ZESTRIL 20 mg TABLETS

Introduction

Package Leaflet: Information for the Patient

Zestril 20 mg Tablets

lisinopril

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

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

Contents of the pack and other information

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

1. What is Zestril and what is it used for

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

Zestril can be used for:

• Treating high blood pressure (hypertension).
• Treating heart failure.
• If you have recently had a heart attack (myocardial infarction).
• Treating kidney problems caused by diabetes type 2 in hypertensive patients.

Zestril works by relaxing 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 Zestril

Do not take Zestril:

• 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 another ACE inhibitor medicine. The allergic reaction could have caused swelling of your hands, feet, ankles, face, lips, tongue or throat. It could have also made it difficult for you to swallow or breathe (angioedema).
• if you are taking or have taken sacubitril/valsartan, a medicine used to treat 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 Zestril at the start of pregnancy - see the section on pregnancy.
• if you have diabetes or kidney problems and are taking a blood pressure medicine that contains aliskiren.

If you are not sure if any of these apply to you, talk to your doctor or pharmacist before taking Zestril.

If you develop a dry cough that lasts for a long time after starting treatment with Zestril, talk to your doctor.

Warnings and precautions:

Talk to your doctor or pharmacist before starting to take Zestril:

• if you have a narrowing (stenosis) of the aorta (one of the arteries that comes from 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 (collagen vascular disease).
• if you have low blood pressure. You may notice this as a feeling of dizziness or lightheadedness, especially when standing up.
• if you have kidney problems or are having dialysis.
• if you have liver problems.
• if you have diabetes.
• if you are taking any of the following medicines, as 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 transplant rejection and for cancer).
• racecadotril, 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 related to diabetes.
• aliskiren

Your doctor may check your kidney function, blood pressure and levels of electrolytes in your blood (such as potassium) at regular intervals.

See also the information under the heading “Do not take Zestril”.

• if you have recently had diarrhea or vomiting.
• if your doctor has told you to control the amount of salt in your diet.
• if you have high cholesterol levels and are having a treatment called "LDL apheresis”.
• you must tell your doctor if you think you are (or might become) pregnant. Zestril is not recommended during the first trimester 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.
• if you are black, as Zestril 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, talk to your doctor or pharmacist before taking Zestril.

Allergy treatment such as for insect bites

Tell your doctor if you are having or are going to have treatment to reduce the effect of an allergy such as to insect bites (desensitization treatment). If you take Zestril while having this treatment, it may cause a severe allergic reaction.

Surgery

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

Children and adolescents

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

Using Zestril with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This is because Zestril can affect the way some medicines work and some medicines can have an effect on Zestril. 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 to help lower your blood pressure.
• If you are taking an angiotensin II receptor antagonist (ARA) or aliskiren (see also the information under the headings “Do not take Zestril” and “Warnings and precautions”).
• Medicines used to increase urine production (diuretics).
• Beta-blocker medicines, such as atenolol and propranolol.
• Nitrate-based medicines (for heart problems).
• Non-steroidal anti-inflammatory medicines (NSAIDs) for pain and arthritis.
• Aspirin (acetylsalicylic acid), if you are taking more than 3 grams a day.
• Medicines for depression and mental problems, including lithium.
• 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 transplant rejection; and heparin, a medicine used to thin the blood to prevent clots).
• Insulin or oral antidiabetics.
• Medicines for asthma.
• Medicines for nasal or sinus congestion or other treatments for the common cold (including those you can buy at the pharmacy).
• Medicines to suppress the body's immune response (immunosuppressants).
• Allopurinol (for gout).
• Procainamide (for heart rhythm problems).
• Medicines that contain gold salts, such as sodium aurothiomalate, which will be given to you by 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 to dissolve blood clots (tissue plasminogen activator) that are usually given in hospital.
• Medicines given to prevent organ transplant rejection (temsirolimus, sirolimus, everolimus and other medicines belonging to the class of mTOR inhibitors). See section 2 “Warnings and precautions”.
• Racecadotril used to treat diarrhea.
• Vildagliptin, a medicine used to treat diabetes.

Pregnancy and breast-feeding

Pregnancy

You must tell your doctor if you think you are (or might become) pregnant. Your doctor will normally advise you to stop taking Zestril before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Zestril. Zestril is not recommended during the first trimester 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 about to start breast-feeding. Zestril is not recommended for mothers who are breast-feeding, and your doctor may choose another treatment for you if you want to breast-feed, 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 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 Zestril

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Once you start taking Zestril your doctor may take blood samples. Your doctor may then adjust your dose so 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 if you take Zestril before or after food.
• Keep taking Zestril for as long as your doctor tells you to. It is a long-term treatment. It is important to keep taking Zestril every day.

Taking the first dose

• Be particularly careful when you first start taking Zestril or if your dose is increased. It may cause a greater fall in blood pressure than later doses.
• This effect can make you feel dizzy or lightheaded. If this happens, lying down may help. If you are concerned, talk to your doctor as soon as possible.

Adults

Your dose will depend 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, talk to your doctor or pharmacist.

• For high blood pressure

• The recommended starting dose is 10 mg once a day.
• The usual long-term dose is 20 mg once a day.

• For heart failure

• The recommended starting dose is 2.5 mg once a day.
• The long-term dose is 5 mg to 35 mg once a day.

• After a heart attack

• The recommended starting 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

• Zestril 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 starting dose is 2.5 mg once a day.
• For children who weigh more than 50 kg, the recommended starting dose is 5 mg once a day.

If you take more Zestril than you should

If you take more Zestril than you should, talk to a doctor or go to a hospital immediately. The most common symptoms are: dizziness, palpitations.

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

If you forget to take Zestril

• 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 a forgotten dose.

If you stop taking Zestril

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

If you have any further questions on 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 Zestril 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 by 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 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 Zestril is affecting your blood. The signs may include tiredness, 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 can produce symptoms such as tiredness, 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 urine output or inability to urinate.
• Liver failure.
• Hives.
• Intestinal inflammation.

Frequency not known (cannot be estimated from the available data)

• Depression symptoms.
• 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 that does not appear in this prospectus. You can also report it 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 Zestril

• 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 and blister after CAD. The expiration date is the last day of the month indicated.
• Do not store at a temperature above 30°C.
• Medicines should not be disposed of through wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Zestril 20 mg tablets

• The active ingredient is lisinopril (as dihydrate).
• The other components are: mannitol, calcium hydrogen phosphate dihydrate, cornstarch, pregelatinized starch, magnesium stearate, and red iron oxide (E172).

Appearance of the Product and Package Contents

Round tablet, brown-red, uncoated, biconvex with a "♥ 20" on one side and smooth on the other. Diameter 8 mm.

Zestril tablets are available in aluminum blister packs of 14, 20, 28, 28x1, 30, 42, 50, 56, 56x1, 60, 84, 98, 100, 400, and 500 tablets.

Zestril tablets are also available in bottles of 20, 30, 50, 100, and 400 tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Holder:

Atnahs Pharma Netherlands B.V.

Copenhagen Towers

Ørestads Boulevard 108, 5.tv

DK-2300 København S

Denmark

Manufacturer:

AstraZeneca AB

Gärtunavägen

SE-152 57 Södertälje

Sweden

AstraZeneca UK Ltd

Silk Road Business Park

Macclesfield

Cheshire SK 10 2NA

United Kingdom

AstraZeneca Reims Production,

Parc industriel de la Pompelle, Chemin de Vrilly, 51100

Reims, France

ROVI Pharma Industrial Services S.A.

Vía Complutense, 140

Alcalá de Henares, Madrid, 28805

Spain

This medicine is authorized in the Member States of the European Economic Area under the following names:

Acemin: Austria

Zestril: Belgium, Spain, France, Greece, Ireland, Italy, Luxembourg, Netherlands, Norway, Sweden, United Kingdom

Date of the last revision of this prospectus: March 2022

Other Sources of Information

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