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Package leaflet: Information for the patient Lisinopril 2.5mg, 5mg, 10mg, and 20mg Tablets lisinopril

Read all of this leaflet carefully before you start using 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 or pharmacist. This includes any possible side effects not listed in this leaflet.

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

Lisinopril belongs to a group of medicines called angiotensin converting enzyme inhibitors (sometimes called ACE inhibitors). These work by widening blood vessels, which helps reduce your blood pressure and makes it easier for your heart to pump blood to all parts of your body.

Your doctor has prescribed this medicine for you for one of the following reasons:

•    Your blood pressure is too high (hypertension)

•    You have a heart condition known as symptomatic heart failure, where the heart does not pump your blood around your body as well as it should.

•    You have had a heart attack (myocardial infarction) that may lead to a weakening of your heart.

•    You have kidney problems related to your diabetes and high blood pressure.

2.    What you need to know before you take Lisinopril Tablets.

Do not take Lisinopril Tablets:

•    If you are allergic (hypersensitive) to lisinopril

•    If you are allergic to any of the other ingredients in this medicine (see section 6, Further Information)

•    If you are allergic to other ACE inhibitors

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

•    If you or someone in your family has had symptoms such as swelling of the face, tongue or throat, intense itching, skin rashes, difficulty in swallowing and/or breathing associated with previous

ACE inhibitor treatment or have had these symptoms in any other circumstances (this is a condition called ‘angioedema’)

If you are unsure, talk to your doctor.

Warnings and precautions

Talk to your doctor or pharmacist before taking Lisinopril Tablets if any of the following apply to you:

•    If you have any kidney disease including narrowing of the artery to the kidney (renal artery stenosis). Your doctor may need to monitor you and change the dose of your medicine

•    If you have a narrowing of the main blood vessel leading from the heart (aortic or mitral valve stenosis) or cardiac muscle disease (hypertrophic cardiomyopathy)

•    If you are dehydrated due to treatment with water tablets, are on a salt restricted diet, are undergoing dialysis or have been suffering from vomiting or diarrhoea

•    If you are taking potassium supplements or potassium containing salt substitutes

•    If you suffer from diabetes

•    If you need blood separation treatment (apheresis)

•    If you are taking lithium a medicine used for the treatment of mania or depression

•    If you have a dry cough which is persistent for a long time

•    If you have low blood pressure (you may notice this as dizziness or light headedness especially when standing)

•    If you are on haemodialysis using high flux polyacrylonitrile (AN69) membranes. Tell your doctor this so that a different technique can be chosen to prevent allergic reactions

•    If you need an operation or an anaesthetic; tell your doctor or dentist that you are taking lisinopril

•    If you are undergoing or will undergo desensitisation treatment for an allergy e.g to bee stings

•    If you have collagen vascular disease such as scleroderma or systemic lupus erythematous and/or you are receiving immunosuppressant therapy, or you are taking the medicines allopurinol or procainamide tell your doctor immediately if you develop any sort of infection while taking lisinopril.

You must tell your doctor if you think you are (or might become) pregnant. Lisinopril Tablets are 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).

It is important that you tell your doctor everything about your condition and of any problems that you may have had in the past. Tell him if you have ever reacted badly to Lisinopril Tablets.

Your doctor may check your kidney function before you start to take Lisinopril Tablets and may need to repeat this test whilst you are taking Lisinopril Tablets.

Other medicines and Lisinopril Tablets

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. The following as they may interact with your medicine:

•    Diuretics (‘water tablets’) including potassium sparing diuretics such as amiloride, spironolactone or triamterene

•    Medicines used for the treatment of schizophrenia or depression

•    Lithium (for mania or depression)

•    Allopurinol (a treatment for gout) and/or procainamide (used to correct irregular heartbeats)

•    Other medicines for the treatment of high blood pressure (antihypertensives)

•    Immunosuppressants used for the treatment of auto-immune disease (eg rheumatoid arthritis ) or following transplant surgery

•    Vasodilators including nitrates (medicines that make the blood vessels wider)

•    Medicines or supplements containing potassium (eg. potassium supplements or potassium-containing salt substitutes)

•    Medicines used to treat pain and inflammation known as non-steroidal anti-inflammatory drugs-NSAID’S (eg. ibuprofen, indometacin)

•    Sodium aurothiomalate (injectable gold)

•    Acetylsalicylic acid

•    Medicines used for the treatment of diabetes including insulin and oral anti-diabetic medicines

•    Heparin (used to thin the blood and stop it clotting so easily)

•    Medicines for coughs/colds, asthma medication and decongestants (ephedrine, pseudoephedrine and salbutamol)

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

Pregnancy, breast-feeding and fertility 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 Tablets before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Lisinopril Tablets. Lisinopril Tablets are 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

Lisinopril Tablets can sometimes cause side effects which include feeling sleepy or dizzy. If this happens do not drive or operate machinery.

It is important that you read all of this leaflet carefully before you start taking this medicine to see how it may affect you and your ability to drive or operate machinery. If you are unsure about anything you should discuss it with your doctor or pharmacist.

3. How to take Lisinopril Tablets.

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Take your tablets with a glass of water at the same time each day. Your tablets can be taken with or without food.

The number of tablets that you will need will depend on what you are being treated for. If you have problems with your kidneys your doctor may tell you to take a lower dose than usual.

Always follow your doctor’s advice carefully.

Hypertension (high blood pressure)

Adults:

The usual starting dose is 10mg taken once a day. Your doctor will increase this depending on how you get on, up to a usual maintenance dose of 20mg once a day. This dose may be further increased if needed, at 2 to 4 weekly intervals, to a maximum dose of 80mg once a day.

If you are already on diuretic medicine (‘water tablets’) your doctor may tell you to reduce the dose of the diuretic or even stop taking it before you start to take Lisinopril Tablets.

Children & Adolescents (aged 6-16 years):

The usual starting dose is 2.5mg once daily in patients weighing 20 to 50kg, and 5mg once daily in patients weighing 50kg or more. This may be increased up to a maximum of 20mg daily in patients weighing 20 to 50kg and 40mg in patients weighing 50kg or more.

If your child has any kidney problems, the doctor may choose a lower starting dose.

Symptomatic Heart Failure:

Lisinopril will be used in addition to diuretics and where necessary digitalis or beta-blockers for the treatment of heart failure.

The usual starting dose is 2.5mg once a day, taken under close medical supervision. This dose may then be increased at increments of no more than 10mg and intervals of at least 2 weeks to a maximum dose of 35mg once a day if necessary.

Following a heart attack (Acute myocardial infarction):

The usual dose is 5mg taken within 24 hours of the heart attack, followed by 5mg taken 24 hours later, followed by 10mg after a further 24 hours.

A usual daily dose of 10mg once a day is then taken for 6 weeks, after which time your doctor will reassess you.

Patients with diabetes and associated kidney problems:

The usual starting dose is 2.5mg taken once a day. This may be increased to a maximum dose of 20mg once a day, if necessary.

Use in children and adolescents

Lisinopril is only recommended in children and adolscents for the treatment of hypertension.

Lisinopril is not recommended in children below the age of 6, or in children with severe kidney problems.

If you take more Lisinopril Tablets than you should

An overdose can cause very low blood pressure, which can lead to light headedness and dizziness. Symptoms may also include shortness of breath, a rapid or slow pulse, palpitations anxiety or coughing. If you take more Lisinopril Tablets than you should or if someone else accidently takes them, you should contact your doctor immediately or go to the nearest hospital casualty department. Remember to take the pack and any remaining tablets with you.

If you forget to take Lisinopril Tablets

Take the missed dose as soon as you remember. If it is almost time for your next dose, do not take the missed dose but simply take your next dose at the normal time. Do not take a double dose to make up for the one you missed.

If you stop taking Lisinopril Tablets

It is important that you continue to take your tablets until your doctor tells you to stop. If you stop taking this medicine, your condition may deteriorate and your blood pressure may increase.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects.

Like all medicines, this medicine can cause side effects, although not everyone gets them.

Stop taking Lisinopril Tablets and contact your doctor immediately if you notice a rash, blistering or other effects on the skin, eyes, mouth or genitals, itching or high temperature, you get a swollen face, tongue and/or throat, severe reddening of the skin (hives) and/or have difficulty in swallowing and/or breathing (angioedema)

Tell your doctor immediately if:

•    You feel ill after your first dose (a few people react to their first dose and feel very dizzy, weak, faint and are sick)

•    You get a lot of infections. Lisinopril Tablets may cause a reduction in the number of white blood cells and your resistance to infection may be decreased. If you experience an infection with symptoms such as fever and serious deterioration of your general condition, or fever with local infection symptoms such as sore throat/pharynx/mouth or urinary problems you should see your doctor immediately. A blood test will be taken to check possible reduction of white blood cells (agranulocytosis). It is important to inform your doctor about your medicine.

•    You have loss of appetite, unexplained tiredness, yellowing of your skin or whites of eyes (jaundice), nausea, stomach pain, dark urine, inflammation of the liver (hepatitis)

If you feel dizzy or light-headed, especially when you stand up quickly, it may help to lie down. Talk to your doctor if the dizziness persists or if you are concerned.

The following side effects have also been reported:

Common (affects 1 to 10 users in 100):

•	dizziness/light-	• fainting when standing up	•	diarrhoea
	headedness	• cough	•	being sick (vomiting)
•	headache		•	kidney problems
Uncommon (affects 1 to 10 users in		1,000):
•	mood changes	• change in taste	•	itching
•	numb or tingling	• Raynaud’s phenomenon	•	impotence
	hands/feet	(white or bluish and cold	•	tiredness
•	vertigo, (dizziness,	or numb fingers and toes)	•	feeling of weakness
	spinning feeling)	• feeling sick	•	increases in potassium,
•	heart problems such as	• indigestion and stomach		creatinine or urea in the
	chest pain, irregular or fast	pain		blood

heartbeat    • rash

• sleeping problems    •

•    runny or stuffy nose

Very rare (affects less than 1 user in 10,000):

Some patients have reported (frequency not known)

•    Symptoms of depression

•    Fainting

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

5. How to store Lisinopril Tablets.

Keep out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and blister strip after EXP. Do not store above 25°C.

Do not throw away any medicines 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.

6. Contents of the pack and other information.

What Lisinopril Tablets contain

-    The active substance is Lisinopril.Each tablet contains 2.5mg, 5mg, 10mg or 20mg of lisinopril (as dihydrate).

-    The other ingredients are mannitol, calcium hydrogen phosphate dihydrate, maize starch, pregelatinised starch, silica colloidal anhydrous and magnesium stearate

What Lisinopril Tablets look like and contents of the pack Lisinopril 2.5mg Tables are white, round and biconvex marked ‘X side.

Lisinopril 5mg Tables are white, round and biconvex marked ‘L | side.

Lisinopril 10mg Tables are white, round and biconvex marked ‘L | side.

Lisinopril 20mg Tables are white, round and biconvex marked ‘L | side.

Lisinopril 2.5mg Tablets are available in blister packs of 14, 28, 30, 50, 98, 100 and 500 (bundle pack of 10 x 50) tablets.

Lisinopril 5mg, 10mg and 20mg Tablets are available in blister packs of 28, 30, 50, 98, 100 and 500 (bundle pack of 10 x 50) tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder:

Arrow Generics Limited Whiddon Valley,

Barnstaple, Devon, EX32 8NS United Kingdom

Manufacturer:

Arrow Pharm (Malta) Limited

HF 62, Hal Far Industrial Estate, Birzebbugia, BBG06, Malta

Heumann Pharma GmbH Nurnberger Strabe, D-90537, Germany

Arrow Generics Limited

Unit 2, Eastman Way, Stevenage, SG1 4SZ, United Kingdom

Qualiti (Burnley) Limited

Talbot Street, Briercliffe, Burnley, BB10 2JY, United Kingdom Arrow Generics Limited

Units 4/5 Willsborough Cluster, Clonshaugh Industrial Estate, Clonshaugh, Dublin 17, Republic Ireland

This medicinal product is authorised in the Member States of the EEA under the following names:

Germany    Lisidoc X mg Tabletten

Denmark Norway Sweden United Kingdom

Lisinopril Arrow X mg Lisinopril Arrow X mg Lisinopril Arrow X mg Lisinopril X mg Tablets

This leaflet was last revised in 06/2012    [To be completed nationally]