Prospecto: information for theuser

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

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

-Keep this prospect, 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 prospect. See section 4.

1.What is Lisinopril/Hidroclorotiazida Viatris and how is it used

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

3.How to take Lisinopril/Hidroclorotiazida Viatris

4.Adverse effects

5.Storage of Lisinopril/Hidroclorotiazida Viatris

6.Contents of the package and additional information

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

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

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

Do not take Lisinopril/Hidroclorotiazida Viatris:

• if you are allergic (hypersensitive) to lisinopril, hidroclorotiazida, or any of the other components of this medication (listed in section 6).
• if you are allergic (hypersensitive) to any sulfamida-derived drugs or any other angiotensin-converting enzyme (ACE) inhibitors. If you are unsure which ones, consult your doctor.
• if you have previously taken medications from the same group as lisinopril (ACE inhibitors) and have experienced allergic reactions such as facial swelling, lips, tongue, and/or throat, with difficulty swallowing or breathing. You should not take lisinopril/hidroclorotiazida 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 recommended to avoid this medication at the beginning of pregnancy - see Pregnancy section).
• if you are not urinating.
• if you have diabetes or kidney insufficiency and are being treated with a blood pressure medication that contains aliskirén.
• if you have taken or are currently taking sacubitril/valsartán, a medication used to treat a type of chronic heart failure in adults, as the risk of angioedema (rapid swelling under the skin in areas such as the throat) is high.
• 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.

Consult your doctor if you are unsure if you should start taking lisinopril/hidroclorotiazida.

Warnings and precautions

Consult your doctor or pharmacist before starting this medication:

• if you have difficulty breathing or swallowing with or without facial swelling, stop taking this medication and seek medical assistance immediately. Note that in black patients, the risk of these types of reactions to ACE inhibitors is increased.
• if you are taking any of the following medications, the risk of angioedema (rapid swelling under the skin in areas such as the throat) is increased:
• Temsirolimus, sirolimus, everolimus, and other mTOR inhibitors (used to prevent organ transplant rejection).
• if you have recently experienced excessive vomiting or diarrhea.
• if you have aortic stenosis, renal artery stenosis, or mitral valve stenosis, or hypertrophic cardiomyopathy.
• if you have kidney function impairment or are on dialysis.
• if you have liver dysfunction (liver function impairment).
• if you have vascular disease (collagen vascular disease) and/or are being treated with allopurinol (for gout), procainamide (for heart rhythm disorders), immunosuppressants (medications that suppress the body's immune response), as you may be at risk of severe infections. Inform your doctor of any signs of infection.
• if you have diabetes and are taking oral antidiabetic medications or insulin. Lisinopril/hidroclorotiazida may increase the risk of hypoglycemia (low blood sugar), so you should have closer control of your blood glucose levels, especially during the first month of treatment with this medication. You may need to adjust the dosage of your diabetes medications.
• if you are on a low-sodium diet, taking potassium supplements or salt substitutes that contain potassium, taking potassium-sparing diuretics (medications that increase urine production), have diabetes or any kidney problems, as this may cause high potassium levels in the blood, which can be severe. In these cases, your doctor may need to adjust the dosage of Lisinopril/Hidroclorotiazida or monitor your potassium levels in the blood.
• if you have a cough, as it may be caused by the treatment.
• if you have gout or high cholesterol levels.
• if you are undergoing a treatment called LDL apheresis.
• if you are undergoing 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. The use of hidroclorotiazida, particularly 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 Lisinopril/Hidroclorotiazida.
• if you experience a decrease in vision or eye pain, which may be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased eye pressure, which can occur within a few hours to a week after taking Lisinopril/Hidroclorotiazida.

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

• Angiotensin II receptor antagonists (ARAs) (also known as "sartanes" - e.g., valsartán, telmisartán, irbesartán), particularly if you have kidney problems related to diabetes.
• Aliskirén.
• Medications containing a neprilysin inhibitor (e.g., sacubitril or sacubitril/valsartán). Do not administer Lisinopril/Hidroclorotiazida within 36 hours before or after taking sacubitril/valsartán.

Your doctor may monitor your kidney 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 Lisinopril/Hidroclorotiazida Viatris".

The use of lisinopril/hidroclorotiazida, especially in the first doses, may cause a sudden drop in blood pressure (you may feel dizzy or lightheaded when standing up. In these cases, lying down may help).

Before undergoing a surgical procedure with general or local anesthesia (even at the dentist's office), inform your doctor or dentist that you are taking this medication, as it may cause a sudden drop in blood pressure associated with anesthesia.

Inform your doctor if you think you may be pregnant (or could be). Lisinopril/hidroclorotiazida 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 during this period (see Pregnancy section).

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

Children

The safety and efficacy have not been established in children.

Other medications and Lisinopril/Hidroclorotiazida Viatris

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

Particularly, discuss with your doctor or pharmacist if you are taking, have taken recently, or may need to take any of the following medications:

• Diuretics (medications that increase urine production).
• Potassium supplements (including salt substitutes), potassium-sparing diuretics ("urine tablets"), and other medications that may increase potassium levels in the blood (e.g., trimetoprima and cotrimoxazol for bacterial infections; ciclosporina, an immunosuppressant used to prevent organ transplant rejection; and heparin, a medication used to thin the blood and prevent clots).
• Medications for mental disorders such as lithium, antipsychotics, or tricyclic antidepressants.
• Medications for arthritis or muscle pain, such as gold salts and nonsteroidal anti-inflammatory drugs (NSAIDs), including indometacina and high doses of aspirin (more than 3 grams per day).

• Other antihypertensives (medications that reduce high blood pressure).
• Angiotensin II receptor antagonists (ARAs) or aliskirén (see also the information under the headings "Do not take Lisinopril/Hidroclorotiazida Viatris" and "Be careful with Lisinopril/Hidroclorotiazida Viatris").
• Sympathomimetic medications (that stimulate the central nervous system).
• Medications used to treat diabetes, such as insulin or oral antidiabetic medications.
• Medications used more frequently to prevent organ transplant rejection (temsirolimus, sirolimus, everolimus, and other mTOR inhibitors). See the section "Warnings and precautions".
• Medications containing a neprilysin inhibitor (e.g., sacubitril).

Pregnancy and lactation

Consult your doctor or pharmacist before using any medication.

Pregnancy

Lisinopril/hidroclorotiazida is not recommended during pregnancy.

Inform your doctor if you think you may be pregnant (or could be). Normally, your doctor will advise you to stop taking lisinopril/hidroclorotiazida before becoming pregnant or as soon as you know you are pregnant, and will change lisinopril/hidroclorotiazida for another medication. Lisinopril/Hidroclorotiazida 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 severe damage to your baby if used from the third month of pregnancy.

Lactation

Inform your doctor if you are breastfeeding or are about to start breastfeeding your baby. Lisinopril/hidroclorotiazida is not recommended in lactating mothers, and if you want to breastfeed, your doctor may choose another treatment, especially if your baby is newborn or premature.

Driving and operating machinery

The responses to the medication may vary individually. Certain adverse effects have been reported with lisinopril/hidroclorotiazida that may affect a patient's ability to drive or operate machinery. If you experience symptoms of dizziness or fatigue, avoid performing tasks that require special attention until you know how you tolerate the medication (see 4. Possible adverse effects).

Use in athletes

Inform athletes that this medication contains a component (hidroclorotiazida) that may establish a positive analytical result for doping control.

Follow exactly the administration instructions for this medication as 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 the patient's condition and whether they are taking other medications.

The recommended dose is one tablet once a day taken orally, with meals or without them. Most people take this medication with water.

If you estimate that the action of this medication is too strong or weak, inform your doctor or pharmacist.

Take this medication 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 ingest more tablets than the prescribed dose.

If you take more Lisinopril/Hidroclorotiazida Viatris than you should

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

The most likely symptoms will be a feeling of dizziness or drowsiness, due to the decrease in blood pressure and/or excessive thirst, confusion, reduced urine volume, or rapid heart palpitations.

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

If you forget to take Lisinopril/Hidroclorotiazida Viatris

You should take Lisinopril/Hidroclorotiazida Viatris as prescribed. Do not take a double dose to compensate for the missed doses. Continue with the normal plan prescribed.

If you interrupt treatment with Lisinopril/Hidroclorotiazida Viatris

Do not stop taking this medication even if you feel well, unless your doctor indicates so.

Your doctor will inform you of the duration of your treatment with Lisinopril/Hidroclorotiazida. Do not suspend treatment before then.

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.

If you experience any of the following side effects, stop taking this medicine and seek immediate medical attention in any of the following cases:

• if you notice swelling of the face, lips, tongue, and/or throat that makes it difficult to breathe or swallow
• if you notice swelling of the hands, feet, or ankles
• if you develop urticaria

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 greater decrease in blood pressure than experienced when continuing treatment. Symptoms will be dizziness and dizziness. In this case, it is advisable to lie down. If it causes concern, consult your doctor.

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

Medicine side effects are classified as follows:

Very common : can affect more than 1 in 10 people.

Common : can affect up to 1 in 10 people.

Rare : can affect up to 1 in 100 people.

Uncommon : can affect up to 1 in 1,000 people.

Very rare : can affect up to 1 in 10,000 people.

Frequency unknown : cannot be estimated from available data.

Common (can affect up to 1 in 10 people)

Uncommon (can affect up to 1 in 100 people)

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

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

• dry mouth

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

Frequency unknown (cannot be estimated from available data)

Additional side effects reported for individual components that may be potential side effects of this medicine are:

Hydrochlorothiazide

Frequency unknown (cannot be estimated from available data)

Lisinopril

Common (can affect up to 1 in 10 people)

Uncommon (can affect up to 1 in 100 people)

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

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

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 not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

This medication does not require special conditions for conservation.

Store in the original packaging.

Do not use this medication after the expiration date that appears on the packagingafter 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 packaging and medications you no longer need at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition ofLisinopril/HidroclorotiazidaViatris

The active principles are lisinopril(20 mg) and hidroclorotiazida (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 contents of the packaging

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

Holder of the marketing authorization and responsible for the manufacturing

Holderof the marketing authorization:

Viatris Pharmaceuticals, S.L.U.

C/ General Aranaz, 86

28027 - Madrid

Spain

Responsible for the manufacturing:

Neuraxpharm Pharmaceuticals,S.L.

Avda. Barcelona, 69

08970 - Sant Joan Despí (Barcelona)

Spain

Date of the last review ofthis prospectus:December 2022

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