Leaflet: information for the user

Imidapril Qualigen 10 mg tabletsEFG

Imidapril hydrochloride

Read this 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, consult your doctor or pharmacist.

-This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.

-If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1. What Imidapril Qualigen is and what it is used for

2. What you need to know before starting to take Imidapril Qualigen

3. How to take Imidapril Qualigen

4. Possible side effects

5. Storage of Imidapril Qualigen

6. Contents of the pack and additional information

Imidapril Qualigen belongs to a group of medicines called angiotensin-converting enzyme (ACE) inhibitors.

Imidapril Qualigen is indicated for the treatment ofhigh blood pressure(hypertension).

If you have high blood pressure, Imidapril Qualigen will work by dilating blood vessels, making it easier for blood to flow. As blood pressure depends on the diameter of blood vessels, your blood pressure will decrease with the help of Imidapril Qualigen. It will also be easier for your heart to pump blood through the vessels to the rest of the body.

Do not take Imidapril Qualigen

• If you areallergicto imidapril, other ACE inhibitors, or any of the other components of this medication (listed in section 6).
• If you have ever hadangioedema (a severe allergic reactionthat manifests asswelling of the hands, feet, or ankles, face, lips, tongue, and throat, and which can lead todifficulty swallowing or breathing), after taking a similar medication to imidapril (ACE inhibitor).
• If you or a close relative have experiencedangioedema.
• If you haveany kidney diseaseor if you need to undergodialysis.
• If you have diabetes or kidney insufficiency and are being treated with a medication to lower blood pressure that contains aliskiren.
• If you are pregnant more than 3 months (it is also recommended to avoid Imidapril Qualigen at the beginning of pregnancy – see Pregnancy section).

Do not take Imidapril Qualigen if you are in any of the above situations.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Imidapril Qualigen

• If you aredehydrateddue to treatment withdiuretics (medications to urinate), dialysis, a low-sodium diet, or because you have hadsevere and prolonged vomiting or diarrhea. You are more likely to experience a significant drop in blood pressure (hypotension) when starting to take the tablets and may feel dizzy or faint.
• If you have been told that you haveheart problems. Consult your doctor if you think you may have them.
• If you haveliver problems
• If you arediabetic
• If you are following a treatment withpotassium supplements or salt substitutes containing potassium.
• If you are following a treatment withalopurinolto prevent gout, kidney stones, or elevated uric acid levels.
• If you are following a treatment withprocainamideto correct irregular heartbeats and to slow down a rapid heartbeat.
• If you are taking amedication containing lithiumused to treat mania or depression.
• If you are allergic to insect bites and are following someallergy treatment.
• If you are following someimmunosuppressive treatment, for example after a transplant.
• If you have recently undergone akidney transplant.
• If you are following some treatment called“apheresis of LDL”to reduce blood cholesterol levels.
• If you suffer from a condition called“cerebrovascular disease”(narrowing of blood vessels in the brain).
• If you suffer from a disease known as“vascular collagen disease”,such as rheumatoid arthritis.
• If you are going to undergosurgeryor receive ananesthesia, inform your doctor or dentist.
• If your blood pressure is not low enough. This type of medication seems to be less effective in people of black race.
• If you experienceswelling of the lips and face, tongue, and throat, neck, and possibly hands and feet, difficulty swallowing and breathing, hives, and hoarseness (“angioedema”).This can occur at any time during treatment. People of black race may have a higher risk of experiencing this situation. If you develop these symptoms, inform your doctor immediately.
• If you are taking any of the following medications used to treat high blood pressure (hypertension):

OrAAngiotensin II receptor antagonist (ARA) (also known as “sartanes” - for example, valsartan, telmisartan, irbesartan), particularly if you have kidney problems related to diabetes.

OrAliskiren.

Your doctor may need to monitor your kidney function, blood pressure, and electrolyte levels in the blood (such as potassium), at regular intervals.

See also the information under the heading “Do not take Imidapril Qualigen”.

If you are pregnant (or if you suspect you may be), you must inform your doctor. Imidapril Qualigen is not recommended for use at the beginning of pregnancy, and it should not be used after the third month of pregnancy because it can cause serious harm to your baby (see Pregnancy section).

Children and adolescents

The use of Imidapril Qualigen tablets is not recommended in children.

While taking Imidapril Qualigen

If you experience any of the following symptoms, inform your doctor immediately:

• If you feel dizzy after the first dose. Some people react to the first dose or when the dose is increased, and feel vertigo, weakness, faintness, or nausea.
• Elevated temperature, sore throat, or ulcers in the mouth (these may be symptoms of an infection caused by a decrease in white blood cells in the blood).
• Yellowing of the skin and eyes (jaundice) that may besign of liver disease.

You will need to have regular medical check-ups while taking Imidapril Qualigen, including regular blood tests. A careful monitoring will be done when starting treatment or in case of dose modification. Your doctor will indicate the frequency of visits.

Other medications and Imidapril Qualigen

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

Your doctor may need to modify 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 Imidapril Qualigen” and “Warnings and precautions”).

Pregnancy and breastfeeding

Pregnancy

You must inform your doctor if you are pregnant, think you may be pregnant, or plan to become pregnant, before using this medication. Your doctor will usually advise you to stop taking Imidapril Qualigen before becoming pregnant or as soon as you become pregnant, and will recommend taking another antihypertensive medication instead. Imidapril Qualigen is not recommended for use at the beginning of pregnancy, and it should not be used after the third month of pregnancy, as it can cause serious harm to your baby, when administered from that time.

Breastfeeding

Inform your doctor if you plan to start or are breastfeeding, as Imidapril Qualigen is not recommended for use in breastfeeding women. Your doctor may decide to administer a treatment that is more suitable if you want to breastfeed, especially in newborns or premature babies.

Driving and operating machines

Imidapril Qualigen may make you feel dizzy or drowsy.

Avoid driving a vehicle or operating machines until you know if Imidapril Qualigen affects you.

Imidapril Qualigen contains lactose and sodium

This medication contains lactose. If your doctor has told you that you have a lactose intolerance, consult with him before taking this medication.

This medication contains less than 23 mg of sodium (1 mmol) per tablet; it is essentially “sodium-free”.

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

• Take the tablets approximately 15 minutes before meals
• Swallow the tablets with plenty of water
• Take the tablets always at the same time
• The tablet can be divided into equal doses

The recommended dose is:

Adults

The usual initial dose is 5 mg per day. After 3 weeks, it will be necessary to measure your blood pressure again to assess the results. Your doctor may increase the daily dose to 10 mg or up to 20 mg.

Your doctor may instruct you to start with 2.5 mg per day

• if you have mild kidney problems or liver problems
• if you have heart problems, chest pain, problems related to cerebral blood vessels, low sodium levels and/or fluid levels, or
• if there is a risk that your blood pressure may drop suddenly

Patients over 65 years of age

Your doctor will start your treatment with 2.5 mg once a day and increase to 10 mg, depending on your reaction to the treatment.

Use in children

The use of Imidapril Qualigen tablets is not recommended in children.

If you take more Imidapril Qualigen than you should

If you have accidentally taken more tablets than the prescribed dose, consult your doctor immediately. Remember to bring the leftover tablets and the packaging with you. The most common signs and symptoms of overdose are decreased blood pressure, shock, and stupor (a state of almost total loss of consciousness), decreased heart rate, alterations in potassium levels or other electrolytes, and renal failure. This may cause a general feeling of discomfort, feeling your heartbeat, or swelling of the fingers of the hands, legs, and toes (edema).

In case of overdose or accidental ingestion, consult your doctor, pharmacist, or call the Toxicology Information Service, phone 91.562.04.20, indicating the medication and the amount ingested.

If you forget to take Imidapril Qualigen

Do not take a double dose to compensate for the missed doses. Do not take the missed dose and then continue with the regular dosing schedule.

If you interrupt treatment with Imidapril Qualigen

Do not stop taking Imidapril Qualigen unless your doctor recommends it. If you stop taking this medication, your blood pressure may rise. If your blood pressure is too high, it may affect the functioning of your heart and kidneys.

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.

It is very important that you contact your doctor immediately and stop taking Imidapril Qualigen if you develop any of the following symptoms:

• headache, dizziness, vertigo, possibly accompanied by vision disturbances. This is particularly important whenstarting treatmentor when thedose is increased
• difficulty breathing
• eruption or itching
• a severe allergic reaction that causes swelling in the face or throat (angioedema) blisters on the skin, mouth, eyes, and genital organs (toxic epidermal necrolysis, Stevens-Johnson syndrome)
• yellowing of the skin and eyes caused by liver or blood problems (jaundice)

Inform your doctor or pharmacist if you develop any of the following side effects::

Frequent side effects(may affect up to 1 in 10 people)

• fatigue/sleep
• cough
• nausea (gag reflex)

Less frequent side effects(may affect up to 1 in 100 people)

• feeling your own heartbeat (palpitations)
• constriction of blood vessels in the brain (cerebrovascular disease)
• sensation of fainting
• tingling or numbness in the hands or feet
• swelling and irritation inside the nose
• vomiting
• upper abdominal pain
• indigestion (stomach discomfort)
• bronchitis
• viral infection
• upper respiratory tract infection
• chest pain
• limb pain
• swelling of the fingers of the hands, legs, and toes (edema)

Rare side effects(may affect up to 1 in 1,000 people)

• reduction (decrease in number) of white blood cells, making infections more likely
• reduction (decrease in number) of red blood cells, which can cause pale skin, weakness, and shortness of breath

Effects on blood test results

Imidapril Qualigen may cause changes in blood composition. Your doctor will perform regular blood tests and explain the results to you.

The following side effects were described with this type of medication:

• blurred vision
• balance disorders; confusion; tinnitus
• fatigue; depression; sleep disorders; impotence
• alterations in taste
• alterations in heart rhythm (faster, irregular); myocardial infarction; transient ischemic symptoms
• increased risk of bleeding or hematomas
• urticaria; skin redness
• hair loss
• shortness of breath; wheezing
• inflammations - for example, of the nasal cavities (sinusitis), tongue (glossitis), liver (hepatitis), pancreas (pancreatitis), or stomach lining (gastritis)
• diarrhea; constipation; dry mouth
• intestinal blockage; inflammation of the intestines causing cramps
• kidney problems
• fever
• muscle pain; joint pain.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:Medicating the reporting of side effects you can contribute toproviding more information on the safety of this medicine.

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

Do not store at a temperature above 30°C. Store in the original packaging.

Do not use this medication after the expiration date that appears on the packaging and the blister pack after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Imidapril Qualigen

- The active ingredient is imidapril hydrochloride. Each tablet contains 10 mg of imidapril hydrochloride.

- The other components are: anhydrous calcium hydrogen phosphate, pregelatinized cornstarch, lactose monohydrate, sodium croscarmellose (E 468) and glycerol distearate.

Appearance of the product and content of the packaging

Imidapril Qualigen tablets are white, oblong, with the inscription “K2” on one face and scored on both faces.

The medication is available in aluminum/aluminum blisters, packaging with 14, 28, and 56 tablets.

Only some package sizes may be commercially marketed.

Holder of the marketing authorization

Neuraxpharm Spain, S.L.U.

Avda. Barcelona, 69

08970 Sant Joan Despí (Barcelona) - Spain

Responsible for manufacturing

Neuraxpharm Pharmaceuticals, S.L.

Avda. Barcelona, 69

08970 Sant Joan Despí (Barcelona) - Spain

Last review date of this leaflet: June 2021

The detailed information on this medication is available on the website of theSpanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/.