Prospecto: information for the patient

Zestril 20 mg tablets

lisinopril

Read this prospect carefully before starting to take this medicine, as it contains important information for you.

• Keep this prospect as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed only for you, and you must 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 prospect. See section 4.

1.What Zestril is and for what it is used

2.What you need to know before starting to take Zestril

3.How to take Zestril

4.Possible adverse effects

5.Storage of Zestril

6.Contents of the package and additional information

Zestril contains a medication called lisinopril. This belongs to a group of medications known as angiotensin-converting enzyme (ACE) inhibitors.

Zestril 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 experienced a heart attack (myocardial infarction).
• For the treatment of diabetic nephropathy in patients with hypertension.

Zestril 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 Zestril:

• if you are allergic to lisinopril or any of the other ingredients in this medication (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 medication 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 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 best to avoid Zestril at the beginning of pregnancy - see the section on pregnancy.
• if you have diabetes or kidney failure and are being treated with a medication 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 Zestril.

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

Warnings and precautions:

Consult your doctor or pharmacist before starting to take Zestril:

• 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 an alteration of renal function or are on dialysis.
• if you have liver problems.
• if you have diabetes.
• if you are taking any of the following medications, which increases the risk of angioedema (rapid swelling under the skin in an area such as the throat):

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

- racecadotrilo, a medication used to treat diarrhea.

- vildagliptina, a medication used to treat diabetes.

• if you are taking any of the following medications 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 renal function, blood pressure, and electrolyte levels 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 levels of cholesterol and are receiving a treatment called "LDL apheresis”.
• you must inform your doctor if you think you are (or plan to become) pregnant. Zestril 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 period (see the section on pregnancy).
• if you are of black race, as Zestril 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 Zestril.

Treatment of allergies such as insect bites

Inform your doctor if you are receiving or will receive a treatment to reduce the effect of an allergy such as an insect bite (allergy desensitization treatment). If you take Zestril 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 Zestril. This is because you may experience 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, consult your doctor. Zestril is not recommended for children under 6 years of age or for children with severe kidney problems.

Use of Zestril with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication. This is because Zestril may affect the way some medications work, and some medications may have an effect on Zestril. 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 medications:

• Other medications that help to 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 Zestril” and “Warnings and precautions”).
• Diuretics (medications used to increase the elimination of urine).
• Beta-blockers, such as atenolol and propranolol.
• Nitrate-derived medications (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.
• Medications for depression and mental disorders, including lithium.
• Potassium supplements (including salt substitutes) and other medications that may increase the amount of potassium in the blood (for example, trimethoprim and cotrimoxazole for bacterial infections; ciclosporin, an immunosuppressant medication used to prevent organ rejection; and heparin, a medication used to dilute the blood to prevent clots).
• Insulin or oral antidiabetic medications.
• Medications for the treatment of asthma.
• Medications for the treatment of nasal or sinus congestion or other treatments for a cold (including those that you can buy at a pharmacy).
• Medications that inhibit the body's immune response (immunosuppressants).
• Alopurinol (for gout).
• Procainamide (for heart rhythm disorders).
• Medications that contain gold salts, such as aurothiomalate sodium, which will be administered as an injection.
• The following medications 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):

• Medications used to dissolve blood clots (tissue plasminogen activator) that are normally administered in a hospital.
• Medications administered to prevent organ rejection (temsirolimus, sirolimus, everolimus, and other medications that belong to the class of mTOR inhibitors). See section 2 “Warnings and precautions”.
• Racecadotrilo used to treat diarrhea.
• Vildagliptina, a medication 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 Zestril before becoming pregnant or as soon as you find out you are pregnant and recommend that you take another medication instead of Zestril. Zestril 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 period.

Breastfeeding

Inform your doctor if you are breastfeeding or plan to start breastfeeding. Zestril is not recommended for mothers during breastfeeding, and your doctor may choose another treatment for you if you want 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 medication. If this happens, do not drive or operate any tools or machinery.

You should wait to see how the medication affects you before attempting to perform 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 Zestril, 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 whether you take Zestril before or after meals.
• Continue taking Zestril for the time your doctor tells you to, as it is a long-term treatment. It is essential to continue taking Zestril every day.

First dose intake

• Be extra careful when taking the first dose of Zestril or if your doctor increases the dose. It may cause a further decrease in blood pressure than the one you will experience 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 whether 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 initial recommended dose is 10 mg once a day.
• The usual long-term dose is 20 mg once a day.

• Heart failure

• The initial recommended 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 initial recommended 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 elderly, 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

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

If you take more Zestril than you should

If you take more Zestril 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 the Toxicology Information Service. Phone 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 the missed doses.

If you interrupt treatment with Zestril

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 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 Zestril and consult your doctor immediately.

• Severe allergic reactions (rare, between 1 and 10 of 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 skin itching (with hives).

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

Other possible side effects:

Frequent (between 1 and 10 of 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 of every 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.
• Sensation of vertigo.
• Difficulty sleeping.
• Stroke.
• Fast heart rate.
• Runny nose.
• Nausea.
• Stomach pain or indigestion.
• Skin rash or itching.
• Inability to achieve 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, 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 of every 10,000 patients)

• Confusion.
• Rash with hives.
• Dry mouth.
• Hair loss.
• Poriasis (a skin disorder).
• Change in the smell of things.
• Development of breasts 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 Zestril 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 (in fewer than 1 of every 10,000 patients)

• Sinusitis (sensation of pain and pressure behind the cheeks and eyes).
• Chills.
• 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).
• 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 it directly throughthe 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 about 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 and blister after CAD. The expiration date is the last day of the month indicated.
• Do not store at a temperature above 30°C.
• Medications should not be disposed of through drains or in the trash.Deposit the packaging and medications that you no longer need at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications that you no longer need. By doing so, you will help protect the environment.

Composition of Zestril 20 mg tablets

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

Appearance of the product and contents of the container

Round, brown-red, uncoated, biconvex tablet with a “♥ 20” on one face 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 container sizes may be marketed.

Holder of the marketing authorization and responsible manufacturer

Holder:

Atnahs Pharma Netherlands B.V.

Copenhagen Towers

Ørestads Boulevard 108, 5.tv

DK-2300 København S

Denmark

Responsible 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 with the following names:

Acemin:Austria

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

Last review date of this leaflet: March 2022

Other sources of information

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