Inhibace

LEAFLET INCLUDED IN THE PACKAGING: INFORMATION FOR THE PATIENT

Warning! Keep the leaflet, the information on the immediate packaging is in a foreign language!

Inhibace

5 mg, coated tablets

Cilazapril

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

• Keep this leaflet, so you can read it again if you need to.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you and should not be given to others, as it may harm them, even if their symptoms are the same.
• If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

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

1. What is Inhibace and what is it used for

Inhibace contains cilazapril (as cilazapril monohydrate).
Inhibace is used to treat:

• high blood pressure (hypertension);
• chronic (long-term) heart failure.

Cilazapril belongs to a group of medicines called ACE inhibitors (angiotensin-converting enzyme inhibitors). The action of this medicine is to relax and dilate blood vessels. This helps to lower blood pressure. It also makes it easier for the heart to pump blood in patients with chronic heart failure.
The doctor may prescribe other medicines to be taken at the same time as Inhibace.

2. Important information before taking Inhibace

When not to take Inhibace:

• if the patient is allergic (hypersensitive) to cilazapril or any of the other ingredients of this medicine (listed in section 6);
• if the patient is allergic (hypersensitive) to other ACE inhibitors. These include captopril, enalapril, lisinopril, and ramipril;
• if the patient has experienced a severe side effect called angioedema after taking other ACE inhibitors. Symptoms include swelling of the face, lips, mouth, or tongue. Patients taking certain oral anti-diabetic medicines or medicines that suppress the immune system are at increased risk of angioedema;
• after the third month of pregnancy (Inhibace should also be avoided in early pregnancy - see "Pregnancy" and "Breast-feeding");
• 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 a certain type of chronic (long-term) heart failure in adults, as the risk of angioedema (rapid swelling of tissues under the skin, such as in the throat) is increased.

If any of the above situations apply to the patient, they should not take Inhibace. In case of any doubts, the patient should consult their doctor or pharmacist before taking Inhibace.

Warnings and precautions

Before taking Inhibace, the patient should consult their doctor or pharmacist if:

• the patient has heart disease. Inhibace may not be suitable for patients with certain heart diseases;
• the patient has had a stroke or problems with blood flow to the brain;
• the patient is taking any of the following medicines for high blood pressure:
• an angiotensin II receptor antagonist (also known as sartans - e.g., valsartan, telmisartan, irbesartan), especially if the patient has kidney problems related to diabetes;
• aliskiren; The doctor may monitor kidney function, blood pressure, and electrolyte levels (e.g., potassium) in the blood at regular intervals. See also the information under "When not to take Inhibace";
• the patient is taking medicines that suppress the immune system;
• the patient has severe liver disease or jaundice;
• the patient has kidney disease or problems with 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 diet;
• the patient is scheduled to undergo desensitization to bee or wasp stings;
• the patient is scheduled to undergo surgery (including dental surgery). Some anesthetics may lower blood pressure, which can become too low;
• the patient has fluid in the abdominal cavity (ascites);
• the patient has diabetes or is taking anti-diabetic medicines;
• the patient has collagen vascular disease;
• 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 may be increased:

• racecadotril, a medicine used to treat diarrhea;
• medicines used to prevent the rejection of transplanted organs and to treat cancer (e.g., temsirolimus, sirolimus, everolimus);
• vildagliptin, a medicine used to treat diabetes.

If any of the above situations apply to the patient or in case of any doubts, the patient should consult their doctor or pharmacist before taking Inhibace.
The patient should inform their doctor if they are pregnant or planning to become pregnant. Inhibace should not be taken in early pregnancy and should not be taken after the third month of pregnancy, as it may seriously harm the baby (see "Pregnancy" and "Breast-feeding").

Children and adolescents

Inhibace should not be used in children.

Inhibace and other medicines

The patient should tell their doctor or pharmacist about all medicines they have taken recently. This includes medicines obtained without a prescription and herbal medicines. This is because Inhibace may affect the action of other medicines. Some medicines may also affect the action of Inhibace.
The doctor may need to change the dose and/or take other precautions: If the patient is taking an angiotensin II receptor antagonist (ARB) or aliskiren (see also the information in "When not to take Inhibace" and "Warnings and precautions").
In particular, the patient should inform their doctor or pharmacist if they are currently taking, have recently taken, or might take any of the following medicines:

• diuretics - see "High blood pressure (hypertension)" in section 3 "How to take Inhibace";
• any medicines used to treat high blood pressure;
• non-steroidal anti-inflammatory drugs (NSAIDs). These include acetylsalicylic acid, indomethacin, and ibuprofen;
• insulin or other anti-diabetic medicines;
• lithium (used to treat depression);
• corticosteroids (such as hydrocortisone, prednisolone, and dexamethasone) or other medicines that suppress the immune system;
• potassium supplements (including salt substitutes), potassium-sparing diuretics, and other medicines that increase potassium levels in the blood (e.g., trimethoprim and co-trimoxazole, used to treat bacterial infections; cyclosporin, an immunosuppressive medicine used to prevent the rejection of transplanted organs, and heparin, a medicine used to thin the blood to prevent clots);
• aldosterone antagonists;
• sympathomimetics;
• anesthetics, narcotic analgesics;
• tricyclic antidepressants, antipsychotics;
• gold compounds (used to treat rheumatoid arthritis).

Inhibace with food and drink

The patient should inform their doctor or pharmacist if they are taking dietary supplements containing potassium.

Pregnancy

Before taking Inhibace, the patient should consult their doctor if they are pregnant or planning to become pregnant. The patient should inform their doctor if they are pregnant or planning to become pregnant.
The doctor will usually advise the patient to stop taking Inhibace before planned pregnancy or as soon as pregnancy is confirmed and advise the patient to take a different medicine instead of Inhibace. Inhibace should not be taken in early pregnancy and should not be taken after the third month of pregnancy, as it may seriously harm the baby.

Breast-feeding

Before taking Inhibace, the patient should consult their doctor if they are breast-feeding or planning to breast-feed. The patient should inform their doctor if they are breast-feeding or planning to breast-feed.
Inhibace should not be taken during breast-feeding, especially during the breast-feeding of newborns or premature babies. The doctor may advise the patient to take a different medicine.

Driving and using machines

While taking Inhibace, the patient may experience dizziness. This is more likely to occur at the start of treatment. If the patient experiences dizziness, they should not drive, use tools, or operate machinery.

Inhibace contains lactose monohydrate

Inhibace contains lactose monohydrate, a type of sugar. If the doctor has told the patient that they have an intolerance to some sugars, they should consult their doctor before taking Inhibace.

Inhibace contains sodium

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

3. How to take Inhibace

Inhibace should always be taken as directed by the doctor. In case of doubts, the patient should consult their doctor or pharmacist again.
Inhibace is available in the following strengths: 1 mg, 2.5 mg, 5 mg.

High blood pressure (hypertension)

• The usual initial dose for adults is 1 mg per day.
• The doctor will increase the dose until blood pressure is normalized - the usual maintenance dose is between 2.5 mg and 5 mg per day.
• The doctor may prescribe a lower dose for patients with kidney problems or in elderly patients.
• If the patient is taking diuretics, the doctor may advise them to stop taking them about 3 days before starting Inhibace. The usual initial dose of Inhibace is then 0.5 mg per day. The doctor will then increase the dose until blood pressure is normalized.

Chronic heart failure

• The usual initial dose is 0.5 mg per day.
• The doctor will then increase the dose - the usual maintenance dose is between 1 mg and 2.5 mg per day.
• The doctor may prescribe a lower dose for patients with kidney problems or in elderly patients.
• For patients with liver cirrhosis without ascites, the doctor will not prescribe a dose greater than 0.5 mg per day and will closely monitor blood pressure.

How to take the medicine

• The tablet should be swallowed with water.
• The time of taking the tablet does not matter. However, the patient should take the tablet at the same time every day.
• Inhibace can be taken before or after a meal.
• The tablet can be divided into equal doses.

Taking a higher dose of Inhibace than recommended

If the patient takes more Inhibace than they should or if someone else takes their medicine, they should contact their doctor or go to the nearest hospital immediately. They should take the packaging with them. The following symptoms may occur: dizziness or a feeling of "emptiness" in the head, shallow breathing, cold and sweaty skin, inability to move or speak, and slow heart rate.

Missing a dose of Inhibace

• If the patient misses a dose, they should skip the missed dose. Then they should take the next dose at the usual time.
• The patient should not take a double dose (two doses at once) to make up for the missed dose.

In case of doubts about taking the medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

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

Some side effects may be serious and may require immediate medical attention:

If the patient experiences a severe reaction called angioedema or an allergic reaction, they should stop taking Inhibace and go to their doctor immediately. Symptoms include:

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

If the patient experiences the following blood disorders, they should contact their doctor immediately:

• 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 (neutropenia, agranulocytosis). Symptoms include increased number of infections, such as in the mouth, gums, throat, and lungs.
• low platelet count (thrombocytopenia). Symptoms include easy bruising and bleeding from the nose.

Other possible side effects:

Common(occurring in less than 1 in 10 people)

• dizziness
• cough
• nausea
• fatigue
• headache

Uncommon(occurring in less than 1 in 100 people)

• low blood pressure. This may cause weakness, dizziness, 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 or blocked nose and sneezing (rhinitis)
• dryness or swelling of the mouth
• loss of appetite
• change in taste
• diarrhea and vomiting
• rash (which may be severe)
• muscle cramps or muscle or joint pain
• impotence
• increased sweating
• sudden flushing (especially of the face)
• sleep disturbances

Rare(occurring in less than 1 in 1,000 people)

• decreased red and white blood cell or platelet count, found in blood tests (anemia, neutropenia, agranulocytosis, and thrombocytopenia)
• severe allergic reaction (anaphylactic reaction)
• brain hypoperfusion, transient ischemic attack, ischemic stroke (may occur if blood pressure is too low)
• myocardial infarction (may occur if blood pressure is too low)
• arrhythmias
• interstitial lung disease
• systemic lupus erythematosus-like reactions
• tingling or numbness of the 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 inflammation or liver damage
• severe skin reactions, including blisters 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

Reporting side effects

If the patient experiences any side effects, including those not listed in the leaflet, they should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Medicinal Product Monitoring of the 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
Website: https://smz.ezdrowie.gov.pl
By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Inhibace

The medicine should be stored out of sight and reach of children.
There are no special storage instructions.
Inhibace should not be taken after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines they no longer use. This will help protect the environment.

6. Contents of the packaging and other information

What Inhibace contains

• The active substance is cilazapril.
• Each coated tablet contains 5 mg of cilazapril in the form of cilazapril monohydrate (5.22 mg).
• The other ingredients are: lactose monohydrate, cornstarch, hypromellose 3 cP, talc, sodium stearyl fumarate. Coating: hypromellose 6 cP, titanium dioxide (E 171), iron oxide red (E 172), talc. (See section 2: "Inhibace contains lactose monohydrate.")

What Inhibace looks like and contents of the pack

Red-brown, oval, biconvex, coated tablets with a score line on one side and the imprint "CIL 5" on the other side.
The packaging contains 28 coated tablets.
Al/Al blisters in a cardboard box.
For more detailed information, the patient should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in the Czech Republic, the country of export:

CHEPLAPHARM Arzneimittel GmbH
Ziegelhof 24
17489 Greifswald
Germany

Manufacturer:

CHEPLAPHARM Arzneimittel GmbH
Ziegelhof 23-24
17489 Greifswald
Germany

Parallel importer:

Medezin Sp. z o.o.
Zbąszyńska Street 3
91-342 Łódź

Repackaged by:

Medezin Sp. z o.o.
Zbąszyńska Street 3
91-342 Łódź
Marketing authorization number in the Czech Republic, the country of export: 58/080/03-C
Parallel import authorization number: 126/20

Translation of the days of the week on the packaging:

MON - PO – Monday
TUE - ÚT – Tuesday
WEN - ST – Wednesday
THU - ČT – Thursday
FRI - PÁ – Friday
SAT - SO – Saturday
SUN - NE – Sunday

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Austria, Belgium, Czech Republic, Hungary, Poland: Inhibace
Germany: Dynorm
Greece: Vascace
Italy: Inibace

Date of revision of the leaflet: 24.03.2025

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