Inhibace Plus

PATIENT INFORMATION LEAFLET

Information leaflet included in the packaging: patient information

Inhibace Plus, 5 mg+12.5 mg, film-coated tablets

Cylazapril + Hydrochlorothiazide

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. The medicine may harm them, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

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

1. What is Inhibace Plus and what is it used for

Inhibace Plus contains a combination of two medicines, cylazapril and hydrochlorothiazide.
Inhibace Plus is used to treat high blood pressure. The two active substances work together to lower blood pressure. They are used together when treatment with one of these substances is not sufficient.
Cylazapril belongs to a group of medicines called ACE inhibitors (angiotensin-converting enzyme inhibitors). Its action is to relax and dilate blood vessels. This helps to lower blood pressure and make it easier for the heart to pump blood to all parts of the body.
Hydrochlorothiazide belongs to a group of medicines called thiazide diuretics. Its action is to increase the amount of urine excreted. This helps to lower blood pressure.

2. Important information before taking Inhibace Plus

When not to take Inhibace Plus:

• if the patient is allergic (hypersensitive) to cylazapril, hydrochlorothiazide or any of the other ingredients of this medicine (listed in section 6).
• if the patient is allergic (hypersensitive) to medicines similar to Inhibace Plus, such as: other ACE inhibitors, other thiazide diuretics or sulfonamides.
• if the patient has experienced a severe side effect called angioedema after taking other ACE inhibitors, or has hereditary angioedema or angioedema of unknown cause. Symptoms include swelling of the face, lips, mouth or tongue.

or angioedema of unknown cause. Do not take Inhibace Plus if any of the above situations apply to you. In case of doubt, consult a doctor or pharmacist before taking Inhibace Plus.
Patients taking certain oral anti-diabetic medicines or medicines that suppress the immune system may have an increased risk of angioedema.

• if the patient has severe kidney disease (creatinine clearance less than 30 ml/min) or anuria (no urine production).
• after the third month of pregnancy (it is also recommended to avoid taking Inhibace Plus in early pregnancy - see sections "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/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 in the throat) may increase.

If any of the above situations apply to you, do not take Inhibace Plus. In case of doubt, consult a doctor or pharmacist before taking Inhibace Plus.

Warnings and precautions

Before starting treatment with Inhibace Plus, consult a doctor, pharmacist or nurse if:

• the patient has heart disease. Inhibace Plus 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 blood electrolyte levels (e.g. potassium) at regular intervals. See also the information under the heading "When not to take Inhibace Plus";
• the patient is taking immunosuppressive medicines.
• if the patient has had breathing or lung problems (including pneumonia or fluid accumulation in the lungs) after taking hydrochlorothiazide in the past. If the patient experiences severe shortness of breath or difficulty breathing after taking Inhibace Plus, they should seek medical attention immediately.
• if the patient has had skin cancer or has had an unexpected skin change during treatment. Treatment with hydrochlorothiazide, especially in high doses and for a long time, may increase the risk of certain types of skin cancer and lip cancer (non-melanoma skin cancer). During treatment with Inhibace Plus, the skin should be protected from sunlight and UV radiation.
• if the patient has severe liver disease or jaundice.
• if the patient has kidney disease or renal artery stenosis.
• if the patient is undergoing dialysis.
• if the patient has recently had vomiting or diarrhea.
• if the patient is on a low-salt (sodium) diet.
• if the patient is scheduled for bee or wasp venom desensitization.
• if the patient is scheduled for surgery (including dental surgery). Some anesthetics may lower blood pressure, which may become too low.
• if the patient has fluid accumulation in the abdominal cavity (ascites).
• if the patient has diabetes or is taking anti-diabetic medicines.
• if the patient has collagen vascular disease.
• if the patient is undergoing low-density lipoprotein (LDL) apheresis using dextran sulfate.
• if the patient has gout.
• if the patient has porphyria.
• if the patient experiences vision loss or eye pain. These may be symptoms of fluid accumulation in the vascular layer surrounding the eye (excessive fluid accumulation between the choroid and sclera) or increased pressure inside the eye - these may occur within a few hours to weeks after taking Inhibace Plus. This can lead to permanent vision loss if left untreated. If the patient has previously been allergic to penicillin or sulfonamide, they may be more prone to developing this disease (see also the information in the section "When not to take Inhibace Plus")

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. sirolimus, everolimus, temsirolimus);
• wildagliptin, a medicine used to treat diabetes.

If any of the above situations apply to the patient or in case of doubt, consult a doctor or pharmacist before taking Inhibace Plus.
Inform the doctor about suspected or planned pregnancy. It is not recommended to take Inhibace Plus in early pregnancy and it should not be taken after the third month of pregnancy, as it may seriously harm the baby (see sections "Pregnancy" and "Breast-feeding").

Children and adolescents

Inhibace Plus should not be used in children and adolescents under 18 years of age.

Inhibace Plus and other medicines

Tell the doctor or pharmacist about all medicines being taken or recently taken, as well as any medicines planned to be taken. This includes medicines available without a prescription and herbal medicines. This is because Inhibace Plus may affect the action of other medicines, and some medicines may affect the action of Inhibace Plus.
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 under the headings "When not to take Inhibace Plus" and "Warnings and precautions").
In particular, inform the doctor or pharmacist if the patient is currently taking, has recently taken or may take any of the following medicines:

• all medicines used to treat high blood pressure;
• non-steroidal anti-inflammatory medicines (NSAIDs), including 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 immunosuppressive medicines;
• 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 transplant rejection, and heparin, a medicine used to thin the blood to prevent clots);

Warnings and precautions

Inhibace Plus with food and drink

Inhibace Plus can be taken with or without food.
Inform the doctor or pharmacist about taking potassium supplements.

Pregnancy

Before taking the medicine, consult a doctor if the patient is pregnant or plans to become pregnant. The doctor will usually advise stopping Inhibace Plus before planned pregnancy or as soon as possible after confirmation of pregnancy, and will recommend taking another medicine. It is not recommended to take Inhibace Plus in early pregnancy and it should not be taken after the third month of pregnancy, as it may seriously harm the baby.

Breast-feeding

Before taking the medicine, consult a doctor if the patient is breast-feeding or plans to breast-feed.
Inhibace Plus should not be taken during breast-feeding, especially in the case of a newborn or premature baby. The doctor may recommend taking another medicine.

Driving and using machines

While taking Inhibace Plus, 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 machinery.

Inhibace Plus contains lactose

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

Inhibace Plus 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 Plus

Take this medicine always as directed by the doctor. In case of doubt, consult a doctor or pharmacist.
The recommended dose is one tablet per day.

Taking the medicine

• Swallow the tablet with water.
• The time of taking the tablet does not matter. However, the tablet should be taken at the same time every day.
• Inhibace Plus can be taken before or after a meal.
• The tablet can be divided into equal doses. Do not crush or chew the tablets.

Taking a higher dose of Inhibace Plus than recommended

In case of taking a higher dose of Inhibace Plus than recommended or taking the medicine by another person, consult a doctor or go to the nearest hospital immediately. Take the medicine packaging with you. The following symptoms may occur: dizziness, feeling of "emptiness" in the head, shallow breathing, cold and moist skin, inability to move or speak, and slow or irregular heart rate.

Missing a dose of Inhibace Plus

• If a dose of the medicine is missed, skip the missed dose. Then take the next dose at the usual time.
• Do not take a double dose (two doses at the same time) to make up for the missed dose.

In case of any further doubts about taking this medicine, consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, Inhibace Plus 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, stop taking Inhibace Plus and go to a doctor immediately. Symptoms include:

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

In case of the following blood disorders, consult a doctor immediately:

• Low red blood cell count (anemia). Symptoms include feeling tired, pale skin, fast or irregular heart rate (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

Frequent(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 or feeling of "emptiness" in the head, blurred vision and fainting. Excessive lowering of blood pressure in some patients may increase the risk of heart attack or stroke
• rapid 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 may be severe)
• muscle cramps or muscle pain, or joint pain
• impotence
• increased sweating
• sudden flushing (especially of the face)
• sleep disturbances
• blood test results indicating low red blood cell count, white blood cell count or platelet count (anemia, neutropenia, agranulocytosis and thrombocytopenia)
• blood test results indicating abnormal electrolyte levels (sodium, potassium, chloride, magnesium, calcium, bicarbonate) or increased glucose, uric acid, cholesterol and triglyceride levels
• a type of severe allergic reaction (anaphylaxis)
• cerebral hypoperfusion, transient ischemic attack, ischemic stroke (may occur when blood pressure is too low)
• myocardial infarction (may occur when blood pressure is too low)
• arrhythmias
• interstitial lung disease
• a condition resembling lupus erythematosus
• tingling or numbness of the hands or feet
• wheezing
• feeling of fullness or pulsating pain behind the nose, cheeks and eyes (sinusitis)
• irritation of the tongue
• 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
• depression
• confusion
• dry eyes
• yellow vision

Rare(occurring in less than 1 in 10,000 people)

• acute respiratory failure (symptoms include severe shortness of breath, fever, weakness and confusion).

Frequency not known(frequency cannot be estimated from the available data)

• skin cancers and lip cancer (non-melanoma skin cancer)
• vision loss or eye pain due to increased pressure (possible symptoms of fluid accumulation in the vascular layer surrounding the eye - excessive fluid accumulation between the choroid and sclera - or acute angle-closure glaucoma).

Reporting side effects

If any side effects occur, including any side effects not listed in the leaflet, tell the 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
02-222 Warsaw
Phone: +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.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Inhibace Plus

Keep out of sight and reach of children.
Do not store above 25°C.
Do not use after the expiry date stated on the packaging and blister after EXP.
Medicines should not be disposed of via wastewater or household waste. Ask the pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Inhibace Plus contains

• The active substances of the medicine are: cylazapril and hydrochlorothiazide.
• Each film-coated tablet contains 5.22 mg of cylazapril, equivalent to 5 mg of anhydrous cylazapril, and 12.5 mg of hydrochlorothiazide.
• The other ingredients of the medicine are: lactose monohydrate; maize starch; sodium stearyl fumarate; hypromellose 3cP; hypromellose 6cP; talc; titanium dioxide; iron oxide red (see section 2: Inhibace Plus contains lactose monohydrate).

What Inhibace Plus looks like and contents of the pack

Pale red, oval, biconvex film-coated tablets.
The pack of Inhibace Plus contains 28 film-coated tablets in blisters.

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:

Belgium: Co-Inhibace
Greece: Vascace Plus
Austria, Czech Republic, Hungary, Poland, Spain: Inhibace Plus
Germany: Dynorm Plus
Italy: Inibace Plus
Date of last revision of the leaflet:April 2022