PRINIVIL 20 mg TABLETS

Introduction

Package Leaflet: Information for the User

PRINIVIL 20 mg tablets

Lisinopril

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 thepackage leaflet:

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

1. What is Prinivil and what is it used for

Prinivil belongs to a group of medicines called angiotensin-converting enzyme inhibitors (ACE inhibitors).

Prinivil is indicated for:

• Treatment of high blood pressure (hypertension).
• Treatment of symptomatic heart failure.
• Short-term treatment of acute myocardial infarction.
• Treatment of kidney complications in type 2 diabetes patients with hypertension.

2. What you need to know before you take Prinivil

Do not take Prinivil

• If you are allergic (hypersensitive) to lisinopril, to other medicines of the same group (ACE inhibitors), or to any of the other ingredients of this medicine (listed in section 6).
• If you have previously taken a medicine of the same group of drugs as lisinopril (ACE inhibitors) and have experienced an allergic reaction that caused swelling of the hands, feet, or ankles, face, lips, tongue, and/or throat with difficulty swallowing or breathing, or if a family member has had a similar reaction (angioedema).
• If you are more than 3 months pregnant (it is also better to avoid Prinivil at the beginning of pregnancy - see section Pregnancy).
• If you have diabetes or kidney problems 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 areas 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.

Warnings and precautions

Talk to your doctor or pharmacist before starting to use Prinivil.

Tell your doctor if you are in any of the following situations, as you may need a dose adjustment or to stop treatment with Prinivil:

• If you have difficulty breathing or swallowing with or without swelling of the face, lips, tongue, and/or throat, stop taking Prinivil and seek medical attention immediately.
• If you are taking any of the following medicines, the risk of angioedema (rapid swelling under the skin in areas such as the throat) may increase:
• • Temsirolimus, sirolimus, everolimus, and other medicines of 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), 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 had a recent acute myocardial infarction.
• If you have kidney problems or are on dialysis.
• If you have liver problems (liver function impairment).
• If you have a disease of the blood vessels (collagen vascular disease) and/or are being treated with allopurinol (for gout treatment), procainamide (for heart rhythm disorders), or 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. Prinivil may increase the risk of hypoglycemia (low blood sugar levels), so you will need to have your glucose levels monitored more closely, especially during the first month of treatment with Prinivil.
• If you are on a low-salt diet, take potassium supplements, or take potassium-sparing diuretics (medicines that increase urine production), have diabetes, or have kidney problems, as these may cause increases in blood potassium levels that can be serious. In these cases, your doctor may need to adjust the dose of Prinivil or monitor your potassium levels in the blood.
• If you have a cough, as it may be due to treatment.
• 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 a bee or wasp sting allergy.
• If you have low blood pressure, as the use of Prinivil, especially in the first doses, may cause a sudden drop in blood pressure (which you may notice as dizziness or lightheadedness when standing up. In these cases, lying down may help).
• 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, particularly if you have kidney problems related to diabetes.
  • Aliskiren.
  • If you are taking a medicine that contains a neprilysin inhibitor (e.g., sacubitril or sacubitril/valsartan). Prinivil 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 Prinivil".

Before undergoing surgery with general or local anesthesia (even at the dentist), inform your doctor or dentist that you are taking Prinivil, as it may cause a sudden drop in blood pressure associated with anesthesia.

You must inform your doctor if you think you are pregnant (or might be). Prinivil 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).

Children and adolescents

Prinivil has been studied in children. For more information, talk to your doctor.

Using Prinivil with other medicines

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

Note that these instructions may also apply to medicines that you have used before or may use after.

Taking some medicines with Prinivil may affect the action of Prinivil or the other medicine, so in these cases, it may be necessary to change the dose or stop treatment with one of them. Your doctor may need to adjust your dose and/or take other precautions.

In particular, talk to your doctor or pharmacist if you are taking, have recently taken, or might 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 potassium levels in the blood (e.g., trimethoprim and cotrimoxazole for bacterial infections; cyclosporin, an immunosuppressant used to prevent organ transplant rejection; and heparin, a medicine used to thin the blood to prevent clots).
• If you are taking an angiotensin II receptor antagonist (ARA) or aliskiren (see also the information under the headings "Do not take Prinivil" and "Take special care with Prinivil").
• Medicines for mental disorders such as lithium, antipsychotics, or tricyclic antidepressants.
• Non-steroidal anti-inflammatory medicines (NSAIDs) such as indomethacin, and high doses of aspirin (more than 3 grams per day) and gold treatment used for arthritis or muscle pain.
• Antihypertensives (medicines that lower high blood pressure).
• Sympathomimetic medicines (which stimulate the central nervous system).
• Medicines for diabetes, such as insulin or oral antidiabetics.
• Thrombolytic medicines (which prevent blood clots from forming).
• Medicines used more frequently to prevent organ transplant rejection (temsirolimus, sirolimus, everolimus, and other medicines of the mTOR inhibitor type). See section "Warnings and precautions".
• Medicines that contain a neprilysin inhibitor (e.g., sacubitril).

Taking Prinivil with food and drinks

This medicine can be taken before or after meals.

Pregnancy and breastfeeding

Ask your doctor or pharmacist for advice before taking any medicine.

Pregnancy

You must inform your doctor if you think you are pregnant (or might be). Normally, your doctor will advise you to stop taking Prinivil before you become pregnant or as soon as you know you are pregnant and will advise you to take a different medicine instead of Prinivil. Prinivil is not recommended at the beginning of pregnancy and should not be taken 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 onwards.

Breastfeeding

Tell your doctor if you are breastfeeding or about to start breastfeeding.

Prinivil is not recommended for mothers who are breastfeeding, 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

It is unlikely that Prinivil tablets will affect your ability to drive or use machines; however, if you notice symptoms of dizziness or fatigue, avoid performing tasks that require special attention until you know how you tolerate the medicine.

3. How to take Prinivil

Follow exactly the administration instructions of this medicine given by your doctor. Ask your doctor or pharmacist if you have any doubts.

Remember to take your medicine.

Your doctor will tell you how many tablets to take each day and the duration of your treatment with Prinivil. Do not stop treatment before.

Adults

The recommended usual doses are:

• Hypertension:

Initial dose: 10 mg once a day.

Long-term dose: 20 mg once a day.

• Symptomatic heart failure:

Initial dose: 2.5 mg once a day.

Long-term dose: 5 mg up to a maximum of 35 mg once a day.

• Acute myocardial infarction:

Initial dose: 5 mg on the first and second day after the infarction, followed by 10 mg once a day.

• Kidney complications in diabetes:

The usual dose is 10 mg or 20 mg once a day.

Patient with kidney function impairment

Your doctor will adjust the dose.

Mode of administration:

• Swallow the tablet with water.
• Try to take your tablets at the same time every day. Prinivil can be taken before or after meals.

Remember, the first dose of Prinivil may cause a greater decrease in blood pressure than will be seen with continued treatment. This effect may be noticed as dizziness, in which case lying down may help.

If you think the action of Prinivil is too strong or too weak, talk to your doctor or pharmacist.

If you take more Prinivil than you should

If you take more Prinivil than you should, talk to your doctor or pharmacist immediately.

The most common symptoms in case of overdose are: hypotension (low blood pressure), shock, kidney failure (kidney function impairment), hyperventilation (very rapid breathing), tachycardia (increased heart rate), palpitations (rapid and irregular heartbeat), bradycardia (decreased heart rate), dizziness, anxiety, and cough.

In case of overdose or accidental ingestion, talk to your doctor or pharmacist immediately or call the Toxicology Information Service, telephone 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Prinivil

Do not take a double dose to make up for forgotten doses and wait for the next administration.

If you stop taking Prinivil

Your doctor will tell you the duration of your treatment with Prinivil. Do not stop treatment before, even if you feel better.

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.

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 available data)

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

Common(may affect up to 1 in 10 people)

• alteration in kidney function
• cough
• feeling of dizziness or lightheadedness, especially when standing up quickly
• dizziness
• headache
• diarrhea

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 and irregular heartbeat
• rapid and unusual heartbeats
• numbness and spasms in the fingers, followed by heat and pain (Raynaud's phenomenon)
• tingling sensation in certain limbs
• inability to obtain an erection
• skin rash
• itching
• increase in liver enzymes
• increase in blood urea
• increase in blood creatinine
• increase in blood potassium
• mood changes
• nausea
• stomach pain
• fatigue
• tiredness

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

• cardiac arrest
• kidney function disorder
• allergic reaction (angioedema) characterized by swelling of the face, limbs, lips, tongue, and/or larynx
• chronic bronchial inflammation
• skin rash with hives or wheals
• psoriasis
• hair loss
• increase in blood urea
• increase in blood bilirubin
• decrease in hemoglobin (a blood protein)
• decrease in hematocrit (proportion of red blood cells in the blood)
• decrease in blood sodium
• increase in breast tissue in men
• mental confusion
• dry mouth
• tongue disorders
• visual field defect (area of vision)

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

• contraction of bronchial muscles and difficulty breathing (bronchospasm)
• lung inflammation (allergic alveolitis/eosinophilic pneumonia)
• decrease in the body's ability to form blood cells
• decrease in the amount of red blood cells and/or hemoglobin in the blood
• decrease in platelet count in the blood
• low white blood cell count
• decrease in the amount of a certain type of white blood cell (neutrophils)
• absence of a certain type of white blood cell (agranulocytosis)
• lymph node disorders
• autoimmune disease
• decrease in blood glucose
• liver inflammation
• pancreas inflammation
• yellowish color of skin and/or eyes
• excessive release of antidiuretic hormone (SIADH)
• decrease in urine output or inability to urinate
• intestinal inflammation
• excessive sweating

Adverse effects observed in people treated with Prinivil, of unknown causal relationship:

Common: may affect up to 1 in 10 people

• vomiting

Uncommon: may affect up to 1 in 100 people

• sleep disorders (insomnia and somnolence)
• feeling of vertigo
• rhinitis
• indigestion
• taste disorders

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

• blurred vision

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

• severe skin disorders (pemphigus, toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme, cutaneous pseudolymphoma) with symptoms including redness, blistering, and peeling
• decrease in red blood cell count due to rapid destruction
• sinusitis (feeling of pain and pressure behind the cheeks and eyes)

Frequency not known(cannot be estimated from available data)

• stroke (cerebrovascular accident)
• chest pain and heart rhythm disorders
• liver function disorder
• urinary tract infection
• breathing difficulties (dyspnea)
• bronchial inflammation
• chest pain
• back pain
• shoulder pain
• joint pain
• muscle cramps
• depression
• decreased sexual desire
• gout
• fainting
• loss of appetite
• constipation
• gas
• nasal congestion
• sore throat
• upper respiratory system symptoms
• redness

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 is not listed in this leaflet. 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. Storage of Prinivil

Keep out of the reach and sight of children.

No special storage conditions are required.

Do not use Prinivil after the expiration date stated on the packaging after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through wastewater or household waste. Deposit the packaging and any unused medicines in the pharmacy's SIGRE point. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Prinivil

• The active ingredient is lisinopril. Each 20 mg Prinivil tablet contains 20 mg of lisinopril in the form of lisinopril dihydrate.

• The other ingredients are mannitol, calcium hydrogen phosphate dihydrate, cornstarch, pregelatinized cornstarch, magnesium stearate, yellow iron oxide (E-172), and red iron oxide (E-172).

Appearance of the Product and Package Contents

Prinivil 20 mg is presented in the form of peach-colored tablets. Each package contains 28 tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

PAN QUÍMICA-FARMACÉUTICA, S.A.

Rufino González, 50

28037 Madrid

Spain

Manufacturer

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

Date of Last Revision of this Leaflet:April 2020

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