Candesartan and hydrochlorothiazide Zentiva Italia: detailed information

Candesartan and Hydrochlorothiazide Zentiva Italia

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Candesartan and Hydrochlorothiazide Zentiva Italia 32 mg/12.5 mg tablets, mg/25 mg tablets

Equivalent medicine
Please read this leaflet carefully before 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 give it to other people, even if their symptoms are the same as yours, as it may be harmful.
If you experience any adverse reactions, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Candesartan and Hydrochlorothiazide Zentiva Italia is and what it is used for
What you need to know before taking Candesartan and Hydrochlorothiazide Zentiva Italia
How to take Candesartan and Hydrochlorothiazide Zentiva Italia
Possible side effects
How to store Candesartan and Hydrochlorothiazide Zentiva Italia
Package contents and other information

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

The name of the medicine is Candesartan and Hydrochlorothiazide Zentiva Italia.
It is used to treat high blood pressure (hypertension) in adult patients. It contains
two active substances: 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 dilation of blood vessels. This helps to reduce blood pressure.
Hydrochlorothiazide belongs to a group of medicines called diuretics (tablets that help increase urination). It helps the body eliminate water and salts such as sodium through the urine. This contributes to lowering blood pressure.

Your doctor may prescribe Candesartan and Hydrochlorothiazide Zentiva Italia 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 Italia

Do not take Candesartan and Hydrochlorotiazide Zentiva Italia:

if you are allergic to candesartan cilexetil, hydrochlorothiazide, or any of the other ingredients of this medicine listed in section 6;
if you are allergic to sulfonamide medicines. If you are unsure whether this applies to you, consult your doctor;
if you are more than 3 months pregnant (it is best to avoid using Candesartan and Hydrochlorothiazide Zentiva Italia even in the early stages of pregnancy – see the section on pregnancy);
if you have severe kidney problems;
if you have severe liver disease or biliary obstruction (a problem with bile drainage from the gallbladder);
if you have diabetes or impaired kidney function and are being treated with a blood pressure-lowering medicine 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 unsure whether any of these conditions apply to you, consult your doctor or pharmacist before taking Candesartan and Hydrochlorothiazide Zentiva Italia.

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

if you have diabetes;
if you have heart, liver, or kidney problems;
if you have recently undergone a kidney transplant;
if you are vomiting, have recently experienced severe vomiting, or have diarrhea;
if you have a disease of the adrenal gland known as Conn's syndrome (also called primary hyperaldosteronism);
if you have previously had skin cancer or are developing unexpected skin lesions during treatment. Treatment with hydrochlorothiazide, particularly long-term use at high doses, may increase the risk of certain types of non-melanoma skin cancer and lip cancer. Protect your skin from exposure to sunlight and UV rays while taking Candesartan and Hydrochlorothiazide Zentiva Italia;
if you have had a condition 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;
you must inform your doctor if you think you may be pregnant (or if there is a possibility of becoming pregnant). Candesartan and Hydrochlorothiazide Zentiva Italia is not recommended during early pregnancy and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to the unborn child 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" (e.g., enalapril, lisinopril, ramipril), especially if you have kidney problems related to diabetes;
aliskiren.

Your doctor may check your kidney function, blood pressure, and levels of electrolytes (such as potassium) in your blood at regular intervals.
See also the section "Do not take Candesartan and Hydrochlorothiazide Zentiva Italia:"
Your doctor may want to examine you more frequently and carry out tests if you have any of these conditions.
The active substance hydrochlorothiazide may cause an unusual reaction leading to decreased vision and eye pain. These could be symptoms of increased intraocular pressure and may occur within hours or weeks after starting Candesartan and Hydrochlorothiazide Zentiva Italia. Increased eye pressure, if left untreated, may lead to permanent loss of vision.
If you are about to undergo surgery, inform your doctor or dentist that you are taking Candesartan and Hydrochlorothiazide Zentiva Italia. This is because Candesartan and Hydrochlorothiazide Zentiva Italia, when combined with certain anesthetics, may cause excessive lowering of blood pressure.
Candesartan and Hydrochlorothiazide Zentiva Italia may increase skin sensitivity to sunlight.
Children and adolescents
There is no experience with the use of Candesartan and Hydrochlorothiazide Zentiva Italia in children (under 18 years of age). Therefore, Candesartan and Hydrochlorothiazide Zentiva Italia must not be administered to children.
For those engaged in sports: the use of this medicine constitutes doping and may result in a positive anti-doping test.
Other medicines and Candesartan and Hydrochlorothiazide Zentiva Italia
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. Candesartan and Hydrochlorothiazide Zentiva Italia may affect how other medicines work, and some medicines may affect Candesartan and Hydrochlorothiazide Zentiva Italia. If you are taking certain medicines, your doctor may need to perform blood tests from time to time.
In particular, tell your doctor if you are taking any of the following medicines, as your 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 to relieve pain and inflammation).
Acetylsalicylic acid (if taking more than 3 g per day) (a medicine to relieve pain and inflammation).
Potassium supplements or potassium-containing salt substitutes (medicines that increase potassium levels in the blood).
Calcium supplements or vitamin D.
Medicines to lower cholesterol, such as colestipol or cholestyramine.
Medicines for diabetes (tablets or insulin).
Medicines to control heart rhythm (antiarrhythmics) such as digoxin and beta-blockers.
Medicines whose action may be influenced by blood potassium levels, such as certain 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 treating fungal infections).
Lithium (a medicine for mental health conditions).
Steroids such as prednisolone.
Pituitary hormone (ACTH).
Medicines for treating cancer.
Amantadine (for treating Parkinson's disease or severe viral infections).
Barbiturates (a type of sedative also used to treat epilepsy).
Carbenoxolone (used to treat esophageal diseases or oral ulcers).
Anticholinergic agents such as atropine and biperiden.
Cyclosporine, a medicine used in organ transplants to prevent rejection.
Other medicines that may enhance the antihypertensive effect, such as baclofen (a medicine to relieve spasticity), amifostine (used in cancer treatment), and certain antipsychotic medicines.

Your doctor may consider it necessary to adjust your dose and/or take other precautions if you are taking or starting treatment with:

an ACE inhibitor or aliskiren (see also the sections: "Do not take Candesartan and Hydrochlorothiazide Zentiva Italia:" and "Warnings and precautions").

Candesartan and Hydrochlorothiazide Zentiva Italia with food, drinks, and alcohol
When Candesartan and Hydrochlorothiazide Zentiva Italia is prescribed for you, talk to your doctor before drinking alcohol. Alcohol may make you feel weak or dizzy.
Pregnancy, breastfeeding, and fertility
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or breastfeeding, ask your doctor for advice before taking this medicine.
Pregnancy
You must inform your doctor if you think you may be pregnant (or if there is a possibility of becoming pregnant).
Usually, your doctor will advise you to stop taking Candesartan and Hydrochlorothiazide Zentiva Italia before becoming pregnant, or as soon as you find out you are pregnant, and will recommend another medicine instead of Candesartan and Hydrochlorothiazide Zentiva Italia. Candesartan and Hydrochlorothiazide Zentiva Italia is not recommended during pregnancy and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to the unborn child if taken after the third month of pregnancy.
Breastfeeding
Inform your doctor if you are breastfeeding or planning to breastfeed. Candesartan and Hydrochlorothiazide Zentiva Italia is not recommended for breastfeeding mothers, and your doctor may choose another treatment for you if you wish to breastfeed, especially if your 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 Italia. If this happens to you, do not drive or operate tools or machinery.

3. How to take Candesartan and Hydrochlorothiazide Zentiva Italia

Take this medicine exactly as your doctor has told you. If you have any doubts, consult your doctor or pharmacist. It is important to continue taking Candesartan and Hydrochlorothiazide Zentiva Italia every day.
The usual dose of Candesartan and Hydrochlorothiazide Zentiva Italia is one tablet daily.
Swallow the tablet with a glass of water. You may take Candesartan and Hydrochlorothiazide Zentiva Italia with or without food.
Try to take the tablet at the same time each day. This will help you remember to take it.
Candesartan and Hydrochlorothiazide Zentiva Italia 32 mg/12.5 mg tablets
The break line is only intended to help you divide the tablet if you have difficulty swallowing it whole.
Candesartan and Hydrochlorothiazide Zentiva Italia 32 mg/25 mg tablets
The tablet may be divided into two equal doses.
If you take more Candesartan and Hydrochlorothiazide Zentiva Italia than you should
If you take more Candesartan and Hydrochlorothiazide Zentiva Italia than prescribed by your doctor, contact your doctor or pharmacist immediately for advice.
If you forget to take Candesartan and Hydrochlorothiazide Zentiva Italia
Do not take a double dose to make up for the forgotten tablet. Take only the next dose as usual.
If you stop taking Candesartan and Hydrochlorothiazide Zentiva Italia
If you stop treatment with Candesartan and Hydrochlorothiazide Zentiva Italia, your blood pressure may rise again. Therefore, do not stop treatment with Candesartan and Hydrochlorothiazide Zentiva Italia without first talking to your doctor.
If you have any questions about 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 gets them.
It is important that you are aware of what these side effects might be.
Some of the side effects of Candesartan and Hydrochlorothiazide Zentiva Italia are caused by candesartan cilexetil, and some are caused by hydrochlorothiazide.
Stop taking Candesartan and Hydrochlorothiazide Zentiva Italia 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 may cause difficulty swallowing;
severe itching of the skin (with raised blisters).

Candesartan and Hydrochlorothiazide Zentiva Italia may cause a reduction 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 occurs, contact your doctor. Your doctor may occasionally perform blood tests to check whether Candesartan and Hydrochlorothiazide Zentiva Italia has affected your blood (agranulocytosis).
Other possible side effects include:
Common (may affect up to 1 in 10 people):

Changes in blood test results: reduced sodium levels in the blood. If this reduction is severe, you may experience weakness, lack of energy, or muscle cramps; increased or decreased potassium levels in the blood, especially if you already have kidney problems or heart failure. If this increase or decrease is severe, you may experience fatigue, weakness, irregular heartbeat, or tingling; increased levels of cholesterol, glucose, or uric acid in the blood.
Presence of glucose in the urine.
Dizziness, lightheadedness, or weakness.
Headache.
Respiratory tract infection.

Uncommon (may affect up to 1 in 100 people):

Low blood pressure. This may make you feel weak or dizzy.
Loss of appetite, diarrhoea, 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 whites of the eyes). If this occurs, contact your doctor immediately.
Effects on kidney function, especially if you already have kidney problems or heart failure.
Difficulty sleeping, depression, feeling restless.
Tingling or prickling sensations in the arms or legs.
Brief episodes of blurred vision.
Irregular heartbeat.
Breathing difficulties (including lung inflammation and fluid in the lungs).
High temperature (fever).
Inflammation of the pancreas. This causes mild to severe stomach pain.
Muscle cramps.
Damage to blood vessels causing red or purple spots on the skin.
Reduction in red blood cells, white blood cells, or platelets. You may notice fatigue, infection, fever, or increased tendency to bruise.
Severe skin rash developing rapidly, with blistering and peeling of the skin, sometimes also affecting 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 whites of the eyes, and flu-like symptoms.
Cough.
Nausea.

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

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

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at the following website:
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 Italia

Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
Do not use this medicine after the expiry date stated on the carton and blister. The
expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist
how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Candesartan and Hydrochlorothiazide Zentiva Italia contains
Candesartan and Hydrochlorothiazide Zentiva Italia 32 mg/12.5 mg tablets
The active substances are candesartan cilexetil and hydrochlorothiazide.
Each tablet contains 32 mg of candesartan cilexetil and 12.5 mg of hydrochlorothiazide.
The other components are: mannitol (E421), maize starch, copovidone, glycerol, magnesium stearate, and yellow iron oxide (E172).

Candesartan and Hydrochlorothiazide Zentiva Italia 32 mg/25 mg tablets
The active substances are candesartan cilexetil and hydrochlorothiazide.
Each tablet contains 32 mg of candesartan cilexetil and 25 mg of hydrochlorothiazide.
The other components are: mannitol (E421), maize starch, copovidone, glycerol, magnesium stearate, yellow iron oxide (E172), and red iron oxide (E172).

Description of the appearance of Candesartan and Hydrochlorothiazide Zentiva Italia and pack sizes
Candesartan and Hydrochlorothiazide Zentiva Italia 32 mg/12.5 mg tablets
Candesartan and Hydrochlorothiazide Zentiva Italia 32 mg/12.5 mg tablets are uncoated, yellow, oval, biconvex tablets (~12 x 6 mm), with a score line on one side.
Candesartan and Hydrochlorothiazide Zentiva Italia 32 mg/12.5 mg tablets are packaged in blisters, available in packs of 14, 28, 30, 56, and 98 tablets.

Candesartan and Hydrochlorothiazide Zentiva Italia 32 mg/25 mg tablets
Candesartan and Hydrochlorothiazide Zentiva Italia 32 mg/25 mg tablets are uncoated, peach-colored, oval, biconvex tablets (~12 x 6 mm), with a score line on one side and marked with the letters “C” and “H”.
Candesartan and Hydrochlorothiazide Zentiva Italia 32 mg/25 mg tablets are packaged in blisters, available in packs of 14, 28, 56, and 98 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder:
Zentiva Italia S.r.l.
Viale L. Bodio, 37/B
20158 Milan, Italy

Manufacturers:
Delorbis Pharmaceuticals Ltd.
17, Athinon Street, Ergates Industrial Area
2643 Nicosia, Cyprus

HBM Pharma s.r.o.
Sklabinská 30
036 80 Martin, Slovak Republic

S.C. Zentiva S.A.
50 Theodor Pallady Blvd., District 3
03226 Bucharest, Romania

This medicinal product is authorized in the European Economic Area countries under the following names:
Portugal: Candesartan + Hidroclorotiazida Zentiva
Czech Republic: CARZAP HCT
Germany: Candesartan Zentiva comp
Italy: Candesartan e Idroclorotiazide Zentiva Italia
Poland: CARZAP HCT