Cazaprol

Leaflet accompanying the packaging: patient information

Cazaprol, 1 mg, coated tablets

Cazaprol, 2.5 mg, coated tablets

Cazaprol, 5 mg, coated tablets

Cilazapril

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Cazaprol and what is it used for
• 2. Important information before taking Cazaprol
• 3. How to take Cazaprol
• 4. Possible side effects
• 5. How to store Cazaprol
• 6. Contents of the packaging and other information

1. What is Cazaprol and what is it used for

The active substance of Cazaprol, cilazapril, belongs to a group of medicines called angiotensin-converting enzyme inhibitors (ACE inhibitors).
Cazaprol is used to treat:

• high blood pressure (hypertension),
• chronic (long-term) heart failure (a condition where the heart is not able to pump enough blood to meet the body's needs).

The medicine works by relaxing and widening the blood vessels, which helps to lower blood pressure. This also makes it easier for the heart to pump blood in patients with chronic heart failure.
Your doctor may prescribe other medicines to take with Cazaprol.

2. Important information before taking Cazaprol

When not to take Cazaprol:

• if you are allergic to cilazapril or any of the other ingredients of this medicine (listed in section 6);
• if you are allergic (hypersensitive) to other ACE inhibitors. These include captopril, enalapril, lisinopril, and ramipril;
• if you have ever had a severe side effect called angioedema after taking other ACE inhibitors. If you have ever had hereditary or idiopathic angioedema;
• after the third month of pregnancy (also avoid taking Cazaprol during early pregnancy - see "Pregnancy and breastfeeding");
• if you have diabetes or kidney problems and are taking a blood pressure-lowering medicine containing aliskiren;
• if you have taken or are currently taking sacubitril/valsartan, a medicine used to treat a certain type of long-term (chronic) heart failure in adults, as the risk of angioedema (rapid swelling of tissues under the skin, e.g., in the throat) is increased;

If any of the above applies to you, do not take Cazaprol. In case of any doubts, consult your doctor or pharmacist before taking Cazaprol.

Warnings and precautions

Before starting to take Cazaprol, discuss it with your doctor or pharmacist if:

• you have heart disease. Cazaprol may not be suitable for patients with certain heart diseases;
• you have had a stroke or cerebral blood flow disorders;
• you have severe liver disease or jaundice;
• you have kidney disease or renal artery stenosis;
• you are undergoing dialysis;
• you have recently had vomiting or diarrhea;
• you are on a low-salt diet;
• you are scheduled to undergo desensitization to bee or wasp venom;
• you are scheduled to undergo surgery (including dental surgery). Some anesthetics may lower your blood pressure, which can become too low.
• you have fluid in your abdominal cavity (ascites);
• you have diabetes;
• you have collagen vascular disease;
• you are undergoing low-density lipoprotein (LDL) apheresis using dextran sulfate;
• if you are taking any of the following medicines, the risk of angioedema (rapid swelling of tissues under the skin, e.g., in the throat) is increased:
• racecadotril, a medicine used to treat diarrhea;
• temsirolimus, sirolimus, everolimus, and other medicines belonging to the class of mTOR inhibitors (used to prevent rejection of transplanted organs and to treat cancer);
• vildagliptin, a medicine used to treat diabetes;
• if you are taking any of the following medicines used to treat high blood pressure:
• angiotensin receptor antagonist (ARB) (also known as sartans - e.g., valsartan, telmisartan, irbesartan), especially if you have diabetic kidney problems,
• aliskiren.

Your doctor will monitor your kidney function, blood pressure, and electrolyte levels (e.g., potassium) at regular intervals.
See also the information under the heading "When not to take Cazaprol".
If any of the above applies to you or in case of any doubts before taking Cazaprol, consult your doctor or pharmacist.
You must inform your doctor if you are pregnant or planning to become pregnant. It is not recommended to take Cazaprol during early pregnancy and it must not be taken after the third month of pregnancy, as it may seriously harm the baby (see "Pregnancy and breastfeeding").

Children and adolescents

Cazaprol is not recommended for children.

Cazaprol and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might take, including those obtained without a prescription and herbal medicines. This is because Cazaprol may affect the way other medicines work. Some medicines may also affect the way Cazaprol works.
In particular, tell your doctor or pharmacist if you are taking any of the following medicines:

• other blood pressure-lowering medicines and/or medicines used to treat heart failure, including diuretics (water tablets),
• medicines for diabetes (insulin or tablets),
• medicines for pain relief in joints (non-steroidal anti-inflammatory drugs (NSAIDs), including aspirin, indometacin, and ibuprofen),
• medicines for inflammation (corticosteroids for general use, such as hydrocortisone, prednisolone, and dexamethasone) or medicines that suppress the immune system (immunosuppressants),
• medicines used to treat mania and depression (lithium),
• potassium supplements or salt substitutes containing potassium, diuretics (especially those that spare potassium), and other medicines that may increase potassium levels in the body (such as trimethoprim and cotrimoxazole, also known as trimethoprim/sulfamethoxazole, used to treat bacterial infections; cyclosporin, an immunosuppressant used to prevent organ rejection, and heparin, a medicine used to thin the blood to prevent clots),
• aldosterone antagonists,
• sympathomimetics,
• anesthetics, opioids,
• medicines used to treat mental disorders, such as depression, anxiety disorders, schizophrenia (tricyclic antidepressants, antipsychotics),
• gold compounds (used to treat rheumatoid arthritis),
• medicines most commonly taken to prevent rejection of transplanted organs (sirolimus, everolimus, and other medicines belonging to the class of mTOR inhibitors). See the "Warnings and precautions" section.

Your doctor may need to change the dose and/or take other precautions:

• if you are taking an angiotensin receptor antagonist (ARB) or aliskiren (see also the information under the headings "When not to take Cazaprol" and "Warnings and precautions").

Cazaprol with food and drink

Take the medicine before or after meals. Swallow the tablets whole with water or another non-alcoholic drink.
Tell your doctor or pharmacist if you are taking potassium supplements.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
Tell your doctor if you are pregnant or planning to become pregnant. Your doctor will usually advise you to stop taking Cazaprol before you become pregnant or as soon as you find out you are pregnant, and will advise you to take a different medicine instead of Cazaprol. Do not take Cazaprol during early pregnancy and do not take it after the third month of pregnancy, as it may seriously harm the baby (see "Pregnancy and breastfeeding").
Breastfeeding
Tell your doctor if you are breastfeeding or planning to breastfeed. It is not recommended to take Cazaprol while breastfeeding, especially if you are breastfeeding a newborn or premature baby. Your doctor may advise you to take a different medicine.

Driving and using machines

Cazaprol does not affect the ability to drive or use machines. However, consider the possibility of dizziness, especially at the start of treatment, when increasing the dose, or when taking Cazaprol with other blood pressure-lowering medicines.
If you experience dizziness, do not drive, use tools, or operate machines.

Cazaprol contains lactose and sodium

If you have been told you have an intolerance to some sugars, consult your doctor before taking this medicine.
This medicine contains less than 1 mmol sodium (23 mg) per tablet, which is essentially "sodium-free".

3. How to take Cazaprol

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.

Taking Cazaprol

• Take one Cazaprol tablet daily.
• Swallow the tablet with water.
• The time of day you take the tablet does not matter. However, take the tablet at the same time every day.
• Cazaprol can be taken before or after a meal.

High blood pressure (hypertension)

• The usual initial dose for adults is 1 mg per day.
• Your doctor will increase the dose until your blood pressure is controlled - the usual maintenance dose is between 2.5 mg and 5 mg per day.
• Your doctor may prescribe a lower dose if you have kidney problems or are elderly.
• If you are taking diuretics, your doctor may stop them about 3 days before starting Cazaprol. The usual initial dose of Cazaprol is then 0.5 mg per day. Your doctor will then increase the dose until your blood pressure is controlled.

Chronic heart failure

• The usual initial dose is 0.5 mg per day.
• Your doctor will then increase the dose - the usual maintenance dose is between 1 mg and 2.5 mg per day.
• Your doctor may prescribe a lower dose if you have kidney problems or are elderly.
• Patient with liver cirrhosis without ascites, your doctor will not prescribe a dose higher than 0.5 mg per day and will closely monitor your blood pressure.

Taking Cazaprol in children

Do not give Cazaprol to children.
Do not intentionally change the prescribed dose. If you feel the effect of the medicine is too strong or too weak, consult your doctor or pharmacist.

Overdose of Cazaprol

If you have taken more than the prescribed dose of Cazaprol or if someone else has taken your medicine, contact your doctor or go to the nearest hospital immediately. Take the medicine packaging with you. The following symptoms may occur: dizziness or a feeling of "emptiness" in the head, shallow breathing, cold and clammy skin, inability to move or speak, and slow heart rate.

Missing a dose of Cazaprol

If you forget to take a dose, skip the missed dose. Then take the next dose at the usual time.
Do not take a double dose (two doses at the same time) to make up for the missed dose.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Cazaprol can cause side effects, although not everybody gets them.

Severe side effects:

If you experience a severe reaction called angioedema, stop taking Cazaprol and go to your doctor immediately. Symptoms include:

• sudden swelling of the face, throat, lips, or mouth. This swelling can cause difficulty breathing or swallowing.

Other possible side effects:

Common side effects(may affect up to 1 in 10 people):

• dizziness
• cough
• nausea
• fatigue
• headache

Uncommon side effects(may affect up to 1 in 100 people):

• low blood pressure. This can cause weakness, dizziness, or a feeling of "emptiness" in the head, blurred vision, and fainting. Excessive lowering of blood pressure in some patients may increase the risk of heart attack or stroke.
• rapid heartbeat
• weakness
• chest pain
• breathing difficulties, including shortness of breath and tightness in the chest
• runny nose or stuffy nose and sneezing (rhinitis)
• dryness or swelling of the mouth
• loss of appetite
• change in taste
• diarrhea and vomiting
• skin rash (which can be severe)
• muscle cramps or muscle pain, or joint pain
• impotence
• increased sweating
• sudden flushing (especially of the face)
• sleep disturbances

Rare side effects(may affect up to 1 in 1,000 people):

• low red blood cell count, low white blood cell count, or low platelet count, found in blood tests (anemia, neutropenia, agranulocytosis, and thrombocytopenia)
• severe allergic reaction (anaphylaxis)
• brain damage due to low blood flow, transient ischemic attack, ischemic stroke (may occur if blood pressure is too low)
• heart attack (may occur if blood pressure is too low)
• heart rhythm disorders
• interstitial lung disease
• systemic lupus erythematosus-like reactions
• tingling or numbness of hands or feet
• wheezing
• feeling of pressure or pulsating pain behind the nose, cheeks, and eyes (sinusitis)
• tongue pain
• pancreatitis; symptoms include severe abdominal pain radiating to the back
• changes in kidney or liver function (shown in blood and urine tests)
• liver disorders, such as hepatitis or liver damage
• severe skin reactions, including blistering or peeling of the skin
• increased sensitivity to light
• hair loss (which may be temporary)
• loosening or separation of the nail from the nail bed
• breast enlargement in men

Blood disorders reported with ACE inhibitors:

• low red blood cell count (anemia). Symptoms include feeling tired, pale skin, fast or irregular heartbeat (palpitations), and shortness of breath.
• low white blood cell count. Symptoms include increased risk of infection, e.g., of the mouth, gums, throat, and lungs.
• low platelet count. Symptoms include easy bruising and bleeding from the nose.

Reporting side effects
If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Jerozolimskie Avenue 181C, 02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
e-mail: ndl@urpl.gov.pl.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Cazaprol

Keep the 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 month.
Store in the original packaging to protect from moisture. Do not store above 30°C.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the packaging and other information

What Cazaprol contains

• The active substance is cilazapril. Each coated tablet contains 1 mg, 2.5 mg, or 5 mg of cilazapril.
• The other ingredients are: sodium stearylfumarate, talc, lactose monohydrate, hypromellose, and cornstarch in the tablet core; and hypromellose, talc, and titanium dioxide (E 171), yellow iron oxide (E 172) in Cazaprol 1 mg, and red iron oxide (E 172) in Cazaprol 2.5 mg and Cazaprol 5 mg, in the tablet coating. See section 2 "Cazaprol contains lactose and sodium".

What Cazaprol looks like and contents of the pack

Cazaprol 1 mg: yellow, elongated, slightly biconvex coated tablets
Cazaprol 2.5 mg: light reddish-brown, elongated, slightly biconvex coated tablets
Cazaprol 5 mg: reddish-brown, elongated, slightly biconvex coated tablets
Packaging: 28 or 30 coated tablets in blisters, in a cardboard box

Marketing authorization holder and manufacturer

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
Date of last revision of the leaflet:21.03.2019