INHIBACE PLUS 5 mg/12.5 mg FILM-COATED TABLETS

Introduction

Leaflet:information for the user

InhibacePlus5mg/12.5mg film-coated tablets

Cilazapril/hydrochlorothiazide

Read the entire leaflet carefully beforestarting to takethis medication, as 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 medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the leaflet

1. What is Inhibace Plus and what is it used for
2. What you need to know before taking Inhibace Plus
3. How to take Inhibace Plus
4. Possible side effects
5. Storage of Inhibace Plus
6. Package contents and additional information

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

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

Inhibace Plus is used in the treatment of high blood pressure. The two active substances work together to lower blood pressure. They are used together when treatment with one of them is insufficient.

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

Hydrochlorothiazide belongs to a group of medicines called "thiazide diuretics" or "water pills". It works by increasing the amount of water (urine) produced. This reduces 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 ingredients of this medication (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 had a severe side effect called angioedema after taking other ACE inhibitors, hereditary angioedema, or angioedema of unknown cause. The signs include swelling of the face, lips, mouth, or tongue. There is a higher risk of angioedema if you are taking certain oral medications for diabetes or medications to 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 pregnant for more than 3 months. (It is also recommended to avoid Inhibace Plus during the first months of pregnancy - see section "Pregnancy and breastfeeding").
• if you have diabetes mellitus or kidney failure and are being treated with a blood pressure medication that contains aliskiren.
• if you have taken or are taking sacubitril/valsartan, a medication used to treat a type of long-term (chronic) heart failure in adults, as it increases the risk of angioedema (rapid onset swelling under the skin in areas such as the throat).

Do not take Inhibace Plus if you are in any of these situations. If you are unsure, consult your doctor or pharmacist before taking Inhibace Plus.

Warnings and precautions

Consult 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 problems.
• if you have had a stroke or have had problems with blood flow to the brain.
• if you are taking any of the following medications used to treat high blood pressure (hypertension):
• an "angiotensin II receptor antagonist" (ARA) (also known as "sartans", e.g., valsartan, telmisartan, irbesartan), especially 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 medications to suppress the immune system
• if you have had respiratory or lung problems (such as inflammation or fluid in the lungs) after taking hydrochlorothiazide in the past. If you experience shortness of breath or severe difficulty breathing after taking Inhibace Plus, seek medical attention immediately.
• if you have 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 cancer and lip cancer (non-melanoma skin cancer). Protect your skin from sun and UV exposure while taking Inhibace Plus.
• if you have severe liver problems or if you develop jaundice.
• if you have kidney problems or have a problem with blood flow to your kidneys called renal artery stenosis.
• if you are on renal dialysis.
• if you have recently been vomiting or have had diarrhea.
• if you are on a low-sodium diet to control the amount of salt you take.
• if you are planning to undergo desensitization treatment for bee or wasp sting allergy.
• if you are planning to undergo surgery (including dental surgery). This is because some anesthetics can lower your blood pressure, which can become too low.
• if you have fluid accumulation in the abdomen (ascites).
• if you have diabetes and are taking medications to treat 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, they could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or an increase in eye pressure, and can occur within hours to weeks after taking Inhibace Plus. This can lead to permanent vision loss if not treated. If you have previously had an allergy to penicillin or sulfonamides, you may be at high risk of developing it (see also the information under the title "Do not take Inhibace Plus").

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

• Racecadotril, a medication used to treat diarrhea
• Medications used to prevent rejection in organ transplants and for cancer (e.g., sirolimus, everolimus, temsirolimus)
• Vildagliptin, a medication used to treat diabetes.

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

Tell your doctor if you are pregnant (or think you may be pregnant). Inhibace Plus is not recommended during the first trimester of pregnancy, and in no case should it be administered after the third month of pregnancy, as it may cause serious harm to your baby when administered from that time on (see section "Pregnancy and breastfeeding").

Children and adolescents

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

Taking Inhibace Plus with other medications

Tell your doctor or pharmacist that you are taking, have recently taken, or may take any other medication, including those obtained without a prescription or herbal remedies. This is because Inhibace Plus may affect the way other medications work. Similarly, other medications may affect the way 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) or aliskiren (see also the information under the headings: "Do not take Inhibace Plus" and "Warnings and precautions").

Especially, consult your doctor or pharmacist if you are taking, have recently taken, or may take any of the following medications:

• Any medication used to treat high blood pressure.
• Medications called "non-steroidal anti-inflammatory drugs" (NSAIDs), including acetylsalicylic acid, indomethacin, and ibuprofen.
• Insulin or other medications used to treat diabetes.
• Lithium (used to treat depression).
• Corticosteroids (such as hydrocortisone, prednisolone, and dexamethasone) or other medications that suppress the immune system.
• Potassium supplements (including salt substitutes), potassium-sparing diuretics, and other medications that may increase the amount of potassium in your blood (e.g., trimethoprim and cotrimoxazole for bacterial infections), cyclosporine, and immunosuppressive medications to prevent organ transplant rejection, and heparin, a medication used to thin the blood to prevent clots).
• Aldosterone antagonists.
• Sympathomimetics.
• Anesthetics, narcotics.
• Tricyclic antidepressants, antipsychotics.
• Gold compounds (used to treat rheumatoid arthritis).
• Medications to treat heart failure or heart rhythm abnormalities.
• Calcium and vitamin D supplements.
• Colestyramine/colestipol (used to reduce the amount of fat in your blood).
• Anticholinergics.
• Cytotoxic medications (e.g., methotrexate, cyclophosphamide).
• Cyclosporine (used to prevent organ rejection after a transplant).
• Contrast media containing iodine (administered to patients before certain types of X-ray examinations).

Taking Inhibace Plus with food and drinks

Inhibace Plus can be taken with or without food.

Tell your doctor or pharmacist if you are taking dietary supplements that contain potassium.

Pregnancy and breastfeeding

Pregnancy

If you are pregnant, think you may be pregnant, or are planning to become pregnant, consult your doctor before using this medication. Your doctor will generally advise you to stop taking Inhibace Plus before becoming pregnant, or as soon as you know you are pregnant, and will recommend that you take another medication instead of Inhibace Plus. Inhibace Plus is not recommended during the first trimester of pregnancy, and in no case should it be administered after the third month of pregnancy, as it may cause serious harm to your baby when administered from that time on.

Breastfeeding

If you are breastfeeding or plan to start breastfeeding, consult your doctor before taking this medication. Inhibace Plus is not recommended during breastfeeding, and your doctor will choose another treatment for you if you want to breastfeed, especially if your baby is newborn or premature.

Driving and using machines

You may feel dizzy while taking Inhibace Plus. This is more likely to occur when you start treatment for the first time. If you feel dizzy, do not drive or operate tools or machines.

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 with them before taking this medication.

Inhibace Plus contains sodium

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

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

3. How to take Inhibace Plus

Follow the instructions for administration of this medication exactly as indicated 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 medication

• Swallow each tablet with water.
• You can take Inhibace Plus at any time of the day. However, you should take it approximately at the same time every day.
• Inhibace Plus can be taken before or after meals.
• The tablets can 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 box with you. You can also call the Toxicology Information Service, telephone 91 562.04.20, indicating the medication and the amount taken. The following effects may occur: dizziness or drowsiness, 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 missed doses.

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

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

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

If you have a serious adverse effect called angioedema or allergic reaction, stop taking Inhibace Plus and see a doctor immediately. The signs may include:

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

If you have the following blood problems, consult your doctor immediately:

• Low number of red blood cells (anemia). The signs include fatigue, pale skin, rapid or irregular heartbeat (palpitations), and shortness of breath.
• Low number of all types of white blood cells (neutropenia, agranulocitosis). The signs include an increased number of infections, for example in the mouth, gums, throat, and lungs.
• Low number of platelets in the blood (thrombocytopenia). The 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 can cause you to feel weak, dizzy, or faint, and may lead to blurred vision and fainting. Excessive decrease in blood pressure can increase the risk of a heart attack or stroke in some patients.
• Increased heart rate
• Weakness
• Chest pain
• Breathing problems, including shortness of breath and chest tightness
• Runny or stuffy nose and sneezing (rhinitis)
• Dry or swollen mouth
• Loss of appetite
• Change in taste
• Diarrhea and vomiting
• Skin rash (which can be severe)
• Muscle or joint cramps or pain
• Impotence
• Excessive sweating
• Redness
• Sleep problems
• Blood tests show a decrease in the number of red blood cells, white blood cells, or platelets in the blood (anemia, neutropenia, agranulocitosis, and thrombocytopenia)
• Blood tests show altered 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 ischemia, transient ischemic attack, ischemic 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 similar to systemic lupus erythematosus
• Numbness or tingling of hands or feet
• Wheezing
• Feeling of fullness or sharp pain behind the nose, cheeks, and eyes (sinusitis)
• Tongue pain
• Pancreatitis (inflammation of the pancreas). The signs include severe stomach pain that radiates to the back.
• Changes in liver or kidney function (appears in blood and urine tests)
• Liver problems such as hepatitis (inflammation of the liver) or liver damage
• Severe skin reactions including blistering or peeling of the skin
• Increased sensitivity to light
• Hair loss (which can be temporary)
• Loosening or separation of the nails from the nail bed
• Enlargement of the breast in men
• Depression
• Confusion
• Dry eyes
• Distortion of yellow color vision

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

• Acute respiratory distress (the signs include severe difficulty breathing, fever, weakness, and confusion).

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

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

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

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this leaflet. You can also report them directly through the Spanish Medicines Monitoring System for Human Use: www.notificaram.es. By reporting adverse effects, you can contribute to providing 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 expiration date that appears on the packaging and blister after CAD.

Medicines should not be disposed of through wastewater or household waste.Deposit the packaging and medicines you no longer need at the SIGRE point of the pharmacy.If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need.This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Inhibace Plus

• The active ingredients 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, cornstarch, 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 Package Contents

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

The package 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 medicine 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 the Last Revision of this Leaflet:April 2022

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/