Prospecto: Information for the Patient

Lisinopril Aurovitas 20 mg TabletsEFG

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

• Keep this prospect as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed only for you, and you should not give it to others, even if they have the same symptoms 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 prospect. See section 4.

Content of the Prospect:

1. What Lisinopril Aurovitas is and for what it is used
2. What you need to know before starting to take Lisinopril Aurovitas
3. How to take Lisinopril Aurovitas
4. Possible adverse effects
5. Storage of Lisinopril Aurovitas
6. Contents of the package and additional information

This medication contains a medication called lisinopril. This belongs to a group of medications 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.
• After suffering a recent heart attack (myocardial infarction).
• For the treatment of diabetic nephropathy in type II diabetic patients with hypertension.

Lisinopril acts by dilating your blood vessels. This helps to decrease your blood pressure. It also facilitates your heart pumping blood to all parts of your body.

Do not take Lisinopril Aurovitas:

• If you are allergic to lisinopril or any of the other components of this medication (listed in section 6).
• If you have ever had an allergic reaction to any other ACE inhibitor. The allergic reaction could have caused swelling of the hands, feet, ankles, face, lips, tongue, or throat. It could also have caused difficulty swallowing or breathing (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 best to avoid lisinopril at the beginning of pregnancy - see the section on pregnancy.
• If you have diabetes or kidney failure and are being treated with a medication to lower blood pressure that contains aliskiren.
• If you have taken or are currently taking sacubitril/valsartan, a medication 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 high.

If you are unsure if any of these situations apply to you, consult your doctor or pharmacist before taking this medication.

If you develop persistent dry cough after starting treatment with lisinopril, consult your doctor.

Warnings and precautions:

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

• If you have a narrowing (stenosis) of the aorta (one of the arteries that are 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 (vascular collagen disease).
• If you have low blood pressure. You may notice it as dizziness or lightheadedness, especially when standing up.
• If you have kidney function impairment or are on dialysis.
• If you have liver problems.
• If you have diabetes.
• If you are taking any of the following medications used to treat high blood pressure:
• • An angiotensin II receptor antagonist (ARA) (also known as "sartanes" - for example, valsartan, telmisartan, irbesartan), particularly if you have kidney problems related to diabetes.
  • Aliskiren.
• If you are taking any of the following medications, it increases the risk of angioedema:
• • Racecadotrilo, a medication used to treat diarrhea.
  • Medications used to prevent organ rejection and for cancer (for example, temsirolimus, sirolimus, everolimus).
  • Vildagliptina, a medication used to treat diabetes.

Your doctor may monitor your kidney function, blood pressure, and blood electrolyte levels (such as 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 plan to become) pregnant. Lisinopril is not recommended at the beginning of pregnancy, and it should not be taken if you are more than 3 months pregnant as it may cause serious harm to the baby if used during this period (see the section on pregnancy).
• If you are of black race, as lisinopril may be less effective. It is also more likely that you will develop the adverse effect “angioedema” (a severe allergic reaction).

If you are unsure if you are in any of these situations, consult your doctor or pharmacist before taking lisinopril.

Treatment of allergies such as insect bites

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

Surgery

If you are to undergo 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 you are given certain local or general anesthetics while taking this medication.

Children and adolescents

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

Other medications and Lisinopril Aurovitas

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication. This is because lisinopril may affect the way some medications work, and some medications may affect lisinopril. Your doctor may need to modify your dose and/or take other precautions.

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

• Other medications that help lower blood pressure.
• ACE inhibitors or aliskiren (see also the information under the headings “Do not take Lisinopril Aurovitas” and “Warnings and precautions”).
• Diuretics (medications used to increase urine production).
• Beta-blockers, such as atenolol and propranolol.
• Nitrate-derived medications (for heart problems).
• Non-steroidal anti-inflammatory drugs (NSAIDs) for pain and arthritis treatment.
• Aspirin (acetylsalicylic acid), if you are taking more than 3 grams per day.
• Medications for depression and mental disorders, including lithium.
• Potassium supplements (including salt substitutes), potassium-sparing diuretics, and other medications that may increase blood potassium levels (for example, trimethoprim and cotrimoxazole for bacterial infections; ciclosporin, an immunosuppressant used to prevent organ rejection; and heparin, a medication used to thin the blood to prevent clots).
• Insulin or oral antidiabetic medications.
• Medications for asthma treatment.
• Medications for nasal or sinus congestion or other treatments for colds (including those you can buy at the pharmacy).
• Medications that inhibit the body's immune response (immunosuppressants).
• Alopurinol (for gout).
• Procainamide (for heart rhythm disorders).
• Medications containing gold salts, such as sodium aurothiomalate, which will be administered as an injection.
• The following medications 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):
• • Medications used to dissolve blood clots (tissue plasminogen activator) that are normally administered in the hospital.
  • Medications administered to prevent organ rejection (sirolimus, everolimus, and other medications belonging to the class of mTOR inhibitors). See section 2 “Warnings and precautions”.
  • Racecadotrilo used to treat diarrhea.

Pregnancy and breastfeeding

Pregnancy

You must inform your doctor if you think you are (or plan to become) pregnant. Normally, your doctor will advise you to stop taking lisinopril before becoming pregnant or as soon as you know you are pregnant and recommend that you take another medication instead of lisinopril. This medication is not recommended at the beginning of pregnancy, and it should not be taken if you are more than 3 months pregnant as it may cause serious harm to the baby if used during this period.

Breastfeeding

Inform your doctor if you are breastfeeding or plan to start breastfeeding. Lisinopril is not recommended for mothers during breastfeeding, and your doctor may choose another treatment for you if you wish to start breastfeeding, especially if your baby is newborn or premature.

Driving and operating machinery

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

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Once you start taking lisinopril, your doctor may perform blood tests. Your doctor may then adjust the dose so that you take the right amount of medication.

Medication intake

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

First dose intake

• Be extra careful when taking the first dose of lisinopril or if your doctor increases the dose. It may cause a greater decrease in blood pressure than the subsequent doses.
• This effect may make you feel dizzy or experience vertigo. If this happens, lying down may help. If you are concerned, consult your doctor as soon as possible.

Adults

Your dose depends on your condition and if you are taking any other medication. Your doctor will tell you how many tablets you should take each day. If you are unsure, consult your doctor or pharmacist.

Hypertension

Heart failure

After a myocardial infarction

Renal problems caused by diabetes

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

Use in children and adolescents (6 to 16 years old) with hypertension

If you take more Lisinopril Aurovitas than you should

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

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

If you forgot to take Lisinopril Aurovitas

• If you forgot 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 compensate for the missed doses.

If you interrupt the 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 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.

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

Other possible side effects:

Frequent (may affect up to 1 in 10 people)

Occasional (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 unknown (cannot be estimated from available data)

The side effects in children appear to be similar to those observed in adults.

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 it 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 this medication out of the sight and reach of children.

This medication does not require special storage conditions.

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

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Lisinopril Aurovitas 20 mg Tablets Composition

Appearance of the Product and Contents of the Package

Tablet.

Lisinopril Aurovitas 20 mg Tablets EFG are yellowish clear tablets, capsule-shaped, biconvex, non-coated, marked with “L” on one face and “20” on the other. The size of the tablet is 10 mm x 5 mm.

This medicine is available in blisters.

Package Sizes:

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

Only some package sizes may be commercially available.

Marketing Authorization Holder and Responsible Manufacturer

Marketing Authorization Holder

Aurovitas Spain, S.A.U.

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

28036 Madrid

Spain

Responsible Manufacturer

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

O

Generis Farmacêutica, S.A.

Rua João de Deus, 19

2700-487 Venda Nova, Amadora

Portugal

O

Arrow Generiques

26 Avenue Tony Garnier

69007 Lyon, Rhone

France

This medicine is authorized in the European Economic Area member states with 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

Last Review Date of this Leaflet:May 2021

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