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
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. Do not pass it on to others. It may harm them,
even if their symptoms 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.
What is in this leaflet:
1. What Candesartan is and what it is used for
2. What you need to know before you take Candesartan
3. How to take Candesartan
4. Possible side effects
5. How to store Candesartan
6. Contents of the pack and other information

The name of your medicine is Candesartan cilexetil 8mg/16mg/32mg tablets referred as
Candesartan throughout the leaflet. 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:
• treating high blood pressure (hypertension) in adult patients.
• treating adult heart failure patients with reduced heart muscle function, in addition to
Angiotensin Converting Enzyme (ACE) inhibitors or when ACE inhibitors cannot be used
(ACE inhibitors are a group of medicines used to treat heart failure).

2. What you need to know before you take Candesartan
Do not take this medicine
• if you are allergic (hypersensitive) to candesartan cilexetil or any of the other ingredients of
Candesartan (see Section 6).
• if you are more than 3 months pregnant (it is also better to avoid Candesartan 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 you are not sure if any of these apply to you, talk to your doctor or pharmacist before taking
this medicine
Warnings and precautions
Talk to your doctor before taking Candesartan.
• 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 Crohn’s Syndrome (also called primary
hyperaldosteronism).
• if you have low blood pressure.
• if you have ever had a stroke.
You must tell your doctor if you think you are (or might become) pregnant. Candesartan 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 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. This is because Candesartan, when combined with some anaesthetics, may
cause a drop in blood pressure.
Children
There is no experience with the use of Candesartan in children (below the age of 18 years).
Therefore Candesartan should not be given to children.
Other medicines and Candesartan
Please tell your doctor or pharmacist if you are using, or have recently used, any other
medicines, including medicines obtained without a prescription.
Candesartan can affect the way some other medicines work and some medicines can have an
effect on Candesartan. 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).
Candesartan with food and drinks and alcohol
• You can take this medicine with or without food.
• When you are prescribed Candesartan, 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 before you become pregnant or as soon as
you know you are pregnant and will advise you to take another medicine instead of
Candesartan. Candesartan 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 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. If this happens to you, do not
drive or use any tools or machines.
Candesartan tablets contain lactose
Candesartan 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
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.
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.

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540 mm

1. What Candesartan is and what it is used for

140 mm

• 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 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 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 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
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
If you stop taking this medicine 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 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 issevere 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 may cause a reduction in number of red orwhite 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.
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
• Keep this medicine out of the sight and reach of children.
• Do not use Candesartan 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

V05 17-12-2013 D1

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What Candesartan contains
The active substance is candesartan cilexetil. Each tablet of Candesartan 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 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 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
This medicinal product is authorised in the Member States of the EEA under the following
names:
The Netherlands: Kairasec 8 mg/16 mg/32 mg tabletten
Austria:
Kairasec 8 mg/16 mg/32 mg tabletten
Belgium:
Kairasec 8 mg/16 mg/32 mg comprimés
Germany:
Kairasec 8 mg/16 mg/32 mg tabletten
Denmark:
Kairasec 8 mg/16 mg/32 mg tabletter
Finland:
Kairasec 8 mg/16 mg/32 mg tabletit
Sweden:
Kairasec 8 mg/16 mg/32 mg tabletter
United Kingdom: Kairasec 8 mg/16 mg/32 mg tablets
Candesartan cilexetil 8mg/16mg/32mg tablets
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 December 2013
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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