Leaflet: information for the user

Prinivil Plus 20 mg / 12.5 mg tablets

lisinopril / hydrochlorothiazide

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

1. What Prinivil Plus is and what it is used for

2. What you need to know before you start taking Prinivil Plus

3. How to take Prinivil Plus

4. Possible side effects

5. Storage of Prinivil Plus

6. Contents of the pack and additional information

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

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

Lisinopril/hydrochlorothiazide is indicated for essential hypertension (high blood pressure).

Do not take Prinivil Plus

• if you are allergic (hypersensitive) to lisinopril, hydrochlorothiazide, or any of the other components of this medication (listed in section 6).
• if you are allergic (hypersensitive) to any sulfonamide-derived drug or any other angiotensin-converting enzyme (ACE) inhibitor. If you are unsure which ones, consult your doctor.
• if you have already been treated with medications from the same group as lisinopril (ACE inhibitors) and have experienced 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 pregnantover 3 months(it is also recommended to avoidthis medication at thebeginning of pregnancy - see Pregnancy section).

• if you 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 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 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/hydrochlorothiazide.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Prinivil Plus:

• if you have difficulty breathing or swallowing with or without swelling of the face, lips, tongue, and/or throat, stop taking this medication and seek medical assistance 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 medications, the risk of angioedema (rapid swelling under the skin in areas such as the throat) is increased:
• Temsirolimus, sirolimus, everolimus, and other medications in the class of mTOR inhibitors (used to prevent organ transplant rejection).
• if you have recently experienced excessive vomiting or diarrhea.
• if you have a narrowing of the aorta (aortic stenosis), the renal arteries (renal artery stenosis), or 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 insufficiency (liver function disorder).
• if you have a vascular disease (collagen vascular disease) and/or are being treated with allopurinol (for gout treatment), procainamide (for heart rhythm disorders), immunosuppressants (medications that suppress the body's immune response),because you may be at risk of severe infections. In these cases, inform your doctor of any signs of infection.
• if you have diabetes and are taking oral antidiabetic medications or insulin.Lisinopril/hydrochlorothiazidemay increase the risk of hypoglycemia (low blood sugar levels), so you will need to have a closer control of your blood glucose levels, especially during the first month of treatment withthis medication. You may need to adjust the dose of your diabetes medications.
• if you are on a low-sodium diet, taking potassium supplements or salt substitutes containing potassium, taking potassium-sparing diuretics (medications that increase urine production), have diabetes or any kidney problems, as they may cause a significant increase in potassium levels in the blood that can be serious. In these cases, your doctor may need to adjust the dose ofPrinivil Plus 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 a 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 treatment with hydrochlorothiazide, 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 Prinivil Plus.
• 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 and may occur within a few hours to a week after taking Prinivil Plus.

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

• An angiotensin II receptor antagonist (ARA) also known as "sartanes" - for example, valsartan, telmisartan, irbesartan), particularly if you have kidney problems related to diabetes.
• Aliskirén.
• Sacubitril/valsartán. Do not administer Prinivil Plus 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 Prinivil Plus”.

The use oflisinopril/hydrochlorothiazide, 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 in the dentist's office), inform your doctor or dentist that you are taking this medication, as a sudden drop in blood pressure may occur associated with anesthesia.

You should inform your doctor if you think you are pregnant (or may be). Lisinopril/hydrochlorothiazideis not recommended at the beginning of pregnancy and should not be used if you are pregnant over 3 months, as it may cause serious damage to your baby if used during this stage (see Pregnancy section).

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

Children

The safety and efficacy have not been established in children.

Other medications and Prinivil Plus

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

Particularly, talk to 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).
• Supplements of potassium (including salt substitutes), potassium-sparing diuretics (“urine tablets”) and other medications that may increase the amount of potassium in the blood (e.g., trimethoprim and cotrimoxazole for bacterial infections; cyclosporine, an immunosuppressant used to prevent organ transplant rejection; and heparin, a medication used to dilute the blood to 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 indomethacin and high doses of aspirin (more than 3 grams per day).
• Other antihypertensives (medications that lower high blood pressure).
• Angiotensin II receptor antagonists (ARAs) or aliskirén (see also the information under the headings “Do not take Prinivil Plus” and “Be careful with Prinivil Plus”).
• Sympathomimetics (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 breastfeeding

Consult your doctor or pharmacist before using any medication.

Pregnancy

Lisinopril/hydrochlorothiazideis not recommended during pregnancy.

You should inform your doctor if you think you are pregnant (or may be). Normally, your doctor will advise you to stop taking Prinivil Plus before becoming pregnant or as soon as you know you are pregnant and will change Prinivil Plus for another medication. Lisinopril/hydrochlorothiazideis not recommended at the beginning of pregnancy and should not be taken, in any case, if you are pregnant over 3 months, as it may cause serious damage to your baby if used from the third month of pregnancy.

Breastfeeding

Inform your doctor if you are breastfeeding or are about to start breastfeeding your baby.PrinivilPlus is not recommended in breastfeeding 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 from person to person. Certain adverse effects have been reported with lisinopril/hydrochlorothiazide that may affect a person'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

It is reported to athletes that this medication contains a component (hydrochlorothiazide) 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. If in 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 effect of this medication is too strong or too 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 Prinivil Plus than you should

If you have taken Prinivil Plus more than you should, consult your doctor or pharmacist immediately.

The most likely symptoms will be dizziness or drowsiness, due to a drop in blood pressure and/or excessive thirst, confusion, reduced urine volume, or rapid heartbeats.

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

If you forgot to take Prinivil Plus

You should take this medication 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 Prinivil Plus

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 Prinivil Plus. Do not discontinue 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 concerns you, 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.

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.

Frequency not known:cannot be estimated from available data.

Common(can affect up to 1 in 10 people)

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

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 feeling of tiredness.

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

• dry mouth.

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

• pancreatitis.

Frequency not known(cannot be estimated from available data)

• muscle cramps or weakness
• gout
• chest pain.

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

HYDROCHLOROTHIAZIDE

Frequency not known(cannot be estimated from available data)

• decreased number of blood cells
• decreased red blood cells due to premature destruction
• low white blood cell count
• decreased number of a certain type of white blood cell (neutrophils)
• decreased 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 skin peeling, and possibly ulcers in the mouth
• renal insufficiency
• kidney function alteration
• kidney inflammation
• yellow discoloration 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 of objects
• transient blurred vision
• decreased vision or eye pain due to high pressure [possible signs of fluid accumulation in the vascular layer of the eye (choroidal hemorrhage) or acute angle-closure glaucoma].
• imbalance of salts in the blood (including low sodium levels)
• high levels of uric acid in the blood
• high levels of glucose in the blood and/or urine
• loss of appetite
• stomach irritation
• constipation
• dizziness
• fever
• muscle spasms
• tiredness.
• skin and lip cancer (non-melanoma skin cancer).

LISINOPRIL

Common(can affect up to 1 in 10 people)

• kidney function alteration.

Uncommon(can affect up to 1 in 100 people)

• myocardial infarction or stroke, possibly secondary to excessive blood pressure reduction in high-risk patients
• irregular or unusual heartbeat
• stomach pain
• skin pruritus
• mood alterations.

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

• acute renal insufficiency
• increased urea levels in the blood
• skin rash
• hair loss
• confusion.

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

• decreased ability of the body to form blood cells, manifested as
• decreased number of red blood cells, platelets, and/or white blood cells
• excessive release of the antidiuretic hormone (leading to symptoms such as weakness, tiredness, and confusion)
• liver inflammation
• yellow discoloration of the skin and the white part of the eyes
• cutaneous pseudolymphoma
• difficulty breathing
• decreased urine output or inability to urinate
• increased sweating.
• Acute respiratory distress (symptoms include severe difficulty breathing, fever, weakness, and confusion).

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 theSistema Español de Farmacovigilancia de Medicamentos de Uso Humano: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 packaging after CAD. 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 point at 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 Prinivil Plus

• The active principles are lisinopril (as dihydrate) and hydrochlorothiazide.

Each tablet contains 20 mg of lisinopril (as dihydrate) and 12.5 mg of hydrochlorothiazide.

• The other components are: mannitol (E-421), calcium dihydrogen phosphate, cornstarch, pregelatinized cornstarch, magnesium stearate, and yellow iron oxide (E-172).

Appearance of the product and content of the packaging

Yellow, hexagonal, scored tablet on one side. Prinivil Plus is presented in packs of 28 tablets.

Prinivil Plus contains two distinct active principles.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

PAN QUÍMICA-FARMACÉUTICA, S.A.

Rufino González, 50

28037 Madrid

Spain

Responsible for manufacturing

ROVI Pharma Industrial Services, S.A.

Vía Complutense, 140

Alcalá de Henares 28805 – Madrid

(Spain)

Local representative

Laboratorios Farmacéuticos ROVI, S.A.

Julián Camarillo, 35

28037 Madrid

Spain

Last review date of this prospectus: February 2022

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