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CANDESARTAN 4MG TABLETS

Active substance(s): CANDESARTAN CILEXETIL

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Candesartan 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.
• 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 or
pharmacist. This includes any possible side effects not
listed in this leaflet. See section 4.
• The full name of this medicine is Candesartan 4mg,
8mg, 16mg and 32mg Tablets but within the leaflet it
will be referred to as 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
3 How to take
4 Possible side effects
5 How to store
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 4mg,
8mg, 16mg and 32mg 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.
This medicine is used for:
• t reating high blood pressure (hypertension) in adult
patients and in children and adolescents aged 6<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 ACEinhibitors 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
Do not take Candesartan tablets if:

• you are allergic to candesartan cilexetil or any of the
other ingredients of this medicine (listed in section 6).
• you are more than 3 months pregnant (it is also better
to avoid Candesartan tablets in early pregnancy – see
pregnancy section).
• you have severe liver disease or biliary obstruction
(a problem with the drainage of the bile from the gall
bladder).
• the patient is a child under 1 year of age.
• 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

Talk to your doctor before taking Candesartan tablets if
you:
• h ave heart, liver or kidney problems, or are on dialysis.
• h ave recently had a kidney transplant.
• are vomiting, have recently had severe vomiting, or have
diarrhoea.
• have a disease of the adrenal gland called Conn’s
syndrome (also called primary hyperaldosteronism).
• h ave low blood pressure.
• 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
Continued top of next column
AAAH2250

• h ave ever had a stroke.
• 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 Candesartan tablets”).

You must tell your doctor if you think that you are (or
might become) pregnant. Candesartan tablets 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).
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 if”
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 must
not be given to children under 1 year of age due to the
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:
• Other medicines to help lower your blood pressure,
including beta-blockers, diazoxide and ACE inhibitors
such as enalapril, captopril, lisinopril or ramipril.
•N
 on-steroidal anti-inflammatory drugs (NSAIDs) such as
ibuprofen, naproxen, diclofenac, celecoxib or etoricoxib
(medicines to relieve pain and inflammation).
• Aspirin (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).
•H
 eparin (a medicine for thinning the blood).
•W
 ater tablets (diuretics).
• L ithium (a medicine for mental health problems).
Your doctor may need to change your dose and/or to take
other precautions:
• If you are taking an ACE-inhibitor or aliskiren (see
also information under the headings “Do not take
Candesartan tablets if” 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 receptors
antagonists (MRA) (for example spironolactone,
eplerenone).

Candesartan tablets with food and drink
• Y ou can take Candesartan tablets with or without food.
•W
 hen you are prescribed Candesartan tablets, discuss
with your doctor before drinking alcohol. Alcohol may
make you feel faint or dizzy.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be
pregnant or are planning to have a baby, ask your doctor or
pharmacist for advice before taking this medicine.
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 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.
Continued over page

Candesartan 4mg, 8mg, 16mg and 32mg Tablets PIL - UK
item no:

AAAH2250

dimensions:

print proof no:

5

pharmacode:

origination date: 15.09.14
approved for print/date

min pt size:

148 x 270

1. black
2.
3.
4.

7 pt

5.
6.

originated by:
revision date:

colours/plates:

12.01.15

Non Printing Colours

Technical Approval

revised by:

date sent:

06.10.14

supplier:

approved:

09.10.14

1.
2.
3.

Breast-feeding
Tell your doctor if you are breast-feeding or about to start
breast-feeding. 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.

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.

Candesartan tablets contain lactose

Candesartan tablets contain 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

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:
• 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.
Heart failure:
• 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.

Use in children and adolescents with high blood
pressure
Children 6 to <18 years of age: The recommended starting
dose is 4mg once a day.
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 a day.
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 a
day or to 16mg once a day.

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

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.
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 Candesartan tablets 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.
• s evere itching of the skin (with raised lumps).

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 has had any effect on your
blood (agranulocytosis).
Continued top of next column
AAAH2250

Other possible side effects include:
Common (may affect up to 1 in 10 users)
• F eeling dizzy/spinning sensation.
•H
 eadache.
• R espiratory infection.
• L ow blood pressure. This may make you feel faint or dizzy.
• C hanges 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, 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 (may affect up to 1 in 10,000 users)
• 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.
• Nausea.
•C
 hanges 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.
• Cough.
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, pharmacist
or nurse. 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.

5 How to store

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 and on the blister pack after EXP. The
expiry date refers to the last day of that month.
This medicinal product does not require any special
storage conditions.
Do not throw away any medicines via wastewater or
household waste. Ask your pharmacist how to throw
away medicines no longer used. These measures will help
protect the environment.

6 Contents of the pack and other
information

What Candesartan tablets contains
The active substance is candesartan cilexetil. Each tablet
contains either 4mg, 8mg,16mg or 32mg of candesartan
cilexetil.
The other ingredients are lactose monohydrate, maize
starch, hydroxypropylcellulose, croscarmellose sodium,
magnesium stearate and triethyl citrate.

What Candesartan tablets look like and contents
of the pack

Candesartan 4mg Tablets are white, biconvex tablets with a
score line on one side and embossing C4 on the same side.
Candesartan 8mg Tablets are white, biconvex tablets with a
score line on one side and embossing C8 on the same side.
Candesartan 16mg Tablets are white, biconvex tablets
with a score line on one side and embossing C16 on the
same side.
Candesartan 32mg Tablets are white, biconvex tablets
with a score line on one side and embossing C32 on the
same side.
The tablet can be divided into equal halves.
Pack sizes: 7 and 28 tablets.

Marketing Authorisation Holder
Actavis Group PTC ehf., Reykjavikurvegi 76-78,
220 Hafnarfjordur, Iceland
Manufacturers
Siegfried Malta Ltd, HHF070 Hal Far Industrial Estate,
Hal Far BBG3000, Malta
Actavis Group PTC ehf., Reykjavíkurvegi 76-78, IS-220 Hafnarfjörður,
Iceland

This leaflet was last revised in September 2014

If you would like a leaflet with
larger text, please contact
01271 385257. Actavis, Barnstaple, EX32 8NS, UK

Candesartan 4mg, 8mg, 16mg and 32mg Tablets PIL - UK
item no:

AAAH2250

dimensions:

print proof no:

5

pharmacode:

origination date: 15.09.14
approved for print/date

min pt size:

148 x 270

1. black
2.
3.
4.

7 pt

5.
6.

originated by:
revision date:

colours/plates:

12.01.15

Non Printing Colours

Technical Approval

revised by:

date sent:

06.10.14

supplier:

approved:

09.10.14

1.
2.
3.

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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