Leaflet: information for the user

ENALAPRIL QUALIGEN 20 mg tablets EFG

Enalapril maleate

Read this leaflet carefully before you start to take the medicine.

• 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 and should not be given to others, even if they have the same symptoms, as it may harm them.
• If you think any of the side effects are serious or if you notice any side effects not mentioned in this leaflet, tell your doctor or pharmacist.

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. Additional information

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

ENALAPRIL QUALIGEN is indicated for:

- Treatment of hypertension (high blood pressure).

- Treatment of symptomatic heart failure.

- Prevention of symptomatic heart failure.

Do not take ENALAPRIL QUALIGEN:

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

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

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

• If you have diabetes or kidney insufficiency and are being treated with a medication to lower blood pressure that contains aliskirén.

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

Be especially careful with ENALAPRIL QUALIGEN:

• If you have heart disease.
• If you have a disease that affects the blood vessels of the brain.
• If you present with blood disorders such as low white blood cell count (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 receiving treatment with diuretics (medications that increase urine elimination).
• If you have recently had excessive vomiting or diarrhea.
• If you are following a low-sodium diet, taking potassium supplements, medications that conserve potassium, 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 problem (including kidney transplant), as these can lead to high potassium levels in the blood that 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 a desensitization treatment to reduce the effect of an allergy to bee or wasp stings.
• If you have low blood pressure (you may feel dizzy or lightheaded, especially at the beginning of treatment and when standing up. In these cases, lying down may help).
• If you have vascular collagen disease (e.g., lupus erythematosus, rheumatoid arthritis, or scleroderma), are being treated with immunosuppressive medications, are taking allopurinol or procainamide, or any combination of these.

•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, valsartán, telmisartán, irbesartán), particularly if you have kidney problems related to diabetes.

- aliskirén

Your doctor may need to monitor your kidney function, blood pressure, and electrolyte levels (e.g., potassium) at regular intervals.

Inform your doctor in all these cases, as you may need to adjust your dose or discontinue ENALAPRIL QUALIGEN or monitor your potassium levels in the blood. If you have diabetes and are taking oral antidiabetic medications 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 reduces blood pressure in black patients less effectively than in non-black patients.

Inform your doctor if you think you may be pregnant. ENALAPRIL QUALIGEN is not recommended at the beginning of pregnancy and should not be used if you are more than 3 months pregnant, as it may cause serious harm to your baby if used during this period (see Pregnancy section).

Use of other medications:

Inform your doctor or pharmacist if you are using or have recently used any other medication, including those purchased without a prescription.

Certain medications may interact with ENALAPRIL QUALIGEN; your doctor may need to modify your dose and/or take other precautions or discontinue one of them.

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

• An angiotensin II receptor antagonist (ARA) or aliskirén (see also the information under the headings “Do not take ENALAPRIL QUALIGEN” and “Be especially careful with ENALAPRIL QUALIGEN”).
• Antihypertensive medications (reduce elevated blood pressure).
• Diuretics (medications that increase urine elimination).
• Medications with potassium (including salt substitutes).
• Diabetes medications (including oral antibiotics and insulin).
• Lithium (medication used to treat certain types of depression).
• Tricyclic antidepressants.
• Antipsychotics.
• Anesthetics.
• Nonsteroidal anti-inflammatory drugs (NSAIDs) (medications for pain or certain inflammation, e.g., acetylsalicylic acid).
• Sympathomimetics.
• Certain medications for pain or arthritis, including gold treatment.
• Nonsteroidal anti-inflammatory drugs (NSAIDs), including COX-2 inhibitors (medications that reduce inflammation and can be used to help alleviate pain).

Use of ENALAPRIL QUALIGEN with food and beverages:

Food does not affect the absorption of ENALAPRIL QUALIGEN.

Alcohol potentiates the hypotensive effect (reduction of blood pressure) of enalapril, so inform your doctor if you are taking beverages that contain alcohol while taking this medication.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medication.

Pregnancy

Inform your doctor if you think you may be pregnant. Your doctor will usually advise you to stop taking ENALAPRIL QUALIGEN before becoming pregnant or as soon as you know you are pregnant and will advise you to take a different medication 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

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

While taking ENALAPRIL QUALIGEN, it is not recommended to breastfeed newborns (first weeks after birth), and especially 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 operating machinery:

Individual responses to medication can vary.

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

Important information about some of the components of ENALAPRIL QUALIGEN:

This medication contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with them 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 for ENALAPRIL QUALIGEN as indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

Remember to take your medication.

Your doctor will inform you of the duration of your treatment with ENALAPRIL QUALIGEN. Do not discontinue treatment before.

ENALAPRIL QUALIGEN can be taken with meals or between them along with a glass of water.

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

Hypertension

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

The usual long-term dose is 20 mg once a day.

Heart Failure

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

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

Caution should be exercised at the beginning of treatment due to the possibility of dizziness or vertigo appearing.

Inform your doctor immediately if you experience these symptoms.

If you estimate that the action of ENALAPRIL QUALIGEN 20 mg is too strong or weak, inform your doctor or pharmacist.

If you take more ENALAPRIL QUALIGEN than you should:

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

In case of an 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, consult the Toxicological Information Service, phone: 91 562 04 20 indicating the medication and the amount taken.

If you forget to take ENALAPRIL QUALIGEN:

You should continue taking ENALAPRIL QUALIGEN as prescribed. Do not take a double dose to compensate for the missed doses.

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

Like all medicines, ENALAPRIL QUALIGEN can have side effects, although not everyone will experience them.

The registered side effects are detailed below according to the following frequencies:

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

In the event of occurrence, the following may 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 cells, bone marrow depression, lymph node disease, or abnormal immune response.

Metabolism and nutrition disorders:

Uncommon: low blood sugar (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.

Eye disorders:

Very common: blurred vision.

Cardiac and vascular disorders:

Very common: dizziness.

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

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

Rare: small arteries, usually in the hands or feet, that produce spasms causing pale or unevenly colored skin (Raynaud's phenomenon).

Respiratory, thoracic, and mediastinal disorders:

Very common: cough.

Common: breathing difficulties.

Uncommon: nasal mucus discharge, sore throat, hoarseness, asthma.

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

Gastrointestinal disorders:

Very common: nausea.

Uncommon: diarrhea, abdominal pain, taste disturbances.

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

Rare: mouth and tongue inflammation.

Very rare: intestinal swelling.

Skin and subcutaneous tissue disorders:

Common: skin rash, hypersensitivity or allergic reaction causing facial, limb, lip, tongue, glottis, and larynx swelling.

Uncommon: sweating, itching, hives, hair loss.

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

A complex of symptoms has been observed that may include some of the following reactions: fever, blood vessel inflammation, muscle and joint pain, blood disorders affecting blood components, skin rash, light sensitivity, and other skin effects.

Liver and biliary tract disorders:

Rare: liver insufficiency, hepatitis, reduced or obstructed bile flow from the bile duct to the liver (cholestasis), yellow skin discoloration (jaundice).

Renal and urinary disorders:

Uncommon: reduced kidney function or renal insufficiency, proteinuria.

Rare: reduced urine production per day.

Reproductive and mammary disorders:

Uncommon: impotence.

Rare: breast enlargement in men.

General disorders and administration site conditions:

Very common: weakness.

Common: fatigue.

Uncommon: muscle cramps, flushing, ear noises, general discomfort, fever.

Clinical laboratory tests::

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

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

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

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

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

Reporting of adverse reactions:
If you experience any type of adverse reaction, consult your doctor or pharmacist, even if it is a possible adverse reaction not listed in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicinal Products for Human Use:https://www.notificaram.es. By reporting adverse reactions, you can contribute to providing more information on the safety of this medication.

Keep out of reach and sight of children.

Do not use ENALAPRIL QUALIGEN after the expiration date that appears on the packaging CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and medicines you no longer need at the SIGRE point of the pharmacyAsk your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

Storage Conditions:

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

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), cornstarch, magnesium stearate (E-470b), and iron oxide red (E-172).

Appearance of the product and contents of the package

ENALAPRIL QUALIGEN is presented in the form of tablets. Each package contains 28 and 500 tablets. The tablets arepink, flat, cylindrical, with a groove on one face and the inscription “20”on the other.

Holder of the marketing authorization

Neuraxpharm Spain, S.L.U.

Avda. Barcelona, 69

08970 Sant Joan Despí

Barcelona – SpainResponsible for manufacturing

Neuraxpharm Pharmaceuticals, S.L.

Avda. Barcelona, 69

08970 Sant Joan Despí (Barcelona)

Spain

This leaflet was approved inMarch 2021.

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