Label: information for the user

PRINIVIL 20 mg tablets

Lisinopril

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

• Keep this label, 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 and should not be given to others, even if they have the same symptoms of illness 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 label. See section 4.

Contents ofthe label:

1.What Prinivil is and for what it is used

2. What you need to knowbefore starting to take Prinivil

3.How to take Prinivil

4.Possible adverse effects

5.Storage of Prinivil

6. Contents of the package and additional information

Prinivil belongs to a group of medications known as 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 associated with type 2 diabetes in 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 ifa 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:

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) increases:
• • 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 a recent heart attack.
• If you have kidney function impairment or are on dialysis.
• If you have liver dysfunction (liver function impairment).
• 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 diabetesand are taking oral antidiabetic medications or insulin. Prinivil may increase the risk of hypoglycemia (low blood sugar levels), so you will need to have closer control of your glucose levels, especially during the first month of treatment withPrinivil.
• 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 they may cause high potassium levels 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 feel dizzy or lightheaded 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 neprilysin 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”.

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 Prinivil, as it may cause a sudden drop in blood pressure associated with 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 serious harm 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 recently used, 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 afterwards.

The use of some medications with Prinivil may modify the effect (interaction) of both Prinivil and the medications in question, 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 recently taken, or may need to take any of the following medications:

• Diuretics (medications that increase urine production).
• Potassium supplements (including salt substitutes), diuretics that spare potassium (“urine tablets”), and other medications that may increase potassium levels 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 thin the blood to prevent clots).
• Angiotensin II receptor antagonists (ARAs) or aliskirén (see also the information under the headings “Do not take Prinivil” and “Be careful with Prinivil”.
• Mental health medications 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 to treat arthritis or muscle pain.
• Antihypertensives (medications that reduce high blood pressure).
• Sympathomimetics (medications that stimulate the central nervous system).
• Diabetes medications, such as insulin or oral antidiabetic medications.
• Thrombolytic medications (thatprevent blood clots from forming).
• 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 neprilysin 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 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.

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 operate machines; however, if you experience dizziness or fatigue, avoid 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 interrupt 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 may 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)

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)

• 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 decrease in blood pressure in high-risk patients
• rapid and irregular heartbeat sensation
• abnormal 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
• blood potassium increase
• 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
• decreased hemoglobin (a blood protein)
• decreased hematocrit (proportion of red blood cells in the blood)
• decreased blood sodium
• 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/eosinophilic pneumonia)
• decreased ability of the body to form blood cells
• decreased red blood cell count and/or hemoglobin
• decreased platelet count in the blood
• low white blood cell count
• decreased count of a certain type of white blood cell (neutrophils)
• absence of a certain type of white blood cell (agranulocytosis)
• lymph node alterations
• autoimmune disease
• decreased blood glucose
• liver inflammation
• pancreatitis
• yellow skin and/or eye discoloration
• excessive release of antidiuretic hormone (SIADH)
• decreased urine output 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
• alterationsof taste.

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). Symptoms include redness, blistering, and peeling.
• rapid destruction of red blood cells
• sinusitis(sensation of pain and pressure behind the cheeks and eyes).

Frequency not known(cannot be estimated from available data)

• stroke (cerebral infarction)
• 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 leaflet. You can also report them directly through theSistema Español de Farmacovigilancia de medicamentos de Uso Humano: https://www.notificaram.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep out of the 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 the packaging and medicines you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. In this way, you will help protect the environment.

Composition of Prinivil

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

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

Appearance of the product and contents of the packaging

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