ENALAPRIL/HYDROCHLOROTHIAZIDE VIATRIS 20/12.5 mg TABLETS

Introduction

Package Leaflet: Information for the User

Enalapril/Hydrochlorothiazide Viatris 20 mg/12.5 mg Tablets EFG

Enalapril Maleate/Hydrochlorothiazide

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

• Keep this leaflet, 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. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet

1. What is Enalapril/Hydrochlorothiazide Viatris and what is it used for
2. What you need to know before you take Enalapril/Hydrochlorothiazide Viatris
3. How to take Enalapril/Hydrochlorothiazide Viatris
4. Possible side effects
5. Storage of Enalapril/Hydrochlorothiazide Viatris

1. Package Contents and Further Information

1. What is Enalapril/Hydrochlorothiazide Viatris and what is it used for

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

The enalapril component of Enalapril/Hydrochlorothiazide Viatris is a medicine that belongs to a group of medicines 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 hydrochlorothiazide component of Enalapril/Hydrochlorothiazide Viatris belongs to a group of medicines known as thiazide diuretics (medicines that increase urine elimination).

Together, enalapril and hydrochlorothiazide help to decrease high blood pressure.

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

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

Do not take Enalapril/Hydrochlorothiazide Viatris

• If you are allergic to enalapril maleate, hydrochlorothiazide, or any of the other ingredients of this medicine (listed in section 6).
• If you are allergic to sulphonamide-derived substances. Ask your doctor if you are not sure what sulphonamide-derived medicines are.
• If you have previously been treated with a medicine from the same group as enalapril (ACE inhibitors), and have had allergic reactions with swelling of the face, lips, tongue, and/or throat with difficulty swallowing or breathing.
• If you have had such allergic reactions without a known cause, or if you have been diagnosed with hereditary or idiopathic angioedema (an immune system disease that causes inflammation in the face and respiratory tract, and abdominal colic).
• If you have severe liver disease.
• If you have severe kidney disease.
• If you have anuria (do not urinate).
• If you have diabetes or kidney failure and are being treated with a blood pressure-lowering medicine that contains aliskiren.
• If you are pregnant for more than 3 months. (It is also best to avoid Enalapril/Hydrochlorothiazide Viatris at the beginning of pregnancy - see pregnancy section).
• If you have taken or are currently taking sacubitril/valsartan, a medicine used to treat a type of long-term (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 not sure if you should start taking Enalapril/Hydrochlorothiazide Viatris, consult your doctor.

Warnings and Precautions

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

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 shortness of breath or severe difficulty breathing after taking Enalapril/Hydrochlorothiazide 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 left ventricular outflow (hypertrophic obstructive cardiomyopathy).
• If you have disorders that reduce fluid volume or sodium levels in the body (e.g., 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 medicines to treat diabetes, including insulin, as your doctor may need to adjust your dose of diabetes medicines. 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 these 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 medicines (medicines that increase potassium levels), salt substitutes that contain potassium, or other medicines that can increase blood potassium levels, such as heparin (a medicine used to prevent blood clots), trimethoprim, or cotrimoxazole (also known as trimethoprim/sulfamethoxazole, medicines used to treat bacterial infections).
• If an allergic reaction with swelling of the face, lips, tongue, and/or throat with difficulty swallowing or breathing occurs during treatment. You should be aware that black patients are more sensitive to this type of medicine.
• If you are about to undergo a treatment called LDL apheresis (a procedure similar to dialysis to remove bad cholesterol from the blood in cases where it is excessively high).
• If you are going to undergo desensitization treatment to reduce the effect of 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 drop in blood pressure (you may notice dizziness or fainting, especially when standing up).
• Consult your doctor before starting to take Enalapril/Hydrochlorothiazide Viatris if you have had skin cancer or if you develop an unexpected skin lesion during treatment. Treatment with hydrochlorothiazide, in particular its long-term use at high doses, may increase the risk of certain types of skin and lip cancer (non-melanoma skin cancer). Protect your skin from sun and UV radiation while taking enalapril/hydrochlorothiazide.
• If you are taking any of the following medicines, the risk of angioedema may increase:

• Racecadotril, a medicine used to treat diarrhea.
• Medicines used to prevent organ transplant rejection and for cancer (e.g., temsirolimus, sirolimus, everolimus).
• Vildagliptin, a medicine used to treat diabetes.

• Tell your doctor if you are taking any of the following medicines used to treat high blood pressure:

• An angiotensin II receptor antagonist (ARB, also known as "sartans" - e.g., valsartan, telmisartan, irbesartan), especially if you have diabetes-related kidney problems.
• Aliskiren.

• Tell your doctor if you experience a decrease in vision or eye pain; 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 sulphonamides.

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

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

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 the anesthesia.

You must inform your doctor if you think you are pregnant (or might be). Enalapril/hydrochlorothiazide is not recommended at the start of pregnancy and must not be used if you are pregnant for more than 3 months, as it can cause serious harm to your baby if used during this period (see pregnancy section).

Children and Adolescents

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

Use in Elderly

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

Other Medicines and Enalapril/Hydrochlorothiazide Viatris

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

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

• An angiotensin II receptor antagonist (ARB) or aliskiren (see also the information under the headings "Do not take Enalapril/Hydrochlorothiazide Viatris" and "Warnings and Precautions").
• Blood pressure-lowering medicines (e.g., vasodilators, beta blockers, diuretics).
• Potassium supplements (including salt substitutes), potassium-sparing diuretics, and other medicines that can increase blood potassium levels (e.g., trimethoprim and cotrimoxazole for bacterial infections; cyclosporin, an immunosuppressive medicine used to prevent organ transplant rejection; and heparin, a medicine used to thin the blood to prevent clots). See also the information in the "Warnings and Precautions" section.
• Medicines used to treat certain mental disorders, such as lithium, antipsychotics, or tricyclic antidepressants.
• Anesthetics.
• Opioids (pain-relieving medicines).
• 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 medicines).
• Pressor amines, such as noradrenaline.
• Muscle relaxants, such as tubocurarine.
• Thrombolytic medicines (used to prevent blood clots).
• Calcium salts and vitamin D.
• Ion exchange resins (medicines used to lower cholesterol in the blood), such as cholestyramine and colestipol.
• Antiarrhythmic medicines (used to prevent and control heart rhythm disorders), such as digitalis glycosides, quinidine, amiodarone.
• Anticholinergic medicines (used to decrease gastric emptying), such as atropine (used before general anesthesia or to prevent spasms) or biperiden (used in patients with Parkinson's disease).
• Medicines used to treat gout, such as probenecid, sulfinpyrazone, and allopurinol.
• Antiviral medicines (used to treat viral infections), such as amantadine.
• Cytotoxic medicines (used to treat cancer), such as cyclophosphamide and methotrexate.
• Immunosuppressive medicines (used to prevent organ transplant rejection), such as cyclosporin.
• Antibiotics (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 medicine that contains 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/Hydrochlorothiazide Viatris" and "Warnings and Precautions".

Taking Enalapril/Hydrochlorothiazide Viatris with Food and Drink

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 medicine.

Pregnancy and Breastfeeding

Consult your doctor or pharmacist before taking any medicine.

Pregnancy

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before taking this medicine. 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 medicine instead of enalapril/hydrochlorothiazide. Enalapril/hydrochlorothiazide is not recommended during pregnancy and must 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 substances in this medicine, 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 start. If you notice these effects, you should consult your doctor before performing these activities.

Enalapril/Hydrochlorothiazide Viatris Contains Lactose

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

Enalapril/Hydrochlorothiazide Viatris Contains Sodium

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

Use in Athletes:this medicine 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 Viatris, as it may alter the test results.

3. How to Take Enalapril/Hydrochlorothiazide Viatris

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Remember to take your medicine.

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

Take Enalapril/Hydrochlorothiazide every day, exactly as indicated by your doctor. It is very important that you continue taking this medicine during the time your doctor prescribes it. Do not take more tablets than the prescribed dose. 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 medicine during the time your doctor prescribes it. Do not take more tablets than the prescribed dose.

The initial dose may cause a greater drop in blood pressure than will occur after continued treatment. You may notice dizziness or fainting, and lying down may help. If you are concerned, consult your doctor.

Use in Patients with Impaired Renal Function:

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

Method of Administration

This medicine 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 Viatris Than You Should

If you have taken more enalapril/hydrochlorothiazide than you should, consult your doctor, pharmacist, or call the Toxicology Information Service, telephone 91 562 04 20, indicating the medicine and the amount taken. It is recommended to take the package and the leaflet of the medicine to the healthcare personnel.

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

If you forgot to take Enalapril/Hydrochlorothiazide Viatris

You should take Enalapril/Hydrochlorothiazide as prescribed. Do not take a double dose to make up for missed doses. Just take the next dose as usual.

If you interrupt treatment with Enalapril/Hydrochlorothiazide Viatris

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 adverse effects

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

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

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

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

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

• Alteration in blood tests: increase or decrease in potassium, increase in cholesterol, increase in triglycerides, increase in uric acid, increase in serum creatinine.
• Headache.
• Depression.
• Fainting.
• Taste alteration.
• Decrease in blood pressure associated with fainting, heart rhythm disturbances, chest pain, tachycardia (increase in heart rate).
• Diarrhea, abdominal pain.
• Skin rash (exanthema), hypersensitivity (allergic reaction)/angioedema: swelling of the face, limbs, 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, blood cells that carry oxygen).
• General malaise, fever, joint pain*.
• Decrease in blood glucose (sugar).
• Confusion, drowsiness, insomnia, nervousness, tingling sensation, vertigo, decreased sexual appetite*, ringing in the ears.
• Hot flashes, palpitations (rapid and irregular heartbeat), myocardial infarction or stroke, possibly secondary to excessive decrease in blood pressure in high-risk patients (see "Warnings and precautions" section).
• Mucus secretion, sore throat and hoarseness, bronchospasm (difficulty breathing), asthma.
• Pancreatitis, vomiting, digestive discomfort, constipation, intestinal obstruction with severe pain, loss of appetite, stomach irritation, dry mouth, peptic ulcer, flatulence*.
• Excessive sweating, itching, urticaria, hair loss.
• Kidney dysfunction (alteration of kidney function), kidney failure, presence of protein in the urine.
• Impotence.
• Increased blood urea, decreased sodium and magnesium in blood, gout.

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

• 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 blood), decrease in white blood cell count, bone marrow depression (decrease in the body's ability to form blood cells), lymph node inflammation, immune system diseases.
• Increased blood glucose (sugar).
• Pulmonary infiltrates, respiratory difficulty (including pneumonia and pulmonary edema), inflammation of the nasal mucosa, allergic alveolitis (inflammation of the pulmonary alveolus due to allergy), eosinophilic pneumonia (disease in which a type of white blood cell, called eosinophils, accumulates in the lungs).
• 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).
• Redness of the skin, severe blistering or bleeding in the skin (Stevens-Johnson syndrome), severe redness/rash with skin and hair loss, skin peeling, appearance of red spots on the skin, skin alteration, blistering of the skin.

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.

• Inadequate urine secretion, kidney cell inflammation.
• Increased breast size in men.
• Elevations of liver enzymes, elevation of serum bilirubin.
• Changes in skin color of fingers, hands, and feet, nose, or ears (Raynaud's phenomenon).
• Mouth mucosa infection or inflammation, tongue inflammation.
• Abnormal dreams, sleep disorders.
• Paresis (mild paralysis consisting of muscle weakness).
• Paralysis (due to low potassium levels in the 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 respiratory difficulty, fever, weakness, and confusion).

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

• Skin and lip cancer (non-melanoma skin cancer).
• Syndrome of inadequate antidiuretic hormone secretion (SIADH).
• Decreased vision or eye pain due to high pressure [possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion), 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 hives.

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

† The frequency of muscle cramps as "frequent" 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 adverse effects

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

5. Conservation of Enalapril/Hydrochlorothiazide Viatris

Keep in the original packaging.

This medication does not require special storage conditions.

Keep this medication out of 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 thrown away through drains or trash. Deposit the packaging and medications you no longer need in the SIGRE Point of the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This way, you will help protect the environment.

6. Package contents and additional information

Composition of Enalapril/Hydrochlorothiazide Viatris

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

Appearance of the product and package contents

The tablets are yellow, elongated, and biconvex, with a score on one side.

They are packaged in blisters included in packages of 28 tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Viatris Pharmaceuticals, S.L.U.

C/ General Aranaz, 86

28027 - Madrid

Spain

Manufacturer:

Neuraxpharm Pharmaceuticals, S.L.

Avda. Barcelona, 69

08970 - Sant Joan Despí

Barcelona

Spain

Date of the last revision of this prospectus:January 2023

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