Cazhap

Package Leaflet: Information for the User

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.

Carzap, 16 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 necessary.
• In case of any doubts, you should consult a doctor or pharmacist .
• This medicine has been prescribed to you specifically. Do not pass it on to others. The medicine may harm another person, even if the symptoms of their illness 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 pack 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 (obstruction of 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 doubts about 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 baby (see section "Pregnancy").
• If the patient is taking any of the following medicines for high blood pressure:
• ACE inhibitors (such as 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 the patient is going to have 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 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 thinner);
• cotrimoxazole (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) (such as 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 baby.
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 such 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 medicine contains less than 1 mmol (23 mg) of sodium per tablet, which is considered "sodium-free".

3. How to take Carzap

Carzap is available in the following strengths: 8 mg, 16 mg, and 32 mg.
This medicine should always be taken as directed by the doctor or pharmacist. In case of doubts, 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 the use of diuretics.

• In black patients, the response to treatment may be weaker if Carzap is used as monotherapy. A higher dose may be necessary in this case.

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 of <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 of ≥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.

Overdose of Carzap

In case of overdose of Carzap, the patient should immediately contact their doctor or pharmacist.

Missed dose of Carzap

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

Stopping treatment with Carzap

If treatment with Carzap is stopped, blood pressure may rise 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 such 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 affect up to 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 pre-existing kidney problems or heart failure. In very rare cases, kidney failure may occur.

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

• Swelling of the face, lips, tongue, and/or throat;
• 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 sore throat, 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 Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
By reporting side effects, more information can be collected 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 packaging. The expiry date refers to the last day of the month.
There are no special storage precautions.
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 pack and other information

What Carzap contains

The active substance of the medicine is candesartan cilexetil. Each tablet contains 16 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, 16 mg, is a round, biconvex, white or almost white tablet 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.
The tablet can be divided into equal doses.
Pack sizes: 28, 56 tablets.
For more detailed information, the patient should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in the Czech Republic, the country of export:

Zentiva, k. s., U Kabelovny 130, 102 37 Prague 10, Czech Republic

Manufacturer:

Zentiva, k. s., U Kabelovny 130, 102 37 Prague 10, Czech Republic

Parallel importer:

InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw

Repackaged by:

InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing authorization number in the Czech Republic, the country of export:58/746/11-C
Parallel import authorization number:182/21
Date of leaflet approval: 30.11.2022
[Information about the trademark]