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CANDESARTAN CILEXETIL 8 MG TABLETS

Active substance: 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
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 symptoms are the same as yours.
- If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please
tell your doctor or pharmacist. 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

This medicine is used for:
• 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).

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE
CANDESARTAN CILEXETIL
Do not take Candesartan cilexetil
• if you are allergic (hypersensitive) to candesartan cilexetil or any of the other ingredients of Candesartan
cilexetil (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 related to the drainage of the bile
from the gall bladder).
• 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.
• if you have any 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 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”).
• 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 not take Candesartan cilexetil”
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 taking, have recently taken or might take 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.
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.
• 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 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).
• Heparin (a medicine for thinning the blood).
• Water tablets (diuretics).
• Lithium (a medicine for mental health problems).
Your doctor may need to change your dose and/ or 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).
Taking Candesartan cilexetil with food 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, breast-feeding and fertility
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 tablets contain lactose
Candesartan cilexetil 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 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 every day.

140 mm
Candestran Insert
Front

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540 mm

The name of your medicine is Candesartan cilexetil 8mg/16mg/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.

You can take Candesartan 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 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.
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 e” 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 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.
If you take more Candesartan cilexetil than you should
If you take more Candesartan 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 dose.
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 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.
• Skin rash, severe itching of the skin (with raised lumps)
• 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.
• 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.
• Candesartan cilexetil may cause a reduction in number of red or white blood cells. Your resistance to
infection may be decreased and you may notice tiredness, an infection or fever. If it happens contact
your doctor. Your doctor may occasionally do blood tests to check whether Candesartan has had
any effect on your blood (agranulocytosis).
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.
Very rare (affects less than 1 user in 10,000)
• Back pain, pain in joint and muscles.
• 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.
• 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.
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 Candesartan cilexetil after the expiry date which is stated on the carton and blister. The
expiry date refers to the last day of that month.
• This medicinal product does not require any special storage conditions.
• Do not throw any medicines via wastewater or household waste. Ask your pharmacist how to
throw away medicines you no longer used. These measures will help to protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Candesartan cilexetil contains
The active substance is candesartan cilexetil. Each tablet of Candesartan cilexetil 8 mg, 16 mg and 32 mg
contains 8 mg, 16 mg or 32 mg of candesartan cilexetil.
The other ingredients are: hydroxypropyl cellulose (E463), lactose monohydrate, magnesium stearate,
maize starch, diethylene glycol monoethyl ether (Transcutol), and ferric oxide red (E172).
What Candesartan cilexetil tablets look like and contents of the pack
The 8 mg tablets are bevelled round and pink in colour, scored on one face.
The 16 mg tablets are round and pink, scored on one face.
The 32 mg tablets are round and pink, scored on one face.
Candesartan cilexetil 8 mg, 16 mg and 32 mg tablets are supplied in: transparent ALU/PVC blisters of
7, 14, 15, 20, 28, 30, 50, 50x1 (single dose unit), 56, 98, 98x1 (single dose unit), 100 or 300 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
LABORATORIOS LICONSA, S.A.
GRAN VÍA CARLOS III 98, 7ª PLANTA
08028, BARCELONA, SPAIN
Manufacturer responsible for batch release:
Laboratorios LICONSA, S.A.
Avda. Miralcampo, Nº 7, Polígono Industrial Miralcampo
19200 Azuqueca de Henares (Guadalajara), Spain
Distributed by:
Bristol Laboratories Ltd.
Unit 3, Canalside, Northbridge Road, Berkhamsted, Hertfordshire, HP4 1EG, UK
Tel:
0044 (0) 1442200922
Fax:
0044 (0) 1442873717
Email:
info@bristol-labs.co.uk
Candesartan cilexetil 8mg tablets; PL 23218/0092
Candesartan cilexetil 16mg tablets; PL 23218/0093
Candesartan cilexetil 32mg tablets; PL 23218/0094
This leaflet was last revised in October 2014

V6 06-11-2014 D1

Candestran Insert
Back

XXXXXX

If you would like any further Information about this medicine, please contact Bristol Laboratories Ltd.
at the address (or telephone, fax, email) above.

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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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