Enalapril Qualigen 20 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

ENALAPRIL QUALIGEN 20 mg tablets EFG

Enalapril maleate

Read the entire leaflet carefully before you start taking this 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 you should not give it to other people, even if they have the same symptoms, as it could harm them.

• If you consider any of the side effects you experience to be severe, or if you notice any side effect not listed in this leaflet, inform your doctor or pharmacist.

What this leaflet contains:

1. What ENALAPRIL QUALIGEN is and what it is used for
2. Before you take ENALAPRIL QUALIGEN
3. How to take ENALAPRIL QUALIGEN
4. Possible side effects
5. How to store 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 hypertension (high blood pressure).
• 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 to any of the components of ENALAPRIL QUALIGEN.

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

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

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

• If you are more than 3 months pregnant. (ENALAPRIL QUALIGEN should also be avoided in early pregnancy – See Pregnancy section).

Take special care with ENALAPRIL QUALIGEN:

• If you have heart disease.

• If you have a condition affecting the blood vessels of 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 receiving treatment with diuretics (medicines that increase urine elimination).

• If you have recently experienced excessive vomiting or diarrhea.

• If you are on a salt-free diet, taking potassium supplements, potassium-sparing medicines, salt substitutes containing potassium, or medicines associated with increased blood potassium levels (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 may 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, accompanied by difficulty swallowing or breathing. Please note that patients of black race are more susceptible 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 experience fainting or dizziness, especially with initial doses and when standing up. In such cases, lying down may help).

• If you have vascular collagen disease (e.g., systemic lupus erythematosus, rheumatoid arthritis, or scleroderma), are being treated with immunosuppressive medicines, or are taking allopurinol, 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" – for example, valsartan, telmisartan, irbesartan), particularly 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 require a dose adjustment, discontinuation of ENALAPRIL QUALIGEN, or monitoring of your blood potassium levels. If you have diabetes and are taking oral antidiabetic medicines 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 (including at the dentist's office), inform your doctor or dentist that you are taking ENALAPRIL QUALIGEN, as a sudden drop in blood pressure may occur in association with anesthesia.

Please note that ENALAPRIL QUALIGEN is less effective in lowering blood pressure in black patients compared to non-black patients.

You should inform your doctor if you think you are pregnant (or could be). ENALAPRIL QUALIGEN is not recommended during early pregnancy and must 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 medicines:

Inform 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 the medicines.

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 information under the headings “Do not take ENALAPRIL QUALIGEN” and “Take special care with ENALAPRIL QUALIGEN”).
• Antihypertensive medicines (reduce high blood pressure).
• Diuretics (medicines that increase urine elimination).
• Potassium-containing medicines (including dietary salt substitutes).
• Medicines for diabetes (including oral antidiabetics and insulin).
• Lithium (a medicine used to treat certain types of depression).
• Tricyclic antidepressants.
• Antipsychotics.
• Anesthetics.
• Non-steroidal anti-inflammatory drugs (NSAIDs) (medicines used to treat pain or certain inflammations, e.g., acetylsalicylic acid).
• Sympathomimetics.
• Certain medicines for pain or arthritis, including gold therapy.
• Non-steroidal anti-inflammatory drugs (NSAIDs), including COX-2 inhibitors (medicines that reduce inflammation and may help relieve pain).

Use of ENALAPRIL QUALIGEN with food and drinks:

Food does not affect the absorption of ENALAPRIL QUALIGEN.

Alcohol enhances the hypotensive effect (blood pressure lowering) of enalapril; therefore, inform your doctor if you are consuming alcoholic beverages while taking this medicine.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medicine.

Pregnancy

Inform your doctor if you think you are pregnant (or could be). 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 recommend an alternative medicine. ENALAPRIL QUALIGEN is not recommended during early pregnancy and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if used from the third month of pregnancy onward.

Breastfeeding

Inform your doctor if you are breastfeeding or planning to breastfeed.

Breastfeeding is not recommended in newborns (first weeks after birth) while taking ENALAPRIL QUALIGEN, especially in premature infants. For older infants, 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 medication may vary.

ENALAPRIL QUALIGEN may cause dizziness or fatigue. Avoid performing tasks that require special attention (such as driving vehicles or operating machinery) until you know how you tolerate the medicine.

Important information about some of the components of ENALAPRIL QUALIGEN:

This medicine contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult with him 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 ENALAPRIL QUALIGEN

Follow exactly the administration instructions for ENALAPRIL QUALIGEN provided by your doctor. Consult your doctor or pharmacist if you have any doubts.

Remember to take your medication.

Your doctor will determine the duration of your treatment with ENALAPRIL QUALIGEN. Do not stop treatment prematurely.

ENALAPRIL QUALIGEN may be taken with meals or between meals, together 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 medications.

High blood pressure

For most patients, the recommended initial dose is usually 5 to 20 mg once daily. Some patients may require 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 for your case is reached. The usual long-term dose is 20 mg daily, taken in one or two doses.

Your doctor will decide the duration of your treatment with ENALAPRIL QUALIGEN 20 mg. Do not stop treatment early, as this may prevent you from achieving the expected results. Likewise, do not use it longer than prescribed by your doctor.

Particular caution is required at the beginning of treatment due to the possibility of experiencing 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, inform your doctor or pharmacist.

If you take more ENALAPRIL QUALIGEN than you should:

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

In case of overdose, the most likely symptom is 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, telephone: 91 562 04 20, indicating the medication and the amount taken.

If you forget to take ENALAPRIL QUALIGEN:

Continue taking ENALAPRIL QUALIGEN as prescribed. Do not take a double dose to make up for missed doses.

If you have forgotten to take several doses, consult your doctor for advice on how to resume treatment.

4. Possible adverse effects

Like all medicines, ENALAPRIL QUALIGEN may have adverse effects, although not everyone experiences them.

The reported adverse effects are listed below according to the following frequency categories:

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 may be observed:

Disorders of the blood and lymphatic system:

Uncommon: anaemia (including aplastic and haemolytic anaemia).

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

Metabolic and nutritional disorders:

Uncommon: low blood glucose levels (hypoglycaemia).

Nervous system and psychiatric disorders:

Common: headache, depression.

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

Rare: sleep disturbances, sleep problems.

Eye disorders:

Very common: blurred vision.

Heart and blood vessel disorders:

Very common: dizziness.

Common: drop in 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 up), rapid and strong heartbeats, myocardial infarction or stroke possibly due to excessively low blood pressure in high-risk patients (patients with impaired blood flow to the heart and/or brain).

Rare: small arteries, usually in the fingers or toes, causing spasms that make the skin appear pale or mottled blue-red (Raynaud's phenomenon).

Respiratory, thoracic and mediastinal disorders:

Very common: cough.

Common: difficulty breathing.

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

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

Gastrointestinal disorders:

Very common: nausea.

Uncommon: diarrhoea, abdominal pain, altered taste.

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

Rare: mouth inflammation and ulcers, tongue inflammation.

Very rare: intestinal swelling.

Skin and subcutaneous tissue disorders:

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

Uncommon: sweating, itching, hives, hair loss.

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

A symptomatic complex has been observed which may include some of the following reactions: fever, inflammation of blood vessels, muscle and joint pain and swelling, blood disorders affecting blood components, skin rash, photosensitivity and other skin effects.

Liver and biliary system disorders:

Rare: liver failure, liver inflammation (hepatitis), reduced or obstructed 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 protein in the urine.

Rare: decreased daily urine output.

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 blood potassium levels, increased blood creatinine.

Uncommon: increased blood urea, decreased blood sodium levels.

Rare: increased liver enzymes, increased blood bilirubin.

Stop taking ENALAPRIL QUALIGEN and consult your doctor immediately if any of the following occur:

• Swelling of the face, lips, tongue and/or throat causing difficulty breathing or swallowing.
• Swelling of the hands, feet or ankles.
• Appearance of urticaria (itching and redness in certain areas of the body).

Please note that black patients are more susceptible to these types of adverse reactions.

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: https://www.notificaram.es. By reporting adverse 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 container marked EXP. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

Storage conditions:

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

6. Additional Information

Composition of ENALAPRIL QUALIGEN 20 mg

The active substance 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 contents of the pack

ENALAPRIL QUALIGEN is presented in the form of tablets. Each pack contains 28 or 500 tablets. The tablets are pink-colored, cylindrical, flat, with a score on one side and the imprint “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

KeVaRo Group Ltd

9 Tsaritsa Eleonora Str.,

Office 23, Sofia 1618

Bulgaria

This leaflet was approved inMarch 2021.

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