Carzap

Package leaflet: Information for the patient

Warning! Please keep the leaflet. Information on the immediate packaging is in a foreign language.
Carzap (Canzeno)
32 mg, tablets
Candesartanum cilexetili
Carzap and Canzeno are different trade names for the same medicine.
Please read the entire leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet for future reference.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not give it to others. This medicine may harm other people, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet:

1. What Carzap is and what it is used for
2. Important information before taking Carzap
3. How to take Carzap
4. Possible side effects
5. How to store Carzap
6. Contents of the pack and other information

1. What Carzap is and what it is used for

The name of the medicine is Carzap. The active substance is candesartan cilexetil. It belongs to a group of medicines called angiotensin II receptor antagonists. It causes relaxation and widening of blood vessels. This helps lower blood pressure. This medicine also helps the heart pump blood to all parts of the body more easily.
Carzap is used:

• for the treatment of high blood pressure (hypertension) in adult patients and in children and adolescents aged 6 to 18 years,
• in adult patients for the treatment of heart failure with reduced cardiac muscle function, when angiotensin-converting enzyme (ACE) inhibitors cannot be used, or as an add-on to ACE inhibitor therapy when heart failure symptoms persist despite treatment, and mineralocorticoid receptor antagonists (MRA) cannot be used. (ACE inhibitors and MRAs are medicines used in the treatment of heart failure).

2. Important information before using Carzap

When not to use Carzap

• If the patient is allergic to candesartan cilexetil or any of the other ingredients of this medicine (listed in section 6).
• If the patient is more than 3 months pregnant (it is also preferable to avoid using Carzap early in pregnancy - see section "Pregnancy and breastfeeding").
• If the patient has severe liver disease or biliary obstruction (impaired bile flow from the gallbladder).
• If the patient is a child under 1 year of age.
• If the patient has diabetes or kidney problems and is being treated with a blood pressure-lowering medicine containing aliskiren.

If in doubt whether any of the above situations apply to the patient, consult a doctor or pharmacist before using Carzap.
Warnings and precautions
Before starting Carzap, discuss this with your doctor or pharmacist:

• If the patient has heart, liver or kidney problems or is undergoing dialysis.
• If the patient has recently undergone a kidney transplant.
• If the patient is experiencing vomiting or has recently had severe vomiting or diarrhoea.
• If the patient has an adrenal gland disorder called Conn's syndrome (primary hyperaldosteronism).
• If the patient has low blood pressure.
• If the patient has ever had a stroke.
• Inform your doctor if pregnancy is suspected (or planned). Use of Carzap is not recommended during early pregnancy and must not be used after the 3rd month of pregnancy, as it may seriously harm the unborn child (see section "Pregnancy").
• If the patient is taking any of the following medicines used to treat high blood pressure:
• an ACE inhibitor (e.g. enalapril, lisinopril, ramipril), especially if the patient has kidney problems related to diabetes.
• aliskiren.
• If the patient is taking an ACE inhibitor together with a medicine belonging to a group of medicines known as mineralocorticoid receptor antagonists (MRAs). These medicines are used in the treatment of heart failure (see "Carzap with other medicines").

The treating doctor may monitor kidney function, blood pressure and blood electrolyte levels (e.g.
potassium) at regular intervals.
See also information under the heading "When not to use Carzap".
If any of the above conditions apply to the patient, the doctor may recommend more frequent
check-ups and tests.
If the patient experiences abdominal pain, nausea, vomiting or diarrhoea after taking Carzap,
discuss this with the doctor.
The doctor will decide on further treatment. Do not make independent decisions to stop taking Carzap.
If the patient is to undergo surgery, inform the doctor or dentist about taking Carzap. This is because Carzap, in combination with certain anaesthetics, may cause excessive lowering of blood pressure.
Children and adolescents
Studies on the use of candesartan cilexetil in children have been conducted. For further information, consult the treating doctor. Carzap must not be given to children under 1 year of age due to potential risk to kidney development.
Carzap with other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Carzap may affect the action of other medicines, and other medicines may affect Carzap. If the patient takes certain medicines, the doctor may periodically recommend blood tests.
In particular, inform the doctor if the patient is taking any of the following medicines:

• other medicines that lower blood pressure, including beta-blockers, diazoxide and ACE inhibitors such as enalapril, captopril, lisinopril or ramipril;
• non-steroidal anti-inflammatory drugs (NSAIDs), such as: ibuprofen, naproxen, diclofenac, celecoxib or etoricoxib (medicines that relieve pain and inflammation);
• acetylsalicylic acid (at doses greater than 3 g per day) (a medicine that relieves pain and inflammation);
• potassium supplements, salt substitutes containing potassium (medicines that increase blood potassium levels);
• heparin (a blood-thinning medicine);
• co-trimoxazole, also known as trimethoprim/sulfamethoxazole (an antibiotic);
• diuretics (water tablets);
• lithium (a medicine used to treat psychiatric disorders).

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

• If the patient is taking an ACE inhibitor or aliskiren (see also information under the headings "When not to use Carzap" and "Warnings and precautions").
• If the patient is taking an ACE inhibitor together with certain medicines used to treat heart failure, known as mineralocorticoid receptor antagonists (MRAs) (e.g. spironolactone, eplerenone).

Carzap with food, drink and alcohol
During treatment with Carzap, consult your doctor if alcohol consumption is planned. Alcohol may cause fainting or dizziness.
Pregnancy, breastfeeding and fertility
Pregnancy
If the patient suspects she may be pregnant (or is planning a pregnancy), she should consult a
doctor. The doctor will usually recommend discontinuing Carzap before a planned pregnancy or
immediately after pregnancy is confirmed, and will recommend an alternative medicine. Use of Carzap is not recommended during early pregnancy and must not be used after the 3rd month of
pregnancy, as it may seriously harm the unborn child.
Breastfeeding
Inform the doctor about breastfeeding or plans to breastfeed. Use of Carzap is not recommended during breastfeeding, especially when breastfeeding a newborn or premature infant. The doctor may recommend an alternative medicine.
Driving and using machines
While taking Carzap, some patients may experience fatigue and dizziness. If these symptoms occur, do not drive, operate tools or machinery.
Carzap contains lactose monohydrate and sodium
Carzap contains lactose monohydrate, which is a type of sugar. If the patient has previously been diagnosed with intolerance to certain sugars, the patient should contact the doctor before taking Carzap.
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. How to use Carzap

This medicine should always be taken as prescribed by the doctor or pharmacist. If in doubt,
consult your doctor or pharmacist.
The following Carzap strengths are available: 8 mg, 16 mg, 32 mg.
It is important to take Carzap every day. Carzap may be taken during meals or independently of meals.
The tablet should be swallowed with water.
Tablets should be taken daily at approximately the same time. This will help the patient remember to take the dose.

High blood pressure:

• The recommended dose of Carzap is 8 mg once daily. Your doctor may increase the dose to 16 mg once daily, and subsequently to 32 mg once daily, depending on the response to treatment.
• Your doctor may recommend a lower starting dose for certain patients, e.g. patients with liver or kidney disorders, or patients who have lost a significant amount of fluid due to vomiting, diarrhoea, or diuretic therapy.
• In black patients, the response to treatment may be weaker when Carzap is used as monotherapy. Higher doses may therefore be required.

Use in children and adolescents with high blood pressure
Children aged 6 to 18 years:
The recommended initial dose is 4 mg once daily.
Patients with body weight <50 kg: if blood pressure is not adequately controlled, the treating physician may decide to increase the dose up to a maximum of 8 mg once daily.
Patients with body weight ≥50 kg: if blood pressure is not adequately controlled, the treating physician may decide to increase the dose to 8 mg once daily, then to 16 mg once daily.

Heart failure in adults:
The recommended starting dose of Carzap is 4 mg once daily. Your doctor may increase the dose by doubling it at intervals of at least two weeks, up to 32 mg once daily. Carzap may be taken together with other medicines used in the treatment of heart failure, and your doctor will decide which treatment is most appropriate for you.

Taking more Carzap than prescribed
If you take more Carzap than prescribed, contact your doctor or pharmacist immediately.

Missing a dose of Carzap
Do not take a double dose to make up for a missed dose. Take the next dose at the usual time.

Stopping Carzap
If you stop taking Carzap, your blood pressure may rise again. Therefore, do not discontinue Carzap without first consulting your doctor.
If you have any further doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although they do not occur in everyone.
It is important that the patient is aware of the possibility that such effects may occur.
The treatment with Carzap must be stopped immediately and medical help should be sought if the
patient experiences 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 in swallowing
• Severe itching of the skin (with raised rashes)

Carzap may cause a reduction in the number of white blood cells. Immunity to infections may be
reduced and fatigue, infection or fever may occur. If such symptoms occur, contact your doctor.
Your doctor may recommend periodic blood tests to check whether Carzap affects blood composition (agranulocytosis).
Other possible adverse effects include:
Common (may occur in fewer than 1 in 10 people)

• Dizziness/spinning sensation
• Headache
• Respiratory tract infection
• Low blood pressure. This may cause fainting or dizziness
• Changes in blood test results: Increased potassium levels in blood, particularly if the patient has kidney disorders or heart failure. In case of a significant increase in potassium levels, fatigue, weakness, irregular heartbeat or tingling sensation may occur
• Effect on kidney function, especially in case of existing kidney disorders or heart failure. In very rare cases, kidney failure may occur

Very rare (may occur in fewer than 1 in 10,000 people)

• Swelling of the face, lips, tongue and (or) throat
• Angioedema of the intestine: intestinal swelling with symptoms such as abdominal pain, nausea, vomiting and diarrhoea
• Decrease in the number of red or white blood cells. Fatigue, infection or fever may occur
• Skin rash, urticaria
• Itching
• Back pain, joint and muscle pain
• Changes in liver function, including hepatitis. Fatigue, yellowing of the skin and eyes, and flu-like symptoms may occur
• Nausea
• Cough
• Changes in blood test results: Decreased sodium levels in blood. In case of a significant decrease in sodium levels, weakness, lack of energy or muscle cramps may occur

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

• Diarrhoea

In children treated for high blood pressure, adverse effects appear to be similar to those occurring
in adults, but occur more frequently. A very common adverse effect occurring in children but not
reported in adults is sore throat. Additionally, adverse effects such as runny nose, fever and
increased heart rate occur commonly in children but were not reported in adults.
Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products,
Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: 22 49-21-301, fax: 22 49-21-309, website:
https://smz.ezdrowie.gov.pl
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Carzap

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
No special storage conditions apply.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Carzap contains
The active substance is candesartan cilexetil.
Each tablet contains 32 mg of candesartan cilexetil.
The other ingredients are: monohydrate lactose, corn starch, hydroxypropylcellulose,
sodium croscarmellose, magnesium stearate, triethyl citrate.

What Carzap looks like and contents of the pack
Carzap is a round, biconvex, white or almost white tablet, with a division line and an imprint C/32 on one side. The tablet diameter is approximately 10.5 mm.
The tablet can be divided into equal doses.
Pack size: 30 tablets.
For more detailed information, please contact the responsible party or the parallel importer.

Marketing Authorisation Holder in Romania, country of export:
Zentiva, k.s., U kabelovny 130, 102 37 Prague 10, Dolní Měcholupy, Czech Republic

Manufacturer:
Zentiva, k.s., U kabelovny 130, 102 37 Prague 10, Dolní Měcholupy, Czech Republic

Parallel importer:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź

Repackaged in:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź

Romania, country of export Marketing Authorisation Number: 10066/2017/04
Parallel Import Licence Number: 271/20