Inhibace

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Inhibace, 1 mg, film-coated tablets
Inhibace, 2.5 mg, film-coated tablets
Inhibace, 5 mg, film-coated tablets
Cilazapril
Please read the entire leaflet carefully before using this medicine, as it contains important information for you.

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

Table of contents:

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 a substance called cilazapril.
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 taken 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 immunosuppressive drugs have an increased risk of developing angioedema;
• during the third trimester of pregnancy (Inhibace should also be avoided in 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 taking sacubitril with valsartan, a medicine used to treat certain types of chronic (long-term) heart failure in adults, because this increases the risk of angioedema (rapid swelling of tissues under the skin, such as in the throat).

If any of the above situations apply, Inhibace must not be taken. If in doubt, consult a doctor or pharmacist before taking Inhibace.

Warnings and precautions

Before taking Inhibace, consult a doctor or pharmacist if:

• the patient has heart disease. Inhibace must not be used by 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. The 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 immunosuppressive medicines;
• 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 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 drop 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 be increased if the patient is taking any of the following medicines:

• racecadotril, a medicine used to treat diarrhoea;
• medicines used to prevent organ transplant rejection and to treat cancer (e.g. temsirolimus, sirolimus, everolimus);
• vildagliptin, a medicine used to treat diabetes.

If any of the above situations apply, or if there are any doubts, consult a doctor or pharmacist before taking Inhibace.

Inform the doctor if pregnancy is suspected (or planned). Use of Inhibace 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 “Breast-feeding”).

Children and adolescents

Inhibace is not recommended for use in children.

Inhibace and other medicines

Tell the doctor or pharmacist about all medicines taken recently, including those obtained without a prescription and herbal medicines. This is because Inhibace may affect the action of other medicines, and some medicines may affect the action of Inhibace.

The 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 sections “When not to use Inhibace” and “Warnings and precautions”).

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

• diuretics – see paragraph “High blood pressure (hypertension)” in section 3 “How to use 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 immunosuppressive medicine 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 the doctor or pharmacist if taking dietary supplements containing potassium.

Pregnancy

Consult a doctor before taking Inhibace if the patient suspects she is pregnant or plans to become pregnant. Inform the doctor if pregnancy is suspected or planned. The 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 a doctor before taking Inhibace if the patient is breast-feeding or planning to breast-feed. Inform the doctor if breast-feeding or intending to breast-feed. Use of Inhibace is not recommended during breast-feeding, especially when breast-feeding a newborn or preterm infant. The doctor may recommend using another medicine.

Driving and operating machinery

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

Inhibace contains lactose

Inhibace contains lactose, which is a type of sugar. If the doctor has diagnosed an intolerance to certain sugars, consult the 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 exactly as directed by your doctor. If in doubt,
you should contact your doctor or pharmacist again.
High blood pressure (hypertension)

• The usual starting dose for adults is 1 mg once daily.
• Your doctor will increase the dose until your 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 problems or elderly patients.
• If you are taking diuretics, your doctor may advise you to stop taking them approximately 3 days before starting Inhibace. The usual starting dose of Inhibace in this case is then 0.5 mg once daily. Your doctor will then gradually increase the dose until your blood pressure is normalized.

Chronic heart failure

• The usual starting 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 problems or elderly patients.
• For patients with liver cirrhosis without ascites, your doctor will not prescribe a dose greater than 0.5 mg once daily and will carefully monitor your blood pressure.

How to take the medicine

• Swallow the tablet with water.
• The time of day when the Inhibace tablet is taken is not important. However, the tablet should be taken at the same time each day.
• Inhibace may be taken before or after food.
• The tablet may be divided into equal doses.

Taking more Inhibace than you should
If you take more Inhibace than prescribed, or if someone else takes the medicine,
contact your doctor immediately or go to the nearest hospital. 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 heartbeat.
If you miss a dose of Inhibace

• If you miss a dose, skip the missed dose. Then take the next dose at your usual 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 all medicines, 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 should be stopped immediately and medical advice should be sought without delay. 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, fast or irregular heartbeat (palpitations), and shortness of breath.
• Low number of all types of white blood cells (neutropenia, agranulocytosis). Symptoms include increased number of infections, for example of the mouth, gums, throat and lungs.
• Low number of platelets (thrombocytopenia). Symptoms include easy bruising and nosebleeds.

Other possible adverse reactions:

Common (occur in less than 1 in 10 people)

• dizziness
• cough
• nausea
• fatigue
• headache

Uncommon (occur 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 chest tightness
• runny or blocked nose and sneezing (rhinitis)
• dryness or swelling of the mucous membrane of the mouth
• loss of appetite
• taste disturbances
• 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 (occur in 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)
• 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
• feeling 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 (shown in blood and urine tests)
• liver disorders, such as hepatitis 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 of adverse reactions

If any adverse effects 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, PL-02 222 Warsaw, tel.: + 48 22 49 21 301, fax: + 48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorisation holder.
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.
1 mg: Do not store above 25°C.
2.5 mg: Do not store above 25°C.
5 mg: No special storage instructions for this medicine.
Do not use Inhibace after the expiry date stated on the packaging and blister after EXP.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the packaging and other information

What Inhibace contains

• The active substance in Inhibace is cilazapril.
• Each coated tablet contains:
  Inhibace 1 mg: 1.044 mg cilazapril, equivalent to 1 mg anhydrous cilazapril
  Inhibace 2.5 mg: 2.61 mg cilazapril, equivalent to 2.5 mg anhydrous cilazapril
  Inhibace 5 mg: 5.22 mg cilazapril, equivalent to 5 mg anhydrous cilazapril
• Other ingredients are:

Inhibace 1 mg: monohydrate lactose, corn starch, hypromellose 3 cP, talc, sodium stearyl fumarate, hypromellose 6 cP, titanium dioxide (E 171), yellow iron oxide (E 172).
Inhibace 2.5 mg: monohydrate lactose, corn starch, hypromellose 3 cP, talc, sodium stearyl fumarate, hypromellose 6 cP, titanium dioxide (E 171), yellow iron oxide (E 172), and red iron oxide (E 172).
Inhibace 5 mg: monohydrate lactose, corn starch, hypromellose 3 cP, talc, sodium stearyl fumarate, hypromellose 6 cP, titanium dioxide (E 171), red iron oxide (E 172).
(See section 2: Inhibace contains monohydrate lactose)

What Inhibace looks like and contents of the pack
Coated tablets:
Light yellow, oval, biconvex coated tablets with a score line on one side and printed “CIL 1” on the other side.
Dark red, oval, biconvex coated tablets with a score line on one side and printed “CIL 2.5” on the other side.
Reddish-brown, oval, biconvex coated tablets with a score line on one side and printed “CIL 5” on the other side.

Marketing Authorisation Holder
CHEPLAPHARM Arzneimittel GmbH
Ziegelhof 24
17489 Greifswald
Germany

Manufacturer
CHEPLAPHARM Arzneimittel GmbH
Ziegelhof 23-24
17489 Greifswald
Germany

This medicinal product is authorised for marketing 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