Inhibace

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Warning! Keep this leaflet, information on the immediate packaging in a foreign language!
Inhibace
5 mg, coated tablets
Cilazaprilum
Please read the entire leaflet carefully before using this medicine, as it contains
important information for the patient.

• Keep this leaflet for future reference.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual and should not be passed on to others, even if their symptoms appear identical, as it may harm them.
• If you experience any adverse reactions, including those not listed in this leaflet, inform your doctor or pharmacist immediately. See section 4.

Table of contents of the leaflet:

1. What Inhibace is and what it is 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 pack and other information

1. What Inhibace is and what it is 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 known as ACE inhibitors (angiotensin-converting enzyme inhibitors). This medicine works by relaxing and widening blood vessels. This helps lower blood pressure. It also makes it easier for the heart to pump blood in patients with chronic heart failure.
Your doctor may prescribe other medicines to be used together with Inhibace.

2. Important information before using Inhibace

When not to use 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 has an allergy (hypersensitivity) to other ACE inhibitors. These include captopril, enalapril, lisinopril, and ramipril;
• if the patient has previously experienced a serious 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. Patients taking certain oral antidiabetic medicines or immunosuppressants have an increased risk of developing angioedema;
• after the third month of pregnancy (Inhibace should also be avoided during early pregnancy – see section “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 using 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) increases.

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

Warnings and precautions

Talk to your doctor or pharmacist before taking Inhibace if:

• the patient has heart disease. Inhibace 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 is taking any of the following medicines used to treat high blood pressure:
• an angiotensin II receptor antagonist (also known as sartans – for example, valsartan, telmisartan, irbesartan), especially if the patient has kidney problems related to diabetes;
• aliskiren;
  Your 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 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 impaired blood flow to the kidneys, known as renal artery stenosis;
• the patient is undergoing dialysis;
• the patient has recently had vomiting or diarrhoea;
• the patient is on a low-salt (sodium) diet;
• the patient is undergoing desensitisation treatment for bee or wasp venom;
• the patient is scheduled for surgery (including dental surgery). Some anaesthetics may lower blood pressure, causing it to become too low;
• the patient has fluid in the abdominal cavity (ascites);
• the patient has diabetes or is taking antidiabetic medicines;
• the patient has vascular collagenosis;
• the patient is undergoing low-density lipoprotein (LDL) apheresis using dextran sulfate.

The risk of angioedema may increase if the patient is taking any of the following medicines:

• racecadotril, a medicine used to treat diarrhoea;
• medicines used to prevent organ transplant rejection or 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 if you have any doubts, consult your doctor or pharmacist before taking Inhibace.
Inform your doctor if you suspect (or are planning) pregnancy. Use of Inhibace 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 (see section “Pregnancy” and “Breast-feeding”).

Children and adolescents

Use of Inhibace is not recommended in children.

Inhibace and other medicines

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

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 Inhibace” and “Warnings and precautions”).

In particular, inform your doctor or pharmacist if the patient is currently taking, has recently taken, or might have taken any of the following medicines:

• diuretics – see the section “High blood pressure (hypertension)” in section 3 “How to take Inhibace”;
• any medicines used to treat high blood pressure;
• medicines known as non-steroidal anti-inflammatory drugs (NSAIDs), including acetylsalicylic acid, indomethacin, and ibuprofen;
• insulin or other medicines used to treat diabetes;
• lithium (used to treat depression);
• corticosteroids (such as hydrocortisone, prednisolone, and dexamethasone) or other immunosuppressive medicines;
• potassium supplements (including salt substitutes), potassium-sparing diuretics, and other medicines that increase blood potassium levels (e.g. trimethoprim and co-trimoxazole, 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;
• anaesthetics, narcotic medicines;
• tricyclic antidepressants, antipsychotic medicines;
• gold compounds (used to treat rheumatoid arthritis).

Inhibace with food and drink

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

Pregnancy

Consult your doctor before taking this medicine if you suspect you are pregnant or are planning a pregnancy. Inform your doctor if you suspect (or are planning) pregnancy. Your doctor will usually advise stopping Inhibace before a planned pregnancy or immediately after pregnancy is confirmed and will recommend an alternative medicine. Use of Inhibace 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.

Breast-feeding

Consult your doctor before taking this medicine if you are breast-feeding or planning to breast-feed. Inform your doctor if you are breast-feeding or intend to breast-feed. Use of Inhibace is not recommended during breast-feeding, especially when breast-feeding a newborn or premature infant. Your doctor may recommend using another medicine.

Driving and using machines

Dizziness may occur while taking Inhibace. This is more likely at the beginning of treatment. If the patient experiences dizziness, they should not drive, operate tools, or use machinery.

Inhibace contains lactose monohydrate

Inhibace contains lactose monohydrate, which is a type of sugar. If your doctor has informed you that you have an intolerance to certain sugars, consult your doctor before taking this medicine.

Inhibace contains sodium

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

3. How to take Inhibace

Inhibace must always be taken as prescribed by your doctor. If in doubt,
consult your doctor or pharmacist again.
Inhibace is available in the following doses: 1 mg, 2.5 mg, 5 mg.
High blood pressure (hypertension)

• The usual initial dose for adults is 1 mg once daily.
• Your doctor will gradually increase the dose until blood pressure is normalized – the usual maintenance dose is generally between 2.5 mg and 5 mg once daily.
• Your doctor may prescribe a lower dose for patients with kidney disorders or elderly patients.
• If you are taking diuretics, your doctor may advise you to stop taking them approximately 3 days before starting Inhibace. In such cases, the usual initial dose of Inhibace is 0.5 mg once daily. Your doctor will then gradually increase the dose until blood pressure is normalized.

Chronic heart failure

• The usual initial dose is 0.5 mg once daily.
• Your doctor will then increase the dose – the usual maintenance dose is generally between 1 mg and 2.5 mg once daily.
• Your doctor may prescribe a lower dose for patients with kidney disorders or elderly patients.
• For patients with liver cirrhosis without ascites, your doctor will not prescribe a dose higher than 0.5 mg once daily and will carefully monitor blood pressure.

How to take the medicine

• Swallow the tablet with water.
• The time of day for taking Inhibace tablets is not important. However, you should take the tablet at the same time every day.
• Inhibace may be taken before or after meals.
• The tablet may be divided into equal doses.

Taking more Inhibace than prescribed
If you take more Inhibace 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 feeling of "emptiness" in the head, shallow breathing, cold and clammy skin, inability to move or speak, and slow heartbeat.
If you miss a dose of Inhibace

• If you miss a dose, skip the missed dose. Then take the next dose at your regular time.
• Do not take a double dose (two doses at once) to make up for a missed dose.

If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like any medicine, Inhibace may cause adverse reactions, although not everyone experiences them.
Some side effects may be serious and may require immediate medical attention:
If a severe reaction called angioedema or an allergic reaction occurs, treatment with Inhibace must be discontinued and medical help should be sought immediately. Symptoms include:

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

If any of the following blood disorders occur, contact your doctor immediately:

• 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 (neutropenia, agranulocytosis). Symptoms include increased frequency of infections, for example in the mouth, gums, throat, and lungs.
• low number of platelets (thrombocytopenia). Symptoms include easy bruising and nosebleeds.

Other possible adverse reactions:
Common (affects less than 1 in 10 people)

• dizziness
• cough
• nausea
• fatigue
• headache

Uncommon (affects 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 chest tightness
• nasal discharge or congestion and sneezing (rhinitis)
• dryness or swelling of the oral mucosa
• loss of appetite
• taste disturbance
• diarrhoea and vomiting
• rash (which may be severe)
• muscle cramps or muscle or joint pain
• impotence
• excessive sweating
• sudden flushing (especially of the face)
• sleep disturbances

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

• decreased number of red blood cells, white blood cells, or platelets, detected in blood tests (anaemia, neutropenia, agranulocytosis, and thrombocytopenia)
• severe allergic reaction (anaphylactic reaction)
• 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 in hands or feet
• wheezing
• sensation of pressure 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 (detected in blood and urine tests)
• liver 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

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
Phone: +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 this medicine.

5. How to store Inhibace

Keep the medicine out of the sight and reach of children.
No special storage conditions apply.
Do not use Inhibace after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures 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).
• Excipients: lactose monohydrate, corn starch, hypromellose 3 cP, talc, sodium stearyl fumarate. Coating: hypromellose 6 cP, titanium dioxide (E 171), red iron oxide (E 172), talc. (See section 2: "Inhibace contains lactose monohydrate.")

What Inhibace looks like and contents of the pack
Reddish-brown, oval, biconvex coated tablets, with a break line on one side and the imprint “CIL 5” on the other.
Pack contains 28 coated tablets.
Al/Al blisters in a cardboard box.
For more detailed information, please contact the marketing authorization holder or the parallel importer.

Marketing Authorization Holder in the Czech Republic, 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.
ul. Zbąszyńska 3
91-342 Łódź
Poland

Repackaged in:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Poland

Marketing Authorization number in the Czech Republic, country of export: 58/080/03-C
Parallel import authorization number: 126/20

Translation of weekday symbols printed next to each tablet in the immediate 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 for sale in the European Economic Area countries under the following names:
Austria, Belgium, Czech Republic, Hungary, Poland: Inhibace
Germany: Dynorm
Greece: Vascace
Italy: Inibace