Label: information for the user

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

Enalapril maleate/Hidroclorotiazida

Read this label carefully before starting to take this medicine, as it contains important information for you.

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

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

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

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

6. Contents of the pack and additional information

This medication contains two active ingredients, 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 Viatris is a medication that belongs to a group of medications known as angiotensin-converting enzyme inhibitors (ACE inhibitors), which acts by dilating blood vessels, making it easier for the heart to pump blood to all parts of the body. The hidroclorotiazida component of Enalapril/Hidroclorotiazida Viatris 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 Viatris to treat hypertension (high blood pressure) because it is not adequately controlled with enalapril or an ACE inhibitor alone.

Do not take Enalapril/Hidroclorotiazida Viatris

• If you are allergic to enalapril maleate, hydrochlorothiazide, or any of the other components of this medication (listed in section 6).
• If you are allergic to sulfonamide derivatives. Ask your doctor if you are unsure what sulfonamide derivatives are.
• If you have previously been treated with a medication from the same group as enalapril (ACE inhibitors), and you have had allergic reactions with swelling of the face, lips, tongue, and/or throat, 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 tract, and abdominal cramps).
• If you have severe liver disease.
• If you have severe kidney disease.
• If you have anuria (do not urinate).
• If you have diabetes or kidney insufficiency and are being treated with a medication to lower blood pressure that contains aliskiren.
• If you are more than 3 months pregnant. (It is also best to avoid Enalapril/Hidroclorotiazida Viatris at the beginning of pregnancy - see the pregnancy section).
• If you have taken or are currently taking sacubitril/valsartan, 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 Viatris, consult your doctor.

Warnings and precautions

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

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

• If you have had respiratory or pulmonary problems (such as inflammation or fluid in the lungs) after taking hydrochlorothiazide in the past. If you experience severe shortness of breath or difficulty breathing after taking Enalapril/Hidroclorotiazida Viatris, 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 chamber of the heart (hypertrophic obstructive cardiomyopathy).
• If you have conditions that reduce the volume of fluids or the level of sodium in the body (e.g., intense vomiting, diarrhea, or if you are 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 your dose of 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, medications that conserve potassium (medications that increase potassium levels), potassium-containing salt substitutes, or other medications that may increase potassium levels, such as heparin (a medication used to prevent blood clots), trimethoprim/sulfamethoxazole (medications used to treat infections), etc.
• If you experience an allergic reaction with swelling of the face, lips, tongue, and/or throat, 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/hydrochlorothiazide, especially in the first doses, can cause a sudden drop in blood pressure (you may notice it as dizziness or lightheadedness, especially when standing up).
• Consult your doctor before starting to take Enalapril/Hidroclorotiazida Viatris if you have had skin cancer or if you develop an unexpected skin lesion during treatment. The treatment with hydrochlorothiazide, 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/hydrochlorothiazide.
• If you are taking any of the following medications, the risk of angioedema may increase:

• racecadotril, a medication used to treat diarrhea.
• medications used to prevent organ transplant rejection and for cancer (e.g., temsirolimus, sirolimus, everolimus).
• vildagliptin, 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, valsartan, telmisartan, irbesartan), particularly if you have kidney problems related to diabetes.
• aliskiren.

• 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 pressure in the eye, and may occur within a few hours to several weeks after taking enalapril/hydrochlorothiazide. If left untreated, this can lead to permanent vision loss. You may be at a higher risk if you have previously had an allergy to penicillin or sulfonamide.

Your doctor may 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 Viatris”.

Before undergoing surgery or anesthesia (including dental consultation), inform your doctor or dentist that you are taking enalapril/hydrochlorothiazide, 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/hydrochlorothiazide is not recommended at the beginning of pregnancy and should not be used if you are more than 3 months pregnant, as it may cause severe damage to your baby if used in this stage (see the pregnancy section).

Children and adolescents

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

Use in the elderly

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

Other medications and Enalapril/Hidroclorotiazida Viatris

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 adjust 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 aliskiren (see also the information under the headings “Do not take Enalapril/Hidroclorotiazida Viatris” and “Warnings and precautions”).
• Anti-hypertensive medications (reduce elevated blood pressure), for example, vasodilators, beta-blockers, diuretics.
• Potassium supplements (including salt substitutes), potassium-sparing diuretics, and other medications that may increase potassium levels in the blood (e.g., trimethoprim and sulfamethoxazole for bacterial infections; ciclosporin, 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 aspirin, including selective COX-2 inhibitors.
• Sympathomimetics (medications used in the treatment of certain heart and blood vessel disorders and some medications for colds).
• Amines that increase blood pressure, such as noradrenaline.
• Muscle relaxants, such as tubocurarine.
• Thrombolytic medications (that prevent blood clot formation).
• Calcium salts and vitamin D.
• Ionic exchange resins (medications used to reduce cholesterol in the blood), such as cholestyramine and colestipol.
• Antiarrhythmic medications (used to prevent and control abnormal heart rhythms), 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.
• 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 ciclosporin.
• 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 containing a neprilysin inhibitor such as sacubitril (available in a fixed-dose combination with valsartan), racecadotril, or vildagliptin. 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 Viatris” and “Warnings and precautions”.

Enalapril/Hidroclorotiazida Viatris with food and drinks

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

Alcohol may increase the hypotensive effect of this medication.

Pregnancy and breastfeeding

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 before using this medication.Normally, your doctor will advise you to stop taking enalapril/hydrochlorothiazide before becoming 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 more than 3 months pregnant, as it may 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/hydrochlorothiazide is not recommended for mothers who are breastfeeding.

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

Driving and operating machinery

It is unlikely that enalapril/hydrochlorothiazide 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 Viatris contains lactose

This medication contains lactose. If your doctor has told you that you have a certain sugar intolerance, consult with them before taking this medication.

Enalapril/Hidroclorotiazida Viatris contains sodium

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

Use in athletes:This medication contains hydrochlorothiazide, which may produce a positive result in doping control tests.

Interference with diagnostic tests

If you are to undergo any diagnostic test to assess parathyroid gland function, inform your doctor that you are taking Enalapril/Hidroclorotiazida Viatris, as it may alter the results.

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 whether 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. Do not take more tablets than the prescribed dose. 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 what will occur after continued treatment. You may notice dizziness or fainting and lying down may help. If you are concerned, consult your doctor.

Use in patients with altered kidney function:

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

Administration form

This medication is administered orally.

Take the 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 Viatris than you should

If you have taken more Enalapril/Hidroclorotiazida than you should, consult your doctor, pharmacist, or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount taken.It is recommended to bring the packaging and the medication leaflet to the healthcare staff.

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

If you forgot to take Enalapril/Hidroclorotiazida Viatris

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 Viatris

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 recorded side effects are listed below according to the following frequencies:

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

• Dizziness.
• Blurred vision.
• Cough.
• Nausea.
• Fatigue.

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

• Alteration in blood tests: increased or decreased potassium, increased cholesterol, increased triglycerides, increased uric acid, increased serum creatinine.
• Headache.
• Depression.
• Fainting.
• Alteration of taste.
• Decreased blood pressure associated with fainting, alterations of heart rhythm, angina pectoris, tachycardia (increased frequency of heartbeats).
• Diarrhea, abdominal pain.
• Skin rash (exanthema), hypersensitivity (allergic reaction)/angioneuritic edema: swelling of face, extremities, lips, tongue, glottis, and/or larynx.
• Muscle cramps†.
• Chest pain, fatigue.
• Shortness of breath.

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

• Anemia (decrease in red blood cells in the blood, cells that transport oxygen).
• General malaise, fever, joint pain*.
• Decreased blood glucose (sugar).
• Confusion, drowsiness, insomnia, nervousness, tingling sensation, dizziness, decreased sexual appetite*, ringing in the ears.
• Hot flashes, palpitations (sensation of rapid and irregular heartbeats), myocardial infarction or stroke, possibly secondary to excessive decrease in blood pressure in high-risk patients (see "Warnings and precautions").
• Mucus secretion, sore throat, and hoarseness, bronchospasm (difficulty breathing), asthma.
• Pancreatitis, vomiting, digestive-related discomfort, constipation, intestinal obstruction with intense pain, loss of appetite, stomach irritation, dry mouth, peptic ulcer, flatulence (gases)*.
• Excessive sweating, itching, urticaria, hair loss.
• Renal dysfunction (alteration of kidney function), renal insufficiency, presence of proteins in urine.
• Impotence.
• Increased urea in blood, decreased sodium and magnesium in blood, gout.

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

• Reduction of a type of white blood cells (neutrophils), decrease in hemoglobin (protein of red blood cells that transports oxygen), decrease in platelets in blood, decrease in hematocrit (proportion of red blood cells in blood), decrease in white blood cells, depression of bone marrow (decrease in the body's ability to form blood cells), lymph node inflammation, immune system diseases.
• Increased blood glucose (sugar).
• Pulmonary infiltrates, difficulty breathing (including pneumonia and pulmonary edema), inflammation of nasal mucosa, allergic alveolitis (inflammation of the alveolar lung by allergy), eosinophilic pneumonia (disease in which a type of white blood cells, called eosinophils, accumulate in the lungs).
• Hepatic insufficiency, hepatic necrosis (which can be fatal), liver inflammation, suppression or cessation of bile secretion, yellow discoloration of skin or eyes, inflammation of the gallbladder (particularly in patients with pre-existing formation ofstonesin the bile ducts).
• Severe skin redness, severe blistering or hemorrhaging in the skin (Stevens-Johnson syndrome), severe skin redness/eruption with skin and hair loss, skin peeling, appearance of red patches on skin, skin alteration, vesicles formation on skin.

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

• Decreased urine secretion, kidney cell inflammation.
• Enlargement of breast tissue in men.
• Elevation of liver enzymes, elevation of serum bilirubin.
• Changes in skin color of hands and feet, nose, or ears (Raynaud's phenomenon).
• Infection or inflammation of oral mucosa, tongue inflammation.
• Abnormal dreams, sleep disorders.
• Paresis (mild paralysis consisting of muscle weakness).
• Paralysis (due to low potassium levels in blood).

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

• Increased calcium in blood.
• Intestinal angioedema (inflammation of the intestinal wall).
• Acute respiratory difficulty (signs include severe difficulty breathing, fever, weakness, and confusion).

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

• Skin and lip cancer (non-melanoma skin cancer).
• SIADH (syndrome of inappropriate antidiuretic hormone secretion).
• Decreased vision or eye pain due to increased pressure [possible signs of fluid accumulation in the vascular layer of the eye (choroidal hemorrhage), acute myopia, or acute angle-closure glaucoma].

Stop taking enalapril/hydrochlorothiazide and consult your doctor immediately in any of the following cases:

• If your face, lips, tongue, and/or throat swell, making it difficult to breathe or swallow.
• If your hands, feet, or ankles swell.
• If you develop urticaria.

* Only observed with hydrochlorothiazide doses of 12.5 mg and 25 mg, as found in Enalapril/Hydrochlorothiazide Viatris.

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

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the 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.

Store in the original packaging.

This medicationdoes not require special storage conditions.

Keep this medication out of the sight and reach of children.

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

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Enalapril/Hidroclorotiazida Viatris

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, cornstarch, pregelatinized cornstarch, sodium hydrogen carbonate, magnesium stearate (E-470b) and yellow iron oxide (E-172).

Appearance of the product and contents of the packaging

The tablets are yellow, elongated, biconvex-faced, with a groove in one of them.

It is packaged in blisters included in containers of 28 tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Viatris Pharmaceuticals, S.L.U.

C/ General Aranaz, 86

28027 - Madrid

Spain

Responsible for manufacturing:

Neuraxpharm Pharmaceuticals, S.L.

Avda. Barcelona, 69

08970 - Sant Joan Despí

Barcelona

Spain

Last review date of this prospectus:January 2023

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