Lisinopril 5mg Tablets
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• Stroke
• Stomach pain or indigestion
• Skin rash
• Itching
• Impotence
• Tiredness
• Weakness (loss of strength).
• An excessive drop in blood pressure may be experienced in patients with coronary heart disease, or those with a narrowing of the aorta (aortic stenosis), the kidney artery (renal artery stenosis) or the heart valves (mitral valve stenosis), or those patients with an increase in the thickness of the heart muscle (hypertrophic cardiomyopathy)
• Changes in blood tests that show how well your liver and kidneys are working.
• Heart attack
Rare (affects less than 1 in 1,000 people)
• Confusion
• Dry mouth
• Hair loss
• Psoriasis
• Skin rash (hives)
• Development of breasts in men
• Rarely, there may be changes to some of the cells or other parts of your blood. It is possible that your doctor may occasionally take blood samples to check whether Lisinopril has had any effect on your blood. Sometimes these changes may show themselves as tiredness or a sore throat, or they may be accompanied by a fever, joint and muscle pains, swelling of the joints or glands, or sensitivity to sunlight
• Changes in the way things smell
• Sudden renal failure
Very rare (affects less than 1 in 10,000 people)
• Sinus pain
• Wheezing
• Low levels of sugar in your blood (hypoglycaemia)
• Inflammation of the lungs
• Yellow skin and/or eyes (jaundice) Inflammation of the liver or pancreas
• Severe skin disorders (symptoms of which include redness, blistering and peeling)
• A patch or lump on the skin which slowly grows in size
• Sweating
• Passing less water (urine) than normal or passing no water
• Liver failure
• Inflamed gut
Others (it is unknown how many people may be affected)
• Fainting
• Mood changes including feeling depressed
• Low levels of sodium in your blood
Side effects in children appear to be comparable to those seen in adults.
Do not take this medicine after the expiry date shown on the label. Any out of date medicines should be returned to your pharmacist.
Do not store Lisinopril Tablets above 25°C.
Keep out of the sight and reach of children.
Do not use Lisinopril Tablets after the expiry date which is stated on the label/carton. The expiry date refers to the last day of that month.
Do not use Lisinopril Tablets if you notice description of the visible signs of deterioration.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
What Lisinopril Tablets contain
The active substance is lisinopril dihydrate. Each tablet contains 2.5 mg, 5 mg, 10 mg or 20 mg of the active ingredient.
The other ingredients are mannitol, calcium hydrogen phosphate dihydrate, pregelatinised maize starch, croscarmellose sodium and magnesium stearate. The 10 mg and 20 mg tablets also contain red, black and yellow iron oxide colourings (E172).
What Lisinopril Tablets look like and contents of the pack
Lisinopril 2.5 mg, 5 mg, 10 mg and 20 mg Tablets are available in packs of 28 or 50*.
Marketing Authorisation Holder:
Morningside Healthcare Ltd
115 Narborough Road, Leicester, LE3 0PA, UK
Manufacturer:
Morningside Pharmaceuticals Ltd 5 Pavillion Way, Loughborough, LE11 5GW, UK
* Only marketed pack sizes will be shown
Package leaflet: Information for the user
Lisinopril 2.5 mg, 5 mg, 10 mg
Lisinopril Dihydrate
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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.
In this leaflet:
1. What Lisinopril Tablets are and what they are used for
2. What you need to know before you take Lisinopril Tablets
3. How to take Lisinopril Tablets
4. Possible side effects
5. How to store Lisinopril Tablets
6. Contents of the pack and other information
The name of your medicine is Lisinopril Tablets. The active ingredient, Lisinopril, belongs to a group of medicines called angiotensin converting enzyme (ACE) inhibitors which work by widening your blood vessels. This helps reduce blood pressure and also relieves the workload of the heart in patients with heart failure and following a heart attack.
Lisinopril Tablets are useful in the treatment of:
• high blood pressure (hypertension)
• heart failure
• patients who are stable but have had a heart attack within the last 24 hours
Do not take Lisinopril Tablets
• if you are allergic (hypersensitive) to lisinopril, a similar medicine or any of the other ingredients of Lisinopril Tablets ( see section 6 ). Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue.
• if you are more than 3 months pregnant. (It is also better to avoid Lisinopril in early pregnancy -see
and 20 mg Tablets
pregnancy section).
• if you suffer from swellings, particularly of the hands, feet, face, tongue or throat, that have no apparent cause (angioedema) or if you have an inherited disorder which causes such swellings (hereditary angioedema).
• if you have diabetes or impaired kidney function and you are treated with a blood pressure lowering medicine containing aliskiren.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking Lisinopril Tablets:
• if 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 have a narrowing of a valve in the heart (aortic stenosis/outflow obstruction).
• if you have an enlarged heart (hypertrophic cardiomyopathy) or an enlarged right heart ventricle (cor pulmonale),
• if you have had a heart attack,
• if you have low blood pressure,
• if you have kidney problems or narrowing of the artery to the kidney,
• if you are undergoing dialysis treatment,
• if you are on a low salt diet,
• if you have recently had a bout of vomiting or diarrhoea,
• if you have diabetes,
• if you are having an operation or an anaesthetic,
• if you are Afro-Caribbean and taking Lisinopril tablets as the only treatment for your high blood pressure, you may have a reduced response to this medicine. This may mean that you may need a higher dose than usually recommended.
• if you are taking any of the following medicines used to treat high blood pressure:
- 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 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 Tablets”.
Other Medicines and Lisinopril Tablets
Tell your doctor if you are taking, or have recently taken, any other medicine. This includes medicines that you buy without prescription.
In particular, tell your doctor or pharmacist if you are taking any of the following medicines as your doctor may need to change your dose and/or to take other precautions:
• Beta-blocker medicines such as atenolol and propranolol.
• Diuretics (water tablets including those which conserve potassium).
• Other medicines for your high blood pressure or heart problems (antihypertensives).
• Non-steroidal anti-inflammatory medicines (NSAIDs) such as indometacin and high doses of aspirin (more than 3 grams per day), which are used to treat arthritis or muscle pain.
• Medicines for mental disorders such as lithium, antipsychotics or tricyclic antidepressants.
• Potassium tablets or potassium containing salt substitutes.
• Medicines for the treatment of diabetes, such as insulin or those taken orally, to lower blood sugar.
• Medicines to break up blood clots.
• Medicines that stimulate the central nervous system (sympathomimetics). These include ephedrine, pseudoephedrine and salbutamol and may be found in some decongestants, cough/cold remedies and asthma medication.
• Medicines that suppress the body’s immune response (immunosuppressants), treatment with allopurinol (for gout) or procainamide (for abnormal heartbeats).
• Gold (such as sodium aurothiomalate). This may be given to you as an injection and possible side effects of gold include feeling flushed, sick or dizzy and low blood pressure. These reactions are more likely to occur if you are also taking an ACE-inhibitor such as Lisinopril Tablets.
• If you are taking an angiotensin II receptor blocker (ARB) oraliskiren (see also information under the headings “Do not take Lisinopril Tablets” and “Warnings and precautions”).
If you are on desensitisation treatment, e.g. for an allergic reaction to wasp or bee stings, let the doctor treating you know, prior to the start of therapy, that you are taking lisinopril.
Your doctor may monitor your blood pressure and kidney function prior to and during treatment.
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Taking Lisinopril Tablets with food and drink
Lisinopril Tablets can be taken with or without food.
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking any 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 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.
Breastfeeding
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
Your Lisinopril Tablets are unlikely to affect your ability to drive a car or to operate machinery. However, you should not perform tasks that require special attention until you know how your medicine will affect you as occasionally dizziness or tiredness may occur.
3. Howto take Lisinopril Tablets
Always follow your doctor’s instructions as to how and when to take your medicine; your pharmacist may be able to advise you if you are not sure.
Exactly how many tablets, and how often you must take them, will be written on the label. Please read it carefully.
The recommended doses are given below. However, doctors sometimes prescribe different doses to these: if this applies to you, discuss it with your doctor, if you have not already done so.
Swallow the tablets whole with water. Take the dose at approximately the same time each day.
Adults and elderly patients over 65 years:
High blood pressure: If you are already taking water tablets (diuretics) for high blood pressure the (Hypertension) doctor may discontinue them, or reduce the dose 2 to 3 days before starting treatment with lisinopril.
The recommended starting dose is 2.5 mg once daily. This may be adjusted by your doctor until your blood pressure is controlled. The usual effective dose range is 10 mg to 20 mg once daily. The maximum recommended dose is 40 mg once daily.
Heart failure: If you are taking water tablets (diuretics), your doctor may reduce the dose of diuretic before starting treatment with lisinopril.
Treatment will be started under close medical supervision by your doctor or in hospital. The recommended starting dose is 2.5 mg. This may be adjusted by your doctor until effective control is achieved. (This is usually a dose of 5 mg to 20 mg.)
Heart attack: Treatment may be started within 24 hours of having a heart attack as long as your blood pressure is not too low. The usual dose is 5 mg straight away, followed by 5 mg after 24 hours, 10 mg after 48 hours and then 10 mg once every day.
If you have low blood pressure you may start treatment on 2.5 mg each day. If you begin to get low blood pressure while taking the tablet the doctor may reduce your dose to 5 mg or 2.5 mg. However if you have continuous low blood pressure the doctor may stop treating you with Lisinopril Tablets.
Your treatment will usually last for about 6 weeks but if you have symptoms of heart failure, treatment will probably be continued.
Children under 6 years:
Lisinopril Tablets are not recommended.
Children and adolescents ages 6 to 16 years:
High blood pressure: The dose depends on your child’s weight.
For children who weigh between 20kg and 50kg the usual starting dose is between 2.5mg once daily, which can be increased to a maximum of 20mg once daily.
For children who weigh more than 50kg the usual starting dose is between 5mg once daily, which can be increased to a maximum of 40mg once daily.
Lisinopril Tablets are not recommended in children with severe kidney problems.
If you stop taking Lisinopril Tablets
If you wish to stop treatment, discuss this with your doctor first as your original symptoms will return.
If you take more Lisinopril Tablets than you should
If you or someone else has taken more then the prescribed dose, contact your doctor or local hospital accident and emergency department immediately. Signs of an overdose include dizziness and palpitations (racing heart beat).
If you forget to take Lisinopril Tablets
Do not take a double dose to make up for a forgotten tablet dose. If you have forgotten to take your medicine, take the missed dose as soon as you remember. If the next dose is due within 8 hours, take the missed dose now and skip the next dose, then continue as before.
If you stop taking Lisinopril Tablets
Do not discontinue the treatment without consulting your doctor even if you feel better. It is important that you take Lisinopril Tablets for as long as your doctor prescribes it. If you have any further questions on the use of this product, ask your doctor or pharmacist
4. Possible side effects
Like all medicines, Lisinopril Tablets can cause side effects, although not everybody gets them.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
It is vital to stop taking Lisinopril Tablets and seek medical attention immediately if you begin to have the following symptoms:
• Allergic reaction - you may get an itch, shortness of breath or wheeziness and develop swelling of your hands, mouth, throat, face or eyes.
• Severe skin disorder, like sudden unexpected rash or peeling of the skin
• Symptoms of a fever and serious feeling of being unwell.
Common (affects less than 1 in 10 people)
• Headache
• Dizziness or light-headedness especially when standing up quickly
• Diarrhoea
• A dry cough that does not go away
• Vomiting
• Lisinopril may affect the kidneys, causing abnormally low or no urine to be passed.
Uncommon (affects less than 1 in 100 people)
• Mood changes
• Change of colour (pale blue followed by redness) and/or numbness or tingling in the fingers or toes
• Changes in the way things taste
• Feeling sleepy or difficulty in going to sleep, strange dreams
• Rapid heartbeat
• Running nose
• Nausea (feeling sick)