Inhibace plus 5 mg/12,5mg comprimidos recubiertos con pelicula

Prospecto:Information for the User

InhibacePlus5mg/12,5mg Film-Coated Tablets

Cilazapril/hydrochlorothiazide

Read this entire prospectus carefully beforestarting to takethis medication, as it contains important information for you.

• Keep this prospectus, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed only for you, 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 any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospectus. See section 4.

1. What isInhibace Plusand for what it is used

2. What you need to know before starting to takeInhibace Plus

3. How to takeInhibace Plus

4. Possible adverse effects

5. Storage ofInhibace Plus

6. Contents of the package and additional information

Inhibace Pluscontainsa combination of two active ingredients:cilazapril and hydrochlorothiazide.

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

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

Hydrochlorothiazide belongs to a group of medications known as “thiazide diuretics” or “water pills”. It works by increasing the amount of urine produced. This reduces your blood pressure.

Do not take Inhibace Plus

-if you are allergic to cilazapril, hydrochlorothiazide, or any of the other ingredients in thismedication (listed in section 6).

-if you are allergic (hypersensitive) to similar medications toInhibacePlus such as other angiotensin-converting enzyme (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. Symptoms include swelling of the face, lips, mouth, or tongue. There is a higher risk of angioedema if you are taking certain medications for diabetes or immunosuppressants.

-if you have severe kidney problems (creatinine clearance less than 30ml/min) or anuria (inability to urinate).

-if you are more than 3 months pregnant. (It is also recommended to avoidInhibacePlus during the first months of pregnancy - see section “Pregnancy and breastfeeding”).

-if you have diabetes mellitus or kidney insufficiency and are being treated with a medication to lower blood pressure that contains aliskiren.

• if you have taken or are taking sacubitril/valsartan, a medication used to treat a type of chronic heart failure in adults, as it increases the risk of angioedema (rapid swelling under the skin in areas such as the throat).

Do not take Inhibace Plus if you are in any of these cases. 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 “sartanes”, for example: valsartan, telmisartan, irbesartan), particularly if you have kidney problems related to diabetes.

-aliskiren

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

-if you are taking immunosuppressants

-if you have had respiratory or pulmonary problems (such as inflammation or fluid in the lungs) after taking hydrochlorothiazide in the past. If you experience severe shortness of breath or difficulty breathing after taking Inhibace Plus, seek medical attention immediately.

-if you have skin cancer or if you develop an unexpected skin lesion during treatment. The 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 the sun and UV rays 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 dialysis.

-if you have recently been vomiting or have had diarrhea.

-if you are on a low-sodium diet.

-if you are planning to undergo a treatment to reduce your allergy to bee or wasp stings (desensitization).

-if you are planning to undergo surgery (including dental surgery). This is because some anesthetics may lower your blood pressure, which can become too low.

-if you have ascites (fluid accumulation in the abdomen).

-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, which may be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased eye pressure, which 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 this (see also the information under the heading “Do not take Inhibace Plus”).

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

• 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 cases, or if you are unsure, consult your doctor or pharmacist before taking Inhibace Plus.

Inform your doctor if you are pregnant (or if you suspect you may be). Inhibace Plus is not recommended for use during the first months of pregnancy, and it should not be administered if you are more than three months pregnant, as it may cause serious harm to your baby when administered from that point onwards (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

Inform your doctor or pharmacist that you are taking, have taken recently, or may need to take any other medication, including those purchased without a prescription or herbal medications. This is becauseInhibacePlus may affect how other medications work. Similarly, other medications may affect howInhibacePlus 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 taken recently, or may take any of the following medications:

-any medication used to treat high blood pressure.

-Non-steroidal anti-inflammatory drugs (NSAIDs). These include acetylsalicylic acid, indomethacin, and ibuprofen.

-Insulin or other medications used to treat diabetes.

-Lithium (used to treat depression).

-steroids (such as hydrocortisone, prednisolone, and dexamethasone) or other immunosuppressants.

-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 co-trimoxazole for bacterial infections), ciclosporin, and immunosuppressants for preventing 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 used to treat heart failure or arrhythmias.

-calcium and vitamin D supplements.

-cholestyramine/cholesterol (used to reduce the amount of fat in your blood).

-anticholinergics.

-cytotoxic medications (e.g. methotrexate, cyclophosphamide).

-ciclosporin (used to prevent organ transplant rejection).

-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.

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

Pregnancy and breastfeeding

Pregnancy

If you are pregnant, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medication. Your doctor will usually recommend that you stop taking Inhibace Plus before becoming pregnant, or as soon as you know you are pregnant, and recommend that you take another medication instead of Inhibace Plus. Inhibace Plus is not recommended for use during the first months of pregnancy, and it should not be administered if you are more than three months pregnant, as it may cause serious harm to your baby when administered from that point onwards.

Lactation

If you are breastfeeding or plan to start, consult your doctor before taking this medication. Inhibace Plus is not recommended for use 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 operating machines

You may feel dizzy while taking InhibacePlus. This is more likely to occur when you first start treatment. 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 a certain type of sugar intolerance, 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”.

It is reported to athletes that this medication contains a component (hydrochlorothiazide) that may result in a positive analytical result for doping control as positive.

Follow exactly the administration instructions for this medication as indicated by your doctor. In case of doubt, 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, take it always approximately at the same hour of the day.

-Inhibace Plus can be taken before or after meals.

-Tablets can be divided into equal doses. Do not crush orchewthe tablets.

If You Take MoreInhibacePlus Than You Should

If you take moreInhibacePlus than you should, or if someone else takes yourInhibacePlus tablets, consult a doctor or go to the hospital immediately. Bring the medication box with you. You can also call the Toxicological Information Service, Phone 91 562.04.20, indicating the medication and the amount ingested.The following effects may occur: dizziness or drowsiness, shallow breathing, cold and sticky 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 the missed doses.

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Some side effects can be severe and require immediate medical attention:

If you have a severe side effect called angioedema or an allergic reaction, stop takingInhibacePlus and see your doctor immediately. The signs may include:

-Sudden inflammation 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 red blood cell count (anemia). The signs include fatigue, pale skin, rapid or irregular heartbeat (palpitations), and shortness of breath.

-Low white blood cell count (neutropenia, agranulocytosis). The signs include an increased number of infections, such as in the mouth, gums, throat, and lungs.

-Low platelet count (thrombocytopenia). The signs include easy bruising and nosebleeds.

Other possible side effects

Frequent(can affect up to 1 in 10 people)

-Dizziness

-Cough

-Nausea

-Fatigue

-Headache

Rare(can affect up to 1 in 100 people)

-Low blood pressure. This can cause you to feel weak, dizzy, or disoriented, and may lead to blurred vision and fainting. A significant drop in blood pressure can increase the risk of heart attack or stroke in some patients

-Increased heart rate

-Weakness

-Chest pain

-Respiratory problems, including shortness of breath and chest tightness

-Runny or stuffy nose and sneezing (rhinitis)

-Dry or swollen mouth

-Loss of appetite

-Change in the taste of things

-Diarrhea and vomiting

-Rash (which can be severe)

-Muscle or joint pain

-Impotence

-Excessive sweating

-Redness

-Sleep problems

-Electrolyte imbalances (sodium, potassium, chloride, magnesium, calcium, bicarbonate) or elevated levels of glucose, urate, cholesterol, and triglycerides in blood tests

-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

-Pulmonary interstitial disease

-A condition similar to systemic lupus erythematosus

-Numbness or tingling in hands or feet

-Whistling when breathing

-Sensation of fullness or stabbing 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 that include blistering or peeling of the skin

-Increased sensitivity to light

-Temporary hair loss

-Loosening or separation of the nail from the nail bed

-Enlargement of the breasts in men

-Depression

-Confusion

-Dry eyes

-Distortion of yellow color vision

Very rare(can affect fewer than 1 in 10,000 people)

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

Frequency «unknown»(the frequency cannot be estimated from 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 hemorrhage) or acute angle-closure glaucoma)

If you experience side effects, consult your doctor or pharmacist,even if it's about side effects that don't appear in this prospectus.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it's about possible side effects that don't appear in this prospectus. You can also report them directly through theSistema Español de Farmacovigilancia de Medicamentos de Uso Humano:www.notificaram.es. By reporting side effects, you can contribute to providing more information about the safety of this medicine.

Keepthis medicationout of the sight andreach of children.

Store below25°C.

Do not usethis medicationafter the expiration date that appears on the packagingand the blisterafter CAD.

Medicines should not be disposed of through drains or in thewaste..Deposit the packaging and unused medicines at the SIGRE point of the pharmacy.Ask your pharmacist for advice on how to dispose of packaging and unused medicines if you are unsure. By doing so,,you will help protect the environment.

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 cilazapril anhydrous and 12.5 mg of hydrochlorothiazide.

-The other components (excipients) are: lactose monohydrate, cornstarch,fumaric acid stearate, hypromellose 3 cp,hypromellose 6 cp,talco, titanium dioxide (E 171) and iron oxide red (E 172). (See section 2: Inhibace Plus contains lactose monohydrate).

Appearance of the product and contents of the packaging

Film-coated tablet, oval, biconvex shape, pale red color, scored on one face and marked with “CIL+5+12,5”on the other face.

The packaging contains 28 film-coated tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

CHEPLAPHARM Arzneimittel GmbH

Ziegelhof 24

17489 Greifswald

Germany

Responsible for manufacturing

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 with 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 review of this leaflet:April 2022

The detailed and updated information on this medicine is available on the website ofthe Spanish Agencyof Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/