LISINOPRIL AUROVITAS 20 mg TABLETS

Introduction

Patient Information: Summary of Product Characteristics

Lisinopril Aurovitas 20 mg TabletsEFG

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 the Pack

1. What is Lisinopril Aurovitas and what is it used for
2. What you need to know before you take Lisinopril Aurovitas
3. How to take Lisinopril Aurovitas
4. Possible side effects
5. Storage of Lisinopril Aurovitas
6. Pack contents and further information

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

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

Lisinopril can be used for:

• Treatment of high blood pressure (hypertension).
• Treatment of heart failure.
• If you have recently had a heart attack (myocardial infarction).
• Treatment of kidney problems (nephropathy) due to type 2 diabetes in hypertensive patients.

Lisinopril works by widening your blood vessels. This helps to lower your blood pressure. It also makes it easier for your heart to pump blood to all parts of your body.

2. What you need to know before you take Lisinopril Aurovitas

Do not take Lisinopril Aurovitas:

• If you are allergic to lisinopril or any of the other ingredients of this medicine (listed in section 6).
• If you have ever had an allergic reaction to another ACE inhibitor. The allergic reaction could have caused swelling of your hands, feet, ankles, face, lips, tongue, or throat. It could have also made it difficult for you to swallow or breathe (angioedema).
• If a member of your family has had a severe allergic reaction (angioedema) to an ACE inhibitor or if you have had a severe allergic reaction (angioedema) for unknown reasons.
• If you are more than 3 months pregnant. It is also better to avoid lisinopril at the start of pregnancy - see section on pregnancy.
• If you have diabetes or kidney problems and are being treated with a blood pressure 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 an area such as the throat) is increased.

If you are not sure if any of these apply to you, talk to your doctor or pharmacist before taking this medicine.

If you develop a dry cough that lasts for a long time after starting treatment with lisinopril, talk to your doctor.

Warnings and Precautions:

Talk to your doctor or pharmacist before starting this medicine:

• If you have a narrowing (stenosis) of the aorta (one of the arteries in the heart) or a narrowing of the heart valves (mitral valves).
• If you have a narrowing (stenosis) of the renal artery.
• If you have an increase in the thickness of the heart muscle (known as hypertrophic cardiomyopathy).
• If you have a disease of the blood vessels (collagen vascular disease).
• If you have low blood pressure. You may notice this as a feeling of dizziness or lightheadedness, especially when standing up.
• If you have kidney problems 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), especially if you have kidney problems related to diabetes.
  • Aliskiren.
• If you are taking any of the following medicines, the risk of angioedema is increased:
• • Racecadotril, a medicine used to treat diarrhea.
  • Medicines used to prevent organ rejection after transplants 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 told 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 tell your doctor if you think you are (or might become) pregnant. Your doctor will normally advise you to stop taking lisinopril before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of lisinopril. This medicine is not recommended during the first trimester of 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 after the third month of pregnancy.
• If you are black, as lisinopril may be less effective. You are also more likely to develop the side effect “angioedema” (a severe allergic reaction).

If you are not sure if you are in any of these situations, talk to your doctor or pharmacist before taking lisinopril.

Treatment of Allergies such as Insect Bites

Tell your doctor if you are receiving or are going to receive treatment to reduce the effect of an allergy such as an insect bite (desensitization treatment). If you take lisinopril while receiving this treatment, it could cause a severe allergic reaction.

Surgery

If you are going to have surgery (including dental surgery), tell your doctor or dentist that you are taking lisinopril. This is because you may have low blood pressure (hypotension) if you are given certain local or general anesthetics while taking this medicine.

Children and Adolescents

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

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

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

• Other medicines that help to lower blood pressure.
• If you are taking an angiotensin II receptor antagonist (ARA) or aliskiren (see also the information under the headings “Do not take Lisinopril Aurovitas” and “Warnings and Precautions”).
• Medicines used to increase urine production (diuretics).
• Beta-blocker medicines, such as atenolol and propranolol.
• Nitrate-derived medicines (for heart problems).
• Non-steroidal anti-inflammatory medicines (NSAIDs) for 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 potassium levels in the blood (e.g., trimethoprim and cotrimoxazole for bacterial infections; cyclosporin, an immunosuppressant used to prevent organ rejection; and heparin, a medicine used to thin the blood to prevent clots).
• Insulin or oral antidiabetics.
• Medicines for asthma.
• Medicines for nasal or sinus congestion or other treatments for the common cold (including those you can buy at 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 will be given to you by injection.
• The following medicines may increase the risk of angioedema (the 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) that are usually given in the hospital.
  • Medicines given to prevent organ rejection after transplants (sirolimus, everolimus, and other medicines belonging to the class of mTOR inhibitors). See section 2 “Warnings and Precautions”.
  • Racecadotril used to treat diarrhea.

Pregnancy and Breastfeeding

Pregnancy

You must tell your doctor if you think you are (or might become) pregnant. Your doctor will normally advise you to stop taking lisinopril before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of lisinopril. This medicine is not recommended during the first trimester of 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 after the third month of pregnancy.

Breastfeeding

Tell your doctor if you are breastfeeding or plan to breastfeed. It is not recommended to take lisinopril while breastfeeding, and your doctor may choose another treatment for you if you want to start breastfeeding, especially if your baby is newborn or premature.

Driving and Using Machines

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

3. How to Take Lisinopril Aurovitas

Always take this medicine exactly as your doctor has told you. If you are not sure, check with your doctor or pharmacist.

Once you start taking lisinopril, your doctor may do blood tests. Then, your doctor may adjust the dose to make sure you are taking the right amount of medicine.

Taking the Medicine

• Swallow the tablet with water.
• Try to take your tablets at the same time each day. It does not matter if you take lisinopril before or after food.
• Keep taking lisinopril for as long as your doctor tells you. It is a long-term treatment. It is important that you keep taking lisinopril every day.

Taking the First Dose

• Be careful when you take the first dose of lisinopril or if your dose is increased. It may cause a greater decrease in blood pressure than the following doses.
• This effect may make you feel dizzy or lightheaded. If this happens, lying down may help. If you are concerned, talk to your doctor as soon as possible.

Adults

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

For High Blood Pressure

• The recommended initial dose is 10 mg once a day.
• The usual long-term dose is 20 mg once a day.

For Heart Failure

• The recommended initial dose is 2.5 mg once a day.
• The long-term dose is 5 mg to 35 mg once a day.

After a Heart Attack

• The recommended initial dose is 5 mg in the first 24 hours after the heart attack and 5 mg the next day.
• The usual long-term dose is 10 mg once a day.

Kidney Problems due to Diabetes

• The recommended dose is 10 mg or 20 mg once a day.

If you are elderly, have kidney problems, or are taking diuretic medicines, your doctor may prescribe 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 in children under 6 years of age or in children with severe kidney problems.
• The doctor will calculate the correct dose for the child. The dose depends on the child's weight.
• For children who weigh between 20 kg and 50 kg, the recommended initial dose is 2.5 mg once a day.
• For children who weigh more than 50 kg, the recommended initial dose is 5 mg once a day.

If you Take More Lisinopril Aurovitas than you Should

If you take more lisinopril than you should, talk to your doctor or go to a hospital straight away. The most common 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 a forgotten dose.

If you Stop Taking 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 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.

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

• Severe allergic reactions (rare, may affect up to 1 in 1,000 people). The signs may include the sudden appearance of:
• • Swelling of the face, lips, tongue, or throat. This can make swallowing difficult.
  • Severe or sudden swelling of the hands, feet, or ankles.
  • Difficulty breathing.
  • Severe skin itching (with hives).
• Severe skin disorders, such as an unexpected and sudden rash, redness, or peeling of the skin (very rare, may affect up to 1 in 10,000 people).
• An infection with symptoms such as fever and severe deterioration of your general condition, or fever with symptoms of local infection such as throat/pharynx/mouth irritation 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.
• Feeling of dizziness or lightheadedness, especially when standing up quickly.
• Diarrhea.
• Persistent dry cough.
• Vomiting.
• Kidney disorders (detected by blood tests).

Infrequent (may affect up to 1 in 100 people)

• Mood changes.
• Change in color of the fingers of the hands and feet (pale blue followed by redness) or numbness or tingling in the fingers of the hands or feet.
• Changes in the taste of things.
• Drowsiness.
• Feeling of dizziness.
• Difficulty sleeping.
• Stroke.
• Rapid heartbeat.
• Rhinitis.
• Nausea.
• Stomach pain or indigestion.
• Skin rash or itching.
• Inability to have an erection (impotence).
• Feeling of tiredness or weakness (lack of strength).
• A significant decrease in blood pressure that can occur in people in the following situations: coronary artery disease, narrowing of the aorta (a heart artery), renal arteries, or heart valves; thickening of the heart muscle. If this happens to you, you may feel dizzy or lightheaded, especially if you stand up quickly.
• Changes in blood tests to determine the proper functioning of your liver and kidneys.
• Myocardial infarction.
• Seeing and/or hearing hallucinations.

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

• Confusion.
• Rash with hives.
• Dry mouth.
• Hair loss.
• Psoriasis (a skin problem).
• Change in the smell of things.
• Development of breast tissue in men.
• Changes in some cells or other components of your blood. Your doctor may take samples from time to time to check if lisinopril is affecting your blood. The signs may include fatigue, pale skin, throat irritation, fever, joint and muscle pain, inflammation of the joints or glands, or sensitivity to sunlight.
• Low sodium levels in the blood (which can produce 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 sugar levels (hypoglycemia). The signs may include a feeling of hunger or weakness, sweating, and rapid heartbeat.
• Inflammation of the lungs. The signs include cough, shortness of breath, and high fever.
• Yellowing of the skin or the whites of the eyes (jaundice).
• Inflammation of the liver. This can cause a loss of appetite, yellowing of the skin and eyes, and dark-colored urine.
• Inflammation of the pancreas. This causes moderate to severe stomach pain.
• Severe skin disorders. The symptoms include redness, blistering, and peeling.
• Sweating.
• Decreased amount of urine or inability to urinate.
• Liver failure.
• Hives.
• Intestinal inflammation.

Frequency not known (cannot be estimated from the available data)

• Symptoms of depression.
• Fainting.

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

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 it 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 Lisinopril Aurovitas

Keep this medicine out of the sight and reach of children.

This medicine does not require special storage conditions.

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

Medicines should not be thrown away through wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Lisinopril Aurovitas 20 mg Tablets

• The active ingredient is lisinopril.
• The other ingredients are: hydrogenated calcium phosphate, corn starch, mannitol, pregelatinized corn starch, magnesium stearate, and yellow iron oxide (E 172).

Appearance of the Product and Package Contents

Tablet.

Lisinopril Aurovitas 20 mg tablets EFG are yellowish-colored, capsule-shaped, biconvex, uncoated tablets, marked with "L" on one face and "20" on the other. The tablet size is 10 mm x 5 mm.

This medicine is available in blisters.

Package Sizes:

Blisters: 14, 28, 56, and 84 tablets.

Not all package 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

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Generis Farmacêutica, S.A.

Rua João de Deus, 19

2700-487 Venda Nova, Amadora

Portugal

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Arrow Generiques

26 Avenue Tony Garnier

69007 Lyon, Rhone

France

This medicine is authorized in the Member States of the European Economic Area under the following names:

France: Lisinopril Arrow Lab 20 mg, tablet

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 Last Revision of this Leaflet:May 2021

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