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AMIAS 2MG TABLETS

Active substance(s): CANDESARTAN CILEXETIL

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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Amias 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 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 drainage of
the bile from the gall bladder).
• if the patient is a child under 1 year of age.
• if you have diabetes or impaired kidney
function and you are treated with a blood
pressure lowering medicine containing
aliskiren.
If you are not sure if any of these apply to you,
talk to your doctor or pharmacist before taking
Amias.
Warnings and precautions
Talk to your doctor before taking Amias.
• if you have heart, liver or kidney problems,
• or are on dialysis.
• if you have recently had a kidney transplant.
• if you are vomiting, have recently had severe

vomiting, or have diarrhoea.
• if you have a disease of the adrenal gland
called Conn’s syndrome (also called primary
hyperaldosteronism).
• if you have low blood pressure.
• if you have ever had a stroke.
• you must tell your doctor if you think you
are (or might become) pregnant. Amias is
not recommended in early pregnancy, and
must not be taken if you are more than
3 months pregnant, as it may cause serious
harm to your baby if used at that stage (see
pregnancy section).
• if you are taking any of the following
medicines used to treat high blood pressure:
- an ACE-inhibitor (for example enalapril,
lisinopril, ramipril), in particular if you
have diabetes related kidney problems.
- aliskiren
• if you are taking an ACE-inhibitor together
with a medicine which belongs to the class
of medicines known as mineralocorticoid
receptors antagonists (MRA). These
medicines are for the treatment of heart
failure (see “Other medicines and Amias”).
Your doctor may check your kidney function,
blood pressure, and the amount of electrolytes
(e.g. potassium) in your blood at regular
intervals.
See also information under the heading “Do
not take Amias”.
Your doctor may want to see you more often
and do some tests if you have any of these
conditions.
If you are going to have an operation, tell your
doctor or dentist that you are taking Amias.
This is because Amias, when combined with
some anaesthetics, may cause an excessive in
blood pressure.
Children and adolescents.
Amias has been studied in children. For more
information, talk to your doctor. Amias must
not be given to children under 1 year of age
due to the potential risk to the developing
kidneys.
Other medicines and Amias
Tell your doctor or pharmacist if you are using,
have recently used or might use any other
medicines as your doctor may need to change
your dose and/or take other precautions:
Amias can affect the way some other medicines
work and some medicines can have an effect
on Amias. If you are using certain medicines,
your doctor may need to do blood tests from
time to time.
In particular, tell your doctor if you are using
any of the following medicines as your doctor
may need to change your dose and/or take
other precautions:
• Other medicines to help lower your
blood pressure, including beta-blockers,
diazoxide and ACE inhibitors such as
enalapril, captopril, lisinopril or ramipril.
• Non-steroidal
anti-inflammatory
drugs
(NSAIDs) such as ibuprofen, naproxen,
diclofenac,
celecoxib
or
etoricoxib
(medicines to relieve pain and inflammation).
• Acetylsalicylic acid (if you are taking more
than 3 g each day) (medicine to relieve pain
and inflammation).

PAGE 1

ARTWORK
THIS ARTWORK IS PROPERTY OF:

SEPARATIONS:

PRODUCT NAME:

MEASURES (mm): 160x600 (2x300)
DECA CODE (mm): X I I I I (47)

TAKEDA

I-AMIAS 2-4-8-16-32mg
(GB)
PRODUCT CODE:

6127461.02

PDF 1.5

Realized by:

( BLACK )

QUALITY SYSTEM - ISO 9001:2008

(X=1,5mm /I=0,5mm/spazi=1 mm)

PREVIOUS CODE: 6127461.01
FONT TYPE: Helvetica Neue LT
Size: 9 pt

ISSUE DATE

DRAFT

OPERATOR

01

02/12/2015 RI007M

EURPACK Grafifarma Grafiflex - Aprilia (LT) tel. +39 06 92732420 produzione@grafifarma.it - Robecco s/N (MI) tel. +39 02 94974002 milano@grafifarma.it

CLIENT APPROVAL
Ricordiamo che il risultato cromatico delle stampe potrà essere diverso in funzione del supporto e della tecnica utilizzata. We remind you that prints
chromatic results could be different depending on support and used technique. - La responsabilità della EURPACK GRAFIFARMA GRAFIFLEX Srl,
termina con l’approvazione del seguente documento. EURPACK GRAFIFARMA GRAFIFLEX’s responsability ends with the approval of the present
document. - Vietato l’utilizzo del presente tassello di informazioni se non espressamente autorizzato dalla EURPACK GRAFIFARMA GRAFIFLEX Srl.
It is forbidden the use of the present information if not officially allowed from EURPACK GRAFIFARMA GRAFIFLEX Srl.
v.01-2013

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• Potassium supplements or salt substitutes Use in children and adolescents with high
containing potassium (medicines that blood pressure:
increase the amount of potassium in your
Children 6 to under 18 years of age:
blood).
• Heparin (a medicine for thinning the blood). The recommended starting dose is 4mg once
daily.
• Water tablets (diuretics).
• Lithium (a medicine for mental health For patients weighing less that 50kg: In some
patients whose blood pressure is not
problems).
• If you are taking an ACE-inhibitor or aliskiren adequately controlled, your doctor may decide
(see also information under the headings the dose needs to be increased to a maximum
“Do not take Amias” and “Warnings and of 8mg once daily.
precautions”)
• If you are being treated with an ACE-inhibitor For patients weighing 50kg or more: In some
together with certain other medicines to patients whose blood pressure is not
treat your heart failure, which are known adequately controlled, your doctor may decide
as mineralocorticoid receptors antagonists the dose needs to be increased to 8mg once
(MRA)(for
example
spironolactone, daily and to 16mg once daily.
eplerenone).”
Heart failure in adults
• The recommended starting dose of Amias is
Amias with food and drink and alcohol.
4 mg once a day. Your doctor may increase
• You can take Amias with or without food.
your dose by doubling the dose at intervals
• When you are prescribed Amias, discuss
of at least 2 weeks up to 32 mg once a day.
with your doctor before drinking alcohol.
Amias can be taken together with other
Alcohol may make you feel faint or dizzy.
medicines for heart failure, and your doctor
will decide which treatment is suitable for
Pregnancy and breast-feeding
you.
Pregnancy
You must tell your doctor if you think you are
(or might become) pregnant. Your doctor will If you take more Amias than you should
normally advise you to stop taking Amias If you take more Amias than prescribed by
before you become pregnant or as soon as you your doctor, contact a doctor or pharmacist
know you are pregnant and will advise you to immediately for advice.
take another medicine instead of Amias. Amias
is not recommended in early pregnancy, and If you forget to take Amias
must not be taken when more than 3 months Do not take a double dose to make up for a
pregnant, as it may cause serious harm to your forgotten tablet. Just take the next dose as
baby if used after the third month of pregnancy. normal.
If you stop taking Amias
If you stop taking Amias, your blood pressure
may increase again. Therefore do not stop
taking Amias without first talking to your doctor.

Breast-feeding
Tell your doctor if you are breast-feeding or
about to start breast-feeding. Amias is not
recommended for mothers who are breastfeeding, and your doctor may choose another
treatment for you if you wish to breast-feed,
especially if your baby is newborn, or was born
prematurely.
Driving and using machines
Some people may feel tired or dizzy when
taking Amias. If this happens to you, do not
drive or use any tools or machines.
Amias contains lactose. Lactose is a type of
sugar. If you have been told by your doctor
that you have an intolerance to some sugars,
contact your doctor before taking this
medicine.’
3. How to take AMIAS

Always take this medicine exactly as your
doctor has told you. Check with your doctor or
pharmacist if you are not sure. It is important
to keep taking Amias every day. You can take
Amias with or without food.
Swallow the tablet with a drink of water.
Try to take the tablet at the same time each day.
This will help you to remember to take it.
Amias 4mg, 8mg, 16mg and 32mg tablets: The
tablet can be divided into equal doses.
High blood pressure:
• The recommended dose of Amias is 8  mg
once a day. Your doctor may increase this
dose to 16  mg once a day and further up
to 32  mg once a day depending on blood
pressure response.
• In some patients, such as those with liver
problems, kidney problems or those who
recently have lost body fluids, e.g., through
vomiting or diarrhoea or by using water
tablets, the doctor may prescribe a lower
starting dose.
• Some black patients may have a reduced
response to this type of medicine, when
given as the only treatment, and these
patients may need a higher dose.

If you have any further questions on the use of
this medicine, ask your doctor or pharmacist.
4. Possible side effects

Like all medicines, this medicine can cause
side effects, although not everybody gets them.
It is important that you are aware of what these
side effects may be.
Stop taking Amias and seek medical help
immediately if you have any of the following
allergic reactions:
• difficulties in breathing, with or without
swelling of the face, lips, tongue and/or
throat
• swelling of the face, lips, tongue and/
or throat, which may cause difficulties in
swallowing
• severe itching of the skin (with raised lumps)
Amias may cause a reduction in number of white
blood cells. Your resistance to infection may
be decreased and you may notice tiredness,
an infection or a fever. If this happens contact
your doctor. Your doctor may occasionally do
blood tests to check whether Amias has had
any effect on your blood (agranulocytosis).
Other possible side effects include:
Common (affects 1 to 10 users in 100)
• Feeling dizzy/spinning sensation.
• Headache.
• Respiratory infection.
• Low blood pressure. This may make you
feel faint or dizzy.
• Changes in blood test results:
- An increased amount of potassium in
your blood, especially if you already
have kidney problems or heart failure. If
this is severe you may notice tiredness,
weakness, an irregular heart beat or pins
and needles.

PAGE 2

ARTWORK
THIS ARTWORK IS PROPERTY OF:

SEPARATIONS:

PRODUCT NAME:

MEASURES (mm): 160x600 (2x300)
DECA CODE (mm): X I I I I (47)

TAKEDA

I-AMIAS 2-4-8-16-32mg
(GB)
PRODUCT CODE:

6127461.02

PDF 1.5

Realized by:

( BLACK )

QUALITY SYSTEM - ISO 9001:2008

(X=1,5mm /I=0,5mm/spazi=1 mm)

PREVIOUS CODE: 6127461.01
FONT TYPE: Helvetica Neue LT
Size: 9 pt

ISSUE DATE

DRAFT

OPERATOR

01

02/12/2015 RI007M

EURPACK Grafifarma Grafiflex - Aprilia (LT) tel. +39 06 92732420 produzione@grafifarma.it - Robecco s/N (MI) tel. +39 02 94974002 milano@grafifarma.it

CLIENT APPROVAL
Ricordiamo che il risultato cromatico delle stampe potrà essere diverso in funzione del supporto e della tecnica utilizzata. We remind you that prints
chromatic results could be different depending on support and used technique. - La responsabilità della EURPACK GRAFIFARMA GRAFIFLEX Srl,
termina con l’approvazione del seguente documento. EURPACK GRAFIFARMA GRAFIFLEX’s responsability ends with the approval of the present
document. - Vietato l’utilizzo del presente tassello di informazioni se non espressamente autorizzato dalla EURPACK GRAFIFARMA GRAFIFLEX Srl.
It is forbidden the use of the present information if not officially allowed from EURPACK GRAFIFARMA GRAFIFLEX Srl.
v.01-2013

DATE

SIGNATURE

• Effects on how your kidneys work, especially
if you already have kidney problems or heart
failure. In very rare cases, kidney failure may
occur.
Very rare (affects less than 1 user in 10,000)
• Swelling of the face, lips, tongue and/or
throat.
• A reduction in your red or white blood cells.
You may notice tiredness, an infection or a
fever.
• Skin rash, lumpy rash (hives).
• Itching.
• Back pain, pain in joints and muscles.
• Changes in how your liver is working,
including inflammation of the liver (hepatitis).
You may notice tiredness, yellowing of your
skin and the whites of your eyes and flu like
symptoms.
• Cough.
• Nausea.
• Changes in blood test results:
- A reduced amount of sodium in your
blood. If this is severe then you may
notice weakness, lack of energy, or
muscle cramps.
In children treated for high blood pressure,
side effects appear to be similar to those seen
in adults, but they happen more often. Sore
throat is a very common side effect in children
but not reported in adults and runny nose,
fever and increased heart rate are common in
children but not reported in adults.
Reporting of side effects.
If you get any side effects talk to your doctor.
This includes any side effects not listed in this
leaflet. You can also report side effects directly
via the Yellow Card Scheme at: www.mhra.
gov.uk/yellowcard. By reporting side effects
you can help provide more information on the
safety of this medicine.

Amias 2 mg tablets come in a blister pack
containing 7 or 14 tablets.
Amias 4 mg, 8 mg and 16 mg tablets come in
blister packs containing 7, 14, 20, 28, 50, 56,
98, 98x1 (single dose unit) 100 or 300 tablets.
Amias 32 mg tablets come in blister packs of
7, 10, 14, 20, 28, 50, 56, 98, 100 or 300 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and
Manufacturer
The Marketing Authorisations for Amias are
held by Takeda UK Ltd., Building 3, Glory Park,
Glory Park Avenue, Wooburn Green, BUCKS,
HP10 0DF, UK
Your tablets are manufactured by Takeda Italia
SpA, Via Crosa 86, 28065 Cerano (No), Italy
(all strengths) or Takeda Ireland Ltd., Bray
Business Park, Kilruddery, Co. Wicklow,
Ireland (4mg, 8mg, 16mg 32mg tablets only).
This medicinal product is authorised in
the Member States of the EEA under the
following names:
Member State
Austria, Germany, Spain, Ireland,
Italy, Portugal, UK
France
Spain
UK

Name
Blopress
Kenzen
Parapres
Amias

This leaflet was last revised in September
2014.
Other sources of information.
Detailed information on this medicine is
available on the MHRA web site.

5. How to store AMIAS

• Keep this medicine out of the sight and
reach of children.
• Do not use this medicine after the expiry
date which is stated on the carton label and
blister foil (after EXP). The expiry date refers
to the last day of that month.
• Do not store above 30ºC.






Do not throw away medicine via wastewater or
household waste. Ask your pharmacist how to
throw away any medicines you no longer use.
These measures will help to protect the
environment.
6. Contents of the pack and other
information

What Amias contains
• The active substance is candesartan cilexetil.
Each tablet contains 2 mg, 4 mg, 8 mg, 16
mg or 32 mg of candesartan cilexetil.
• The other ingredients are carmellose
calcium, hydroxypropylcellulose, lactose
monohydrate, magnesium stearate, maize
starch and macrogol. The 8 mg, 16 mg and
32 mg tablets also contain red iron oxide
(E172).
What Amias looks like and contents of the
pack
• 2 mg tablets are white, round tablets.
• 4 mg tablets are white, round tablets with a
score line on each side.
• 8 mg tablets are pale pink, round tablets
with a score line on each side.
• 16 mg tablets are light pink, round tablets
with one convex side embossed “16” and
one flat side with a score line.
• 32 mg tablets are light pink, round tablets
with convex faces, debossed “32” on one
side and with a score line on the other.

PAGE 3

ARTWORK
THIS ARTWORK IS PROPERTY OF:

SEPARATIONS:

PRODUCT NAME:

MEASURES (mm): 160x600 (2x300)
DECA CODE (mm): X I I I I (47)

TAKEDA

I-AMIAS 2-4-8-16-32mg
(GB)
PRODUCT CODE:

6127461.02

PDF 1.5

Realized by:

( BLACK )

QUALITY SYSTEM - ISO 9001:2008

(X=1,5mm /I=0,5mm/spazi=1 mm)

PREVIOUS CODE: 6127461.01
FONT TYPE: Helvetica Neue LT
Size: 9 pt

ISSUE DATE

DRAFT

OPERATOR

01

02/12/2015 RI007M

EURPACK Grafifarma Grafiflex - Aprilia (LT) tel. +39 06 92732420 produzione@grafifarma.it - Robecco s/N (MI) tel. +39 02 94974002 milano@grafifarma.it

CLIENT APPROVAL
Ricordiamo che il risultato cromatico delle stampe potrà essere diverso in funzione del supporto e della tecnica utilizzata. We remind you that prints
chromatic results could be different depending on support and used technique. - La responsabilità della EURPACK GRAFIFARMA GRAFIFLEX Srl,
termina con l’approvazione del seguente documento. EURPACK GRAFIFARMA GRAFIFLEX’s responsability ends with the approval of the present
document. - Vietato l’utilizzo del presente tassello di informazioni se non espressamente autorizzato dalla EURPACK GRAFIFARMA GRAFIFLEX Srl.
It is forbidden the use of the present information if not officially allowed from EURPACK GRAFIFARMA GRAFIFLEX Srl.
v.01-2013

DATE

SIGNATURE

6127461.02

PAGE 4

ARTWORK
THIS ARTWORK IS PROPERTY OF:

SEPARATIONS:

PRODUCT NAME:

MEASURES (mm): 160x600 (2x300)
DECA CODE (mm): X I I I I (47)

TAKEDA

I-AMIAS 2-4-8-16-32mg
(GB)
PRODUCT CODE:

6127461.02

PDF 1.5

Realized by:

( BLACK )

QUALITY SYSTEM - ISO 9001:2008

(X=1,5mm /I=0,5mm/spazi=1 mm)

PREVIOUS CODE: 6127461.01
FONT TYPE: Helvetica Neue LT
Size: 9 pt

ISSUE DATE

DRAFT

OPERATOR

01

02/12/2015 RI007M

EURPACK Grafifarma Grafiflex - Aprilia (LT) tel. +39 06 92732420 produzione@grafifarma.it - Robecco s/N (MI) tel. +39 02 94974002 milano@grafifarma.it

CLIENT APPROVAL
Ricordiamo che il risultato cromatico delle stampe potrà essere diverso in funzione del supporto e della tecnica utilizzata. We remind you that prints
chromatic results could be different depending on support and used technique. - La responsabilità della EURPACK GRAFIFARMA GRAFIFLEX Srl,
termina con l’approvazione del seguente documento. EURPACK GRAFIFARMA GRAFIFLEX’s responsability ends with the approval of the present
document. - Vietato l’utilizzo del presente tassello di informazioni se non espressamente autorizzato dalla EURPACK GRAFIFARMA GRAFIFLEX Srl.
It is forbidden the use of the present information if not officially allowed from EURPACK GRAFIFARMA GRAFIFLEX Srl.
v.01-2013

DATE

SIGNATURE

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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