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CANDESARTAN/HYDROCHLORTHIAZIDE 32 MG/12.5 MG TABLETS

Active substance(s): CANDESARTAN CILEXETIL / HYDROCHLOROTHIAZIDE

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NA. CANDESARTAN TBL GB prva stran

Package leaflet: Information for the user

Candesartan/Hydrochlorthiazide
8 mg/12.5 mg tablets
Candesartan/Hydrochlorthiazide
16 mg/12.5 mg tablets
Candesartan/Hydrochlorthiazide
32 mg/12.5 mg tablets
Candesartan/Hydrochlorthiazide
32 mg/25 mg tablets
Candesartan cilexetil/Hydrochlorothiazide
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/Hydrochlorthiazide is and what it is
used for
2. What you need to know before you take Candesartan/
Hydrochlorthiazide
3. How to take Candesartan/Hydrochlorthiazide
4. Possible side effects
5. How to store Candesartan/Hydrochlorthiazide
6. Contents of the pack and other information

1. What Candesartan/Hydrochlorthiazide
is and what it is used for
The name of your medicine is Candesartan/
Hydrochlorthiazide. 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/Hydrochlorthiazide
if your blood pressure has not been properly controlled by
candesartan cilexetil or hydrochlorothiazide alone.

70 mm ± 0,5 mm

2. What you need to know before you take
Candesartan/Hydrochlorthiazide
Do not take Candesartan/Hydrochlorthiazide:
• if you are allergic to candesartan cilexetil or
hydrochlorothiazide or any of the other ingredients of this
medicine (listed in 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/Hydrochlorthiazide in early
pregnancy – see pregnancy section).
• 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/
Hydrochlorthiazide.
Warnings and precautions
Talk to your doctor or pharmacist before taking
Candesartan/Hydrochlorthiazide.
• 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.
• 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.
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/Hydrochlorthiazide”.
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/Hydrochlorthiazide 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/Hydrochlorthiazide.

This is because Candesartan/Hydrochlorthiazide, when
combined with some anaesthetics, may cause a drop in
blood pressure.
Candesartan/Hydrochlorthiazide may cause increased
sensitivity of the skin to sun.
Children and adolescents
There is no experience with the use of Candesartan/
Hydrochlorthiazide in children (below the age of 18 years).
Therefore Candesartan/Hydrochlorthiazide should not be
given to children.
Other medicines and Candesartan/Hydrochlorthiazide
Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines.
Candesartan/Hydrochlorthiazide can affect the way some
other medicines work and some medicines can have an
effect on Candesartan/Hydrochlorthiazide 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.
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/Hydrochlorthiazide” and “Warnings and
precautions”).
Candesartan/Hydrochlorthiazide with food, drink and
alcohol
• You can take Candesartan/Hydrochlorthiazide 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
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/Hydrochlorthiazide before you
become pregnant or as soon as you know you are
pregnant and will advise you to take another medicine
instead of Candesartan/Hydrochlorthiazide. Candesartan/
Hydrochlorthiazide 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/Hydrochlorthiazide is not
recommended for mothers who are breast-feeding, and
your doctor may choose another treatment for you if you
wish to breast-feed.
Driving and using machines

Navodila prepognjena na sredini
z vidno prvo stranjo (naslovom);
pharma kodi, ki izhajata iz sredine
navodila, morata biti vidni!

- PMS-433U-KRKA

Šifra: xxxxxx
Emb. mat.: NA. CANDESARTAN TBL

GB
Dimenzije: 148 ± 0,5 mm x 520 ± 0,8 mm
Material: papir tip B
PhC št.: xxx
Merilo: 1:1
Datum: 02.10.2014
Izdelal: K. Savnik
Pregledal: J. Kastelic

Oddelek za oblikovanje
smer vlaken

70 mm ± 0,5 mm

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DPMockUp043702_1

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130 mm ± 0,5 mm

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

3. How to take Candesartan/
Hydrochlorthiazide
Always take this medicine exactly as described in this
leaflet or as your doctor or pharmacist have told you.
Check with your doctor or pharmacist if you are not sure.
It is important to keep taking Candesartan/
Hydrochlorthiazide every day.
The recommended dose of Candesartan/
Hydrochlorthiazide 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/Hydrochlorthiazide than
you should
If you take more Candesartan/Hydrochlorthiazide than
prescribed by your doctor, contact a doctor or pharmacist
immediately for advice.
If you forget to take Candesartan/Hydrochlorthiazide
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/Hydrochlorthiazide

If you stop taking Candesartan/Hydrochlorthiazide, your
blood pressure may increase again. Therefore do not stop
taking Candesartan/Hydrochlorthiazide 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. Some of the
side effects of Candesartan/Hydrochlorthiazide are caused
by candesartan cilexetil and some are caused by
hydrochlorothiazide.
Stop taking Candesartan/Hydrochlorthiazide 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/Hydrochlorthiazide 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/Hydrochlorthiazide has had any effect on
your blood (agranulocytosis).
Other possible side effects include:

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Common (may affect up to 1 in 10 people)
• 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.

• 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.

Uncommon (may affect up to 1 in 100 people)
• 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.

Very rare (may affect up to 1 in 10,000 people)
• 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.

Rare (may affect up to 1 in 1,000 people)
• 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.

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 Yellow Card Scheme,
Website: 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/
Hydrochlorthiazide
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is
stated on the packaging after EXP. 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.
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/Hydrochlorthiazide 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.

130 mm ± 0,5 mm

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.

Marketing Authorisation Holder and Manufacturer
KRKA, d.d., Novo mesto, Šmarješka cesta 6,
8501 Novo mesto, Slovenia
This leaflet was last revised in

What Candesartan/Hydrochlorthiazide looks like and
contents of the pack
Candesartan/Hydrochlorthiazide 8 mg/12.5 mg tablets are
white, biconvex, oval, with a score on one side.
The score line is only to facilitate breaking for ease of
swallowing and not to divide into equal doses.
Candesartan/Hydrochlorthiazide 16 mg/12.5 mg tablets
are pale pink, biconvex, oval, with a score on one side.
The score line is only to facilitate breaking for ease of
swallowing and not to divide into equal doses.
Candesartan/Hydrochlorthiazide 32 mg/12.5 mg tablets
are yellowish white, biconvex, oval, with a score on one
side.
The score line is only to facilitate breaking for ease of
swallowing and not to divide into equal doses.
Candesartan/Hydrochlorthiazide 32 mg/25 mg tablets are
pale pink, biconvex, oval, with a score on one side.
The tablet can be divided into equal doses.
Boxes of 14, 15, 28, 30, 56, 60, 84, 90, 98 tablets in
blisters are available.
Not all pack sizes may be marketed.

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