Lisinopril Cinfa 5 mg tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

lisinopril cinfa 5 mg tablets EFG

lisinopril dihydrate

Read the entire leaflet carefully before you start taking this medicine, as 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, and you should not give it to others, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet Contents

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

1. What lisinopril cinfa is and what it is used for

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

lisinopril cinfa can be used in the following cases:

• 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 disorders in patients with type II diabetes who also have hypertension.

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.

2. What you need to know before taking lisinopril cinfa

Do not take lisinopril cinfa

• If you are allergic to lisinopril or to 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 medicine. The allergic reaction may have caused swelling of the hands, feet, ankles, face, lips, tongue, or throat. It may also have caused difficulty swallowing or breathing (angioedema).
• If you have taken or are currently taking sacubitril/valsartan, a medicine used to treat a certain type of long-term (chronic) heart failure in adults, as the risk of angioedema (rapid swelling under the skin, for example in 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 advisable to avoid lisinopril in early pregnancy (see section “Pregnancy and breastfeeding”).
• If you have diabetes or kidney failure and are being treated with a blood pressure-lowering medicine containing aliskiren.

If you are unsure whether 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

Talk to your doctor or pharmacist before taking lisinopril cinfa:

• If you have narrowing (stenosis) of the aorta (one of the arteries in the heart) or narrowing of the heart valves (mitral valves).

• If you have narrowing (stenosis) of the renal artery.

• If you have thickening of the heart muscle (known as hypertrophic cardiomyopathy).

• If you have a blood vessel disease (collagen vascular disease).

• If you have low blood pressure. You may feel dizzy or lightheaded, especially when standing up.

• If you have impaired kidney function 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, for example in the throat) may increase:

• temsirolimus, sirolimus, everolimus, and other medicines belonging to the class of mTOR inhibitors (used to prevent organ transplant rejection and in cancer treatment).

• racecadotril, a medicine used to treat diarrhoea.

• vildagliptin, 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 “sartans” – for example, valsartan, telmisartan, irbesartan), particularly if you have kidney problems related to diabetes.

• aliskiren.

Your doctor may monitor your kidney function, blood pressure, and blood electrolyte levels (e.g., potassium) at regular intervals (see section “Do not take lisinopril cinfa”).

• If you have recently had diarrhoea 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 should inform your doctor if you think you are (or are planning to become) pregnant. Use of lisinopril is not recommended in early pregnancy, and it must 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. You are also more likely to develop the adverse effect “angioedema” (a severe allergic reaction).

If you are unsure whether any of these situations apply to you, consult your doctor or pharmacist before taking lisinopril.

Allergy treatments such as for insect stings

Inform your doctor if you are receiving or are about to receive treatment to reduce the effect of an allergy, such as to insect stings (desensitisation treatment). If you take lisinopril while undergoing this treatment, you may experience a severe allergic reaction.

Surgery

If you are scheduled for surgery (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 certain local or general anaesthetics are administered while you are taking lisinopril.

Children and adolescents

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

Other medicines and lisinopril cinfa

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

In particular, inform your doctor or pharmacist if you are taking 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 sections “Do not take lisinopril cinfa” and “Warnings and precautions”).

• Medicines used to increase urine elimination (diuretics).

• Beta-blockers such as atenolol and propranolol.

• Nitrate medicines (for heart problems).

• Non-steroidal anti-inflammatory drugs (NSAIDs) used to treat 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 blood potassium levels (e.g., trimethoprim and cotrimoxazole for bacterial infections; cyclosporine, an immunosuppressant used to prevent organ transplant 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 nasal or sinus congestion or other cold remedies (including those available over the counter).

• Medicines that suppress the body’s immune response (immunosuppressants).

• Allopurinol (for gout).

• Procainamide (for heart rhythm disorders).

• Gold-containing medicines, such as sodium aurothiomalate, which are administered by injection.

• The following medicines may increase the risk of angioedema (symptoms 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), usually administered in hospital.

• Medicines given to prevent organ transplant rejection (temsirolimus, sirolimus, everolimus, and other medicines belonging to the class of mTOR inhibitors) (see section “Warnings and precautions”).

• Racecadotril used to treat diarrhoea.

• Vildagliptin, a medicine used to treat diabetes.

Taking lisinopril cinfa with food and drink

Lisinopril may be taken with or without food.

Pregnancy and breastfeeding

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

Pregnancy

Your doctor will usually advise you to stop taking lisinopril before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine. Lisinopril is not recommended during early pregnancy, and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to the baby if used beyond the third month of pregnancy.

Breastfeeding

Inform your doctor if you are breastfeeding or planning to breastfeed. Use of lisinopril is not recommended for breastfeeding mothers, and your doctor may choose another treatment if you wish to breastfeed, especially if your baby is a newborn or was born prematurely.

Driving and using machines

Some people may feel dizzy or tired when taking this medicine. If this occurs, do not drive or operate tools or machinery.

You should wait to see how the medicine affects you before attempting these activities.

3. How to take lisinopril cinfa

Follow exactly the instructions for taking this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Remember to take your medicine.

Once you start taking lisinopril, your doctor may carry out blood tests. Afterwards, your doctor may adjust your dose so that you take the appropriate amount of medicine.

How to take the medicine

• Swallow the tablet with water.
• Try to take your tablets at the same time every day. It does not matter whether you take the medicine before or after meals.
• Continue taking lisinopril for as long as your doctor tells you, as it is a long-term treatment. It is important that you continue taking the medicine every day.
• The tablet can be divided into equal doses.

Taking the first dose

• Take special care when taking the first dose of lisinopril or if your dose is increased. This may cause a greater decrease in blood pressure than subsequent 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.

Adults

Your dose depends on your condition and whether you are taking any other medicines. 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 daily.

• The usual long-term dose is 20 mg once daily.

• For heart failure

• The recommended initial dose is 2.5 mg once daily.

• The long-term dose is 5 mg to 35 mg once daily.

• After a myocardial infarction (heart attack)

• The recommended initial dose is 5 mg within the first 24 hours after the infarction, and 5 mg one day later.

• The usual long-term dose is 10 mg once daily.

• Kidney problems caused by diabetes

• The recommended dose is 10 mg or 20 mg once daily.

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 body weight.
• For children weighing between 20 kg and 50 kg, the recommended starting dose is 2.5 mg once daily.
• For children weighing more than 50 kg, the recommended starting dose is 5 mg once daily.

If you take more lisinopril cinfa than you should

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

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take lisinopril cinfa

• 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 cinfa

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 may cause adverse effects, although not everyone experiences them.

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

• Severe allergic reactions (rare, may affect up to 1 in 1,000 patients). Signs may include sudden onset of:

• Swelling of the face, lips, tongue, or throat. This may make swallowing difficult.

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

• Difficulty breathing.

• Severe itching of the skin (with hives).

• Serious skin disorders, such as sudden and unexpected rash, redness, or skin peeling (very rare, may affect up to 1 in 10,000 patients).

• An infection with symptoms such as fever and severe deterioration in your general condition, or fever with symptoms of localized infection such as sore throat/pharynx/mouth or urinary disturbances (very rare, may affect up to 1 in 10,000 patients).

Other possible adverse effects

Common (may affect up to 1 in 10 patients)

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

Uncommon (may affect up to 1 in 100 patients)

• Mood changes.
• Change in color of fingers or toes (pale blue followed by redness) or numbness or tingling in fingers or toes.
• Changes in taste.
• Drowsiness.
• Dizziness.
• Difficulty sleeping.
• Stroke.
• Rapid heartbeat.
• Rhinitis.
• Nausea.
• Stomach pain or indigestion.
• Skin rash or itching.
• Inability to achieve an erection (impotence).
• Feeling of tiredness or weakness (lack of strength).
• A significant drop in blood pressure that may occur in patients with: coronary artery disease, narrowing of the aorta (a heart artery), renal arteries, or heart valves; or thickening of the heart muscle. If this occurs, you may feel dizzy or lightheaded, especially when standing up quickly.
• Changes in blood tests used to monitor proper liver and kidney function.
• Myocardial infarction.
• Visual and/or auditory hallucinations.

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

• Confusion.
• Hives rash.
• Dry mouth.
• Hair loss.
• Psoriasis (a skin condition).
• Change in the sense of smell.
• Breast development in men.
• Changes in certain blood cells or other blood components. Your doctor may take blood samples from time to time to check whether lisinopril is affecting your blood. Signs may include fatigue, pale skin, sore throat, fever, joint and muscle pain, joint or gland swelling, or sensitivity to sunlight.
• Low sodium levels in blood (which may cause symptoms such as fatigue, headache, nausea, vomiting).
• Sudden kidney failure.

Very rare (may affect up to 1 in 10,000 patients)

• Sinusitis (feeling of pain and pressure behind cheeks and eyes).
• Wheezing.
• Low blood glucose levels (hypoglycemia). Signs may include feeling hungry or weak, sweating, and rapid heartbeat.
• Lung inflammation. Signs include cough, shortness of breath, and high fever.
• Yellowing of the skin or whites of the eyes (jaundice).
• Liver inflammation. This may cause loss of appetite, yellowing of the skin and eyes, and dark-colored urine.
• Pancreatitis. This causes moderate to severe stomach pain.
• Serious skin disorders. Symptoms include redness, blistering, and peeling.
• Sweating.
• Decreased urine output or inability to urinate.
• Liver failure.
• Hives.
• Intestinal inflammation.

Frequency not known (cannot be estimated from 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 not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of lisinopril cinfa

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

Do not use this medicine after the expiry date stated on the container after EXP. The expiry date is the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of containers and any medicines you no longer need at a SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of lisinopril cinfa

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

Appearance of the product and contents of the pack

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

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

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta.

31620 Huarte (Navarra) - Spain

Date of the most recent review of this leaflet: July 2021

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

You can access detailed and up-to-date information about this medicinal product by scanning with your mobile phone (smartphone) the QR code included in the package leaflet and outer packaging. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/64563/P_64563.html

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