Carzap

Package leaflet: Information for the user

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

• Keep this leaflet so that you can read it again if necessary.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual only. Do not share it with others. The medicine may harm another person, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet:

1. What Carzap is and what it is used for
2. What you need to know 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, which 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 left ventricular ejection fraction 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 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 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.
• 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 "Carzap with other medicines").

Your doctor may monitor kidney function, blood pressure, and blood levels of electrolytes (e.g. potassium) at regular intervals.

See also the 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 is to undergo surgery, inform the doctor or dentist that you are 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 the 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 (at doses greater than 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 tablets);
• lithium (a medicine used to treat psychiatric disorders).

The treating doctor may need to adjust the dose and/or take other 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

While taking Carzap, consult your doctor if you plan to consume alcohol. Alcohol may cause dizziness or fainting.

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 advise stopping treatment with Carzap before a planned pregnancy or immediately after pregnancy is confirmed, and will recommend taking another medicine instead of 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.

Breastfeeding

Inform your doctor if you are breastfeeding or planning to breastfeed. Use of Carzap is not recommended during breastfeeding, especially when breastfeeding a newborn or premature infant. The doctor may recommend using another medicine.

Driving and using machines

While taking Carzap, some patients may experience fatigue or 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 been previously diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.

The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is considered "sodium-free".

3. How to use Carzap

Carzap is available in the following doses: 8 mg, 16 mg, and 32 mg.
This medicine should always be taken exactly as directed by your doctor or pharmacist. If in doubt,
consult your doctor or pharmacist. It is important to take Carzap every day.
Carzap may be taken during meals or independently of meals.
Swallow the tablet 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 large amount of
fluid, for example due to vomiting, diarrhoea, or use of diuretic medicines.

• In black patients, the response to treatment may be weaker when Carzap is used as monotherapy. Higher doses may therefore be necessary.

Use in children and adolescents with high blood pressure
Children aged 6 to 18 years:
The recommended starting dose is 4 mg once daily.
Patients with body weight <50 kg: in patients whose 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: in patients whose 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 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 the patient.

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

Missed 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 stop taking 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 of such reactions occurring.
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 swallowing;
• Severe skin itching (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 a doctor. The doctor may recommend periodic blood tests to check whether Carzap affects blood composition (agranulocytosis).

Other possible adverse reactions include:

Common (may affect 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 blood potassium levels, particularly if the patient has kidney disorders or heart failure. In case of a significant increase, fatigue, weakness, irregular heartbeat or tingling sensations may occur;
• Effect on kidney function, particularly in case of existing kidney disorders or heart failure. In very rare cases, kidney failure may occur.

Very rare (may affect 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, 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 occurring in adults, but they occur more frequently. A very common adverse reaction occurring in children but not reported in adults is sore throat. Additionally, adverse reactions such as cold, 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 or pharmacist. Adverse reactions 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, phone: +48 22 4921301, fax: +48 22 4921309, website: https://smz.ezdrowie.gov.pl.
Reporting adverse reactions helps to increase the knowledge about the safety of this medicine.

5. How to store Carzap

Keep this medicine out of the 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 required.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the packaging 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, maize 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 and an imprint C/16 on one side. The tablet diameter is approximately 8 mm.
The tablet can be divided into equal doses.
Pack sizes: 28, 56 tablets.
For more detailed information, please contact the marketing authorisation holder or the parallel importer.

Marketing authorisation holder in the Czech Republic, 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
Poland

Repackaged by:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Poland

Marketing authorisation number in the Czech Republic, country of export: 58/746/11-C
Parallel import authorisation number: 182/21