Package Leaflet: Information for the User

Lisinopril Cinfa 5 mg Tablets EFG

Lisinopril dihydrate

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

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

lisinopril cinfa 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 kidney disorders in type 2 diabetes patients who are hypertensive.

Lisinopril works by dilating 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.

Do not take lisinopril cinfa

• 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 the 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 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 this medicine.

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take lisinopril cinfa:

• 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 a feeling of dizziness or lightheadedness, especially when standing up.
• If you have a kidney function disorder or 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 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 need to monitor your kidney function, blood pressure, and electrolyte levels in your blood (such as potassium) at regular intervals (see section “Do not take lisinopril cinfa”).

• 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 stage (see section “Pregnancy and breastfeeding”).
• 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 (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 this medicine. This is because you may experience low blood pressure (hypotension) if you are given certain local or general anesthetics while taking lisinopril.

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 medicines and lisinopril cinfa

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medicine. 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 modify your dose and/or take other precautions.

In particular, 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 sections “Do not take lisinopril cinfa” and “Warnings and precautions”).
• Diuretics.
• Beta-blockers, such as atenolol and propranolol.
• Nitrate-derived medicines (for heart problems).
• Non-steroidal anti-inflammatory drugs (NSAIDs) for the treatment of 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), diuretics that save potassium, and other medicines that may increase the amount of potassium in the blood (for example, trimethoprim and cotrimoxazole for bacterial infections; ciclosporin, an immunosuppressant used to prevent organ 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 the treatment of nasal or sinus congestion or other treatments for a cold (including those that you can buy at a pharmacy).
• Medicines that inhibit the body's immune response (immunosuppressants).
• Alopurinol (for gout).
• Procainamide (for heart rhythm disorders).
• Medicines that contain gold salts, such as aurothiomalate sodium, which will be administered as an 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 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 “Warnings and precautions”).
• racecadotrilo used to treat diarrhea.
• vildagliptina, a medicine used to treat diabetes.

Taking lisinopril cinfa with food and drink

Lisinopril can be taken with or without food.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

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 medicine instead of lisinopril. 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 stage.

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 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 perform these activities.

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

Remember to take your medication.

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 the medication 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 the medication every day.
• The tablet can be divided into equal doses.

First dose intake

• Be especially careful when taking the first dose of lisinopril or if your doctor increases the dose. It may cause a further decrease in blood pressure than the one that will occur with subsequent doses.
• This effect may make you feel dizzy or experience vertigo. If this happens, lying down may help. If this concerns you, 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.

• 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 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 indicate a lower dose than the usual dose.

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

• Lisinopril is not recommended for children under 6 years old or for 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 initial dose is 2.5 mg once a day.
• For children weighing more than 50 kg, the recommended initial dose is 5 mg once a day.

If you take more lisinopril cinfa 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 and palpitations.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take lisinopril cinfa

• 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 cinfa

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 may cause side effects, although not everyone will experience them.

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

• Severe allergic reactions (rare, may affect up to 1 in 1,000 patients). The signs may include 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 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 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, may affect up to 1 in 10,000 patients).

Other possible side effects

Frequent (may affect up to1in10 patients)

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

Not frequent (may affect up to1in100 patients)

• Mood changes.
• Changes 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.
• Dizziness.
• Difficulty sleeping.
• Stroke.
• Fast heart rate.
• Runny nose.
• Nausea.
• Stomach pain or indigestion.
• Skin rash or itching.
• Impotence.
• Feeling tired or weak (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, 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 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 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 may cause symptoms such as fatigue, headache, nausea, vomiting).
• Sudden kidney failure.

Very rare (may affect up to1 in10,000 patients)

• Sinusitis (sensation of pain and pressure behind the cheeks and eyes).
• Cramping.
• Low blood glucose levels (hypoglycemia). The signs may include feeling hungry or weak, sweating, and rapid heart rate.
• Pneumonitis. The signs include cough, shortness of breath, and high fever.
• Yellowing of the skin or white of the eyes (jaundice).
• Inflammation of the liver. This may 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 urine output or inability to urinate.
• Liver insufficiency.
• Hives.
• Inflammatory bowel disease.

Frequency unknown (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 or pharmacist, 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 Vigilance of Medicinal Products 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.

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.

This medication does not require special conditions for conservation.

Medications should not be thrown down the 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 cinfa composition

• The active ingredient is lisinopril. Each tablet contains 10 mg of lisinopril (as lisinopril dihydrate).
• The other components are: mannitol (E-421), calcium dihydrogen phosphate, cornstarch, pregelatinized cornstarch, magnesium stearate, red iron oxide (E-172), and anhydrous colloidal silica.

Appearance of the product and content of the packaging

Light pink, cylindrical, biconvex, scored on one face, and marked with the code “LI5” on the other face.

It is presented in PVC-PVDC/Aluminum blisters, in packs of 60 or 500 (clinical pack) tablets.

Only some package sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Cinfa Laboratories, S.A.

Carretera Olaz-Chipi, 10. Areta Industrial Estate.

31620 Huarte (Navarra) - Spain

Last review date of this leaflet:July 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/

You can access detailed and updated information about this medicine by scanning the QR code included in the leaflet and packaging with your smartphone. You can also access this information at the following internet address:https://cima.aemps.es/cima/dochtml/p/64563/P_64563.html

QR code to:https://cima.aemps.es/cima/dochtml/p/64563/P_64563.html