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CANDESARTAN/HYDROCHLORTHIAZIDE 32 MG/12.5 MG TABLETS

Active substance(s): CANDESARTAN CILEXETIL / HYDROCHLOROTHIAZIDE

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PACKAGE LEAFLET:
INFORMATION FOR THE USER

Candesartan/Hydrochlorothiazide
8 mg/12.5 mg tablets

Candesartan/Hydrochlorothiazide

In this leaflet:
1. What Candesartan/Hydrochlorothiazide is and what it is
used for
2. Before you take Candesartan/Hydrochlorothiazide
3. How to take Candesartan/Hydrochlorothiazide
4. Possible side effects
5. How to store Candesartan/Hydrochlorothiazide
6. Further information

16 mg/12.5 mg tablets

Candesartan/Hydrochlorothiazide
32 mg/12.5 mg tablets

Candesartan/Hydrochlorothiazide
32 mg/25 mg tablets

Candesartan cilexetil/Hydrochlorothiazide
Read all of this leaflet carefully before you start taking
this medicine.
• 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 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.

1. WHAT Candesartan/Hydrochlorothiazide IS AND
WHAT IT IS USED FOR
The name of your medicine is Candesartan/Hydrochlorothiazide.
It is used for treating high blood pressure (hypertension) in adult
patients. It contains two active ingredients: candesartan cilexetil
and hydrochlorothiazide.
These work together to lower your blood pressure.
Candesartan cilexetil belongs to a group of medicines called
angiotensin II receptor antagonists. It makes your blood vessels
relax and widen. This helps to lower your blood pressure.
Hydrochlorothiazide belongs to a group of medicines called
diuretics (water tablets). It helps your body to get rid of water
and salts like sodium in your urine. This helps to lower your blood
pressure.
Your doctor may prescribe Candesartan/Hydrochlorothiazide if
your blood pressure has not been properly controlled by
candesartan cilexetil or hydrochlorothiazide alone.

2. Before you take Candesartan/
Hydrochlorothiazide
Do not take Candesartan/Hydrochlorothiazide
• if you are allergic (hypersensitive) to candesartan cilexetil or
hydrochlorothiazide or any of the other ingredients of
Candesartan/Hydrochlorothiazide (see section 6).
• if you are allergic to sulphonamide medicines. If you are not
sure if this applies to you, please ask your doctor.
• if you have severe liver disease or biliary obstruction (a
problem with the drainage of the bile from the gall bladder).
• if you have severe kidney problems.
• if you have ever had gout.
• if you have persistently low levels of potassium in your blood,
• if you have persistently high levels of calcium in your blood.
• if you are more than 3 months pregnant (it is also better to
avoid Candesartan/Hydrochlorothiazide in early pregnancy –
see pregnancy section ).
If you are not sure if any of these apply to you, talk to your doctor
or pharmacist before taking Candesartan/Hydrochlorothiazide.
Take special care with Candesartan/Hydrochlorothiazide
• if you have diabetes.
• if you have heart, liver or kidney problems.
• if you have recently had a kidney transplant.
• if you are vomiting, have recently been vomiting a lot, or have
diarrhoea.
• if you have a disease of the adrenal gland called Conn’s
syndrome (also called primary hyperaldosteronism).

• if you have ever had a disease called systemic lupus
erythematosus (SLE).
• if you have low blood pressure.
• if you have ever had a stroke.
• if you have ever had allergy or asthma.
Your doctor may want to see you more often and do some tests if
you have any of these conditions.
You must tell your doctor if you think you are (or might become)
pregnant. Candesartan/Hydrochlorothiazide 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 going to have an operation, tell your doctor or dentist
that you are taking Candesartan/Hydrochlorothiazide. This is
because Candesartan/Hydrochlorothiazide, when combined with
some anaesthetics, may cause a drop in blood pressure.
Candesartan/Hydrochlorothiazide may cause increased
sensitivity of the skin to sun.
Use in children
There is no experience with the use of Candesartan/
Hydrochlorothiazide in children (below the age of 18 years).
Therefore Candesartan/Hydrochlorothiazide should not be given
to children.

Taking other medicines
Please tell your doctor or pharmacist if you are taking or have
recently taken any other medicines, including medicines
obtained without a prescription. Candesartan/Hydrochlorothiazide can affect the way some other medicines work and some
medicines can have an effect on Candesartan/Hydrochlorothiazide tablets. If you are using certain medicines, your doctor may
need to do blood tests from time to time.
It particularly, tell your doctor if you are taking any of the
following medicines:
• Other medicines to help lower your blood pressure, including
beta-blockers, diazoxide and Angiotensin Converting Enzyme
(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).
• Calcium or vitamin D supplements.
• Medicines to lower your cholesterol, such as colestipol or
cholestyramine.
• Medicines for diabetes (tablets or insulin).
• Medicines to control your heart beat (antiarrhythmic agents)
such as digoxin and beta-blockers.

















Heparin (a medicine for thinning the blood).
Water tablets (diuretics).
Laxatives.
Penicillin (an antibiotic).
Amphotericin (for the treatment of fungal infections).
Lithium (a medicine for mental health problems).
Steroids such as prednisolone.
Pituitary hormone (ACTH).
Medicines to treat cancer.
Amantadine (for the treatment of Parkinson’s disease or for
serious infections caused by viruses).
Barbiturates (a type of sedative also used to treat epilepsy).
Carbenoxolone (for treatment of esophageal disease, or oral
ulcers).
Anticholinergic agents such as atropine and biperiden.
Cyclosporine, a medicine used for organ transplant to avoid
organ rejection.
Other medicines that may lead to enhancement of the
antihypertensive effect such as baclofen (a medicine for relief
of spasticity), amifostin (used in cancer treatment) and some
antipsychotic medicines.

Taking Candesartan/Hydrochlorothiazide with food and
drink (in particular alcohol)
• You can take Candesartan/Hydrochlorothiazide with or
without food.
• Avoid taking alcohol until you have talked to your doctor.
Alcohol may make your blood pressure fall more and/or
increase the risk of you becoming dizzy or feeling faint.

Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking any
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/Hydrochlorothiazide before you become pregnant
or as soon as you know you are pregnant and will advise you to
take another medicine instead of Candesartan/Hydrochlorothiazide. Candesartan/Hydrochlorothiazide 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.
Breastfeeding
Tell your doctor if you are breast-feeding or about to start
breast-feeding. Candesartan/Hydrochlorothiazide 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/
Hydrochlorothiazide. If this happens to you, do not drive or use
any tools or machines.

Important information about some of the ingredients of
Candesartan/Hydrochlorothiazide
Candesartan/Hydrochlorothiazide 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 medicinal product.

If you stop taking Candesartan/Hydrochlorothiazide
If you stop taking Candesartan/Hydrochlorothiazide, your blood
pressure may increase again. Therefore do not stop taking
Candesartan/Hydrochlorothiazide without first talking to your
doctor.
If you have any further questions on the use of this product, ask
your doctor or pharmacist.

3. How to take Candesartan/Hydrochlorothiazide
4. POSSIBLE SIDE EFFECTS
Always take Candesartan/Hydrochlorothiazide exactly as your
doctor has told you. You should check with your doctor or
pharmacist if you are not sure. It is important to keep taking
Candesartan/Hydrochlorothiazide every day.
The usual dose of Candesartan/Hydrochlorothiazide is one tablet
once a day.
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.
If you take more Candesartan/Hydrochlorothiazide than
you should
If you take more Candesartan/Hydrochlorothiazide than
prescribed by your doctor, contact a doctor or pharmacist
immediately for advice.
If you forget to take Candesartan/Hydrochlorothiazide
Do not take a double dose to make up for a forgotten tablet.
Just take the next dose as normal.

Like all medicines, Candesartan/Hydrochlorothiazide can cause
side effects, although not everybody gets them. It is important
that you are aware of what these side effects may be. Some of
the side effects of Candesartan/Hydrochlorothiazide are caused
by candesartan cilexetil and some are caused by
hydrochlorothiazide.
These side effects may occur with certain frequencies, which are
defined as follows:
Very common

Affects more than 1 user in 10

Common

Affects 1 to 10 users in 100

Uncommon

Affects 1 to 10 users in 1,000

Rare

Affects 1 to 10 users in 10,000

Very rare

Affects less than 1 user in 10,000

Not known


Frequency cannot be estimated from
the available data

Stop taking Candesartan/Hydrochlorothiazide 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/Hydrochlorothiazide 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 tell your doctor. Your doctor may occasionally do
blood tests to check whether Candesartan/Hydrochlorothiazide
has had any effect on your blood (agranulocytosis).
Other possible side effects include:
Common
• 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.
- An increased or reduced 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.
- An increased amount of cholesterol, sugar, or uric acid in
your blood.
• Sugar in your urine.

• Feeling dizzy/spinning sensation or weak.
• Headache.
• Respiratory infection.
Uncommon
• Low blood pressure. This may make you feel faint or dizzy.
• Loss of appetite, diarrhoea, constipation, stomach irritation.
• Skin rash, lumpy rash (hives), rash caused by sensitivity to
sunlight.
Rare
• Jaundice (yellowing of your skin or the whites of your eyes). If
this happens to you, contact your doctor immediately.
• Effects on how your kidneys work, especially if you already
have kidney problems or heart failure.
• Difficulty in sleeping, depression, being restless.
• Tingling or prickling in your arms or legs.
• Blurred vision for a short time.
• Abnormal heart beat.
• Breathing difficulties (including lung inflammation and fluid
in the lungs).
• High temperature (fever).
• Inflammation of the pancreas. This causes moderate to severe
pain in the stomach.
• Muscle cramps.
• Damage to blood vessels causing red or purple dots in the
skin.
• A reduction in your red or white blood cells or platelets. You
may notice tiredness, an infection, fever or easy bruising.
• A severe rash, that develops quickly, with blistering or peeling
of the skin and possibly blistering in the mouth.

• Worsening of existing lupus erythematosus like reactions or
appearance of unusual skin reactions.
Very rare
• Swelling of the face, lips, tongue and/or throat.
• 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.
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.
5. How to store Candesartan/
Hydrochlorothiazide
Keep out of the reach and sight of children.
Do not use Candesartan/Hydrochlorothiazide after the expiry
date which is stated on the packaging. The expiry date refers to
the last day of that month.
Tablets packaged in blisters of PVC/PVDC film and aluminium
foil:
Do not store above 30°C.

Tablets packaged in blisters of laminated OPA/Al/PVC foil and
aluminium foil:
This medicinal product does not require any special storage
conditions.
Medicines should not be disposed of via wastewater or
household waste. Ask your pharmacist how to dispose of
medicines no longer required. These measures will help to
protect the environment.
6. FURTHER INFORMATION
What Candesartan/Hydrochlorothiazide contains
• The active substances are candesartan cilexetil and
hydrochlorothiazide.
Each tablet contains 8 mg candesartan cilexetil and 12.5 mg
hydrochlorothiazide.
Each tablet contains 16 mg candesartan cilexetil and 12.5 mg
hydrochlorothiazide.
Each tablet contains 32 mg candesartan cilexetil and 25 mg
hydrochlorothiazide.
Each tablet contains 32 mg candesartan cilexetil and 12.5 mg
hydrochlorothiazide.
• The other ingredients are lactose monohydrate, maize starch,
macrogol 8000, hydroxypropylcellulose, carmellose calcium,
magnesium stearate, red iron oxide (E172) only for
16 mg/12.5 mg and 32 mg/25 mg and yellow iron oxide
(e172) only for 32 mg/12.5 mg.

What Candesartan/Hydrochlorothiazide looks like and
contents of the pack
Candesartan/Hydrochlorothiazide 8 mg/12.5 mg tablets are
white, biconvex, oval, with a score on one side.
The scoreline is only to facilitate breaking for ease of swallowing
and not to divide into equal doses.
Candesartan/Hydrochlorothiazide 16 mg/12.5 mg tablets are
pale pink, biconvex, oval, with a score on one side.
The scoreline is only to facilitate breaking for ease of swallowing
and not to divide into equal doses.
Candesartan/Hydrochlorothiazide 32 mg/12.5 mg tablets are
yellowish white, biconvex, oval, with a score on one side.
The scoreline is only to facilitate breaking for ease of swallowing
and not to divide into equal doses.
Candesartan/Hydrochlorothiazide 32 mg/25 mg tablets are pale
pink, biconvex, oval, with a score on one side.
The tablet can be divided into equal halves.
Boxes of 14, 15, 28, 30, 56, 60, 84, 90, 98 tablets in blisters are
available.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and manufacturer:
Krka d.d., Šmarješka cesta 6, 8501 Novo mesto, Slovenia
Distributed by: Consilient Health (UK) Ltd, 500 Chiswick High
Road, London, W4 5RG

This leaflet was last revised in March 2011

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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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