Carzap

Package leaflet: Information for the user

Warning! Keep this leaflet! Information on the immediate packaging in a foreign language.
Carzap (Canzeno)
16 mg, tablets
Candesartanum cilexetili
Carzap and Canzeno are different trade names for the same medicine.
Please read this leaflet carefully before taking 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. Do not pass it on to 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.
  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 package 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 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 left ventricular ejection fraction, when angiotensin-converting enzyme (ACE) inhibitors cannot be used, or as an add-on 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 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 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 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 third 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:
  • ACE inhibitors (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 known as mineralocorticoid receptor antagonists (MRAs). These medicines are used in the treatment of heart failure (see "Carzap with other medicines"). The 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 to undergo surgery, inform the doctor or dentist that they 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 potential risk to kidney development.

Carzap with other medicines

Tell your doctor or pharmacist if the patient is currently taking, has recently taken, or might take any other medicines.

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 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 (an antibiotic) also known as trimethoprim/sulfamethoxazole;
• 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 drink 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 recommend stopping Carzap before a 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 third 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 an alternative medicine.

Driving and using machines

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, they should consult their 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

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.
The tablet should be swallowed with water.
Tablets should be taken at approximately the same time each day. 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 due to vomiting, diarrhoea, or diuretic therapy.
• In black patients, the response to treatment may be less pronounced 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. 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 recommended 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 doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like any medicine, this medicine can cause adverse reactions, although not everyone experiences them.
It is important for the patient to be aware that such reactions may occur.
The use of 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 itching of the skin (with raised rash).

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/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 in patients with kidney disorders or heart failure. In case of a significant increase, fatigue, weakness, irregular heartbeat, or tingling sensations may occur;
• Effect on kidney function, especially in patients with 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, weakness, lack of energy, or muscle cramps may occur.

In children treated for high blood pressure, adverse reactions appear to be similar to those in adults, but occur more frequently. A very common adverse reaction in children 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 or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration 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.
Reporting adverse reactions helps to collect additional information on the safety of the 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 instructions are 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 on one side and
the imprint C/16 on the same side. The tablet diameter is approximately 8 mm.
The tablet can be divided into equal doses.
Pack sizes: 30, 60 tablets.

For more detailed information, please contact the responsible party or the parallel importer.

Marketing Authorisation Holder in Romania, the country of export:
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
Siegfried Malta Ltd.
HHF070 Hal Far Industrial Estate (P.O. Box 14)
BBG 3000 Hal Far
Malta

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 Romania, the country of export: 10065/2017/04
Parallel Import Authorisation Number: 358/22