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CANDESARTAN CILEXETIL 8MG TABLETS

Active substance(s): CANDESARTAN CILEXETIL

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Package leaflet: Information for the user
Candesartan cilexetil 8 mg Tablets
Candesartan cilexetil 16 mg Tablets
Candesartan cilexetil 32 mg Tablets

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.

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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.

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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.

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 medicine is used for:



2.

Treating high blood pressure (hypertension) in adult patients and in children and adolescents
aged 6 to <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 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).

What you need to know before you take Candesartan cilexetil

Do not take Candesartan cilexetil
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if you are allergic to candesartan cilexetil or any of the other ingredients of this medicine
(listed in section 6).

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if you are more than 3 months pregnant (it is also better to avoid Candesartan cilexetil in
early pregnancy – see section 2: Pregnancy and breast-feeding).

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if you have severe liver disease or biliary obstruction (a problem with the drainage of the
bile from the gall bladder).

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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 cilexetil.

Warnings and precautions

Talk to your doctor or pharmacist before taking Candesartan cilexetil:
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if you have heart, liver or kidney problems, or are on dialysis.

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if you have recently had a kidney transplant.

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if you are vomiting, have recently had severe vomiting, or have diarrhoea.

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if you have a disease of the adrenal gland called Conn’s syndrome (also called primary
hyperaldosteronism).

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if you have low blood pressure

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if you have ever had a stroke.

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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
section 2: Pregnancy and breast-feeding).

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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 diabetesrelated 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’).
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’.

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
cilexetil. This is because Candesartan cilexetil 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 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, including medicines obtained without a prescription.
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.

In particular, tell your doctor if you are using any of the following medicines:
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Other medicines to help lower your blood pressure, including beta-blockers and diazoxide

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Non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen, naproxen, diclofenac,
celecoxib or etoricoxib (medicines to relieve pain and inflammation).

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Acetylsalicylic acid (if you are taking more than 3 g each day) (medicine to relieve pain
and inflammation).

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Potassium supplements or salt substitutes containing potassium (medicines that increase the
amount of potassium in your blood).

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Heparin (a medicine for thinning the blood).

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Water tablets (diuretics).

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Lithium (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 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 receptors antagonists (MRA) (for example
spironolactone, eplerenone).

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
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 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 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 Candesartan cilexetil

Always take this medicine exactly as your doctor or pharmacist 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.
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.
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 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 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 an effect on your blood (agranulocytosis).

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:
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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 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, 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 Candesartan cilexetil

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 blister foil and carton after
{EXP}. The expiry date refers to the last day of that month.
Do not store above 30°C. Store in original packaging 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.

Contents of the pack and other information

What Candesartan cilexetil contains

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The active substance is Candesartan cilexetil.
Each Candesartan cilexetil 8 mg Tablet contains 8 mg of Candesartan cilexetil.
Each Candesartan cilexetil 16 mg Tablet contains 16 mg of Candesartan cilexetil.
Each Candesartan cilexetil 32 mg Tablet contains 32 mg of Candesartan cilexetil.

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The other ingredients are pregelatinized maize starch, povidone K-30, carmellose calcium,
microcrystalline cellulose (E460), lactose monohydrate, magnesium stearate, poloxamer
188 and red iron oxide (E172).

What Candesartan cilexetil looks like and contents of the pack
- Candesartan cilexetil 8 mg Tablet is a pink, capsule shaped tablet, 7.7 mm in length and 3.5
mm in width, scored on both sides. One side of the tablet is debossed with “C | 8” and the other
side is debossed with “8 | C”.
- Candesartan cilexetil 16 mg Tablet is a pink, capsule shaped tablet, 9.7 mm in length and 4.3
mm in width, scored on one side. One side of the tablet is debossed with the number “16”. The
other side of the tablet is debossed with “C | C”.
- Candesartan cilexetil 32 mg Tablet is a pink, capsule shaped tablet, 12.2 mm in length and 5.4
mm in width, scored on one side. One side of the tablet is debossed with the number “32”. The
other side of the tablet is debossed with “C | C”.

Candesartan cilexetil Tablets are available in OPA/Aluminium/PVC –
PVC/PVAC/Aluminium/OPA blisters in pack sizes of 7, 14, 15, 20, 28, 30, 50, 50 x 1 unit dose
blisters (hospital pack), 56, 60, 84, 90, 98, 100, 250 & 300 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Teva UK Limited, Eastbourne BN22 9AG

OR*

Marketing Authorisation Holder
Teva UK Limited, Eastbourne BN22 9AG

Manufacturer:
TEVA Pharmaceutical Works Private Limited Company, Pallagi út 13, 4042 Debrecen, Hungary
OR*
Pharmachemie B.V., Swensweg 5, 2031 GA Haarlem, The Netherlands

OR*
Teva Operations Poland Sp. z.o.o., ul. Mogilska 80. 31-546, Krakow, Poland
OR*
Teva Pharma S.L.U., n. 4, Poligono Industrial Malpica, 50016 Zaragoza, Spain
OR*
Merckle GmbH, Ludwig-Merckle Strasse 3, 89143 Blaubeuren-Weiler, Germany

This leaflet was last revised in March 2016

PL 00289/1535-7

*

Only the paragraph containing the details of the current batch release site will be included in the printed version of the PIL

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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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