ENALAPRIL QUALIGEN 20 mg TABLETS

Introduction

Package Leaflet: Information for the User

ENALAPRIL QUALIGEN 20 mg tablets EFG

Enalapril maleate

Read all of this leaflet carefully before you start taking this medicine.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.

• This medicine has been prescribed for you. Do not pass it on to others, as it may harm them, even if their symptoms are the same as yours.
• If you experience any of the side effects, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Contents of the pack:

1. What ENALAPRIL QUALIGEN is and what it is used for
2. Before taking ENALAPRIL QUALIGEN
3. How to take ENALAPRIL QUALIGEN
4. Possible side effects
5. Storage of ENALAPRIL QUALIGEN
6. Further information

1. What ENALAPRIL QUALIGEN is and what it is used for

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

ENALAPRIL QUALIGEN is indicated for:

• Treatment of high blood pressure (hypertension).
• Treatment of symptomatic heart failure.
• Prevention of symptomatic heart failure.

2. Before taking ENALAPRIL QUALIGEN

Do not take ENALAPRIL QUALIGEN:

• If you are allergic (hypersensitive) to enalapril or any of the other ingredients of ENALAPRIL QUALIGEN.

• If you have previously been treated with a medicine from the same group as Enalapril Qualigen (ACE inhibitors) and have had allergic reactions with swelling of the face, lips, tongue, and/or throat with difficulty swallowing or breathing.

• If you have been diagnosed with hereditary or idiopathic angioedema (development of large hives on the skin surface, especially around the eyes and lips, which can also affect hands, feet, and throat, and can also cause swelling of the face, lips, tongue, and/or throat with difficulty swallowing or breathing).

• If you have diabetes or kidney problems and are being treated with a blood pressure-lowering medicine containing aliskiren.

• If you are more than 3 months pregnant. (It is also recommended to avoid ENALAPRIL QUALIGEN at the beginning of pregnancy - see section Pregnancy).

Be especially careful with ENALAPRIL QUALIGEN:

• If you have heart disease.
• If you have a disease that affects the blood vessels in the brain.
• If you have blood disorders such as low or absent white blood cells (neutropenia/agranulocytosis), low platelet count (thrombocytopenia), or low red blood cell count (anemia).
• If you have liver problems.
• If you are undergoing dialysis.
• If you are being treated with diuretics (medicines that increase urine production).
• If you have recently had excessive vomiting or diarrhea.
• If you are on a low-salt diet, taking potassium supplements, potassium-sparing diuretics, or salt substitutes that contain potassium, or medications associated with elevated potassium levels in the blood (e.g., anticoagulants such as heparin).
• If you are over 70 years old.
• If you have diabetes mellitus or any kidney problems (including kidney transplant), as these can lead to high levels of potassium in the blood, which can be serious.
• If you have ever had an allergic reaction with swelling of the face, lips, tongue, or throat with difficulty swallowing or breathing. You should be aware that black patients are more sensitive to this type of reaction to ACE inhibitors.
• If you are about to undergo a treatment called LDL apheresis or desensitization treatment to reduce the effect of an allergy to bee or wasp stings.
• If you have low blood pressure (you may notice this as fainting or dizziness, especially when standing up. In these cases, lying down may help).
• If you have a disease of the collagen vascular system (e.g., lupus erythematosus, rheumatoid arthritis, or scleroderma), are being treated with medicines that suppress your immune system, or are taking the medicines allopurinol or procainamide, or any combination of these.

• If you are taking any of the following medicines 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.

In all these cases, inform your doctor, as you may need a dose adjustment or discontinuation of the medication with ENALAPRIL QUALIGEN, or monitoring of your potassium levels in the blood. If you have diabetes and are taking oral antidiabetics or insulin, you should closely monitor your blood glucose levels, especially during the first month of treatment with ENALAPRIL QUALIGEN.

Before undergoing surgery or anesthesia (even at the dentist's office), inform your doctor or dentist that you are taking ENALAPRIL QUALIGEN, as there may be a sudden drop in blood pressure associated with anesthesia.

You should be aware that ENALAPRIL QUALIGEN lowers blood pressure in black patients less effectively than in non-black patients.

You must inform your doctor if you think you are pregnant (or might be). Normally, your doctor will advise you to stop taking ENALAPRIL QUALIGEN before you become pregnant or as soon as you know you are pregnant, and will advise you to take a different medicine instead of ENALAPRIL QUALIGEN. ENALAPRIL QUALIGEN is not recommended at the beginning of pregnancy and should not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if used during this period (see section Pregnancy).

Use of other medicines:

Tell your doctor or pharmacist if you are using or have recently used any other medicines, including those obtained without a prescription.

Certain medicines may interact with ENALAPRIL QUALIGEN; your doctor may need to adjust your dose and/or take other precautions, or discontinue treatment with one of them.

It is especially important that you inform your doctor if you are taking or have recently taken any of the following medicines:

• An angiotensin II receptor antagonist (ARA) or aliskiren (see also the information under the headings “Do not take ENALAPRIL QUALIGEN”and “Be especially careful with ENALAPRIL QUALIGEN”).
• Antihypertensive medicines (lowering high blood pressure).
• Diuretics (medicines that increase urine production).
• Potassium-containing medicines (including dietary salt substitutes).
• Medicines for diabetes (including oral antibiotics and insulin).
• Lithium (a medicine used to treat certain types of depression).
• Tricyclic antidepressants.
• Antipsychotics.
• Anesthetics.
• Non-steroidal anti-inflammatory medicines (NSAIDs) (medicines for pain or certain inflammations, e.g., acetylsalicylic acid).
• Sympathomimetics.
• Certain medicines for pain or arthritis, including gold treatment.
• Non-steroidal anti-inflammatory medicines (NSAIDs), including COX-2 inhibitors (medicines that reduce inflammation and can be used to help relieve pain).

Use of ENALAPRIL QUALIGEN with food and drinks:

Food does not affect the absorption of ENALAPRIL QUALIGEN.

Alcohol enhances the blood pressure-lowering effect of enalapril, so inform your doctor if you are taking alcoholic beverages while being treated with this medicine.

Pregnancy and breastfeeding:

Ask your doctor or pharmacist for advice before taking any medicine.

Pregnancy

You must inform your doctor if you think you are pregnant (or might be). Normally, your doctor will advise you to stop taking ENALAPRIL QUALIGEN before you become pregnant or as soon as you know you are pregnant, and will advise you to take a different medicine instead of ENALAPRIL QUALIGEN. ENALAPRIL QUALIGEN is not recommended at the beginning of pregnancy and should not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if used during this period.

Breastfeeding

Tell your doctor if you are breastfeeding or about to start breastfeeding.

While taking ENALAPRIL QUALIGEN, breastfeeding is not recommended in newborns (first few weeks after birth), and especially in premature babies. In the case of an older baby, your doctor should advise you on the benefits and risks of taking ENALAPRIL QUALIGEN, compared to other treatments, while breastfeeding.

Driving and using machines:

Individual responses to the medicine may vary.

ENALAPRIL QUALIGEN may cause dizziness or fatigue, so be careful not to perform tasks that require special attention (driving vehicles or operating machinery) until you know how you tolerate the medicine.

Important information about some of the ingredients of ENALAPRIL QUALIGEN:

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; it is essentially “sodium-free”.

3. How to take ENALAPRIL QUALIGEN

Take ENALAPRIL QUALIGEN exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.

Remember to take your medicine.

Your doctor will decide the duration of your treatment with ENALAPRIL QUALIGEN. Do not stop treatment before then.

ENALAPRIL QUALIGEN can be taken with or without food, with a glass of water.

Your doctor will decide the appropriate dose of ENALAPRIL QUALIGEN for you, depending on your condition and whether you are taking other medicines.

High blood pressure

For most patients, the recommended initial dose is 5 to 20 mg once daily. Some patients may need a lower initial dose.

The usual long-term dose is 20 mg once daily.

Heart failure

The recommended initial dose is usually 2.5 mg once daily. Your doctor will gradually increase the dose until the appropriate dose is reached in your case. The usual long-term dose is 20 mg per day in one or two doses.

Your doctor will decide the duration of your treatment with ENALAPRIL QUALIGEN 20 mg. Do not stop treatment before then, as the expected results will not be achieved. Similarly, do not use it for longer than indicated by your doctor.

At the start of treatment, precautions should be taken due to the possibility of dizziness or vertigo.

Inform your doctor immediately if you experience these symptoms.

If you think the effect of ENALAPRIL QUALIGEN 20 mg is too strong or too weak, tell your doctor or pharmacist.

If you take more ENALAPRIL QUALIGEN than you should:

If you take more ENALAPRIL QUALIGEN than you should, contact your doctor or pharmacist immediately.

In case of overdose, the most likely symptom is a feeling of dizziness or vertigo due to a sudden or excessive drop in blood pressure.

In case of overdose or accidental ingestion, contact the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take ENALAPRIL QUALIGEN:

Continue taking ENALAPRIL QUALIGEN as prescribed by your doctor. Do not take a double dose to make up for forgotten doses.

If you have forgotten to take several doses, consult your doctor to find out how to restart treatment.

4. Possible side effects

Like all medicines, ENALAPRIL QUALIGEN can cause side effects, although not everybody gets them.

The side effects reported are listed below according to their frequency:

Very common: more than 1 in 10 patients

Common: less than 1 in 10 but more than 1 in 100 patients

Uncommon: less than 1 in 100 but more than 1 in 1,000 patients

Rare: less than 1 in 1,000 but more than 1 in 10,000 patients

Very rare: less than 1 in 10,000 patients

If they occur, the following can be detected:

Blood and lymphatic system disorders:

Uncommon: anemia (including aplastic and hemolytic anemia).

Rare: blood disorders, such as abnormally low neutrophil counts, low hemoglobin levels, reduction or complete absence of granulocytes, deficiency of all blood cell elements, bone marrow depression, lymph node disease, or abnormal immune response.

Metabolism and nutrition disorders:

Uncommon: low blood sugar levels (hypoglycemia).

Nervous system and mental disorders:

Common: headache, depression.

Uncommon: confusion, drowsiness or inability to sleep, nervousness, tingling or numbness, dizziness.

Rare: sleep disturbances, sleep problems.

Eyes disorders

Very common: blurred vision.

Cardiac and vascular disorders:

Very common: dizziness.

Common: low blood pressure (including orthostatic hypotension), fainting, chest pain, heart rhythm disturbances, angina pectoris, rapid heartbeat.

Uncommon: orthostatic hypotension (decrease in blood pressure when sitting or standing), rapid and strong heartbeats, myocardial infarction or stroke possibly due to excessively low blood pressure in high-risk patients (patients with alterations in heart and/or brain blood flow).

Rare: small arteries, usually in the fingers of the hands or feet, that produce spasms that make the skin turn pale or unevenly red to blue (Raynaud's phenomenon).

Respiratory, thoracic, and mediastinal disorders:

Very common: cough.

Common: difficulty breathing.

Uncommon: runny nasal discharge, sore throat and hoarseness, asthma.

Rare: fluid in the lungs, inflammation of the nasal mucosa, allergic inflammation of the lungs.

Gastrointestinal disorders:

Very common: nausea.

Uncommon: diarrhea, abdominal pain, altered taste.

Uncommon: intestinal obstruction, pancreatitis, vomiting, indigestion, constipation, anorexia, gastric irritation, dry mouth, oral ulcers.

Very rare: intestinal edema.

Skin and subcutaneous tissue disorders:

Common: skin rash, hypersensitivity or allergic reaction that causes swelling of the face, limbs, lips, tongue, glottis, and larynx.

Uncommon: sweating, itching, hives, hair loss.

Rare: severe skin reaction, including excessive redness of the skin, blisters, peeling of the skin.

A symptom complex has been observed that may include some of the following reactions: fever, inflammation of the blood vessels, pain and inflammation of muscles and joints, blood disorders that affect blood components, skin rash, hypersensitivity to light, and other skin effects.

Liver and biliary disorders:

Rare: liver failure, liver inflammation (hepatitis), reduction or obstruction of bile flow from the bile duct to the liver (cholestasis), yellowing of the skin (jaundice).

Kidney and urinary disorders:

Uncommon: reduced kidney function or kidney failure, presence of proteins in the urine.

Rare: reduction in the amount of urine produced per day.

Reproductive system and breast disorders:

Uncommon: impotence.

Rare: breast enlargement in men.

General disorders and administration site conditions:

Very common: weakness.

Common: fatigue.

Uncommon: muscle cramps, flushing, ringing in the ears, general malaise, fever.

Clinical laboratory tests:

Common: high potassium levels in the blood, increased creatinine levels in the blood.

Uncommon: increased urea levels in the blood, decreased sodium levels in the blood.

Rare: increased liver enzymes, increased bilirubin levels in the blood.

Stop taking ENALAPRIL QUALIGEN and consult your doctor immediately in any of the following cases:

• If your face, lips, tongue, and/or throat swell, making it difficult to breathe or swallow.
• If your hands, feet, or ankles swell.
• If you develop hives (itching and redness in some areas of the body).

You should be aware that black patients are more sensitive to this type of adverse reaction.

Reporting of side effects:If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly through the Spanish Medicines Monitoring System for Human Use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of ENALAPRIL QUALIGEN

Keep out of the reach and sight of children.

Do not use ENALAPRIL QUALIGEN after the expiry date stated on the packaging. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Return the packaging and any unused medicine to the pharmacy. If you are unsure, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

Storage conditions:

No special storage conditions are required. Store in the original packaging.

6. Additional Information

Composition of ENALAPRIL QUALIGEN 20 mg

The active ingredient is enalapril maleate. Each tablet contains 20 mg of enalapril maleate.

The other components are lactose monohydrate, sodium hydrogen carbonate (E-500), corn starch, magnesium stearate (E-470b), and red iron oxide (E-172).

Appearance of the Product and Packaging Contents

ENALAPRIL QUALIGEN is presented in the form of tablets. Each package contains 28 and 500 tablets. The tablets are pink, flat, and cylindrical, with a notch on one side and the inscription "20" on the other.

Marketing Authorization Holder

Neuraxpharm Spain, S.L.U.

Avda. Barcelona, 69

08970 Sant Joan Despí

Barcelona – SpainManufacturer

Neuraxpharm Pharmaceuticals, S.L.

Avda. Barcelona, 69

08970 Sant Joan Despí (Barcelona)

Spain

This leaflet was approved inMarch 2021.

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