Enalapril/hydrochlorothiazide Viatris 20/12.5 mg tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Enalapril/Hydrochlorothiazide Viatris 20 mg/12.5 mg tablets EFG

enalapril maleate/hydrochlorothiazide

Read the entire leaflet carefully before you start taking this medicine, as 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 should not give it to others, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet Contents

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

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

3. How to take Enalapril/Hydrochlorothiazide Viatris

4. Possible side effects

5. How to store Enalapril/Hydrochlorothiazide Viatris

6. Contents of the pack and other information

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

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

The enalapril component of Enalapril/Hydrochlorothiazide Viatris is a medicine that belongs to a class of medicines known as angiotensin-converting enzyme inhibitors (ACE inhibitors), which works by dilating blood vessels, allowing the heart to pump blood more easily to all parts of the body. The hydrochlorothiazide component of Enalapril/Hydrochlorothiazide Viatris belongs to a group of medicines known as thiazide diuretics (medicines that increase urine elimination).

Together, enalapril and hydrochlorothiazide help lower high blood pressure.

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

2. What you need to know before starting 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 sulfonamide-derived substances. Ask your doctor if you are unsure about what sulfonamide-derived medicines are.
• If you have previously been treated with a medicine from the same group as enalapril (ACE inhibitors) and experienced allergic reactions with swelling of the face, lips, tongue, and/or throat, accompanied by difficulty swallowing or breathing.
• If you have had such allergic reactions without a known cause, or if you have been diagnosed with hereditary or idiopathic angioedema (an immune system disorder causing inflammation of the face and airways, and abdominal cramps).
• If you have severe liver disease.
• If you have severe kidney disease.
• If you suffer from anuria (you do not urinate).
• If you have diabetes or renal impairment and are being treated with a blood pressure-lowering medicine containing aliskiren.
• If you are more than 3 months pregnant. (It is also advisable to avoid enalapril/hydrochlorothiazide in early pregnancy – see pregnancy section.)
• If you have taken or are currently taking sacubitril/valsartan, a medicine used to treat chronic heart failure in adults, as the risk of angioedema (rapid swelling beneath the skin, such as in the throat) is high.

If you are unsure whether you should start taking Enalapril/Hydrochlorothiazide Viatris, consult your doctor.

Warnings and precautions

Talk to your doctor or pharmacist before starting 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 previously experienced breathing or lung problems (such as inflammation or fluid in the lungs) after taking hydrochlorothiazide. If you develop shortness of breath or severe difficulty breathing after taking enalapril/hydrochlorothiazide, seek medical attention immediately.

• If you have a heart condition involving narrowing of heart valves (mitral or aortic valve stenosis) or other factors that reduce blood flow from the left chamber of the heart (obstructive hypertrophic cardiomyopathy).

• If you have conditions that reduce fluid volume or sodium levels in the body (e.g., severe vomiting, diarrhea, or if you are taking high doses of medicines that increase urine output).

• If you have blood disorders.

• If you have diabetes and are taking diabetes medications, including insulin, as a dosage adjustment of your diabetes medications may be needed. Diabetes can cause high levels of potassium in the blood, which can be serious.

• If you have liver problems.

• If you have kidney problems (including after kidney transplant), as these may cause high blood potassium levels, which can be serious.

• If you undergo dialysis.

• If you are on a salt-free diet, take potassium supplements, potassium-sparing medicines (medicines that raise potassium levels), salt substitutes containing potassium, or other medicines that may increase blood potassium levels, such as heparin (a medicine used to prevent blood clots), or medicines containing trimethoprim or cotrimoxazole (also known as trimethoprim/sulfamethoxazole), which are used to treat infections.

• If you develop an allergic reaction during treatment, with swelling of the face, lips, tongue, and/or throat, accompanied by difficulty swallowing or breathing. Note that patients of Black race 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 LDL particles or "bad cholesterol" from the blood when levels are excessively high).

• If you are scheduled to undergo desensitization therapy to reduce the effect of an allergy to bee or wasp stings.

• If you have low blood pressure, as taking enalapril/hydrochlorothiazide, especially with the first doses, may cause a sudden drop in blood pressure (you may feel faint or dizzy, particularly when standing up).

• Talk to your doctor before starting 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 non-melanoma skin and lip cancer. Protect your skin from exposure to sunlight and UV rays while taking enalapril/hydrochlorothiazide.

• If you are taking any of the following medicines, your risk of developing 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.

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

• an angiotensin II receptor antagonist (ARA) (also known as "sartans" – e.g., valsartan, telmisartan, irbesartan), particularly if you have kidney problems related to diabetes.

• aliskiren.

• Inform your doctor if you experience vision changes or eye pain, as these could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased eye pressure, which may occur within hours to weeks after taking enalapril/hydrochlorothiazide. If untreated, this may lead to permanent vision loss. Your risk may be higher if you have previously had an allergy to penicillin or sulfonamides.

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 (including at the dentist), inform the doctor or dentist that you are taking enalapril/hydrochlorothiazide, as you may experience a sudden drop in blood pressure due to anesthesia.

Inform your doctor if you think you are pregnant (or might be). Enalapril/hydrochlorothiazide is not recommended during early pregnancy and must not be used if you are more than 3 months pregnant, as it may cause serious harm to your baby if used at this stage (see pregnancy section).

Children and adolescents

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

Use in elderly patients

In studies where enalapril and hydrochlorothiazide were administered together, the effect of the drugs and their tolerability were similar in younger adult and elderly patients with high blood pressure.

Other medicines and Enalapril/Hydrochlorothiazide Viatris

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. 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 medicines:

• An angiotensin II receptor antagonist (ARA) or aliskiren (see also information under the headings “Do not take Enalapril/Hydrochlorothiazide Viatris” and “Warnings and precautions”).
• Antihypertensive medicines (which reduce high blood pressure), for example vasodilators, beta-blockers, diuretics.
• Potassium supplements (including salt substitutes), potassium-sparing diuretics, and other medicines that may increase blood potassium levels (for example, trimethoprim and co-trimoxazole for bacterial infections; cyclosporine, an immunosuppressant 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 section “Warnings and precautions”.
• Medicines used to treat certain mental disorders such as lithium, antipsychotics, or tricyclic antidepressants.
• Anaesthetics.
• Opioids (medicines used to treat severe pain).
• Medicines used to treat diabetes such as insulin or oral antidiabetics (e.g. metformin).
• Medicines used to treat pain or certain inflammations, such as non-steroidal anti-inflammatory drugs (NSAIDs), including acetylsalicylic acid, and selective cyclooxygenase-2 (COX-2) inhibitors.
• Sympathomimetic medicines (used in the treatment of certain heart and blood vessel disorders and some cold remedies).
• Pressor amines, such as noradrenaline.
• Muscle relaxants such as tubocurarine.
• Thrombolytic medicines (which prevent blood clots from forming).
• Calcium salts and vitamin D.
• Ion-exchange resins (medicines used to lower blood cholesterol), such as cholestyramine and colestipol.
• Antiarrhythmics (medicines used for prevention and control of heart rhythm disorders), such as digitalis glycosides, quinidine, amiodarone.
• Anticholinergic medicines (which reduce gastric emptying rate), such as atropine (used before general anaesthesia or to prevent spasms) or biperiden (used in patients with Parkinson's disease).
• Medicines for the treatment of gout, such as probenecid, sulfinpyrazone, and allopurinol.
• Antivirals (medicines to treat viral infections), such as amantadine.
• Cytotoxic medicines (used in cancer treatment), such as cyclophosphamide and methotrexate.
• Immunosuppressants (used to prevent organ transplant rejection), such as cyclosporine.
• Antibiotics (medicines to treat certain infections), such as tetracyclines, amphotericin B.
• Gold salts (used to treat rheumatic diseases such as rheumatoid arthritis).
• Concomitant administration of mTOR inhibitors (e.g. temsirolimus, sirolimus, everolimus) may increase the risk of an allergic reaction called angioedema.
• A medicine 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/Hydrochlorothiazide Viatris” and “Warnings and precautions”.

Taking Enalapril/Hydrochlorothiazide Viatis with food and drink

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

Alcohol may increase the blood pressure-lowering (hypotensive) 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 plan to become pregnant, consult your doctor before using this medicine. Normally your doctor will advise you to stop taking enalapril/hydrochlorothiazide before becoming pregnant or as soon as you find out you are pregnant, and will recommend an alternative treatment to enalapril/hydrochlorothiazide. Enalapril/hydrochlorothiazide is not recommended during pregnancy and must not be taken after the first three months of pregnancy, as it may cause serious harm to your baby if used from the third month of pregnancy onwards.

Breastfeeding

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

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

Driving and use of machines

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

Enalapril/Hydrochlorothiazide Viatris contains lactose

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

Enalapril/Hydrochlorothiazide Viatris contains sodium

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

Use in athletes: This medicine contains hydrochlorothiazide, which may lead to a positive result in doping control tests.

Interference with diagnostic tests

If you are due to have any diagnostic tests to assess parathyroid gland function, inform your doctor that you are being treated with enalapril/hydrochlorothiazide, as it may alter the results.

3. How to take Enalapril/Hydrochlorothiazide Viatris

Follow exactly the instructions given by your doctor or pharmacist for taking this medicine. If in doubt, consult your doctor or pharmacist again.

Remember to take your medicine.

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

Take Enalapril/Hydrochlorothiazide every day, exactly as directed by your doctor. It is very important that you continue taking this medicine for as long as your doctor prescribes it. Do not take more tablets than the prescribed dose. The recommended dose is one or two tablets taken once daily. Take enalapril/hydrochlorothiazide every day, exactly as directed by your doctor. It is very important that you continue taking this medicine for as long as 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 occurs during continued treatment. You may feel faint or dizzy, and lying down may help. If you are concerned, consult your doctor.

Use in patients with impaired kidney function:

If you have any kidney disease, your doctor will determine the most appropriate dose for you.

Method of administration

This medicine is administered orally.

Take the enalapril/hydrochlorothiazide tablets with a glass of water. Enalapril/hydrochlorothiazide may 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, contact your doctor or pharmacist immediately, or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medication and the amount taken. It is recommended to bring the medicine package and leaflet to healthcare professionals.

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 tachycardia.

If you forget to take Enalapril/Hydrochlorothiazide Viatris

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

If you stop taking Enalapril/Hydrochlorothiazide Viatris

Your doctor will determine how long you should take enalapril/hydrochlorothiazide. Do not stop treatment early, even if you feel better.

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

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

4. Possible adverse effects

Like all medicines, this medicine may produce adverse effects, although not everyone experiences them.

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

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):

• Blood test abnormalities: increased or decreased potassium, increased cholesterol, increased triglycerides, increased uric acid, increased serum creatinine
• Headache
• Depression
• Fainting
• Altered taste
• Decreased blood pressure associated with fainting, heart rhythm disturbances, angina, tachycardia (increased 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):

• Anaemia (reduced red blood cells in the blood, blood cells that carry oxygen)
• General malaise, fever, joint pain*
• Decreased blood glucose (sugar)
• Confusion, drowsiness, insomnia, nervousness, tingling sensation, dizziness, decreased libido*, tinnitus (ringing in the ears)
• Hot flushes, palpitations (rapid or irregular heartbeat), myocardial infarction or stroke, possibly secondary to excessive drop in blood pressure in high-risk patients (see section “Warnings and precautions”)
• 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 (gas)*
• Excessive sweating, itching, urticaria, hair loss
• Renal dysfunction (impaired kidney function), renal failure, presence of protein in urine
• Impotence
• Increased blood urea, decreased sodium and magnesium in blood, gout

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

• Reduction in a type of white blood cells (neutrophils), decreased hemoglobin (oxygen-carrying protein in red blood cells), decreased platelet count, decreased hematocrit (proportion of red blood cells in blood), decreased white blood cell count, bone marrow depression (reduced ability of the body to produce blood cells), lymph node inflammation, immune system disorders
• Increased blood glucose (sugar)
• Pulmonary infiltrates, breathing difficulty (including pneumonia and pulmonary edema), nasal mucosa inflammation, allergic alveolitis (inflammation of the lung alveoli due to allergy), eosinophilic pneumonia (a condition in which a type of white blood cells called eosinophils accumulate in the lungs)
• Liver failure, hepatic necrosis (which may be fatal), liver inflammation, suppression or cessation of bile secretion, yellowing of the skin or eyes (jaundice), gallbladder inflammation (particularly in patients with pre-existing gallstones)
• Skin redness, severe blistering or bleeding of the skin (Stevens-Johnson syndrome), severe skin redness/rash with skin and hair loss, skin peeling, appearance of red spots on the skin, skin disorders, blister formation on the skin

A symptomatic complex has been reported that may include all or some of the following symptoms: fever, serositis, vasculitis, muscle pain/swelling, joint pain/swelling, positive antinuclear antibody test, increased erythrocyte sedimentation rate, eosinophilia, and leukocytosis. Skin rash, photosensitivity, or other skin manifestations may also occur.

• Inadequate urine output, inflammation of kidney cells
• Breast enlargement in men
• Increased liver enzymes, increased serum bilirubin
• Changes in skin color of fingers, toes, nose, or ears (Raynaud's phenomenon)
• Infection or inflammation of the mouth mucosa, tongue inflammation
• Abnormal dreams, sleep disorders
• Paresis (mild paralysis characterized by weakness of muscle contractions)
• Paralysis (due to low blood potassium levels)

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

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

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

• Skin and lip cancer (non-melanoma skin cancer)
• Syndrome of inappropriate antidiuretic hormone secretion (SIADH)
• Decreased vision or eye pain due to elevated pressure [possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion), acute myopia, or acute angle-closure glaucoma]
• Psoriasis or worsening of psoriasis (a skin disease causing scaly red lesions, typically on elbows, knees, trunk, and scalp)

Stop taking enalapril/hydrochlorothiazide and contact your doctor immediately if any of the following occur:

• Swelling of the face, lips, tongue, and/or throat causing difficulty in breathing or swallowing

• Swelling of the hands, feet, or ankles

• Appearance of hives (urticaria)

• Observed only 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 this event is "uncommon" and applies to the 6 mg hydrochlorothiazide dose as found in other medicines.

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Enalapril/Hydrochlorothiazide Viatris

Keep in the original packaging.

This medicine does not require any special storage conditions.

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

Do not use this medicine after the expiry date stated on the container after CAD or EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Enalapril/Hydrochlorothiazide Viatris

The active substances 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: monohydrate lactose, corn starch, pregelatinized corn starch, sodium hydrogen carbonate, magnesium stearate (E-470b), and yellow iron oxide (E-172).

Description of the product and pack contents

The tablets are yellow, elongated, biconvex-faced, with a score line on one side.

They are packaged in blisters contained in packs of 28 tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Viatris Pharmaceuticals, S.L.
C/ General Aranaz, 86
28027 - Madrid
Spain

Manufacturer:

Neuraxpharm Pharmaceuticals, S.L.
Avda. Barcelona, 69
08970 - Sant Joan Despí
Barcelona
Spain

or

KeVaRo GROUP Ltd
9 Tsaritsa Eleonora Str., office 23,
1618 Sofia
Bulgaria

Date of the most recent revision of this leaflet: January 2023

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