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CANDESARTAN CILEXETIL 2 MG TABLETS

Active substance(s): CANDESARTAN CILEXETIL

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PAGE 1: FRONT FACE (INSIDE OF REEL)

Pharma code 99 (100100)
First bar is 105mm from the top edge of the leaflet.

used to treat heart failure).

Your doctor may need to change your dose and/or to take
other precautions:
you need to know before you take
• If you are taking an ACE-inhibitor or aliskiren (see also
2 What
Candesartan cilexetil
information under the headings “Do not take
Do NOT take Candesartan cilexetil
Candesartan cilexetil” and “Warnings and precautions”)
• if you are allergic to candesartan cilexetil or any of the
• If you are being treated with an ACE-inhibitor together with
other ingredients of this medicine (listed in section 6)
certain other medicines to treat your heart failure, which
• if you are more than 3 months pregnant (it is also better
are known as mineralocorticoid receptors antagonists
to avoid Candesartan cilexetil in early pregnancy – see
(MRA) (for example spironolactone, eplerenone).
section 2: Pregnancy and breast-feeding)
Candesartan cilexetil with food, drink and alcohol
• if you have severe liver disease or biliary obstruction (a
• You can take Candesartan cilexetil with or without food
problem with the drainage of the bile from the gall
• When you are prescribed Candesartan cilexetil, discuss
bladder)
with your doctor before drinking alcohol. Alcohol may
• if you have diabetes or impaired kidney function and you
make you feel faint or dizzy.
are treated with a blood pressure lowering medicine
Pregnancy
and breast-feeding
containing aliskiren
If you are pregnant or breast-feeding, think you may be
• if the patient is a child under 1 year of age.
pregnant or are planning to have a baby, ask your doctor
If you are not sure if any of these apply to you, talk to your or pharmacist for advice before taking this medicine.
doctor or pharmacist before taking Candesartan cilexetil.
Pregnancy
Warnings and precautions
You must tell your doctor if you think you are (or might
Talk to your doctor or pharmacist before taking
become) pregnant. Your doctor will normally advise you to
Candesartan cilexetil:
stop taking Candesartan cilexetil before you become
• if you have heart, liver or kidney problems, or are on
pregnant or as soon as you know you are pregnant and
dialysis
will advise you to take another medicine instead of
• if you have recently had a kidney transplant
Candesartan cilexetil. Candesartan cilexetil is not
• if you are vomiting, have recently had severe vomiting,
recommended in early pregnancy, and must not be taken
or have diarrhoea
when more than 3 months pregnant, as it may cause
• if you have a disease of the adrenal gland called Conn’s
serious harm to your baby if used after the third month of
syndrome (also called primary hyperaldosteronism)
pregnancy.
• if you have low blood pressure
Breast-feeding
• if you have ever had a stroke
Tell your doctor if you are breast-feeding or about to start
• you must tell your doctor if you think you are (or might
breast-feeding. Candesartan cilexetil is not recommended
become) pregnant. Candesartan cilexetil is not
recommended in early pregnancy, and must not be taken for mothers who are breast-feeding, and your doctor may
if you are more than 3 months pregnant, as it may cause choose another treatment for you if you wish to breast-feed,
especially if your baby is newborn or was born prematurely.
serious harm to your baby if used at that stage (see
section 2: Pregnancy and breast-feeding)
Driving and using machines
• if you are taking any of the following medicines used to
Some people may feel tired or dizzy when taking
treat high blood pressure:
Candesartan cilexetil. If this happens to you, do not drive
• an ACE-inhibitor (for example enalapril, lisinopril,
or use any tools or machines.
ramipril), in particular if you have diabetes-related
Candesartan cilexetil contains lactose which is a type of
kidney problems
sugar. If you have been told by your doctor that you have
• aliskiren
an intolerance to some sugars, contact your doctor before
• if you are taking an ACE-inhibitor together with a
taking this medicine.

Top of page cut-off to middle of registration mark: 44 mm.

medicine which belongs to the class of medicines known
as mineralocorticoid receptor antagonists (MRA). These
Package leaflet: information for the user
medicines are for the treatment of heart failure (see
Read all of this leaflet carefully before you start taking this
“Other medicines and Candesartan cilexetil”).
medicine because it contains important information for you.
Your doctor may check your kidney function, blood
• Keep this leaflet. You may need to read it again.
pressure, and the amount of electrolytes (e.g. potassium)
• If you have any further questions, ask your doctor or
in your blood at regular intervals.
pharmacist.
See also information under the heading “Do not take
• This medicine has been prescribed for you only. Do not
pass it on to others. It may harm them, even if their signs Candesartan cilexetil.
of illness are the same as yours.
If you are going to have an operation, tell your doctor or
• If you get any of the side effects, talk to your doctor or
dentist that you are taking Candesartan cilexetil. This is
pharmacist. This includes any possible side effects not
because Candesartan cilexetil when combined with some
listed in this leaflet. See section 4.
anaesthetics, may cause a drop in blood pressure.
What is in this leaflet:
Children and adolescents
1. What Candesartan cilexetil is and what it is used for
Candesartan has been studied in children. For more
2. What you need to know before you take Candesartan
information, talk to your doctor. Candesartan must not be
cilexetil
given to children under 1 year of age due to the potential
3. How to take Candesartan cilexetil
risk to the developing kidneys.
4. Possible side effects
Other medicines and Candesartan cilexetil
5. How to store Candesartan cilexetil
Tell your doctor or pharmacist if you are taking, have
6. Contents of the pack and other information
recently taken or might take any other medicines.
What
Candesartan
cilexetil
is
and
what
it
is
Candesartan cilexetil can affect the way some other
1 used for
medicines work and some medicines can have an effect on
Candesartan cilexetil. If you are using certain medicines,
The name of your medicine is Candesartan cilexetil. The
active ingredient is Candesartan cilexetil. This belongs to a your doctor may need to do blood tests from time to time.
group of medicines called Angiotensin II receptor
In particular, tell your doctor if you are using any of the
antagonists. It works by making your blood vessels relax
following medicines:
and widen. This helps to lower your blood pressure. It also • other medicines to help lower your blood pressure,
makes it easier for your heart to pump blood to all parts of
including beta-blockers and diazoxide
your body.
• non-steroidal anti-inflammatory drugs (NSAIDs) such as
ibuprofen, naproxen, diclofenac, celecoxib or etoricoxib
This medicine is used for:
(medicines to relieve pain and inflammation)
• treating high blood pressure (hypertension) in adult
• acetylsalicylic acid (if you are taking more than 3 g each
patients and in children and adolescents aged 6 to <18
day) (medicine to relieve pain and inflammation)
years
• potassium supplements or salt substitutes containing
• treating adult heart failure patients with reduced heart
potassium (medicines that increase the amount of
muscle function when Angiotensin Converting Enzyme
potassium in your blood)
(ACE) inhibitors cannot be used or in addition to

heparin
(a medicine for thinning the blood)
ACE-inhibitors when symptoms persist despite treatment
• water tablets (diuretics)
and mineralocorticoid receptor antagonists (MRA)
cannot be used. (ACE-inhibitors and MRAs are medicines • lithium (a medicine for mental health problems).

CANDESARTAN CILEXETIL 2 mg TABLETS

PAGE 2: REAR FACE (OUTSIDE OF REEL)

3

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.
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 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.
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.
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.
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.

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 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
• Cough
• 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.
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.
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 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 Candesartan cilexetil

• Keep this medicine out of the sight and reach of children.

• Do not use this medicine after the expiry date which is
If you take more Candesartan cilexetil than you should
stated on the blister foil and carton after {EXP}. The
If you take more Candesartan cilexetil than prescribed by
expiry date refers to the last day of that month.
your doctor, contact a doctor or pharmacist immediately for
• Tablets in Al-Al blisters: Do not store above 25°C.
advice.
Store in original packaging to protect from moisture.
If you forget to take Candesartan cilexetil
• Tablets in Al-Al blisters with desiccant layer: Store in
Do not take a double dose to make up for a forgotten
original packaging to protect from moisture.
tablet. Just take the next dose as normal.
Do not throw away any medicines via wastewater or
If you stop taking Candesartan cilexetil
household waste. Ask your pharmacist how to throw away
If you stop taking Candesartan cilexetil, your blood
medicines you no longer use. These measures will help
pressure may increase again. Therefore do not stop taking protect the environment.
Candesartan cilexetil 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

6

Contents of the pack and other information

What Candesartan cilexetil contains
The active substance is Candesartan cilexetil.
Each Candesartan cilexetil 2 mg Tablet contains 2 mg of
Candesartan cilexetil.

Like all medicines, this medicine can cause side effects,
although not everybody gets them.
The other ingredients are pregelatinized maize starch,
It is important that you are aware of what these side effects povidone K-30, carmellose calcium, microcrystalline
may be.
cellulose (E460), lactose monohydrate, magnesium
stearate, L-leucine.
Stop taking Candesartan cilexetil and seek medical help
immediately if you have any of the following allergic
What Candesartan cilexetil looks like and contents of the
reactions:
pack
• difficulties in breathing, with or without swelling of the
Candesartan cilexetil 2 mg Tablet is a white to off white,
face, lips, tongue and/or throat
round standard convex tablet. One side of the tablet is
• swelling of the face, lips, tongue and/or throat, which
debossed with the number “2”.The other side of the tablet
may cause difficulties in swallowing
is debossed with “C”.
• severe itching of the skin (with raised lumps).
Candesartan cilexetil Tablets are available in
Candesartan cilexetil may cause a reduction in number of
OPA/Aluminium/PVC – PVC/PVAC/Aluminium blisters or
white blood cells. Your resistance to infection may be
OPA/Aluminium/PE with desiccant agent/PE –PE/Aluminium
decreased and you may notice tiredness, an infection or a blisters in pack sizes of 7, 14, 15, 20, 28, 30, 50, 50 x 1 unit
fever. If this happens contact your doctor. Your doctor may dose blisters (hospital pack), 56, 60, 84, 90, 98, 100, 250 &
occasionally do blood tests to check whether Candesartan 300 tablets.
cilexetil has had an effect on your blood (agranulocytosis).
Not all pack sizes may be marketed.
Other possible side effects include:
Marketing Authorisation Holder and Manufacturer
Common (may affect up to 1 in 10 people)
TEVA UK Limited, Eastbourne, BN22 9AG, UK
• Feeling dizzy/spinning sensation
This leaflet was last revised in 10/2014
• Headache
• Respiratory infection
PL 00289/1174
• Low blood pressure. This may make you feel faint or dizzy
• Changes in blood test results:
• An increased amount of potassium in your blood,
82113-C
especially if you already have kidney problems or heart

200 x 323

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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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