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CANDESARTAN CILEXETIL 4MG TABLETS

Active substance(s): CANDESARTAN CILEXETIL

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PACKAGE LEAFLET: INFORMATION FOR THE USER

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Candesartan Cilexetil 4 mg Tablets
Candesartan Cilexetil 8 mg Tablets
Candesartan Cilexetil 16 mg Tablets
Candesartan Cilexetil 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, please 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.
What is in this leaflet:
1. What Candesartan Cilexetil is and what it is used for
2. What you need to know before you take Candesartan Cilexetil
3. How to take Candesartan Cilexetil
4. Possible side effects
5. How to store Candesartan Cilexetil
6. Contents of the pack and other information

1

not take Candesartan Cilexetil”

What Candesartan Cilexetil is and what it
is used for

The name of your medicine is Candesartan Cilexetil. 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 is medicine is used for:
• treating high blood pressure (hypertension) in adult patients
and in children and adolescents aged 6 to <18 years.
• Canderstartan Cilexetil can be used to 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 MRAs are medicines
used to treat heart failure).

2

What you need to know before you take
Candesartan Cilexetil

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Do not take Candesartan Cilexetil
• if you are allergic to candesartan cilexetil or to any of the
ingredients of this medicine (listed in section 6)
• if you are more than 3 months pregnant. (it is also better to
avoid Candesartan Cilexetil 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 have diabetes or impaired kidney function and you
are treated with a blood pressure lowering medicine
containing aliskiren.
• if the patient is a child under 1 year of age.
If you are not sure if any of these apply to you, talk to your
doctor or pharmacists before taking Candesartan Cilexetil .
Warnings and precautions
Talk to you doctor or pharmacist before taking Candesartan Cilexetil:
• 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
disease (also called primary hyperaldosteronism)
• if you have low blood pressure
• if you have ever had a stroke
• 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 Candesartan Cilexetil”).
• you must tell your doctor if you think you are (or might
become) pregnant. Candesartan Cilexetil 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

If you are going to have an operation, tell your doctor or dentist
that you are taking Candesartan Cilexetil. This is because
Candesartan Cilexetil, when combined with some anaesthetics,
may cause a drop in blood pressure.
Children and adolescents
Candesartan cilexetil has been studied in children. For more
information, talk to your doctor. Candesartan Cilexetil must not
be given to children under 1 year of age due to the potential risk
to the developing kidneys.
Other medicines and Candesartan Cilexetil
Tell your doctor or pharmacist if you are using, have recently
used, or might use any other medicines.
Candesartan Cilexetil can affect the way some other medicines
work and some medicines can have an effect on Candesartan
Cilexetil. If you are using certain medicines, your doctor may
need to do blood tests from time to time.
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 Cilexetil” and “Warnings
and precautions”).
• 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).
• 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)
• 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).
Candesartan Cilexetil with food and drink (in particular alcohol)
• You can take Candesartan Cilexetil with or without food
• When you are prescribed Candesartan Cilexetil, 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 Cilexetil before you become pregnant or as soon
as you know you are pregnant and will advise you to take another
medicine instead of Candesartan Cilexetil. Candesartan Cilexetil
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
breast-feeding. Candesartan Cilexetil 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.
Driving and using machines
Some people may feel tired or dizzy when taking Candesartan
Cilexetil. If this happens to you, do not drive or use any tools or
machines.
Candesartan Cilexetil contains lactose
If you have been told by your doctor that you have an intolerance
to some sugars, contact your doctor before taking this medicine.
Continued on the next page >>

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• 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
• 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
• Cough.

How to take Candesartan Cilexetil

Always take Candesartan Cilexetil 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 Cilexetil
every day. You can take Candesartan Cilexetil with or without
food. Swallow the tablet with a drink of water.

Additional side effects in children and adolescents
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.

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 Candesartan Cilexetil is 8 mg once daily.
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.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist.
This includes any possible side effects not listed in this leaflet.
You can also report side effects directly via the Yellow Card
Scheme (www.mhra.gov.uk/yellowcard). By reporting side effects
you can help provide more information on the safety of this medicine.

5

Use in children and adolescents with high blood pressure:
Children 6 to <18 years of age:
The recommended starting dose is 4 mg once daily.
For patients weighing < 50 kg: In some patients whose blood
pressure is not adequately controlled, your doctor may decide
the dose needs to be increased to a maximum of 8 mg once daily.

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 blister after EXP. The expiry date refers to the
last day of that month.
HDPE bottles: use within 3 months after first opening.

For patients weighing ≥ 50 kg: In some patients whose blood
pressure is not adequately
controlled, your doctor may decide the dose needs to be increased to 8 mg once daily and to 16 mg once daily.

Store in the original package in order to protect from moisture.
Do not throw away any medicines via wastewater or household
waste. Ask your pharmacist how to throw away medicines you
no longer use. These measures will help protect the environment.

Heart failure:
• The usual starting dose of Candesartan Cilexetil 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 Cilexetil can be taken together with other
medicines for heart failure, and your doctor will decide which
treatment is suitable for you.

6

If you forget to take Candesartan Cilexetil
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 Cilexetil
If you stop taking Candesartan Cilexetil, your blood pressure
may increase again. Therefore do not stop taking Candesartan
Cilexetil without first talking to your doctor.
If you have any further questions on the use of this product, ask
your doctor or pharmacist.

What Candesartan Cilexetil looks like and contents of the pack
Tablet
Candesartan Cilexetil 4 mg tablets: white, round biconvex tablet,
debossed with 4 on one side and scored on the other side.

Possible side effects

Candesartan Cilexetil 8 mg tablets: pink, mottled, round biconvex
tablet, debossed with 8 in one side and scored on the other side.

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.

Candesartan Cilexetil 16 mg tablets: pink, mottled, round biconvex
tablet, debossed with 16 in one side and scored on the other side.

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

Candesartan Cilexetil 32 mg tablets: pink, mottled, round biconvex
tablet, debossed with 32 in one side and scored on the other side.
The tablet can be divided into equal halves.
Candesartan Cilexetil 4 mg, 8mg and 16 mg tablets
Al/Al Blister: 7, 14, 20, 28, 30, 50, 56, 58, 60, 84, 90, 91, 98,
100, 250, 300 tablets.
Al/Al perforated unit dose blister: 50 x 1 tablets.
Al/Al Blister with desiccant: 7, 14, 20, 28, 30, 50, 56, 58, 60, 84,
90, 91, 98, 100, 250, 300 tablets.
Al/Al perforated unit dose blister with desiccant: 50 x 1 tablets.
HDPE bottle with PP cap and silica gel desiccant: 30, 100, 500
tablets.
Candesartan Cilexetil 32 mg tablets
Al/Al Blister: 7, 14, 20, 28, 30, 50, 56, 58, 60, 84, 90, 91, 98,
100, 250, 300 tablets.
Al/Al Blister with desiccant: 7, 14, 20, 28, 30, 50, 56, 58, 60, 84,
90, 91, 98, 100, 250, 300 tablets.
HDPE bottle with PP cap and silica gel desiccant: 30, 100, 500 tablets.
Notice! HDPE bottle contains desiccant. Do not swallow.
Not all pack sizes may be marketed.

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, 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.

Marketing Authorisation Holder and Manufacturer
Sandoz Ltd, Frimley Business Park, Frimley, Camberley, Surrey,
GU16 7SR, UK.
Manufacturer:
Lek Pharmaceuticals d.d., Verovśkova 57, 1526 Ljubljana,
Slovenia or Lek Pharmaceuticals d.d., Trimlini 2D, 9220
Lendava, Slovenia or LEK S.A., ul. Podlipie 16, 95-010 Strykow,
Poland or LEK S.A., ul. Domaniewska 50 C, 02-672 Warszawa,
Poland or Salutas Pharma GmbH, Otto-von-Guericke-Allee 1,
39179 Barleben, Germany or Salutas Pharma GmbH,
Dieselstrasse 5, 70839 Gerlingen, Germany.

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

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44032831, 44032833
laetus code: 00000000 (2D)
mat.no.: 00000000

Contents of the pack and other information

What Candesartan Cilexetil contains
• The active substance is candesartan cilexetil.
Each tablet contains 4, 8, 16 or 32 mg of candesartan cilexetil
• The other ingredients are:
Lactose monohydrate
Maize starch
Povidone 30
Carrageenan
Croscarmellose sodium
Magnesium stearate
Iron oxide, red (E172) (only for 8, 16 and 32 mg tablets)
Titanium dioxide (E171) (only for 8, 16 and 32 mg tablets).

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

4

How to store Candesartan Cilexetil

This leaflet was last revised in 08/2014.

Artwork Proof Box
Ref: N003 - Sandoz logo update (Phase 13)
Proof no.
008.0

Date prepared:
04/09/2015

Colours:
Black
Dimensions: 165 x 310 mm

Font size:
7pt
Fonts:
Helvetica

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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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