CANDESARTAN 8 mg /12,5 Mg Tabletka Powlekana

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1. Candesartan and Hydrochlorothiazide HCS 8 mg/12.5mg tablets, 16 mg /12.5 mg tablets, 32 mg/12.5 mg tablets, 32 mg/25 mg tablets
   1. What is Candesartan and Idroclorotiazide HCS and what is it used for
   2. What you need to know before taking Candesartan and Hydrochlorothiazide HCS
   3. How to take Candesartan e Idroclorotiazide HCS
   4. Possible side effects
   5. How to store Candesartan e Idroclorotiazide HCS
   6. Package contents and other information

Candesartan and Hydrochlorothiazide HCS 8 mg/12.5mg tablets, 16 mg /12.5 mg tablets, 32 mg/12.5 mg tablets, 32 mg/25 mg tablets

Candesartan cilexetil/Hydrochlorothiazide

Generic medicine

Read this leaflet carefully before you start to take this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it may be harmful.
• If any of the side effects gets worse, or if you notice any side effect not listed in this leaflet, tell your doctor or pharmacist (see section 4).

Contents of this leaflet:

• 1. What Candesartan and Hydrochlorothiazide HCS is and what it is used for
• 2. What you need to know before you take Candesartan and Hydrochlorothiazide HCS
• 3. How to take Candesartan and Hydrochlorothiazide HCS
• 4. Possible side effects
• 5. How to store Candesartan and Hydrochlorothiazide HCS
• 6. Contents of the pack and other information

1. What is Candesartan and Idroclorotiazide HCS and what is it used for

Your medicine is called Candesartan and Idroclorotiazide HCS and is used for the treatment of
high blood pressure (hypertension) in adult patients. It contains two active ingredients: candesartan cilexetil and
hydrochlorothiazide. These active ingredients work together to reduce blood pressure.
Candesartan cilexetil belongs to a group of drugs called angiotensin II receptor blockers. It relaxes and widens blood vessels. This helps to reduce blood pressure.
Hydrochlorothiazide belongs to a group of drugs called diuretics. It helps the body to eliminate water
and salts such as sodium through urine. This helps to reduce blood pressure.
Your doctor may prescribe Candesartan and Idroclorotiazide HCS if your blood pressure has not been
adequately controlled with candesartan cilexetil or hydrochlorothiazide alone.

2. What you need to know before taking Candesartan and Hydrochlorothiazide HCS

Do not take Candesartan and Hydrochlorothiazide HCS

• if you are allergic to candesartan cilexetil or hydrochlorothiazide, or to any of the other ingredients of this medicine (listed in section 6).
• if you are allergic to sulfonamides. If you are not sure, ask your doctor.
• if you are more than three months pregnant (it is also best to avoid Candesartan and Hydrochlorothiazide HCS in the first months of pregnancy - see section “Pregnancy and breastfeeding”).
• if you have severe kidney problems.
• if you have severe liver disease or bile duct obstruction (problems with draining bile from the gallbladder).
• if you have consistently low levels of potassium in your blood.
• if you have consistently high levels of calcium in your blood.
• if you have had gout.
• if you suffer from diabetes or your kidney function is impaired and you are being treated with a medicine that lowers blood pressure, containing aliskiren

If you are not sure if any of these conditions apply to you, consult your doctor or pharmacist before
taking Candesartan and Hydrochlorothiazide HCS.

Warnings and precautions
Talk to your doctor or pharmacist before taking Candesartan and Hydrochlorothiazide HCS

• if you have diabetes,
• if you have heart, liver or kidney problems,
• if you have had a transplant recently,
• if you have been vomiting, have recently been vomiting or have diarrhoea,
• if you have a condition of the adrenal gland called Conn's syndrome (also called primary hyperaldosteronism),
• if you have ever had systemic lupus erythematosus (SLE),
• if you have low blood pressure,
• if you have had a stroke,
• if you have ever suffered from allergies or asthma,
• You must tell your doctor if you are (or might be) pregnant. Candesartan and Hydrochlorothiazide HCS is not recommended in the first months of pregnancy and should not be taken after the third trimester of pregnancy, as it can cause serious harm to the baby if used during this period (see the section “Pregnancy and breastfeeding”). if you are taking any of the following medicines used to treat high blood pressure:
• an "ACE inhibitor” (e.g. enalapril, lisinopril, ramipril etc.), especially if you have kidney problems related to diabetes.
• aliskiren

The doctor may check your kidney function, blood pressure, and the amount of electrolytes
(e.g. potassium) in your blood at regular intervals.
See also what is stated under "Do not take Candesartan and Hydrochlorothiazide HCS".
The doctor may want to check you more often and perform further tests if you suffer from any of these
conditions.
If you are on the list for surgery, tell your doctor or dentist that you are taking Candesartan and
Hydrochlorothiazide HCS. This is because Candesartan and Hydrochlorothiazide HCS, in combination with some
anaesthetics, can cause an excessive drop in blood pressure.
Candesartan and Hydrochlorothiazide HCS can cause an increase in the sensitivity of your skin to the sun.

Children and adolescents
There is no experience in the use of Candesartan and Hydrochlorothiazide HCS in children (under 18 years
of age). Therefore Candesartan and Hydrochlorothiazide HCS should not be given to children.

For athletes: the use of the drug without therapeutic need constitutes doping and may

still result in positive doping tests.

Other medicines and Candesartan and Hydrochlorothiazide HCS
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
Candesartan and Hydrochlorothiazide HCS can affect the way other medicines work and some
medicines can affect Candesartan and Hydrochlorothiazide HCS tablets. If you are taking
any other medicine, your doctor may occasionally need to perform blood tests.
In particular, tell your doctor if you are taking any of the following medicines as your doctor
may need to change the dose and/or take other precautions:

• other medicines that lower blood pressure, including beta-blockers, medicines containing aliskiren, diazoxide and ACE inhibitors such as enalapril, captopril, lisinopril or ramipril,
• non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen, naproxen or diclofenac, celecoxib or etoricoxib (medicines to relieve pain and inflammation),
• acetylsalicylic acid (if you take more than 3 g per day) (a medicine to relieve pain and inflammation),
• potassium preparations or salt substitutes that contain potassium (medicines that increase the amount of potassium in the blood),
• calcium or vitamin D supplements,
• medicines to lower cholesterol, such as colestipol or colestyramine,
• medicines for diabetes (tablets or insulin),
• medicines to control the heartbeat (antiarrhythmics), such as digoxin and beta-blockers,
• medicines that can be affected by potassium levels in the blood such as antipsychotics,
• heparin (a medicine used to thin the blood),
• diuretics,
• laxatives,
• penicillin or co-trimoxazole also known as trimethoprim/sulfamethoxazole (antibiotic medicines),
• amphotericin (for the treatment of fungal infections),
• lithium (a medicine used for mental problems),
• steroids, such as prednisolone,
• pituitary gland hormone (ACTH),
• medicines to treat cancer,
• amantadine (for the treatment of Parkinson's disease or severe viral infections),
• barbiturates (a type of sedative also used to treat epilepsy),
• carbenoxolone (for the treatment of esophageal disease or mouth ulcers),
• anticholinergic agents, such as atropine and viperide,
• cyclosporine, a medicine used in organ transplantation to prevent rejection,
• other medicines that can increase the antihypertensive effect such as baclofen (a medicine for relief of spasticity), amifostine (used to treat cancer) and some antipsychotic medicines.
• If you are taking an ACE inhibitor or aliskiren (see also information under "Do not take Candesartan and Hydrochlorothiazide HCS" and "Warnings and precautions").

Candesartan and Hydrochlorothiazide HCSwith food, drinks and alcohol

• You can take Candesartan and Hydrochlorothiazide HCS with or without food.
• When you are prescribed Candesartan and Hydrochlorothiazide HCS, talk to your doctor before drinking alcohol. Alcohol can make you feel dizzy or faint.

Pregnancy and breastfeeding

Pregnancy
You must tell your doctor if you are (or might be) pregnant. The doctor will normally advise you to
stop taking Candesartan and Hydrochlorothiazide HCS before becoming pregnant or as soon as
pregnancy is confirmed and will advise you on another medicine to use instead of Candesartan and
Hydrochlorothiazide HCS. Candesartan and Hydrochlorothiazide HCS is not recommended in the first months of
pregnancy and should not be taken after the third trimester of pregnancy, as it can cause serious
harm to the baby if used after the third month of pregnancy.

Breastfeeding
Tell your doctor if you are breastfeeding or if you are about to start breastfeeding. Candesartan and
Hydrochlorothiazide HCS is not recommended for mothers who are breastfeeding and your doctor may suggest
another therapy if you wish to breastfeed, especially if your baby is a newborn or was born
prematurely.

Driving and using machines
Some people may experience fatigue or dizziness during treatment with Candesartan and
Hydrochlorothiazide HCS. If this happens, do not drive and do not use tools or machines.

Candesartan and Hydrochlorothiazide HCS containslactose, 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 medicine.

3. How to take Candesartan e Idroclorotiazide HCS

Take this medicine following the instructions described in this leaflet exactly as your doctor or pharmacist has told you. If you have any doubts, ask your doctor or pharmacist. It is important that you take Candesartan e Idroclorotiazide HCS every day.
The recommended dose is 1 tablet of Candesartan e Idroclorotiazide HCS once a day.
Swallow the tablet with a glass 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 e Idroclorotiazide HCS than you should
If you take more Candesartan e Idroclorotiazide HCS than you have been prescribed, contact your doctor or pharmacist immediately.

If you forget to take Candesartan e Idroclorotiazide HCS
Do not take a double dose to make up for a missed dose.
Take the next dose as usual.

If you stop taking Candesartan e Idroclorotiazide HCS
If you stop taking Candesartan e Idroclorotiazide HCS, your blood pressure may increase again. For this reason, do not stop taking Candesartan e Idroclorotiazide HCS without first consulting 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 know about these side effects. Some of these side effects of Candesartan and Idroclorotiazide HCS are caused by candesartan cilexetil, while others are caused
by hydrochlorothiazide.

Stop taking Candesartan and Idroclorotiazide HCS and seek immediate medical attention
if you have any of the following allergic reactions:

• difficulty 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 difficulty swallowing,
• severe itching of the skin (with skin rash).

Candesartan and Idroclorotiazide HCS can cause a decrease in the number of white blood cells. The
resistance to infection may be reduced and you may notice tiredness, an infection or fever. If this happens
contact a doctor. The doctor may occasionally perform blood tests to check
the possible effect of Candesartan and Idroclorotiazide HCS on the blood (agranulocytosis).
Other possible side effects include:

Common(may affect up to 1 in 10 people)

• changes in blood test results:
• low levels of sodium in the blood. In severe cases, you may notice fatigue, lack of energy or muscle cramps.
• increase or decrease in potassium levels in the blood, especially if you already have kidney problems or suffer from heart failure. In severe cases, you may notice tiredness, fatigue, irregular heartbeat or tingling.
• increase in cholesterol, sugar or uric acid levels in the blood.
• Sugar in urine.
• Sensations of dizziness/lightheadedness or weakness.
• Headache.
• Respiratory infection. Uncommon(may affect up to 1 in 100 people)
• Low blood pressure, which may make you feel weak or dizzy.
• Loss of appetite, diarrhoea, constipation, upset stomach.
• Skin rash, rash in the form of bruises (urticaria), rash caused by sensitivity to sunlight.

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

• Jaundice (yellowing of the skin or whites of the eyes). If this affects you, contact your doctor immediately.
• Effects on kidney function, especially if you already have kidney problems or suffer from heart failure.
• Difficulty sleeping, depression, restlessness.
• Pins and needles or tingling in legs and arms.
• Temporary blurred vision.
• Abnormal heartbeat.
• Difficulty breathing (including inflammation of the lungs and fluid in the lungs).
• High temperature (fever).
• Inflammation of the pancreas, which involves moderate to severe pain in the stomach area.
• Muscle cramps.
• Damage to blood vessels, causing red spots or bruising on the skin.
• Decrease in the number of red blood cells or white blood cells or platelets. This may involve tiredness, infection, fever or increased susceptibility to bruising.
• A severe rash that develops rapidly with blisters or scaling skin and possible blisters in the mouth.

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

• Swelling of the face, lips, tongue and/or throat.
• Itching.
• Back pain, joint and muscle pain.
• Changes in liver function, including inflammation of the liver (hepatitis). You may notice tiredness, yellowing of the skin and whites of the eyes and flu-like symptoms.
• Cough.
• Nausea.

Not known(frequency cannot be estimated from the available data)

• Sudden myopia
• Sudden eye pain (acute angle-closure glaucoma)
• Systemic and cutaneous lupus erythematosus (allergic condition that causes fever, joint pain,

rashes that may include redness, blisters, peeling and lumps).

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet. You can also report side effects directly through
the national reporting system at www.aifa.gov.it/content/come-segnalare-una-sospetta-
reazione-avversa.
By reporting side effects you can help provide more information on the safety of
this medicine

5. How to store Candesartan e Idroclorotiazide HCS

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 pack after EXP. The expiry date refers to the last day of that month.

Tablets packaged in PVC/PVDC film blisters and aluminium foil:
Do not store at temperatures above 30°C.

Tablets packaged in OPA laminate/Al/PVC film blisters and aluminium foil:
This medicine does not require any special storage conditions.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Candesartan and Hydrochlorothiazide HCS contains
The active ingredients are candesartan cilexetil and hydrochlorothiazide.
Each tablet contains 8 mg of candesartan cilexetil and 12.5 mg of hydrochlorothiazide.
Each tablet contains 16 mg of candesartan cilexetil and 12.5 mg of hydrochlorothiazide.
Each tablet contains 32 mg of candesartan cilexetil and 12.5 mg of hydrochlorothiazide.
Each tablet contains 32 mg of candesartan cilexetil and 25 mg of hydrochlorothiazide.
The excipients are lactose monohydrate, corn starch, macrogol 8000, hydroxypropylcellulose,
calcium carmellose, 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.

Description of the appearance of Candesartan and Hydrochlorothiazide HCSand package contents
Candesartan and Hydrochlorothiazide HCS 8 mg/12.5 mg tablets are white,
biconvex, oval tablets with a score line on one side. The score line on the tablet is intended to
facilitate breaking the tablet for easier swallowing and not for dividing it into equal doses.
Candesartan and Hydrochlorothiazide HCS 16 mg/12.5 mg tablets are light pink,
biconvex, oval tablets with a score line on one side.
The score line on the tablet is intended to facilitate breaking the tablet for easier swallowing and not for
dividing it into equal doses.
Candesartan and Hydrochlorothiazide HCS 32 mg/12.5 mg tablets are off-white,
biconvex, oval tablets with a score line on one side.
The score line on the tablet is intended to facilitate breaking the tablet for easier swallowing and not for
dividing it into equal doses.
Candesartan and Hydrochlorothiazide HCS 32 mg/25 mg tablets are pale pink,
biconvex, oval tablets with a score line on one side.
The tablet can be divided into equal doses.
Packs 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 responsible for release
HCS bvba, H Kennisstraat 53, B 2650 Edegem, Belgium

Local Representative for Italy:
KRKA Farmaceutici Milano S.r.l. Viale Achille Papa 30, 20149 Milano, Italy

This medicinal product is authorised in the Member States of the European Economic Area with the
following names: