Lisinopril 10mg Tablets
Package leaflet: Information for the patient
Lisinopril belongs to a group of medicines called ACE (Angiotensin-Converting Enzyme) Inhibitors. These work by expanding your blood vessels making it easier for your heart to pump blood to your body.
Adults
Lisinopril is used in the treatment or prevention of high blood pressure (hypertension), heart failure, kidney disease resulting from high blood pressure & diabetes and patients recovering from a heart attack (myocardial infarction).
Children
Lisinopril is only recommended for the treatment of high blood pressure (hypertension) in children aged 6 years or above.
Lisinopril should not be used in children under the age of 6 years or in children aged 6 - 16 years who have severe kidney problems.
^ What you need to know before you take Lisinopril
Do not take Lisinopril:
■ If you are allergic (hypersensitive) to Lisinopril, other ACE Inhibitors or any of the other ingredients of this medicine (see Section 6 "Contents of the pack and other information”)
■ If you are more than 3 months pregnant. (It is also better to avoid Lisinopril in early pregnancy - see pregnancy section)
■ If you have a history of suffering from swelling of the deeper layers of the skin caused by a build-up of fluid relating to previous treatment with an ACE Inhibitor (angioneurotic oedema)
■ If you suffer from an inherited swelling of the deeper layers of the skin caused by a build-up of fluid or without an identifiable cause (hereditary or idiopathic angiodema)
■ If you have diabetes or impaired kidney function and you are treated with a blood pressure lowering medicine containing aliskiren (see "Other medicines and Lisinopril” section)
Warnings and precautions
Talk to your doctor before taking Lisinopril:
■ If you are suffering from dehydration as a result of diuretic treatment, dialysis, low salt diet, vomiting or diarrhoea
■ If you suffer from heart problems
■ 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 suffering from collagen vascular disease such as systemic lupus erythematosus (SLE) or scleroderma
■ If you suffer from kidney problems or you are on dialysis
■ If you have low blood pressure. You may notice this as feeling dizzy or light-headed, especially when standing
up
■ If you are receiving treatment to reduce the effects of an allergy to a bee or wasp sting
■ If you are having a non-surgical treatment that removes Low-Density Lipoprotein (LDL) cholesterol from the blood by a procedure called LDL apheresis with dextran sulphate
■ If you are diabetic, as the dose of your oral anti-diabetic medicine or insulin may need to be adjusted
■ If you are taking potassium-containing supplements or salt substitutes or medicines associated with increases in potassium in the blood e.g. heparin (see "Other medicines and Lisinopril” section)
■ If you suffer from liver problems
■ If you are currently suffering from a cough
■ If you are undergoing an operation with a general anaesthetic
■ If you experience symptoms of an infection
■ If you are breast-feeding
■ If you have been told that you have a problem with the valves of your heart or that your heart muscle is thicker than usual (cardiomyopathy)
■ If you are pregnant, think you may be pregnant or are planning to have a baby (see "Pregnancy and breast-feeding” section)
■ If you are of black origin as Lisinopril may be less effective. You may also more readily get the side effect 'angioedema' (a severe allergic reaction)
Other medicines and Lisinopril
Tell your doctor or pharmacist if you are taking, have
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”)
Medicines which may interact with Lisinopril
■ Medicines used to increase frequency of urination e.g. Spironolactone, Triamerene, Amiloride (Diuretics including potassium-sparing Diuretics)
■ Medicines used to treat high blood pressure e.g. Atenolol (Antihypertensives)
■ Medicines used to treat arthritis or muscle pain e.g. Indometacin (Non-steroidal anti-inflammatory drugs -NSAIDs).
■ Aspirin at doses of over 3g per day
■ Medicines used to treat mood disorders e.g. Lithium
■ Medicines used to treat depression e.g. Amitriptyline (Tricyclic Antidepressant)
■ Antipsychotics e.g. Risperidone
■ Nitrate medicines used to treat heart problems
■ Potassium-containing supplements or Salt Substitutes
■ Medicines used to treat gout e.g. Allopurinol
■ Medicines used to treat irregular heartbeats e.g. Procainamide
■ Medicines used to treat the immune system
■ Blood sugar lowering medicines including Insulin
■ Stimulants e.g. Ephedrine, Pseudoephedrine which could be included in cold remedies and Salbutamol used to treat asthma
■ Medicines that contain gold e.g. Sodium Aurothiomalate, which may be given to you as an injection
■ Medicines used to break up blood clots (usually given in hospital)
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 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 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.
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 new born, or was born prematurely.
In the case of an older baby your doctor should advise you on the benefits and risks of taking Lisinopril whilst breast-feeding, compared with other treatments.
Driving or using machines
Lisinopril can cause dizziness and tiredness. If this is experienced it is necessary to avoid driving or operating machinery or pursuing any activity in which full attention is required.
How to take Lisinopril
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
■ Lisinopril Tablets should be taken orally in a single daily dose at approximately the same time each day
■ Lisinopril 5mg, 10mg and 20mg tablets can be divided into equal halves.
Adults
The recommended starting dose is 10mg. For severe conditions, a starting dose of 2.5-5mg is recommended under medical supervision. A lower starting dose is required for patients suffering from kidney problems. The usual effective maintenance dose is 20mg as a single daily dose. This can be increased up to a maximum of 80mg daily.
Diuretic-treated patients
If possible the diuretic should be discontinued 2 to 3 days before taking Lisinopril. Patients with high blood pressure who cannot discontinue the diuretic, should begin Lisinopril at 5mg.
Heart conditions
The usual starting dose is 2.5mg. This dose may be increased if required at intervals of not less than 2 weeks and by no more than 10mg at a time, up to a maximum of a 35mg dose daily.
continued....
Following a heart attack
The usual dose is 5mg on Days 1 & 2, then 10mg taken once daily.
Diabetic Patients with kidney problems
The usual dose is 10mg which may be increased to 20mg. Do not change your dose unless your doctor tells you to do so.
Patients following recent kidney transplant
The use of Lisinopril is not recommended.
Elderly, over 65 years
No special adjustment is necessary. In case of reduced kidney function, the dose should be adjusted carefully.
Use in children under 6 years
The use of Lisinopril is not recommended.
Use in 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. Your doctor will decide the correct dose for you.
If you take more Lisinopril than you should
If you accidentally take too many tablets, contact your doctor or nearest hospital emergency department immediately for advice. Remember to take this leaflet or any remaining tablets with you. Symptoms of overdose include: low blood pressure, circulatory shock, kidney failure, faster/deeper breathing than normal, faster/slower heartbeat, feeling your heartbeat (palpitations), dizziness, anxiety, cough.
If you forget to take Lisinopril
Take it as soon as you remember, unless it is nearly time for your next dose. If you miss a dose do not take a double dose to make up for a forgotten dose.
If you stop taking Lisinopril
It is important that you keep on taking Lisinopril until the prescribed dose has finished. Do not stop taking the tablets even though you may feel better. Do not stop or change your treatment before talking to your doctor.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4 Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking Lisinopril and seek medical advice immediately if you develop the following symptoms:
■ Allergic reactions such as:
o Swelling of the face, throat or tongue, fever, difficulty in breathing, dizziness o swelling of the face, hands, feet, lips, tongue, throat (angioneurotic oedema)
o Swelling of the intestines which may cause stomach pain, with or without being sick (intestinal angioedema)
o Severe blistering of the skin (toxic epidermal necrolysis), mouth, eyes and genitals (Stevens Johnson Syndrome)
Common side effects (may affect up to 1 in 10 people)
■ Dizziness
■ Headache
■ Low blood pressure when changing position (orthostatic hypotension)
■ Cough
■ Diarrhoea
■ Vomiting
■ Kidney problems
Uncommon side effects (may affect up to 1 in 100 people)
■ Mood changes
■ Tingling or numbness in the hand or feet (paraesthesia)
■ A sensation of whirling and loss of balance, feeling dizzy or giddy (vertigo)
■ Taste disturbance
■ Sleep disorders
■ Seeing or hearing things that are not real (hallucinations)
■ Possible heart attack
■ Stroke (cerebrovascular accident)
■ Faster heartbeat (tachycardia)
■ Feeling your heartbeat (palpitations)
■ Tingling or numbness in the fingers, toes, ears or nose (Raynauds Phenomenon)
■ Cold-like symptoms; sneezing, itchiness, blocked/runny nose
■ Feeling sick (nausea)
■ Abdominal pain
■ Indigestion
■ Skin rashes (exanthema)
■ Itching (pruritus)
■ Inability to maintain an erection (impotence)
■ Tiredness (fatigue)
■ General weakness
■ Increase in blood urea, creatinine or liver enzyme values and potassium
Rare side effects (may affect up to 1 in 1,000 people)
■ Mental confusion
■ Dry mouth
■ Skin problem (psoriasis)
■ Hair loss (alopecia)
■ Excess urea in the blood (uraemia)
■ Kidney failure
■ 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)
■ Breast enlargement in men (gynaecomastia)
■ Low blood levels of sodium (hyponatraemia) which can cause tiredness and confusion, muscle twitching, fits and coma
■ Increased level of bilirubin in the blood
■ Decrease in haemoglobin which can cause anaemia
■ Decrease in the number of blood cells
■ Changes to sense of smell
■ Skin rashes with the formation of wheals (urticaria)
Very rare side effects (may affect up to 1 in 10,000 people)
■ Abnormal condition of the bone marrow in which it is unable to produce normal amounts of red blood cells, white blood cells, and platelets leaving the immune system in a weakened state and vulnerable to infection (bone marrow depression) which may cause pale skin and feeling tired (anaemia) and/or increase the risk of bleeding or bruising (thrombocytopenia) and/or make infections more likely (leucopenia, neutropenia, agranulocytosis)
■ Reduction in red blood cells which can make the skin pale yellow and cause weakness or breathlessness (haemolytic anaemia)
■ Swollen/enlarged lymph nodes (lymphadenopathy)
■ Autoimmune disease
■ Low blood sugar levels
■ Difficulty in breathing, inflammation of nasal sinuses, certain forms of pneumonia
■ Inflammation of the pancreas
■ Sweating
■ Liver failure or other liver disorders such as jaundice (yellowing of skin and eyes)
■ Severe skin disorders including Stevens-Johnson Syndrome
■ Passing urine less frequently
■ Inflammation of the skin
Not known: frequency cannot be estimated from the available data
■ Symptoms of depression
■ Fainting
■ 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.
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 internet at www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.
How to store Lisinopril
■ Keep this medicine out of the sight and reach of children.
■ Store in the original package.
■ Do not use this medicine after the expiry date which is stated on the carton/blister after "EXP". The expiry date refers to the last day of that month.
■ Do not throw away any medicine via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.
Contents of the pack and other information
What Lisinopril contains:
Each 2.5mg Tablet contains: 2.72mg of Lisinopril Dihydrate equivalent to 2.5mg Lisinopril
Each 5mg Tablet contains: 5.44mg of Lisinopril Dihydrate equivalent to 5mg Lisinopril
Each 10mg Tablet contains: 10.89mg of Lisinopril Dihydrate equivalent to 10mg Lisinopril
Each 20mg Tablet contains: 21.78mg of Lisinopril Dihydrate equivalent to 20mg Lisinopril
Other ingredients are calcium hydrogen phosphate dihydrate, mannitol, maize starch, croscarmellose sodium and magnesium stearate.
Lisinopril 5mg, 10mg and 20mg Tablets also contain ferric oxide red.
What Lisinopril looks like and contents of the pack:
Lisinopril 2.5mg: white, round, convex tablets with a diameter of 5.3-5.7mm and height of 2.2-2.6mm Lisinopril 5mg: slightly red with a degree of mottling, round, convex tablets of diameter 5.3-5.7mm and height of 2.1-2.6mm with score notch on one side Lisinopril 10mg: slightly red with a degree of mottling, round, convex tablets of diameter 6.9-7.2mm and height of 2.5-2.9mm with score notch on one side Lisinopril 20mg: slightly red with a degree of mottling, round, convex tablets of diameter 8.9-9.2mm and height of 3.4-3.8mm with score notch on one side
Lisinopril is available in:
Lisinopril Tablets are available in packs of :
Lisinopril 2.5mg Tablets: 14, 28, 30, 50, 100 Lisinopril 5mg Tablets: 10, 14, 28, 30, 30x1,50, 56, 60, 98, 100
Lisinopril 10mg Tablets: 10, 14, 28, 30, 50, 98, 100 Lisinopril 20mg Tablets: 10, 14, 28, 30, 50, 56, 98, 100, 100x1
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer:
Tillomed Laboratories Ltd,
3 Howard Road,
Eaton Socon, St. Neots,
Cambridgeshire. PE19 8ET,
United Kingdom.
Product Licence Numbers:
Lisinopril 2.5mg Tablets: PL 11311/0394 Lisinopril 5mg Tablets: PL 11311/0395 Lisinopril 10mg Tablets: PL 11311/0396 Lisinopril 20mg Tablets: PL 11311/0397
Date of revision: May 2016
Hard to Read? Phone 0800 970 6115 for help
Till-Ver.10.1s