CANDESARTAN 16 mg /12,5 Mg Tabletka Powlekana

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1. Candesartan e Idroclorotiazide Zentiva 16 mg/12,5 mg tablets
   1. What is Candesartan and Hydrochlorothiazide Zentiva and what is it used for
   2. What you need to know before taking Candesartan and Hydrochlorothiazide Zentiva
   3. How to take Candesartan and Hydrochlorothiazide Zentiva
   4. Possible side effects
   5. How to store Candesartan and Hydrochlorothiazide Zentiva
   6. Package contents and other information

Candesartan e Idroclorotiazide Zentiva 16 mg/12,5 mg tablets

Generic medicine

Read this leaflet carefully before you start taking this medicine as 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 could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is Candesartan and Hydrochlorothiazide Zentiva and what is it used for

The name of the medicine is Candesartan and Hydrochlorothiazide Zentiva 16 mg/12.5 mg tablets.
It is used to treat high blood pressure (hypertension) in adult patients. It contains
two active ingredients: candesartan cilexetil and hydrochlorothiazide. These work together to
lower blood pressure.

• Candesartan cilexetil belongs to a group of medicines called angiotensin II receptor antagonists. It causes the relaxation and widening of blood vessels. This helps to reduce blood pressure.
• Hydrochlorothiazide belongs to a group of medicines called diuretics (which help you to urinate). This helps the body to eliminate water and salts such as sodium in the urine. This contributes to reducing blood pressure.

The doctor may prescribe Candesartan and Hydrochlorothiazide Zentiva if your blood
pressure has not been adequately controlled by candesartan cilexetil or hydrochlorothiazide
alone.

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

Do not take Candesartan and Hydrochlorothiazide Zentiva:

• 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 sulfonamide medicines. If you are not sure if this condition may concern you, consult your doctor;
• if you are pregnant for more than 3 months (it is best to avoid the use of Candesartan and Hydrochlorothiazide Zentiva even in the early stages of pregnancy - see the section relating to pregnancy);
• if you have severe kidney problems;
• if you have a severe liver disease or obstruction of the bile ducts (a problem with the drainage of bile from the gallbladder);
• 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 have persistently low levels of potassium in your blood;
• if you have persistently high levels of calcium in your blood;
• if you have had gout.

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

Warnings and precautions
Talk to your doctor or pharmacist before taking Candesartan and Hydrochlorothiazide Zentiva.
Tell your doctor:

• if you have diabetes;
• if you have problems with your heart, liver or kidneys;
• if you have recently had a kidney transplant;
• if you vomit, have recently had severe vomiting or have diarrhoea;
• if you have a disease of the adrenal gland known as Conn's syndrome (also called primary hyperaldosteronism);
• if you have had skin cancer in the past or if you are developing an unexpected skin lesion during treatment. Treatment with hydrochlorothiazide, especially long-term use with high doses, may increase the risk of some types of skin cancer and lips (non-melanoma skin cancer). Protect your skin from exposure to the sun and UV rays while taking Candesartan and Hydrochlorothiazide Zentiva;
• if you have or 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 allergies or asthma;
• if you think you may be pregnant (or if there is a possibility of starting a pregnancy), you should inform your doctor. Candesartan and Hydrochlorothiazide Zentiva is not recommended in early pregnancy, and should not be taken if you are pregnant for more than 3 months, as it can cause serious harm to the baby if taken during this period (see section “Pregnancy”);
• if you are taking any of the following medicines used to treat high blood pressure:
• an "ACE inhibitor" (for example enalapril, lisinopril, ramipril), especially if you suffer from 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 reported in the section "Do not take Candesartan and Hydrochlorothiazide Zentiva
if:".
The doctor may want to visit you more often and have you undergo tests if you have any of
these conditions.
The active ingredient hydrochlorothiazide can cause an unusual reaction that determines a
decrease in vision and eye pain. These may be symptoms of
increased pressure in the eye and can occur within hours or weeks
of taking Candesartan and Hydrochlorothiazide Zentiva. This can lead to permanent
loss of vision.
If you are about to undergo surgery, tell your doctor or dentist that you are taking Candesartan and
Hydrochlorothiazide Zentiva. This is because Candesartan and Hydrochlorothiazide Zentiva, when
combined with certain anesthetics, can cause an excessive drop in blood pressure.
Candesartan and Hydrochlorothiazide Zentiva may increase your skin's sensitivity to the sun.
For those who play sports: the use of the drug constitutes doping and may still result in
positive doping tests.

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

Other medicines and Candesartan and Hydrochlorothiazide Zentiva
Tell your doctor or pharmacist if you are taking, have recently taken or might
take any other medicines. Candesartan and Hydrochlorothiazide Zentiva can affect the
mechanism of action of other medicines, and some medicines can have an effect on
Candesartan and Hydrochlorothiazide Zentiva. If you are taking certain medicines, your doctor
may need to have blood tests from time to time.
In particular, tell your doctor if you are taking any of the following medicines as the
doctor may need to adjust your dose and/or take other precautions:

• other medicines that help lower blood pressure, including beta-blockers, diazoxide;
• non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen, naproxen, diclofenac, celecoxib or etoricoxib (medicines for relieving pain and inflammation);
• acetylsalicylic acid (if you are taking more than 3 g per day) (medicine for relieving pain and inflammation);
• potassium supplements or salt substitutes containing potassium (medicines that increase the level of potassium in the blood);
• calcium or vitamin D supplements;
• medicines to lower cholesterol, such as colestipol or colestyramine;
• medicines for diabetes (oral tablets or insulin);
• medicines to control the heartbeat (antiarrhythmic agents) such as digoxin and beta-blockers;
• medicines whose action may be affected by blood potassium levels, such as some antipsychotic drugs;
• heparin (a medicine to thin the blood);
• medicines that help you urinate (diuretics);
• laxatives;
• penicillin or co-trimoxazole also known as trimethoprim/sulfamethoxazole (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 severe infections caused by viruses);
• barbiturates (a type of sedative also used to treat epilepsy);
• carbenoxolone (used for the treatment of esophageal diseases or oral ulcers);
• anticholinergic agents such as atropine and biperidene;
• cyclosporine, a medicine used in organ transplants to prevent rejection;
• other medicines that can enhance the antihypertensive effect, such as baclofen (a medicine to relieve spasticity), amifostine (used for the treatment of cancer) and some antipsychotic drugs.

The doctor may need to adjust the dose and / or take other precautions:

• if you are taking an ACE inhibitor or aliskiren (see also what is reported in the section: "Do not take Candesartan and Hydrochlorothiazide Zentiva if:" and "Warnings and precautions”).

Taking Candesartan and Hydrochlorothiazide Zentiva with food, drinks and alcohol
When you are prescribed Candesartan and Hydrochlorothiazide Zentiva, talk to your doctor before
drinking alcohol. Alcohol can make you feel weak or dizzy.

Pregnancy, breastfeeding and fertility

Pregnancy
You should inform your doctor if you think you may be pregnant (or if there is a possibility of
becoming pregnant).
As a rule, your doctor will advise you to stop taking Candesartan and
Hydrochlorothiazide Zentiva before starting a pregnancy or as soon as you become aware of being pregnant and will advise you to take another medicine
instead of Candesartan and Hydrochlorothiazide Zentiva. Candesartan and Hydrochlorothiazide Zentiva is not
recommended during pregnancy and should not be taken if you are pregnant
for more than 3 months, as it can cause serious harm to the baby if taken after the third month
of pregnancy.

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

Driving and using machines
Some people may feel tired or dizzy when taking Candesartan and
Hydrochlorothiazide Zentiva. If this happens to you, do not drive or use tools or machinery.

Candesartan and Hydrochlorothiazide Zentiva contains lactose monohydrate and sodium
Candesartan and Hydrochlorothiazide Zentiva contains lactose monohydrate, which is a type of
sugar. If your doctor has diagnosed you with an intolerance to certain sugars, contact them
before taking this medicine.
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, which
is essentially “sodium-free”.

3. How to take Candesartan and Hydrochlorothiazide Zentiva

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have any doubts, ask your doctor or pharmacist.
It is important to continue taking Candesartan and Hydrochlorothiazide Zentiva every day.

• The recommended dose of Candesartan and Hydrochlorothiazide Zentiva is one tablet a day.
• Swallow the tablet whole with a glass of water. You can take Candesartan and Hydrochlorothiazide Zentiva with or without food.
• Try to take the tablet at the same time each day. This will help you to remember to take the tablet.
• The score line is only to help you break the tablet if you have difficulty swallowing it whole.

If you take more Candesartan and Hydrochlorothiazide Zentiva than you should
If you take more Candesartan and Hydrochlorothiazide Zentiva than prescribed by your doctor, contact
your doctor or pharmacist immediately for advice.

If you forget to take Candesartan and Hydrochlorothiazide Zentiva
Do not take a double dose to make up for a missed tablet. Just take the
next dose as usual.

If you stop taking Candesartan and Hydrochlorothiazide Zentiva
If you stop taking Candesartan and Hydrochlorothiazide Zentiva, your blood
pressure may increase again. Therefore, do not stop taking Candesartan and
Hydrochlorothiazide Zentiva 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 everyone will experience them. It is important that you are aware of what these side effects may be. Some of the side effects of Candesartan and Idroclorotiazide Zentiva are caused by candesartan cilexetil, and some are caused by hydrochlorothiazide.

Stop taking Candesartan and Idroclorotiazide Zentiva and seek immediate medical help if you experience 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 can cause difficulty swallowing;
• intense itching of the skin (with raised blisters).

Candesartan and Idroclorotiazide Zentiva may cause a decrease in the number of white blood cells in the blood. Your resistance to infections may decrease and you may notice fatigue, infection or fever. If this happens, contact your doctor. The doctor may occasionally perform blood tests to check if Candesartan and Idroclorotiazide Zentiva has had any effects on your blood (agranulocytosis).
Other possible side effects include:

Common (may affect up to 1 in 10 people)

• Changes in blood test results:

a reduced amount of sodium in the blood. If this reduction is severe, you may notice weakness, lack of energy or muscle cramps;
an increased or decreased amount of potassium in the blood, especially if you already have kidney problems or heart failure. If this increase or decrease is severe, you may notice fatigue, weakness, an irregular heartbeat or tingling;
an increased amount of cholesterol, sugar or uric acid in the blood.

• Presence of sugar in the urine.
• Feeling of dizziness/lightheadedness and weakness.
• Headache.
• Respiratory infection.

Uncommon (may affect up to 1 in 100 people)

• Low blood pressure. This may make you feel weak or dizzy.
• Loss of appetite, diarrhea, constipation, stomach irritation.
• Skin rash, rash with swelling (urticaria), rash caused by sensitivity to sunlight.

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

• Jaundice (yellowing of the skin or the white of the eye). If this happens to you, contact your doctor immediately.
• Effects on the functioning of your kidneys, especially if you already have kidney problems or heart failure.
• Difficulty sleeping, depression, feeling restless.
• Tingling or prickling in the arms or legs.
• Blurred vision for a short period.
• Abnormal heartbeat.
• Difficulty breathing (including lung inflammation and fluid in the lungs).
• High temperature (fever).
• Inflammation of the pancreas. This causes moderate to severe stomach pain.
• Muscle cramps.
• Damage to blood vessels causing the appearance of red or purple spots on the skin.
• A reduction in red blood cells, white blood cells or platelets. You may notice fatigue, infection, fever, easy bruising.
• Severe skin rash that develops rapidly, with blistering and peeling of the skin and sometimes 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 fatigue, yellowing of the skin and the white of the eyes and flu-like symptoms.
• Cough.
• Nausea.

Frequency not known (the frequency cannot be estimated from the available data)

• Sudden myopia.
• Skin cancer and lip cancer (non-melanoma skin cancer).
• Decreased vision and sudden eye pain (possible signs of acute myopia or acute angle-closure glaucoma).
• Systemic and cutaneous lupus erythematosus (an allergic condition that causes fever, joint pain, rashes that may include redness, blistering, peeling and swelling).

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly through the national reporting system at
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Candesartan and Hydrochlorothiazide Zentiva

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the box and blister. The expiry date
refers to the last day of that month.
The medicine does not require special storage conditions.
Do not dispose of any medicine in waste water 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 Zentiva contains
The active ingredients are candesartan cilexetil and hydrochlorothiazide. Each tablet contains 16 mg
of candesartan cilexetil and 12.5 mg of hydrochlorothiazide.
The other ingredients are: lactose monohydrate, corn starch, hydroxypropylcellulose,
sodium croscarmellose, magnesium stearate and triethyl citrate.

Description of the appearance of Candesartan and Hydrochlorothiazide Zentiva and package contents
Candesartan and Hydrochlorothiazide Zentiva tablets are biconvex, white in color,
with a score line on one side and the inscription CH16 embossed on the same side.
Package sizes: 7, 14, 28, 30, 56, 70, 90 and 98 tablets.
Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer
Marketing authorisation holder:
Zentiva Italia S.r.l.
Viale L. Bodio, 37/B
20158 Milan
Manufacturer:
Siegfried Malta Ltd
HHF070 Hal Far Industrial Estate
P.O. box 14
Hal Far BBG 07
Malta
Sanofi S.P.A.
Viale Europa, 11
21040 Origgio (VA)
Italy
Zentiva k.s.
U Kabelovny 130
Prague 10 – Dolni Mecholupy 102 37
Czech Republic

This medicinal product is authorised in the Member States of the European Economic Area
under the following denominations: