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PACKAGE LEAFLET: INFORMATION FOR THE USER_

LISINOPRIL 2.5MG TABLETS LISINOPRIL 5MG TABLETS LISINOPRIL 10MG TABLETS LISINOPRIL 20MG TABLETS (Lisinopril dihydrate)

Read all of this leaflet carefully before you start taking 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. Do not pass it on to others. It may harm them, even if their symptoms 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. See section 4._

What is in this leaflet:

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

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

3.    How to take Lisinopril Tablets

4.    Possible Side Effects

5.    How to Store Lisinopril Tablets

6.    Contents of the pack and other information_

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

Lisinopril belongs to a group of medicines called Angiotensin Converting Enzyme (ACE) inhibitors.

Lisinopril can be used for the following conditions:

•    To treat high blood pressure (hypertension).

•    To treat heart failure.

•    If you have recently had a heart attack (myocardial infarction).

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

Lisinopril works by making your blood vessels widen. This helps to lower your blood pressure. It also makes it easier for your heart to pump blood to all parts of your body.

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

Do not take Lisinopril Tablets:

•    If you are allergic to lisinopril, or to any of the other ingredients listed in Section 6,

•    If you have ever had an allergic reaction to another ACE inhibitor medicine. The allergic reaction may have caused swelling of the hands, feet, ankles, face, lips, tongue or throat. It may also have made it difficult to swallow or breathe (angioedema).

•    If a member of your family has had severe allergic reactions (angioedema) to an ACE inhibitor or you have had severe allergic reactions (angioedema) without a known cause.

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

•    If you have diabetes or impaired kidney function and you are treated with a blood pressure lowering medicine containing aliskiren

Do not take Lisinopril if any of the above applies to you. If you are not sure, talk to your doctor or pharmacist before taking Lisinopril.

If you develop a dry cough which is persistent for a long time after starting treatment with Lisinopril, talk to your doctor.

Warnings and precautions:

Talk to your doctor or pharmacist before taking this medicine:

•    If you have a narrowing (stenosis) of the aorta (an artery in your heart) or a narrowing of the heart valves (mitral valves).

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

•    If you have a narrowing (stenosis) of the kidney artery.

•    If you have an increase in the thickness of the heart muscle (known as hypertrophic cardiomyopathy).

•    If you have problems with your blood vessels (collagen vascular disease).

•    If you have low blood pressure. You may notice this as feeling dizzy or light headed, especially when standing up.

•    If you have liver problems.

•    If you have diabetes

•    If you have recently had diarrhoea or vomiting (being sick).

•    If your doctor has told you to control the amount of salt in your diet.

•    If you have high levels of cholesterol and you are having a treatment called 'lDl apheresis'.

•    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).

•    If you are taking any of the following medicines used to treat high blood pressure:

-    an angiotensin II receptor blocker (ARBs) (also known as sartans - for example valsartan, telmisartan, irbesartan), in particular if you have diabetes-related kidney problems.

-    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 tablets')

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).

If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Lisinopril.

Treatment for allergies such as insect stings

Tell your doctor if you are having or are going to have treatment to lower the effects of an allergy such as insect stings (desensitisation treatment). If you take Lisinopril tablets while you are having this treatment, it may cause a severe allergic reaction.

Operations

If you are going to have an operation (including dental surgery) tell your doctor or dentist that you are taking Lisinopril tablets. This is because you can get low blood pressure (hypotension) if you are given certain local or general anaesthetics while you are taking lisinopril.

Children and adolescents

Lisinopril has been studied in children. For more information, talk to your doctor. Lisinopril is not recommended in children under 6 years of age or in any child with severe kidney problems.

Other medicines and Lisinopril Tablets

Tell your doctor if you are taking, or have recently taken, or might take any other medicines.

This is because Lisinopril can affect the way some medicines work and some medicines can have an effect on Lisinopril.

Please tell your doctor or pharmacist if you are taking any of the following medicines.

•    Other medicines to help lower your blood pressure.

•    Water tablets (diuretic medicines).

•    Medicines to break up blood clots (usually given in hospital).

•    Beta-blocker medicines, such as atenolol and propranolol.

•    Nitrate medicines (for heart problems).

•    Non-steroidal anti-inflammatory drugs (NSAIDs) used to treat pain and arthritis.

•    Aspirin (Acetylsalicylic acid), if you are taking more than 3 grams each day.

•    Medicines for depression and for mental problems, including lithium.

•    Potassium tablets or salt substitutes that have potassium in them.

•    Insulin or medicines that you take by mouth for diabetes.

•    Medicines used to treat asthma.

•    Medicines to treat nose or sinus congestion or other cold remedies (including those you can buy in the pharmacy).

•    Medicines to suppress the body's immune response (immunosuppressants).

•    Allopurinol (for gout).

•    Procainamide (for heart beat problems).

•    Medicines that contain gold, such as sodium aurothiomalate, which may be given to you as an injection.

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 tablets' and 'Warnings and precautions')

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 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.

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

Some people feel dizzy or tired when taking this medicine. If this happens to you, do not drive or use any tools or machines.

You must wait to see how your medicine affects you before trying these activities.

|    3. How to take Lisinopril Tablets    |

•    Always take these tablets exactly as advised by your doctor. Check with your doctor or pharmacist if you are not sure. Once you have started taking Lisinopril your doctor may take blood tests. Your doctor may then adjust your dose so you take the right amount of medicine for you.

Taking your medicine

•    Swallow the tablet with a drink of water.

•    Try to take your tablets at the same time each day. It does not matter if you take these tablets before or after food.

Keep taking these tablets for as long as your doctor tells you to, it is a long term treatment. It is important to keep taking the tablets every day.

The usual dose is as follows:

Taking your first dose

•    Take special care when you have your first dose of Lisinopril or if your dose is increased. It may cause a greater fall in blood pressure than later doses.

•    This may make you feel dizzy or light-headed. If this happens, it may help to lie down. If you are concerned, please talk to your doctor as soon as possible.

Adults

Your dose depends on your medical condition and whether you are taking any other medicines. Your doctor will tell you how many tablets to take each day. Check with your doctor or pharmacist if you are unsure.    _x

For high blood pressure

•    The recommended starting dose is 10 mg once a day.    |

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Back

•    The usual long-term dose is 20 mg once a day.

For heart failure

•    The recommended starting dose is 2.5 mg once a day.

•    The long-term dose is 5 to 35 mg once a day.

After a heart attack

•    The recommended starting dose is 5 mg within 24 hours of your attack and 5 mg one day later.

•    The usual long-term dose is 10 mg once a day.

For kidney problems caused by diabetes

•    The recommended dose is either 10 mg or 20 mg once a day.

If you are elderly, have kidney problems or are taking diuretic medicines,

your doctor may give you a lower dose than the usual dose.

Children under 6 years of age

•    Lisinopril tablets are not recommended for children under 6 years or in any children with severe kidney problems.

Children and adolescents (6 to 16 years old) with high blood pressure

•    The doctor will work out the correct dose for your child. The dose depends on the child's body weight.

•    For children who weigh between 20 kg and 50 kg, the usual starting dose is 2.5 mg once a day.

•    For children who weigh more than 50 kg, the usual starting dose is 5 mg once a day.

If you take more Lisinopril Tablets than you should

•    If you take more tablets than prescribed by your doctor, talk to a doctor or go to a hospital immediately.

•    The following effects are most likely to happen: Dizziness, palpitations.

If you forget to take Lisinopril Tablets

•    If you forget to take a dose, take it as soon as you remember. However, if it is nearly time for the next dose, skip the missed dose.

•    Do not take a double dose to make up for a forgotten dose.

If you stop taking Lisinopril Tablets

•    Do not stop taking your tablets, even if you are feeling well, unless your doctor tells you to.

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

|    4. Possible side effects    |

Like all medicines Lisinopril tablets can cause side effects, although not everybody

gets them.

If you experience any of the following reactions, STOP TAKING this medicine

and see your doctor immediately

•    Severe allergic reactions (rare, may affect up to 1 in 1,000 people). The signs may include sudden onset of:

• Swelling of your face, lips, tongue or throat. This may make it difficult

to swallow.

•    Severe or sudden swelling of your hands, feet and ankles.

•    Difficulty breathing.

•    Severe itching of the skin (with raised lumps).

•    Severe skin disorders, like a sudden, unexpected rash or burning, red or peeling skin (very rare, may affect up to 1 in 10,000 people ).

•    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 (very rare, may affect up to 1 in 10,000 people).

Other possible side effects:

Common: may affect up to 1 in 10 people

•    Headache.

•    Feeling dizzy or light-headed, especially if you stand up quickly.

•    Diarrhoea.

•    A dry cough that does not go away.

•    Being sick (vomiting).

•    Kidney problems (shown in a blood test).

Uncommon: may affect up to 1 in 100 people

•    Mood changes.

•    Change of colour in your fingers or toes (pale blue followed by redness) or numbness or tingling in your fingers or toes.

•    Changes in the way things taste.

•    Feeling sleepy.

•    Spinning feeling (vertigo).

•    Having difficulty sleeping.

•    Stroke.

•    Fast heart beat

•    Runny nose

•    Feeling sick (nausea).

•    Stomach pain or indigestion.

•    Skin rash or itching.

•    Being unable to get an erection (impotence).

•    Feeling tired or feeling weak (loss of strength).

•    A very big drop in blood pressure may happen in people with the following conditions: Coronary heart disease; narrowing of the aorta (a heart artery), kidney artery or heart valves; an increase in the thickness of the heart muscle. If this happens to you, you may feel dizzy or light-headed, especially if you stand up quickly.

•    Changes in blood tests that show how well your liver and kidneys are working.

•    Heart attack.

•    Seen and/or heard hallucinations.

Rare: may affect up to 1 in 1,000 people

•    Feeling confused.

•    A lumpy rash (hives).

•    Dry mouth.

•    Hair loss.

•    Psoriasis (a skin problem).

•    Changes in the way things smell.

•    Development of breasts in men.

•    Changes to some of the cells or other parts of your blood. Your doctor may take blood samples from time to time to check whether Lisinopril has had any effect on your blood. The signs may include feeling tired, pale skin, a sore throat, high temperature (fever), joint and muscle pains, swelling of the joints or glands, or sensitivity to sunlight.

•    Low levels of sodium in your blood. (The symptoms may be tiredness, headache, nausea, vomiting.)

•    Sudden renal failure.

Very rare: may affect up to 1 in 10,000 people

•    Sinusitis (a feeling of pain and fullness behind your cheeks and eyes).

•    Wheezing.

•    Low levels of sugar in your blood (hypoglycaemia). The signs may include feeling hungry or weak, sweating and a fast heart beat.

•    Inflammation of the lungs. The signs include cough, feeling short of breath and high temperature (fever).

•    Yellowing of the skin or the whites of the eyes (jaundice).

•    Inflammation of the liver. This can cause loss of appetite, yellowing of the skin and eyes, and dark coloured urine.

•    Inflammation of the pancreas. This causes moderate to severe pain in the stomach.

•    Severe skin disorders. The symptoms include redness, blistering and peeling.

•    Sweating

•    Passing less water (urine) than normal or passing no water.

•    Liver failure.

•    Swollen lymph glands

•    Inflamed gut

Not known (frequency cannot be estimated from available data)

•    Symptoms of depression.

•    Fainting.

Side effects in children appear to be comparable to those seen in adults.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.

|    5. How to store Lisinopril Tablets    |

•    Keep out of the sight and reach of children.

•    Do not use these tablets after expiry date (EXP) which is stated on the carton. The expiry date refers to the last day of that month.

•    Blisters: Do not store above 25°C. Store in the original package.

Containers: Do not store above 25°C. Keep the container tightly closed.

•    Do not throw away any medicines via waste-water or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

|    6. Contents of the pack and other information    |

What Lisinopril Tablets contain

•    The active substance is lisinopril dihydrate.

•    Lisinopril Tablets come in four strengths. Each tablet contains the active ingredient lisinopril dihydrate which is equivalent to 2.5mg, 5mg, 10mg or 20mg of Lisinopril respectively.

•    The other ingredients are: mannitol (E421), calcium hydrogen phosphate, maize starch and magnesium stearate. The 5 mg, 10 mg and 20 mg tablets also contain the colouring agent ferric (iron) oxide (E172).

What Lisinopril Tablets look like and contents of the pack

•    The 2.5 mg tablets are round, white or almost white coloured, uncoated tablets with the markings ”2.5" on one side and ”BL" on the reverse.

•    The 5 mg tablets are round, light pink coloured, uncoated tablets with the markings ”5" and a breakline on one side and ”BL" on the reverse.

•    The 10 mg tablets are round, light pink coloured, uncoated tablets with the markings ”10" on one side and ”BL" on the reverse.

•    The 20 mg tablets are round, pink coloured, uncoated tablets with the markings ”20" on one side and ”BL" on the reverse.

•    Lisinopril Tablets are available in packs of 28, 30, 56, 60, 84, 250, 500 or 1000 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer:

Marketing Authorisation Holder:Special Concept Development (UK) Ltd., Units 1-7 Colonial Way, Watford, Hertfordshire, WD24 4YR.

Manufacturer: Bristol Laboratories Ltd., Unit 3, Canalside, Northbridge Road, Berkhamsted, Hertfordshire, HP4 1EG

Lisinopril 2.5mg Tablets; PL 36722/0087 Lisinopril 5mg Tablets; PL 36722/0088

Lisinopril 10mg Tablets; PL 36722/0089    «

Lisinopril 20mg Tablets; PL 36722/0090

This leaflet was last revised in November 2015    8

To request a copy of this leaflet in Braille, large print or audio format, please contact the licence holder at the address (or telephone, fax, email) above.