Amias 16mg tablets
Country: United Kingdom
Language: English
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Patient Information leaflet
(PIL)
27-01-2023
Summary of Product characteristics
(SPC)
27-01-2023
Active ingredient:
Candesartan cilexetil
Available from:
Neon Healthcare Ltd
ATC code:
C09CA06
INN (International Name):
Candesartan cilexetil
Dosage:
16mg
Pharmaceutical form:
Oral tablet
Administration route:
Oral
Class:
No Controlled Drug Status
Prescription type:
Valid as a prescribable product
Product summary:
BNF: 02050502; GTIN: 5035382000411
Patient Information leaflet
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) cannot be used
(ACE inhibitors and MRAs are medicines
used to treat heart failure).
2. WHAT YOU NEED TO KNOW BEFORE YOU
TAKE AMIAS
Do not take Amias
• if you are allergic to candesartan cilexetil
or any of the other ingredients of this medicine
(listed in section 6).
• if you are more than 3 months pregnant
(it is also better to avoid Amias in early
pregnancy – see pregnancy section).
• if you have severe liver disease or biliary
obstruction (a problem with the drain
Read the complete document
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Amias 16 mg Tablets.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 16 mg candesartan cilexetil.
Each tablet contains 81.3 mg lactose monohydrate.
For a full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Tablet.
Amias 16 mg Tablets are round light pink tablets with one convex side
and one
scored flat side, embossing 16 on convex side.
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
Read the complete document
