What Zestril is and what it is used for
Zestril contains the active substance lisinopril. It belongs to a group of drugs called ACE inhibitors.
Zestril can be used under the following conditions:
- Treatment of high blood pressure ( hypertension )
- Treatment of heart failure
- If you have recently had a heart attack (myocardial infarction)
- Treatment for incipient kidney disease in connection with adult diabetes and high blood pressure.
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 previously had an allergic reaction to ACE inhibitors. The allergic reaction has caused swelling of the hands, feet, ankles or face, lips, tongue, and/or throat, with difficulty swallowing or breathing ( angioedema )
- if you have taken or are taking sacubitril/valsartan, a medicine used to treat a type of long-term ( chronic ) heart failure in adults, as it increases the risk of angioedema (rapid swelling under the skin in an area such as the throat)
- if someone in your family has had severe allergic reactions ( angioedema ) to ACE inhibitors or you have had severe allergic reactions ( angioedema ) without a known cause
- if you have been pregnant for more than 3 months. Pregnant women should not use Zestril during the last 6 months of pregnancy (even earlier in pregnancy it is good to avoid Zestril, see section Pregnancy and breast-feeding)
- if you have diabetes or impaired kidney function and are being treated with an antihypertensive medicine containing aliskiren.
If you are not sure if any of these apply to you, talk to your doctor or pharmacist before taking Zestril.
Warnings and precautions
Talk to your doctor or pharmacist before taking Zestril.
- if you have a narrowing ( stenosis ) of the aorta (large artery) or narrowing ( stenosis ) of the heart valve (mitral valve)
- if you have a narrowing ( stenosis ) of the renal artery (blood vessel leading to the kidneys)
- if you have thickened heart muscle (hypertrophic cardiomyopathy )
- if you have blood vessel disease ( collagen vascular disease)
- if you have low blood pressure. It can be experienced as dizziness or vertigo, especially when you stand up
- if you have reduced kidney function or if you are receiving dialysis treatment
- if you have liver disease
- if you have diabetes
- if you take any of the following medicines, the risk of angioedema (rapid swelling under the skin in areas such as the throat) is higher:
- temsirolimus, sirolimus, everolimus, and other medicines belonging to the group of mTOR inhibitors (used to prevent rejection of transplanted organs and against 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 blocker (ARB) (also called sartans – for example, valsartan, telmisartan, irbesartan), especially if you have diabetes-related kidney problems
- the aliskiren
Your doctor may need to check your kidney function, blood pressure, and the number of electrolytes (eg potassium ) in your blood at regular intervals.
See also the information under the heading “Do not take Zestril”.
- if you have had severe diarrhea or vomiting recently
- if you have been prescribed a low-salt diet
- if you have high cholesterol levels that are treated with so-called LDL apheresis
- if you think you are pregnant or become pregnant during treatment, contact your doctor. Zestril is not recommended during pregnancy and should not be used during the last 6 months of pregnancy as it may cause birth defects, see Pregnancy and breast-feeding
- if you are dark-skinned, as Zestril may be less effective. You may also be more likely to have angioedema as a side effect (a serious allergic reaction )
If you are not sure if any of these apply to you, talk to your doctor or pharmacist before taking Zestril.
Treatment of allergies, for example to insect stings
Tell your doctor if you are undergoing or are going to undergo treatment to reduce allergies to, for example, insect stings (hyposensitization treatment). If you take Zestril during that treatment, you may have a serious allergic reaction.
If you are going to have surgery (which also applies to dental surgery), tell your doctor or dentist that you are taking Zestril. There may be a risk of a severe drop in blood pressure if you receive certain types of anesthesia or anesthesia while taking Zestril.
Children and young people
Zestril has been studied in children. For more information, talk to your doctor. Zestril is not recommended for children under 6 years of age or 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. Some medicines can affect or be affected by treatment with Zestril. Your doctor may need to change the dose and/or take other precautions.
In particular, tell your doctor or pharmacist if you are taking any of the following medicines:
- other medicines for high blood pressure (blood pressure-lowering medicines) for example beta-blockers such as atenolol or propranolol.
- an angiotensin II receptor blocker (ARB) or aliskiren (see also the information under the headings “Do not take Zestril” and “Warnings and precautions”)
- water-reducing drugs ( diuretics )
- medicines for angina (nitrates)
- pain relievers and antipyretics, such as indomethacin and ibuprofen
- aspirin if you take more than 3 grams per day
- medicines for depression and certain mental illnesses, for example, lithium
- potassium supplements (including salt substitutes), potassium-sparing diuretics, and other medicines that can increase the amount of potassium in your blood (eg trimethoprim and co-trimoxazole (trimethoprim/sulfamethoxazole) for infections caused by bacteria; ciclosporin, an immunosuppressant medicine which prevents rejection of transplanted organs; and heparin, a drug used to thin the blood to prevent blood clots)
- Insulin and other diabetes medicines that you take by mouth
- medicines for asthma
- medicines for blocked sinuses and nasal congestion and cold medicines (including over-the-counter ones)
- medicines that inhibit the body’s immune system (immunosuppressive medicines)
- medicines for gout (allopurinol)
- medicines for disturbances in the rhythm of the heart (for example procainamide )
- injection with gold (sodium aurothiomalate) which is used against rheumatism
The following medicines may increase the risk of angioedema (signs of angioedema include swelling of the face, lips, tongue, and/or throat and difficulty swallowing or breathing):
- medicines that prevent the formation of blood clots (tissue plasminogen activators), which are usually given in a hospital
- medicines most often used to prevent rejection of transplanted organs (temsirolimus, sirolimus, everolimus, and other medicines belonging to the group of mTOR inhibitors). See section 2 “Warnings and precautions”
- racecadotril is used to treat diarrhea.
- vildagliptin, a medicine used to treat diabetes.
Pregnancy and breastfeeding
If you think you are pregnant or become pregnant during treatment, contact your doctor. Usually, your doctor will suggest that you stop taking Zestril before pregnancy or as soon as you know you are pregnant and will recommend another medicine for you instead. Zestril should not be used in early pregnancy and should not be used during the last 6 months of pregnancy as it may cause birth defects.
Tell your doctor if you are breastfeeding or intend to start breastfeeding. Zestril is not recommended during breastfeeding and your doctor may choose another treatment for you if you wish to breastfeed your baby, especially if your baby is a newborn or was born prematurely.
Driving ability and use of machinery
- Some patients may feel dizzy or tired while taking Zestril. This may affect the ability to drive and use machines
- You should be observant of how you react before driving and using machines
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased vigilance. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. A description of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. Discuss with a doctor or pharmacist if you are unsure.
How to take Zestril
Always take this medicine as directed by your doctor. Ask your doctor or pharmacist if you are unsure.
Once you have started treatment with Zestril, your doctor may need to take blood tests. Based on the results, your doctor may need to adjust the dose to suit you.
How to take your medicine
- The tablet should be taken with at least half a glass of water
- Try to take the tablet at the same time every day. It does not matter if Zestril is taken with or without food
- Take the tablets as long as your doctor prescribes, Zestril should be taken for a long time. You must take Zestril every day
First dose one
- The first dose of Zestril or the first dose after a dose increase, you may experience a greater drop in blood pressure than the treatment gives in the future
- You may experience this as dizziness or feel faint and it may help to lie down. If you are worried, talk to your doctor as soon as possible
The usual dose for adults
The dose you need depends on your medical condition and whether you are taking other medicines at the same time. Your doctor will decide how many tablets you should take each day. If you are unsure, contact a doctor or pharmacist.
- the recommended starting dose is 10 mg once a day
- the usual dose for continued treatment is 20 mg once a day
- the recommended starting dose is 2.5 mg once a day
- the usual dose for continued treatment is 5-35 mg once a day
After a heart attack:
- the recommended starting dose is 5 mg once a day for the first two days
- the usual dose for continued treatment is 10 mg once a day
Incipient kidney disease associated with adult-onset diabetes and high blood pressure:
- the recommended dose is 10-20 mg once a day
If you are elderly, have impaired kidney function, or take diuretic medication, your doctor may prescribe a lower dose than usual.
Use for children and adolescents (between 6 and 16 years) with high blood pressure
- Zestril is not recommended for children under 6 years of age or children with severe kidney disease
- The doctor calculates the dose that is right for your child. Does one depends on the child’s weight.
- recommended starting dose for children weighing between 20 and 50 kg is 2.5 mg once a day
- the recommended starting dose for children weighing more than 50 kg is 5 mg once a day
If you have taken too much Zestril
If you have taken too much of the medicine, you may feel faint or dizzy due to low blood pressure. You may also experience palpitations. Contact your doctor, or the nearest hospital for an assessment of the risk and advice.
If you forget to take Zestril
- If you forget a dose, take it as soon as you remember. If it is almost time for the next dose, skip the missed dose one
- Do not take a double dose to make up for a missed dose
If you stop taking Zestril
Do not stop taking the tablets without first consulting your doctor, even if you feel well.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking Zestril and seek medical attention immediately if the following side effects occur:
- Serious allergic reaction (rare, affects 1 to 10 users in 10,000) which may include rapidly occurring symptoms such as:
- Swelling of the face, tongue, or throat. These can cause swallowing difficulties
- Severe or sudden swelling of hands, feet, and ankles
- Severe itching and hives (raised blisters)
- Difficulty breathing
- Severe skin infection with rapid onset of unexpected itching and burning and peeling skin. (very rare, affecting less than 1 in 10,000 users).
- infection with symptoms such as fever with severe worsening of the general condition or fever with local symptoms of infection such as sore throat/pharynx/mouth or vomiting (very rare, affects less than 1 in 10,000 users).
Other side effects ar
Common (affects more than 1 in 100 users)
- dizziness or feeling faint, especially when standing up quickly
- dry cough that does not go away
- reduced kidney function (seen in blood test results)
Uncommon (affects less than 1 in 100 users)
- changed mood
- changes in the color of fingers or toes (pale blue followed by redness ), numbness or tingling in fingers or toes
- taste change
- sleep disorder
- blood clot in the brain ( stroke )
- runny nose
- stomach pain or indigestion
- itching, skin irritations
- severe drop in blood pressure may occur in patients with heart disease, narrowing of the large carotid artery, or blood vessels leading to the kidneys or heart valves, or in patients with the thickened heart muscle. If this occurs, it is experienced as dizziness or vertigo, especially if you stand up quickly
- changes in blood tests that indicate how well your liver and kidneys are working.
- heart attack
- visual and/or auditory hallucinations
Rare (affects less than 1 in 1,000 users)
- dry mouth
- hair loss
- skin problems ( psoriasis )
- change in smell
- breast development in men
- changes in blood count. Your doctor may take blood tests from time to time to see if Zestril has any effect on the blood. Such changes can cause symptoms such as fatigue, pallor, sore throat, fever, joint and muscle pain, swollen joints and glands, sensitivity to sunlight
- low blood levels of sodium (symptoms may be tiredness, headache, nausea, vomiting)
- kidney failure
Very rare (affects less than 1 in 10,000 users):
- low blood sugar (hypoglycemia) with symptoms such as hunger, weakness, sweating, and palpitations
- pneumonia with cough, shortness of breath, and fever
- inflammation of the liver with symptoms such as loss of appetite, yellow skin, and whites of the eyes, and dark-colored urine
- inflammation of the pancreas with symptoms such as moderate to severe pain in the abdomen
- severe skin problems, redness with blisters, and peeling skin
- less urine than usual or no urine
- liver failure
- intestinal inflammation
Frequency not known (frequency cannot be calculated from available data):
- symptoms of depression
Side effects in children appear to be similar to those seen in adults.
How to store Zestril
- Keep this medicine out of the sight and reach of children.
- Use before the expiry date stated on the blister card and carton after “EXP”. The expiration date is the last day of the specified month.
- Tablets 2.5 mg: Store at a maximum of 25 °C.
- Tablets 5 mg, 10 mg, 20 mg and 30 mg: Store at a maximum of 30 °C.
- Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
- The active substance is lisinopril (as dihydrate). Other ingredients are mannitol, calcium hydrogen phosphate, magnesium stearate, corn starch, and pregelatinized corn starch. In addition, the pink and brown-red tablets contain red iron oxide (E 172).
- Zestril is available in strengths of 2.5 mg, 5 mg, 10 mg, 20 mg, or 30 mg lisinopril (as dihydrate).
Appearance and package sizes of the medicine
The tablet can be divided into two equal doses.
Zestril tablets are available in aluminum foil blister packs of 14, 20, 28, 28×1, 30, 50, 56, 56×1, 60, 84, 98, 100, 400, and 500 pcs.
Blister packs containing even multiples of 7 tablets are also available with marking of the days of the week.
Zestril tablets are also available in plastic cans of 20, 30, 50, 100, and 400.
Marketing Authorisation Holder:
Atnahs Pharma Netherlands BV
Ørestads Boulevard 108, 5.tv
DK-2300 København S
Atnahs Pharma Nordics A/S
Ørestads Boulevard 108, 5.tv
DK-2300 København S
AstraZeneca UK Ltd. Macclesfield, England
This medicine is approved in the European Economic Area under the names:
Acemin (AT), Acerbon (DE), Zestril (BE, ES, IE, FR, IT, EL, LU, NO, NL, SE, UK), Zestril-5/Zestril Mite/Zestril (PT).