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PATIENT INFORMATION LEAFLET

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

M| What this medicine is and what it is used for

Lisinopril is one of a group of medicines known as 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.

[2 Before you take

Do not take Lisinopril:

■    If you are allergic (hypersensitive) to Lisinopril, other ACE Inhibitors or any of the other ingredients in the tablets (these are listed in Section 6, Further information)

■    If you are more than 3 months pregnant. (It is also better to avoid Lisinopril in early pregnancy - see pregnancy section)

Take special care with Lisinopril - Tell your doctor if any of the following apply to you:

■    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 suffering from collagen vascular disease such as systemic lupus (SLE) or scleroderma

■    If you suffer from kidney problems or you are on dialysis

■    If you are receiving treatment to reduce the effects of an allergy to a bee or wasp sting

■    If you suffer from liver complaints

■    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)

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).

Taking other medicines

Please inform your doctor or pharmacist if you are taking, or have recently taken, any other medicines, including medicines obtained without a prescription.

Medicines which may interact with Lisinopril

■    Medicines used to increase frequency of urination e.g. Spironolactone, Triamerene, Amiloride (Diuretics including potassiumsparing 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 antiinflammatory 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 Aurothiomalate, which may be given to you as an injection

Pregnancy and breast-feeding

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 breastfeeding, 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 machinery

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

Always take Lisinopril as your doctor has told you. You should 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

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.

Children

Lisinopril Tablets are not recommended for children.

Elderly, over 65 years

No special adjustment is necessary. In case of reduced kidney function, the dose should be adjusted carefully.

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. 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.

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 tablet.

If you stop taking/using 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 product, ask your doctor or pharmacist.

4 Possible side effects

Like all medicines, Lisinopril 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:

-    swelling of the face, hands, feet, lips, tongue, throat

-    difficulty in breathing

-    itching

■    Blistering of the skin, mouth, eyes and genitals

Common side effects (affects 1-10 users in 100)

■    Dizziness

■    Headache

■    Low blood pressure (hypotension)

■    Cough

■    Diarrhoea

■    Vomiting

■    Kidney problems

Uncommon side effects (affects 1-10 users in 1000)

■    Mood changes

■    Tingling or numbness in the hand or feet (paraesthesia)

■    Taste disturbance

■    Possible heart attack

■    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 (affects 1-10 users in 10,000)

■ Mental confusion    ■ Dry mouth

■ Psoriasis    ■ Kidney failure

■    Hair loss (alopecia)

■    Breast enlargement in men (gynaecomastia)

■    Decrease in haemoglobin which can cause anaemia

■    Decrease in the number of blood cells

■    Changes to sense of smell

Very rare side effects (affects less than 1 user

in 10,000)

■    Looking pale and feeling tired (anaemia)

■    Bruising

■    Low blood sugar levels

■    Difficulty in breathing, inflammation of nasal sinuses, certain forms of pneumonia

■    Inflammation of the pancreas

■    Excessive sweating (diaphoresis)

■    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

Other side effects (frequency not known)

■    Symptoms of depression

■    Fainting

■    Low blood levels of sodium which can cause tiredness and confusion, muscle twitching, fits and coma

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.

5| How to store

Keep out of the reach and sight of children.

Store in the original package.

Do not use Lisinopril after the expiry date which is stated on the carton/blister after "EXP". The expiry date refers to the last day of that month.

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.

6| Further information

What Lisinopril contains:

The active ingredient is Lisinopril Dihydrate. Each tablet contains:

Lisinopril 2.5mg Tablets: 2.72mg Lisinopril Dihydrate equivalent to 2.5mg Lisinopril Lisinopril 5mg Tablets: 5.44mg Lisinopril Dihydrate equivalent to 5mg Lisinopril Lisinopril 10mg Tablets: 10.89mg Lisinopril Dihydrate equivalent to 10mg Lisinopril Lisinopril 20mg Tablets: 21.78mg 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 red iron oxide.

What Lisinopril looks like and contents of the pack:

Lisinopril 2.5mg: white, round, convex tablets Lisinopril 5mg: slightly red, round, convex tablets with score notch on one side Lisinopril 10mg: slightly red, round, convex tablets with score notch on one side Lisinopril 20mg: slightly red, round, convex tablets with score notch on one side

Lisinopril 5mg, 10mg and 20mg tablets can be broken into equal halves.

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

Yiling Limited

Units 3-4 Quidhampton Business Units, Polhampton Lane, Overton Basingstoke, Hampshire, RG25 3ED, UK

Manufacturer:

Tillomed Laboratories Ltd,

3 Howard Road, Eaton Socon, St. Neots, Cambridgeshire. PE19 8ET,

United Kingdom.

Product Licence Numbers:

Lisinopril 2.5mg Tablets: PL 39667/0022 Lisinopril 5mg Tablets: PL 39667/0023 Lisinopril 10mg Tablets: PL 39667/0024 Lisinopril 20mg Tablets: PL 39667/0025

Leaflet was last revised in November 2013

Product Name	Lisinopril
Strength / Form	2.5mg, 5mg, 10mg & 20mg Tabs
Type	PIL
Dimensions	150 x 365 mm
Typefaces	Font SansSerif - Min. Text 8pt
Rev #
Last updated	16/11/2013
No. of Colours	Pantone Black CVC