ENALAPRIL/HYDROCHLOROTHIAZIDE QUALIGEN 20 mg/12.5 mg TABLETS

2. Before taking ENALAPRIL/HYDROCHLOROTHIAZIDE QUALIGEN 20mg/12.5 mg tablets

Do not take ENALAPRIL/HYDROCHLOROTHIAZIDE QUALIGEN tablets

• If you are allergic (hypersensitive) to enalapril, hydrochlorothiazide, or any of the other ingredients of ENALAPRIL/HYDROCHLOROTHIAZIDE QUALIGEN.
• If you are allergic to sulphonamide-derived substances. Ask your doctor if you are not sure what sulphonamide-derived medicines are.
• If you have been previously treated with a medicine from the same group as ENALAPRIL/HYDROCHLOROTHIAZIDE 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 respiratory tract, and abdominal colic).
• If you have severe liver disease.
• If you have severe kidney disease.
• If you have anuria (do not urinate).
• If you are pregnant for more than 3 months (It is also best to avoid ENALAPRIL/HYDROCHLOROTHIAZIDE QUALIGEN at the beginning of pregnancy - see section Pregnancy and breastfeeding).

If you are not sure if you should start taking ENALAPRIL/HYDROCHLOROTHIAZIDE QUALIGEN, consult your doctor.

Be especially careful withENALAPRIL/HYDROCHLOROTHIAZIDEQUALIGEN tablets

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

• If you have had skin cancer or if you develop an unexpected skin lesion during treatment. Treatment with hydrochlorothiazide, in particular its long-term use at high doses, may increase the risk of certain types of skin and lip cancer (non-melanoma skin cancer). Protect your skin from sun exposure and UV rays while taking ENALAPRIL/HYDROCHLOROTHIAZIDE QUALIGEN.
• If you experience a decrease in vision or eye pain, they could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or an increase in eye pressure and can occur within a few hours to a week after taking ENALAPRIL/HYDROCHLOROTHIAZIDE 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/HYDROCHLOROTHIAZIDE QUALIGEN, go to the doctor immediately.

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

• If you have heart disease with narrowing of the heart valves (mitral or aortic stenosis) or other factors that reduce left ventricular outflow (hypertrophic obstructive cardiomyopathy).
• If you have disorders that reduce fluid volume or sodium levels in the body (for example: severe vomiting, diarrhea, or if you are being treated with high doses of diuretics).
• If you have any blood disorders.
• If you have diabetes and are taking medications to treat diabetes, including insulin, as it may be necessary to adjust the dose of the medications used to treat diabetes. Diabetes can cause high potassium levels in the blood that can be serious.
• If you have liver problems.
• If you have kidney problems (including kidney transplant), as they can cause high potassium levels in the blood that can be serious.
• If you are undergoing dialysis.
• If you follow a salt-free diet, take potassium supplements, potassium-sparing medications (medicines that increase urine production), or salt substitutes that contain potassium.
• If an allergic reaction with swelling of the face, lips, tongue, and/or throat with difficulty swallowing or breathing occurs during treatment. You should be aware that black patients 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 LDL or bad cholesterol from the blood in cases where it is excessively high).
• If you are going 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/HYDROCHLOROTHIAZIDE QUALIGEN, especially in the first doses, can cause a sudden drop in blood pressure (you may notice dizziness or fainting, 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/HYDROCHLOROTHIAZIDE QUALIGEN, as you may experience a sudden drop in blood pressure due to anesthesia.

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

Using other medicines

Tell your doctor or pharmacist if you are using or have recently used any other medicines, including those obtained without a prescription, homeopathic medicines, herbal remedies, and other health-related products, as it may be necessary to interrupt treatment or adjust the dose of one of them.

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

• Antihypertensive medicines (which reduce high blood pressure), such as vasodilators, beta blockers, diuretics.
• Potassium-containing medicines (including dietary salt substitutes).
• Medicines used to treat certain mental disorders, such as lithium, antipsychotics, or tricyclic antidepressants.
• Anesthetics.
• Narcotics (medicines used to treat severe pain).
• Medicines used to treat diabetes, such as insulin or oral antidiabetics (e.g., metformin).
• Medicines used to treat pain or certain inflammations, such as non-steroidal anti-inflammatory drugs (NSAIDs), such as acetylsalicylic acid, including selective cyclooxygenase-2 (COX-2) inhibitors.
• Sympathomimetic medicines (medicines used to treat certain heart and blood vessel disorders and some cold medicines).
• Pressor amines, such as noradrenaline.
• Muscle relaxants, such as tubocurarine.
• Thrombolytic medicines (which prevent blood clot formation).
• Calcium salts and vitamin D.
• Ion exchange resins (medicines used to lower cholesterol in the blood), such as cholestyramine and colestipol.
• Antiarrhythmics (medicines used to prevent and control heart rhythm disorders), such as digitalis glycosides, quinidine, amiodarone.
• Anticholinergic medicines (medicines that decrease gastric emptying rate), such as atropine (used before general anesthesia or to prevent spasms) or biperiden (used in patients with Parkinson's disease).
• Medicines for the treatment of gout, such as probenecid, sulfinpyrazone, and allopurinol.
• Antivirals (medicines used to treat viral infections), such as amantadine.
• Cytotoxic medicines (used to treat cancer), such as cyclophosphamide and methotrexate.
• Immunosuppressive medicines (used to prevent organ rejection in transplants), such as cyclosporine.
• Antibiotics (medicines used to treat certain infections), such as tetracyclines, amphotericin B.
• Gold salts (used to treat rheumatic diseases, such as rheumatoid arthritis).

Taking ENALAPRIL/HYDROCHLOROTHIAZIDE QUALIGEN 20 mg/12.5 mg tablets with food and drink

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

Alcohol may increase the blood pressure-lowering effect of this medicine.

Pregnancy and breastfeeding

Consult your doctor or pharmacist 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/HYDROCHLOROTHIAZIDE QUALIGEN before becoming pregnant or as soon as you know you are pregnant and will advise you to take a different medicine than ENALAPRIL/HYDROCHLOROTHIAZIDE QUALIGEN. ENALAPRIL/HYDROCHLOROTHIAZIDE QUALIGEN is not recommended during pregnancy and should not be taken if you are pregnant for more than 3 months, as it can cause serious harm to your baby if used from the third month of pregnancy.

Breastfeeding

Tell your doctor if you are breastfeeding or about to start breastfeeding. ENALAPRIL/HYDROCHLOROTHIAZIDE QUALIGEN is not recommended in breastfeeding mothers.

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

Use in children and adolescents

The safety and efficacy of Enalapril/Hydrochlorothiazide QUALIGEN have not been established in this population, so its use is not recommended in children.

Use in the elderly

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

Use in athletes

Athletes are informed that this medicine contains a component that can produce a positive result in doping tests.

Driving and using machines

It is unlikely that Enalapril/Hydrochlorothiazide QUALIGEN will affect your ability to drive or use machines. However, dizziness or fatigue may occasionally occur during treatment of high blood pressure, especially at the beginning. If you experience such effects, you should consult your doctor before performing these activities.

Important information about some of the ingredients of ENALAPRIL/HYDROCHLOROTHIAZIDE QUALIGEN 20 mg/12.5 mg tablets

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

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

Interference with diagnostic tests

If you are to undergo any diagnostic tests to assess parathyroid gland function, inform your doctor that you are being treated with Enalapril/Hydrochlorothiazide QUALIGEN, as it may alter the results.

3. How to take ENALAPRIL/HYDROCHLOROTHIAZIDE QUALIGEN 20 mg/12.5 mg tablets

Follow the instructions for administration of Enalapril/Hydrochlorothiazide QUALIGEN indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

Remember to take your medicine.

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

The normal dose is one or two tablets administered once a day. Take Enalapril/Hydrochlorothiazide QUALIGEN every day, exactly as indicated by your doctor. It is very important to continue taking this medicine for the time recommended by your doctor. Do not take more tablets than the prescribed dose.

The initial dose may cause a greater drop in blood pressure than 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 impaired renal function

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

Method of administration

This medicine is administered orally.

Take the Enalapril/Hydrochlorothiazide QUALIGEN tablets with the help of a glass of water.

Enalapril/Hydrochlorothiazide QUALIGEN can be taken before or after meals.

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

If you have taken more Enalapril/Hydrochlorothiazide QUALIGEN than you should, consult your doctor or pharmacist immediately or call the Toxicology Information Service, telephone 91 562 04 20, indicating the medicine and the amount taken.

It is recommended to take the packaging and the leaflet of the medicine to the healthcare personnel.

The most likely symptoms would be 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 forget to take ENALAPRIL/HYDROCHLOROTHIAZIDE QUALIGEN tablets

You should take ENALAPRIL/HYDROCHLOROTHIAZIDE QUALIGEN as indicated by your doctor.

Do not take a double dose to make up for forgotten doses. Just take the next dose as usual.

If you stop taking ENALAPRIL/HYDROCHLOROTHIAZIDE QUALIGEN tablets

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

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

4. Possible Adverse Effects

Like all medications, ENALAPRIL/HYDROCHLOROTHIAZIDE QUALIGEN may produce adverse effects, although not all people suffer from them.

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

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

Frequent: (occur in at least 1 in 100 and less than 1 in 10 treated patients).

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

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

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

Frequency not known (cannot be estimated from available data)

Blood and lymphatic system disorders:

infrequent: decrease in red blood cells (oxygen-transporting blood cells)

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

Endocrine disorders:

unknown frequency: syndrome of inappropriate antidiuretic hormone secretion (SIADH).

Metabolic and nutritional disorders:

frequent: high potassium levels in the blood, increased cholesterol, increased triglycerides, increased uric acid in the blood

infrequent: low glucose and magnesium levels in the blood, gout

rare: increased glucose in the blood

very rare: high calcium levels in the blood

Nervous system disorders:

frequent: headache, syncope, altered taste

infrequent: confusion, somnolence, insomnia, tingling sensation, vertigo

rare: paralysis (due to low potassium levels).

Psychiatric disorders: Frequent: depression

infrequent: nervousness, decreased libido*

rare: abnormal dreams, sleep disorders.

Eye disorders:

very frequent: blurred vision.

unknown frequency: decreased vision or eye pain due to high pressure [possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or acute angle-closure glaucoma].

Ear and labyrinth disorders:

infrequent: ringing in the ears.

Cardiac and vascular disorders:

very frequent: dizziness

frequent: low blood pressure associated with fainting, heart rhythm disorders, chest pain, tachycardia (rapid heartbeats)

infrequent: flushing, palpitations (rapid and irregular heartbeats), myocardial infarction or stroke, possibly secondary to excessive blood pressure reduction in high-risk patients (see section Take special care with ENALAPRIL/HYDROCHLOROTHIAZIDE QUALIGEN tablets)

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

Respiratory, thoracic, and mediastinal disorders:

very frequent: cough

frequent: difficulty breathing

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

rare: pulmonary infiltrates, respiratory distress (including pneumonia and pulmonary edema), nasal mucosa inflammation, allergic alveolitis (inflammation of the lung alveoli due to allergy)/eosinophilic pneumonia (disease in which a type of white blood cells, called eosinophils, accumulate in the lungs).

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

Gastrointestinal disorders:

very frequent: nausea

frequent: diarrhea, abdominal pain

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

rare: infection or inflammation of the mouth mucosa, tongue inflammation

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

Hepatobiliary disorders:

rare: liver failure, 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 bile duct stones).

Skin and subcutaneous tissue disorders:

frequent: skin rash (exanthema)

hypersensitivity/angioedema: swelling of the face, limbs, lips, tongue, glottis, and/or larynx

infrequent: excessive sweating, itching, urticaria, hair loss

rare: skin redness, severe blistering or bleeding in the skin (Stevens-Johnson syndrome), severe skin rash with skin and hair loss, skin peeling, appearance of red spots on the skin, skin alteration, skin redness, blistering on the skin, Stevens-Johnson syndrome.

unknown frequency: skin and lip cancer (non-melanoma skin cancer).

A symptomatic complex has been observed that may include some of the following reactions: fever, serositis, vasculitis, muscle inflammation/pain, joint inflammation/pain, positive antinuclear antibody test, increased erythrocyte sedimentation rate, eosinophilia, and leukocytosis. Skin rash, sun sensitivity, or other skin manifestations may also occur.

Musculoskeletal, connective tissue, and bone disorders:

frequent: muscle cramps †

infrequent: joint pain *

Renal and urinary disorders:

infrequent: renal dysfunction (kidney function alteration), renal failure, proteinuria

rare: inadequate urine secretion, kidney cell inflammation.

Reproductive system and breast disorders:

infrequent: impotence

rare: breast enlargement in men.

General disorders and administration site conditions:

very frequent: fatigue

frequent: chest pain, fatigue

infrequent: general malaise, fever.

Investigations:

frequent: high potassium levels in the blood, increased serum creatinine

infrequent: increased blood urea, low sodium levels in the blood

rare: increased liver enzymes, increased serum bilirubin.

• Only observed with hydrochlorothiazide doses of 12.5 mg and 25 mg, as found in ENALAPRIL/HYDROCHLOROTHIAZIDE QUALIGEN

† The frequency of muscle spasms as "frequent" applies to hydrochlorothiazide doses of 12.5 mg and 25 mg, as found in ENALAPRIL/HYDROCHLOROTHIAZIDE QUALIGEN, although the frequency of the event is "infrequent".

Reporting of adverse effects:

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

5. Storage of ENALAPRIL/HYDROCHLOROTHIAZIDE QUALIGEN 20 mg/12.5 mg TABLETS

Keep out of the reach and sight of children.

Do not use ENALAPRIL/HYDROCHLOROTHIAZIDE QUALIGEN after the expiration date stated 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 via wastewater or household waste. Deposit the packaging and unused medicines at the SIGRE point in your usual pharmacy. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Additional Information

Composition of ENALAPRIL/HYDROCHLOROTHIAZIDE QUALIGEN 20 mg/12.5 mg TABLETS

The active ingredients 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), corn starch (gluten-free), pregelatinized corn starch, magnesium stearate (E-470b), and yellow iron oxide (E-172).

Appearance of the product and packaging content

ENALAPRIL/HYDROCHLOROTHIAZIDE QUALIGEN 20 mg/12.5 mg is presented in packages of 28 tablets. The tablets are biconvex, elongated, yellow, and scored on one side.

The score line is for breaking and facilitating swallowing but not for dividing into equal doses.

Marketing authorization holder and manufacturer

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

This prospectus was approved inSeptember 2022

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/