Carzap

Package leaflet: Information for the patient

Warning! Keep this leaflet! Information on the immediate packaging is in a foreign language.
Carzap (Candesartan Zentiva)
32 mg, tablets
Candesartanum cilexetili
Carzap and Candesartan Zentiva are different brand names of the same medicine.
Please read this 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, 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.
• If you experience any adverse effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet :

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. The 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 function, when angiotensin-converting enzyme (ACE) inhibitors cannot be used, or as add-on therapy to ACE inhibitors when heart failure symptoms persist despite therapy 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 during 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 cause serious harm to 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 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.
Also refer to 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 experiences abdominal pain, nausea, vomiting or diarrhoea after taking Carzap, discuss this with a doctor.
The doctor will decide on further treatment. Do not stop taking Carzap on your own initiative.
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 potential risk to kidney development.
Carzap with other medicines
Inform your doctor or pharmacist about any medicines you are currently taking, have recently taken or 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, 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 a dose greater than 3 g per day) (a medicine that relieves pain and inflammation);
• potassium supplements, salt substitutes containing potassium (medicines that increase blood potassium levels);
• heparin (a blood-thinning medicine);
• cotrimoxazole, 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 additional precautions:

• If the patient is taking an ACE inhibitor or aliskiren (also see 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 you plan to consume alcohol. Alcohol may cause fainting or dizziness.
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 discontinuing Carzap before a planned pregnancy or immediately after pregnancy is confirmed, and will recommend an alternative medicine. 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 intend to breastfeed. Use of Carzap is not recommended during breastfeeding, especially when breastfeeding 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, 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

Carzap is available in the following doses: 8 mg, 16 mg, and 32 mg.
This medicine should always be taken as prescribed by a doctor or pharmacist. If in doubt,
consult a 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 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. The doctor may increase the dose to 16 mg once daily, and subsequently to 32 mg once daily, depending on the response to treatment.
• The 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. 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 appropriate for the patient.

Taking more Carzap than prescribed
If more Carzap is taken than prescribed, contact a doctor or pharmacist immediately.

If a dose of Carzap is missed
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 Carzap treatment is stopped, blood pressure may increase again. Therefore, do not stop taking Carzap without first consulting a 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 everybody 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 in 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 in 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, the patient should 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 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 blood, particularly in patients with kidney disorders or heart failure. If potassium levels increase significantly, 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 less than 1 in 10,000 people)

• Swelling of the face, lips, tongue and (or) throat;
• Angioedema of the intestine: swelling in the intestine causing symptoms such as abdominal pain, nausea, vomiting and diarrhoea;
• 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 sodium levels in blood. If sodium levels decrease significantly, weakness, lack of energy or muscle cramps may occur.

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

• Diarrhoea.

In children treated for high blood pressure, adverse reactions appear to be similar to those occurring in adults, but 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 reactions occur, including any adverse reactions not listed in this leaflet, the patient should inform their 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 provide more information on the safety of the medicine.

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 conditions 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 pack and other information

What Carzap contains
The active substance is candesartan cilexetil. Each tablet contains 32 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 is a round, biconvex, white or almost white tablet, with a division line on one side and an imprint "C/32" on the same side. The tablet diameter is approximately 10.5 mm.
The tablet can be divided into equal doses.
Pack size: 28 tablets.

For further detailed information, please contact the responsible entity or parallel importer.

Marketing Authorisation Holder in Portugal, the country of export:
Zentiva Portugal, Lda.
Miraflores Premium I, Alameda Fernão Lopes, 16 A - 8º piso A, 1495-190 Algés, Portugal

Manufacturer:
Siegfried Malta Ltd
HHF070 Hal Far Industrial Estate, P.O. box 14, Hal Far BBG 3000, Malta
Zentiva k.s.
U kabelovny 130, 102 37, Prague 10 - Dolní Měcholupy, Czech Republic

Parallel Importer:
InPharm Sp. z o.o., ul. Strumykowa 28/11, 03-138 Warsaw, Poland

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

Marketing Authorisation Number in Portugal, the country of export: 5404561
Parallel Import Authorisation Number: 181/21

This medicinal product is authorised in the European Economic Area countries under the following names: