BLOPRESS 32 Milligram Tablets

Nchi: Ayalandi

Lugha: Kiingereza

Chanzo: HPRA (Health Products Regulatory Authority)

Viambatanisho vya kazi:

CANDESARTAN CILEXETIL

Inapatikana kutoka:

Takeda UK Limited

ATC kanuni:

C09CA06

INN (Jina la Kimataifa):

CANDESARTAN CILEXETIL

Kipimo:

32 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:

2009-01-16

Taarifa za kipeperushi

ARTWORK
ISSUE DATE
28-07-2016
OPERATOR
RI006M
DRAFT
02
SEPARATIONS:

BLACK

P334
PRODUCT CODE:
6127363.02
PRODUCT NAME:
I-BLOPRESS
2-4-8-16-32 MG
COUNTRY: IRL
Laetus code I X I I I I I (159)
MEASURES (mm): 160X600 (2X300)
FONT TYPE: HELVETICA NEUE LT
Size: 9PT
PREVIOUS CODE: 6127363.01
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ATTIVA
SOVRASTAMPA
NON ATTIVA
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PAGE 1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
BLOPRESS 2 MG, 4 MG, 8 MG, 16 MG AND 32 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.
This includes any possible side effects not
listed in this leaflet. See section 4.
What is in this leaflet:
1. What Blopress is and what it is used for
2. What you need to know before you take
Blopress
3. How to take Blopress
4. Possible side effects
5. How to store Blopress
6. Contents of the pack and other information
1. What BlopRess is and What it is used
foR
The name of your medicine is Blopress. 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 under 18 years.
• treating
adult
heart
failure
patients
with
reduced
heart
muscle
function
when
Angiotensin
Converting
Enzyme
(ACE)
inhibitors cannot be used or in addition to
ACE
inhibitors
when
sympt

Tabia za bidhaa

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Blopress 32 mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 32 mg candesartan cilexetil.
Each tablet contains 162.7 mg lactose monohydrate.
For a full list excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet.
Blopress 32 mg Tablets are round light pink tablets with convex faces,
debossed 32 on one face and scored on the other
face.
The tablet can be divided into equal doses.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Blopress is indicated for the:
•
Treatment of essential hypertension in adults.
•
Treatment of hypertension in children and adolescents aged 6 to <18
years.
•
Treatment of adult patients with heart failure and impaired left
ventricular systolic function (left ventricular
ejection fraction
40 when Angiotensin Converting Enzyme (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).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology in Hypertension
The recommended initial dose and usual maintenance dose of Blopress 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.
Blopress 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 Blopress.
_Older people_
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 risk for
hypotension, such as patients with possible volume
depletion (see section 4.4).
_