Enalapril/hydrochlorothiazide Qualigen 20 mg/12.5 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

ENALAPRIL/HYDROCHLOROTHIAZIDE QUALIGEN 20 mg/12.5 mg tablets EFG

Enalapril/Hydrochlorothiazide

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 only and must not be given to other people, even if they have the same symptoms as you, because it may harm them.
• If you think any of the side effects you experience is serious, or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist.

Contents of the leaflet

1. What ENALAPRIL/HYDROCHLOROTHIAZIDE QUALIGEN 20 mg/12.5 mg tablets are and what they are used for
2. Before taking ENALAPRIL/HYDROCHLOROTHIAZIDE QUALIGEN 20 mg/12.5 mg tablets
3. How to take ENALAPRIL/HYDROCHLOROTHIAZIDE QUALIGEN 20 mg/12.5 mg tablets
4. Possible side effects
5. How to store ENALAPRIL/HYDROCHLOROTHIAZIDE QUALIGEN 20 mg/12.5 mg tablets
6. Further information

1. What ENALAPRIL/HYDROCHLOROTHIAZIDE QUALIGEN 20 mg/12.5 mg TABLETS is and what it is used for

This medicine contains two active substances, enalapril and hydrochlorothiazide, which belong to the group of antihypertensive medicines and reduce high blood pressure through different mechanisms.

The enalapril component in ENALAPRIL/HYDROCHLOROTHIAZIDE QUALIGEN is a medicine belonging to a class of medicines known as angiotensin-converting enzyme (ACE) inhibitors, which works by dilating blood vessels, allowing the heart to pump blood more easily to all parts of the body. The hydrochlorothiazide component in ENALAPRIL/HYDROCHLOROTHIAZIDE QUALIGEN belongs to a group of medicines known as thiazide diuretics (medicines that increase urine elimination). Together, enalapril and hydrochlorothiazide help lower high blood pressure.

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

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

Do not take ENALAPRIL/HYDROCHLOROTHIAZIDE QUALIGEN tablets

• If you are allergic (hypersensitive) to enalapril, hydrochlorothiazide, or any of the other components of ENALAPRIL/HYDROCHLOROTHIAZIDE QUALIGEN.
• If you are allergic to sulfonamide-derived substances. Ask your doctor if you are unsure what sulfonamide-derived medicines are.
• If you have previously been treated with a medicine of the same class as ENALAPRIL/HYDROCHLOROTHIAZIDE QUALIGEN (ACE inhibitors) and experienced allergic reactions with swelling of the face, lips, tongue, and/or throat, accompanied by 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 condition causing swelling of the face and airways, and abdominal cramps).
• If you have severe liver disease.
• If you have severe kidney disease.
• If you suffer from anuria (you do not urinate).
• If you are more than 3 months pregnant (ENALAPRIL/HYDROCHLOROTHIAZIDE QUALIGEN should also be avoided in early pregnancy – see section Pregnancy and breastfeeding).

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

Take special care with ENALAPRIL/HYDROCHLOROTHIAZIDE QUALIGEN tablets

Consult your doctor or pharmacist before starting treatment with ENALAPRIL/HYDROCHLOROTHIAZIDE QUALIGEN

• If you have had skin cancer or develop an unexpected skin lesion during treatment. Treatment with hydrochlorothiazide, particularly long-term use at high doses, may increase the risk of certain types of non-melanoma skin cancer and lip cancer. Protect your skin from exposure to sunlight and UV rays while taking ENALAPRIL/HYDROCHLOROTHIAZIDE QUALIGEN.
• If you experience vision disturbances or eye pain, which could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased intraocular pressure. These may occur within hours to a week after taking ENALAPRIL/HYDROCHLOROTHIAZIDE QUALIGEN.
• If you have previously experienced respiratory or lung problems (such as inflammation or fluid in the lungs) after taking hydrochlorothiazide. If you develop severe shortness of breath or difficulty breathing after taking ENALAPRIL/HYDROCHLOROTHIAZIDE QUALIGEN, seek medical attention immediately.

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

• If you have a heart condition involving narrowing of heart valves (mitral or aortic valve stenosis) or other factors that reduce blood flow from the left side of the heart (obstructive hypertrophic cardiomyopathy).
• If you have conditions that reduce body fluid volume or sodium levels (e.g., severe vomiting, diarrhea, or if you are taking high doses of diuretic medicines that increase urine output).
• If you have blood disorders.
• If you have diabetes and are taking antidiabetic medicines, including insulin, as a dose adjustment of your diabetes medication may be necessary. Diabetes may cause high blood potassium levels, which can be serious.
• If you have liver problems.
• If you have kidney problems (including kidney transplant), as these may lead to high blood potassium levels, which can be serious.
• If you are undergoing dialysis.
• If you are on a salt-free diet, taking potassium supplements, potassium-sparing diuretics (medicines that increase urine output), or salt substitutes containing potassium.
• If you develop an allergic reaction during treatment, with swelling of the face, lips, tongue, and/or throat, accompanied by difficulty swallowing or breathing. Note that black patients are more susceptible to this type of reaction with these medicines.
• If you are about to undergo a treatment called LDL apheresis (a procedure similar to dialysis used to remove LDL or "bad" cholesterol particles from the blood when levels are excessively high).
• If you are scheduled to undergo desensitization treatment to reduce the effects of an allergy to bee or wasp stings.
• If you have low blood pressure, as taking ENALAPRIL/HYDROCHLOROTHIAZIDE QUALIGEN, especially during the first doses, may cause a sudden drop in blood pressure (you may experience fainting or dizziness, particularly when standing up).

Before undergoing surgery or anesthesia (including at the dentist), 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.

Inform your doctor if you think you are pregnant (or might be). ENALAPRIL/HYDROCHLOROTHIAZIDE 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 at this stage (see section Pregnancy and breastfeeding).

Use of other medicines

Inform your doctor or pharmacist if you are currently 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 discontinue treatment or adjust the dose of one or more of these medicines.

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

• Antihypertensive medicines (reduce high blood pressure), for example vasodilators, beta-blockers, diuretics.
• Medicines containing potassium (including dietary salt substitutes).
• Medicines used to treat certain mental disorders, such as lithium, antipsychotics, or tricyclic antidepressants.
• Anaesthetics.
• Opioids (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), like acetylsalicylic acid, including selective cyclooxygenase-2 (COX-2) inhibitors.
• Sympathomimetic medicines (used to treat certain heart and blood vessel disorders and some cold remedies).
• 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 blood cholesterol), such as cholestyramine and colestipol.
• Antiarrhythmics (medicines used to prevent and control heart rhythm disorders), such as digitalis glycosides, quinidine, amiodarone.
• Anticholinergic medicines (which slow gastric emptying), 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 to treat viral infections), such as amantadine.
• Cytotoxic medicines (used in cancer treatment), such as cyclophosphamide and methotrexate.
• Immunosuppressants (used to prevent organ transplant rejection), such as cyclosporine.
• Antibiotics (medicines 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 may be taken before or after meals.

Alcohol may increase the hypotensive effect (blood pressure lowering) of this medicine.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medicine.

Pregnancy

You must inform your doctor if you think you are pregnant (or might be). Your doctor will normally advise you to stop taking ENALAPRIL/HYDROCHLOROTHIAZIDE QUALIGEN before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine to ENALAPRIL/HYDROCHLOROTHIAZIDE QUALIGEN. ENALAPRIL/HYDROCHLOROTHIAZIDE QUALIGEN is not recommended during 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 onwards.

Breastfeeding

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

The two active substances in ENALAPRIL/HYDROCHLOROTHIAZIDE QUALIGEN, enalapril and hydrochlorothiazide, pass into breast milk. If you are breastfeeding or intend to breastfeed, consult your doctor.

Use in children and adolescents

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

Use in the elderly

In studies where enalapril and hydrochlorothiazide were administered together, the drug effects and tolerability were similar in young adult and elderly patients with high blood pressure.

Use in athletes

Athletes are advised that this medicine contains a component that may lead to a positive result in doping control tests.

Driving and operating machinery

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

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

This medicine contains lactose. If your doctor has informed you of an intolerance to certain sugars, consult him before taking this medicine.

This medicine contains less than 23 mg of sodium (1 mmol) per tablet; thus, it is essentially “sodium-free”.

Interference with diagnostic tests

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

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

Follow exactly the administration instructions for Enalapril/Hydrochlorothiazide QUALIGEN as prescribed by your physician. Consult your doctor or pharmacist if you have any doubts.

Remember to take your medication.

Your doctor will determine the appropriate dose based on your condition and whether you are taking other medications.

The usual dose is one or two tablets taken once daily. Take Enalapril/Hydrochlorothiazide QUALIGEN every day, exactly as directed by your doctor. It is very important to continue taking this medicine for the length of 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 occurs during continued treatment. You may experience fainting or dizziness, and lying down may help. If you are concerned, consult your doctor.

Use in patients with impaired kidney function

If you have any kidney disease, your doctor will advise you on the most appropriate dose.

Method of administration

This medicine is administered orally.

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

Enalapril/Hydrochlorothiazide QUALIGEN may 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, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medication and the amount taken.

It is recommended to bring the medicine's packaging and leaflet to the healthcare professional.

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 output and/or tachycardia.

If you forget to take ENALAPRIL/HYDROCHLOROTHIAZIDE QUALIGEN tablets

You must take ENALAPRIL/HYDROCHLOROTHIAZIDE QUALIGEN exactly as prescribed by your doctor.

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

If you stop taking ENALAPRIL/HYDROCHLOROTHIAZIDE QUALIGEN tablets

Your doctor will determine how long you should take ENALAPRIL/HYDROCHLOROTHIAZIDE QUALIGEN. Do not stop treatment earlier, even if you feel better.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, ENALAPRIL/HYDROCHLOROTHIAZIDE QUALIGEN may cause adverse effects, although not everyone experiences them.

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

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

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

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

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

Very rare: (occur in less 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 (blood cells that carry oxygen)

Rare: reduction in a type of white blood cells (neutrophils), decrease in hemoglobin (protein in red blood cells that carries oxygen), decrease in platelet count in blood, decrease in hematocrit (proportion of red blood cells in blood), decrease in white blood cell count, bone marrow depression (reduced ability of the body to produce blood cells), lymph node inflammation, immune system disorders.

Endocrine disorders:

Frequency not known: syndrome of inappropriate antidiuretic hormone secretion (SIADH).

Metabolism and nutrition disorders:

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

Uncommon: low blood glucose and magnesium levels, gout

Rare: increased blood glucose

Very rare: high calcium levels in blood

Nervous system disorders:

Common: headache, syncope, taste disturbances

Uncommon: confusion, drowsiness, insomnia, tingling sensation, dizziness

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 elevated pressure [possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or acute angle-closure glaucoma]

Ear and labyrinth disorders:

Uncommon: ringing in the ears

Cardiac and vascular disorders:

Very common: dizziness

Common: drop in blood pressure associated with fainting, heart rhythm disorders, angina pectoris, tachycardia (rapid heartbeat)

Uncommon: flushing, palpitations (rapid and irregular sensation of heartbeat), myocardial infarction or stroke, possibly secondary to excessive drop in blood pressure in high-risk patients (see section "Take special care with ENALAPRIL/HYDROCHLOROTHIAZIDE QUALIGEN tablets")

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

Respiratory, thoracic and mediastinal disorders:

Very common: cough

Common: difficulty breathing

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

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

Very rare: acute respiratory difficulty (symptoms include severe shortness of breath, fever, weakness, and confusion)

Gastrointestinal disorders:

Very common: nausea

Common: diarrhea, abdominal pain

Uncommon: 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, inflammation of the tongue

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

Hepatobiliary disorders:

Rare: liver failure, hepatic necrosis (which may be fatal), liver inflammation, suppression or cessation of bile secretion, yellowing of the skin or eyes (jaundice), gallbladder inflammation (particularly in patients with pre-existing gallstones in the bile ducts)

Skin and subcutaneous tissue disorders:

Common: skin rash (exanthema)

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

Uncommon: excessive sweating, itching, urticaria, hair loss

Rare: skin redness, severe blistering or bleeding of the skin (Stevens-Johnson syndrome), severe skin redness/rash with loss of skin and hair, skin peeling, appearance of red spots on the skin, skin disorders, skin redness, blister formation on the skin, Stevens-Johnson syndrome

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

A symptomatic complex has been observed which 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, photosensitivity, or other skin manifestations may also occur.

Musculoskeletal, connective tissue and bone disorders:

Common: muscle cramps †

Uncommon: joint pain *

Renal and urinary disorders:

Uncommon: renal dysfunction (impaired kidney function), renal failure, presence of protein in urine

Rare: reduced urine output, inflammation of kidney cells

Reproductive system and breast disorders:

Uncommon: impotence

Rare: breast enlargement in men

General disorders and administration site conditions:

Very common: fatigue

Common: chest pain, tiredness

Uncommon: general malaise, fever

Investigations:

Common: elevated potassium levels in blood, increased serum creatinine

Uncommon: increased blood urea, low sodium levels in blood

Rare: increased liver enzymes, increased serum bilirubin

* Observed only with hydrochlorothiazide doses of 12.5 mg and 25 mg, as contained in ENALAPRIL/HYDROCHLOROTHIAZIDE QUALIGEN

† The frequency of muscle spasms as "common" applies to hydrochlorothiazide doses of 12.5 mg and 25 mg, as contained in ENALAPRIL/HYDROCHLOROTHIAZIDE QUALIGEN, although the actual frequency of this event is "uncommon".

Reporting of adverse effects:

If you experience any type of adverse effect, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

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 expiry date stated on the packaging. The expiry date refers to the last day of the month indicated.

No special storage conditions are required.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point at your usual pharmacy. Ask your pharmacist how to dispose of medicines and containers 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 substances 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 monohydrate lactose, sodium hydrogen carbonate (E-500), maize starch (gluten-free), pregelatinized maize starch, magnesium stearate (E-470b), and yellow iron oxide (E-172).

Appearance of the medicinal product and contents of the container

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

The score line is intended to facilitate breaking the tablet for ease of swallowing, but it is not intended to divide the tablet into equal doses.

Marketing Authorization Holder and Manufacturing Responsible Party

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

KeVaRo Group Ltd

9 Tsaritsa Eleonora Str., office 23,

1618 Sofia

Bulgaria

This leaflet was last approved in September 2022

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