Prinivil 20 mg tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

PRINIVIL 20 mg tablets

Lisinopril

Read the entire 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 only and should not be given to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet contents:

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

1. What Prinivil is and what it is used for

Prinivil belongs to a group of medicines called angiotensin-converting enzyme (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 II diabetes patients with hypertension.

2. What you need to know before taking Prinivil

Do not take Prinivil

• If you are allergic (hypersensitive) to lisinopril, to other medicines in the same group (ACE inhibitors), or to any of the other ingredients of this medicine (listed in section 6).
• If you have previously received a medicine from the same class as lisinopril (ACE inhibitors) and experienced an allergic reaction causing 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 (Prinivil should also be avoided at the beginning of pregnancy – see Pregnancy section).
• If you have diabetes or renal failure and are being treated with a blood pressure-lowering medicine containing aliskiren.
• If you have taken or are currently taking sacubitril/valsartan, a medicine used to treat 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 developing angioedema may increase:
  • Racecadotril, a medicine used to treat diarrhoea.
  • 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.

Inform your doctor if you are in any of the following situations, as you may need a dose adjustment or discontinuation of Prinivil treatment:

• If you have difficulty breathing or swallowing, with or without swelling of the face, lips, tongue, and/or throat, stop taking Prinivil and seek immediate medical help.

• If you are taking any of the following medicines, the risk of angioedema (rapid swelling under the skin in areas such as the throat) increases:

  • Temsirolimus, sirolimus, everolimus, and other medicines in the class of mTOR inhibitors (used to prevent rejection of transplanted organs).

• If you have recently experienced excessive vomiting or diarrhoea.

• If you have narrowing of the aorta (aortic stenosis), narrowing of the renal arteries (renal artery stenosis), narrowing of the heart valves (mitral valve stenosis), or thickening of the heart muscle (hypertrophic cardiomyopathy).

• If you have acute myocardial infarction.

• If you have impaired kidney function or are on dialysis.

• If you have hepatic impairment (impaired liver function).

• If you have a blood vessel disease (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 develop serious infections. In such cases, inform your doctor at the first sign of infection.

• If you have diabetes and are taking oral antidiabetic medicines or insulin. Prinivil may increase the risk of hypoglycaemia (low blood sugar levels), so you should monitor your glucose levels more closely, especially during the first month of treatment with Prinivil.

• If you are on a salt-free diet, take potassium supplements or salt substitutes containing potassium, take potassium-sparing diuretics (medicines that increase urine output), have diabetes, or any kidney problems, as these may cause significant increases in blood potassium levels. In such cases, your doctor may need to adjust your dose of Prinivil or monitor your blood potassium levels.

• If you have a cough, as this may be due to the treatment.

• If you are about to undergo a treatment called low-density lipoprotein (LDL) apheresis.

• If you are about to undergo desensitization treatment to reduce the effect of an allergy to bee or wasp stings.

• If you have low blood pressure, as use of Prinivil, especially in the first doses, may cause a sudden drop in blood pressure (you may feel faint or dizzy when standing up. In such 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” – for example, valsartan, telmisartan, irbesartan), particularly if you have kidney problems related to diabetes.
  • Aliskiren.
  • If you are taking a medicine containing a neprilysin inhibitor (e.g., sacubitril or sacubitril/valsartan). Prinivil must not be administered within 36 hours before or after taking sacubitril/valsartan.

Your doctor may need to 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 any surgical procedure with general or local anaesthesia (including at the dentist), inform the doctor or dentist that you are taking Prinivil, as a sudden drop in blood pressure may occur in association with anaesthesia.

Inform your doctor if you think you are pregnant (or could be). Prinivil is not recommended during early pregnancy and must 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 Pregnancy section).

Children and adolescents

Prinivil has been studied in children. For further information, speak with your doctor.

Taking Prinivil with other medicines

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

Note that these instructions may also apply to medicines you have used previously or may use in the future.

Taking certain medicines together with Prinivil may alter the effect (interaction) of both Prinivil and those medicines, so it may be necessary to adjust 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 need to take any of the following medicines:

• Diuretics (medicines that increase urine output).
• Potassium supplements (including salt substitutes), potassium-sparing diuretics (“water tablets”), and other medicines that may increase blood potassium levels (e.g., trimethoprim and cotrimoxazole for bacterial infections; cyclosporine, 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 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 drugs (NSAIDs), such as indomethacin, high-dose aspirin (more than 3 grams per day), and gold therapy, used to treat arthritis or muscle pain.
• Antihypertensives (medicines that lower high blood pressure).
• Sympathomimetic medicines (which stimulate the central nervous system).
• Medicines for the treatment of diabetes, such as insulin or oral antidiabetics.
• Thrombolytic medicines (which prevent blood clots).
• Medicines more commonly used to prevent rejection of transplanted organs (temsirolimus, sirolimus, everolimus, and other mTOR inhibitors). See section “Warnings and precautions”.
• Medicines containing a neprilysin inhibitor (e.g., sacubitril).

Taking Prinivil with food and drink

This medicine may be taken with or without food.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medicine.

Pregnancy

Inform your doctor if you think you are pregnant (or could be). Your doctor will usually advise you to stop taking Prinivil before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine. Prinivil is not recommended during early pregnancy and must 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

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

Prinivil is not recommended for breastfeeding mothers, and if you wish to breastfeed, your doctor may choose an alternative treatment, especially if your baby is a newborn or was born prematurely.

Driving and using machines

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

3. How to take Prinivil

Follow exactly the instructions given by your doctor for taking this medicine. If you have any doubts, consult your doctor or pharmacist.

Remember to take your medicine.

Your doctor will tell you how many tablets to take each day and how long your treatment with Prinivil should last. Do not stop treatment early.

Adults

The usual recommended doses are:

• Hypertension:

Initial dose: 10 mg once daily.

Long-term dose: 20 mg once daily.

• Symptomatic heart failure:

Initial dose: 2.5 mg once daily.

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

• Acute myocardial infarction:

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

• Diabetic kidney complications:

The usual dose is 10 mg or 20 mg once daily.

Patients with impaired kidney function

Your doctor will adjust your dose.

Method of administration:

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

Please remember, the first dose of Prinivil may cause a greater decrease in blood pressure than subsequent doses. This effect may manifest as dizziness; in such a case, lying down will help.

If you feel that the effect 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, contact your doctor or pharmacist immediately.

The most common symptoms in case of overdose are: hypotension (low blood pressure), shock, renal failure (impaired kidney function), 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, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Prinivil

Do not take a double dose to make up for missed doses; wait until the next scheduled dose.

If you stop taking Prinivil

Your doctor will tell you how long your treatment with Prinivil should last. Do not stop treatment early, even if you feel better.

If you have any further questions about 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 everyone will experience them.

Medicine-related adverse 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 drop in blood pressure in high-risk patients
• Rapid or irregular heartbeat
• Unusual rapid heartbeats
• Numbness and spasms in the fingers, followed by warmth and pain (Raynaud's phenomenon)
• Tingling sensation in certain limbs
• Inability to achieve an erection
• Skin rash
• Itching
• Increased liver enzymes
• Increased blood urea
• Increased blood creatinine
• Increased blood potassium
• Mood disturbances
• Nausea
• Stomach pain
• Fatigue
• Tiredness

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

• Cardiac arrest
• Impaired kidney function
• Allergic reaction (angioedema) characterized by swelling of the face, limbs, lips, tongue, and/or larynx
• Inflammation of the bronchi, which may be chronic
• Skin rash with wheals or hives
• Psoriasis
• Hair loss
• Increased blood urea levels
• Increased blood bilirubin
• Decreased hemoglobin (a blood protein)
• Decreased hematocrit (proportion of red blood cells in the blood)
• Decreased blood sodium
• Breast enlargement 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 breathing difficulty (bronchospasm)
• Lung inflammation (allergic alveolitis/eosinophilic pneumonia)
• Reduced ability of the body to produce blood cells
• Decreased number of red blood cells and/or hemoglobin in the blood
• Decreased platelet count in the blood
• Low white blood cell levels
• Decreased levels of a certain type of white blood cells (neutrophils)
• Absence of a certain type of white blood cells (agranulocytosis)
• Lymph node disorders
• Autoimmune disease
• Decreased blood glucose
• Liver inflammation
• Pancreatitis
• Yellowing of the skin and/or eyes
• Excessive release of antidiuretic hormone (SIADH)
• Reduced urine output or inability to urinate
• Intestinal inflammation
• Excessive sweating

Adverse effects observed in patients treated with Prinivil, with 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
• Rhinitis
• Indigestion
• Taste disturbances

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.
• Decreased number of red blood cells due to their 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)
• Angina and heart rhythm disturbances
• Impaired liver function
• Urinary tract infection
• Breathing difficulty (dyspnea)
• Bronchial inflammation
• Chest pain
• Back pain
• Shoulder pain
• Joint pain
• Muscle cramps
• Depression
• Decreased libido
• Gout
• Fainting
• Loss of appetite
• Constipation
• Flatulence
• Nasal congestion
• Sore throat
• Upper respiratory tract symptoms
• Redness

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide 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 expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of containers and unused medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Prinivil

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

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

Appearance of the medicine and contents of the pack

Prinivil 20 mg is presented as peach-colored tablets. Each pack 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 the most recent revision of this leaflet: April 2020

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es