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CANDESARTAN CILEXETIL 4MG TABLETS

Active substance(s): CANDESARTAN CILEXETIL

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PACKAGE LEAFLET: INFORMATION FOR THE USER

SZ00000LT000

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, 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

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 an excessive drop in blood pressure.

What Candesartan Cilexetil is and what it
is used for

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.

The name of your medicine is Candesartan Cilexetil. The active
substance 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.

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.

This medicine is used to:
• 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 MRAs are medicines used to treat heart failure).

2

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).
• Potassium supplements or salt substitutes containing
potassium (medicines that increase the amount of potassium
in your blood).
• Heparin (a medicine for thinning the blood).
• Co-trimoxazole (an antibiotic medicine) also known as
trimethoprim/sulfamethoxazole.
• 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
Cilexetil” 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).

What you need to know before you take
Candesartan Cilexetil

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 pharmacist before taking Candesartan Cilexetil.

Warnings and precautions
Talk to your 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
syndrome (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 receptor 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).

Candesartan Cilexetil with food, drink and 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.

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 Cilexetil”

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.

draft: 44032828, 44032829,
44032831, 44032832,
44032833,
laetus code: supplier to add
mat.no.: supplier to add

Your doctor may want to see you more often and do some tests
if you have any of these conditions.

Continued on the next page >>

Artwork Proof Box
Ref: V037- Change in pack size of the finished product
Proof no.
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Date prepared:
16/08/2017

Colours:
Black
Dimensions: 165 x 310 mm

Font size:
7pt
Fonts:
Helvetica

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.

3

• 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 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 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.

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.

High blood pressure:
• The recommended 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.

5

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.

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.

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.

6

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.
Heart failure:
• The recommended 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.

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.

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.

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

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

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

Possible side effects

Candesartan Cilexetil 32 mg tablets: pink, mottled, round biconvex
tablet, debossed with 32 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.

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).

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, 120,
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.
HDPE bottle contains desiccant. Do not swallow.
Not all pack sizes may be marketed.

Other possible side effects include:
Common (may affect up to 1 in 10 people)
• 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 (may affect up to 1 in 10,000 people
• 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

draft: 44032828, 44032829,
44032831, 44032832,
44032833,
laetus code: supplier to add
mat.no.: supplier to add

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 K30
Carrageenan
Croscarmellose sodium
Magnesium stearate
Iron oxide, red (E172) (only for 8 mg , 16 mg and 32 mg
tablets)Titanium dioxide (E171) (only for 8 mg, 16 mg 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 08/2017.

SZ00000LT000

Artwork Proof Box
Ref: V037- Change in pack size of the finished product
Proof no.
011.0

Date prepared:
16/08/2017

Colours:
Black
Dimensions: 165 x 310 mm

Font size:
7pt
Fonts:
Helvetica

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