IMIDAPRIL QUALIGEN 20 mg TABLETS

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

Do not take Imidapril Qualigen

• If you are allergicto imidapril, other ACE inhibitors, or any of the other ingredients of this medicine (listed in section 6).
• If you have ever suffered from angioedema(a severe allergic reaction characterized by swelling of the hands, feet, or ankles, face, lips, tongue, and throat, and which can lead to difficulty swallowing or breathing) after taking a medicine similar to imidapril (ACE inhibitor).
• If you or a close relative have experienced angioedema.
• If you have any kidney diseaseor if you need to undergo dialysis.
• If you have diabetes or kidney failure and are being treated with a blood pressure-lowering medicine that contains aliskiren.
• If you are pregnant for more than 3 months (it is also best to avoid Imidapril Qualigen at the start of pregnancy – see section Pregnancy).

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 are dehydrated due to treatment with diuretics (water pills), dialysis, a low-salt diet, or because you have had severe and prolonged vomiting or diarrhea. You are more likely to suffer from 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 have heart problems. Consult your doctor if you think you may have them.
• If you have liver problems.
• If you are diabetic.
• If you are following a treatment with potassium supplements or salt substitutes containing potassium.
• If you are following a treatment with allopurinolto prevent gout, kidney stones, or high levels of uric acid.
• If you are following a treatment with procainamideto correct irregular heartbeats and to slow down a rapid heartbeat.
• If you are taking a medicine containing lithiumused to treat mania or depression.
• If you are allergic to insect bites and are undergoing desensitization treatment.
• If you are undergoing treatment for your immune system, for example after an organ transplant.
• If you have recently undergone a kidney transplant.
• If you are undergoing a treatment called “LDL apheresis”to reduce cholesterol levels in the blood.
• If you suffer from a problem called “cerebrovascular disease”(narrowing of the blood vessels in the brain).
• If you suffer from a disease known as “collagen vascular disease”, such as rheumatoid arthritis.
• If you are going to undergo surgeryor receive anesthesia, inform your doctor or dentist.
• If your blood pressure is not low enough. This type of medicine seems to be less effective in people of black race.
• If you feel a sudden swelling of the lips and face, tongue and throat, neck, and also 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 be at higher risk of suffering from this situation. If you develop these symptoms, inform your doctor immediately.
• If you are taking any of the following medicines used to treat high blood pressure:

Or An angiotensin II receptor antagonist (ARA) (also known as “sartans” - e.g., valsartan, telmisartan, irbesartan), especially if you have kidney problems related to diabetes.

Or 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 Imidapril Qualigen”.

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

Children and adolescents

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

While taking Imidapril Qualigen

If you develop 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 dizziness, weakness, fainting, or nausea.
• High temperature, sore throat, or mouth ulcers (these can be symptoms of an infection caused by a decrease in white blood cells in the blood).
• Yellowing of the skin and eyes (jaundice) which can be a sign of liver disease.

It will be necessary to undergo regular medical check-ups while taking Imidapril Qualigen, including regular blood tests. Close monitoring will be carried out when starting treatment or in case of dose modification. Your doctor will indicate the necessary frequency of visits.

Other medicines and Imidapril Qualigen

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

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 medicine. In general, your doctor will advise you to stop taking Imidapril Qualigen before becoming pregnant or as soon as you become pregnant and will recommend taking another anti-hypertensive medicine instead. It is not recommended to take Imidapril Qualigen at the start of pregnancy and in no case should it be administered from the third month of pregnancy, as it can cause serious harm to your baby.

Breastfeeding

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

Driving and using machines

Imidapril Qualigen may make you feel dizzy or sleepy.

Do not drive a vehicle or use machines until you know if Imidapril Qualigen affects you.

Imidapril Qualigen contains lactose and sodium

This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, consult with them before taking this medicine.

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

3. How to take Imidapril Qualigen

Follow exactly the administration instructions of this medicine 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 indicate that you 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 salt and/or fluid levels, or
• if there is a risk that your blood pressure may drop suddenly

Patient over 65 years of age

Your doctor will start your treatment with 2.5 mg once a day and increase up 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 take the remaining tablets and the packaging with you. The most frequent 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 or other electrolyte levels, and kidney failure. This can produce a feeling of general discomfort, feeling your heartbeat, or swelling of the fingers, 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 medicine and the amount ingested.

If you forget to take Imidapril Qualigen

Do not take a double dose to make up for forgotten doses. Do not take the forgotten dose and continue with the usual dosing schedule.

If you stop taking Imidapril Qualigen

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

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets 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, dizziness, possibly accompanied by vision disturbances. This is particularly important when starting treatmentor when the dose is increased
• difficulty breathing
• rash or itching
• a severe allergic reaction that causes swelling in the face or throat (angioedema) blisters on the skin, mouth, eyes, and genitals (toxic epidermal necrolysis, Stevens-Johnson syndrome)
• yellowing of the skin and eyes caused by liver or blood problems (jaundice)

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

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

• fatigue/sleepiness
• cough
• nausea

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

• feeling your own heartbeat (palpitations)
• narrowing of the blood vessels in the brain (cerebrovascular disease)
• feeling of fainting
• tingling or numbness of 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, legs, and toes (edema)

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

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

Effects on blood test results

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

The following side effects have been described with this type of medicine:

• blurred vision
• balance disorders; confusion; ringing in the ears
• fatigue; depression; sleep disorders; impotence
• taste disturbances
• heart rhythm disturbances (faster, irregular); heart attack; transient ischemic symptoms
• increased risk of bleeding or bruising
• hives; 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 colic
• kidney problems
• fever
• muscle pain; joint pain

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible side effects not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use: By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Imidapril Qualigen

Keep this medicine out of sight and reach of children.

Do not store above 30°C. Store in the original package.

Do not use this medicine after the expiry date stated on the packaging and blister after CAD. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and any unused medicines at the SIGRE collection point in your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Imidapril Qualigen

• The active ingredient is imidapril hydrochloride. Each tablet contains 20 mg of imidapril hydrochloride.
• The other ingredients are: anhydrous calcium hydrogen phosphate, pregelatinized corn starch, lactose monohydrate, sodium croscarmellose (E 468), and glycerol distearate.

Appearance of the Product and Package Contents

Imidapril Qualigen tablets are white, oblong, with the inscription "K3" on one side and scored on both sides.

The medicine is available in aluminum/aluminum blisters, packs of 14, 28, and 56 tablets.

Only some pack sizes may be marketed.

Marketing Authorization Holder

Neuraxpharm Spain, S.L.U.

Avda. Barcelona, 69

08970 Sant Joan Despí (Barcelona) - Spain

Manufacturer

Neuraxpharm Pharmaceuticals, S.L.

Avda. Barcelona, 69

08970 Sant Joan Despí (Barcelona) - Spain

Date of Last Revision of this Leaflet: June 2021

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