Inhibace

PATIENT INFORMATION LEAFLET

LEAFLET INCLUDED IN THE PACKAGING: PATIENT INFORMATION

Inhibace, 1 mg, coated tablets

Inhibace, 2.5 mg, coated tablets

Inhibace, 5 mg, coated tablets

Cylazapril

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

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you, do not pass it on 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 pack and other information

1. What is Inhibace and what is it used for

Inhibace contains the active substance cylazapril.
Inhibace is used to treat:

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

Cylazapril 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 cylazapril 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. If the patient has hereditary angioedema or angioedema of unknown cause. Symptoms include swelling of the face, lips, mouth, or tongue.

if the patient is taking certain oral antidiabetic medicines or medicines that suppress the immune system, the risk of angioedema may be increased;

• after the third month of pregnancy (Inhibace should also be avoided in early pregnancy - see "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/valsartan, a medicine used to treat a certain type of long-term (chronic) heart failure in adults, as the risk of angioedema (rapid swelling of tissues under the skin, such as the throat) may increase.

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

Warnings and precautions

Before taking Inhibace, the patient should consult a 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 cerebral blood flow disorders in the past;
• the patient is taking any of the following medicines for high blood pressure:
• angiotensin II receptor antagonist (also known as sartans - e.g., valsartan, telmisartan, irbesartan), especially if the patient has diabetic kidney disease;
• 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 the heading "When not to take Inhibace";
• the patient is taking immunosuppressive medicines;
• the patient has severe liver disease or jaundice;
• the patient has kidney disease or renal artery stenosis;
• the patient is undergoing dialysis;
• the patient has recently experienced vomiting or diarrhea;
• the patient is on a low-sodium diet;
• the patient is scheduled for desensitization to bee or wasp venom;
• the patient is scheduled for surgery (including dental surgery). Some anesthetics 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 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 increase:

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

If any of the above situations apply to the patient or in case of any doubts, before taking Inhibace, the patient should consult a doctor or pharmacist.
The patient should inform their doctor about suspected or planned pregnancy. Inhibace should not be taken during pregnancy, especially during the first trimester, and should not be taken after the third month of pregnancy, as it may seriously harm the fetus (see "Pregnancy" and "Breastfeeding").

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 the sections "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 the section "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 antidiabetic medicines;
• 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 potassium levels in the blood (e.g., trimetoprim and co-trimoxazole, used to treat bacterial infections; cyclosporine, an immunosuppressive medicine used to prevent transplant rejection, and heparin, a medicine used to thin the blood to prevent clots);
• aldosterone antagonists;
• sympathomimetics;
• anesthetics, narcotics;
• tricyclic antidepressants, antipsychotics;
• gold compounds (used to treat rheumatoid arthritis).

Inhibace with food and drink

The patient should inform their doctor or pharmacist about taking dietary supplements containing potassium.

Pregnancy

Before taking the medicine, the patient should consult a doctor if they are pregnant or plan to become pregnant. The patient should inform their doctor about suspected or planned pregnancy. 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 during pregnancy, especially during the first trimester, and should not be taken after the third month of pregnancy, as it may seriously harm the fetus.

Breastfeeding

Before taking the medicine, the patient should consult a doctor if they are breastfeeding or plan to breastfeed. The patient should inform their doctor about breastfeeding or planned breastfeeding. Inhibace should not be taken during breastfeeding, especially during the breastfeeding of a newborn or premature baby. The doctor may advise the patient to take a different medicine.

Driving and using machines

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

Inhibace contains lactose

Inhibace contains lactose, 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 the medicine.

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 exactly as advised by the doctor. In case of doubts, the patient should consult their doctor or pharmacist again.

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 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 elderly patients.
• For patients with liver cirrhosis without ascites, the doctor will not prescribe a dose higher than 0.5 mg per day and will closely monitor blood pressure.

Taking 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

In case of taking a higher dose of Inhibace than recommended or taking the medicine by another person, the patient should contact their doctor or go to the nearest hospital as soon as possible. The patient should take the packaging of the medicine with them. The following symptoms may occur: dizziness or a feeling of "emptiness" in the head, shallow breathing, cold and moist skin, inability to move or speak, and slow heart rate.

Missing a dose of Inhibace

• If a dose is missed, the patient 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 can be serious and may require immediate medical attention:

In case of a severe reaction called angioedema or an allergic reaction, the patient should stop taking Inhibace and go to their doctor as soon as possible. Symptoms include:

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

In case of the following blood disorders, the patient 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, e.g., 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 can cause weakness, dizziness, blurred vision, and fainting. Excessive lowering of blood pressure in some patients may increase the risk of heart attack or stroke
• fast heart rate
• weakness
• chest pain
• breathing difficulties, including shortness of breath and tightness in the chest
• runny or stuffy nose and sneezing (rhinitis)
• dryness or swelling of the mouth
• loss of appetite
• change in taste
• diarrhea and vomiting
• rash (which can be severe)
• muscle cramps or muscle pain, or joint pain
• impotence
• increased sweating
• sudden flushing (especially of the face)
• sleep disturbances

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

• low red and white blood cell or platelet count, found in blood tests (anemia, neutropenia, agranulocytosis, and thrombocytopenia)
• severe allergic reaction (anaphylactic reaction)
• brain underperfusion, transient ischemic attack, ischemic stroke (may occur if blood pressure is too low)
• heart attack (may occur if blood pressure is too low)
• heart rhythm disorders
• 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 Drug Safety Monitoring 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
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, more information can be gathered on the safety of the medicine.

5. How to store Inhibace

Keep out of 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 precautions.
Do not use Inhibace after the expiry date stated on the packaging and blister after EXP.
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 need. This will help protect the environment.

6. Contents of the pack and other information

What Inhibace contains

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

Inhibace 1 mg:lactose monohydrate, 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:lactose monohydrate, 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:lactose monohydrate, 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 lactose monohydrate)

What Inhibace looks like and contents of the pack

Coated tablet:
Light yellow, oval, biconvex coated tablets with a dividing line on one side and the imprint "CIL 1" on the other side.
Dark red, oval, biconvex coated tablets with a dividing line on one side and the imprint "CIL 2.5" on the other side.
Brown-red, oval, biconvex coated tablets with a dividing line on one side and the imprint "CIL 5" on the other 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 Member States of the European Economic Area under the following names:

Countries:

Austria, Belgium, Czech Republic, Hungary, Poland: Inhibace
Germany: Dynorm
Greece: Vascace
Italy: Inibace
Date of last revision of the leaflet:11/2020