Zestril 20 mg tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Zestril 20 mg tablets

lisinopril

Read the entire 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 only for you; do not give it to other people, 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 Zestril is and what it is used for
2. What you need to know before taking Zestril
3. How to take Zestril
4. Possible side effects
5. How to store Zestril
6. Contents of the pack and other information

1. What Zestril is and what it is used for

Zestril contains a medicine called lisinopril. It belongs to a group of medicines known as ACE inhibitors.

Zestril 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 type II diabetes in patients with hypertension.

Zestril works by dilating your blood vessels. This helps 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 Zestril

Do not take Zestril:

• 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 type of long-term (chronic) heart failure in adults, as the risk of angioedema (rapid swelling under the skin in areas 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 advisable to avoid Zestril early in pregnancy – see pregnancy section.
• 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 Zestril.

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

Warnings and precautions:

Talk to your doctor or pharmacist before taking Zestril:

• 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 experience this as dizziness or lightheadedness, 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, as they increase the risk of angioedema (rapid swelling under the skin in areas such as the throat):

• temsirolimus, sirolimus, everolimus, and other medicines belonging to the class of mTOR inhibitors (used to prevent rejection of transplanted organs 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 also the information under the heading “Do not take Zestril”.

• 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 undergoing a treatment called "LDL apheresis".
• you must inform your doctor if you think you are (or are planning to become) pregnant. Use of Zestril is not recommended early in pregnancy, and it must not be taken after 3 months of pregnancy as it may cause serious harm to the baby if used during this stage (see pregnancy section).
• if you are of Black African or Afro-Caribbean origin, as Zestril may be less effective. You are also more likely to develop the adverse effect "angioedema" (a serious allergic reaction).

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

Treatment of allergies such as insect stings

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

Surgery

If you are undergoing surgery (including dental surgery), inform your doctor or dentist that you are taking Zestril. This is because you may experience low blood pressure (hypotension) if certain local or general anaesthetics are administered while you are taking Zestril.

Children and adolescents

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

Taking Zestril with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. This is because Zestril can affect how some medicines work, and some medicines can affect Zestril. 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 also information under the headings “Do not take Zestril” and “Warnings and precautions”).

• Medicines used to increase urine elimination (diuretics).

• Beta-blockers, such as atenolol and propranolol.

• Nitrate-containing 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 at pharmacies).

• 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 to dissolve blood clots (tissue plasminogen activator), usually administered in hospital.

• Medicines given to prevent rejection of transplanted organs (temsirolimus, sirolimus, everolimus, and other medicines belonging to the class of mTOR inhibitors). See section 2 “Warnings and precautions”.

• Racecadotril used to treat diarrhoea.

• Vildagliptin, a medicine used to treat diabetes.

Pregnancy and breastfeeding

Pregnancy

You must inform your doctor if you think you are (or are planning to become) pregnant. Your doctor will usually advise you to stop taking Zestril before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine instead of Zestril. Zestril is not recommended during early pregnancy, and must not be taken after 3 months of pregnancy, 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 plan to breastfeed. Use of Zestril is not recommended for breastfeeding mothers, and your doctor may choose a different treatment for you 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 happens, 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 Zestril

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

Once you start taking Zestril, your doctor may carry out blood tests. Your doctor may then adjust your dose so that you receive the appropriate 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 whether you take Zestril before or after meals.
• Continue taking Zestril for as long as your doctor has instructed you, as it is a long-term treatment. It is important that you continue taking Zestril every day.

Taking the first dose

• Take special care when taking the first dose of Zestril or when your dose is increased. This may cause a greater drop in blood pressure than subsequent doses.
• This effect may make you feel dizzy or lightheaded. If this occurs, 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 medication. Your doctor will tell you how many tablets to take each day. If you are unsure, consult your doctor or pharmacist.

• For high blood pressure

• The recommended starting dose is 10 mg once daily.

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

• For heart failure

• The recommended starting 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 starting 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

• Zestril is not recommended for children under 6 years of age or for 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 Zestril than you should

If you take more Zestril 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 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 missed 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 about using this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

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

• Severe allergic reactions (rare, occurring in 1 to 10 out of 10,000 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 skin itching (with hives).

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

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

Other possible adverse effects:

Frequent (in 1 to 10 out of 100 patients)

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

Uncommon (in 1 to 10 out of 1,000 patients)

• Mood changes.
• Changes in the 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, which 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 (in 1 to 10 out of 10,000 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 periodically to check whether Zestril 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 the blood (which may cause symptoms such as fatigue, headache, nausea, vomiting).
• Sudden kidney failure.

Very rare (less than 1 in 10,000 patients)

• Sinusitis (feeling of pain and pressure behind the 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 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 adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report it 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 Zestril

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date which is stated on the pack and blister after EXP. The expiry date refers to the last day of the month indicated.
• Do not store above 30°C.
• Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at a SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Zestril 20 mg tablets

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

Appearance of the product and contents of the pack

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

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

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

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Atnahs Pharma Netherlands B.V.

Copenhagen Towers

Ørestads Boulevard 108, 5.tv

DK-2300 København S

Denmark

Manufacturers:

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 medicinal product is authorized in the European Economic Area member states under the following names:

Acemin: Austria

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

Date of the latest revision of this leaflet: March 2022

Other sources of information

Up-to-date, detailed information about this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/