Carzap

Package leaflet: Information for the patient

Warning! Keep this leaflet. Information on the immediate packaging is in a foreign language.
Carzap
16 mg, tablets
Candesartanum cilexetili
Please read the entire leaflet carefully before using this medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm someone else, even if their symptoms are the same as yours.
• 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:

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. Carzap also makes it easier for the heart to pump blood to all parts of the body.
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 function, when angiotensin-converting enzyme (ACE) inhibitors cannot be used, or as an add-on therapy to ACE inhibitors 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 advisable to avoid using Carzap in early 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 treatment with Carzap, discuss the following 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 you suspect (or are planning) pregnancy. 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 section "Carzap with other medicines").

Your 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 monitoring and tests.

If the patient is scheduled for 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 is taking 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 (in doses exceeding 3 g per day) (a medicine that relieves pain and inflammation);
• potassium supplements, potassium-containing salt substitutes (medicines that increase blood potassium levels);
• heparin (a blood-thinning medicine);
• co-trimoxazole, also known as trimethoprim/sulfamethoxazole (an antibiotic);
• diuretics (water pills);
• 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 dizziness or fainting.

Pregnancy, breastfeeding and fertility

Pregnancy

If the patient suspects she may be pregnant (or is planning to become pregnant), she should consult a doctor. The doctor will usually advise stopping treatment with Carzap before planned pregnancy or immediately after pregnancy is confirmed, and will recommend an alternative medicine to Carzap. 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.

Breast-feeding

Inform your doctor if you are breast-feeding or intend to breast-feed. Use of Carzap is not recommended during breast-feeding, especially when breast-feeding a newborn or premature infant. The doctor may recommend an alternative medicine.

Driving and operating machinery

While taking Carzap, some patients may experience fatigue or dizziness. If these symptoms occur, do not drive, use tools or operate 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 consult a 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 directed by the doctor or pharmacist. If in doubt,
consult the 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 then 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, for example due to vomiting, diarrhoea, or use of diuretics.

• In patients of Black race, 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 doctor 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 doctor may decide to increase the dose to 8 mg once daily, and then to 16 mg once daily.

Heart failure in adults:
The recommended initial dose of Carzap is 4 mg once daily. The 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 the doctor will decide which treatment is most suitable for the patient.

Taking more Carzap than recommended
If more Carzap has been taken than recommended by the doctor, contact the 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 treatment
If treatment with Carzap is stopped, blood pressure may rise again. Therefore, do not discontinue Carzap without first consulting your doctor.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
It is important that the patient is aware of the possibility that such reactions may occur.
The treatment with Carzap must be stopped immediately and medical help must 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 swallowing
• Severe skin itching (with raised skin lesions)

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 a doctor. The doctor may recommend periodic blood tests to check whether Carzap affects blood composition (agranulocytosis).
Other possible adverse reactions include:
Common (may occur in fewer than 1 in 10 people)

• Dizziness/feeling of spinning
• Headache
• Respiratory tract infection
• Low blood pressure. This may cause fainting or dizziness
• Changes in blood test results: Increased blood potassium levels, particularly in patients with kidney disorders or heart failure. In case of a significant increase in potassium levels, fatigue, weakness, irregular heartbeat or tingling sensations may occur
• Effect on kidney function, particularly in patients with pre-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
• 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 blood sodium levels. 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)

• Diarrhea

In children treated for high blood pressure, adverse reactions appear to be similar to those observed in adults, but occur more frequently. A very common adverse reaction reported in children but not reported in adults is sore throat. Additionally, adverse reactions such as nasal congestion, fever and rapid heartbeat occur frequently in children, but were not reported in adults.
Reporting of adverse reactions
If any adverse symptoms occur, including any adverse reactions not listed in this leaflet, inform a doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring of 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 of adverse reactions allows further information on the safety of the medicine to be collected.

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 instructions apply.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. 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 16 mg of candesartan cilexetil.
The other ingredients are: monohydrate lactose, corn starch, hydroxypropylcellulose (E 463),
sodium croscarmellose (E 468), magnesium stearate (E 572), triethyl citrate (E 1505).

What Carzap looks like and contents of the pack
Carzap 16 mg are round, biconvex, white or almost white tablets with a division line on one side and an imprint C/16 on the same side. The tablet diameter is approximately 8 mm.
The tablet can be divided into equal doses.
Pack sizes: 14, 28, 56 or 98 tablets.
For more detailed information, please contact the marketing authorisation holder or the parallel importer.

Marketing authorisation 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:
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

Marketing authorisation number in the Czech Republic, the country of export: 58/746/11-C
Parallel import authorisation number: 125/21