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 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. See section 4.

What is in this leaflet

1.    What Lisinopril 1 mg/ml Oral Solution is and what it is used for

2.    What you need to know before you take Lisinopril 1 mg/ml Oral Solution

3.    How to take Lisinopril 1 mg/ml Oral Solution

4.    Possible side effects

5.    How to store Lisinopril 1 mg/ml Oral Solution

6.    Contents of the pack and other information

1. What Lisinopril 1 mg/ml Oral Solution is and what it is used for

Lisinopril 1 mg/ml Oral Solution contains a medicine called lisinopril. This belongs to a group of medicines called 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 1 mg/ml Oral Solution

Do not take Lisinopril 1 mg/ml Oral Solution if:

•    you are allergic (hypersensitive) to lisinopril or any of the other ingredients of Lisinopril 1 mg/ml Oral Solution (listed in Section 6)

•    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)

•    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

•    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 1 mg/ml Oral Solution if any of the above applies to you. If you are not sure, talk to your doctor or pharmacist before taking this medicine.

If you develop a dry cough which is persistent for a long time after starting treatment with Lisinopril 1 mg/ml Oral Solution, talk to your doctor.

Warning and precautions

Talk with your doctor or pharmacist before taking Lisinopril 1 mg/ml Oral Solution:

•    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 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 kidney problems or you are having kidney dialysis

•    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’

•    you must tell your doctor if you think you are (or might become) pregnant. Lisinopril 1 mg/ml Oral Solution 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 of black origin as Lisinopril 1 mg/ml Oral Solution 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 1 mg/ml Oral Solution”

If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Lisinopril 1 mg/ml Oral Solution.

Treatment for allergies such as insect stings

Tell your doctor if you are having or are going to have

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treatment to lower the effects of an allergy such as insect stings (desensitisation treatment). If you take Lisinopril 1 mg/ml Oral Solution 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 the doctor or dentist that you are taking Lisinopril 1 mg/ml Oral Solution. This is because you can get low blood pressure (hypotension) if you are given certain local or general anaesthetics while you are taking Lisinopril 1 mg/ml Oral Solution.

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 1 mg/ml Oral Solution

Tell your doctor or pharmacist if you are taking, or have recently taken, or might take any other medicines. This includes medicines that you buy without a prescription. This is because Lisinopril 1 mg/ml Oral Solution can affect the way some medicines work and some medicines can have an effect on Lisinopril 1 mg/ml Oral Solution.

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 1 mg/ml Oral Solution” and “Warnings and precautions”)

In particular, 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.

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 1 mg/ml Oral Solution before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Lisinopril 1 mg/ml Oral Solution. Lisinopril 1 mg/ml Oral Solution 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 1 mg/ml Oral Solution 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 1 mg/ml Oral Solution

Always take Lisinopril 1 mg/ml Oral Solution exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Once you have started taking Lisinopril 1 mg/ml Oral Solution your doctor may take blood tests. Your doctor may then adjust your dose so you take the right amount of medicine for you. The carton contains a 10 ml measuring device which should be properly cleaned after use.

Taking your medicine

•    Try to take your medicine at the same time each day. It does not matter if you take Lisinopril 1 mg/ml Oral Solution before or after food.

•    Mixing with food or drinks has not been studied, and any mixing with food and drinks is therefore the responsibility of the health care professional or the user.

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