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CANDESARTAN CILEXETIL / HYDROCHLOROTHIAZIDE 16 MG/12.5 MG TABLETS

Active substance(s): CANDESARTAN CILEXETIL / HYDROCHLOROTHIAZIDE

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PACKAGE LEAFLET: INFORMATION FOR THE USER
Candesartan cilexetil / hydrochlorothiazide 8 mg/12.5 mg tablets
Candesartan cilexetil / hydrochlorothiazide 16 mg/12.5 mg tablets
Candesartan cilexetil / hydrochlorothiazide 32 mg/12.5 mg tablets
Candesartan cilexetil / hydrochlorothiazide 32 mg/25 mg tablets
Candesartan cilexetil/Hydrochlorothiazide
Read all o f t his l eaflet c arefully before you start taking this m edicine because i t c ontains
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 signs of illness are the same as yours.
- If you get a ny side e ffects, t alk t o y our d octor or ph armacist. This i ncludes a ny pos sible s ide
effects not listed in this leaflet. See section 4..
What is in this leaflet
1.
What Candesartan cilexetil / hydrochlorothiazide is and what it is used for
2.
What you need to know before you take Candesartan cilexetil / hydrochlorothiazide
3.
How to take Candesartan cilexetil / hydrochlorothiazide
4.
Possible side effects
5
How to store Candesartan cilexetil / hydrochlorothiazide
6.
Contents of the pack and other information
1.

What Candesartan cilexetil / hydrochlorothiazide is and what it is used for

The name of your medicine is Candesartan cilexetil / hydrochlorothiazide. It is used for treating high
blood p ressure ( hypertension) i n a dult pa tients. I t c ontains two a ctive i ngredients: c andesartan
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 t o a g roup o f m edicines c alled di uretics (water tablets). I t he lps
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 cilexetil / hydrochlorothiazide if your blood pressure has not
been properly controlled by candesartan cilexetil or hydrochlorothiazide alone.
2.

What you need to know before you take Candesartan cilexetil / hydrochlorothiazide

Do not take Candesartan cilexetil / hydrochlorothiazide if:
- you are al lergic (hypersensitive) t o candesartan cilexetil or hy drochlorothiazide or a ny of t he
other ingredients of Candesartan cilexetil / hydrochlorothiazide (see section 6).
- you are allergic to sulphonamide medicines. If you are not sure if this applies to you, please ask
your doctor.
- you a re m ore t han 3 m onths pregnant ( it i s a lso be tter t o a void Candesartan ci lexetil /
hydrochlorothiazide in early pregnancy – see pregnancy section).
- you have severe kidney problems.
- you have severe liver disease or biliary obstruction (a problem with the drainage of bile from the
gall bladder).
- you have persistently low levels of potassium in your blood.

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you have persistently high levels of calcium in your blood.
you have ever had gout.

If you a re no t s ure if a ny of t hese a pply t o y ou, t alk t o y our doc tor o r ph armacist before t aking
Candesartan cilexetil / hydrochlorothiazide.
Take special care with Candesartan cilexetil / hydrochlorothiazide
Before you take, or whilst you are taking Candesartan cilexetil / hydrochlorothiazide, tell your doctor
if:
you have diabetes.
you have heart, liver or kidney problems.
you have recently had a kidney transplant.
you are vomiting, have recently had severe vomiting, or have diarrhoea.
you have a disease of the adrenal gland called Conn’s syndrome (also called primary
hyperaldosteronism).
you have ever had a disease called systemic lupus erythaematosus (SLE)
you have low blood pressure
you have ever had a stroke.
you have ever had allergy or asthma.
you must t ell y our doc tor if y ou think y ou a re ( or might be come) p regnant. Candesartan
cilexetil / hy drochlorothiazide is not r ecommended in e arly pr egnancy, a nd m ust 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 a re g oing t o ha ve a n ope ration, tell y our doctor or de ntist that y ou a re t aking Candesartan
cilexetil / hy drochlorothiazide. This is be cause Candesartan cilexetil / hy drochlorothiazide, w hen
combined with some anaesthetics, may cause a drop in blood pressure.
Candesartan cilexetil / hydrochlorothiazide may cause increased sensitivity of the skin to sun.
Use in children
There is no experience with the use of Candesartan cilexetil / hydrochlorothiazide in children (below
the age of 18 years). Therefore Candesartan cilexetil / hy drochlorothiazide should n ot be g iven t o
children.
Using other medicines
Please t ell y our do ctor o r pharmacist if y ou are u sing or ha ve r ecently us ed any ot her m edicines,
including medicines obtained without a prescription. Candesartan cilexetil / hydrochlorothiazide can
affect the way some other medicines work and some medicines can have an effect on Candesartan
cilexetil / hydrochlorothiazide. 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 t o help l ower your blood pressure, including beta-blockers, diazoxide a nd
Angiotensin C onverting E nzyme ( ACE) i nhibitors such as e nalapril, c aptopril, l isinopril o r
ramipril.

Non-steroidal a nti-inflammatory dr ugs ( NSAIDs) s uch a s i buprofen, na proxen, di clofenac,
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.
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Medicines for diabetes (tablets or insulin).
Medicines t o con trol y our he art be at (antiarrhythmic ag ents) such a s d igoxin and be tablockers.
Medicines that c an be a ffected by po tassium bl ood levels su ch as som e a ntipsychotic
medicines.
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 t reatment of P arkinson’s di sease o r for se rious infections cau sed by
viruses).
Barbiturates (a type of sedative also used to treat epilepsy).
Carbenoxolone (for treatment of oesophageal 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 cilexetil / hydrochlorothiazide with food and drink (in particular alcohol)

You can take Candesartan cilexetil / hydrochlorothiazide with or without food.

When y ou are p rescribed Candesartan c ilexetil / h ydrochlorothiazide, d iscuss w ith y our
doctor before drinking alcohol.
Alcohol may make you feel faint or dizzy.
Pregnancy and breast-feeding
Pregnancy
You m ust t ell y our doc tor i f y ou t hink y ou a re ( or m ight be come) pr egnant. Y our doc tor w ill
normally a dvise you t o s top t aking Candesartan cilexetil / hydrochlorothiazide before you be come
pregnant or a s s oon a s y ou k now y ou a re pr egnant and w ill a dvise y ou t o t ake a nother m edicine
instead of Candesartan cilexetil / hydrochlorothiazide. Candesartan cilexetil / 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.
Breast-feeding
Tell y our d octor if y ou a re br east-feeding o r ab out t o start b reast-feeding. Candesartan cilexetil /
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 cilexetil / hydrochlorothiazide. If this
happens to you, do not drive or use any tools or machines.
Important information about some of the ingredients of Candesartan cilexetil /
hydrochlorothiazide
Candesartan cilexetil / hy drochlorothiazide contains l actose w hich is a t ype of sug ar. If you have
been told by doctor that you have an intolerance to some sugars, contact your doctor before taking
this medicine.

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3.

How to take Candesartan cilexetil / hydrochlorothiazide

Always t ake Candesartan c ilexetil / hydrochlorothiazide exactly a s y our doctor ha s t old y ou. Y ou
should check w ith your doc tor or ph armacist if you a re no t s ure. I t i s important to keep t aking
Candesartan cilexetil / hydrochlorothiazide every day.
The usual dose of Candesartan cilexetil / hydrochlorothiazide is one tablet once a day
Swallow the tablet with a drink of water.
The score line in 8 mg/12.5 mg tablets, 32 mg/12.5 mg tablets and 32 mg/25 mg tablets is only there
to help you break the tablet if you have difficulty swallowing it whole.
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 cilexetil / hydrochlorothiazide than you should
If you take more Candesartan cilexetil / hydrochlorothiazide than prescribed by your doctor, contact
a doctor or pharmacist immediately for advice.
If you forget to take use Candesartan cilexetil / hydrochlorothiazide
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 / hydrochlorothiazide
If you stop t aking Candesartan c ilexetil / hy drochlorothiazide, y our blood pr essure m ay i ncrease
again. Therefore do not stop taking Candesartan cilexetil / hydrochlorothiazide without first talking
to your doctor.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4.
Possible side effects
Like all medicines, Candesartan cilexetil / 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 cilexetil / hydrochlorothiazide are caused by candesartan cilexetil and
some are caused by hydrochlorothiazide.
Stop taking Candesartan cilexetil / 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 c ilexetil / hydrochlorothiazide may caus e a r eduction in number o f w hite 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 bl ood tests to check whether
Candesartan cilexetil / hydrochlorothiazide has had any effect on your blood (agranulocytosis).
Other possible side effects include:
Common (affects 1 to 10 users in 100)

Changes in blood test results:
- A r educed a mount of sodium i n your bl ood. I f this i s s evere then y ou m ay not ice
weakness, lack of energy, or muscle cramps.
- An i ncreased or r educed amount of pot assium i n your bl ood, e specially i f y ou
already ha ve k idney probl ems or he art failure. If t his i s sev ere, you may notice
tiredness, weakness, irregular heartbear 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.
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Headache.
Respiratory infection.

Uncommon (affects less than 1 user in 100)

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 (affects less than 1 user in 1,000)

Jaundice (yellowing of the 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 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 r eduction i n y our r ed or w hite b lood c ells or pl atelets. Y ou m ay not ice t iredness, a n
infection, fever or easy bruising.

A sev ere r ash that develops qui ckly, w ith b listering or pe eling of t he s kin a nd pos sibly
blistering in the mouth.

Worsening of e xisting l upus e rythaematosus-like r eactions o r appearance of u nusual sk in
reactions.
Very rare (affects less than 1 user in 10,000)

Swelling of the face, lips, tongue and/or throat.

Itching.

Back pain, pain in joints and muscles.

Changes in how y our liver is working, including i nflammation of the liver (hepatitis).You
may not ice t iredness, y ellowing of y our s kin a nd the w hites o f y our eyes a nd f lu like
symptoms.

Cough

Nausea.
Not Known (frecuency cannot be stimated from the available data)

Sudden Shortsightedness

Sudden eye pain (acute angle-closure glaucoma)
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.
Reporting of side effects:
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects
not listed i n this l eaflet. Y ou c an a lso report s ide effects directly v ia t he Yellow C ard 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 / hydrochlorothiazide



Keep this medicine out of the sight and reach of children.
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This medicinal product does not require any special storage conditions.
Do not use Candesartan cilexetil / hydrochlorothiazide after the expiry date which is stated
on the carton, blister pack or bottle. The expiry date refers to the last day of that month.

Do not t hrow away any medicines v ia w astewater. A sk y our pha rmacist ho w t o throw a way
medicines you no longer use. These measures will help to protect the environment.
6.

Contents of the pack and other information

What Candesartan cilexetil / hydrochlorothiazide contains
The active substances are: Candesartan and Hydrochlorthiazide
The tablets contain either 8 mg, 16 mg or 32 mg of candesartan cilexetil and either 12.5 mg or
25 mg of hydrochlorothiazide.
The other excipients are:
Candesartan cilexetil / hydrochlorothiazide 8 mg/12.5 mg tablets Hydroxypropyl Cellulose
(HPC-L), Lactose M onohydrate, M aize S tarch, Diethylene g lycol m onoethyl ether
(Transcutol), Magnesium Stearate, Calcium Carmellose.
Candesartan ci lexetil / hydrochlorothiazide 16 m g/12.5 m g tablets Hydroxypropyl
Cellulose ( HPC-L), Lactose Monohydrate, M aize S tarch, D iethylene glycol monoethyl e ther
(Transcutol), Magnesium Stearate, Calcium Carmellose, Ferric Oxid Red (E-172), Ferric Oxid
Yellow (E-172).
Candesartan ci lexetil / hydrochlorothiazide 32 m g/12.5 m g tablets Hydroxypropyl
Cellulose ( HPC-L), L actose M onohydrate, M aize S tarch, D iethylene glycol monoethyl e ther
(Transcutol), Magnesium Stearate, Calcium Carmellose, Ferric Oxid Yellow (E-172).
Candesartan cilexetil / hydrochlorothiazide 32 mg/25 mg tablets Hydroxypropyl Cellulose
(HPC-L), Lactose Monohydrate, M aize Starch, D iethylene g lycol m onoethyl ether
(Transcutol), Magnesium Stearate, Calcium Carmellose, Ferric Oxid Red (E-172), Ferric Oxid
Yellow (E-172).
What Candesartan cilexetil / hydrochlorothiazide looks like and contents of the pack
Candesartan cilexetil/ hydrochlorothiazide 8 mg/12.5 m g tablets are scored oblong tablets with
white colour.
Candesartan cilexetil/ hydrochlorothiazide 16 mg/12.5 mg tablets are oblong tablets with orange
colour.
Candesartan cilexetil/ hydrochlorothiazide 32 mg/12.5 mg tablets are scored oblong tablets with
yellow colour.
Candesartan ci lexetil/ h ydrochlorothiazide 32 mg/25 m g tablets are scored oblong ta blets w ith
orange colour.
Candesartan cilexetil / hydrochlorothiazide is supplied in Aluminium-PVC (treated with PE/PVDC).
Pack sizes: 7, 14, 15, 28, 28x1 (single dose unit), 30, 50, 50x1 (single dose unit), 56, 56x1 (single
doses unit) 98, 98x1 (single dose unit), 100 and 300 tablets
Not all the pack sizes may be marketed
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
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Laboratorios Liconsa, S.A.
Gran Vía Carlos III, 98, 7th floor
08028 - Barcelona, Spain
Manufacturer
Laboratorios Liconsa, S.A.
Avda. Miralcampo, nº 7, Polígono Industrial Miralcampo
19200 Azuqueca de Henares (Guadalajara)
Spain
Laboratorios Cinfa, S.A.
Olaz-Chipi 10, Polígono Industrial Areta
31620 Huarte (Navarra)
Spain
Laboratorios Cinfa, S.A.
Travesía Roncesvalles 1, Polígono Olloki
31699 Olloki (Navarra)
Spain
Cyndea Pharma, S.L.
Polígono Industrial Emiliano Revilla Sanz, Avenida de Agreda 31
42110 Ólvega (Soria)
Spain
For any i nformation about t his m edicine, please co ntact the local representative of t he M arketing
Authorisation Holder:

This m edicinal product i s authorized i n t he Member States of t he EEA under t he f ollowing
names:
The Netherlands:

candesartan cilexetil hydrochlorothiazide Liconsa 8/12,5 mg tablets
candesartan cilexetil hydrochlorothiazide Liconsa 16/12,5 mg tablets
candesartan cilexetil hydrochlorothiazide Liconsa 32/12,5 mg tablets
candesartan cilexetil hydrochlorothiazide Liconsa 32/25 mg tablets

Spain:

candesartan hidroclorotiazida cinfalab 8/12,5 mg comprimidos EFG
candesartan hidroclorotiazida cinfalab 16/12,5 mg comprimidos EFG
candesartan hidroclorotiazida cinfalab 32/12,5 mg comprimidos EFG
candesartan hidroclorotiazida cinfalab 32/25mg comprimidos EFG

Portugal:

candesartan hydrochlorothiazide cinfalab 8/12,5 mg tablets
candesartan hydrochlorothiazide cinfalab 16/12,5 mg tablets
candesartan hydrochlorothiazide cinfalab 32/12,5 mg tablets
candesartan hydrochlorothiazide cinfalab 32/25 mg tablets

France:

candesartan hydrochlorothiazide Liconsa 8/12,5 mg tablets
candesartan hydrochlorothiazide Liconsa 16/12,5 mg tablets
candesartan hydrochlorothiazide Liconsa 32/12,5 mg tablets
candesartan hydrochlorothiazide Liconsa 32/25 mg tablets

Italy:

candesartan idroclorotiazide Liconsa

United Kingdom:

Candesartan cilexetil / hydrochlorothiazide 8 mg/12,5 mg tablets
Candesartan cilexetil / hydrochlorothiazide 16 mg/12,5 mg tablets
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Candesartan cilexetil / hydrochlorothiazide 32 mg/12,5 mg tablets
Candesartan cilexetil / hydrochlorothiazide 32 mg/25 mg tablets
Poland:

Candesartan + HTC Genoptim

Germany:

candesartan hydrochlorothiazide Liconsa 8/12,5 mg tablets
candesartan hydrochlorothiazide Liconsa 16/12,5 mg tablets
candesartan hydrochlorothiazide Liconsa 32/12,5 mg tablets
candesartan hydrochlorothiazide Liconsa 32/25 mg tablets

This leaflet was last revised in November/2014

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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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