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Lisinopril 2.5mg, 5.0mg, lOmg and 20mg Tablets

Lisinopril dihydrate

PACKAGE LEAFLET: INFORMATION FORTHE USER

Read all of this leaflet carefully before you start

taking these tablets

•    Keep this leaflet. You may need to read it again.

• Ifyou have any further questions, askyour doctor or pharmacist.

•    Your doctor has prescribed these tablets for you. Do not pass them on to others. They may harm them even if their symptoms are the same as yours.

•    If any of the side effects get serious, or if you notice any side effects not listed in the leaflet, please tell your doctor or pharmacist.

In this leaflet:

1.    What Lisinopril Tablets are and what they are used for

2.    Before you take Lisinopril Tablets

3.    Howtotake Lisinopril Tablets

4.    Possible side effects

5.    Howto store Lisinopril Tablets

6.    Further information

I. What Lisinopril Tablets are and what they are used for

The active ingredient Lisinopril belongs to a group of medicines called ACE inhibitors (Angiotensin Converting Enzyme inhibitors). These allow blood vessels to dilate, widening the blood vessels which helps reduce blood pressure and makes it easier for the heart to pump blood through the body in patients with heart failure or following a heart attack.

Your doctor has prescribed Lisinopril Tablets for one of the following reasons:

•    High blood pressure (hypertension) where they can be used on their own or with other blood pressure lowering medicines.

•    Heart failure where they are used with other treatments.

•    Within 24 hours of a heart attack as part of a longterm treatment.

•    To treat kidney problems caused by Type II diabetes in people with high blood pressure.

2. Before you take Lisinopril Tablets

Do not take Lisinopril Tablets:

•    If you have taken ACE inhibitors before and suffered an allergic reaction (such as angioneurotic oedema/ angioedema); symptoms of a reaction may include sudden appearance of nettle-like rash and swellings particularly of the lips, face or neck.

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

•    If you are allergic to lisinopril or any of the other ingredients in these tablets.

•    If you suffer from swellings particularly of the hands, feet, face, tongue or throat that have no apparent cause (angioedema) or a member of your family has had a similar reaction (hereditary angioedema).

Take special care with Lisinopril Tablets:

Tell your doctor before you start taking these tablets:

•    If you are undergoing a type of dialysis for removing fats from your blood.

•    If you have an aortic stenosis (abnormal narrowing of the heart valve).

• If you have peripheral vascular disease or outflow tract obstruction (problems with your veins and arteries).

•    If you have an enlarged heart (hypertrophic cardiomyopathy) or an enlarged right heart ventricle (cor pulmonale).

•    Ifyou have had a heart attack.

•    Ifyou have low blood pressure

•    If you have kidney problems or are undergoing dialysis treatment.

• Ifyou are on a low salt diet

•    If you have recently had a bout of vomiting or diarrhoea.

•    Before treatments involving an anaesthetic.

• 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:

It is important to let your doctor know if you are taking or have recently taken any other medicines including herbal remedies or supplements.

Please tell your doctor if you are taking any of the following medicines:

•    Beta-B/ockers (e.g propranolol, atenolol, bisoprolol) or other medicines for treating high blood pressure.

•    Diuretics (water tablets) including potassium supplements and salt substitutes.

•    NSA/Ds (non steroidal anti-inflammatory drugs) when taken at a dose of 3g and above per day, such as aspirin, ibuprofen orindomethacin.

•    Lithium (antidepressants).

•    Immunosuppressants - medicines that suppress the body's immune response e.g for an allergic reaction to wasp or bee stings.

•    Antidiabetic drugs e.g insulin, metformin and sulphonylureas.

•    fndometac/n used in treatment for rheumatoid disease.

•    Inform your doctorthatyou are taking lisinopril if you are undergoing a desensitisation treatment for a wasp or bee sting.

Your doctor may monitor your blood pressure and kidney function prior to and during the treatment with lisinopril.

Pregnancy and Breastfeeding:

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 or as soon as you knowyou 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 afterthe 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.

3. Howtotake Lisinopril Tablets

Always take Lisinopril Tablets exactly as your doctor has told you. Exactly how many tablets and how often you must take them, will be written on the label. Please read it carefully. You should check with your doctor or pharmacist ifyou are not sure.

The recommended doses are given below. 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 (Hypertension):

The recommended starting dose is 2.5mg once daily. This may be adjusted by your doctor until your blood pressure is controlled. The usual effective dose range is lOmg to 20mg once daily. The maximum recommended dose is 40 mg once daily.

If you are already taking water tablets (diuretics) for high blood pressure the doctor may discontinue the water tablets, or reduce the dose several days before starting treatment with lisinopril.

Heartfailure:

The recommended starting dose is 2.5mg. This may be adjusted by your doctor until effective control is achieved. The usual effective dose range is 5mg to

20mg. Treatment should be started under close medical supervision.

If you are taking water tablets (diuretics), your doctor may reduce the dose before starting treatment with lisinopril.

Heart attack:

Treatment may be started within 24 hours of having a heart attack and dose is dependent on blood pressure.

The usual dose is 5mg straight away, followed by 5mg after 24 hours, lOmg after 48 hours and then lOmg once every day.

If you have low blood pressure you may start treatment on 2.5mg each day.

Ifyou begin to get low blood pressure while taking the tablet the doctor may reduce your dose to 5mg or 2.5mg. 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.

If you wish to stop treatment discuss this with your doctor first asyouroriginal symptoms will return.

Paediatric Patients aged 6-16 years:

Hypertension: The recommended initial dose is 2.5mg once daily. This may be adjusted by the doctor.The maximum recommened dose is 40mg daily.

Children:

Lisinopril Tablets are not recommended for children aged above 6 years in other indicatons than hypertension.

Lisinopril is not recommended in children belowthe age of 6, or in children with severe renal impairment

If you take more Lisinopril Tablets than you should:

If you have taken one extra dose this is unlikely to cause problems. If you or someone else has taken more than one extra dose or a large overdose of Lisinopril Tablets, contact your doctor or local hospital accident and emergency department immediately.

Ifyou forget to take Lisinopril Tablets:

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. Do not double the next dose to make up for the missed one. If you are concerned about this you should consultyour doctor or pharmacist.

Ifyou stop taking Lisinopril Tablets:

Do not stop taking Lisinopril Tablets without first discussing it with your doctor.

If you have any further questions on the use of Lisinopril Tablets askyour doctor or pharmacist.

4. Possible Side Effects

Like all medicines, Lisinopril Tablets can cause side

effects, although not everyone gets them.

If you experience any of the following symptoms

contactyour doctor or hospital immediately:-

•    Sudden signs of an allergic reaction such as rash, itching, swelling on the face, hands or lips or problems breathing.

•    Sudden severe pain in the upper abdomen and back caused by inflammation of the pancreas (pancreatitis).

•    Serious skin reactions such as red itchy target type marks on the skin and other more serious skin complaints with reddening, blistering or peeling of the skin.

Common: (>1/100, <1/10)

•    Headache, dizziness and tiredness.

•    Cough which normally resolves after stopping treatment.

• Feeling sick and diarrhoea.

•    A feeling of weakness/loss of strength.

•    Low blood pressure (hypotension)

•    Allergy-like reactions such as rash and wheezing.

Uncommon: (>1/1000 to <1/100)

•    Irregular heartbeats and increased heart rate. There have been rare incidences of heart attacks or strokes in patients who have very low blood pressure and blood vessel disorders.

•    Abdominal pain, indigestion and dry mouth.

•    Impotence (inability to sustain an erection).

•    Mood changes, vertigo, mental confusion, sleep disturbances and taste disturbances.

Rare: (>1/10000, <1/1000)

•    Blood disorders may develop with a tendency to bruise easily, prolonged bleeding after injury, bleed from the gums or elsewhere, pale appearance and feel tired. Contact your doctor.

•    Fever, mouth and throat ulcers. Contact your doctor or local hospital accident and emergency department as soon as possible.

•    One or more of the following symptoms occurring together: fever, patchy swelling of small blood vessels (symptoms: rash, bleeding into the skin, arthritis and kidney failure); muscle pain; joint pain or inflammation; changes to your blood; rash; sensitivity to sunlight; or other skin conditions.

•    Yellowing of the skin and the whites of the eyes (jaundice) and sickness caused by inflammation of the liver (hepatitis).

•    Low or no urine to pass, or blood in the urine caused by kidney problems.

•    Sinusitis (inflammation of the internal areas of the nose).

•    Wheezing, runny noseorsinusitis.

•    Hair loss, excessive sweating, a scaly rash (psoriasis) and an itchy or raised rash may occur.

•    loss of sense of smell

•    Depression

Frequency not known: Syncope (fainting).

Ifyou develop any of these serious conditions, contact your doctor as soon as possible.

If you experience any adverse effects and they become severe or upsetting, or you have any other unpleasant effects which you think could be due to taking Lisinopril Tablets, contact your doctor or pharmacist for advice.

5. Howto store Lisinopril Tablets

Keep out of the reach and sight of children.

Do not use Lisinopril Tablets after the expiry date which is stated on the carton.

Do not keep the tablets above 25°C.

6. Further information

What Lisinopril Tablets contain

Each tablet contains 2.5mg, 5mg, lOmg, or 20mg of lisinopril as the active ingredient lisinopril dihydrate. The other ingredients are mannitol, calcium hydrogen phosphate dihydrate, pregelatinised maize starch, croscarmellose sodium and magnesium stearate. The lOmg and 20mg tablets also contain red, black and yellow oxide colourings (EI72).

What Lisinopril Tablets look like and contents of the pack

Lisinopril 2.5mg and 5.0mg Tablets are white circular biconvex tablets. The Lisinopril lOmg and 20mg Tablets are light pink circular biconvex tablets.

The tablets are supplied in packs of 28 or 50 tablets.

Marketing Authorisation Holder and Manufacturer

Relonchem Limited, Cheshire House, Gorsey Lane Widnes, Cheshire,WA80RF? UK

Date leaflet last revised: October 2012 iPOMl

PL 20395/0019-0022