Inhibace Plus 5 mg/12.5 mg film-coated tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

InhibacePlus 5mg/12.5mg film-coated tablets

Cilazapril/hydrochlorothiazide

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as 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, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

1. What Inhibace Plus is and what it is used for
2. What you need to know 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 Inhibace Plus is and what it is used for

Inhibace Plus contains a combination of two active substances: cilazapril and hydrochlorothiazide.

Inhibace Plus is used to treat high blood pressure. The two active substances work together to lower blood pressure. They are used in combination when treatment with either one alone is not sufficient.

Cilazapril belongs to a group of medicines called “ACE inhibitors” (Angiotensin Converting Enzyme inhibitors). It works by causing the blood vessels to relax and widen. This helps reduce your blood pressure. It also helps your heart pump blood more easily to all parts of the body.

Hydrochlorothiazide belongs to a group of medicines known as “thiazide diuretics” or “water pills”. It works by increasing the amount of fluid passed from the body as urine. This helps lower your blood pressure.

2. What you need to know before taking Inhibace Plus

Do not take Inhibace Plus

• if you are allergic to cilazapril, hydrochlorothiazide, or any of the other components of this medicine (listed in section 6).
• if you are allergic (hypersensitive) to medicines similar to Inhibace 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, hereditary angioedema, or angioedema of unknown cause. Signs include swelling of the face, lips, mouth, or tongue. The risk of angioedema is higher if you are taking certain oral medicines for diabetes or medicines that suppress the immune system.
• if you have severe kidney problems (creatinine clearance less than 30 ml/min) or anuria (inability to urinate).
• if you are more than 3 months pregnant. (It is also best to avoid Inhibace Plus during the first months of pregnancy – see section “Pregnancy and breastfeeding”).
• if you have diabetes mellitus or renal insufficiency and are being treated with a blood pressure-lowering medicine containing aliskiren.
  • if you have taken or are currently taking sacubitril/valsartan, a medicine used to treat 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 Inhibace Plus if any of these apply to you. If you are unsure, consult your doctor or pharmacist before taking Inhibace Plus.

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before starting to take Inhibace Plus

• if you have heart problems. Inhibace Plus is not suitable for people with certain types of heart conditions.
• if you have had a stroke or problems with blood supply to the brain.
• if you are taking any of the following medicines for high blood pressure (hypertension):
• an “angiotensin II receptor antagonist” (ARA-II) (also known as “sartans”, e.g. valsartan, telmisartan, irbesartan), particularly if you have kidney problems related to diabetes.
• aliskiren

Your doctor may monitor your kidney function, blood pressure, and blood electrolyte levels (e.g. potassium) at regular intervals. See also the information under the heading: “Do not take Inhibace Plus”.

• if you are taking medicines to suppress the immune system.
• if you have previously had breathing or lung problems (such as inflammation or fluid in the lungs) after taking hydrochlorothiazide. If you develop shortness of breath or severe difficulty breathing after taking Inhibace Plus, seek medical attention immediately.
• if you have had skin cancer or 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 non-melanoma skin cancer and lip cancer. Protect your skin from exposure to sunlight and UV rays while taking Inhibace Plus.
• if you have severe liver problems or develop jaundice.
• if you have kidney problems or a condition affecting blood supply to your kidneys called renal artery stenosis.
• if you are undergoing renal dialysis.
• if you have recently been vomiting or have had diarrhoea.
• if you are on a diet to control your 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 have surgery (including dental surgery). This is because certain anaesthetics can lower your blood pressure, potentially to dangerously low levels.
• if you have fluid accumulation in the abdomen (ascites).
• if you have diabetes and are taking medicines for diabetes.
• if you have collagen vascular disease.
• if you are undergoing LDL apheresis with dextran sulfate.
• if you have gout.
• if you have porphyria.
• if you experience a decrease in vision or eye pain, which could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased eye pressure, occurring within hours to weeks after taking Inhibace Plus. This may lead to permanent vision loss if not treated. If you have previously had an allergy to penicillin or sulfonamides, you may be at higher risk (see also information under the heading “Do not take Inhibace Plus”).

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

• Racecadotril, a medicine used to treat diarrhoea.
• Medicines used to prevent organ transplant rejection and for cancer (e.g. sirolimus, everolimus, temsirolimus).
• Vildagliptin, a medicine used to treat diabetes.

If any of these apply to you, or if you are unsure, consult your doctor or pharmacist before taking Inhibace Plus.

Inform your doctor if you are pregnant (or suspect you might be). Inhibace Plus is not recommended during early pregnancy, and must not be used after the third month of pregnancy, as it may cause serious harm to your baby from this stage onwards (see section “Pregnancy and breastfeeding”).

Children and adolescents

The use of Inhibace Plus is not recommended in children and adolescents under 18 years of age.

Taking Inhibace Plus with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including over-the-counter medicines or herbal remedies. This is because Inhibace Plus may affect how other medicines work. Likewise, other medicines may affect how Inhibace Plus works.

Your doctor may need to adjust your dose and/or take other precautions: If you are taking an angiotensin II receptor antagonist (ARA-II) or aliskiren (see also information under the headings: “Do not take Inhibace Plus” and “Warnings and precautions”).

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

• Any medicine used to treat high blood pressure.
• Medicines called “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).
• 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 may increase potassium levels in your blood (e.g. trimethoprim and cotrimoxazole for bacterial infections), cyclosporine, immunosuppressants used to prevent organ transplant rejection, and heparin, a medicine used to thin the blood and prevent clots.
• Aldosterone antagonists.
• Sympathomimetics.
• Anaesthetics, narcotics.
• Tricyclic antidepressants, antipsychotics.
• Gold compounds (used to treat rheumatoid arthritis).
• Medicines used to treat heart failure or heart rhythm disorders.
• Calcium and vitamin D supplements.
• Cholestyramine/colestipol (used to reduce blood fat levels).
• Anticholinergics.
• Cytotoxic medicines (e.g. methotrexate, cyclophosphamide).
• Cyclosporine (used to prevent organ transplant rejection).
• Iodine-containing contrast agents (given to patients before certain types of X-ray examinations).

Taking Inhibace Plus with food and drink

Inhibace Plus can be taken with or without food.

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

Pregnancy and breastfeeding

Pregnancy

If you are pregnant, think you might be pregnant, or plan to become pregnant, consult your doctor before using this medicine. Your doctor will usually advise you to stop taking Inhibace Plus before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine. Inhibace Plus is not recommended during early pregnancy and must not be used from the third month of pregnancy onwards, as it may cause serious harm to your baby from this stage.

Breastfeeding

If you are breastfeeding or planning to breastfeed, consult your doctor before taking this medicine. The use of Inhibace Plus during breastfeeding is not recommended. Your doctor will choose an alternative treatment if you wish to breastfeed, especially if your baby is a newborn or premature.

Driving and using machines

You may feel dizzy while taking Inhibace Plus. This is more likely when you first start treatment. If you feel dizzy, do not drive or operate tools or machinery.

Inhibace Plus contains lactose

Inhibace Plus contains lactose, a type of sugar. If your doctor has told you that you have an intolerance to certain sugars, consult him before taking this medicine.

Inhibace Plus contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per tablet, which is essentially “sodium-free”.

Athletes are advised that this medicine contains a component (hydrochlorothiazide) that may result in a positive doping test.

3. How to take Inhibace Plus

Follow exactly the instructions for use of this medicine given by your doctor. If you are unsure, consult your doctor or pharmacist again.

The recommended dose is one tablet per day.

How to take this medicine

• Swallow each tablet with water.
• You may take Inhibace Plus at any time of day. However, you should take it at approximately the same time each day.
• Inhibace Plus may be taken before or after meals.
• The tablets may be divided into equal doses. Do not crush or chew the tablets.

If you take more Inhibace Plus than you should

If you take more Inhibace Plus than you should, or if someone else takes your Inhibace Plus tablets, consult a doctor or go to a hospital immediately. Take the medicine pack with you. You may also call the Toxicology Information Service, Telephone 91 562.04.20, stating the name of the medicine and the amount taken. The following effects may occur: dizziness or lightheadedness, shallow breathing, cold and clammy skin, inability to move or speak, and slow or irregular heartbeat.

If you forget to take Inhibace Plus

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

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

4. Possible adverse effects

Like all medicines, this medicine can produce adverse effects, although not everyone experiences them.

Some adverse effects may be serious and require immediate medical attention:

If you experience a serious adverse reaction called angioedema or an allergic reaction, stop taking Inhibace Plus and contact your doctor immediately. Signs may include:

• Sudden swelling of the face, throat, lips, or mouth. This may make it difficult to breathe or swallow.

If you experience the following blood-related problems, consult your doctor immediately:

• Low number of red blood cells (anaemia). Signs include tiredness, pale skin, rapid or irregular heartbeat (palpitations), and shortness of breath.
• Low number of all types of white blood cells (neutropenia, agranulocytosis). Signs include an increased number of infections, for example in the mouth, gums, throat, and lungs.
• Low number of platelets in the blood (thrombocytopenia). Signs include easy bruising and nosebleeds.

Other possible adverse effects

Frequent (may affect up to 1 in 10 people)

• Dizziness
• Cough
• Nausea
• Fatigue
• Headache

Uncommon (may affect up to 1 in 100 people)

• Low blood pressure. This may make you feel weak, dizzy, or lightheaded, and may lead to blurred vision and fainting. A significant drop in blood pressure may increase the risk of heart attack or stroke in some patients.
• Increased heart rate
• Weakness
• Chest pain
• Breathing difficulties, including shortness of breath and chest tightness
• Runny or blocked nose and sneezing (rhinitis)
• Dry or swollen mouth
• Loss of appetite
• Change in taste
• Diarrhoea and vomiting
• Skin rash (which may be severe)
• Muscle or joint cramps or pain
• Impotence
• Increased sweating
• Flushing
• Sleep disturbances
• Blood tests show a decrease in the number of red blood cells, white blood cells, or platelets in the blood (anaemia, neutropenia, agranulocytosis, and thrombocytopenia)
• Blood tests show abnormal levels of electrolytes (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 is too low)
• Myocardial infarction (may occur if blood pressure is too low)
• Irregular heartbeat
• Interstitial lung disease
• A disorder resembling systemic lupus erythematosus
• Tingling or numbness in hands or feet
• Wheezing
• Feeling of fullness or sharp pain behind the nose, cheeks, and eyes (sinusitis)
• Tongue pain
• Pancreatitis (inflammation of the pancreas). Signs include severe stomach pain spreading to the back.
• Changes in liver or kidney function (detected in blood and urine tests)
• Liver problems such as hepatitis (liver inflammation) or liver damage
• Severe skin reactions including blistering or peeling of the skin
• Increased sensitivity to light
• Hair loss (which may be temporary)
• Loosening or separation of nails from the nail bed
• Breast enlargement in men
• Depression
• Confusion
• Dry eyes
• Visual distortion of the colour yellow

Very rare (may affect less than 1 in 10,000 people)

• Acute breathing difficulty (signs include severe shortness of breath, fever, weakness, and confusion).

Frequency 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 elevated pressure (possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or acute angle-closure glaucoma)

If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet.

Reporting of adverse effects

If you experience any adverse effects, talk to your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Inhibace Plus

Keep this medicine out of the sight and reach of children.

Store below 25°C.

Do not use this medicine after the expiry date stated on the packaging and blister after EXP.

Medicines should not be disposed of via wastewater drains or in household waste. Dispose of unused medicines and their containers at the SIGRE point****at your pharmacy. If in doubt, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Inhibace Plus

• 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 (excipients) are: lactose monohydrate, maize starch, sodium stearyl fumarate, hypromellose 3 cp, hypromellose 6 cp, talc, titanium dioxide (E 171), and red iron oxide (E 172). (See section 2: Inhibace Plus contains lactose monohydrate.)

Appearance of the product and contents of the pack

Film-coated tablet, oval-shaped, biconvex, pale red in colour, scored on one side and engraved with “CIL+5+12.5” on the other side.

The pack contains 28 film-coated tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

CHEPLAPHARM Arzneimittel GmbH

Ziegelhof 24

17489 Greifswald

Germany

Manufacturer

CHEPLAPHARM Arzneimittel GmbH

Ziegelhof 23-24

17489 Greifswald

Germany

Local Representative

Laboratorios Rubió, S.A.

C/ Industria, 29 - Pol. Ind. Comte de Sert

08755 Castellbisbal (Barcelona)

Spain

This medicinal product is authorized in the European Economic Area member states 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 the most recent review of this leaflet: April 2022

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/