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CANDESARTAN CILEXETIL 8 MG TABLET

Active substance(s): CANDESARTAN CILEXETIL

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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 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

1. What Candesartan Cilexetil is and
what it is used for
Candesartan Cilexetil contains the active
substance candesartan which belongs to a
group of medicines known as angiotensin II
receptor antagonists that lower blood pressure.
It works by making your blood vessels relax
and widen (which helps to lower your blood
pressure). It also makes it easier for your heart to
pump blood to all parts of your body.
Candesartan Cilexetil 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 to candesartan cilexetil or
any of the other ingredients of this medicine
(listed in section 6)
• if you have severe liver disease or biliary
obstruction (a problem with the drainage of
the bile from the gall bladder)
• if you are more than 3 months pregnant. (It is
also better to avoid Candesartan Cilexetil in
early pregnancy - see pregnancy section)
• 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.

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
• 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

Description Candesartan Cilexetil 16,8,4,32 mg all
Component Type Leaflet

Pharma Code TBC

Affiliate Item Code 698586

SAP No. N/A

Superceded Affiliate Item Code 530065
TrackWise PR No. 698586
MA No.

04569/1028,
1029 1030 & 1031

Packing Site/Printer N/A
Supplier Code N/A

Vendor Job No. 261486
Trackwise Proof No. 3
Glams Proof No. N/A
Client Market UK
Keyline/Drawing No. N/A
Barcode Info N/A

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
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. This is because candesartan, 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 taking,
have recently taken or might take 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. Your
doctor may need to change your dose and/or
to take other precautions. 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 taking any of the
following medicines:
• Other medicines to help lower your blood
pressure, including beta-blockers, diazoxide,
ACE-inhibitors (such as enalapril, captopril,
lisinopril or ramipril) or aliskiren (see also
information under the headings “Do not
take Candesartan Cilexetil” and “Warnings
and precautions”).
• 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).
• Non-steroidal anti-inflammatory drugs
(NSAIDs) such as ibuprofen, naproxen,
diclofenac, celecoxib, or etoricoxib (medicines
used 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)
• Diuretics (medicines known as ‘water tablets’)
• Lithium (a medicine used to treat mental
health problems)

TBC

TBC

Package leaflet: Information for the patient

Candesartan Cilexetil with food and
alcohol

• Y
 ou can take Candesartan Cilexetil with or
without food.
• When you are prescribed candesartan discuss
with your doctor before drinking alcohol.
Alcohol, while taking Candesartan Cilexetil,
may make you feel faint and dizzy.

Pregnancy and breast-feeding

Pregnancy
If you are pregnant, think you may be pregnant
or are planning to have a baby, ask your doctor
or pharmacist for advice before taking this
medicine. 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 this medicine. 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
If you are breast-feeding or about to start
breast-feeding ask your doctor or pharmacist for
advice before taking this medicine. Candesartan
Cilexetil is not recommended for mothers who
are breast-feeding, and your doctor may choose
another treatment for you if you wish to breastfeed, especially if your baby is newborn, or was
born prematurely.

Driving and using machines

Some people may feel tired or dizzy when taking
this medicine. If this happens to you, do not
drive or use any tools or machines.

Date: 08 Jan 2016

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If you have been told by your doctor that you
have an intolerance to some sugars, such as
lactose, contact your doctor before taking
this medicine.

3. How to take Candesartan Cilexetil
This is a long-term treatment.
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 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 remember to take it.
The tablet can be divided into equal doses.

To treat high blood pressure:

The recommended starting dose is 8 mg once
a day. Your doctor may increase this dose 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; these patients may need a
higher dose.

To treat heart failure:

The recommended 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.

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 less than 50 kg your
doctor may decide the dose needs to be
increased to a maximum of 8 mg once daily.
For patients weighing 50 kg or more your doctor
may decide the dose needs to be increased to
8 mg once daily and then to 16 mg once daily,
if needed.

If you take more Candesartan Cilexetil
than you should:

TBC

If you take more Candesartan Cilexetil than
prescribed by your doctor, contact a doctor or
pharmacist immediately for advice. Your blood
pressure may become low and you may feel dizzy.

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 this medicine, your blood
pressure may increase again. Therefore, do not
stop taking Candesartan Cilexetil without talking
to your doctor first.
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
contact your doctor or go to the nearest
hospital emergency department if you
have any of the following:

Very rare (may affect less than 1 in 10,000 people):
• swelling of the face, lips, tongue and/or throat,
which may cause difficulties in breathing
or swallowing.
• an increase in the number of infections you
may get which causes fever, severe chills,
sore throats, mouth ulcers or chesty coughs.
These may be due to a low number of white
blood cells.
• abnormal liver function including inflammation
of the liver (hepatitis) which may be seen as
feeling sick (nausea), being sick (vomiting) loss
of appetite, generally feeling unwell, fever,
itching, yellowing of the skin or whites of the
eyes with pale stools or dark coloured urine.
These may be signs of serious problems with
your liver.
• a decrease in kidney function which may be
seen as producing little or no urine, cloudy
urine or blood in the urine, pain when passing
urine or lower back pain. These may be signs
of serious kidney problems. In very rare cases
kidney failure may occur.

Other possible side effects include:
Common (may affect up to 1 in 10 people):
• feeling dizzy/spinning sensation when
standing still (vertigo)

Description Candesartan Cilexetil 16,8,4,32 mg all
Component Type Leaflet

Pharma Code TBC

Affiliate Item Code 698586

SAP No. N/A

Superceded Affiliate Item Code 530065
TrackWise PR No. 698586
MA No.

04569/1028,
1029 1030 & 1031

Packing Site/Printer N/A
Supplier Code N/A

Vendor Job No. 261486
Trackwise Proof No. 3
Glams Proof No. N/A
Client Market UK
Keyline/Drawing No. N/A
Barcode Info N/A

• h
 eadache
• chest infection
• low blood pressure. This may make you feel
faint or dizzy
• an increased amount of potassium in your
blood which can be seen in a blood test,
especially if you already have kidney problems
or heart failure. If this is severe you may notice
tiredness, weakness, an irregular heartbeat or
pins and needles in your hands or feet
Very rare (may affect less than 1 in
10,000 people):
• skin rash, lumpy rash (hives)
• itching
• cough
• back pain, pain in joints and muscles
• feeling sick (nausea)
• changes in blood test results such as a
reduced amount of sodium or an increase in
liver enzymes in your blood.

Additional side effects seen 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. A sore
throat is a very common side effect seen in
children and a blocked or runny nose, fever and
increased heart rate are common side effects in
children but none of these have been 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 out of the sight and reach of children.
Do not use this medicine after the expiry date
which is stated on the carton, blister or bottle
after EXP. The expiry date refers to the last day
of that month. After first opening the bottle, use
within 100 days.
Do not store above 25°C. Store in the original
package in order 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

The active substance is candesartan cilexetil.
One tablet contains either 4 mg, 8 mg, 16 mg, or
32 mg of candesartan cilexetil.
The other ingredients are carmellose calcium,
hydroxypropylcellulose, lactose monohydrate
(see section 2 ‘Candesartan Cilexetil contains
lactose’), magnesium stearate and mannitol.

What Candesartan Cilexetil looks like and
contents of the pack

Candesartan Cilexetil 4 mg tablets are white to
off white, round, biconvex tablet debossed with
“C1” on one side and “M” on one side of the break
line on the other side.
Candesartan Cilexetil 8 mg tablets are white to
off white, round, biconvex tablet debossed with
“M over C5” on one side and plain with break line
on the other side.
Candesartan Cilexetil 16 mg tablets are white to
off white, round, biconvex tablet debossed with
“M over C6” on one side and plain with break line
on the other side.
Candesartan Cilexetil 32 mg tablets are white to
off white, round, biconvex tablet debossed with
“M over C7” on one side and plain with break line
on the other side.
Candesartan Cilexetil is available in blisters either
inside a carton or inside a pouch of 7, 10, 14, 15,
28, 30, 50, 56, 60, 84, 90, 98 and 100 tablets, and
in plastic bottles of 30, 49, 56, 90 and 98 tablets.
The pouch and bottles contain a desiccant. The
bottles also contain cotton wool. Do not eat
the desiccant.
Not all pack sizes may be marketed.

Marketing Authorisation Holder

Mylan, Potters Bar, Hertfordshire, EN6 1TL,
United Kingdom

Manufacturer

Gerard Laboratories, 35/36 Baldoyle Industrial
Estate, Grange Road, Dublin 13, Ireland
Mylan Hungary Kft, H-2900 Komárom, Mylan
utca 1, Hungary
This leaflet was last revised in January 2016.

Code No.: MH/DRUGS/25/NKD/89

Date: 08 Jan 2016

Time: 15:32
Page Count 2/2

No. of colours 1
Colours

698586

TBC

Candesartan Cilexetil contains lactose

Black

Non-Print
Colours
Equate CMYK
with
Main Font Myriad Pro

Body Text Size 9 pt

Dimensions 150 x 400mm

Min Text Size used 9 pt

Sign-offs

v1/May 2015

Expand view ⇕

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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