IMIDAPRIL QUALIGEN 5 MG TABLETS EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Imidapril Qualigen 5 mg tablets EFG

Imidapril hydrochloride

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 could 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 Imidapril Qualigen is and what it is used for
2. What you need to know before taking Imidapril Qualigen
3. How to take Imidapril Qualigen
4. Possible side effects
5. How to store Imidapril Qualigen
6. Contents of the pack and other information

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

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

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

If you have high blood pressure, Imidapril Qualigen will work by dilating your blood vessels, allowing blood to flow more easily. Since blood pressure depends on the diameter of the 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 entire body.

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

Do not take Imidapril Qualigen

• If you are allergic to imidapril, to other ACE inhibitors, or to any of the other ingredients of this medicine (listed in section 6).
• If you have ever had angioedema (a serious allergic reaction characterized by swelling of the hands, feet or ankles, face, lips, tongue and throat, which may lead to difficulty swallowing or breathing) after taking a medicine similar to imidapril (an ACE inhibitor).
• If you or a close family member has experienced angioedema.
• If you have any kidney disease or if you require dialysis.
• If you have diabetes or renal impairment and are being treated with a blood pressure-lowering medicine containing aliskiren.
• If you are more than 3 months pregnant (Imidapril Qualigen should also be avoided at the beginning of pregnancy – see Pregnancy section).

Do not take Imidapril Qualigen if any of the above apply to you.

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Imidapril Qualigen

• If you are dehydrated due to treatment with diuretics (medicines to increase urine output), dialysis, a low-salt diet, or because you have had severe and prolonged vomiting or diarrhoea. You may be more likely to experience a significant drop in blood pressure (hypotension) when starting the tablets, which could cause dizziness or fainting.
• If you have been diagnosed with heart problems. Consult your doctor if you think you may have them.
• If you have liver problems.
• If you are diabetic.
• If you are taking potassium supplements or potassium-containing salt substitutes.
• If you are taking allopurinol to prevent gout, kidney stones, or high levels of uric acid.
• If you are taking procainamide to correct irregular heartbeats or to slow a rapid heartbeat.
• If you are taking a medicine containing lithium used to treat mania or depression.
• If you are allergic to insect stings and are undergoing treatment for hypersensitivity.
• If you are receiving any treatment affecting 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 condition known as "cerebrovascular disease" (narrowing of blood vessels in the brain).
• If you have a condition known as "collagen vascular disease", such as rheumatoid arthritis.
• If you are going to undergo surgery or receive anesthesia, inform your doctor or dentist.
• If your blood pressure is not adequately controlled. This type of medicine appears to be less effective in people of black race.
• If you experience sudden swelling of the lips and face, tongue and throat, neck, and possibly also the hands and feet, difficulty swallowing and breathing, hives, or hoarseness ("angioedema"). This may occur at any time during treatment. People of black race may have a higher risk of experiencing this condition. If you develop these symptoms, inform your doctor immediately.
• If you are taking any of the following medicines used to treat high blood pressure (hypertension):

O An angiotensin II receptor antagonist (ARA) (also known as "sartans" – for example, valsartan, telmisartan, irbesartan), particularly if you have kidney problems related to diabetes.

O 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 suspect you might be), you must inform your doctor. The use of Imidapril Qualigen is not recommended at the beginning of pregnancy, and it must not be used after the third month of pregnancy as it may 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 lightheaded after the first dose. Some people react to the first dose or when the dose is increased, experiencing dizziness, weakness, fainting, or nausea.
• High temperature, sore throat, or mouth ulcers (these may be signs of infection due to a decrease in white blood cells in the blood).
• Yellowing of the skin and eyes (jaundice), which may be a sign of liver disease.

Regular medical check-ups will be necessary while you are taking Imidapril Qualigen, including regular blood tests. Close monitoring will be carried out when starting treatment or when the dose is changed. Your doctor will advise you on how often you need to visit.

Other medicines and Imidapril Qualigen

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

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 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. Your doctor will usually advise you to stop taking Imidapril Qualigen before becoming pregnant or as soon as you become pregnant, and will recommend another antihypertensive medicine instead. Imidapril Qualigen is not recommended during early pregnancy and must not be administered from the third month of pregnancy onwards, as it may cause serious harm to your baby when used from that stage.

Breastfeeding

Inform your doctor if you are planning to breastfeed or are currently breastfeeding, as Imidapril Qualigen is not recommended for administration to women during lactation. Your doctor may decide to prescribe a treatment more suitable for you if you intend to breastfeed, especially if the infant is a newborn or premature.

Driving and use of machines

Imidapril Qualigen may cause dizziness or drowsiness.

Refrain from driving or operating machinery until you know how Imidapril Qualigen affects you.

Imidapril Qualigen contains lactose and sodium

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

This medicine contains less than 23 mg of sodium (1 mmol) per tablet; thus, it is essentially "sodium-free".

3. How to take Imidapril Qualigen

Follow exactly the instructions for using this medicine as given by your doctor or pharmacist. If in 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 at the same time each day
• The tablet may be divided into equal doses

Recommended dose

Adults

The usual initial dose is 5 mg once daily. After 3 weeks, your blood pressure should be measured again to assess the response. Your doctor may increase the daily dose to 10 mg or up to 20 mg.

Your doctor may advise starting with 2.5 mg once daily

• if you have mild kidney or liver problems
• if you have heart problems, chest pain, cerebrovascular disorders, low levels of salt and/or fluids, or
• if there is a risk that your blood pressure might drop suddenly

Patients aged 65 years and older

Your doctor will start your treatment with 2.5 mg once daily and may increase it up to 10 mg, depending on your response to 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 prescribed, contact your doctor immediately. Remember to bring any remaining tablets and the packaging with you. The most common signs and symptoms of overdose include low blood pressure, shock, stupor (a state of near-complete loss of consciousness), slow heartbeat, disturbances in potassium or other electrolyte levels, and kidney failure. This may cause a general feeling of being unwell, awareness of your heartbeat (palpitations), or swelling in the fingers, legs, and toes (edema).

In case of overdose or accidental ingestion, contact your doctor, pharmacist, or call the Toxicology Information Service at 91.562.04.20, indicating the name of the medicine and the amount ingested.

If you forget to take Imidapril Qualigen

Do not take a double dose to make up for a missed dose. Do not take the missed dose; instead, continue with your next dose at the usual time.

If you stop taking Imidapril Qualigen

Do not stop taking Imidapril Qualigen unless your doctor advises you to do so. If you stop taking this medicine, your blood pressure may rise. If your blood pressure becomes too high, it may affect the function of your heart and kidneys.

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 cause adverse 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, lightheadedness, possibly accompanied by visual disturbances. This is particularly important when starting treatment or when the dose is increased
• difficulty breathing
• rash or itching
• a severe allergic reaction causing swelling of 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 due to liver or blood problems (jaundice)

Inform your doctor or pharmacist if you experience any of the following adverse effects:

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

• fatigue/drowsiness
• cough
• feeling sick (nausea)

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

• awareness of your own heartbeat (palpitations)
• narrowing of blood vessels in the brain (cerebrovascular disease)
• feeling faint
• tingling or numbness in the hands or feet
• nasal congestion and irritation
• vomiting
• pain in the upper abdomen
• indigestion (stomach discomfort)
• bronchitis
• viral infection
• upper respiratory tract infection
• chest pain
• limb pain
• swelling of fingers, legs and toes (edema)

Rare adverse 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 may cause paleness of the skin, weakness and shortness of breath

Effects on blood test results

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

The following adverse effects have been reported with this type of medicine:

• blurred vision
• balance disorders; confusion; ringing in the ears
• tiredness; depression; sleep disturbances; impotence
• taste disturbances
• changes in heart rhythm (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 obstruction; inflammation of the intestines causing colic
• kidney problems
• fever
• muscle pain; joint pain

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Imidapril Qualigen Storage

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

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

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

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at a SIGRE point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of unused medicines and packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Imidapril Qualigen

• The active substance is imidapril hydrochloride. Each tablet contains 5 mg of imidapril hydrochloride.
• The other components are: anhydrous calcium hydrogen phosphate, pregelatinized corn starch, lactose monohydrate, sodium croscarmellose (E 468) and glycerol distearate.

Appearance of the medicine and contents of the pack

Imidapril Qualigen tablets are white, oblong-shaped, with the inscription “K1” on one side and scored on both sides.

The medicine is available in aluminum/aluminum blisters in packs containing 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 the most recent revision of this summary: 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/.