Lisinopril 20mg Tablets
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PACAKGE LEAFELT - INFORMATION FOR THE PATIENT
LISINOPRIL 2.5MG, 5MG, 10MG AND 20MG TABLETS
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 further questions, please ask your doctor or your pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
• Your doctor may have given you this medicine before from another company and it may have looked slightly different. Either brand will have the same effect.
In this leaflet:
1. What lisinopril is and what it is used for
2. What you need to know before you take lisinopril
3. How to take lisinopril
4. Possible side-effects
5. How to store lisinopril
6. Contents of the pack and other information
1. WHAT LISINOPRIL IS AND WHAT IT IS USED FOR
The name of this medicine is Lisinopril 2.5mg, 5mg, 10mg and 20mg Tablets (called lisinopril tablets throughout this leaflet).
This belongs to a group of medicines known as ACE inhibitors (Angiotensin Converting Enzyme inhibitors).
Lisinopril works by making your blood vessels wider.
This helps your blood pressure to fall. It also makes it easier for your heart to pump blood around your body.
Lisinopril can be used
•To treat high blood pressure - also called hypertension
• To treat heart failure where the heart has difficulty pumping blood around your body. The signs include shortness of breath, swollen ankles and legs and feeling tired after light exercise
• If you have recently had a heart attack (myocardial infarction) that may lead to a weakening of your heart. Lisinopril slows this weakening down
• If you have kidney problems due to diabetes and have high blood pressure.
Lisinopril is recommended in children (above 6 years old) only for the treatment of high blood pressure (hypertension).
Lisinopril should not be used in children with severe kidney impairment.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE LISINOPRIL
Do not take lisinopril if:
• You are more than 3 months pregnant. (It is also better to avoid lisinopril in early pregnancy- see pregnancy section.)
• You are breast-feeding (see pregnancy and breast-feeding section)
• You are allergic to lisinopril or any of the other ingredients of this medicine (listed in section 6).
• You have ever had an allergic reaction to another ACE inhibitor medicine. The allergic reaction may have caused swelling of the hands, feet, ankles, face, lips, tongue or throat. It may also have made it difficult to swallow or breathe (angioedema).
• Any member of your family has had an allergic reaction to these medicines or you have ever had an allergic reaction for no apparent reason. Signs of an allergic reaction include: rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue.
• You are taking a blood pressure medicines containing aliskiren and you have diabetes.
• You are taking a blood pressure medicines containing aliskiren and you have kidney problems.
Do not take lisinopril if any of the above applies to you. If you are not sure, talk to
your doctor or pharmacist.
If you develop a dry cough which is persistent for a long time after starting
treatment with lisinopril talk to your doctor.
Warnings and precautions
Talk to your doctor or pharmacist before taking lisinopril 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 section).
• Have been told to limit the amount of salt in your diet, are having kidney dialysis, or have had severe diarrhoea or sickness (vomiting).
• If you have liver problems.
• If you have diabetes.
• Have recently had a heart attack (myocardial infarction).
• Have a narrowed heart valve (mitral valve stenosis) or aorta (aortic stenosis), or have a heart problem known as “hypertrophic cardiomyopathy”. These all cause the blood to flow less freely away from the heart.
• If you have problems with your blood vessels (collagen vascular disease).
• If you have low blood pressure. You may notice this as feeling dizzy or
light-headed, especially when standing up.
• Have kidney problems, including narrowed blood vessels in your kidneys (renal artery stenosis) or a recent kidney transplant.
• Have rheumatoid arthritis or other diseases affecting your joints.
• Have ever had “angioneurotic oedema” or “angioedema”. The signs include itching, red marks on the hands, feet and throat, swelling around the eyes and lips, difficulty breathing.
• Are having treatments to reduce your reaction to bee and wasp stings.
• Are having treatment of your blood by a machine to lower cholesterol (LDL apheresis).
• Take extra potassium in your diet or a salt substitute that contains potassium.
If you are taking any of the following medicines used to treat high blood pressure:
• an angiotensin II receptor blocker (ARBs) (also known as sartans - for example valsartan, telmisartan, irbesartan), in particular if you have diabetes-related kidney problems.
• aliskiren
Your doctor may need to 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".
Please talk to your doctor before taking lisinopril if any of the above applies to you, even if they applied only in the past
People who are of black race or African-Caribbean origin need to be aware that in this group of patients:
• Allergic reactions to medicines such as lisinopril are more common
• Lisinopril may not work as well
Operations
If you are going to have an operation (including dental surgery) tell your doctor or dentist that you taking lisinopril. This is because you can get low blood pressure (hypotension) if you are given certain local or general anaesthetics while you are taking lisinopril.
Children and adolescents
Lisinopril has been studied in children. 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
Tell your doctor or pharmacist if you are taking or have recently taken or might take any other medicines. This includes medicines you buy without a prescription, including herbal medicines. This is because lisinopril can affect the way some other medicines work. Also some medicines can affect the way lisinopril works.
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").
Talk to your doctor before taking lisinopril if you are taking any of the
following medicines:
• Water tablets (diuretics) such as spironolactone, triamterene or amiloride. Lisinopril may increase the levels of potassium in your blood
• Water tablets (diuretics) such as thiazides, frusemide, or other medicines to lower your blood pressure, medicines for chest pain (angina). Taking lisinopril at the same time may cause low blood pressure
• Aliskiren containing medicines (for treatment of high blood pressure).
• Medicines to break up blood clots (usually given in hospital).
• Beta-blocker medicines, such as atenolol and propranolol.
• Nitrate medicines (for heart problems).
• Lithium (for some types of mental illnesses)
• Medicines for depression such as amitriptyline, medicines for serious mental illness such as chlorpromazine, morphine (for severe pain) or anaesthetics. Taking these medicines at the same time as lisinopril may cause low blood pressure
• Non-steroidal anti-inflammatory drugs (NSAIDs), such as indometacin or diclofenac (for pain or inflammation). These medicines may make lisinopril work less well
• Aspirin (Acetylsalicylic acid), if you taking more than 3 grams each day.
• Medicines such as ephedrine, noradrenaline or adrenaline (for low blood pressure, shock, heart failure, asthma or allergies). These medicines may make lisinopril work less well
• Medicines for diabetes, such as insulin. Lisinopril may cause your blood sugar levels to drop even further when taken with these medicines. This is more likely to occur during the first weeks of taking lisinopril and in patients with kidney problems. You should check your blood sugar level closely during the first month of taking lisinopril
• Medicines used to treat asthma
• Medicines to treat nose or sinus congestion or other cold remedies (including those you can buy in the pharmacy)
• Allopurinol (used to treat gout and kidney stones), procainamide (used to treat heart rhythm disturbances), medicines used to suppress your immune system (such as ciclosporin after transplant surgery and to treat rheumatoid arthritis).
• Gold injections (for example, sodium aurothiomalate) which may cause flushing, dizziness, nausea (feeling sick) and your blood pressure to drop too much.
If you are going to have an anaesthetic (for an operation), tell your doctor or
dentist that you are taking lisinopril.
Lisinopril with food and drink
You can take lisinopril with or without food.
Pregnancy and breast-feeding Pregnancy
You must tell your doctor if you think you are (or might become) pregnant or you are planning to have a baby. 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 lisinopril. 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 used after the third month of pregnancy.
• Do not take lisinopril during weeks 13 to 40 of your pregnancy. This is because your baby may be harmed.
If you have taken lisinopril during this period, it is best to have an ultrasound (scan) check of the baby’s kidneys and skull.
• Use contraception to stop you getting pregnant when taking lisinopril.
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
• Lisinopril may make you feel tired or dizzy. If this happens do not drive or use any tools or machines.
• You must wait to see how your medicines affect you before trying these activities.
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3. HOW TO TAKE LISINOPRIL
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
The dose of lisinopril will depend on the condition being treated and any other medicines you are taking. This leaflet gives the usual dose but you should read the amount prescribed for you on the medicine label. You should check with your doctor or pharmacist if you are not sure.
Taking lisinopril
• Swallow the tablets with water. You can take them with or without food.
• Take your tablet at about the same time each day. Take the lisinopril tablet marked for the correct day on the blister pack. This will help you remember whether you have taken it.
The first lisinopril tablets you take might make you feel dizzy or light-headed. This is because the first dose may make your blood pressure fall by more than doses you take after that. It may help to lie down until you feel better. If you are concerned talk to your doctor or pharmacist.
The doctor may check how you are responding to taking lisinopril by taking your blood pressure and doing some blood tests.
Adults with high blood pressure (hypertension)
• The starting dose is usually 10mg each day. This may be increased gradually to a maintenance dose (the dose you will stay on) of 20mg daily. The maximum daily dose is 80mg.
• The actual dose, decided by your doctor, will depend on your blood pressure and other medical conditions.
If you are taking a high dose of water tablets (diuretics), your doctor may ask you to stop taking them for 2 to 3 days before you start taking lisinopril.
Adults with heart failure
• The starting dose is usually 2.5mg each day.
• It can be increased to as much as 35mg once daily; your doctor will decide this depending on how your condition changes with lisinopril. Any change will be done gradually over a number of weeks.
Heart attack
• Treatment may be started within 24 hours of having a heart attack.
• The usual starting dose of 5mg each day for 2 days may be increased to 10mg on the third day.
• Treatment may continue for about 6 weeks after your heart attack.
People with kidney problems
• If you have kidney problems, the doctor will alter the amount of lisinopril you take depending on how well your kidneys are working
• If you are on kidney dialysis your dosage will vary day by day. Your doctor will let you know what your dose should be.
Older People
• Your dose will be decided by your doctor. It will depend on how well your kidneys are working.
Children under 6 years
• The use of lisinopril is not recommended.
Children and adolescents aged 6 to 16 years
The dose depends on your weight. The usual starting dose is between 2.5mg and 5mg once daily, which can be increased to a maximum of 20mg to 40mg once daily. Patients with kidney problems should take a lower dose. Your doctor will decide the correct dose for you.
Kidney Transplant patients
• Lisinopril should not be used in patients who have recently had a kidney transplant.
If you take more lisinopril than you should
Contact your doctor or go to the nearest hospital casualty department straight away. Remember to take with you any tablets. The following effects are most likely to happen: Dizziness, palpitations.
If you forget to take lisinopril
If you miss a dose do not worry. Simply take your normal dose when it is next due. Do not take a double dose to make up for a forgotten tablet.
If you stop taking lisinopril
Keep taking your tablets until your doctor tells you to stop. If you feel better, do not stop taking the tablets. If you stop them, your conditions may get worse.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Common (affects less than 1 in 10 people):
• Dizziness, headache or cough
• Feeling faint or light-headed when standing up quickly. This could be due to low blood pressure
• Diarrhoea, being sick (vomiting)
• Kidney problems including kidney failure
Uncommon (affects less than 1 in a 100 people):
• Mood changes, balance problems and dizziness (vertigo), change in the way things taste, sleep problems, unusual skin sensations such as numbness, tingling, pricking, burning, or creeping on the skin (paraesthesia).
• Heart problems including increased heart rate, uneven heart beat, chest pain and more serious conditions including heart attack and stroke
• Raynaud's phenomenon. Symptoms include toes or fingers that change colour when exposed to the cold or when pressure is put on them, pain in the fingers or toes when cold, tingling or pain on warming
• Runny nose, itching, sneezing and stuffy nose (rhinitis)
• Difficulty in getting an erection or ejaculating (impotence)
• Tiredness, lack or loss of strength (weakness)
• Seeing or hearing things that are not there (hallucinations)
Rare (affects less than 1 in 1000 people):
• Feeling confused
• Dry mouth
• Hair loss or balding
• Breast enlargement in men
• Itchy, lumpy rash
• Psoriasis (a skin problem)
• Changes in the way things smell
• Feeling unwell, confused and/or weak, feeling sick (nausea), loss of appetite, feeling irritable. This could be something called a syndrome of inappropriate antidiuretic hormone secretion (SIADH).
Very rare (affects less than 1 in 10000 people):
• Low blood sugar levels (hypoglycaemia). You may feel a sense of nervousness, shaky or sweaty.
• A condition called intestinal angioedema has been reported in patients taking this type of medicine (ACE inhibitors). Symptoms are stomach pain with or without feeling sick (nausea) or being sick (vomiting).
• Passing less urine than usual over the day
• Severe difficulty breathing, wheezing, tightness in the chest
• Pain and tenderness in the sinus area, blocked or runny nose (sinusitis) (other symptoms include high temperature, tiredness, headache, cough, bad breath, pressure in your ears, loss of taste and smell and a feeling of being generally unwell)
• Swelling and rash on the skin (Cutaneous pseudolymphoma)
• Sweating.
Side effects of unknown frequency
• Fainting
• Feeling depressed
Blood tests
Taking lisinopril may affect the results of some blood tests. These include tests on: the blood cells or other parts of it, potassium levels, creatine or urea, sodium, liver enzymes or bilirubin.
If you are going to have a blood test, it is important to tell your doctor that you are taking lisinopril.
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. You can also report side effects directly via the Yellow card Scheme at: www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more information on the safety of this medicine.
5. HOW TO STORE LISINOPRIL
4. POSSIBLE SIDE EFFECTS
• Keep this medicine out of the sight and reach of children.
• Do not store above 25°C.
• Do not use this medicine after the expiry date which is stated on the carton. The expiry date refers to the last day of that month.
• Do not throw away any 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.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking lisinopril and see a doctor or go to a hospital straightaway if:
• You get swelling of the hands, feet, ankle, face, lips or throat which may cause difficulty in swallowing or breathing, itching of the skin and nettle rash.
• You get red, swollen or scalded skin with blisters on the lips, eyes, mouth, nose and/or genitals. You may also have a high temperature swollen glands or joint pain.
This may mean you are having an allergic reaction to lisinopril.
Allergic reactions to medicines such as lisinopril are more common in people of black race or African-Caribbean origin.
Talk to your doctor straight away if you notice any of the following serious side-effects.
These are rare (affect less than 1 in 1000 people):
• Severe stomach or back pain. These could be signs of pancreatitis.
• Blood disorders including the bone marrow problems and anaemia. Symptoms include bruising more easily, bleeding longer after injury, bleeding from the gums or elsewhere, purple spots or blotching on the skin (caused by damage to small blood vessels), a greater chance of infection.
• High temperature, tiredness, loss of appetite, stomach pain, feeling sick, yellowing of the skin or eyes (jaundice) and liver failure. These are symptoms of hepatitis (inflammation of the liver).
• A condition which may include some or all of the following: high temperature, inflamed blood vessels, painful inflamed muscles and joints, blood problems detected by a blood test, rash, being very sensitive to sunlight, other effects on the skin.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What lisinopril contains
Each tablet contains 2.5mg, 5mg, 10mg or 20mg of lisinopril dihydrate as the active substance.
Other ingredients are mannitol, calcium hydrogen phosphate dihydrate, maize starch, pregelatinised starch, colloidal silicone dioxide and magnesium stearate. Lisinopril 5mg, 10mg and 20mg Tablets contain red iron oxide (E172).
What Lisinopril looks like and contents of the pack
Lisinopril 2.5mg Tablets are white, round, biconvex tablets marked S140 on one side Lisinopril 5mg Tablets are white, round, biconvex tablets marked S141 on one side Lisinopril 10mg Tablets are white, round, biconvex tablets marked S142 on one side Lisinopril 20mg Tablets are white, round, biconvex tablets marked S143 on one side They are supplied in blister packs of 28 tablets and 84 tablets Not all pack sizes may be marketed.
The Marketing Authorisation Holder is:
Zentiva, One Onslow Street, Guildford, Surrey, GU1 4YS, UK
The Manufacturer is: Zentiva, One Onslow Street, Guildford, Surrey, GU1 4YS, UK.
This leaflet does not contain all the information about your medicine. If you have any questions or you are not sure about anything ask your doctor or pharmacist.
This leaflet was last revised in August 2014 ‘Zentiva’ is a registered trademark. © 2014 Zentiva.
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