Amias 8mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Candesartan cilexetil

Available from:

Dowelhurst Ltd

ATC code:

C09CA06

INN (International Name):

Candesartan cilexetil

Dosage:

8mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 02050502

Patient Information leaflet

MARKET:
Great Britain (GBR)
FONT(S):
N/A
NAME/INITIALS:
PROOF NUMBER:
1
FILE NAME:
6127461-07 LFT AMIAS 2-4-8-16-32 MG GBR
DATE:
09.03.2020 MAH/address change
FORMAT:
160 x 600 mm
CODE(S):
VARIABLE DATA:
PRINTED COLOURS:
Local language:
English language:
Variable data:
Die cut
Lacquer free area
LOT
MAN
EXP
N/A
NON PRINTED COLOURS:
LS/SGS
6008730_1
Black
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
GTIN: N/A
Pharma code: 135
REVISION NUMBER: 07
BRAILLE:
EXTERNAL SUPPLY EUROPE - ARTWORK
PAGE 1
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 Amias is and what it is used for
2. What you need to know before you take Amias
3. How to take Amias
4. Possible side effects
5. How to store Amias
6. Contents of the pack and other information
1. WHAT AMIAS IS AND WHAT IT IS USED FOR
The name of your medicine is Amias. 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
symptoms
persist
despite
treatment
and
mineralocorticoid
receptor antagonists (MRA)

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Amias 8mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 8 mg candesartan cilexetil.
Each tablet contains 89.4 mg lactose monohydrate.
For a full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Tablets.
Amias 8mg tablets are round pale pink tablets with a singe score line
on both
sides.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Amias 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 Amias 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.
Amias 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 Amias.
_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).
_Patients with renal impairment _
The starting dose is 4 mg in patients with renal impairment, inc