Cazhap

Leaflet attached to the packaging: patient information

Carzap, 8 mg, tablets

Carzap, 16 mg, tablets

Carzap, 32 mg, tablets

Candesartan cilexetil

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should consult a doctor or pharmacist .
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

• 1. What is Carzap and what is it 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 packaging and other information

1. What is Carzap and what is it used for

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

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

2. Important information before taking Carzap

When not to take 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 pregnant over 3 months (it is also recommended to avoid taking Carzap in early pregnancy - see section "Pregnancy and breastfeeding").
• If the patient has severe liver disease or bile duct obstruction (difficulty in 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.

In case of doubt as to whether any of the above situations apply to the patient, they should consult a doctor or pharmacist before taking Carzap.

Warnings and precautions

Before starting to take Carzap, the patient should discuss it with their 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 has had vomiting or recently had severe vomiting or diarrhea.
• If the patient has a disease of the adrenal glands called Conn's syndrome (primary hyperaldosteronism).
• If the patient has low blood pressure.
• If the patient has ever had a stroke.
• The patient should inform their doctor if they suspect (or plan) pregnancy. It is not recommended to take Carzap in early pregnancy and it should not be taken after 3 months of pregnancy, as it may seriously harm the fetus (see section "Pregnancy").
• If the patient is taking any of the following medicines for 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 at the same time as a medicine belonging to a group of medicines known as mineralocorticoid receptor antagonists (MRAs). These medicines are used to treat heart failure (see "Carzap and other medicines").

The doctor may monitor kidney function, blood pressure, and electrolyte levels (e.g., potassium) in the blood at regular intervals.
See also the information under the heading "When not to take Carzap".
If any of the above conditions apply to the patient, the doctor may recommend more frequent checks and tests.
If, after taking Carzap, the patient experiences abdominal pain, nausea, vomiting, or diarrhea, they should discuss it with their doctor.
The doctor will decide on further treatment. The patient should not stop taking Carzap on their own.
If the patient is to undergo surgery, they should inform their doctor or dentist that they are taking Carzap. This is because Carzap, in combination with certain anesthetics, may cause excessive lowering of blood pressure.

Children and adolescents

Studies have been conducted on the use of candesartan cilexetil in children. For further information, the patient should consult their doctor. Carzap should not be given to children under 1 year of age due to the potential risk to kidney development.

Carzap and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
Carzap may affect the action of other medicines, and other medicines may affect Carzap. If the patient is taking certain medicines, the doctor may periodically recommend blood tests.
In particular, the patient should inform their doctor if they are taking any of the following medicines:

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

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

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

Carzap with food, drink, and alcohol

While taking Carzap, the patient should consult their doctor if they plan to consume alcohol. Alcohol may cause dizziness or fainting.

Pregnancy, breastfeeding, and fertility

Pregnancy
If the patient suspects that they may be pregnant (or plans to have a child), they should consult their doctor. The doctor will usually recommend stopping Carzap before planned pregnancy or as soon as pregnancy is confirmed, and recommend taking another medicine instead of Carzap. It is not recommended to take Carzap in early pregnancy and it should not be taken after 3 months of pregnancy, as it may seriously harm the fetus.
Breastfeeding
The patient should inform their doctor if they are breastfeeding or plan to breastfeed. It is not recommended to take Carzap while breastfeeding, especially in the case of breastfeeding a newborn or premature baby. The doctor may recommend taking another medicine.

Driving and using machines

While taking Carzap, some patients may feel tired and dizzy. If these symptoms occur, the patient should not drive vehicles, use tools, or operate machines.

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 some sugars, they should contact their doctor before taking Carzap.
The medicinal product contains less than 1 mmol (23 mg) of sodium per tablet, which is considered "sodium-free".

3. How to take Carzap

This medicine should always be taken as directed by the doctor or pharmacist. In case of doubt, the patient should consult their doctor or pharmacist .It is important to take Carzap every day.
Carzap can be taken with or without food.
The tablet should be swallowed with water.
Tablets should be taken every day at about the same time. This will help the patient remember to take their dose.

High blood pressure:

• The recommended dose of Carzap is 8 mg once a day. The doctor may increase the dose to 16 mg once a day, and then to 32 mg once a day, depending on the patient's response to treatment.
• The doctor may recommend a lower initial dose in certain patients, e.g., patients with liver or kidney problems, patients who have lost a lot of fluid, e.g., due to vomiting, diarrhea, or diuretic use.
• In black patients, the response to treatment may be weaker if Carzap is used as monotherapy. It may be necessary to use higher doses.

Use in children and adolescents with high blood pressure

Children from 6 to 18 years of age:

The recommended initial dose is 4 mg once a day.
Patients with a body weight <50 kg: in patients whose blood pressure is not adequately controlled, the doctor may decide to increase dose a maximum of 8 mg once day.
Patients with a body weight ≥50 kg: in patients whose blood pressure is not adequately controlled, the doctor may decide to increase the dose to 8 mg once a day, and then to 16 mg once a day.

Heart failure in adults:

The recommended initial dose of Carzap is 4 mg once a day. The doctor may increase the dose by doubling it, at intervals of at least 2 weeks, to 32 mg once a day. Carzap can be taken with other medicines used to treat heart failure, and the doctor will decide which treatment is most suitable for the patient.

Taking a higher dose of Carzap than recommended

If a higher dose of Carzap than recommended by the doctor is taken, the patient should immediately contact their doctor or pharmacist.

Missing a dose of Carzap

The patient should not take a double dose to make up for a missed dose. They should take the next dose at the usual time.

Stopping treatment with Carzap

If treatment with Carzap is stopped, blood pressure may increase again.
Therefore, the patient should not stop taking Carzap without consulting their doctor first.
In case of any further doubts about taking this medicine, the patient should consult their doctor or pharmacist .

4. Possible side effects

Like all medicines, Carzap can cause side effects, although not everybody gets them.
It is important for the patient to know that they can occur.

The patient should stop taking Carzap and seek medical help immediately if they 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 bumps)

Carzap may cause a decrease in the number of white blood cells. The patient's resistance to infection may be reduced, and they may experience fatigue, infection, or fever. If these symptoms occur, the patient should contact their doctor. The doctor may recommend periodic blood tests to check if Carzap is affecting the blood (agranulocytosis).
Other possible side effects include:

Common (may occur in less 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 the blood, especially if the patient has kidney problems or heart failure. If the increase is significant, the patient may experience fatigue, weakness, irregular heartbeat, or tingling.
• Affecting kidney function, especially in patients with existing kidney problems or heart failure. In very rare cases, kidney failure may occur.

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

• Swelling of the face, lips, tongue, and/or throat
• Angioedema of the intestine: swelling in the intestine with symptoms such as abdominal pain, nausea, vomiting, and diarrhea
• Decreased number of red or white blood cells. The patient may experience fatigue, infection, or fever
• Skin rash, hives
• Itching
• Back pain, joint and muscle pain
• Changes in liver function, including hepatitis. The patient may experience fatigue, yellowing of the skin and eyes, and flu-like symptoms
• Nausea
• Cough
• Changes in blood test results: Decreased sodium levels in the blood. If the decrease is significant, the patient may experience weakness, lack of energy, or muscle cramps.

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

• Diarrhea.

In children treated for high blood pressure, side effects seem to be similar to those in adults, but they occur more frequently. A very common side effect in children that is not reported in adults is throat pain, and other side effects such as runny nose, fever, and rapid heartbeat in children occur frequently, while they are not reported in adults.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, 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
Side effects can also be reported to the marketing authorization holder or its representative in Poland.
By reporting side effects, more information can be gathered on the safety of the medicine.

5. How to store Carzap

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister. The expiry date refers to the last day of the month.
There are no special precautions for storage of the medicinal product.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed .This will help protect the environment.

6. Contents of the packaging and other information

What Carzap contains

The active substance of the medicine is candesartan cilexetil.
Carzap, 8 mg, tablets: each tablet contains 8 mg of candesartan cilexetil.
Carzap, 16 mg, tablets: each tablet contains 16 mg of candesartan cilexetil.
Carzap, 32 mg, tablets: each tablet contains 32 mg of candesartan cilexetil.
The other ingredients are: lactose monohydrate, corn starch, hydroxypropyl cellulose (E 463), croscarmellose sodium (E 468), magnesium stearate (E 572), triethyl citrate (E 1505).

What Carzap looks like and contents of the pack

Carzap, 8 mg, are round, biconvex, white or almost white tablets with a score line on one side and the imprint C/8 on the same side. The diameter of the tablet is approximately 8 mm.
Carzap, 16 mg, are round, biconvex, white or almost white tablets with a score line on one side and the imprint C/16 on the same side. The diameter of the tablet is approximately 8 mm.
Carzap, 32 mg, are round, biconvex, white or almost white tablets with a score line on one side and the imprint C/32 on the same side. The diameter of the tablet is approximately 10.5 mm.
The tablet can be divided into equal doses.
Pack sizes: 7, 14, 28, 30, 56, 70, 90, 98 tablets.
Not all pack sizes may be marketed.

Marketing authorization holder

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

Manufacturer

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

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

To obtain more detailed information on this medicine, the patient should contact their local representative of the marketing authorization holder:

Zentiva Polska Sp. z o.o.
ul. Bonifraterska 17
00-203 Warsaw
tel.: +48 22 375 92 00
Date of last revision of the leaflet:June 2025