Inibace Plus

PATIENT INFORMATION LEAFLET: INFORMATION FOR THE USER

Inibace Plus 5 mg + 12.5 mg film-coated tablets

Cilazapril/hydrochlorothiazide
Please 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 only. Do not give it to others, even if their symptoms are the same as yours, because it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

Inibace Plus contains a combination of two active substances: cilazapril and hydrochlorothiazide.
Inibace Plus is used to treat high blood pressure. The two active substances work together to lower blood pressure.
They are given together when treatment with either substance alone is insufficient.
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 throughout the body.
Hydrochlorothiazide belongs to a group of medicines called thiazide diuretics. It works by increasing the amount of urine produced. This helps lower blood pressure.

2. What you need to know before taking Inibace Plus

Do not take Inibace Plus

• if you are allergic (hypersensitive) to cilazapril, hydrochlorothiazide, or to any of the other ingredients of this medicine (listed in section 6).
• if you are allergic (hypersensitive) to medicines similar to Inibace Plus such as other ACE inhibitors, other thiazide diuretics, or sulfonamides.
• if you have previously experienced a serious adverse reaction called angioedema after taking other ACE inhibitor medicines, or if you have hereditary angioedema or angioedema of unknown cause. Signs of this reaction include swelling of the face, lips, mouth, or tongue. If you are taking oral medicines for diabetes or medicines that suppress the immune system, you are at increased risk of angioedema.
• if you have severe kidney problems (creatinine clearance <30 ml/min) or anuria (inability to urinate).
• if you are more than 3 months pregnant. (It is advisable to avoid using Inibace Plus even in early pregnancy – see 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 containing 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 Plus if any of the above apply to you. If you are in doubt, consult your doctor or pharmacist before taking Inibace Plus.

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before taking Inibace Plus

• if you have heart problems. Inibace Plus is not suitable for people with certain types of heart problems.
• 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 Plus”.
• if you are taking medicines that suppress the immune system.
• if you have previously experienced breathing or lung problems (including inflammation or fluid in the lungs) after taking hydrochlorothiazide. If you develop shortness of breath or severe difficulty breathing after taking Inibace Plus, contact a doctor immediately.
• if you have previously had skin cancer or if you develop an unexpected skin lesion during treatment. Treatment with hydrochlorothiazide, particularly long-term use at high doses, may increase the risk of certain types of skin and lip cancer (non-melanoma skin cancer). Protect your skin from exposure to sunlight and UV rays while taking Inibace Plus.
• if you have severe liver problems or if you develop jaundice.
• if you have kidney problems or problems with blood supply to the kidneys, a condition known as renal artery stenosis.
• if you are on dialysis.
• if you have recently vomited or suffered from diarrhoea.
• if you are on a diet controlling salt (sodium) intake.
• if you are planning to undergo treatment to reduce 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 a vascular collagen disease (a protein that lines the walls of blood vessels).
• if you are undergoing LDL apheresis (removal) with dextran sulfate.
• if you suffer from gout.
• if you have porphyria (accumulation of porphyrins (reddish-purple pigments) in the body). if you experience decreased vision or eye pain. These could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased pressure in the eye and may occur from hours to weeks after taking Inibace Plus. This could lead to permanent vision loss if not treated. If you have previously had an allergy to sulfonamides or penicillins, you may be at higher risk of developing this condition (see also information under “Do not take Inibace Plus”).

If you are taking any of the following medicines, the 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 sirolimus, everolimus, temsirolimus).
• 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 Plus.

If you think you may be pregnant (or could become pregnant), inform your doctor. Inibace Plus 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 child (see sections “Pregnancy” and “Breast-feeding”).

Children and adolescents

Inibace Plus is not recommended for children and adolescents under 18 years of age.

Other medicines and Inibace Plus

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those without a prescription and herbal preparations. This is because Inibace Plus may affect the action of other medicines and other medicines may affect how Inibace Plus 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 information in sections “Do not take Inibace Plus” 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:

• Any medicine used to treat high blood pressure.
• Medicines called non-steroidal anti-inflammatory drugs (NSAIDs): these include aspirin, indomethacin, and ibuprofen.
• Insulin or other medicines to treat diabetes.
• Lithium (used to treat depression).
• Steroid medicines (such as hydrocortisone, prednisolone, and dexamethasone) or other medicines that suppress the immune system.
• Potassium supplements (including salt substitutes), potassium-sparing diuretics, and other medicines that could increase the amount of potassium in your blood (such as trimethoprim and cotrimoxazole used to treat bacterial infections; cyclosporine, an immunosuppressive medicine used to prevent rejection of transplanted organs; and heparin, a medicine used to thin the blood and prevent clot formation).
• Aldosterone antagonists.
• Sympathomimetics.
• Anaesthetics, narcotics.
• Tricyclic antidepressants, antipsychotics.
• Gold compounds (used in the treatment of rheumatoid arthritis).
• Medicines to treat heart failure or heart rhythm disorders.
• Calcium and vitamin D supplements.
• Cholestyramine/colestipol (used to reduce blood fat levels).
• Anticholinergics.
• Cytotoxic drugs (e.g. methotrexate, cyclophosphamide).
• Cyclosporine (used to prevent rejection of transplanted organs).
• Iodine-containing contrast agents (administered to patients before certain types of X-ray examinations).

Inibace Plus with food and drink

Inibace Plus can be taken with or without food.

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

For athletes: using this medicine without therapeutic need constitutes doping and may result in a positive anti-doping test.

Pregnancy

If you are pregnant, think you may be pregnant, or are planning to become pregnant, ask your doctor for advice before taking this medicine.

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

Breast-feeding

If you are breast-feeding or are planning to breast-feed, ask your doctor for advice before taking this medicine. Inibace Plus is not recommended for breastfeeding mothers, and your doctor may choose another treatment for you if you wish to breast-feed, especially if the baby is a newborn or was born prematurely.

Driving and using machines

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

Inibace Plus contains lactose

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

Inibace Plus 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 Plus

Always take this medicine exactly as instructed by your doctor. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is one tablet daily.

How to take this medicine

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

If you take more Inibace Plus than you should
If you take more Inibace Plus than prescribed, or if someone else takes your Inibace Plus tablets, consult a doctor immediately or go to the hospital straight away. Take the medicine pack with you. The following effects may occur: dizziness or feeling mentally clouded, shallow breathing, cold and clammy skin, inability to move or speak, and irregular heartbeat.

If you forget to take Inibace Plus

• 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 a forgotten dose.

If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets 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 Plus and contact your doctor immediately. Signs include:

• Sudden swelling of the face, throat, lips, or mouth. This 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, fast or irregular heartbeat (palpitations), and shortness of breath.
• Low levels 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 lightheadedness, 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 shortness of breath and tightness in the chest
• 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
• Decreased number of red blood cells, white blood cells, or platelets in blood tests (anaemia, neutropenia, agranulocytosis, and thrombocytopenia)
• Abnormal electrolyte levels in blood tests (sodium, potassium, chloride, magnesium, calcium, bicarbonate), or elevated levels of glucose, urate, cholesterol, and triglycerides
• 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 the hands or feet
• Wheezing
• Feeling of blockage or throbbing pain behind the nose, cheeks, and eyes (sinusitis)
• Irritation of the tongue
• Pancreatitis (inflammation of the pancreas). Signs include severe stomach pain spreading to the back
• Changes in liver or kidney function (visible in blood and urine tests)
• Liver problems such as hepatitis (inflammation of the liver) or other liver damage
• Severe skin reactions including blistering or peeling of the skin
• Increased sensitivity to light
• Hair loss (which may be temporary)
• Nail separation or detachment from the nail bed
• Breast enlargement in men
• Depression
• Confusion
• Dry eyes
• Yellow vision (visual disturbance)

Very rare (occur in less than 1 in 10,000 people)
Acute breathing difficulty (signs include severe breathlessness, fever, weakness, and confusion).
Not known (frequency cannot be estimated from the available data)

• Skin and lip cancer (non-melanoma skin cancer)
• Decreased vision or eye pain due to increased pressure (possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or acute angle-closure glaucoma)

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. You can also report side effects directly via
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 Plus

Keep this medicine out of the sight and reach of children.
Do not store above 25°C.
Do not use this medicine after the expiry date stated on the carton 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 Plus contains

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

Description of the appearance of Inibace Plus and package contents
Pale red, oval, biconvex film-coated tablets.
14 tablets
Marketing Authorization Holder and Manufacturer
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 countries under the following names:
Belgium: Co-Inhibace
Greece: Vascace Plus
Austria, Czech Republic, Hungary, Poland, Spain: Inhibace Plus
Germany: Dynorm Plus
Italy: Inibace Plus