Package Leaflet: Information for the User

ENALAPRIL/HIDROCLOROTIAZIDA QUALIGEN 20 mg/12.5 mg Tablets EFG

Enalapril/Hidroclorotiazida

Read this 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 only. Do not pass it on to others even if their symptoms are the same. It may harm them.
• If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, tell your doctor or pharmacist.

1. What ENALAPRIL/HIDROCLOROTIAZIDA QUALIGEN 20 mg/12.5 mg Tablets are and what they are used for

2. Before taking ENALAPRIL/HIDROCLOROTIAZIDA QUALIGEN 20 mg/12.5 mg Tablets

3. How to take ENALAPRIL/HIDROCLOROTIAZIDA QUALIGEN 20 mg/12.5 mg Tablets

4. Possible side effects

5. Storage of ENALAPRIL/HIDROCLOROTIAZIDA QUALIGEN 20 mg/12.5 mg Tablets

6. Additional informationl

This medicine contains two active principles, enalapril and hidroclorotiazida, which belong to the group of anti-hypertensive drugs and, through different mechanisms, reduce elevated blood pressure.

The enalapril component of ENALAPRIL/HIDROCLOROTIAZIDA QUALIGEN is a medicine that belongs to a group of drugs known as angiotensin-converting enzyme inhibitors (ACE inhibitors), which acts by dilating blood vessels to make it easier for the heart to pump blood to all parts of the body. The hidroclorotiazida component of ENALAPRIL/HIDROCLOROTIAZIDA QUALIGEN belongs to the group of drugs known as thiazide diuretics (medicines that increase the elimination of urine). Together, enalapril and hidroclorotiazida help to reduce elevated blood pressure.

Your doctor has prescribed ENALAPRIL/HIDROCLOROTIAZIDA QUALIGEN to treat hypertension (high blood pressure) because it is not adequately controlled with enalapril or an ACE inhibitor alone.

Do not take ENALAPRIL/HIDROCLOROTIAZIDA QUALIGEN tablets

• If you are allergic (hypersensitive) to enalapril, to hydrochlorothiazide or to any of the other ingredients of ENALAPRIL/HIDROCLOROTIAZIDA QUALIGEN.
• If you are allergic to sulfonamide derivatives. Ask your doctor if you are unsure what sulfonamide derivatives are.
• If you have previously been treated with a medicine from the same group as ENALAPRIL/HIDROCLOROTIAZIDA 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 had such allergic reactions without a known cause, or if you have been diagnosed with hereditary or idiopathic angioedema (a disease that causes inflammation in the face and airways, and abdominal cramps).
• If you have severe liver disease.
• If you have severe kidney disease.
• If you have anuria (you do not urinate).
• If you are more than 3 months pregnant (It is also best to avoid ENALAPRIL/HIDROCLOROTIAZIDA QUALIGEN at the beginning of pregnancy - see Pregnancy section).

If you are unsure whether you should start taking ENALAPRIL/HIDROCLOROTIAZIDA QUALIGEN, consult your doctor.

Be especially careful with ENALAPRIL/HIDROCLOROTIAZIDA QUALIGEN tablets

Consult your doctor or pharmacist before starting to take ENALAPRIL/HIDROCLOROTIAZIDA QUALIGEN.

• Si you have had skin cancer or if a skin lesion appears unexpectedly during treatment. The treatment with hydrochlorothiazide, particularly long-term use at high doses, may increase the risk of certain types of skin cancer and lip cancer (non-melanoma skin cancer). Protect your skin from the sun and UV rays while taking ENALAPRIL/HIDROCLOROTIAZIDA QUALIGEN.
• If you experience a decrease in vision or eye pain, it may be a symptom of fluid accumulation in the vascular layer of the eye (choroidal effusion) or an increase in eye pressure, which can occur within a few hours to a week after taking ENALAPRIL/HIDROCLOROTIAZIDA QUALIGEN.
• If you have had respiratory or pulmonary problems (such as inflammation or fluid in the lungs) after taking hydrochlorothiazide in the past. If you experience severe shortness of breath or difficulty breathing after taking ENALAPRIL/HIDROCLOROTIAZIDA QUALIGEN, seek medical attention immediately.

Your doctor may need to adjust your dose of ENALAPRIL/HIDROCLOROTIAZIDA QUALIGEN or monitor your potassium levels in the blood in the following situations:

• If you have a heart disease that involves narrowing of the heart valves (mitral or aortic stenosis) or other factors that reduce blood flow from the left heart chamber (hypertrophic obstructive cardiomyopathy).
• If you have conditions that reduce the volume of fluids or the level of sodium in the body (e.g. intense vomiting, diarrhea, or if you are taking high doses of medications that increase urine production).
• If you have any blood abnormalities.
• If you have diabetes and are taking medications to treat diabetes, including insulin, as you may need to adjust the dose of your diabetes medications. Diabetes can cause high levels of potassium in the blood, which can be serious.
• If you have liver problems.
• If you have kidney problems (including kidney transplant), as these can cause high levels of potassium in the blood, which can be serious.
• If you are undergoing dialysis.
• If you are following a low-sodium diet, taking potassium supplements, potassium-sparing medications (medications that increase urine production), or salt substitutes that contain potassium.
• If you experience an allergic reaction with swelling of the face, lips, tongue and/or throat with difficulty swallowing or breathing. Note that patients of black race are more sensitive to this type of medication.
• If you are about to undergo a treatment called LDL apheresis (a procedure similar to dialysis, to remove from the blood LDL particles or bad cholesterol in cases where it is excessively elevated).
• If you are about to undergo desensitization treatment to reduce the effect of an allergy to bee or wasp stings.
• If you have low blood pressure, as the use of ENALAPRIL/HIDROCLOROTIAZIDA QUALIGEN, especially in the first doses, can cause a sudden drop in blood pressure (you may feel dizzy or lightheaded, especially when standing up).

Before undergoing surgery or anesthesia (even at the dentist's office), inform your doctor or dentist that you are taking ENALAPRIL/HIDROCLOROTIAZIDA QUALIGEN, as you may experience a sudden drop in blood pressure due to the anesthesia.

You should inform your doctor if you think you may be pregnant (or could be). ENALAPRIL/HIDROCLOROTIAZIDA QUALIGEN is not recommended at the beginning of pregnancy and should not be used if you are more than 3 months pregnant, as it can cause serious harm to your baby if used in this stage (see Pregnancy and breastfeeding section).

Use of other medications

Inform your doctor or pharmacist if you are using or have recently used other medications, including those purchased without a prescription, homeopathic, herbal, and other health-related products, as you may need to interrupt treatment or adjust the dose of one of them.

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

• Anti-hypertensive medications (reduce high blood pressure), such as vasodilators, beta-blockers, diuretics.
• Medications with potassium (including salt substitutes).
• Medications used to treat certain mental disorders such as lithium, antipsychotics, or tricyclic antidepressants.
• Anesthetics.
• Opioids (medications used to treat intense pain).
• Medications used to treat diabetes, such as insulin or oral antidiabetic medications (e.g. metformin).
• Medications used to treat pain or certain inflammation, such as non-steroidal anti-inflammatory drugs (NSAIDs), such as aspirin, including selective COX-2 inhibitors.
• Sympathomimetic medications (medications used to treat certain heart and blood vessel disorders and some medications for colds).
• Amines, such as noradrenaline.
• Muscle relaxants, such as tubocurarine.
• Thrombolytic medications (that prevent blood clot formation).
• Calcium salts and vitamin D.
• Ionic exchange resins (medications used to reduce cholesterol in the blood), such as cholestyramine and colestipol.
• Antiarrhythmic medications (used to prevent and control heart rhythm disorders), such as digitalis glycosides, quinidine, amiodarone.
• Anticholinergic medications (medications that reduce gastric emptying rate), such as atropine (used before general anesthesia or to prevent spasms) or biperiden (used in patients with Parkinson's disease).
• Medications used to treat gout, such as probenecid, sulfinpyrazone, and allopurinol.
• Antiviral medications (used to treat viral infections), such as amantadine.
• Cytotoxic medications (used to treat cancer), such as cyclophosphamide and methotrexate.
• Immunosuppressive medications (used to prevent rejection in organ transplants), such as cyclosporine.
• Antibiotics (used to treat certain infections), such as tetracyclines, amphotericin B.
• Gold salts (used to treat rheumatic diseases such as rheumatoid arthritis).

Take ENALAPRIL/HIDROCLOROTIAZIDA QUALIGEN 20 mg/12.5 mg tablets with food and drinks

ENALAPRIL/HIDROCLOROTIAZIDA QUALIGEN can be taken before or after meals.

Alcohol may increase the hypotensive effect of this medication.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medication.

Pregnancy

You should inform your doctor if you think you may be pregnant (or could be). Normally, your doctor will advise you to stop taking ENALAPRIL/HIDROCLOROTIAZIDA 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/HIDROCLOROTIAZIDA QUALIGEN. ENALAPRIL/HIDROCLOROTIAZIDA QUALIGEN is not recommended during pregnancy and should not be taken if you are more than 3 months pregnant, as it can cause serious harm to your baby if used from the third month of pregnancy.

Breastfeeding

Inform your doctor if you are breastfeeding or are about to start breastfeeding. ENALAPRIL/HIDROCLOROTIAZIDA QUALIGEN is not recommended for mothers who are breastfeeding.

The two active ingredients of ENALAPRIL/HIDROCLOROTIAZIDA QUALIGEN, enalapril and hydrochlorothiazide, pass into breast milk. If you are breastfeeding your baby or plan to do so, consult your doctor.

Use in children and adolescents

The safety and efficacy of Enalapril/Hidroclorotiazida QUALIGEN have not been established in this age group, so it is not recommended for use in children.

Use in the elderly

In studies where enalapril and hydrochlorothiazide were taken together, the effect of the medications and tolerability were similar in young adult patients and elderly patients with high blood pressure.

Use in athletes

Inform athletes that this medication contains a component that can produce a positive result in doping control tests.

Driving and operating machinery

It is unlikely that Enalapril/Hidroclorotiazida QUALIGEN will affect your ability to drive or operate machinery. However, you may occasionally experience dizziness or fatigue during treatment for high blood pressure, especially at the beginning. If you experience these effects, consult your doctor before engaging in these activities.

Important information about some of the components of ENALAPRIL/HIDROCLOROTIAZIDA QUALIGEN 20 mg/12.5 mg tablets

This medication contains lactose. If your doctor has told you that you have a certain sugar intolerance, 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".

Interference with diagnostic tests

If you need to undergo any diagnostic tests to evaluate parathyroid gland function, inform your doctor that you are taking Enalapril/Hidroclorotiazida QUALIGEN, as it may alter the results.

Follow exactly the administration instructions forEnalapril / HidroclorThiazideQUALIGENas indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

Remember to take your medication.

Your doctor will decide on the appropriate dose, depending on your condition and whether you are taking other medications.

The usual dose is one or two tablets taken once a day. TakeEnalapril/HidroclorThiazideQUALIGENevery day, exactly as indicated by your doctor. It is very important to continue taking this medication for the recommended time by your doctor. Do not take more tablets than the prescribed dose.

The initial dose may cause a greater drop in blood pressure than what will occur after continued treatment. You may notice dizziness or fainting, and lying down may help. If you are concerned, consult your doctor.

Use in patients with altered kidney function

If you have any kidney disease, your doctor will indicate the most suitable dose.

Administration form

This medication is administered orally.

Take the tablets ofEnalapril/HidroclorThiazideQUALIGENwith the help of a glass of water.

Enalapril/HidroclorThiazideQUALIGENcan be taken before or after meals.

If you take more ENALAPRIL/HIDROCLOROTIAZIDE QUALIGEN tablets than you should

If you have taken moreEnalapril/HidroclorThiazideQUALIGENthan you should, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount taken.

It is recommended to bring the packaging and the medication leaflet to the healthcare staff.

The most likely symptoms would be a feeling of dizziness or vertigo due to a sudden or excessive drop in blood pressure and/or excessive thirst, disorientation, decreased urine production, and/or tachycardia.

If you forgot to take ENALAPRIL/HIDROCLOROTIAZIDE QUALIGEN tablets

You should takeENALAPRIL/HIDROCLOROTIAZIDE QUALIGENas indicated by your doctor.

Do not take a double dose to compensate for the missed doses.Limit yourself to taking the next dose in the usual manner.

If you interrupt the treatment with ENALAPRIL/HIDROCLOROTIAZIDE QUALIGEN tablets

Your doctor will indicate the duration of your treatment withENALAPRIL/HIDROCLOROTIAZIDE QUALIGEN. Do not stop treatment before, even if you feel better.

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

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

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

Very common: (occur in at least 1 in 10 patients treated).

Common: (occur in at least 1 in 100 and fewer than 1 in 10 patients treated).

Uncommon: (occur in at least 1 in 1,000 and fewer than 1 in 100 patients treated).

Rare: (occur in at least 1 in 10,000 and fewer than 1 in 1,000 patients treated).

Very rare: (occur in fewer than 1 in 10,000 patients treated).

Frequency not known (cannot be estimated from available data)

Blood and lymphatic system disorders:

Uncommon: decrease in red blood cells (cells that transport oxygen)

Rare: reduction of a type of white blood cell (neutrophils), decrease in hemoglobin (protein in red blood cells that transports oxygen), decrease in platelets in blood, decrease in hematocrit (proportion of red blood cells in blood), decrease in white blood cells, depression of the bone marrow (decrease in the body's ability to form blood cells), inflammation of lymph nodes, immune system diseases.

Endocrine disorders:

Unknown: syndrome of inadequate secretion of antidiuretic hormone (SIADH).

Metabolism and nutrition disorders:

Common: elevated potassium levels in blood, increased cholesterol, increased triglycerides, increased uric acid in blood

Uncommon: low glucose and magnesium levels in blood, gout

Rare: increased glucose levels in blood

Very rare: elevated calcium levels in blood

Nervous system disorders:

Common: headache, dizziness, altered taste

Uncommon: confusion, drowsiness, insomnia, numbness, vertigo

Rare: paralysis (due to low potassium levels).

Psychiatric disorders: Common: depression

Uncommon: nervousness, decreased libido*

Rare: abnormal dreams, sleep disorders.

Eye disorders:

Very common: blurred vision.

Frequency not known: decreased vision or eye pain due to high pressure [possible signs of fluid accumulation in the vascular layer of the eye (choroidal hemorrhage) or acute angle-closure glaucoma].

Ear and labyrinth disorders:

Uncommon: ringing in the ears.

CARDIOVASCULAR DISORDERS:

Very common: dizziness

Common: hypotension associated with fainting, cardiac rhythm disorders, angina pectoris, tachycardia (rapid heartbeats)

Uncommon: flushing, palpitations (sensation of irregular heartbeats), myocardial infarction or stroke, possibly secondary to excessive hypotension in high-risk patients (see section Be careful with ENALAPRIL/HIDROCLOROTIAZIDA QUALIGEN tablets)

Rare: changes in skin color of fingers, hands, feet, nose, or ears (Raynaud's phenomenon).

Respiratory, thoracic, and mediastinal disorders:

Very common: cough

Common: shortness of breath

Uncommon: mucus secretion, sore throat, and hoarseness, bronchospasm (difficulty breathing) and asthma

Rare: pulmonary infiltrates, respiratory distress (including pneumonia and pulmonary edema), inflammation of nasal mucosa, allergic alveolitis (inflammation of the alveolar lung by allergy)/eosinophilic pneumonia (disease in which a type of white blood cell, called eosinophils, accumulates in the lungs).

Very rare: acute respiratory distress (signs include severe respiratory distress, fever, weakness, and confusion).

Gastrointestinal disorders:

Very common: nausea

Common: diarrhea, abdominal pain

Uncommon: intestinal obstruction with intense pain, pancreatitis, vomiting, digestive discomfort, constipation, loss of appetite, gastric irritation, dry mouth, peptic ulcer, flatulence (gas)*

Rare: infection or inflammation of the mucous membrane of the mouth, inflammation of the tongue

Very rare: intestinal angioedema (inflammation of the intestinal wall).

Hepatobiliary disorders:

Rare: liver insufficiency, liver necrosis (which can be fatal), liver inflammation, suppression or cessation of bile secretion, yellowing of the skin or eyes, inflammation of the gallbladder (particularly in patients with pre-existing formation of stones in the bile ducts).

Skin and subcutaneous tissue disorders:

Common: skin rash (exanthema)

Hypersensitivity/angioneurotic edema: swelling of the face, extremities, lips, tongue, glottis, and/or larynx

Uncommon: excessive sweating, itching, urticaria, hair loss

Rare: severe skin redness, severe blistering or hemorrhaging in the skin (Stevens-Johnson syndrome), severe skin redness/eruption with skin and hair loss, skin peeling, appearance of red spots on the skin, skin alteration, severe skin redness, vesicles on the skin, Stevens-Johnson syndrome.

Frequency not known: skin cancer and lip cancer (non-melanoma skin cancer).

A complex of symptoms has been observed that may include some of the following reactions: fever, serositis, vasculitis, muscle and joint inflammation, positive antinuclear antibodies test, increased erythrocyte sedimentation rate, eosinophilia, and leukocytosis. It may also cause skin rash, sensitivity to sunlight, or other skin manifestations.

Musculoskeletal, connective tissue, and bone disorders:

Common: muscle cramps †

Uncommon: joint pain *

Renal and urinary disorders:

Uncommon: renal dysfunction (alteration of kidney function), renal insufficiency, presence of proteins in urine

Rare: inadequate urine secretion, inflammation of kidney cells.

Reproductive and breast disorders:

Uncommon: impotence

Rare: breast enlargement in men.

General disorders and administration site conditions:

Very common: fatigue common: chest pain, fatigue

Uncommon: general malaise, fever.

Complementary examinations:

Common: elevated potassium levels in blood, increases in serum creatinine

Uncommon: increases in blood urea, low sodium levels in blood

Rare: increases in liver enzymes, increases in serum bilirubin.

* Only observed with hydrochlorothiazide doses of 12.5 mg and 25 mg, as found in ENALAPRIL/HIDROCLOROTIAZIDA QUALIGENQUALIGEN

† The frequency of muscle spasms as "common" applies to hydrochlorothiazide doses of 12.5 mg and 25 mg, as found in ENALAPRIL/HIDROCLOROTIAZIDA QUALIGENQUALIGEN, although the frequency of the event is "uncommon".

Reporting of side effects:

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Vigilance of Medicines for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep out of the reach and sight of children.

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

No special storage conditions are required.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and unused medicines at your local SIGRE collection point at your usual pharmacy. Ask your pharmacist how to dispose of the packaging and unused medicines. This will help protect the environment.

Composition of ENALAPRIL/HIDROCLOROTIAZIDA QUALIGEN 20 mg/12,5 mg TABLETS

The active principles are enalapril, in the form of maleate, and hydrochlorothiazide. Each tablet contains 20 mg of enalapril and 12.5 mg of hydrochlorothiazide.

The other components are lactose monohydrate, sodium hydrogen carbonate (E-500), cornstarch (gluten-free), pregelatinized cornstarch, magnesium stearate (E-470b), and yellow iron oxide (E-172).

Appearance of the product and contents of the package

ENALAPRIL/HIDROCLOROTIAZIDA QUALIGEN20 mg/12,5 mg is presented in packages of 28 tablets. The tablets are biconvex, elongated, yellow in color, and scored on one of their faces.

The score serves to break and facilitate swallowing but not to divide into equal doses.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Neuraxpharm Spain, S.L.U.

Avda. Barcelona, 69

08970 Sant Joan Despí

Barcelona – Spain

Responsible for manufacturing

Neuraxpharm Pharmaceuticals, S.L.

Avda. Barcelona, 69

08970 Sant Joan Despí (Barcelona)

Spain

This leaflet was approved inSeptember 2022

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/