Lisinopril 20 Mg Tablets
PACKAGE LEAFLET
Lisinopril 2.5 mg Tablets Lisinopril 5 mg Tablets Lisinopril 10 mg Tablets Lisinopril 20 mg Tablets
Lisinopril
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 further questions, ask your doctor or 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.
What is 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
Lisinopril 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
• if you have recently had a heart attack (myocardial infarction)
• to treat kidney problems caused by Type II Diabetes Mellitus in people with high blood pressure
2. What you need to know before you take Lisinopril Do not take Lisinopril
- if you are allergic to lisinopril or any of the other ingredients of this medicine (listed in Section 6).
- if you are allergic (hypersensitive) to any other ACE inhibitor e.g. captopril, enalapril, ramipril.
- 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 earlier 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 section).
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 Lisinopril.
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 lightheaded, 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 light headed.
- if you suffer from heart valve disease, narrowing (stenosis) or hardening of the arteries of your heart or an enlarged heart (known as hypertrophic cardiomyopathy).
- if you suffer from kidney disease or narrowing (stenosis) of the blood vessels to the kidney as your dosage may need to be adjusted.
- if you are of black origin as Lisinopril may not work as well and you may be more at risk of angioedema (a severe allergic reaction).
- if you are having kidney dialysis treatment.
- if you need blood separation treatment (apheresis) eg. for high cholesterol levels 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, SLE or lupus (an allergic condition causing joint pain, skin rashes and fever).
- if you are diabetic.
- if you have high levels of potassium in your blood (hyperkalaemia).
- if you develop a dry cough which is persistent for a long time after starting treatment with Lisinopril, talk to your doctor.
- 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 section).
If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Lisinopril.
Treatment for allergies such as insect stings
Tell your doctor if you are having or are going to have treatment to lower the effects of an allergy such as insect stings (desensitisation treatment). If you take Lisinopril while you are having this treatment, it may cause a severe allergic reaction.
Operations
If you are going to have an operation (including dental surgery) tell the doctor or dentist that you are 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.
Other medicines and Lisinopril
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.
• medicines that increase the amount of potassium in your blood. These include potassium supplements or potassium containing salt substitutes and heparin.
• medicines for depression and for mental problems, including lithium.
• pain killers called non-steroidal anti-inflammatory drugs (NSAIDs) used to treat pain and inflammation e.g. indomethacin.
• high doses of aspirin (more than 3 grams each day).
• 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.
• nitrate medicines (for heart problems).
• beta-blocker medicines, such as atenolol and propranolol.
• medicines to break up blood clots (usually given in hospitals).
• medicines used to treat asthma
• 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.
• anaesthetic medicines.
• medicines to suppress the body’s immune response (immunosuppressants).
• allopurinol (for gout).
• procainamide (for heart beat problems).
Lisinopril with food and drink
You can take Lisinopril with or without food.
Pregnancy and breast-feeding
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 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 it is used after the third month of pregnancy.
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
Do not drive or operate machinery if you feel dizzy or unusually tired while taking this medicine. You must wait to see how your medicine affects you before trying these activities.
3. How to take Lisinopril
Always take Lisinopril exactly as your doctor 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.
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 Lisinopril every day.
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.
Adults
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. He/she may restart the diuretic once your blood pressure is stable.
To treat heart failure: The recommended starting dose is 2.5 mg daily. Your doctor will slowly increase this dose by no more than 10 mg every two weeks or more. The maximum dose is 35 mg once daily. You will also be taking 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 or kidney problems, 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.
If you are elderly, have kidney problems, or are taking diuretic medicines your doctor may give you a lower dose than the recommended dose.
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 children 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.
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, kidney failure, difficulty breathing, an irregular heart rhythm or missed beats, dizziness, anxiety and a 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 happen, stop taking Lisinopril and tell your doctor immediately or go to your nearest hospital emergency department:
• severe allergic reactions causing swelling of the face, lips, tongue and/or throat which may cause difficulty breathing or swallowing (angiodema), or very rarely, shortness of breath and wheezing (anaphylaxis)
• severe abdominal pain or in the back with sickness (pancreatitis)
• severe skin reaction which causes blistering of the skin, mouth, eyes and genitals or sores
• severe condition of the skin which causes red, often itchy spots, which start on the limbs and sometimes on the face and the rest of the body. The spots may blister or may progress to form raised, red, pale-centred marks. Those affected may have fever, sore throat, headache and/or diarrhoea.
• severe chest pain which may spread to the neck and shoulders
• yellowing of your skin or whites of the eyes (jaundice) and dark urine, which can lead to liver failure.
• changes to some of the cells or other parts of your blood. Your doctor may take blood samples from time to time to check whether Lisinopril has had any effect on your blood. The signs may include feeling tired, pale skin, a sore throat, high temperature (fever), joint and muscle pains, swelling of the joints or glands, or sensitivity to sunlight.
• blood clot in the heart or brain possibly caused by severely low blood pressure in high risk patients
• reduction in white blood cells which can increase infections such as fever, severe chills, sore throat or mouth ulcers. This is more likely in patients with kidney problems and a collagen vascular disease e.g. scleroderma, or those on immunosuppressant treatment, allopurinol or procainamide.
• loss of appetite, feeling or being sick or swelling in your legs, ankles or feet could be signs of kidney problems.
It is very important that you stop taking Lisinopril immediately and see your doctor if you have severe dizziness, light-headedness (especially at the start of treatment or when the dose has increased or when you stand up). These side effects are caused by a large drop in your blood pressure and could lead to a heart attack (severe chest pain) or stroke.
Other side effects
Common side effects (may affect up to 1 in 10 people):
• dizziness, or dizziness on standing up, especially when getting up from a sitting or lying position
• cough
Uncommon side effects (may affect up to 1 in 100 people):
• mood changes
• tingling, pins and needles
• feeling of spinning, dizziness (vertigo)
• taste changes
• changes in sleeping pattern
• an irregular heart rhythm or missed beats
• faster heart beat
• blood circulation problem causing cold painful fingers
• an itchy runny nose
• indigestion
• impotence
• raised blood levels of potassium which can cause an abnormal heart rhythm
Rare side effects (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
• breast enlargement in men
• low levels of sodium in your blood (the symptoms may be tiredness, headache, nausea, vomiting)
Very rare side effects (may affect up to 1 in 10,000 people):
• reduction in red or white blood cells or platelets which can cause weakness or breathlessness, tiredness, headaches, dizziness, looking pale and yellowing of the skin and/or eyes
• reduction in blood platelets which increases the risk of bleeding or bruising
• reduction in white blood cells which can increase infections such as fever, severe chills, sore throat or mouth ulcers. This is more likely in patients with kidney problems and a collagen vascular disease eg. scleroderma, or those on immunosuppressant treatment, allopurinol or procainamide.
• swollen glands in the neck, armpit or groin
• problems with the immune system (recurrent infections)
• low sugar (glucose) levels in the blood which can cause sweating, weakness, hunger, dizziness, trembling, headache, flushing or paleness, numbness, having a fast pounding heart beat
• wheezing, difficulty breathing
• inflamed and swollen sinuses causing pain, high temperature, tenderness
• lung infection
• swollen intestines (gut)
• sweating
• disorders of the lymph glands
• changes in urine function, passing more urine than usual or no production of urine.
Not known (frequency cannot be estimated from available data)
• symptoms of depression
• fainting
Side effects in children appear to be comparable to those seen in adults.
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.
Also you can help to make sure that medicines remain as safe as possible by reporting any unwanted side effects via the internet at www.mhra.gov.uk/yellowcard. Alternatively you can call Freephone 0808 100 3352 (available from 10 a.m. to 2 p.m. Mondays to Fridays) or fill in a paper form available from your local pharmacy.
5. How to store Lisinopril
• Keep out of the sight and reach of children.
• Do not use Lisinopril after the expiry date which is stated on the carton and blister after EXP. The expiry date refers to the last day of that month.
• This medicinal product does not require any special storage conditions.
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. Contents of the pack and other information
What Lisinopril contains
The active substance is lisinopril dihydrate. The other ingredients are: calcium hydrogen phosphate dihydrate, mannitol, starch pregelatinized (maize), croscarmellose sodium, povidone, magnesium stearate/Sodium laurilsulfate (94/6) and colloidal silicon dioxide. In addition 5mg, 10 mg & 20 mg tablets also contain iron oxide red (E172).
Lisinopril is supplied in four strengths containing 2.5 mg, 5 mg, 10 mg or 20 mg of lisinopril (as dihydrate).
What Lisinopril looks like and contents of the pack
2.5 mg: A white to off white, round, biconvex tablet debossed with L over 22 on one side of the tablet and M on the other side.
5 mg: A light pink coloured, mottled, round, biconvex tablet debossed with L and 23 on either side of the breakline on one side and M on the other side.
10 mg: A light pink coloured, mottled, round, biconvex tablet debossed with M over L 24 on one side of the tablet and breakline on the other side.
20 mg: A pink coloured, mottled, round, biconvex tablet debossed with M over L 25 on one side of the tablet and breakline on the other side.
Lisinopril is packed in blisters in packs of 10, 14, 28, 30, 50, 56, 60, 84, 98 & 100 tablets and bottles containing silica gel dessicant for hospital use containing 500 & 1000 tablets
Lisinopril is packed in perforated unit dose blisters in packs of 28 x 1 tablets and 60 x 1 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Gerard Laboratories, 35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13, Ireland. Manufacturer
Gerard Laboratories, 35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13, Ireland.
Mylan Hungary Kft.
Mylan utcal., Komarom, 2900 Hungary
This leaflet was last revised in 03/2015.
Page 9 of 9