Leaflet: information for the user

PRINIVIL 5 mg tablets

Lisinopril

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, ask your doctor or pharmacist.

- This medicine has been prescribed for you and should not be given to others, even if they have the same symptoms, 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 is and what it is used for

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

3.How to take Prinivil

4.Possible side effects

5.Storage of Prinivil

6. Contents of the pack and additional information

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

Prinivil is indicated for:

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

Do not take Prinivil

• If you are allergic (hypersensitive) to lisinopril, other medications in the same group (ACE inhibitors), or any of the other components of this medication (listed in section 6).
• If you have previously received a medication in the same group of drugs as lisinopril (ACE inhibitors) and have experienced an allergic reaction that caused swelling of 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 best to avoid Prinivil at the beginning of pregnancy - see Pregnancy section).
• If you have diabetes or kidney failure and are being treated with a medication to lower blood pressure 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 an area 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.

Warnings and precautions

Consult your doctor or pharmacist before starting to use Prinivil.

Inform your doctor if you are in any of the following situations, as you may need to adjust your dose or discontinue 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 assistance immediately.
• If you are taking any of the following medications, the risk of angioedema (rapid swelling under the skin in areas such as the throat) may increase:
• 1. 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 arteries of the kidneys (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 had an acute myocardial infarction.
• If you have a kidney function disorder or are on dialysis.
• If you have liver dysfunction (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.
• If you are following a low-sodium diet, taking potassium supplements or salt substitutes containing potassium, taking potassium-sparing diuretics (medications that increase the elimination of urine), have diabetes or any kidney problems, as they may cause high levels of potassium in the blood that can be severe. In these cases, your doctor may need to adjust your Prinivil dose or monitor your potassium levels in the blood.
• If you have a cough, as it may be caused by the treatment.
• If you are about to undergo a treatment called LDL apheresis.
• If you are about to undergo a desensitization treatment to reduce the effect of an allergy to bee or wasp stings.
• If you have low blood pressure, as the use of Prinivil, especially in the first doses, may cause a sudden drop in blood pressure (you may notice it as dizziness or lightheadedness when standing up. In these cases, lying down may help).
• 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, valsartán, telmisartán, irbesartán, particularly if you have kidney problems related to diabetes.
• Aliskirén.
• If you are taking a medication that contains a neprilisina inhibitor (for example, sacubitril or sacubitril/valsartán). Do not administer Prinivil within 36 hours before or after taking sacubitril/valsartán.

Your doctor may need to monitor your kidney function, blood pressure, and electrolyte levels in the blood (such as potassium) at regular intervals.

See also the information under the heading "Do not take Prinivil".

Inform your doctor or dentist that you are taking Prinivil before undergoing a surgical procedure with general or local anesthesia (even in the dentist's office), as a sudden drop in blood pressure may occur associated with the anesthesia.

You should inform your doctor if you think you may be pregnant (or could 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 severe damage to your baby if used from the third month of pregnancy.

Children and adolescents

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

Use of Prinivil with other medications

Inform your doctor or pharmacist if you are using, or have used recently, other medications, or may need to use any other medication.

Be aware that these instructions may also apply to medications that have been used before or may be used later. The use of some medications with Prinivil may modify the effect (interaction) of both Prinivil and the medications, so in these cases, you may need to change your dose or discontinue treatment with one of them. Your doctor may need to adjust your dose and/or take other precautions.

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 the elimination of urine).
• Potassium supplements (including salt substitutes), diuretics that spare potassium ("urine tablets") and other medications that may increase the amount of potassium in the blood (for example, trimetoprima and cotrimoxazol for bacterial infections; ciclosporina, an immunosuppressant used to prevent organ transplant rejection; and heparin, a medication used to dilute the blood to prevent clots).
• Angiotensin II receptor antagonists (ARA) or aliskirén (see also the information under the headings "Do not take Prinivil" and "Be careful with Prinivil").
• Medications for mental disorders such as lithium, antipsychotics, or tricyclic antidepressants.

• Nonsteroidal anti-inflammatory drugs (NSAIDs), such as indometacina, and high doses of aspirin (more than 3 grams per day) and gold treatment, used for arthritis or muscle pain.
• Anti-hypertensive medications (medications that reduce elevated blood pressure).
• Sympathomimetic medications (that stimulate the central nervous system).
• Medications used to treat diabetes, such as insulin or oral antidiabetic medications.
• Thrombolytic medications (that prevent the formation of blood clots).
• Medications used more frequently to prevent organ transplant rejection (temsirolimus, sirolimus, everolimus, and other mTOR inhibitors). See the section "Warnings and precautions".
• Medications that contain a neprilisina inhibitor (for example, sacubitril).

Prinivil with food and drinks

This medication can be taken before or after meals.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medication.

Pregnancy

You should inform your doctor if you think you may be pregnant (or could be). Normally, your doctor will advise you to stop taking Prinivil before becoming pregnant or as soon as you know you are pregnant and will advise you to take a different medication instead of Prinivil. 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 severe 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.

Prinivil is not recommended for mothers who are breastfeeding, and if you want to breastfeed, your doctor may choose another treatment, especially if your baby is newborn or premature.

Driving and operating machines

It is unlikely that Prinivil tablets will affect your ability to drive vehicles 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 medication.

Follow exactly the administration instructions of this medication indicated by your doctor. Consult your doctor or pharmacist if you have doubts.

Remember to take your medication.

Your doctor will indicate how many tablets you should take each day and the duration of your treatment with Prinivil. Do not discontinue treatment before.

Adults

The usual recommended 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.

• Diabetic kidney complications:

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

Patients with kidney function impairment

Your doctor will adjust the dose.

Administration form:

• 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 what will be seen when continuing treatment. This effect may be felt as dizziness, in which case lying down will help.

If you estimate that the action of Prinivil is too strong or too weak, consult your doctor or pharmacist.

If you take more Prinivil than you should

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

The most common symptoms in case of overdose are: hypotension (low blood pressure), shock, renal insufficiency (kidney function impairment), hyperventilation (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, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20 indicating the medication and the amount ingested.

If you forget to take Prinivil

Do not take a double dose to compensate for the missed doses and wait for the next administration.

If you discontinue treatment with Prinivil

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

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.

Medicine side effects 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)

Unknown frequency (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)

• kidney function impairment
• cough
• 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 blood pressure decrease in high-risk patients
• rapid and irregular heartbeat sensation
• abnormal and rapid heartbeats
• numbness and spasms in the fingers of the hands, followed by heat and pain (Raynaud's phenomenon)
• tingling sensation in certain limbs
• inability to achieve an erection
• skin rash
• itching
• liver enzyme increase
• blood urea increase
• blood creatinine increase
• potassium increase in blood
• mood changes
• nausea
• stomach pain
• fatigue
• lassitude.

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

• cardiac arrest
• kidney function impairment
• allergic reaction (angioedema) characterized by facial, limb, lip, tongue, and/or laryngeal swelling
• chronic bronchitis inflammation
• skin rash with blisters or hives
• psoriasis
• hair loss
• blood urea increase
• blood bilirubin increase
• hemoglobin decrease (a blood protein)
• hematocrit decrease (ratio of red blood cells in blood)
• sodium decrease in blood
• breast enlargement in men
• confusion
• dry mouth
• lingual disorders.
• visual field defect (area of vision).

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

• bronchospasm and difficulty breathing (bronchospasm)
• lung inflammation (allergic alveolitis/neumonía eosinofílica)
• decrease in the body's ability to form blood cells
• decrease in red blood cells and/or hemoglobin in blood
• decrease in platelets in blood
• low white blood cell count
• decrease in a certain type of white blood cell (neutrófilos)
• absence of a certain type of white blood cell (agranulocitosis)
• lymph node alterations
• autoimmune disease
• decrease in blood glucose
• liver inflammation
• pancreatitis
• yellow skin and/or eye color
• excessive release of antidiuretic hormone (SIADH)
• decrease in urine production or inability to urinate
• intestinal inflammation
• intense sweating.

Side 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)
• dizziness sensation
• rhinitis
• indigestion
• taste alterations.

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 (pénfigo, necrólisis epidérmica tóxica, Stevens-Johnson syndrome, eritema multiforme, pseudolinfoma cutáneo). Symptoms include redness, blister formation, and peeling.
• rapid destruction of red blood cells, resulting in decreased red blood cell count.
• sinusitis (sensation of pain and pressure behind the cheeks and eyes).

Unknown frequency (cannot be estimated from available data)

• stroke (cerebral vascular accident)
• angina pectoris and heart rhythm alterations
• liver function impairment
• urinary tract infection
• difficulty breathing (dyspnea)
• bronchitis inflammation
• chest pain
• back pain
• shoulder pain
• joint pain
• muscle cramps
• depression
• decreased libido
• gout
• syncope
• loss of appetite
• constipation
• gas
• nasal congestion
• throat pain
• upper respiratory tract symptoms
• redness.

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 prospectus. You can also report them directly through the Spanish System for the Vigilance 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 out of reach and sight of children.

No special storage conditions are required.

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

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and unused medicines at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medicines. By doing so, you will help protect the environment.

Composition of Prinivil

• The active ingredient is lisinopril.Each Prinivil 5 mg tabletcontains 5 mg oflisinoprilin the form of lisinopril dihydrate.

• The other components are mannitol, calcium dihydrogen phosphate, cornstarch, pregelatinized cornstarch, magnesium stearate.

Appearance of the product and contents of the packaging

Prinivil 5 mg is presented in the form of white tablets. Each package contains 60 tablets.

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: April 2020

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