Zestril

Italy
Brand name Zestril
Form tablets
Active substance / Dosage
LISINOPRIL
Prescription type Prescription only
ATC code
C09AA03
Registration number 026834
Manufacturer ATNAHS PHARMA NETHERLANDS BV
Zestril tablets

Table of Contents

Package leaflet: Information for the user

Zestril 5 mg tablets, 10 mg tablets, 20 mg tablets

lisinopril
Please 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 questions, ask your doctor or pharmacist.
  • This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
  • If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

  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 an active substance called lisinopril. This belongs to a group of medicines called ACE inhibitors.
Zestril can be used for the following conditions:

  • to treat high blood pressure (hypertension).
  • to treat heart failure.
  • if you have recently had a heart attack (myocardial infarction).
  • to treat kidney problems caused by type II diabetes in patients with high blood pressure. Zestril works by causing the blood vessels to widen. This helps to reduce blood pressure. It also makes it easier for your heart to pump blood to all parts of the 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 another ACE inhibitor. The allergic reaction may have caused swelling of the hands, feet, ankles, face, lips, tongue, or throat. It may also have made swallowing or breathing difficult (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 this increases the risk of angioedema (rapid swelling under the skin, for example in the throat).
  • if a member of your family has had a severe allergic reaction (angioedema) with an ACE inhibitor, or if you yourself have had a severe allergic reaction (angioedema) without a known cause.
  • if you are more than three months pregnant (it is also advisable to avoid Zestril during the first months of pregnancy). See "Pregnancy".
  • if you have diabetes or impaired kidney function and are being treated with a blood pressure-lowering medicine containing aliskiren.

If you are unsure whether any of these conditions apply to you, consult your doctor or pharmacist before taking Zestril.
Contact your doctor if you develop a persistent dry cough for a prolonged period after starting treatment with Zestril.

Warnings and precautions
Talk to your doctor or pharmacist before taking Zestril:

  • if you have narrowing (stenosis) of the aorta (an artery of your heart) or narrowing of heart valves (mitral valve).
  • if you have narrowing (stenosis) of the renal artery.
  • if you have thickening of the heart muscle (known as hypertrophic cardiomyopathy).
  • if you have blood vessel disorders (vascular collagen disease).
  • if you have low blood pressure. You may feel dizzy or lightheaded, especially when standing up.
  • if you have kidney problems 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) is increased:
  • temsirolimus, sirolimus, everolimus, and other medicines belonging to the class of mTOR inhibitors (used to prevent rejection of transplanted organs and to treat cancer)
  • 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:
  • an "angiotensin II receptor antagonist" (AIIRA) (also known as sartans, e.g. 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 section "Do not take Zestril".
  • if you have recently had diarrhoea or have vomited (a state of illness).
  • if your doctor has advised you to monitor salt intake.
  • 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 may become) pregnant. Zestril is not recommended during the first months of pregnancy and must not be taken after the first trimester of pregnancy, as it may cause severe harm to the unborn baby if used during that time (see "Pregnancy").
  • if you are of Black origin, as Zestril may be less effective. You may also be more likely to experience the side effect "angioedema" (a serious allergic reaction). If you are unsure whether any of these conditions apply to you, consult your doctor or pharmacist before taking Zestril.

Treatment for allergies such as insect stings
Tell your doctor if you are currently taking or are about to start treatments to reduce the effects of an allergy such as insect stings (desensitisation treatment). If you take Zestril while undergoing this treatment, it may cause a severe allergic reaction.

Surgery
If you are due to have a surgical procedure (including dental surgery), tell your doctor or dentist that you are taking Zestril. This is because you may experience a drop in 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 for children with severe kidney problems.

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

In particular, tell your doctor or pharmacist if you are taking any of the following medicines:

  • Other medicines that help lower blood pressure.
  • An angiotensin II receptor antagonist (AIIRA) or aliskiren (see also sections "Do not take Zestril" and "Warnings and precautions").
  • Medicines that help you urinate (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 g per day.
  • Medicines for depression and mental health conditions, 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 used to treat bacterial infections; cyclosporine, an immunosuppressant used to prevent rejection of transplanted organs; and heparin, a medicine used to thin the blood and prevent clotting).
  • Insulin or oral medicines for diabetes.
  • Medicines used to treat asthma.
  • Medicines used to treat nasal or sinus congestion or other cold remedies (including those available over the counter).
  • Medicines used to suppress the body's immune response (immunosuppressants).
  • Allopurinol (for gout).
  • Procainamide (for heart rhythm problems).
  • Medicines containing gold, such as sodium aurothiomalate, which may be 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 activators), usually administered in hospital.
  • Medicines usually used 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
Tell your doctor if you think you are (or may become) pregnant. Your doctor will normally 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 the first months of pregnancy and must not be taken after the first trimester of pregnancy, as it may cause serious harm to the unborn baby if used after the third month of pregnancy.

Breastfeeding
Inform your doctor if you are breastfeeding or plan to breastfeed. Zestril is not recommended for breastfeeding mothers, and your doctor may choose an alternative treatment if you wish to breastfeed, especially if the baby is a newborn or premature.

Driving and using machines

  • Some people may feel tired or dizzy when taking this medicine. If this happens to you, do not drive or operate tools or machinery.
  • You should wait to see how this medicine affects you before engaging in these activities.

3. How to take Zestril

Take this medicine exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.
Once you have started treatment with Zestril, your doctor may ask you to have blood tests. Your doctor may then adjust your dose to ensure you are taking the correct amount of medicine for you.

Taking your medicine

  • Swallow the tablet with a glass of water.
  • Try to take the tablets at the same time each day. It does not matter whether Zestril is taken before or after meals.
  • Continue taking Zestril for as long as your doctor recommends: this is a long-term treatment. It is important to take Zestril every day.

Taking the first dose

  • Pay particular attention when taking the first dose of Zestril or when the dose has been increased. This may cause a greater reduction in blood pressure than with previous doses.
  • This may make you feel dizzy or lightheaded. If this happens, it may help to lie down. If you are concerned, contact your doctor as soon as possible.

Adults
Your dose depends on your medical condition and on other medicines you may be taking. Your doctor will tell you how many tablets to take each day. Consult your doctor or pharmacist if you are in doubt.

For high blood pressure

  • The recommended starting dose is 10 mg once daily.
  • The maintenance dose is usually 20 mg once daily.

For heart failure

  • The recommended starting dose is 2.5 mg once daily.
  • The maintenance dose ranges from 5 mg to 35 mg once daily.

After a heart attack

  • The recommended starting dose is 5 mg within 24 hours of the heart attack, followed by 5 mg on the next day.
  • The maintenance dose is usually 10 mg once daily.

For 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 than 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 prescribe the correct dose for your child. The dose depends on the child's 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 prescribed by your doctor, contact your doctor immediately or go to hospital. The following symptoms may occur: dizziness, palpitations.

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 the tablets, even if you feel well, unless your doctor tells you to.
If you have any doubts about how to use this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Stop taking Zestril and contact your doctor immediately if you experience any of the following allergic reactions:

  • Severe allergic reactions (rare, affecting 1 to 10 people in 10,000). Symptoms may include sudden onset of:
  • swelling of the face, lips, tongue or throat. This may cause difficulty swallowing.
  • Severe or sudden swelling of hands, feet and ankles.
  • Difficulty breathing.
  • Severe itching of the skin (with raised bumps).
  • Severe skin disorders, such as sudden and unexpected skin rash, burning, redness or peeling skin (very rare, affecting fewer than 1 person in 10,000).
  • An infection with symptoms such as fever and severe worsening of general condition, or fever with local signs of infection such as sore throat/pharynx/mouth or urinary problems (very rare, affecting fewer than 1 person in 10,000).

Other possible side effects:
Common (affects 1 – 10 users in 100)

  • Headache.
  • Dizziness or lightheadedness, especially when standing up quickly.
  • Diarrhoea.
  • Persistent dry cough.
  • Feeling unwell (vomiting).
  • Kidney problems (detected by blood tests).

Uncommon (affects 1 – 10 users in 1,000)

  • Mood changes.
  • Change in the colour of fingers or toes (bluish followed by reddening) or numbness or tingling in fingers or toes.
  • Altered taste.
  • Drowsiness.
  • Dizziness (vertigo).
  • Difficulty falling asleep.
  • Stroke.
  • Rapid heartbeat.
  • Runny nose.
  • Feeling unwell (nausea).
  • Stomach pain or indigestion.
  • Skin rash or itching.
  • Inability to achieve an erection (impotence).
  • Feeling of tiredness or weakness (loss of strength).
  • Excessive drop in blood pressure may occur in people with the following conditions: coronary artery disease; narrowing of the aorta (heart artery), renal artery or heart valves; thickening of the heart muscle. If this happens to you, you may feel dizzy or lightheaded, especially when standing up quickly.
  • Changes in blood tests related to liver and kidney function.
  • Heart attack.
  • Visual and auditory hallucinations.

Rare (affects 1 – 10 users in 10,000)

  • Feeling confused.
  • Nodular skin rash (urticaria).
  • Dry mouth.
  • Hair loss.
  • Psoriasis (a skin condition).
  • Changes in the perception of smells.
  • Breast development in men.
  • Changes in certain blood cells or other blood components. Your doctor may occasionally request blood tests to monitor any possible effect of Zestril on the blood. Signs may include fatigue, paleness, sore throat, high temperature (fever), joint or muscle pain, joint or gland swelling, or sensitivity to sunlight.
  • Low sodium levels in your blood (symptoms may include fatigue, headache, nausea, vomiting).
  • Sudden kidney failure.

Very rare (affects fewer than 1 user in 10,000)

  • Sinusitis (feeling of pain or fullness behind the cheeks and eyes).
  • Shortness of breath.
  • Low blood sugar levels (hypoglycaemia). Signs may include feeling hungry or weak, sweating and rapid heartbeat.
  • Inflammation of the lungs. Signs may include cough, shortness of breath and high temperature (fever).
  • Yellowing of the skin or whites of the eyes (jaundice).
  • Inflammation of the liver. This may cause loss of appetite, yellowing of skin and eyes, and dark-coloured urine.
  • Inflammation of the pancreas. This may cause mild to severe stomach pain.
  • Severe skin disorders. Symptoms include redness, blistering, peeling.
  • Sweating.
  • Reduced urine output compared to normal or absence of urination.
  • Liver failure.
  • Swelling.
  • Inflamed intestine.

Not known (frequency cannot be estimated from the available data)

  • Symptoms of depression.
  • Fainting.

Side effects in children are comparable to those observed in adults.
If any of the side effects worsens, or if you notice any side effect not listed in this leaflet, inform your doctor or pharmacist.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Zestril

  • Keep this medicine out of the sight and reach of children.
  • Do not use this medicine after the expiry date (exp.) stated on the blister and carton. The expiry date refers to the last day of that month.
  • Do not store above 30°C.
  • Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Zestril contains

  • The active substance is lisinopril (as dihydrate).
  • The other components are mannitol, calcium hydrogen phosphate dihydrate, maize starch, pregelatinized starch, and magnesium stearate. Additionally, the pink and brown-red tablets contain red iron oxide (E172).

Zestril is available in pack sizes containing 5 mg, 10 mg, and 20 mg of lisinopril (as dihydrate).
Description of the appearance of Zestril and package contents
5 mg tablets: round, pink, uncoated, biconvex tablets with “♥ 5” on one side and a break line on the other side. Diameter 6 mm.
The tablet can be divided into two equal doses.
10 mg tablets: round, pink, uncoated, biconvex tablets with “♥ 10” on one side and smooth on the other side. Diameter 8 mm.
20 mg tablets: round, brown-red, uncoated, biconvex tablets with “♥ 20” on one side and smooth on the other side. Diameter 8 mm.
Zestril tablets are available in aluminum blisters containing 14, 20, 28, 28x1, 30, 42, 50, 56, 56x1, 60, 84, 98, 100, 400 and 500 tablets. Blisters containing 7 tablets and multiples are also available with days of the week marked.
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
Atnahs Pharma Netherlands B.V.
Copenhagen Towers, Ørestands Boulevard 108, 5.tv DK-2300, København S
Denmark
Tablet release sites for Zestril:
Corden Pharma GmbH
Otto-Hahn Strasse
68723 Plankstadt
Germany
Astrazeneca Reims Production
Parc Industriel Pompelle
Chemin de Vrilly
51100 Reims
France
AstraZeneca UK Ltd
Silk Road Business Park
Macclesfield Cheshire, SK 10 2NA
England
AstraZeneca AB
Gärtunavägen
SE-151 85 Södertälje
Sweden
This medicinal product is authorized in the Member States of the European Economic Area under the following names:
Acemin Austria
Zestril Belgium, France, Greece, United Kingdom, Ireland, Italy, Luxembourg, Norway, Netherlands, Spain, Sweden.
Zestril-5/Zestril Mite/Zestril Portugal
This leaflet was last updated on:
Other sources of information
More detailed information on this medicinal product is available on the website of the Italian Medicines Agency (AIFA): http://www.agenziafarmaco.gov.it/ .