CANDESARTAN TEVA 8 Milligram Tablets

Ülke: İrlanda

Dil: İngilizce

Kaynak: HPRA (Health Products Regulatory Authority)

Aktif bileşen:

CANDESARTAN CILEXETIL

Mevcut itibaren:

Teva Pharma B.V.

ATC kodu:

C09CA06

INN (International Adı):

CANDESARTAN CILEXETIL

Doz:

8 Milligram

Farmasötik formu:

Tablets

Reçete türü:

Product subject to prescription which may be renewed (B)

Terapötik alanı:

Angiotensin II antagonists, plain

Yetkilendirme durumu:

Authorised

Yetkilendirme tarihi:

2012-01-06

Bilgilendirme broşürü

Teva Pharmaceuticals Europe 

MODULE 1.3.1 

PATIENT INFORMATION LEAFLET TEXT 

PACKAGE LEAFLET: INFORMATION FOR THE USER 

CANDESARTAN TEVA 8 MG TABLETS 
CANDESARTAN TEVA 16 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 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  An

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SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Candesartan Teva 8 mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 8 mg candesartan cilexetil.
Excipients with known effects:
Lactose: 43.725 mg lactose monohydrate / 8 mg tablet
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet.
Pink, capsule shaped tablet, 7.7 mm in length and 3.5 mm in width,
scored on both sides. One side of
the tablet is
debossed with " C | 8 " and the other side is debossed with " 8 | 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.
_Older people_
No initial dose adjustment is necessary in older people.
_Patients with intravascular volume depletion_
An initi