Cazaprol

Patient Information Leaflet

Cazaprol, 1 mg, film-coated tablets
Cazaprol, 2.5 mg, film-coated tablets
Cazaprol, 5 mg, film-coated tablets
Cilazapril
Please read this leaflet carefully before taking this medicine, because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for you personally. 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 any not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Leaflet Contents

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

1. What Cazaprol is and what it is used for

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

• high blood pressure (hypertension),
• chronic (long-term) heart failure (a condition in which the heart is unable to pump sufficient blood to meet the body's needs).

The medicine works by relaxing and widening blood vessels, which helps 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 be taken together with Cazaprol.

2. Important information before using Cazaprol

When not to use Cazaprol:

• if the patient is allergic to cilazapril or any of the other ingredients of this medicine (listed in section 6);
• if the patient has an allergy (hypersensitivity) to other ACE inhibitors. These include captopril, enalapril, lisinopril, and ramipril;
• if the patient previously experienced a severe adverse reaction called angioedema after taking other ACE inhibitors, or if the patient has hereditary angioedema or angioedema of unknown cause. Symptoms include swelling of the face, lips, mouth, or tongue;
• after the third month of pregnancy (Cazaprol should also be avoided during early pregnancy – see section "Pregnancy and breastfeeding");
• if the patient has diabetes or kidney problems and is being treated with a blood pressure-lowering medicine containing aliskiren;
• if the patient has taken or is currently taking sacubitril with valsartan, a medicine used to treat certain types of chronic (long-term) heart failure in adults, because the risk of angioedema (rapid swelling of tissues beneath the skin, such as in the throat)

If any of the above situations apply, Cazaprol must not be used.
In case of any doubts, consult your doctor or pharmacist before taking Cazaprol.

Warnings and precautions

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

• the patient has heart disease. Cazaprol must not be used in patients with certain heart conditions;
• the patient has previously had a stroke or impaired blood flow to the brain;
• the patient has severe liver disease or jaundice;
• the patient has kidney disease or impaired blood flow to the kidneys, known as renal artery stenosis;
• the patient is undergoing dialysis;
• the patient has recently experienced vomiting or diarrhea;
• the patient is on a low-salt (low-sodium) diet;
• the patient is undergoing desensitization to bee or wasp venom;
• the patient is scheduled for surgery (including dental surgery). Some anesthetics may lower blood pressure, potentially causing it to drop too low;
• the patient has fluid in the abdominal cavity (ascites);
• the patient has diabetes;
• the patient has vascular collagenosis;
• the patient is undergoing low-density lipoprotein (LDL) apheresis using dextran sulfate;
• if the patient is taking any of the following medicines, the risk of angioedema (rapid swelling beneath the skin, such as in the throat) is increased:
• racecadotril, a medicine used to treat diarrhea;
• temsirolimus, sirolimus, everolimus, and other medicines belonging to the mTOR inhibitor class (used to prevent rejection of transplanted organs and in cancer treatment);
• vildagliptin, a medicine used to treat diabetes;
• if the patient is taking any of the following medicines used to treat high blood pressure:
• an angiotensin II receptor antagonist (Angiotensin Receptor Blockers, ARBs), also known as sartans (e.g., valsartan, telmisartan, irbesartan), especially if the patient has kidney problems related to diabetes,
• aliskiren.

Your doctor may need to 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 Cazaprol”.

If any of the above situations apply or if you have any doubts, consult your doctor or pharmacist before taking Cazaprol.

Inform your doctor if you suspect (or are planning) pregnancy. Cazaprol 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 and breastfeeding”).

Children and adolescents

Cazaprol is not recommended for use in children.

Cazaprol and other medicines

Tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, including those obtained without a prescription and herbal medicines. This is because Cazaprol may affect the action of other medicines, and some medicines may affect the action of Cazaprol.

In particular, inform your doctor or pharmacist if you are taking any of the following medicines:

• other antihypertensive medicines and/or medicines used for heart failure, including diuretics (water tablets);
• antidiabetic medicines (insulin or tablets);
• medicines for joint pain (non-steroidal anti-inflammatory drugs (NSAIDs), including acetylsalicylic acid, indomethacin, and ibuprofen);
• anti-inflammatory medicines (systemic corticosteroids such as hydrocortisone, prednisolone, and dexamethasone) or medicines that suppress the immune system (immunosuppressants);
• medicines used in the treatment of mania and depression (lithium);
• potassium supplements or potassium-containing salt substitutes, potassium-sparing diuretics (water tablets, especially potassium-sparing types), other medicines that may increase potassium levels in the body (such as trimethoprim and co-trimoxazole, also known as trimethoprim with sulfamethoxazole), used for bacterial infections; cyclosporine, an immunosuppressant used to prevent organ transplant rejection, and heparin, a medicine used to thin the blood to prevent clots;
• aldosterone antagonists;
• sympathomimetics;
• anesthetics, opioids;
• medicines used to treat psychiatric disorders such as depression, anxiety, schizophrenia (tricyclic antidepressants, antipsychotics);
• gold compounds (used in the treatment of rheumatoid arthritis);
• medicines commonly used to prevent rejection of transplanted organs (sirolimus, everolimus, and other mTOR inhibitors). See section “Warnings and precautions”.

Your doctor may need to adjust the dose and/or take additional precautions:

• if the patient is taking an angiotensin II receptor antagonist (ARB) or aliskiren (see also information under “When not to use Cazaprol” and “Warnings and precautions”).

Cazaprol with food and drink

Cazaprol may be taken before or after meals. Swallow the tablets whole with water or another non-alcoholic drink.

Inform your doctor or pharmacist if you are taking potassium supplements.

Pregnancy and breastfeeding

If you are pregnant, breastfeeding, think you may be pregnant, or are planning to have a baby, consult your doctor or pharmacist before using this medicine.

Pregnancy

Inform your doctor if you suspect (or are planning) pregnancy. Your doctor will usually advise stopping Cazaprol before planning pregnancy or immediately after pregnancy is confirmed and will recommend an alternative medicine. Cazaprol 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.

Breast-feeding

Inform your doctor if you are breastfeeding or intend to breastfeed. Cazaprol is not recommended during breastfeeding, especially when breastfeeding a newborn or premature infant. Your doctor may recommend an alternative medicine.

Driving and using machines

Cazaprol has no effect on the ability to drive or operate machinery. However, consider the possibility of dizziness occurring in some patients, especially at the beginning of treatment, during dose increases, or when Cazaprol is taken with other medicines used to treat high blood pressure.

If dizziness occurs, do not drive, use tools, or operate machinery.

Cazaprol contains lactose and sodium

If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before starting treatment.

This medicine contains less than 1 mmol of sodium (23 mg) per tablet, therefore it is considered essentially "sodium-free".

3. How to use Cazaprol

This medicine should always be taken as directed by the physician. If in doubt, consult your doctor or pharmacist.

Administration of Cazaprol

• Take one tablet of Cazaprol daily.
• Swallow the tablet with water.
• The time of day when the tablet is taken is not important. However, the tablet should be taken at the same time every day.
• Cazaprol may be taken before or after meals.

Arterial hypertension (high blood pressure)

• The usual initial dose in adults is 1 mg once daily.
• Your doctor will increase the dose until blood pressure is controlled. The usual maintenance dose typically ranges from 2.5 mg to 5 mg once daily.
• Your doctor may prescribe a lower dose for patients with impaired renal function or elderly patients.
• If you are taking diuretics, your doctor may advise discontinuing them approximately 3 days before starting Cazaprol. In such cases, the usual initial dose of Cazaprol is 0.5 mg once daily. Your doctor will then gradually increase the dose until blood pressure is adequately controlled.

Chronic heart failure

• The usual initial dose is 0.5 mg once daily.
• Your doctor will then gradually increase the dose. The usual maintenance dose typically ranges from 1 mg to 2.5 mg once daily.
• Your doctor may prescribe a lower dose for patients with impaired renal function or elderly patients.
• For patients with liver cirrhosis without ascites, your doctor will not prescribe a dose exceeding 0.5 mg once daily and will closely monitor arterial blood pressure.

Use in children
Cazaprol must not be used in children.

Do not deliberately alter 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 take more Cazaprol than prescribed, or if someone else takes the medicine, contact your doctor immediately or go to the nearest hospital. Bring the medicine packaging with you. The following symptoms may occur: dizziness or a sensation of "emptiness" in the head, shallow breathing, cold and clammy skin, inability to move or speak, and slow heart rate.

Missed dose of Cazaprol
If you forget to take a dose, skip the missed dose. Take the next dose at your usual scheduled time.
Do not take a double dose (two doses at the same time) to make up for a missed dose.

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.

Serious adverse reactions:

If a serious reaction called angioedema occurs, stop taking Cazaprol and seek medical advice immediately. Symptoms include:

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

Other possible adverse reactions:

Common adverse reactions (may occur in up to 1 in 10 patients):

• dizziness
• cough
• nausea
• fatigue
• headache

Uncommon adverse reactions (may occur in up to 1 in 100 patients):

• low blood pressure. This may cause weakness, dizziness, a feeling of "emptiness" in the head, blurred vision, and fainting. Excessively low blood pressure in some patients may increase the risk of heart attack or stroke.
• increased heart rate
• weakness
• chest pain
• breathing difficulties, including shortness of breath and chest tightness
• nasal congestion or runny nose and sneezing (rhinitis)
• dryness or swelling of the oral mucosa
• loss of appetite
• altered taste
• diarrhoea and vomiting
• skin rash (which may be severe)
• muscle cramps or muscle or joint pain
• impotence
• excessive sweating
• sudden flushing (especially of the face)
• sleep disturbances

Rare adverse reactions (may occur in up to 1 in 1,000 patients):

• reduced number of red and white blood cells or platelets, detected in blood tests (anaemia, neutropenia, agranulocytosis, and thrombocytopenia)
• severe allergic reaction (anaphylaxis)
• cerebral ischaemia, transient ischaemic attack, ischaemic stroke (may occur if blood pressure is too low)
• myocardial infarction (may occur if blood pressure is too low)
• heart rhythm disorders
• interstitial lung disease
• systemic lupus erythematosus-like disorders
• tingling or numbness of hands or feet
• wheezing
• pressure sensation or pulsating pain behind the nose, cheeks, and eyes (sinusitis)
• tongue pain
• pancreatitis; symptoms include severe upper abdominal pain radiating to the back
• changes in kidney or liver function (shown in blood and urine tests)
• liver function disorders, such as hepatitis or liver damage
• severe skin reactions, including blisters or skin peeling
• 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 during use of ACE inhibitors:

• low number of red blood cells (anaemia). Symptoms include feeling tired, pale skin, rapid or irregular heartbeat (palpitations), and shortness of breath.
• low number of all types of white blood cells. Symptoms include increased frequency of infections, for example in the mouth, gums, throat, and lungs.
• low number of platelets. Symptoms include easy bruising and nosebleeds.

Reporting of adverse reactions

If any adverse reactions occur, including any not listed in this leaflet, inform your 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
Tel.: +48 22 49 21 301
Fax: +48 22 49 21 309
e-mail: [email protected]

Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Cazaprol

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.
Store in the original packaging to protect from moisture. Do not store above 30 °C.
Medicines must 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 stearyl fumarate, talc, monohydrate lactose, hypromellose and corn starch 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
Pack sizes: 28 or 30 coated tablets in blister packs, in a cardboard box
Marketing authorisation holder and manufacturer
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia