Leaflet: information for the user

Enalapril/Hidroclorotiazida STADA 20 mg/12,5 mg tablets EFG

Enalapril maleate/ Hidroclorotiazida

Read this leaflet carefully before you start taking this medicine, because it contains important information for you.

-Keep this leaflet, as you may need to read it again.

-If you have any questions, consult your doctor or pharmacist.

-This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.

-If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1.What Enalapril/Hidroclorotiazida Stada is and what it is used for

2.What you need to know before you start taking Enalapril/Hidroclorotiazida Stada

3.How to take Enalapril/Hidroclorotiazida Stada

4.Possible side effects

5.Storage of Enalapril/Hidroclorotiazida Stada

6.Contents of the pack and additional information

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

The enalapril component of Enalapril/Hidroclorotiazida Stada is a medication that belongs to a group of medications 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 belongs to the group of medications known as thiazide diuretics (medications that increase the elimination of urine). Together, enalapril and hidroclorotiazida help to decrease elevated blood pressure.

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

Do not takeEnalapril/Hidroclorotiazida Stada:

• If you areallergictoenalapril, to hidroclorotiazida, to thiazidesor to any of the other components of this medication (included in section 6).
• If you are allergic to sulfonamide derivatives. Ask your doctor if you are not sure what sulfonamide derivatives are.
• If you have been previously treated with a medication from the same group as enalapril/hidroclorotiazida (ACE inhibitors), and you 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 of the immune system that causes inflammation in the face and respiratory tracts, and abdominal cramps).
• If you have any severe liver disease.
• If you have any severe kidney disease.
• If you have anuria (do not urinate).
• If you have diabetes or renal insufficiency and are being treated with a medication to lower blood pressure that contains aliskireno.
• If you are more than 3 months pregnant. (It is also better to avoid enalapril/hidroclorotiazida at the beginning of pregnancy - see pregnancy section).

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

If you are unsure whether you should start taking enalapril/hidroclorotiazida, consult your doctor.

Warnings and precautions

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

In the following situations, your doctor may need to adjust your enalapril/hidroclorotiazida dose or monitor your potassium level in the blood:

• If you have had respiratory or pulmonary problems (such as inflammation or fluid in the lungs) after taking hidroclorotiazida in the past. If you experience severe shortness of breath or difficulty breathing after taking enalapril/hidroclorotiazida, seek medical attention immediately.
• If you have a heart disease that involves narrowing of the heart valves (mitral or aortic stenosis) or other factors that reduce blood flow to 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 (for example: intense vomiting, diarrhea, or if you are being treated with 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 the diabetes medications. Diabetes can cause high levels of potassium in the blood that can be severe.
• If you have liver problems.
• If you have kidney problems (including kidney transplant), as these can cause high levels of potassium in the blood that can be severe.
• If you are undergoing dialysis.
• If you are following a low-sodium diet, taking potassium supplements, potassium-sparing medications (medications that increase potassium levels), or salt substitutes that contain potassium, or other medications that may increase potassium levels in the blood, such as heparin (a medication used to prevent blood clots), trimethoprim, or 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. 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 LDL or bad cholesterol particles from the blood in cases where it is excessively elevated).
• If you are about to undergo a 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, especially in the first doses, can cause a sudden drop in blood pressure (you may feel dizzy or lightheaded, especially when standing up).
• Consult your doctor before starting to take enalapril/hidroclorotiazida if you have had skin cancer or if you develop an unexpected skin lesion during treatment. The treatment with hidroclorotiazida, particularly its 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 sun exposure and UV rays while taking enalapril/hidroclorotiazida.
• 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:
• racecadotrilo, a medication used to treat diarrhea
• medications used to prevent organ transplant rejection and for cancer (e.g., temsirólimus, sirólimus, everólimus).
• vildagliptina, a medication used to treat diabetes.
• Inform your doctor if you are taking any of the following medications used to treat high blood pressure:
• an angiotensin II receptor antagonist (ARA) (also known as "sartanes" - for example, valsartán, telmisartán, irbesartán), particularly if you have kidney problems related to diabetes.
• aliskireno
• Inform your doctor if you experience a decrease in vision or eye pain, which may be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased eye pressure, and may occur within a few hours to several weeks after taking enalapril/hidroclorotiazida. If left untreated, this can lead to permanent vision loss. You may be at a higher risk of developing this if you have previously had an allergy to penicillin or sulfonamide.

Your doctor may need to monitor your renal function, blood pressure, and electrolyte levels in the blood (e.g., potassium) at regular intervals.

See also the information under the heading “Do not take Enalapril/Hidroclorotiazida Stada”.

Before undergoing surgery or anesthesia (including dental consultation), inform your doctor or dentist that you are taking enalapril/hidroclorotiazida, 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 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 severe damage to your baby if used in this stage (see pregnancy section).

Children and adolescents

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

Older adults

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

Othermedicationsand Enalapril/Hidroclorotiazida Stada

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication. Your doctor may need to modify your dose and/or take other precautions.

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

• An angiotensin II receptor antagonist (ARA) or aliskireno (see also the information under the headings “Do not take Enalapril/Hidroclorotiazida Stada” and “Warnings and precautions”)
• Anti-hypertensive medications (reduce elevated blood pressure), for example vasodilators, beta-blockers, diuretics.
• Medications with potassium (including salt substitutes), potassium-sparing diuretics, and other medications that may increase potassium levels in the blood (e.g., trimethoprim and cotrimoxazole for bacterial infections; ciclosporina, an immunosuppressant used to prevent organ transplant rejection; and heparin, a medication used to prevent blood 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 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 nonsteroidal anti-inflammatory drugs (NSAIDs), such as acetylsalicylic acid, including selective COX-2 inhibitors.
• Sympathomimetics (medications used in the treatment of certain heart and blood vessel disorders and some medications for colds).
• Amines pressors, such as noradrenaline.
• Muscle relaxants, such as tubocurarina.
• 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.
• Procainamide (medication used to treat heart rhythm disorders)
• Antivirals (medications used to treat viral infections), such as amantadine.
• Cytotoxic medications (used to treat cancer), such as cyclophosphamide and methotrexate.
• Immunosuppressants (used to prevent organ transplant rejection), such as ciclosporina.
• 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., temsirólimus, sirólimus, everólimus) may increase the risk of an allergic reaction called angioedema.
• A medication containing a neprilysin inhibitor such as sacubitril (available in a fixed-dose combination with valsartán), racecadotrilo, or vildagliptina. This 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/Hidroclorotiazida Stada” and “Warnings and precautions”.

Enalapril/Hidroclorotiazida Stada with food, drinks, and alcohol

Enalapril/hidroclorotiazida can be taken with or without food. Most people take enalapril/hidroclorotiazida 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 plan to become pregnant, consult your doctor or pharmacist before using this medication.

Normally, your doctor will advise you to stop taking enalapril/hidroclorotiazida 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. Enalapril/hidroclorotiazida is not recommended during pregnancy and should not be taken if you are more than 3 months pregnant, as it can cause severe damage to your baby if used from the third month of pregnancy.

Breastfeeding

Inform your doctor if you are breastfeeding or plan to start breastfeeding. Enalapril/hidroclorotiazida is not recommended for mothers who are breastfeeding.

The two active principles of enalapril/hidroclorotiazida, enalapril, and hidroclorotiazida, pass into breast milk. If you are breastfeeding or plan to start breastfeeding, consult your doctor.

Driving and operating machinery

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

Enalapril/Hidroclorotiazida Stada contains lactose and sodium

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 1 mmolof sodium (23 mg); it is essentially “sodium-free”.

Use in athletes

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

Interference with diagnostic tests

If you need to undergo any diagnostic test to evaluate parathyroid gland function, inform your doctor that you are taking enalapril/hidroclorotiazida, as it may alter the test results.

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Follow exactly the administration instructions of this medication 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 if you are taking other medications.

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

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

The initial dose may cause a greater drop in blood pressure than the one that 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 enalapril/hidroclorotiazida tablets with the help of a glass of water. Enalapril/hidroclorotiazida can be taken before or after meals.

If you take more Enalapril/Hidroclorotiazida Stada than you should

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

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

The most likely symptoms would be a sensation 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/Hidroclorotiazida Stada

You should take enalapril/hidroclorotiazida as prescribed. 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/Hidroclorotiazida Stada

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

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

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

The reported side effects are listed 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)

Malignant, benign, and unspecified neoplasms (including cysts and polyps)

Not known: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 platelets in the blood, decrease in hematocrit (proportion of red blood cells in the blood), decrease in white blood cells, bone marrow depression (decrease in the body's ability to form blood cells), lymph node inflammation, immune system diseases.

Endocrine disorders:

Not known: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 levels in the blood

Very rare:high calcium levels in the blood

Nervous system disorders:

Common:headache, dizziness, altered taste

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

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

Mental and behavioural disorders:

Common:depression

Uncommon:nervousness, decreased libido*

Rare:abnormal dreams, sleep disorders.

Eye disorders::

Very common:blurred vision.

Not known:visual disturbances, decreased vision or eye pain due to increased 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:hypotension associated with fainting, cardiac rhythm disorders, angina pectoris, tachycardia (rapid heartbeats)

Uncommon:flushing, palpitations (sensation of rapid and irregular heartbeats), myocardial infarction or stroke, possibly secondary to excessive hypotension in high-risk patients (see section “Warnings and precautions)

Rare:changes in the color of the skin 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 difficulty (including pneumonia and pulmonary edema), mucosal inflammation of the nose, 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 difficulty (signs 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 mucous membrane of the mouth, inflammation of the tongue

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

Hepatobiliary disorders:

Rare:hepatic insufficiency, hepatic 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/angioneuritic edema: facial swelling, extremities, lips, tongue, glottis, and/or larynx

Uncommon:excessive sweating, itching, urticaria, hair loss

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

A complex of symptoms has been reported that may include any or all of the following symptoms: fever, serositis, vasculitis, muscle and/or joint inflammation, positive antinuclear antibodies, 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, proteinuria

Rare:deficient urine secretion, renal inflammation.

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.

Investigations:

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

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

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

* Only observed with 12.5 mg and 25 mg doses of hydrochlorothiazide, 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 dose of hydrochlorothiazide, as found 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 leaflet. You can also report them directly through the Spanish System for Pharmacovigilance 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 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 that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

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

Composition of Enalapril/Hidroclorotiazida Stada

-The active principles are enalapril in the form of maleate and hidroclorotiazida.

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

-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 content of the packaging

Enalapril/Hidroclorotiazida Stada is presented in the form of yellow, elongated, biconvex, and scored tablets on one side.

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

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

Only some package sizes may be commercially marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

STADA Laboratory, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Responsible for manufacturing

Neuraxpharm Pharmaceuticals, S.L.

Avda. Barcelona, 69

08970 Sant Joan Despí (Barcelona)

Spain

Last review date of this prospectus:March 2024

The detailed information of this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/)