ENALAPRIL/HYDROCHLOROTHIAZIDE STADA 20/12.5 mg TABLETS

2. What you need to know before you take Enalapril/Hydrochlorothiazide Stada

Do not takeEnalapril/Hydrochlorothiazide Stadaif:

• You are allergic to enalapril, hydrochlorothiazide, thiazides, or any of the other ingredients of this medication (listed in section 6).
• You are allergic to sulfonamide-derived substances. Ask your doctor if you are not sure what sulfonamide-derived medications are.
• You have been previously treated with a medication from the same group as enalapril/hydrochlorothiazide (ACE inhibitors), and you have had allergic reactions with swelling of the face, lips, tongue, and/or throat with difficulty swallowing or breathing.
• You have had such allergic reactions without a known cause, or if you have been diagnosed with hereditary or idiopathic angioedema (an immune system disorder that causes inflammation in the face and respiratory tract, and abdominal colic).
• You have severe liver disease.
• You have severe kidney disease.
• You have anuria (you do not urinate).
• You have diabetes or kidney failure and are being treated with a blood pressure medication that contains aliskiren.
• You are pregnant for more than 3 months. (It is also best to avoid enalapril/hydrochlorothiazide at the beginning of pregnancy - see pregnancy section).

• If you have taken or are currently taking sacubitril/valsartan, a medication used to treat a type of long-term (chronic) heart failure in adults, as the risk of angioedema (rapid swelling under the skin in areas such as the throat) is high.

If you are not sure if you should start taking enalapril/hydrochlorothiazide, consult your doctor.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Enalapril/Hydrochlorothiazide Stada.

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

• 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 dyspnea or severe difficulty breathing after taking enalapril/hydrochlorothiazide, go to the doctor immediately.
• If you have a heart condition that involves narrowing of the heart valves (mitral or aortic stenosis) or other factors that reduce blood flow from the left ventricle of the heart (hypertrophic 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 your doctor may need to adjust the dose of your diabetes medications. Diabetes can cause high potassium levels in the blood, which 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, which can be serious.
• If you are undergoing dialysis.
• If you follow a salt-free diet, take potassium supplements, potassium-sparing medications (medications that increase potassium levels), or salt substitutes that contain potassium or other medications that can increase blood potassium levels, such as heparin (a medication used to prevent blood clots), trimethoprim, or cotrimoxazole, also known as trimethoprim/sulfamethoxazole (medications used to treat bacterial infections).
• If you experience an allergic reaction with swelling of the face, lips, tongue, and/or throat with difficulty swallowing or breathing 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 particles from the blood in cases where it is excessively elevated).
• If you are going to undergo desensitization treatment to reduce the effect of a bee or wasp sting allergy.
• If you have low blood pressure, as the use of enalapril/hydrochlorothiazide, especially in the first doses, can cause a sudden decrease in blood pressure (you may notice it as fainting or dizziness, especially when standing up).
• Consult your doctor before starting to take enalapril/hydrochlorothiazide if you have had skin cancer or if you 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 skin and lip cancer (non-melanoma skin cancer). Protect your skin from sun and UV radiation while taking enalapril/hydrochlorothiazide.
• If you are using any of the following medications, the risk of angioedema (rapid swelling under the skin in areas such as the throat) may increase:
• Racecadotril, a medication used to treat diarrhea
• Medications used to prevent organ transplant rejection and cancer (e.g., temsirolimus, sirolimus, everolimus).
• Vildagliptin, a medication used to treat diabetes.
• Tell your doctor if you are taking any of the following medications used to treat high blood pressure:
• An angiotensin II receptor antagonist (ARB) (also known as "sartans" - e.g., valsartan, telmisartan, irbesartan), particularly if you have diabetes-related kidney problems.
• Aliskiren
• Tell your doctor if you experience a decrease in vision or eye pain, as these could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased pressure in the eye, and can occur within hours to weeks after taking enalapril/hydrochlorothiazide. If left untreated, this can lead to permanent vision loss. You may be at higher risk if you have previously been allergic to penicillin or sulfonamide.

Your doctor may monitor your kidney function, blood pressure, and blood electrolyte levels (such as potassium) at regular intervals.

See also the information under the heading "Do not take Enalapril/Hydrochlorothiazide Stada".

Before undergoing surgery or anesthesia (even at the dentist), inform your doctor or dentist that you are taking enalapril/hydrochlorothiazide, 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 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 pregnancy section).

Children and adolescents

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

Elderly patients

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

Other medications and Enalapril/Hydrochlorothiazide Stada

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medications. Your doctor may need to adjust your dose and/or take other precautions.

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

• An angiotensin II receptor antagonist (ARB) or aliskiren (see also the information under the headings "Do not take Enalapril/Hydrochlorothiazide Stada" and "Warnings and precautions")
• Antihypertensive medications (which reduce high blood pressure), such as vasodilators, beta blockers, diuretics.
• Medications containing potassium (including dietary salt substitutes), potassium-sparing diuretics, and other medications that can increase blood potassium levels (such as trimethoprim and cotrimoxazole for bacterial infections; cyclosporine, an immunosuppressive medication used to prevent organ transplant rejection; and heparin, a medication used to thin blood to prevent clots). See also the information in the "Warnings and precautions" section.
• Medications used to treat certain mental disorders, such as lithium, antipsychotics, or tricyclic antidepressants.
• Anesthetics.
• Opioids (medications used to treat severe pain).
• Medications used to treat diabetes, such as insulin or oral antidiabetics (e.g., metformin).
• Medications 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 medications (medications used to treat certain heart and blood vessel disorders and some cold medications).
• Pressor amines, such as norepinephrine.
• Muscle relaxants, such as tubocurarine.
• Thrombolytic medications (which prevent blood clot formation).
• Calcium salts and vitamin D.
• Ion exchange resins (medications used to lower blood cholesterol), 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 decrease 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.
• Procainamide (a medication used to treat heart rhythm problems)
• 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 organ transplant rejection), such as cyclosporine.
• Antibiotics (medications used to treat certain infections), such as tetracyclines, amphotericin B.
• Gold salts (used to treat rheumatic diseases such as rheumatoid arthritis).
• The simultaneous administration of mTOR inhibitors (e.g., temsirolimus, sirolimus, everolimus) may increase the risk of an allergic reaction called angioedema.
• A medication that contains a neprilysin inhibitor such as sacubitril (available in a fixed-dose combination with valsartan), racecadotril, or vildagliptin. It may increase the risk of angioedema (swelling of the face, lips, tongue, or throat with difficulty swallowing or breathing).

See also the information in the sections "Do not take Enalapril/Hydrochlorothiazide Stada" and "Warnings and precautions".

Taking Enalapril/Hydrochlorothiazide Stada with food, drinks, and alcohol

Enalapril/hydrochlorothiazide can be taken with or without food. Most people take enalapril/hydrochlorothiazide with a glass of water.

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

Pregnancy, breastfeeding, and fertility

Consult your doctor or pharmacist before using any medication.

Pregnancy

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medication.

Normally, your doctor will advise you to stop taking enalapril/hydrochlorothiazide before you become pregnant or as soon as you know you are pregnant and will advise you to take a different medication instead of enalapril/hydrochlorothiazide. Enalapril/hydrochlorothiazide 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 onwards.

Breastfeeding

Tell your doctor if you are breastfeeding or about to start breastfeeding. Enalapril/hydrochlorothiazide is not recommended in breastfeeding mothers.

The two active ingredients of enalapril/hydrochlorothiazide, enalapril and hydrochlorothiazide, pass into breast milk. If you are breastfeeding or plan to breastfeed, consult your doctor.

Driving and using machines

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

Enalapril/Hydrochlorothiazide Stada contains lactose and sodium

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

This medication contains less than 1 mmol of sodium (23 mg); that is, it is essentially "sodium-free".

Use in athletes

This medication contains hydrochlorothiazide, which may produce a positive result in doping tests.

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, as it may alter the test results.

3. How to Take Enalapril/Hydrochlorothiazide Stada

Follow the administration instructions for this medication exactly as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Remember to take your medication.

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

Take enalapril/hydrochlorothiazide every day, exactly as indicated by your doctor. It is very important that you continue taking this medication for the duration prescribed by your doctor.

The recommended dose is one or two tablets administered once a day. Take enalapril/hydrochlorothiazide every day, exactly as indicated by your doctor. It is very important that you continue taking this medication for the duration prescribed by your doctor. Do not take more tablets than prescribed.

The initial dose may cause a greater drop in blood pressure than what will occur after continued treatment. You may experience dizziness or lightheadedness, 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.

Method of administration

This medication is administered orally.

Take the enalapril/hydrochlorothiazide tablets with the help of a glass of water. Enalapril/hydrochlorothiazide can be taken before or after meals.

If you take more Enalapril/Hydrochlorothiazide Stada than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately, or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

The most likely symptoms would be dizziness or lightheadedness due to a sudden or excessive drop in blood pressure and/or excessive thirst, disorientation, decreased urine production and/or rapid heart rate.

If you forget to take Enalapril/Hydrochlorothiazide Stada

You should take enalapril/hydrochlorothiazide as prescribed. Do not take a double dose to make up for forgotten doses. Just take the next dose as usual.

If you interrupt treatment with Enalapril/Hydrochlorothiazide Stada

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

Do not stop taking your medication unless your doctor tells you to do so.

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not all people experience them.

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

Very common: (may affect more than 1 in 10 people)

Common: (may affect up to 1 in 10 people)

Uncommon: (may affect up to 1 in 100 people)

Rare: (may affect up to 1 in 1,000 people)

Very rare: (may affect up to 1 in 10,000 people)

Frequency not known: (cannot be estimated from available data)

Benign, malignant, and unspecified neoplasms (including cysts and polyps)

Unknown: skin and lip cancer (non-melanoma skin cancer).

Blood and lymphatic system disorders:

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

Rare: reduction of a type of white blood cell (neutrophils), decrease in hemoglobin (protein in red blood cells that carries 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 disorders.

Endocrine disorders:

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

Metabolism and nutrition disorders:

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

Uncommon: 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:

Common: headache, fainting, altered taste

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

Rare: paralysis (due to low potassium levels in the blood).

Psychiatric disorders:

Common: depression

Uncommon: nervousness, decreased libido*

Rare: abnormal dreams, sleep disorders.

Eye disorders:

Very common: blurred vision.

Unknown: visual disturbances, 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:

Uncommon: ringing in the ears.

Cardiac and vascular disorders:

Very common: dizziness

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

Uncommon: flushing, palpitations (rapid and irregular heartbeat), myocardial infarction or stroke, possibly secondary to excessive blood pressure reduction in high-risk patients (see section "Warnings and precautions")

Rare: changes in skin color of fingers, hands, 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 difficulty (including pneumonia and pulmonary edema), inflammation of the nasal mucosa, allergic alveolitis (inflammation of the lung alveolus due to allergy)/eosinophilic pneumonia (disease in which a type of white blood cell, called eosinophils, accumulates in the lungs).

Very rare: acute respiratory difficulty (symptoms include severe respiratory difficulty, 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, 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 stone formation).

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 in the skin (Stevens-Johnson syndrome), severe skin redness/rash with skin and hair loss, skin peeling, appearance of red spots on the skin, skin disorder, skin redness.

A symptomatic complex has been reported that may include all or some of the following symptoms: 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:

Common: muscle cramps †

Uncommon: joint pain *

Renal and urinary disorders:

Uncommon: renal dysfunction (kidney function impairment), renal failure, proteinuria

Rare: decreased urine production, kidney cell inflammation.

Reproductive system 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.

Investigations:

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

Uncommon: 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

† The frequency of muscle cramps as "common" applies to hydrochlorothiazide doses of 12.5 mg and 25 mg, as found in enalapril/hydrochlorothiazide, although the frequency of the event is "uncommon", and applies to the 6 mg hydrochlorothiazide dose as in enalapril/hydrochlorothiazide.

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 prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Enalapril/Hydrochlorothiazide Stada

Keep out of sight and reach of children.

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

Do not use this medication after the expiration date shown on the packaging after CAD. The expiration date is the last day of the month indicated.

Medications should not be thrown down the drain or into the trash. Deposit the packaging and medications you no longer need at the SIGRE Point in your pharmacy. Ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Enalapril/Hydrochlorothiazide Stada

• The active ingredients are enalapril in the form of maleate and hydrochlorothiazide.

Each tablet contains 20 mg of enalapril maleate and 12.5 mg of hydrochlorothiazide.

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

Appearance of the product and package contents

Enalapril/Hydrochlorothiazide Stada is presented in the form of yellow, elongated, biconvex tablets with a notch on one side.

The notch is only for breaking and facilitating swallowing, but not for dividing into equal doses.

Each package contains 28 or 500 (clinical package) tablets.

Only some package sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Laboratory STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Manufacturer

Neuraxpharm Pharmaceuticals, S.L.

Avda. Barcelona, 69

08970 Sant Joan Despí (Barcelona)

Spain

Date of the last revision of this prospectus:March 2024

Detailed information about this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/)