Lisinopril Aurovitas 20 mg tablets EFG

Package leaflet: Information for the patient

Introduction

Package leaflet: Information for the patient

Lisinopril Aurovitas 20 mg tablets EFG

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 you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Package leaflet contents:

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

1. What Lisinopril Aurovitas is and what it is used for

This medicine contains a drug called lisinopril. It belongs to a group of medicines known as ACE inhibitors.

Lisinopril may be used in the following cases:

• For the treatment of high blood pressure (hypertension).
• For the treatment of heart failure.
• If you have recently had a heart attack (myocardial infarction).
• For the treatment of kidney problems in type II diabetes in patients with high blood pressure.

Lisinopril works by dilating your blood vessels. This helps lower your blood pressure. It also makes it easier for your heart to pump blood throughout your body.

2. What you need to know before taking Lisinopril Aurovitas

Do not take Lisinopril Aurovitas:

• If you are allergic to lisinopril or to any of the other ingredients of this medicine (listed in section 6).
• If you have ever had an allergic reaction to any other ACE inhibitor medicine. The allergic reaction may have caused swelling of the hands, feet, ankles, face, lips, tongue, or throat. It may also have caused difficulty swallowing or breathing (angioedema).
• If a member of your family has ever had a severe allergic reaction (angioedema) to an ACE inhibitor, or if you have ever had a severe allergic reaction (angioedema) of unknown cause.
• If you are more than 3 months pregnant. It is also advisable to avoid lisinopril in the early stages of pregnancy – see section on pregnancy.
• If you have diabetes or kidney 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 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 unsure whether any of these situations apply to you, consult your doctor or pharmacist before taking this medicine.

If you develop a persistent dry cough that lasts a long time after starting treatment with lisinopril, consult your doctor.

Warnings and precautions:

Consult your doctor or pharmacist before starting to take this medicine:

• If you have a narrowing (stenosis) of the aorta (one of the arteries in the heart) or narrowing of the heart valves (mitral valves).
• If you have a narrowing (stenosis) of the renal artery.
• If you have thickening of the heart muscle (known as hypertrophic cardiomyopathy).
• If you have a blood vessel disease (collagen vascular disease).
• If you have low blood pressure. You may experience this as dizziness or lightheadedness, especially when standing up.
• If you have impaired kidney function or are on dialysis.
• If you have liver problems.
• If you have diabetes.
• If you are taking any of the following medicines used to treat high blood pressure:
  • 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 any of the following medicines, your risk of angioedema may increase:
  • Racecadotril, a medicine used to treat diarrhea.
  • Medicines used to prevent rejection of transplanted organs and for cancer (e.g. temsirolimus, sirolimus, everolimus).
  • Vildagliptin, a medicine used to treat diabetes.

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 Lisinopril Aurovitas”.

• If you have recently had diarrhea or vomiting.
• If your doctor has advised you to control the amount of salt in your diet.
• If you have high cholesterol levels and are receiving a treatment called "LDL apheresis".
• You must inform your doctor if you think you are (or are planning to become) pregnant. Lisinopril is not recommended during early pregnancy, and should not be taken after the first 3 months of pregnancy as it may cause serious harm to the baby if used at this stage (see section on pregnancy).
• If you are of Black race, as lisinopril may be less effective. You are also more likely to develop the adverse reaction "angioedema" (a serious allergic reaction).

If you are unsure whether any of these situations apply to you, consult your doctor or pharmacist before taking lisinopril.

Treatment of allergies such as insect sting allergies

Inform your doctor if you are receiving or are about to receive treatment to reduce the effect of an allergy, such as to insect stings (desensitization treatment). If you take lisinopril while undergoing this treatment, it may cause you a severe allergic reaction.

Surgery

If you are undergoing a surgical procedure (including dental surgery), inform your doctor or dentist that you are taking lisinopril. This is because you may experience low blood pressure (hypotension) if certain local or general anesthetics are administered while you are taking this medication.

Children and adolescents

Lisinopril has been studied in children. For further information, consult your doctor. Lisinopril is not recommended for children under 6 years of age or for children with severe kidney problems.

Other medicines and Lisinopril Aurovitas

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. This is because lisinopril may affect how some medicines work, and some medicines may affect lisinopril. Your doctor may need to adjust your dose and/or take other precautions.

In particular, inform your doctor or pharmacist if you are taking any of the following medicines:

• Other medicines that help lower blood pressure.
• If you are taking an angiotensin II receptor antagonist (ARB) or aliskiren (see also information under the headings “Do not take Lisinopril Aurovitas” and “Warnings and precautions”).
• Medicines used to increase urine elimination (diuretics).
• Beta-blockers, such as atenolol and propranolol.
• Nitrate-containing medicines (for heart problems).
• Non-steroidal anti-inflammatory drugs (NSAIDs) used to treat pain and arthritis.
• Aspirin (acetylsalicylic acid), if you are taking more than 3 grams per day.
• Medicines for depression and mental disorders, including lithium.
• Potassium supplements (including salt substitutes), potassium-sparing diuretics, and other medicines that may increase blood potassium levels (for example, 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).
• Insulin or oral antidiabetic medicines.
• Medicines for the treatment of asthma.
• Medicines for nasal or sinus congestion or other cold remedies (including those available from the pharmacy).
• Medicines that suppress the body's immune response (immunosuppressants).
• Allopurinol (for gout).
• Procainamide (for heart rhythm disorders).
• Medicines containing gold salts, such as sodium aurothiomalate, which are administered by injection.
• The following medicines may increase the risk of angioedema (signs of angioedema include swelling of the face, lips, tongue, and/or throat with difficulty swallowing or breathing):
  • Medicines used to dissolve blood clots (tissue plasminogen activator), usually administered in hospital.
  • Medicines given to prevent rejection of transplanted organs (sirolimus, everolimus, and other medicines belonging to the class of mTOR inhibitors). See section 2 “Warnings and precautions”.
  • Racecadotril used to treat diarrhoea.

Pregnancy and breastfeeding

Pregnancy

You should inform your doctor if you think you are (or are planning to become) pregnant. Your doctor will normally advise you to stop taking lisinopril before becoming pregnant or as soon as you know you are pregnant, and will recommend another medicine instead of lisinopril. This medicine is not recommended during early pregnancy, and must not be taken after the first three months of pregnancy, as it may cause serious harm to the baby if used beyond the third month of pregnancy.

Breastfeeding

Inform your doctor if you are breastfeeding or plan to breastfeed. The use of lisinopril is not recommended for breastfeeding mothers, and your doctor may choose an alternative treatment for you if you intend to start breastfeeding, especially if your baby is a newborn or was premature.

Driving and using machines

• Some people may feel dizzy or tired when taking this medicine. If this happens, do not drive or operate any tools or machinery.
• You should wait to see how the medicine affects you before attempting these activities.

3. How to take Lisinopril Aurovitas

Follow exactly the instructions for use of this medicine given by your doctor. If in doubt, consult your doctor or pharmacist again.

Once you start taking lisinopril, your doctor may carry out blood tests. Your doctor may then adjust the dose so that you take the appropriate amount of medicine.

Taking the medicine

• Swallow the tablet with water.
• Try to take your tablets at the same time every day. It does not matter whether you take lisinopril before or after meals.
• Continue taking lisinopril for the length of time prescribed by your doctor, as it is a long-term treatment. It is important that you continue to take lisinopril every day.

Taking the first dose

• Take special care when taking the first dose of lisinopril or if your dose is increased. It may cause a greater decrease in blood pressure than subsequent doses.
• This effect may make you feel dizzy or lightheaded. If this occurs, lying down may help. If you are concerned, consult your doctor as soon as possible.

Adults

Your dose depends on your condition and whether you are taking any other medication. Your doctor will tell you how many tablets you should take each day. If you are not sure, consult your doctor or pharmacist.

For high blood pressure

• The recommended starting dose is 10 mg once daily.
• The usual long-term dose is 20 mg once daily.

For heart failure

• The recommended starting dose is 2.5 mg once daily.
• The long-term dose is 5 mg to 35 mg once daily.

After a myocardial infarction

• The recommended initial dose is 5 mg within the first 24 hours after the infarction and 5 mg one day later.
• The usual long-term dose is 10 mg once daily.

Kidney problems caused by diabetes

• The recommended dose is 10 mg or 20 mg once daily.

If you are elderly, have kidney problems, or are taking diuretic medications, your doctor may prescribe you a lower dose than the usual dose.

Use in children and adolescents (6 to 16 years of age) with high blood pressure

• Lisinopril is not recommended for children under 6 years of age or for children with severe kidney problems.
• The doctor will calculate the correct dose for the child. The dose depends on the child's body weight.
• For children weighing between 20 kg and 50 kg, the recommended starting dose is 2.5 mg once daily.
• For children weighing more than 50 kg, the recommended starting dose is 5 mg once daily.

If you take more Lisinopril Aurovitas than you should

If you take more lisinopril than you should, consult your doctor or go to a hospital immediately. The most frequent symptoms are: dizziness, palpitations.

In case of overdose or accidental ingestion, contact the Toxicology Information Service. Telephone 91 562 04 20.

If you forget to take Lisinopril Aurovitas

• If you forget to take a dose, take it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose.
• Do not take a double dose to make up for forgotten doses.

If you stop treatment with Lisinopril Aurovitas

Do not stop taking your tablets, even if you feel well, unless your doctor tells you to. 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.

If you experience any of the following reactions, stop taking this medicine immediately and consult your doctor.

• Severe allergic reactions (rare, may affect up to 1 in 1,000 people). Signs may include sudden onset of:
  • Swelling of the face, lips, tongue, or throat. This may make swallowing difficult.
  • Severe or sudden swelling of the hands, feet, or ankles.
  • Difficulty breathing.
  • Severe skin itching (with hives).
• Serious skin disorders, such as sudden and unexpected rash, redness, or skin peeling (very rare, may affect up to 1 in 10,000 people).
• An infection with symptoms such as fever and severe deterioration in your general condition, or fever with signs of localized infection such as sore throat/pharynx/mouth or urinary disorders (very rare, may affect up to 1 in 10,000 people).

Other possible adverse effects:

Frequent (may affect up to 1 in 10 people)

• Headache.
• Dizziness or lightheadedness, especially when standing up quickly.
• Diarrhea.
• Persistent dry cough.
• Vomiting.
• Kidney disorders (detected by blood tests).

Uncommon (may affect up to 1 in 100 people)

• Mood changes.
• Change in color of fingers and toes (pale blue followed by redness) or numbness or tingling in fingers or toes.
• Changes in taste.
• Drowsiness.
• Dizziness.
• Difficulty sleeping.
• Stroke.
• Rapid heartbeat.
• Rhinitis.
• Nausea.
• Stomach pain or indigestion.
• Skin rash or itching.
• Inability to achieve an erection (impotence).
• Feeling tired or weak (lack of strength).
• A significant drop in blood pressure that may occur in people in the following situations: coronary heart disease, narrowing of the aorta (a heart artery), renal arteries, or heart valves; thickening of the heart muscle. If this occurs, you may feel dizzy or lightheaded, especially when standing up quickly.
• Changes in blood tests used to monitor proper liver and kidney function.
• Myocardial infarction.
• Visual and/or auditory hallucinations.

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

• Confusion.
• Rash with hives.
• Dry mouth.
• Hair loss.
• Psoriasis (a skin condition).
• Change in the smell of things.
• Breast development in men.
• Changes in certain blood cells or other blood components. Your doctor may take blood samples from time to time to check whether lisinopril is affecting your blood. Signs may include fatigue, pale skin, sore throat, fever, joint and muscle pain, joint or gland swelling, or sensitivity to sunlight.
• Low sodium levels in the blood (which may cause symptoms such as fatigue, headache, nausea, vomiting).
• Sudden kidney failure.

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

• Sinusitis (feeling of pain and pressure behind the cheeks and eyes).
• Wheezing.
• Low blood glucose levels (hypoglycemia). Signs may include feeling hungry or weak, sweating, and rapid heartbeat.
• Lung inflammation. Signs include cough, shortness of breath, and high fever.
• Yellowing of the skin or whites of the eyes (jaundice).
• Liver inflammation. This may cause loss of appetite, yellowing of the skin and eyes, and dark urine.
• Pancreatitis. This causes moderate to severe stomach pain.
• Serious skin disorders. Symptoms include redness, blistering, and peeling.
• Sweating.
• Decreased urine output or inability to urinate.
• Liver failure.
• Hives.
• Intestinal inflammation.

Frequency not known (cannot be estimated from available data)

• Symptoms of depression.
• Fainting.

Adverse effects in children appear to be comparable to those observed in adults.

Reporting of adverse reactions

If you experience any type of adverse reaction, consult your doctor or pharmacist, even if it is a possible adverse reaction not listed in this leaflet. You may also report it directly through the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es/. By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. Storage of Lisinopril Aurovitas

Keep this medicine out of sight and reach of children.

This medicine does not require any special storage conditions.

Do not use this medicine after the expiry date stated on the packaging and blister 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 dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the container and additional information

Composition of Lisinopril Aurovitas 20 mg tablets

• The active substance is lisinopril.
• The other components are: calcium hydrogen phosphate, maize starch, mannitol, pregelatinized maize starch, magnesium stearate, and yellow iron oxide (E 172).

Appearance of the medicinal product and contents of the pack

Tablet.

Lisinopril Aurovitas 20 mg tablets EFG are light yellow, capsule-shaped, biconvex, uncoated tablets, marked with “L” on one side and “20” on the other. The tablet size is 10 mm x 5 mm.

This medicinal product is available in blister packs.

Pack sizes:

Blister pack: 14, 28, 56 and 84 tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D, 5th floor

28036 Madrid

Spain

Manufacturer

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

Or

Generis Farmacêutica, S.A.

Rua João de Deus, 19

2700-487 Venda Nova, Amadora

Portugal

Or

Arrow Generiques

26 Avenue Tony Garnier

69007 Lyon, Rhone

France

This medicinal product is authorised in the Member States of the European Economic Area under the following names:

France: Lisinopril Arrow Lab 20 mg, comprimé

Malta: Lisinopril Aurobindo 10 mg/20 mg tablets

Poland: Lisinopril Aurovitas

Portugal: Lisinopril Generis Phar

Spain: Lisinopril Aurovitas 20 mg tablets EFG

Date of the most recent review of this leaflet: May 2021

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