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CANDESARTAN CILEXETIL16 MG TABLETS

Active substance(s): CANDESARTAN CILEXETIL

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Package leaflet: Information for the user

Candesartan cilexetil 2 mg tablets
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

P150

P150

Candesartan cilexetil

Candesartan cilexetil

Pharmacode position may change as per Supplier's m/c requirement &additional
small pharma code may appear on the front / back panel

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 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).
Water tablets (diuretics).
Lithium (a medicine for mental health problems).

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:
• treating high blood pressure (hypertension) in adult patients
and in children and adolescents aged 6 to <18 years.
• Candesartan cilexetil can be used to 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. What you need to know before you take Candesartan
cilexetil
Do not take Candesartan cilexetil:
• if you are allergic to candesartan cilexetil or any of the other
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 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 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.
• 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).
• 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 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.

Black

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, breast-feeding and fertility
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 breastfeeding. 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 monohydrate
Candesartan cilexetil contains lactose monohydrate. If you have
been told by your doctor that you have an intolerance to some
sugars, contact your doctor before taking this medicinal product.
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.
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.

Heart failure in adults:
• 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 cilexetil than prescribed by your
doctor, contact a doctor or pharmacist immediately for advice.

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
The active substances is candesartan cilexetil. Each tablet
contains 2 mg, 4 mg, 8 mg, 16 mg or 32 mg of candesartan
cilexetil.
-

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 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.
• 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.
Very rare (affects less than 1 user in 10,000)
• 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.
• 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.
• Cough
• 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 adolescentsIn 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 (see details below). By
reporting side effects you can help provide more information on the
safety of this medicine.
Malta
The United Kingdom
ADR Reporting
Yellow Card Scheme
The Medicines Authority
Website:
Post-Licensing Directorate
www.mhra.gov.uk/yellowcard
203 Level 3, Rue D'Argens
GŻR-1368 Gżira
Website:
www.medicinesauthority.gov.mt
e-mail:
postlicensing.medicinesauthority@gov.mt
5. How to store Candesartan cilexetil
Keep this medicine out of the sight and reach of children.
Store below 30OC.
Do not use this medicine after the expiry date which is stated on
the carton, blister and bottle label after EXP. The expiry date refers
to the last day of that month.

The other ingredients are Lactose monohydrate, hydroxypropyl
cellulose, carmellose calcium, magnesium aluminometasilicate,
propylene glycol, magnesium stearate, iron oxide red (E172)
(8 mg tablets only), iron oxide yellow (16 mg & 32 mg tablets
only)

What Candesartan cilexetil looks like and contents of the pack
Tablet
Candesartan cilexetil 2 mg tablets
White to off-white, biconvex, uncoated, round shaped tablets
debossed with "J10" on one side and plain on other side.
Candesartan cilexetil 4 mg tablets
White to off-white, biconvex, uncoated, round shaped tablets
debossed with "J" and “11” separated by score-line on one side and
plain on other side. The tablet can be divided into equal doses.
Candesartan cilexetil 8 mg tablets
Pale pink, biconvex, uncoated, round shaped tablets debossed with
"J" and “12” separated by score-line on one side and plain on other
side. The tablet can be divided into equal doses.
Candesartan cilexetil 16 mg tablets
Yellow, biconvex, uncoated, round shaped tablets debossed with
"J" and “13” separated by score-line on one side and plain on other
side. The tablet can be divided into equal doses.
Candesartan cilexetil 32 mg tablets
Yellow, biconvex, uncoated, round shaped tablets debossed with
"J" and “14” separated by score-line on one side and plain on other
side. The tablet can be divided into equal doses.
Candesartan cilexetil tablets are available in PVC/PVdC –
Aluminium foil blister pack and HDPE container pack with
polypropylene closure.
Pack sizes:
Blister pack: 7, 14, 28, 30, 50, 56, 90, 98 & 500 tablets
HDPE pack: 30, 90 & 500 tablets
Not all pack sizes may be marketed.
Marketing Authorization Holder
UK_ Milpharm Limited
Ares Block, Odyssey Business Park
West End Road
Ruislip HA4 6QD
United Kingdom
MT_

Aurobindo Pharma (Malta) Limited
Vault 14, Level 2, Valletta Waterfront
Floriana FRN 1913
Malta

Manufacturer
APL Swift Services (Malta) Limited
HF26, Hal Far Industrial Estate, Hal Far
Birzebbugia, BBG 3000
Malta
or
Milpharm Limited
Ares Block, Odyssey Business Park
West End Road
Ruislip HA4 6QD
United Kingdom
This medicinal product is authorised in the Member States of
the EEA under the following names:
France
Germany
Malta
Netherlands
Portugal
Romania
Spain
United Kingdom

CANDESARTAN ARROW LAB 4 mg/ 8 mg/
16 mg/ 32 mg comprimés sécable
Candesartan Aurobindo 4 mg/ 8 mg/ 16 mg/
32 mg Tabletten
Candesartan cilexetil 2 mg/ 4 mg/ 8 mg/
16 mg/ 32 mg tablets
Candesartan cilexetil Aurobindo 4 mg/ 8 mg/
16 mg/ 32 mg tabletten
Candesartan Aurobindo
Candesartan Aurobindo 8 mg/ 16 mg
comprimate
CANDESARTAN AUROBINDO 4 mg/ 8 mg/
16 mg/ 32 mg comprimidos EFG
Candesartan cilexetil 2 mg/ 4 mg/ 8 mg/
16 mg/ 32 mg tablets

This leaflet was last revised in 04/2015.

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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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