Inibace

PACKAGE LEAFLET: INFORMATION FOR THE USER

Inibace 1 mg film-coated tablets, 5 mg film-coated tablets

Cilazapril
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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not give it to other people, even if their symptoms are the same as yours, because it may be dangerous.
• If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet

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

1. What Inibace is and what it is used for

Inibace contains the active substance cilazapril.
Inibace is used to treat:

• High blood pressure (hypertension)
• Chronic heart failure.

Cilazapril belongs to a group of medicines called "ACE inhibitors" (angiotensin-converting enzyme inhibitors). It works by causing relaxation and widening of the blood vessels. This helps lower blood pressure and also makes it easier for the heart to pump blood around the body in cases of chronic heart failure.
Your doctor may prescribe other medicines alongside Inibace to treat your condition.

2. What you need to know before taking Inibace

Do not take Inibace

• if you are allergic (hypersensitive) to cilazapril or to any of the other ingredients of this medicine (listed in section 6)
• if you are allergic (hypersensitive) to other drugs containing ACE inhibitors, including captopril, enalapril, lisinopril and ramipril
• if you have previously experienced a serious adverse effect called angioedema after taking other ACE inhibitor-containing medicines, or if you have hereditary angioedema or angioedema of unknown cause. Signs of this effect include swelling of the face, lips, mouth or tongue. If you are taking oral medicines for the treatment of diabetes or medicines to suppress the immune system, you are at increased risk of angioedema
• if you are more than three months pregnant (it is preferable to avoid using Inibace even in early pregnancy – see the sections “Pregnancy” and “Breast-feeding”).
• if you have diabetes mellitus or impaired kidney function and are being treated with medicines used to lower high blood pressure that contain aliskiren.
• if you have taken or are currently taking sacubitril/valsartan, a medicine used to treat a type of long-term (chronic) heart failure in adults, as this increases the risk of angioedema (rapid swelling under the skin, for example in the throat).

Do not take Inibace if any of the above apply to you. If you have any doubts, consult your doctor or pharmacist.

Warnings and precautions

Talk to your doctor or pharmacist before taking Inibace:

• if you have heart problems. Inibace is not suitable for people with certain types of heart conditions.
• if you have had a stroke or suffer from problems with blood supply to the brain.
• if you are taking any of the following medicines used to treat high blood pressure:
  • an “angiotensin II receptor blocker” (ARB) (also known as sartans – for example, valsartan, telmisartan, irbesartan), especially if you have kidney problems due to diabetes.
  • aliskiren. Your doctor may monitor your kidney function, blood pressure, and levels of electrolytes (such as potassium) in your blood at regular intervals. See also the information under “Do not take Inibace”
• if you are taking medicines to suppress the immune system.
• if you have severe liver problems or develop jaundice.
• if you have kidney problems or problems with blood supply to the kidneys, a condition called renal artery stenosis.
• if you are on dialysis.
• if you have recently vomited or had diarrhoea.
• if you are on a diet to control salt (sodium) intake.
• if you are planning to undergo treatment to reduce your allergy to bee or wasp stings (desensitisation).
• if you are planning to undergo surgery (including dental surgery). Some anaesthetics can lower blood pressure, which could drop excessively.
• if you have fluid accumulation in the abdomen (ascites).
• if you have diabetes and are taking medicines to treat this condition.
• if you have collagen vascular disease.
• if you are undergoing LDL apheresis with dextran sulfate.

If you are taking any of the following medicines, your risk of angioedema may be increased:

• Racecadotril, a medicine used to treat diarrhoea.
• Medicines used to prevent rejection of transplanted organs and to treat cancer (such as temsirolimus, sirolimus, everolimus).
• Vildagliptin, a medicine used to treat diabetes.

If any of these conditions apply to you, or if you are unsure, discuss them with your doctor or pharmacist before taking Inibace.

You must inform your doctor if you think you are pregnant (or could become pregnant) or if you are planning a pregnancy. Inibace is not recommended during early pregnancy and must not be taken after the first 3 months of pregnancy because it may cause severe harm to the unborn baby (see the sections on “Pregnancy” and “Breast-feeding”).

Children and adolescents

Inibace is not recommended for use in children.

Other medicines and Inibace

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including over-the-counter medicines and herbal preparations. This is because Inibace may affect how some medicines work. Also, some medicines may affect how Inibace works.

If you are taking an angiotensin II receptor antagonist (ARB) or aliskiren, your doctor may need to adjust your dose and/or take other precautions (see also the information in the sections “Do not take Inibace” and “Warnings and precautions”).

In particular, talk to your doctor or pharmacist if you are taking, have recently taken, or might take any of the following medicines:

• Diuretics – see “High blood pressure (hypertension)” in section 3 “How to take Inibace”.
• Any medicine used to treat high blood pressure.
• Medicines known as non-steroidal anti-inflammatory drugs (NSAIDs), which include aspirin, indometacin and ibuprofen.
• Insulin or other medicines for treating diabetes.
• Lithium (used to treat depression).
• Steroid medicines (such as hydrocortisone, prednisolone and dexamethasone) or other medicines that reduce the activity of the immune system.
• Potassium supplements (including salt substitutes), potassium-sparing diuretics, and other medicines that could increase potassium levels in the blood (such as trimethoprim and cotrimoxazole used to treat bacterial infections; ciclosporin, an immunosuppressive medicine used to prevent rejection of transplanted organs; and heparin, a medicine used to thin the blood and prevent clotting).
• Aldosterone antagonists.
• Sympathomimetics.
• Anaesthetics, narcotics.
• Tricyclic antidepressants, antipsychotics.
• Gold compounds (used in the treatment of rheumatoid arthritis).

Inibace with food and drink

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

Pregnancy

If you are pregnant, suspect you may be pregnant, or are planning to become pregnant, consult your doctor before taking this medicine.

Your doctor will usually advise you to stop taking Inibace before becoming pregnant or as soon as you find out you are pregnant, and will recommend another medicine instead of Inibace. Inibace is not recommended during early pregnancy and must not be taken after the first 3 months of pregnancy because it may cause serious harm to the unborn baby after the third month of pregnancy.

Breast-feeding

If you are breast-feeding or are planning to breast-feed, consult your doctor before taking this medicine. Inibace is not recommended if you are breast-feeding; your doctor may choose another treatment if you wish to breast-feed, especially if your baby is newborn or was born prematurely.

Driving and using machines

You may experience dizziness when taking Inibace. This is more likely at the beginning of treatment. If you feel dizzy, do not drive and do not use tools or machinery.

Inibace contains lactose

Inibace contains lactose, which is a type of sugar. If your doctor has diagnosed you with an intolerance to certain sugars, contact him or her before taking this medicine.

Inibace contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially ‘sodium-free’.

3. How to take Inibace

Always take this medicine exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.

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 under control; the usual maintenance dose ranges between 2.5 mg and 5 mg daily.
• If you have kidney problems or are elderly, your doctor may prescribe a lower dose.
• If you are already taking a diuretic, your doctor may instruct you to stop taking it approximately 3 days before starting Inibace therapy. The usual starting dose of Inibace is then 0.5 mg once daily. Your doctor will then increase the dose until your blood pressure is under control.

Chronic heart failure

• The usual starting dose is 0.5 mg once daily.
• Your doctor will then increase the dose; the usual maintenance dose ranges between 1 mg and 2.5 mg daily.
• If you have kidney problems or are elderly, your doctor may prescribe a lower dose.
• If you have hepatic cirrhosis without ascites, your doctor will not prescribe a dose higher than 0.5 mg daily and will monitor your blood pressure carefully.

How to take this medicine

• Swallow each tablet with a glass of water.
• It does not matter at what time of day you take Inibace. However, take it at about the same time each day.
• Inibace may be taken before or after meals.
• The tablet may be divided into equal doses.

If you take more Inibace than you should
If you take more Inibace than you should, or if someone else takes your tablets, consult a doctor immediately or go to the nearest hospital. Take the medicine pack with you. The following symptoms may occur: dizziness or mental confusion, shallow breathing, cold and clammy skin, inability to move or speak, and slowed heartbeat.

If you forget to take Inibace

• If you forget to take a dose, skip the missed dose and take the next dose at the scheduled time.
• Do not take a double dose (two doses at the same time) to make up for the forgotten dose.

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

4. Possible side effects

Like all medicines, Inibace may cause side effects, although not everybody experiences them.
Some side effects can be serious and require immediate medical attention:
If you experience a severe reaction called angioedema or an allergic reaction, stop taking Inibace and contact your doctor immediately. Signs include:

• Sudden swelling of the face, throat, lips or mouth, which may make breathing or swallowing difficult.

If you experience any of the following blood-related problems, seek immediate medical advice:

• Low red blood cell count (anaemia). Signs include tiredness, paleness, rapid or irregular heartbeat (palpitations), and breathlessness.
• Low count of all types of white blood cells (neutropenia, agranulocytosis). Signs include increased frequency of infections, for example in the mouth, gums, throat and lungs.
• Low platelet count in the blood (thrombocytopenia). Signs include easy bruising and nosebleeds.

Other possible side effects:
Common (occur in less than 1 in 10 people)

• Dizziness
• Cough
• Nausea
• Feeling tired
• Headache

Uncommon (occur in less than 1 in 100 people)

• Low blood pressure. This may cause weakness, dizziness or mental fogginess, blurred vision and fainting. Excessively low blood pressure may increase the risk of heart attack or stroke in certain patients
• Fast heartbeat
• Feeling weak
• Chest pain
• Breathing problems, including breathlessness and chest tightness
• Runny or blocked nose and sneezing (rhinitis)
• Dry or swollen mouth
• Loss of appetite
• Altered taste
• Loose stools and vomiting
• Rash (which may be severe)
• Muscle cramps or muscle and joint pain
• Impotence
• Increased sweating
• Hot flushes
• Sleep problems

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

• Decreased number of red blood cells, white blood cells or platelets in blood tests (anaemia, neutropenia, agranulocytosis and thrombocytopenia)
• A type of severe allergic reaction (anaphylaxis)
• Cerebral ischaemia, transient ischaemic attack, ischaemic stroke (may occur if blood pressure becomes too low)
• Myocardial infarction (may occur if blood pressure becomes too low)
• Irregular heartbeat
• Interstitial lung disease
• A condition resembling systemic lupus erythematosus
• Tingling or numbness in hands or feet
• Wheezing
• Feeling of blockage or pulsating pain behind the nose, cheeks and eyes (sinusitis)
• Tongue irritation
• Pancreatitis (inflammation of the pancreas). Signs include severe stomach pain spreading to the back
• Changes in liver or kidney function (detectable in blood and urine tests)
• Liver problems such as hepatitis (liver inflammation) or other liver damage
• Severe skin reactions including blistering or peeling of the skin
• Increased sensitivity to light
• Hair loss (which may be temporary)
• Detachment or separation of a nail from its nail bed
• Breast enlargement in men

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Inibace

Keep this medicine out of the sight and reach of children.
1 mg: Do not store above 25°C
5 mg: This medicine has no special storage requirements
Do not use this medicine after the expiry date stated on the packaging and blister after "Exp".
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Inibace contains

• The active substance is cilazapril.
• Each film-coated tablet contains:
  Inibace 1 mg: 1.044 mg of cilazapril, equivalent to 1 mg of anhydrous cilazapril
  Inibace 5 mg: 5.22 mg of cilazapril, equivalent to 5 mg of anhydrous cilazapril
• The other components are: monohydrate lactose, maize starch, hypromellose 3 cP, talc, sodium stearyl fumarate, hypromellose 6 cP, titanium dioxide (E 171).
  Inibace 1 mg: yellow iron oxide (E 172)
  Inibace 5 mg: red iron oxide (E 172).
  (See section 2: Inibace contains monohydrate lactose)

Description of the appearance of Inibace and contents of the pack
Film-coated tablet:
Light yellow, oval, biconvex, film-coated tablets with a break line on one side and engraved "CIL 1" on the opposite side.
Red-brown, oval, biconvex, film-coated tablets with a break line on one side and engraved "CIL 5" on the opposite side.

Marketing Authorization Holder
CHEPLAPHARM Arzneimittel GmbH
Ziegelhof 24
17489 Greifswald
Germany

Manufacturer
CHEPLAPHARM Arzneimittel GmbH
Ziegelhof 23-24
17489 Greifswald
Germany

This medicinal product is authorized in the European Economic Area member states under the following names:
Austria, Belgium, Czech Republic, Hungary, Poland: Inhibace
Germany: Dynorm
Greece: Vascace
Italy: Inibace