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PATIENT INFORMATION LEAFLET

Lisinopril 2.5mg, 5mg, 10mg and 20mg Tablets

(Lisinopril Dihydrate)

What Lisinopril is and what it is used for

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 have rheumatoid arthritis or other diseases affecting your joints

■    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)

Other medicines and Lisinopril

Tell your doctor or pharmacist if you are taking, have

recently taken or might take any other medicines, including those obtained without a prescription. This include herbal medicines.

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

■    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 urothiomalate, which may be given to you as an injection

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 Lisinopril 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.

Following a heart attack

The usual dose is 5mg on Days 1 & 2, then 10mg taken once daily.

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