LISINOPRIL NORMON 5 mg TABLETS

Introduction

Package Leaflet: Information for the Patient

Lisinopril Normon 5 mg Tablets EFG

Read this package leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this package 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 symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. See section 4.

Contents of the package leaflet:

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

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

Lisinopril Normon belongs to a group of medicines called angiotensin-converting enzyme inhibitors (ACE inhibitors).

Lisinopril Normon can be used for the following conditions:

• 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 associated with 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 Normon

Do not take Lisinopril Normon

• 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 any other ACE inhibitor. The allergic reaction could have caused swelling of your hands, feet, ankles, face, lips, tongue, or throat. It could also have caused difficulty swallowing or breathing (angioedema).
• 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 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 Normon at the start of pregnancy (see section “Pregnancy and breast-feeding”).
• if you have diabetes or kidney problems and are being treated with a medicine containing aliskiren.

If you are not sure if any of these situations apply to you, consult your doctor or pharmacist before taking Lisinopril Normon.

If you develop a dry cough that persists for a long time after starting treatment with Lisinopril Normon, consult your doctor.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Lisinopril Normon

• if you have a narrowing (stenosis) of the aorta (one of the arteries in the heart) or a narrowing of the heart valves (mitral valve).
• 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 a change in kidney function or if you are on dialysis.
• if you have liver problems.
• if you have diabetes.
• if you are taking any of the following medicines, the risk of angioedema (rapid swelling under the skin in an area such as the throat) is increased:
• - temsirolimus, sirolimus, everolimus, and other medicines belonging to the class of mTOR inhibitors (used to prevent organ rejection and for cancer).
• - racecadotrile, a medicine used to treat diarrhea.
• - vildagliptin, a medicine used to treat 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 associated with diabetes.
• aliskiren.

Your doctor may check 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 Normon”.

• if your doctor has told you to control the amount of salt in your diet
• if you have recently had vomiting or diarrhea.

• if you have high cholesterol levels and are receiving a treatment called "LDL apheresis”.
• if you have low blood pressure. You may notice this as a feeling of dizziness or lightheadedness, especially when standing up.
• you should inform your doctor if you think you are (or might become) pregnant. The use of Lisinopril Normon is not recommended at the start of pregnancy, and it 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 Normon 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, consult your doctor or pharmacist before taking Lisinopril Normon.

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 Normon while receiving this treatment, it may cause a severe allergic reaction.

Surgery

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

Children and adolescents

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

Use of Lisinopril Normon with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This is because Lisinopril Normon may affect the way some medicines work, and some medicines may affect the way Lisinopril Normon works. 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 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 Normon” and “Warnings and precautions”).
• Medicines used to increase urine production (diuretics).
• Beta-blocker medicines, such as atenolol and propranolol.
• Nitrate medicines (for heart problems).
• Potassium supplements (including salt substitutes), potassium-sparing diuretics, and other medicines that may increase potassium levels in the blood (such as 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).
• Medicines for depression and mental disorders, including lithium.
• Non-steroidal anti-inflammatory medicines (NSAIDs) for arthritis or pain.
• Aspirin (acetylsalicylic acid), if you are taking more than 3 grams per day.
• Medicines for depression and mental disorders, including lithium.
• Medicines for asthma.
• Medicines for nasal or sinus congestion or other treatments for colds (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 that contain gold salts, such as sodium aurothiomalate, which will be given to you by injection.
• Insulin or oral antidiabetics.
• 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 to dissolve blood clots (tissue plasminogen activator) that are usually given in the hospital.
• Medicines given to prevent organ rejection (temsirolimus, sirolimus, everolimus, and other medicines belonging to the class of mTOR inhibitors). See section 2 “Warnings and precautions”.
• Racecadotrile used to treat diarrhea.
• Vildagliptin, a medicine used to treat diabetes.

Pregnancy and breast-feeding:

Pregnancy

You should inform your doctor if you think you are (or might become) pregnant. Normally, your doctor will advise you to stop taking Lisinopril Normon before you become pregnant or as soon as you know you are pregnant, and will recommend that you take another medicine instead of Lisinopril Normon. Lisinopril Normon is not recommended at the start 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.

Breast-feeding

Tell your doctor if you are breast-feeding or plan to breast-feed. The use of Lisinopril Normon is not recommended in breast-feeding mothers, and your doctor may choose another treatment for you if you want to breast-feed, especially if your baby is 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 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 Normon

Take this medicine exactly as your doctor has told you. If you are not sure, consult your doctor or pharmacist.

Once you start taking lisinopril, your doctor may perform blood tests. Then, your doctor may adjust the dose so that you take 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 whether you take lisinopril before or after meals.
• Continue taking lisinopril for as long as your doctor tells you to, as it is a long-term treatment. It is important that you continue to take this medicine every day.

Taking the first dose

• Be especially 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, consult your doctor as soon as possible.

The tablet can be divided into equal doses.

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, consult 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 usual 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 caused by 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.
• Your 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 Normon 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: palpitations and/or dizziness.

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

If you forget to take Lisinopril Normon

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 taking Lisinopril Normon

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

If you have any other 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 all people suffer from them.

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

• Severe allergic reactions (rare, between 1 and 10 out of 10,000 patients). 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, in less than 1 out of 10,000 patients).
• 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, in less than 1 out of 10,000 patients).

Other Possible Adverse Effects:

Frequent (between 1 and 10 out of 100 patients)

Headache.

Feeling of dizziness or lightheadedness, especially when standing up quickly.

Diarrhea.

Persistent dry cough.

Vomiting.

Kidney disorders (detected through blood tests).

Infrequent (between 1 and 10 out of 1,000 patients)

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 (between 1 and 10 out of 10,000 patients)

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 blood cells or other components of your blood. Your doctor may take samples from time to time to check if Lisinopril Normon is affecting your blood. The signs may include fatigue, pale skin, throat irritation, fever, joint and muscle pain, joint or gland inflammation, 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 (in less than 1 out of 10,000 patients)

Sinusitis (feeling of pain and pressure behind the cheeks and eyes).

Shortness of breath.

Low blood sugar levels (hypoglycemia). The signs may include a feeling of hunger or weakness, sweating, and rapid heartbeat.

Lung inflammation. The signs include cough, shortness of breath, and high fever.

Yellowing of the skin or the whites of the eyes (jaundice).

Liver inflammation. This can cause a loss of appetite, yellowing of the skin and eyes, and dark-colored urine.

Pancreas inflammation. 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)

Depression symptoms.

Fainting.

The adverse effects in children are, apparently, comparable to those observed in adults.

Reporting of Adverse Effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect that is not listed in this prospectus. You can also report them 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 Normon

It does not require special storage conditions.

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

Do not use this medicine 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 thrown away through the sewers or in the trash. Deposit the packaging and medicines that you no longer need in the SIGRE Point of the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines that you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Lisinopril Normon

• Each tablet contains 5 mg of lisinopril as the active ingredient in the form of lisinopril dihydrate.
• The other components are: mannitol (E-421), calcium hydrogen phosphate dihydrate, colloidal silica, cornstarch, pregelatinized cornstarch, and magnesium stearate.

Appearance of the Product and Package Contents

Lisinopril Normon 5 mg is presented in the form of white or almost white, round, biconvex tablets, with a break line on one face and engraved with "L5" on the other, in packages with 60 tablets in PVC/aluminum blisters and a prospectus.

Marketing Authorization Holder and Manufacturer

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (SPAIN).

Date of the Last Revision of this Prospectus: March 2024

Other Sources of Information

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