Read this leaflet carefully before you start taking this medicine.  (DOWNLOAD)

• Keep this leaflet. You may need to read it again before, during or after use of this medicine. • If you have any further questions, ask your health care provider. 
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if  their symptoms are the same as yours. 
• If any of the side effects become serious, or if you notice any side effects not listed in this leaflet, please  inform your health care provider. 

In this leaflet: 

1. What Lisinopril tablet is and what it is used for. 
2. What you need to know before you take Lisinopril tablet. 
3. How to take Lisinopril tablet. 
4. Possible side effects. 
5. How to store Lisinopril tablet. 
6. Contents of the pack and other information. 
7. WHAT LISINOPRIL TABLET IS AND WHAT IT IS USED FOR 

Lisinopril contains lisinopril, which belongs to a group of medicines called Angiotensin Converting Enzyme  (ACE) inhibitors. ACE inhibitors lower blood pressure by widening your blood vessels. This allows the  blood to flow more easily and reduces the effort needed to pump blood around the body. Lisinopril can be  used for the following conditions: 

• to treat high blood pressure (hypertension). 
• To treat heart failure. 
• to treat patients who have suffered a heart attack. 
• to treat hypertension in patients who have diabetes, comorbid with impaired kidney function

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE LISINOPRIL TABLET Do not take Lisinopril: 

• if you are allergic to lisinopril, any other angiotensin converting enzyme (ACE) inhibitor e.g. captopril,  enalapril, ramipril or any of the other ingredients of this medicine (listed in Section 6). • if you have ever had a severe allergic reaction to another ACE inhibitor. The allergic reaction may  have caused skin rashes, itchy skin and swelling of the hands, ankles, face, lips, tongue, or throat. It  may also have made it difficult to swallow or breathe (angioedema). 
• if a family member has ever had a severe allergic reaction (hereditary angioedema) or if you have  previously had a severe allergic reaction of an unknown cause (idiopathic angioedema). • if you are more than 3 months pregnant (it is also better to avoid lisinopril in early pregnancy – see  Pregnancy and breast-feeding section). 
• if you have diabetes or impaired kidney function and you are treated with a blood pressure lowering  medicine containing aliskiren. 
• 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 an  area such as the throat) is increased 
• Do not take Lisinopril if any of the above applies to you. If you are not sure, talk to your doctor or  pharmacist before taking this medicine.

Warnings and precautions 

Talk to your doctor or pharmacist before taking Lisinopril 

• if you have low blood pressure (hypotension). You may notice this as feeling dizzy or light- headed,  especially when standing up. An additional lowering of blood pressure can occur in some patients  with heart failure being treated with lisinopril. 
• if you are dehydrated due to treatment with diuretic medicine, dialysis, dietary restriction of salt,  vomiting or diarrhoea. You may be more likely to suffer from a very large drop in blood pressure when  you start taking the tablets and may feel faint or lightheaded. 
• if you suffer from abnormal functioning of the heart, heart failure or heart valve disease, narrowing  (stenosis) or hardening of the arteries of your heart or an enlarged heart (known as hypertrophic  cardiomyopathy). 
• if you have had a stroke or mini-stroke (also known as transient ischaemic attack (TIA)). • if you suffer from kidney disease, improper functioning of the kidneys or narrowing (stenosis) of the  blood vessels to the kidney as your dosage may need to be adjusted. 
• if you are having kidney dialysis treatment or have had a kidney transplant. 
• if you are of black person i.e. from the black race, as lisinopril may not work as well and you may be  more at risk of angioedema (a severe allergic reaction). 
• if you need blood separation treatment (apheresis) e.g. for high cholesterol levels or desensitisation  treatment e.g. following a wasp or bee sting; your doctor may wish to interrupt your lisinopril treatment  to prevent a possible allergic reaction. 
• if you have liver problems. 
• if you suffer from a collagen vascular disease eg. scleroderma, Severe Lupus Erythematosus or lupus  (an allergic condition causing joint pain, skin rashes and fever). Your doctor may perform frequent  blood tests to check for any infections that may develop during treatment. 
• if you are diabetic. 
• if you have high levels of potassium in your blood (hyperkalaemia). 
• if you are taking any of the following medicines used to treat high blood pressure: o an angiotensin II receptor blocker (ARBs) (also known as sartans – for example valsartan,  telmisartan, irbesartan), in particular if you have diabetes-related kidney problems. o aliskiren. 

Your doctor may check your kidney function, blood pressure, and the amount of electrolytes (e.g.  potassium) in your blood at regular intervals. 

See also information under the heading “Do not take Lisinopril” 

• if you are taking any of the following medicines, the risk of angioedema (rapid swelling under the skin  in areas such as the throat) may be increased: 

o racecadotril (a medicine used to treat diarrhoea) 

o medicines used to prevent organ transplant rejection and for cancer (e.g. temsirolimus, sirolimus,  everolimus) 

o vildagliptin (a medicine used to treat diabetes). 

You must tell your doctor if you think you are (or might become) pregnant. Lisinopril is not recommended  in early 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 at that stage (see pregnancy and breast-feeding section). 

During treatment 

Talk to your doctor or hospital staff if: 

• you need to have surgery (including dental surgery) or need anaesthesia. This is because you can get  low blood pressure (hypotension) if you are given certain local or general anaesthetics while you are  taking this medicine.
• you develop a dry cough which is persistent for a long time after starting treatment with lisinopril, 

If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Lisinopril. 

Children and adolescents 

Lisinopril has only been studied in children with high blood pressure (see section 3, How to take Lisinopril). For more information, talk to your doctor. Lisinopril is not recommended in children under 6 years of age or in any child with severe kidney problems. 

Other medicines and Lisinopril 

You should not take Lisinopril if you have taken or are currently taking sacubitril-valsartan (see ‘Do not  take Lisinopril above). 

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This is because lisinopril can affect the way some medicines work and some medicines can have an effect  on lisinopril. 

In particular, tell your doctor or pharmacist if you are taking any of the following medicines: • diuretics (‘water tablets’) e.g. amiloride, triamterene, spironolactone. 

• potassium supplements (including salt substitutes), potassium-sparing diuretics and other medicines  that can increase the amount of potassium in your blood (e.g. trimethoprim and co- trimoxazole for  infections caused by bacteria; ciclosporin, an immunosuppressant medicine used to prevent organ  transplant rejection; and heparin, a medicine used to thin blood to prevent clots). 
• lithium used to treat certain mental illnesses. 
• pain killers called non-steroidal anti-inflammatory drugs (NSAIDs) used to treat pain and inflammation (such as indomethacin, acetylsalicylic acid, (when taking more than 3g per day), celecoxib, rofecoxib). • medicines containing gold e.g. sodium aurothiomalate, which may be given to you by injection for  conditions such as arthritis. 
• other medicines to help lower your blood pressure (e.g. glyceryl trinitrate). 
• medicines used to stimulate the central nervous system e.g. ephedrine or pseudoephedrine, often  found in cough or cold remedies. 
• insulin or other medicines for diabetes taken by mouth e.g. gliclazide, metformin; your blood glucose  should be monitored closely in the first month of starting lisinopril. 
• medicines used to treat depression e.g. amitriptyline. 
• antipsychotic medicines 
• anaesthetic medicines such as lidocaine. 
• racecadotril, a medicine used to treat diarrhoea 
• medicines used to prevent organ transplant rejection and for cancer (e.g. temsirolimus, sirolimus,  everolimus). 
• viladagliptan, a medicine used to treat diabetes. 
• allopurinol (for gout). 
• procainamide (to treat abnormal heart rhythms). 

Your doctor may need to change your dose and/or to take other precautions if you are taking an  angiotensin II receptor blocker (ARB) or aliskiren (see also information under the headings “Do not take  Lisinopril” and “Warnings and precautions”). 

Pregnancy and breast-feeding 

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your  doctor or pharmacist for advice before taking this medicine.

Pregnancy 

You must tell your doctor if you think you are (or might become) pregnant. Your doctor will normally advise  you to stop taking Lisinopril before you become pregnant or as soon as you know you are pregnant and  will advise you to take another medicine instead of this medicine. Lisinopril is not recommended in early  pregnancy, and must not be taken when more than 3 months pregnant, as it may cause serious harm to  your baby if it is used after the third month of pregnancy. 

Breast-feeding 

Tell your doctor if you are breast-feeding or about to start breast-feeding. Lisinopril is not recommended  for mothers who are breast-feeding, and your doctor may choose another treatment for you if you wish to  breast-feed, especially if your baby is newborn, or was born prematurely. 

Driving and using machines 

• Some people feel dizzy or tired when taking this medicine. If this happens to you, do not drive or use  any tools or machines. 
• You must wait to see how your medicine affects you before trying these activities. 

3. HOW TO USE LISINOPRIL TABLETS  

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

At the start of treatment your doctor may monitor your condition closely, take blood tests, check how your  kidneys are working and monitor the level of salts in your blood from time to time. 

Adults (including the elderly) 

Your dose depends on your medical condition and whether you are taking any other medicines. Your doctor will tell you how many tablets to take each day. Check with your doctor or pharmacist if you are  unsure. 

To treat high blood pressure: The recommended starting dose is 10 mg daily although, in some cases, this can be lower. Your doctor will slowly increase this to a dose which best controls your blood  pressure. The recommended maintenance dose is 20 mg once daily. The maximum dose is 80 mg once daily. 

If you are already taking a ‘water’ tablet (diuretic) for your blood pressure, your doctor may ask you to stop  taking your diuretic or to reduce the dose before starting lisinopril. Your doctor may restart the water tablets  once your blood pressure is stable. 

To treat heart failure: The recommended starting dose is 2.5 mg daily. Based on your response to the  treatment your doctor may slowly increase this dose by no more than 10 mg every two weeks or more.  The maximum dose is 35 mg once daily. Your doctor may also ask you to take other medicine for your  heart problems such as a diuretic, digoxin or a beta-blocker e.g. atenolol. 

To treat patients who have suffered a heart attack: The recommended starting dose is 5 mg within 24 hours of your attack and 5 mg one day later. The usual long-term dose is 10 mg once a day. If you  have low blood pressure a lower dose of 2.5 mg daily may be given. You should take this medicine for at least 6 weeks. 

For kidney problems caused by diabetes: The recommended dose is 10 mg daily. If needed, your  doctor will increase this to 20 mg once daily.

Patients with kidney problems may be given a lower dose of lisinopril. Your doctor may adjust to a dose  which best controls your blood pressure or to a maximum of 40 mg daily. 

Lisinopril is not recommended in patients who have recently had a kidney transplant. 

Use in children and adolescents (6 to 16 years old) with high blood pressure • Lisinopril is not recommended for children under 6 years or in any child with severe kidney problems. • The doctor will work out the correct dose for your child. The dose depends on the child’s body 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 usual recommended dose is 5 mg once a day. 

Taking your medicine 

• Swallow the tablets with a glass of water. 
• Try to take the tablets at the same time every day. It does not matter if you take Lisinopril before or  after food. 
• Keep taking Lisinopril for as long as your doctor tells you to, it is a long term treatment. It is important  to keep taking this medicine every day. 
• Lisinopril 5 mg, 10 mg and 20 mg Tablets can be divided into two equal doses 

Taking your first dose 

• Take special care when you take your first dose of lisinopril or if your dose is increased. It may cause  a greater fall in blood pressure than later doses, especially in patients with severely high blood  pressure. 
• This may make you feel dizzy or light-headed. If this happens, it may help to lie down. If you are  concerned, please talk to your doctor as soon as possible. 

If you take more Lisinopril than you should 

Contact your doctor or nearest hospital emergency department immediately. Take the container and any  remaining tablets with you. Symptoms of overdose include low blood pressure, shock (a dangerous  decrease of blood pressure which, if untreated, may lead to collapse or loss of consciousness), kidney failure, changes in blood salts which may be seen in blood tests, difficulty with breathing increased or  decreased heartbeat, dizziness, anxiety and cough. 

If you forget to take Lisinopril 

Take the next dose as soon as you remember unless it is almost time for your next dose. Do not take a double dose to make up for a forgotten dose. 

If you stop taking Lisinopril 

Do not suddenly stop taking your medicine. If you want to stop the treatment discuss this with your doctor  or pharmacist first. 

If you have any further questions on the use of this medicine, ask your doctor or pharmacist. 

4. POSSIBLE SIDE EFFECTS 

Like all medicines, Lisinopril can cause side effects, although not everybody gets them. 

If any of the following happens, stop taking lisinopril and tell your doctor immediately or go to  your nearest hospital emergency department:

Uncommon (may affect up to 1 in 100 people): 

• severe sudden chest pain which may spread to the neck, shoulders and arms with shortness of breath  and a clammy feeling. (these may be signs of a heart attack) or weakness or numbness down one  side of the body, confusion, difficulty speaking or loss of coordination (these may be signs of a stroke). These may occur due to a large drop in blood pressure especially if you have symptoms such as  severe dizziness, light-headedness at the start of the treatment, when the dose has increased or when  you stand up. 

Rare (may affect up to 1 in 1,000 people): 

• severe allergic reactions. The signs may include sudden onset of: 

o swelling of the hands, face, lips, tongue and/or throat which may cause difficulty with breathing or  swallowing (angioedema, more likely in black patients) or shortness of breath and wheezing  (anaphylaxis). 

o severe itching of the skin (with raised lumps). 

• producing little or no urine, cloudy urine or blood in the urine with lower back pain, feeling or being sick  (nausea or vomiting) or swelling in your legs, ankles or feet. These may be signs of kidney failure. 

Very rare (may affect up to 1 in 10,000 people): 

• severe abdominal pain radiating to the back with being sick (vomiting) or feeling sick (nausea). These  may be signs of pancreatitis. 
• severe skin reaction which can cause blistering and peeling of the skin, mouth, eyes and genitals.  These may be signs of pemphigus, Stevens-Johnson syndrome or if widespread, toxic epidermal  necrolysis. 
• yellowing of your skin or whites of the eyes (jaundice), dark urine, pale stools, tiredness, fever, feeling  sick (nausea), stomach pain and weakness. These may be signs of serious liver problems such as  inflammation of the liver or blockage in the bile duct, which can lead to liver failure. 
• an increase in the number of infections you may get resulting in fever, severe chills, sore throat or  mouth ulcers (these may be signs of a low number of white blood cells in your body and is more likely  in patients with kidney problems and a collagen vascular disease e.g. scleroderma, or those on  immunosuppressant treatment, allopurinol or procainamide), or if you notice that you bruise or bleed  more easily or without explanation, or yellowing of the skin or eyes or feel tired, pale or weak. These  may be signs of changes, some serious, in the number or type of blood cells, which may be due to a  reduction in the activity of bone marrow (where blood cells are produced). 

Other possible side effects include: Common (may affect up to 1 in 10 people): • dizziness. 

• headache. 
• cough. 
• diarrhoea. 
• being sick (vomiting). 
• other kidney problems. 

Uncommon (may affect up to 1 in 100 people): 

• mood changes. 
• tingling, feeling of pins and needles in the hands or feet. 
• feeling of spinning or dizziness when standing still (vertigo). 
• taste changes. 
• problems with sleeping. 
• fast heartbeat that may feel like a thumping in your chest (palpitations).
• blood circulation problem causing pale, discoloured, cold, painful fingers or toes. • an itchy, runny nose. 
• skin rash, itchy skin. 
• feeling sick (nausea). 
• stomach pain and indigestion. 
• inability to get or maintain an erection impotence. 
• tiredness. 
• weakness. 
• raised blood levels of potassium, urea, liver enzymes and creatinine which can be seen in a blood  test. 

Rare (may affect up to 1 in 1000 people): 

• confusion. 
• dry mouth. 
• a nettle-like rash, hives. 
• hair loss. 
• skin disease with thickened patches of red skin, often with silvery scales (psoriasis). • changes in the way things smell. 
• high urea levels, which could lead to gout (a painful inflammation of the joints). • breast enlargement in men. 
• a decrease in the haemoglobin levels (protein inside blood cells which carry oxygen around), or an  increase in bilirubin in the blood which all may be seen in a blood test. 
• a lower-than-normal level of sodium in the blood, which may make you feel tired, weak and confused  with aching or twitching muscles, fluid retention, fits of loss of consciousness. This may be due to  inappropriate ADH secretion, a hormone that causes the body to retain water and dilute the blood,  reducing the amount of sodium. 

Very rare (may affect up to 1 in 10,000 people): 

• benign (not cancerous) lumps on the skin. 
• swollen or enlarged glands in the neck, armpit, or groin. 
• low sugar (glucose) levels in the blood which can be seen in a blood test and may include symptoms  such as sweating, weakness, hunger, dizziness, trembling, headache, flushing or paleness,  numbness, having a fast-pounding heartbeat. 
• redness of the skin or target like spots with a dark centre and lighter outer ring. • wheezing or difficulty with breathing due to spasm of the windpipe. 
• inflamed and swollen sinuses causing pain, high temperature, tenderness. 
• swollen intestines (gut). 
• sweating. 
• fever and chills. 
• shortness of breath. 
• coughing which produces phlegm or occasionally blood. 

These may be signs of a serious lung infection (eosinophilic pneumonia) or inflammation (alveolitis). • a disease where your immune system (which defends your body against diseases) does not recognise  healthy cells and attacks them. This is called an autoimmune disease and can affect any part of the  body. 

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

• signs of depression.
• fainting. 

One or more of the following have also been seen in patients taking lisinopril: inflamed veins (vasculitis),  inflamed or painful joints, rash or other skin problems such as sensitivity to sunlight or blood tests that  suggest an increase in white blood cells or inflammation. 

Side effects in children 

Side effects in children with high blood pressure appear to be comparable to those seen in adults. 

Reporting of side effects 

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not  listed in this leaflet. 

5. HOW TO STORE LISINOPRIL TABLETS 

Keep all medicines out of reach of children. 

Store below 30ºC. 

Do not use Lisinopril tablet after the expiry date which is stated on the carton as “EXP. DATE” used for  expiry date. The expiry date refers to the last day of that month. 

Do not throw away medicines via wastewater or household waste. Ask your pharmacist how to throw  away medicines you no longer use. These measures will help protect the environment. 

6. FURTHER INFORMATION. 

What Lisinopril Tablet contains 

Lisinopril 2.5, Lisinopril 5, Lisinopril 10 and Lisinopril 20 Tablet contains the active ingredient lisinopril 

What Lisinopril Tablets looks like and contents of the pack 

Lisinopril 2.5, Lisinopril 5, Lisinopril 10 and Lisinopril 20 Tablet are all presented as 3 x 10 tablets in  sachets, placed in an outer carton with insert.