AMIAS TABLETS 8MG

Active substance: CANDESARTAN CILEXETIL

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527 LEAFLET Amias 20130115

PACKAGE LEAFLET: INFORMATION FOR THE USER

AMIAS TABLETS 8mg
(candesartan cilexetil)
Your medicine is known as Amias Tablets 8mg but will be referred
to as Amias throughout the following patient information leaflet.
This medicine is available in other strengths.
Read all of this leaflet carefully before you start taking this
medicine.


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. Do not pass it on to
others. It may harm them, even if their symptoms are the same
as yours.



If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet, please tell your doctor or
pharmacist.

In this leaflet:
1. What Amias is and what it is used for

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 a drop in blood pressure.
Use in children
There is no experience with the use of Amias in children (below the
age of 18 years). Therefore Amias should not be given to children.
Using other medicines
Please tell your doctor or pharmacist if you are using, or have
recently used any other medicines, including medicines obtained
without a prescription.
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:


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 (NSAlDs) 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).



Potassium supplements or salt substitutes containing
potassium (medicines that increase the amount of potassium in
your blood).

2. Before you take Amias
3. How to take Amias
4. Possible side effects
5. How to store Amias
6. Further information


Heparin (a medicine for thinning the blood).

1. WHAT AMIAS IS AND WHAT IT IS USED FOR



Water tablets (diuretics).

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.



Lithium (a medicine for mental health problems).

This medicine is used for:

Taking Amias with food and drink (in particular alcohol)


You can take Amias with or without food.



When you are prescribed Amias, discuss with your doctor
before drinking alcohol. Alcohol may make you feel faint or
dizzy.



treating high blood pressure (hypertension) in adult patients.

Pregnancy and breast-feeding



treating adult heart failure patients with reduced heart muscle
function, in addition to Angiotensin Converting Enzyme (ACE)
inhibitors or when ACE inhibitors cannot be used (ACE
inhibitors are a group of medicines used to treat heart failure).

Pregnancy

2. BEFORE YOU TAKE AMIAS
Do not take Amias


if you are allergic (hypersensitive) to candesartan cilexetil or
any of the other ingredients of Amias (see 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 you are not sure if any of these apply to you, talk to your doctor or
pharmacist before taking Amias.
Take special care with Amias
Before you take, or whilst you are taking Amias, tell your doctor.


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).

You must tell your doctor if you think you are (or might become)
pregnant. Your doctor will normally advise you to stop taking Amias
before you become pregnant or as soon as you know you are
pregnant and will advise you to take another medicine instead of
Amias. Amias is not recommended in early pregnancy, and must
not be taken when more than 3 months pregnant, as it may cause
serious harm to your baby if used after the third month of
pregnancy.
Breast-feeding
Tell your doctor if you are breast-feeding or about to start breastfeeding. 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.
Important information about some of the ingredients of Amias
Amias contains lactose which 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 Amias exactly as your doctor has told you. You should
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.
High blood pressure:






The usual 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.

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.

If any of the side effects get serious, or if you notice any side effects
not listed in this leaflet, please tell your doctor or pharmacist.

Heart failure:


The usual starting dose of Amias is 4 mg once a day. Your
doctor may increase your dose by doubling the dose at intervals
of at least 2 weeks up to 32 mg once a day. Amias can be
taken together with other medicines for heart failure, and your
doctor will decide which treatment is suitable for you.

5. HOW TO STORE AMIAS


KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.



Do not store above 30°C.



If your doctor stops your treatment, take any leftover tablets
back to the pharmacy for safe disposal.

If you take more Amias than prescribed by your doctor, contact a
doctor or pharmacist immediately for advice.



If you forget to take Amias

Do not take your tablets after the expiry date on the container.
Take any tablets which are out of date back to the pharmacy.



If the medicine becomes discoloured or shows any other signs
of deterioration, you should seek the advice of your pharmacist
who will tell you what to do.

If you take more Amias than you should

Do not take a double dose to make up for a forgotten tablet. Just
take the next dose as 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.

6. FURTHER INFORMATION
What Amias contains


Each tablet contains 8mg of the active ingredient candesartan
cilexetil.



If you have any further questions on the use of this product, ask
your doctor or pharmacist.

Amias also contain the following: carmellose calcium,
hydroxypropylcellulose, lactose monohydrate, magnesium
stearate, maize starch, polyethylene glycol and red iron oxide
(E172).

4. POSSIBLE SIDE EFFECTS
Like all medicines, Amias 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)

What Amias looks like and contents of the pack


Amias is round pink tablets either with a score line on both
sides or marked ‘A’ and ‘CG’ with a score line on one side and
marked ‘008’ on the other.



Amias is available as blister packs of 28 or 30 tablets.

Product Licence holder

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.

Procured from within the EU and repackaged by the Parallel Import
Product Licence holder: Chemilines Ltd, Chemilines House,
Alperton Lane, Wembley, HA0 1DX.

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).

Manufacturer

Other possible side effects include:

Amias is manufactured by Takeda Italia Farmaceutici SpA, Via
Crosa 26, Cerano, Italy.

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.

Effects on how your kidneys work, especially if you already
have kidney problems or heart failure. In very rare cases,
kidney failure may occur.

POM

PL 08747/0527

Leaflet revision date: 15 January 2013
Amias is a registered trade mark of Takeda Chemical Industries
Ltd, Japan.
527 LEAFLET Amias 20130115

527 LEAFLET Candesartan 20130115

PACKAGE LEAFLET: INFORMATION FOR THE USER

CANDESARTAN CILEXETIL TABLETS 8mg
(candesartan cilexetil)
Your medicine is known as Candesartan Cilexetil Tablets 8mg but
will be referred to as Candesartan throughout the following patient
information leaflet.
This medicine is available in other strengths.
Read all of this leaflet carefully before you start taking this
medicine.

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 Candesartan. This is because Candesartan, when
combined with some anaesthetics, may cause a drop in blood
pressure.
Use in children
There is no experience with the use of Candesartan in children
(below the age of 18 years). Therefore Candesartan should not be
given to children.
Using other medicines



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. Do not pass it on to
others. It may harm them, even if their symptoms are the same
as yours.



Candesartan can affect the way some other medicines work and
some medicines can have an effect on Candesartan. If you are
using certain medicines, your doctor may need to do blood tests
from time to time.

If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet, please tell your doctor or
pharmacist.

In particular, tell your doctor if you are using any of the following
medicines:

Please tell your doctor or pharmacist if you are using, or have
recently used any other medicines, including medicines obtained
without a prescription.



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 (NSAlDs) 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).



Potassium supplements or salt substitutes containing
potassium (medicines that increase the amount of potassium in
your blood).

1. WHAT CANDESARTAN IS AND WHAT IT IS USED FOR



Heparin (a medicine for thinning the blood).

The name of your medicine is Candesartan. 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.



Water tablets (diuretics).



Lithium (a medicine for mental health problems).

In this leaflet:
1. What Candesartan is and what it is used for
2. Before you take Candesartan
3. How to take Candesartan
4. Possible side effects
5. How to store Candesartan
6. Further information

This medicine is used for:


treating high blood pressure (hypertension) in adult patients.



treating adult heart failure patients with reduced heart muscle
function, in addition to Angiotensin Converting Enzyme (ACE)
inhibitors or when ACE inhibitors cannot be used (ACE
inhibitors are a group of medicines used to treat heart failure).

2. BEFORE YOU TAKE CANDESARTAN
Do not take Candesartan


if you are allergic (hypersensitive) to candesartan cilexetil or
any of the other ingredients of Candesartan (see section 6).



if you are more than 3 months pregnant (It is also better to
avoid Candesartan 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).

Taking Candesartan with food and drink (in particular alcohol)


You can take Candesartan with or without food.



When you are prescribed Candesartan, discuss with your
doctor before drinking alcohol. Alcohol may make you feel faint
or dizzy.

Pregnancy and breast-feeding
Pregnancy
You must tell your doctor if you think you are (or might become)
pregnant. Your doctor will normally advise you to stop taking
Candesartan before you become pregnant or as soon as you know
you are pregnant and will advise you to take another medicine
instead of Candesartan. Candesartan is not recommended in early
pregnancy, and must not be taken when more than 3 months
pregnant, as it may cause serious harm to your baby if used after
the third month of pregnancy.
Breast-feeding
Tell your doctor if you are breast-feeding or about to start breastfeeding. Candesartan is not recommended for mothers who are
breast-feeding, 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.

If you are not sure if any of these apply to you, talk to your doctor or
pharmacist before taking Candesartan.

Driving and using machines

Take special care with Candesartan

Some people may feel tired or dizzy when taking Candesartan. If
this happens to you, do not drive or use any tools or machines.

Before you take, or whilst you are taking Candesartan, tell your
doctor.


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. Candesartan 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).

Important information about some of the ingredients of
Candesartan
Candesartan contains lactose which 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 CANDESARTAN



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.

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.



Changes in blood test results:

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 any of the side effects get serious, or if you notice any side effects
not listed in this leaflet, please tell your doctor or pharmacist.

Always take Candesartan exactly as your doctor has told you. You
should check with your doctor or pharmacist if you are not sure. It is
important to keep taking Candesartan every day. You can take
Candesartan 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.
High blood pressure:






Very rare (affects less than 1 user in 10,000)

The usual dose of Candesartan 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.



A reduced amount of sodium in your blood. If this is severe
then you may notice weakness, lack of energy, or muscle
cramps.

Heart failure:


The usual starting dose of Candesartan is 4 mg once a day.
Your doctor may increase your dose by doubling the dose at
intervals of at least 2 weeks up to 32 mg once a day.
Candesartan can be taken together with other medicines for
heart failure, and your doctor will decide which treatment is
suitable for you.

5. HOW TO STORE CANDESARTAN


KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.



Do not store above 30°C.



If your doctor stops your treatment, take any leftover tablets
back to the pharmacy for safe disposal.

If you take more Candesartan than you should



Do not take your tablets after the expiry date on the container.

If you take more Candesartan than prescribed by your doctor,
contact a doctor or pharmacist immediately for advice.



Take any tablets which are out of date back to the pharmacy.

If you forget to take Candesartan
Do not take a double dose to make up for a forgotten tablet. Just
take the next dose as normal.

If the medicine becomes discoloured or shows any other signs
of deterioration, you should seek the advice of your pharmacist
who will tell you what to do.

If you stop taking Candesartan

6. FURTHER INFORMATION

If you stop taking Candesartan, your blood pressure may increase
again. Therefore do not stop taking Candesartan without first talking
to your doctor.

What Candesartan contains

If you have any further questions on the use of this product, ask
your doctor or pharmacist.



Each tablet contains 8mg of the active ingredient candesartan
cilexetil.



Candesartan also contain the following: carmellose calcium,
hydroxypropylcellulose, lactose monohydrate, magnesium
stearate, maize starch, polyethylene glycol and red iron oxide
(E172).

4. POSSIBLE SIDE EFFECTS
Like all medicines, Candesartan can cause side effects, although
not everybody gets them. It is important that you are aware of what
these side effects may be.

What Candesartan looks like and contents of the pack


Candesartan is round pink tablets either with a score line on
both sides or marked ‘A’ and ‘CG’ with a score line on one side
and marked ‘008’ on the other.
Candesartan is available as blister packs of 28 or 30 tablets.

Stop taking Candesartan 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

Product Licence holder



severe itching of the skin (with raised lumps)

Candesartan 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 Candesartan has had any effect on
your blood (agranulocytosis).

Procured from within the EU and repackaged by the Parallel Import
Product Licence holder: Chemilines Ltd, Chemilines House,
Alperton Lane, Wembley, HA0 1DX.
Manufacturer
Candesartan is manufactured by Takeda Italia Farmaceutici SpA,
Via Crosa 26, Cerano, Italy.

Other possible side effects include:
Common (affects 1 to 10 users in 100)


Headache.



Respiratory infection.



Low blood pressure. This may make you feel faint or dizzy.



Changes in blood test results:

PL 08747/0527

Feeling dizzy/spinning sensation.



POM





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.

Effects on how your kidneys work, especially if you already
have kidney problems or heart failure. In very rare cases,
kidney failure may occur.

Leaflet revision date: 15 January 2013
527 LEAFLET Candesartan 20130115

Expand view ⇕

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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