LISINOPRIL/HYDROCHLOROTHIAZIDE VIATRIS 20/12.5 mg TABLETS

Introduction

Package Leaflet: Information for theuser

Lisinopril/Hydrochlorothiazide Viatris 20 mg/12.5 mg tablets EFG

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 pack

1. What is Lisinopril/Hydrochlorothiazide Viatris and what is it used for
2. What you need to know before you take Lisinopril/Hydrochlorothiazide Viatris
3. How to take Lisinopril/Hydrochlorothiazide Viatris
4. Possible side effects
5. Storage of Lisinopril/Hydrochlorothiazide Viatris
6. Contents of the pack and other information

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

The lisinopril component of the lisinopril/hydrochlorothiazide combination is a drug that belongs to the group of so-called angiotensin-converting enzyme inhibitors (ACE inhibitors). The hydrochlorothiazide component of the lisinopril/hydrochlorothiazide combination is a drug that belongs to the group of so-called diuretics.

The lisinopril component of this medicine dilates the blood vessels that facilitate the pumping of blood from the heart to all parts of the body. The hydrochlorothiazide component of this medicine makes the kidneys pass more water and salt. Both components together contribute to reducing high blood pressure.

The lisinopril/hydrochlorothiazide combination is indicated for essential hypertension (high blood pressure).

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

Do not take Lisinopril/Hydrochlorothiazide Viatris:

• if you are allergic (hypersensitive) to lisinopril, hydrochlorothiazide or any of the other ingredients of this medicine (listed in section 6).
• if you are allergic (hypersensitive) to any sulfonamide-derived drug or to any other angiotensin-converting enzyme inhibitor (ACE inhibitor). If you are not sure what these are, consult your doctor.
• if you have already been treated with drugs from the same group of drugs as lisinopril (ACE inhibitors) and have suffered allergic reactions such as swelling of the face, lips, tongue and/or throat, with difficulty swallowing or breathing. You should not take lisinopril/hydrochlorothiazide if you have had this type of reaction without a known cause or if you have been diagnosed with idiopathic or hereditary angioedema.
• if you are more than 3 months pregnant (it is also best to avoid this medicine at the beginning of pregnancy - see section Pregnancy).
• if you 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 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 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.

Consult your doctor if you are not sure if you should start taking lisinopril/hydrochlorothiazide.

Warnings and precautions

Consult your doctor or pharmacist before starting to take this medicine:

• if you have difficulty breathing or swallowing with or without swelling of the face, lips, tongue and/or throat, stop taking this medicine and seek medical attention immediately. It should be noted that in black patients, the risk of these types of reactions to ACE inhibitors is increased.
• if you are taking any of the following medicines, the risk of angioedema (rapid swelling under the skin in areas such as the throat) is increased:
• Temsirolimus, sirolimus, everolimus, and other medicines of the mTOR inhibitor class (used to prevent organ transplant rejection).
• if you have recently suffered from excessive vomiting or diarrhea.
• if you have a narrowing of the aorta (aortic stenosis), of the kidney arteries (renal artery stenosis), or of the heart valves (mitral valve stenosis), or an increase in the thickness of the heart muscle (hypertrophic cardiomyopathy).
• if you have a kidney function disorder or are on dialysis.
• if you have liver failure (liver function disorder).
• if you have a disease of the blood vessels (collagen vascular disease) and/or are being treated with allopurinol (for the treatment of gout), procainamide (for heart rhythm disorders), immunosuppressants (medicines that suppress the body's immune response), as you may be at risk of serious infections. In these cases, inform your doctor of any signs of infection.
• if you have diabetes and are taking oral antidiabetics or insulin. Lisinopril/hydrochlorothiazide may increase the risk of hypoglycemia (low blood sugar levels), so you will need to have closer control of your blood glucose levels, especially during the first month of treatment with this medicine. It may be necessary to adjust the dose of your diabetes medicines.
• if you are on a low-salt diet, take potassium supplements or salt substitutes that contain potassium, take potassium-sparing diuretics (medicines that increase urine production), have diabetes, or have any kidney problems, as they may cause increases in blood potassium levels that can be serious. In these cases, your doctor may need to adjust the dose of Lisinopril/Hydrochlorothiazide Viatris or monitor your potassium levels in the blood.
• if you have a cough, as it may be due to treatment.
• if you have gout or high cholesterol levels
• if you are going to undergo a treatment called low-density lipoprotein (LDL) apheresis.
• if you are going to undergo desensitization treatment to reduce the effect of an allergy to bee or wasp stings.
• 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 exposure while taking Lisinopril/Hydrochlorothiazide.
• if you experience a decrease in vision or eye pain, they could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or an increase in pressure in the eye, and can occur within a few hours to a week after taking Lisinopril/Hydrochlorothiazide.

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

• An angiotensin II receptor antagonist (ARA) (also known as "sartans" - e.g., valsartan, telmisartan, irbesartan), especially if you have diabetes-related kidney problems.
• Aliskiren.
• If you are taking a medicine that contains a neprilysin inhibitor (e.g., sacubitril or sacubitril/valsartan). Lisinopril/Hydrochlorothiazide should not be administered within 36 hours before or after taking sacubitril/valsartan.

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 Lisinopril/Hydrochlorothiazide Viatris".

The use of lisinopril/hydrochlorothiazide, especially in the first doses, may cause a sudden drop in blood pressure (you may notice it as dizziness or fainting when standing up. In these cases, lying down may help).

Before undergoing surgery with general or local anesthesia (even at the dentist's office), inform your doctor or dentist that you are taking this medicine, as a sudden drop in blood pressure may occur in association with anesthesia.

You should inform your doctor if you think you are pregnant (or might be). Lisinopril/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 serious harm to your baby if used at this stage (see section Pregnancy).

Consult your doctor, even if any of the above circumstances have occurred to you at any time.

Children

The safety and efficacy in children have not been established.

Other medicines and Lisinopril/Hydrochlorothiazide Viatris

Tell your doctor or pharmacist if you are using or have recently used any other medicines, or even those purchased without a prescription.

In particular, talk to your doctor or pharmacist if you are taking, have recently taken, or may take any of the following medicines:

• Diuretics (medicines that increase urine production).
• Potassium supplements (including salt substitutes), potassium-sparing diuretics ("water pills"), and other medicines that may increase the amount of potassium in the blood (e.g., trimethoprim and cotrimoxazole for bacterial infections; cyclosporine, an immunosuppressive medicine used to prevent organ transplant rejection; and heparin, a medicine used to thin the blood to prevent clots).
• Medicines for mental disorders such as lithium, antipsychotics, or tricyclic antidepressants.
• Medicines for the treatment of arthritis or muscle pain, such as gold salts and non-steroidal anti-inflammatory drugs (NSAIDs), including indomethacin and high doses of aspirin (more than 3 grams per day).

• Other antihypertensives (medicines that lower high blood pressure).
• If you are taking an angiotensin II receptor antagonist (ARA) or aliskiren (see also the information under the headings "Do not take Lisinopril/Hydrochlorothiazide Viatris" and "Take special care with Lisinopril/Hydrochlorothiazide Viatris").
• Sympathomimetic medicines (which stimulate the central nervous system).
• Medicines for the treatment of diabetes, such as insulin or oral antidiabetics.
• Medicines commonly used to prevent organ transplant rejection (temsirolimus, sirolimus, everolimus, and other medicines of the mTOR inhibitor class). See the section "Warnings and precautions".
• Medicines that contain a neprilysin inhibitor (e.g., sacubitril).

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medicine.

Pregnancy

The use of lisinopril/hydrochlorothiazide is not recommended during pregnancy.

You should inform your doctor if you think you are pregnant (or might be). Normally, your doctor will advise you to stop taking lisinopril/hydrochlorothiazide before becoming pregnant or as soon as you know you are pregnant, and will switch you to a different medicine. Lisinopril/Hydrochlorothiazide is not recommended at the beginning of pregnancy and should not be taken, in any case, if you are more than 3 months pregnant, as it may cause serious harm to your baby if used from the third month of pregnancy.

Breastfeeding

Tell your doctor if you are breastfeeding or about to start breastfeeding your child. Lisinopril/hydrochlorothiazide is not recommended in breastfeeding mothers, and if you want to breastfeed, your doctor may choose a different treatment, especially if your baby is newborn or premature.

Driving and using machines

Reactions to the medicine may vary from person to person. Certain side effects have been reported with lisinopril/hydrochlorothiazide that may affect the ability to drive or use machines in some patients. If you notice symptoms of dizziness or fatigue, avoid performing tasks that require special attention until you know how you tolerate the medicine (see 4. Possible side effects).

Use in athletes

Athletes are informed that this medicine contains a component (hydrochlorothiazide) that may result in a positive doping test.

3. How to take Lisinopril/Hydrochlorothiazide Viatris

Follow exactly the administration instructions of this medicine as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again. Remember to take your medicine. The doctor will decide the suitable dose, according to the patient's condition and whether or not they are taking other medicines.

The recommended dose is one tablet once a day, orally, with or without food. Most people take this medicine with water.

If you think the effect of this medicine is too strong or too weak, tell your doctor or pharmacist.

Take this medicine daily, following exactly the doctor's instructions. It is very important to continue taking it for the entire time recommended by the doctor.

Do not take more tablets than the prescribed dose.

If you take more Lisinopril/Hydrochlorothiazide Viatris than you should

If you have taken more lisinopril/hydrochlorothiazide than you should, consult your doctor or pharmacist immediately.

The most likely symptoms will be a feeling of dizziness or fainting, due to low blood pressure, and/or excessive thirst, confusion, reduced urine production, or rapid heartbeat.

In case of overdose or accidental ingestion, consult the Toxicology Information Service. Phone: 91 562 04 20.

If you forget to take Lisinopril/Hydrochlorothiazide Viatris

You should take Lisinopril/Hydrochlorothiazide Viatris as prescribed. Do not take a double dose to make up for forgotten doses. Continue with the normal prescribed plan.

If you stop taking Lisinopril/Hydrochlorothiazide Viatris

Do not stop taking this medicine even if you feel well, unless your doctor tells you to.

Your doctor will indicate the duration of your treatment with Lisinopril/Hydrochlorothiazide. Do not suspend treatment before.

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

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

If you experience any of the following effects, stop taking this medicine and go to the doctor immediately in any of the following cases:

• if you notice swelling of the face, lips, tongue and/or throat that makes breathing or swallowing difficult
• if you notice swelling of the hands, feet or ankles
• if you develop hives.

It should be noted that in black patients, the risk of these types of reactions to ACE inhibitors is increased.

The initial dose may cause a drop in blood pressure greater than that experienced with continued treatment. The symptoms will be dizziness and dizziness. In this case, it is best to lie down. If it causes you concern, consult your doctor.

The adverse effects observed are limited to those previously reported with lisinopril or hydrochlorothiazide.

Adverse effects of medicines are classified as follows:

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 the available data.

Common(may affect up to 1 in 10 people)

• dizziness or lightheadedness, especially when standing up quickly
• diarrhea
• vomiting
• cough
• dizziness
• headache.

Uncommon(may affect up to 1 in 100 people)

• rapid and irregular heartbeat
• tingling sensation in certain limbs
• skin rash
• nausea
• inability to obtain an erection (impotence)
• fatigue
• weakness and feeling of weakness.

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

• dry mouth.

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

• pancreatitis.

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

• muscle cramps or weakness
• gout
• chest pain.

Additional adverse effects reported for the individual components that could be potential adverse effects of this medicine are:

Hydrochlorothiazide

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

• decrease in blood cell count
• decrease in red blood cells due to premature destruction
• low white blood cell count
• decrease in the number of a certain type of white blood cell (neutrophils)
• decrease in platelet count
• low platelet count, sometimes with bleeding or bruising under the skin
• damage to blood vessels that can cause red or purple spots on the skin
• allergic reactions
• severe skin reaction that develops rapidly, causing blisters and peeling of the skin, and possibly ulcers in the mouth
• kidney failure
• kidney function alteration
• kidney inflammation
• yellowing of the skin or the white part of the eyes
• photosensitivity reactions
• skin rash
• respiratory disorders, including pneumonia and fluid accumulation in the lungs
• salivary gland inflammation
• yellow vision
• blurred vision
• decreased vision or eye pain due to high pressure [possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or acute angle-closure glaucoma]
• electrolyte imbalance in the blood (including low sodium levels)
• high uric acid levels in the blood
• high glucose levels in the blood and/or urine
• loss of appetite
• stomach irritation
• constipation
• vertigo
• fever
• muscle spasms
• fatigue
• skin and lip cancer (non-melanoma skin cancer).

Lisinopril

Common(may affect up to 1 in 10 people)

• kidney function alteration.

Uncommon(may affect up to 1 in 100 people)

• myocardial infarction or stroke, possibly secondary to excessive decrease in blood pressure in high-risk patients
• rapid or unusual heartbeat
• stomach pain
• skin itching
• mood changes.

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

• acute kidney failure
• increase in blood urea levels
• skin rash
• hair loss
• mental confusion.

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

• decrease in the body's ability to form blood cells, manifested as a decrease in the number of red blood cells, platelets, and/or white blood cells
• excessive release of antidiuretic hormone (leading to symptoms such as weakness, fatigue, and confusion)
• liver inflammation
• yellowing of the skin and the white part of the eyes
• pseudolymphomatous cutaneous reaction
• breathing difficulties
• decrease in urine output or inability to urinate
• increased sweating
• acute respiratory distress (signs include severe respiratory distress, fever, weakness, and confusion).

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 medicine.

5. Conservation of Lisinopril/Hydrochlorothiazide Viatris

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

This medicine does not require special storage conditions.

Keep in the original package.

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

Medicines should not be thrown away through the sewers or in the trash. Deposit the packaging and medicines that 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 medicines that you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Lisinopril/HydrochlorothiazideViatris

The active ingredients are lisinopril (20 mg) and hydrochlorothiazide (12.5 mg).

The other components are: cornstarch, pregelatinized cornstarch, magnesium stearate (E470B), calcium phosphate dibasic dihydrate, mannitol, red iron oxide (E172).

Appearance of the product and package contents

It is presented in packages of 28 round, biconvex tablets of pink color with the inscription 'LHZ' on one face and '32.5' on the other.

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 ofthis prospectus: December 2022

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