Package Insert: Information for the Patient

Lisinopril Normon 20 mg Tablets EFG

Read this entire package insert carefully before starting to take this medication because it contains important information for you.

• Keep this package insert as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed for you only, 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 package insert. See section 4.

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

Lisinopril Normon 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 suffered a heart attack (myocardial infarction).

- For the treatment of diabetic nephropathy in type 2 diabetic patients with hypertension.

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

Do not take Lisinopril Normon

• if you are allergic to lisinopril or any of the other ingredients in 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 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 high.
• if any 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 Normon at the beginning of pregnancy (see section “Pregnancy and breastfeeding”).
• if you have diabetes or kidney failure and are being treated with a medicine to lower blood pressure that contains aliskiren.

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

If you develop a persistent dry cough 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 that are 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 (vascular collagen disease).

- If you have an alteration of renal 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, it increases the risk of angioedema (rapid swelling under the skin in an area such as the throat):

- temsirolimus, sirolimus, everolimus, and other medicines that belong to the class of mTOR inhibitors (used to prevent organ rejection and for cancer).

- racecadotrilo, a medicine used to treat diarrhea.

- vildagliptina, a medicine used to treat diabetes.

• 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 “sartanes”- for example, valsartan, telmisartan, irbesartan), particularly if you have kidney problems related to diabetes.
• aliskiren.

Your doctor may monitor your renal function, blood pressure, and electrolyte levels in the blood (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 levels of cholesterol and are receiving a treatment called "LDL apheresis”.

- If you have low blood pressure. You may notice it as a feeling of dizziness or lightheadedness, especially when standing up.

- You must inform your doctor if you think you are (or plan to become) pregnant. Lisinopril Normon 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 in this stage(see section “Pregnancy and breastfeeding”).

- If you are of black race, as Lisinopril Normon 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 Normon.

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 Normon while receiving this treatment, it could 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 Normon. This is because you may experience 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

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

Especially, inform your doctor or pharmacist if you are using any of the following medicines:

• Other medicines that help to lower blood pressure.
• an angiotensin II receptor antagonist (ARA) or aliskiren (see also the information under the headings “Do not take Lisinopril Normon” and “Warnings and precautions”).
• Diuretics (medicines used to increase the elimination of urine).
• Beta-blockers, such as atenolol and propranolol.
• Nitrate-derived medicines (for heart problems).
• Potassium supplements (including salt substitutes), diuretics that save potassium, and other medicines that may increase the amount of potassium in the blood (for example, trimethoprim and co-trimoxazole for bacterial infections; ciclosporin, an immunosuppressant used to prevent organ rejection; and heparin, a medicine used to dilute the blood to prevent clots).
• Medicines for depression and mental disorders, including lithium.
• Non-steroidal anti-inflammatory drugs (NSAIDs) for the treatment of 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 the treatment of asthma.
• Medicines for the treatment of nasal or sinus congestion or other treatments for a cold (including those that you can buy at a pharmacy).
• Medicines to inhibit the body's immune response (immunosuppressants).
• Alopurinol (for gout).
• Procainamide (for heart rhythm disorders).
• Medicines that contain gold, such as aurothiomalate sodium, which will be administered as an injection.
• Insulin or oral antidiabetic medicines.
• The following medicines may increase the risk of angioedema (the signs of angioedema include swelling of face, lips, tongue, and/or throat with difficulty swallowing or breathing):
• • Medicines to dissolve blood clots (tissue plasminogen activator) that are normally administered in a hospital.
  • Medicines administered to prevent organ rejection (temsirolimus, sirolimus, everolimus, and other medicines that belong to the class of mTOR inhibitors). See section 2 “Warnings and precautions”.
  • Racecadotrilo used to treat diarrhea.
  • Vildagliptina, a medicine used to treat diabetes.

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 Normon before becoming 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 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 in this stage(see section “Pregnancy and breastfeeding”).

Breastfeeding

Inform your doctor if you are breastfeeding or plan to start breastfeeding. Lisinopril Normon 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 medicine. If this happens, do not drive or use any tools or machinery.

You should wait to see how the medicine affects you before trying to do 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 this medication 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.

The tablet can be split into equal doses.

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

The recommended initial dose is 10 mg once a day.

The usual long-term dose is 20 mg once a day.

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 myocardial infarction

The recommended initial dose is 5 mg in the first 24 hours after the infarction and 5 mg the next day.

The usual long-term dose is 10 mg once a day.

Diabetes-related kidney problems

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

If you are an elderly person, 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

• Lisinopril is not recommended for children under 6 years old or children with severe kidney problems.
• Your 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 a day.
• For children weighing more than 50 kg, the recommended starting 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 Toxicological Information Service. Phone 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 compensate for the missed doses.

If you interrupt treatment with Lisinopril Normon

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 Lisinopril Normon and consult your doctor immediately.

• Severe allergic reactions (rare, between 1 and 10 in every 10,000 patients). The signs may include the sudden appearance of:

- Swelling of the face, lips, tongue, or throat. This may make it difficult to swallow.

- Severe or sudden swelling of the hands, feet, or ankles.

- Difficulty breathing.

- Severe itching of the skin (with hives).

• Severe skin disorders, such as an unexpected and sudden rash, redness, or peeling of the skin (very rare, in fewer than 1 in 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, or mouth irritation or urinary tract disorders (very rare, in fewer than 1 in 10,000 patients).

Other possible side effects:

Frequent (between 1 and 10 in every 100 patients)

Headache.

Sensation of dizziness or vertigo, especially when standing up quickly.

Diarrhea.

Persistent dry cough.

Vomiting.

Renal disorders (detected by blood tests).

Occasional (between 1 and 10 in every 1,000 patients)

Mood changes.

Change in color of the fingers and toes (pale blue followed by redness) or numbness or tingling in the fingers or toes.

Changes in the taste of things.

Drowsiness.

Sensation of dizziness.

Difficulty sleeping.

Stroke.

Fast heart rate.

Rhinitis.

Nausea.

Stomach pain or indigestion.

Skin rash or itching.

Inability to have an erection (impotence).

Sensation of fatigue or weakness (lack of strength).

A significant decrease in blood pressure that may occur in people with the following conditions: coronary disease, aortic stenosis (a heart artery), renal arteries, or heart valves; a thickening of the heart muscle. If this happens to you, you may feel dizziness or vertigo, 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 in every 10,000 patients)

Confusion.

Rash with hives.

Dry mouth.

Hair loss.

Psoriasis (a skin disorder).

Change in the smell of things.

Development of breasts 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 Normon is affecting your blood. The signs may include fatigue, pale skin, throat irritation, fever, joint and muscle pain, joint inflammation, 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 (less than 1 in every 10,000 patients)

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

Cramping.

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

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

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

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

Pancreatitis. This causes moderate to severe stomach pain.

Severe skin disorders. The symptoms include redness, blistering, and peeling.

Sweating.

Decreased urine output or inability to urinate.

Liver insufficiency.

Hives.

Intestinal inflammation.

Unknown frequency (cannot be estimated from available data)

Depression symptoms.

Fainting.

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

Reporting side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance 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.

No special storage conditions are required.

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

Do not use this medication 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 disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point of 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 Normon Composition

• Each tablet contains 20 mg of lisinopril as lisinopril dihydrate as the active ingredient.
• The other components are: mannitol (E-421), calcium dihydrogen phosphate dihydrate, colloidal silica, cornstarch, pregelatinized cornstarch, and magnesium stearate.

Appearance of the product and content of the packaging

Lisinopril Normon 20 mg is presented in the form of white or almost white, round, biconvex tablets with a breaking bar and printed with “L20” on one face and anonymous on the other, in packaging with 28 tablets in a PVC/aluminum blister and a leaflet.

Holder of the marketing authorization and responsible for manufacturing

Laboratorios Normon, S.A.

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

Date of the last review of this leaflet: March 2024

Other sources of information

The detailed information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)https://www.aemps.gob.es/.