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CANDESARTAN 16 MG TABLETS

Active substance(s): CANDESARTAN CILEXETIL

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PACKAGE LEAFLET: INFORMATION FOR THE USER

CANDESARTAN 2mg, 4mg, 8mg, 16mg, and 32mg
TABLETS
Candesartan Cilexetil
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
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Keep this leaflet.You may need to read it again.

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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.

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medicines and Candesartan Tablets”).

What is in this leaflet:
1. What Candesartan Tablets are and what they are used for
2. What you need to know before you take Candesartan Tablets
3. How to take Candesartan Tablets
4. Possible side effects
5. How to store Candesartan Tablets
6. Contents of the pack and other information

1. What Candesartan Tablets are and what they
are used for
The name of your medicine is Candesartan Tablets. 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.
Candesartan can be used to:
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treat high blood pressure (hypertension) in adult patients and
in children and adolescents aged 6 to <18 years
treat 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 MRA are medicines used to treat heart failure).

2. What you need to know before you take
Candesartan Tablets
Do not take Candesartan Tablets:
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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 Candesartan Tablets 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 Candesartan Tablets.
Warnings and precautions

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
Candesartan Tablets”.
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 Tablets. This is because
Candesartan Tablets, when combined with some anaesthetics,
may cause a drop in blood pressure.
Children and adolescents
Candesartan has been studied in children. For more information,
talk to your doctor. Candesartan Tablets should not be given to
children under 1 year of age due to potential risk to the
developing kidneys.
Other medicines and Candesartan Tablets
Tell your doctor or pharmacist if you are using, have recently used
or might use any other medicines.
Candesartan Tablets can affect the way some other medicines
work and some medicines can have an effect on Candesartan
Tablets. 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:
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Talk to your doctor before taking Candesartan Tablets:
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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 Tablets are 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:
Ÿ an ACE-inhibitor (for example enalapril, lisinopril, ramipril),
in particular if you have diabetes-related kidney problems.
Ÿ aliskiren.
if you are taking an ACE-inhibitor together with a medicine
which belongs to the class of medicines known as
mineralocorticoid receptor antagonists (MRA). These
medicines are for the treatment of heart failure (see “Other

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 3g 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).
Heparin (a medicine for thinning the blood).
Water tablets (diuretics).
Lithium (a medicine for mental health problems).
If you are taking an ACE-inhibitor or aliskiren (see also
information under the headings “Do not take Candesartan
Tablets” and “Warnings and precautions”).
If you are being treated with an ACE-inhibitor together with
certain other medicines to treat your heart failure, which are
known as mineralocorticoid receptor antagonists (MRA) (for
example: spironolactone, eplerenone).

Candesartan Tablets with food, drink and alcohol
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You can take Candesartan Tablets with or without food.

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When you are prescribed Candesartan Tablets, 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 Tablets before you become pregnant or as soon as
you know you are pregnant and will advise you to take another
medicine instead of Candesartan Tablets.
Candesartan Tablets are 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 Tablets are 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.

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Driving and using machines
Some people may feel tired or dizzy when taking Candesartan
Tablets. If this happens to you, DO NOT drive or use any tools or
machines.

3. How to take Candesartan Tablets
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 Candesartan Tablets every day.
You can take Candesartan Tablets 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:
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The recommended dose of Candesartan Tablets is 8mg once
a day. Your doctor may increase this dose to 16mg once a day
and further up to 32mg 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.

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Changes in blood test results:
Ÿ 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, 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.

Very rare (affects less than 1 user in 10,000)
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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:
Ÿ A reduced amount of sodium in your blood. If this is severe
then you may notice weakness, lack of energy, or muscle
cramps.

Use in children and adolescents with high blood pressure:

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.

Children 6 to <18 years of age:

Reporting of side effects

The recommended starting dose is 4mg once daily.

If you get any side effects, talk to your doctor. This includes any
possible 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.

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For patients weighing < 50kg: In some patients whose blood
pressure is not adequately controlled, your doctor may decide the
dose needs to be increased to a maximum of 8mg once daily.
For patients weighing ≥ 50kg: In some patients whose blood
pressure is not adequately controlled, your doctor may decide the
dose needs to be increased to 8mg once daily and to 16mg once
daily.
Heart failure in adults:
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The recommended starting dose of Candesartan Tablets is
4mg once a day. Your doctor may increase your dose by
doubling the dose at intervals of at least 2 weeks up to 32mg
once a day.
Candesartan Tablets 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 Tablets
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.
This medicine does not require any special storage conditions.
DO NOT throw away any medicine via wastewater or household
waste. Ask your pharmacist how to throw away medicines you no
longer use. These measures will help to protect the environment.

If you take more Candesartan Tablets than you should
If you take more Candesartan Tablets than prescribed by your
doctor, contact a doctor or pharmacist IMMEDIATELY for advice.
If you forget to take Candesartan Tablets
DO NOT take a double dose to make up for a forgotten tablet.
Just take the next dose as normal.
If you stop taking Candesartan Tablets

6. Contents of the pack and other information
What Candesartan Tablets contain
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If you stop taking Candesartan Tablets, your blood pressure may
increase again. Therefore DO NOT stop taking Candesartan
Tablets without first talking to your doctor.

The active substance is candesartan cilexetil. Each tablet
contains 2mg, 4mg, 8mg 16mg or 32mg of candesartan
cilexetil.
The other ingredients are: mannitol, maize starch, copovidone,
glycerol, magnesium stearate, red iron oxide (E172; only for
8mg, 16mg, and 32mg tablets), and microcrystalline cellulose
(only for 16mg and 32mg tablets).

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

What Candesartan Tablets look like and contents of the pack

4. Possible side effects

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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.

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STOP taking Candesartan Tablets and seek medical help
IMMEDIATELY if you have any of the following allergic
reactions:
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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)

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2mg tablets are white to off-white, round tablets
(diameter~5.5mm).
4mg tablets are white to off-white, round tablets
(diameter~7.5mm), with a break-line on one side.
8mg tablets are light red, round tablets (diameter~7.5mm),
with a break line on one side and debossed with T/T on the
same side.
16mg tablets are red, round tablets (diameter~7.5mm) with a
break-line on one side and debossed with C/C on the same
side.
32mg tablets are red, round tablets (diameter~10mm) with a
break line on one side.

The tablet can be divided into equal doses.
Candesartan 2mg and 4mg tablets come in OPA/Alu/PVC-Alu
blister packs containing 7 tablets.

Candesartan Tablets 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 Tablets have had any effect on
your blood (agranulocytosis).

Candesartan 8mg, 16mg and 32mg tablets come in
OPA/Alu/PVC-Alu blister packs containing 28 tablets.

Other possible side effects include:

Units 3 & 4, Quidhampton Business Units,

Common (affects 1 to 10 users in 100)

Polhampton Lane, Overton,

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Feeling dizzy/spinning sensation.
Headache.
Respiratory infection.
Low blood pressure. This may make you feel faint or dizzy.

Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Crescent Pharma Limited,

Hants RG25 3ED
United Kingdom
This leaflet was last revised in 03/2015

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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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