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LISINOPRIL 5.0 MG TABLETS

Active substance(s): LISINOPRIL DIHYDRATE

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P0322T

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

LISINOPRIL 2.5mg, 5mg, 10mg and 20mg
TABLETS
Lisinopril
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
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Keep this leaflet.You may need to read it again.

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If you have any further questions, ask your doctor or pharmacist.

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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.

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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

Treatment for allergies such as insect stings

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

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.

2. What you need to know before you take Lisinopril Tablets
3. How to take Lisinopril Tablets
4. Possible side effects

Operations

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
The full name of your medicine is Lisinopril 2.5mg, 5mg, 10mg
and 20mg tablets but within the leaflet it will be referred to as
Lisinopril Tablets.
Lisinopril 2.5mg, 5mg, 10mg and 20mg tablets contains a
medicine called lisinopril. This belongs to a group of medicines
called ACE inhibitors.
Lisinopril Tablets can be used for the following conditions:
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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.

If you are going to have an operation (including dental surgery)
tell the 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 Tablets.
Other medicines and Lisinopril Tablets
Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines.
This includes medicines that you buy without a prescription. This
is because Lisinopril Tablets can affect the way some medicines
work and some medicines can have an effect on Lisinopril
Tablets.
In particular, tell your doctor or pharmacist if you are taking any of
the following medicines:
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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.

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

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Do not take Lisinopril Tablets:
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If you are allergic (hypersensitive) to lisinopril or any of the
other ingredients of this medicine (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 Tablets 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.

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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 drug (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.

You doctor may need to change your dose and/or to take other
precautions:
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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").

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

Pregnancy and breast-feeding

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

Ask your doctor or pharmacist for advice before taking any
medicine.

Warnings and precautions

Pregnancy

Talk to your doctor or pharmacist or nurse before taking
Lisinopril Tablets:

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.

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If you are taking any of the following medicines used to treat
high blood pressure:
Ÿ an angiotensin II receptor blocker (ARBs) (also known as
sartans - for example valsartan, telmisartan, irbesartan), in
particular if you have diabetes-related kidney problems.
Ÿ 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"
Take special care with Lisinopril Tablets
Check with your doctor or pharmacist before taking Lisinopril
Tablets if:
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You have a narrowing (stenosis) of the aorta (an artery in your
heart) or a narrowing of the heart valves (mitral valves).
You have a narrowing (stenosis) of the kidney artery.
You have an increase in the thickness of the heart muscle
(known as hypertrophic cardiomyopathy).
You have problems with your blood vessels (collagen vascular
disease).
You have low blood pressure. You may notice this as feeling
dizzy or light-headed, especially when standing up.
You have kidney problems or you are having kidney dialysis.
You have liver problems.
You have diabetes.
You have recently had diarrhoea or vomiting (being sick).
Your doctor has told you to control the amount of salt in your
diet.
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 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).
You are of black origin as Lisinopril Tablets may be less
effective. You may also more readily get the side effect
“angioedema” (a severe allergic reaction).

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

Breast-feeding
Tell your doctor if you are breast-feeding or about to start breastfeeding. Lisinopril Tablets are 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
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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 this medicine exactly as your doctor has told you.
Check with your doctor or pharmacist if you are not sure.
Once you have started taking Lisinopril Tablets your doctor may
take blood tests. Your doctor may then adjust your dose so you
take the right amount of medicine for you.
Taking this medicine
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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 Lisinopril Tablets before or after food.
Keep taking Lisinopril Tablets for as long as your doctor tells
you to, it is a long term treatment. It is important to keep taking
Lisinopril Tablets every day.

Taking your first dose
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Take special care when you have your first dose of Lisinopril
Tablets 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

Code

AW.CRC.77.01.V02

1

Grasshopper Sistemas de Informação
geral@gsiportugal.com
www.gsiportugal.com

Customer

Date

2016-01-12

Description

LISINOPRIL 2.5mg, 5mg, 10mg and 20mg
TABLETS
(Package leaflet EN)
Size

210x495 mm

Colours

Pantone Reflex Blue C
Keyline

Notes

NO GOOD FOR COLOR PROOF

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.
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For high blood pressure
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Very rare (affect less than 1 user in 10,000)

The usual starting dose is 10mg once a day.
The usual long-term dose is 20mg once a day.

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For heart failure
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The usual starting dose is 2.5mg once a day.
The long-term dose is 5 to 35mg once a day.

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After a heart attack
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The usual starting dose is 5mg within 24 hours of your attack
and 5mg one day later.
The usual long-term dose is 10mg once a day.

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For kidney problems caused by diabetes
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The usual dose is either 10mg or 20mg 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.

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

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Lisinopril Tablets are not recommended for children under 6
years or in any children with severe kidney problems.
Ÿ The doctor will work out the correct dose for your child. The
dose depends on the child's body weight.
Ÿ For children who weigh between 20kg and 50kg, the usual
starting dose is 2.5mg once a day.
Ÿ For children who weigh more than 50kg, the usual starting
dose is 5mg once a day.
If you take more Lisinopril Tablets than you should

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If you take more Lisinopril 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
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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.

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 Tablets and see your doctor IMMEDIATELY.

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Not known (frequency cannot be estimated from available
data)
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If any of the side effects get serious, or if you notice any side
effects not listed in this leaflet, please tell your doctor or
pharmacist.
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 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.

Severe allergic reactions (uncommon, affects 1 to 10 users in
1,000). The signs may include sudden onset of:
Ÿ Swelling of your face, lips, tongue or throat. This may make
it difficult to swallow.
Ÿ Severe or sudden swelling of your hands, feet and ankles.
Ÿ Difficulty breathing.
Ÿ 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).

KEEP THIS MEDICINE OUT OF THE SIGHT AND REACH OF
CHILDREN.
Store in the original package.
DO NOT use this medicine after the expiry date which is stated
on the carton/blister after "EXP". The expiry date refers to the last
day of that month.
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
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Common (affects 1 to 10 users in 100)
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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)
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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.

Rare (affects 1 to 10 users in 10,000)
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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 Tablets have had any effect on your blood.

Code

2

AW.CRC.77.01.V02

Symptoms of depression.
Fainting.
Low levels of sodium in your blood (the symptoms may be
tiredness, headache, nausea, vomiting)

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

Other possible side effects:

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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.

5. How to store Lisinopril Tablets

4. Possible side effects

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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.
Sudden renal failure.

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The active substance is: Lisinopril Dihydrate.
Each tablet contains:
Lisinopril 2.5mg Tablets: 2.72mg Lisinopril Dihydrate
equivalent to 2.5mg Lisinopril
Lisinopril 5mg Tablets: 5.44mg Lisinopril Dihydrate equivalent
to 5mg Lisinopril
Lisinopril 10mg Tablets: 10.89mg Lisinopril Dihydrate
equivalent to 10mg Lisinopril
Lisinopril 20mg Tablets: 21.78mg Lisinopril Dihydrate
equivalent to 20mg Lisinopril
The other ingredients are calcium hydrogen phosphate
dihydrate, mannitol, maize starch, croscarmellose sodium and
magnesium stearate. Lisinopril 5mg, 10mg and 20mg Tablets
also contain red iron oxide.

What Lisinopril Tablets look like and contents of the pack
Lisinopril 2.5mg: white, round, convex tablets
Lisinopril 5mg: slightly red, round, convex tablets with score notch
on one side
Lisinopril 10mg: slightly red, round, convex tablets with score
notch on one side
Lisinopril 20mg: slightly red, round, convex tablets with score
notch on one side
Lisinopril 5mg, 10mg and 20mg tablets can be broken into equal
halves.
Lisinopril Tablets are available in:
Lisinopril Tablets are available in packs of:
Lisinopril 2.5mg Tablets: 14, 28, 30, 50, 100
Lisinopril 5mg Tablets: 10, 14, 28, 30, 30x1, 50, 56, 60, 98, 100
Lisinopril 10mg Tablets: 10, 14, 28, 30, 50, 98, 100
Lisinopril 20mg Tablets: 10, 14, 28, 30, 50, 56, 98, 100, 100x1
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Crescent Pharma Limited
Units 3-4 Quidhampton Business Units,
Polhampton Lane, Overton
Basingstoke, Hampshire, RG25 3ED
United Kingdom
Manufacturer
Tillomed Laboratories Ltd
3 Howard Road, Eaton Socon, St.Neots,
Cambridgeshire PE19 8ET
United Kingdom
Product Licence Number
Lisinopril 2.5mg Tablets: PL 20416/0351
Lisinopril 5mg Tablets: PL 20416/0352
Lisinopril 10mg Tablets: PL 20416/0353
Lisinopril 20mg Tablets: PL 20416/0354
This leaflet was last revised in November 2015.

Grasshopper Sistemas de Informação
geral@gsiportugal.com
www.gsiportugal.com

Customer

Date

2016-01-12

Description

LISINOPRIL 2.5mg, 5mg, 10mg and 20mg
TABLETS
(Package leaflet EN)
Size

210x495 mm

Colours

Pantone Reflex Blue C
Keyline

Notes

NO GOOD FOR COLOR PROOF

Expand view ⇕

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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