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LISINOPRIL 1 MG/ML ORAL SOLUTION

Active substance(s): LISINOPRIL DIHYDRATE

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• Keep taking this medicine for as long as your doctor tells
you to, it is a long term treatment. It is important to keep
taking Lisinopril 1 mg/ml Oral Solution every day.

Lisinopril 1 mg/ml Oral Solution
Lisinopril
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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Taking your first dose
• Take special care when you have your first dose of Lisinopril
1 mg/ml Oral Solution 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 much Lisinopril 1 mg/ml Oral Solution to take each day.
Check with your doctor or pharmacist if you are unsure.
For high blood pressure
• The usual starting dose is 10 mg (10 ml) once a day.
• The usual long-term dose is 20 mg (20 ml) once a day.
For heart failure
• The usual starting dose is 2.5 mg (2.5 ml) once a day.
• The long-term dose is 5 to 35 mg (5 ml - 35 ml) once a day.
After a heart attack
• The usual starting dose is 5 mg (5 ml) within 24 hours of
your attack and 5 mg (5 ml) one day later.
• The usual long-term dose is 10 mg (10 ml) once a day.
For kidney problems caused by diabetes
• The usual dose is either 10 mg (10 ml) or 20 mg (20 ml)
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.
Use in children and adolescents
• Lisinopril 1 mg/ml Oral Solution is not recommended for
children under 6 years or in any children with severe kidney
problems.
• 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 (2.5 ml) once a day.
• For children who weigh more than 50 kg, the usual starting
dose is 5mg (5 ml) once a day.
If you take more Lisinopril 1 mg/ml Oral Solution than you
should
If you take more Lisinopril 1 mg/ml Oral Solution than you
should, you might experience dizziness and/or palpitations.
1.)Tell your doctor, pharmacist or nearest hospital casualty
department immediately.
2.)Take the bottle and any remaining solution with you so that
people can see what you have taken.
3.)Do this even if you feel well.
If you forget to take Lisinopril 1 mg/ml Oral Solution
• 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 1 mg/ml Oral Solution
Do not stop taking your medicine, 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, this medicine can cause side effects,
although not everybody gets them.
If you experience any of the following reactions, stop taking
Lisinopril 1 mg/ml Oral Solution and see your doctor
immediately:
• severe allergic reactions (rare, affects 1 to 10 users in
10,000). 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, affects less than 1
user in 10,000)
• 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, affects less than 1 user in
10,000).
Other possible side effects:
Common (affects 1 to 10 users in 100)
• 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 (affects 1 to 10 users in 1,000)
• 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
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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 (affects 1 to 10 users in 10,000)
• 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 (affect less than 1 user in 10,000)
• 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
• lumps
• 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 1 mg/ml Oral
Solution
• Keep out of the sight and reach of children.
• Do not use after the expiry date which is stated on the
bottle label and the carton. The expiry date refers to the
last day of that month.
• This medicinal product does not require any special storage
conditions.
• Do not use after 30 days from the first opening of the bottle.
• Do not throw away any medicine via wastewater 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 1 mg/ml Oral Solution contains
The active substance is lisinopril dihydrate equivalent to 1 mg
lisinopril ~ 1 mg lisinopril per 1 ml oral solution.
The other ingredients are glycerol (E422),
hydroxyethylcellulose, sodium benzoate (E211), citric acid
monohydrate (E330) and purified water.
What Lisinopril 1 mg/ml Oral Solution looks like and
contents of the pack
Lisinopril 1 mg/ml Oral Solution is a clear and colourless
solution with a sweet taste
Lisinopril 1 mg/ml Oral Solution is available in a 150 ml brown
glass bottle with a tamper-evident closure and a 10 ml
measuring device graded at each 0.5 ml.
Marketing Authorisation Holder
Essential Pharmaceuticals Ltd, 7 Egham Business Village,
Crabtree Road, Egham, Surrey TW20 8RB, United Kingdom.
Manufacturer:
Famar Nederland B.V., Industrieweg 1, 5531AD Bladel, The
Netherlands.
This medicinal product is authorised in the Member
States of the EEA under the following names:
Lisinopril EssPharm (Norway)
Lisinopril Essential Pharmaceuticals 1 mg/ml Lösung zum
Einnehmen (Austria)
Lisinopril Essential Pharmaceuticals 1 mg/ml Solution buvable
(Belgium)
Lisinopril 1 mg/ml Oral Solution (Ireland)
Lisinopril Essential Pharmaceuticals 1 mg/ml Solution buvable
(Luxemburg)
Lisinopril EssPharm 1 mg/ml Drank (Netherlands)
Lisinopril 1 mg/ml Oral Solution (United Kingdom)
This leaflet was last revised in 07/2015.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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