS AND WHAT IT IS USED FOR 

The name of your medicine is Candesartan Teva. The active
ingredient is 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. 

This medicine is used for: 


Treating  high  blood  pressure  (hypertension)  in  adult  patients  and  in  children  and  adolescents 
aged 6 to <18 years. 


Treating  adult  heart  failure  patients  with  reduced  heart  muscle  function  when  Angiotensin 
Converting  En

Tabia za bidhaa

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Candesartan Teva 4 mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 4 mg candesartan cilexetil.
Excipient with known effect:
Lactose:
42.20 mg lactose monohydrate / 4 mg tablet
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet.
White to off white, capsule shaped tablet, scored on both sides. One
side of the tablet is debossed with "C |
4" and the
other side is debossed with "4 | C". The tablet can be divided into
equal doses.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Candesartan cilexetil Teva is indicated for the:
Treatment of essential hypertension in adults.
The treatment of adult patients with heart failure and impaired left
ventricular systolic function (left ventricular ejection
fraction
40%)
when ACE-inhibitors are not
tolerated or
as add-on therapy to ACE-inhibitors in patients with
symptomatic heart failure, despite optimal therapy, when
mineralocorticoid receptor antagonists are not tolerated (see
sections 4.2, 4.4, 4.5 and 5.1).
Treatment of essential hypertension in children and adolescents aged 6
to <18 years.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology in Hypertension
The recommended initial dose and usual maintenance dose of Candesartan
cilexetil Teva 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 cilexetil
Teva may also be administered with other
antihypertensive agents (see sections 4.3, 4.4, 4.5 and 5.1). Addition
of hydrochlorothiazide has been shown to have an
additive antihypertensive effect with various doses of Candesartan
cilexetil Teva.
_Elderly population_
No initial dose adjustment is necessary in elderly patients.
_Patients with intravascular volume depletion_
An initial dose of 4 mg may b