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LISINOPRIL 20MG TABLETS

Active substance(s): LISINOPRIL / LISINOPRIL DIHYDRATE

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Lisinopril 2.5mg, 5.0mg, 10mg and 20mg Tablets
Lisinopril dihydrate

PACKAGE LEAFLET: INFORMATION FOR THE USER
Read all of this leaflet carefully before you start
taking these tablets
! Keep this leaflet. You may need to read it again.
! If you have any further questions, ask your doctor
or pharmacist.
! Your doctor has prescribed these tablets for you.
Do not pass them on to others. They may harm
them even if their symptoms are the same as
yours.
! If any of the side effects get serious, or if you
notice any side effects not listed in the leaflet,
please tell your doctor or pharmacist.
In this leaflet:
1. What Lisinopril Tablets are and what they are
used for
2. Before you take Lisinopril Tablets
3. How to take Lisinopril Tablets
4. Possible side effects
5. How to store Lisinopril Tablets
6. Further information
1. What Lisinopril Tablets are and what they
are used for
The active ingredient Lisinopril belongs to a group of
medicines called ACE inhibitors (Angiotensin
Converting Enzyme inhibitors). These allow blood
vessels to dilate, widening the blood vessels which
helps reduce blood pressure and makes it easier for
the heart to pump blood through the body in patients
with heart failure or following a heart attack.
Your doctor has prescribed Lisinopril Tablets for one
of the following reasons:
!
!
!
!

High blood pressure (hypertension) where they
can be used on their own or with other blood
pressure lowering medicines.
Heart failure where they are used with other
treatments.
Within 24 hours of a heart attack as part of a longterm treatment.
To treat kidney problems caused by Type II
diabetes in people with high blood pressure.

2. Before you take Lisinopril Tablets
Do not take Lisinopril Tablets:
! If you have taken ACE inhibitors before and
suffered an allergic reaction (such as
angioneurotic oedema/ angioedema); symptoms
of a reaction may include sudden appearance of
nettle-like rash and swellings particularly of the
lips, face or neck.
! If you are more than 3 months pregnant. (It is also
better to avoid Lisinopril in early pregnancy - see
pregnancy section).
! If you are allergic to lisinopril or any of the other
ingredients in these tablets.
! If you suffer from swellings particularly of the
hands, feet, face, tongue or throat that have no
apparent cause (angioedema) or a member of
your family has had a similar reaction (hereditary
angioedema).
Take special care with Lisinopril Tablets:
Tell your doctor before you start taking these tablets:
! If you are undergoing a type of dialysis for
removing fats from your blood.
! If you have an aortic stenosis (abnormal
narrowing of the heart valve).
! If you have peripheral vascular disease or outflow
tract obstruction (problems with your veins and
arteries).
! If you have an enlarged heart (hypertrophic
cardiomyopathy) or an enlarged right heart
ventricle (cor pulmonale).
! If you have had a heart attack.
! If you have low blood pressure
! If you have kidney problems or are undergoing
dialysis treatment.
! If you are on a low salt diet

!
!
!

If you have recently had a bout of vomiting or
diarrhoea.
Before treatments involving an anaesthetic.
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).

Taking other medicines:
It is important to let your doctor know if you are
taking or have recently taken any other medicines
including herbal remedies or supplements.
Please tell your doctor if you are taking any of the
following medicines:
! Beta-Blockers (e.g propranolol, atenolol,
bisoprolol) or other medicines for treating high
blood pressure.
! Diuretics (water tablets) including potassium
supplements and salt substitutes.
! NSAIDs (non steroidal anti-inflammatory drugs)
when taken at a dose of 3g and above per day,
such as aspirin, ibuprofen or indomethacin.
! Lithium (antidepressants).
! Immunosuppressants - medicines that suppress
the body's immune response e.g for an allergic
reaction to wasp or bee stings.
! Antidiabetic drugs e.g insulin, metformin and
sulphonylureas.
! Indometacin used in treatment for rheumatoid
disease.
! Inform your doctor that you are taking lisinopril if
you are undergoing a desensitisation treatment
for a wasp or bee sting.
Your doctor may monitor your blood pressure and
kidney function prior to and during the treatment
with lisinopril.
Pregnancy and Breastfeeding:
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 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.
3. How to take Lisinopril Tablets
Always take Lisinopril Tablets exactly as your doctor
has told you. Exactly how many tablets and how often
you must take them, will be written on the label.
Please read it carefully. You should check with your
doctor or pharmacist if you are not sure.
The recommended doses are given below. Swallow
the tablets whole with water. Take the dose at
approximately the same time each day.
Adults and elderly patients over 65 years:
High blood pressure (Hypertension):
The recommended starting dose is 2.5mg once daily.
This may be adjusted by your doctor until your blood
pressure is controlled. The usual effective dose range
is 10mg to 20mg once daily. The maximum
recommended dose is 40 mg once daily.
If you are already taking water tablets (diuretics) for
high blood pressure the doctor may discontinue the
water tablets, or reduce the dose several days before
starting treatment with lisinopril.

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Heart failure:
The recommended starting dose is 2.5mg. This may
be adjusted by your doctor until effective control is
achieved. The usual effective dose range is 5mg to
20mg. Treatment should be started under close
medical supervision.
If you are taking water tablets (diuretics), your doctor
may reduce the dose before starting treatment with
lisinopril.
Heart attack:
Treatment may be started within 24 hours of having a
heart attack and dose is dependent on blood
pressure.
The usual dose is 5mg straight away, followed by 5mg
after 24 hours, 10mg after 48 hours and then 10mg
once every day.
If you have low blood pressure you may start
treatment on 2.5mg each day.
If you begin to get low blood pressure while taking the
tablet the doctor may reduce your dose to 5mg or
2.5mg. However, if you have continuous low blood
pressure the doctor may stop treating you with
Lisinopril Tablets.
Your treatment will usually last for about 6 weeks but
if you have symptoms of heart failure, treatment will
probably be continued.
If you wish to stop treatment discuss this with your
doctor first as your original symptoms will return.
Paediatric Patients aged 6-16 years:
Hypertension: The recommended initial dose is
2.5mg once daily. This may be adjusted by the
doctor.The maximum recommened dose is 40mg
daily.
Children:
Lisinopril Tablets are not recommended for children
aged above 6 years in other indicatons than
hypertension.
Lisinopril is not recommended in children below the
age of 6, or in children with severe renal impairment
If you take more Lisinopril Tablets than you
should:
If you have taken one extra dose this is unlikely to
cause problems. If you or someone else has taken
more than one extra dose or a large overdose of
Lisinopril Tablets, contact your doctor or local
hospital accident and emergency department
immediately.
If you forget to take Lisinopril Tablets:
If you have forgotten to take your medicine, take the
missed dose as soon as you remember. If the next
dose is due within 8 hours, take the missed dose now
and skip the next dose, then continue as before. Do
not double the next dose to make up for the missed
one. If you are concerned about this you should
consult your doctor or pharmacist.
If you stop taking Lisinopril Tablets:
Do not stop taking Lisinopril Tablets without first
discussing it with your doctor.
If you have any further questions on the use of
Lisinopril Tablets ask your doctor or pharmacist.
4. Possible Side Effects
Like all medicines, Lisinopril Tablets can cause side
effects, although not everyone gets them.
If you experience any of the following symptoms
contact your doctor or hospital immediately:! Sudden signs of an allergic reaction such as rash,
itching, swelling on the face, hands or lips or
problems breathing.
! Sudden severe pain in the upper abdomen and
back caused by inflammation of the pancreas
(pancreatitis).
! Serious skin reactions such as red itchy target
type marks on the skin and other more serious
skin complaints with reddening, blistering or
peeling of the skin.

Common: (≥1/100, <1/10)
! Headache, dizziness and tiredness.
! Cough which normally resolves after stopping
treatment.
! Feeling sick and diarrhoea.
! A feeling of weakness/loss of strength.
! Low blood pressure (hypotension)
! Allergy-like reactions such as rash and wheezing.
Uncommon : (≥1/1000 to <1/100)
! Irregular heartbeats and increased heart rate.
There have been rare incidences of heart attacks
or strokes in patients who have very low blood
pressure and blood vessel disorders.
! Abdominal pain, indigestion and dry mouth.
! Impotence (inability to sustain an erection).
! Mood changes, vertigo, mental confusion, sleep
disturbances and taste disturbances.
Rare: (≥1/10000, <1/1000)
! Blood disorders may develop with a tendency to
bruise easily, prolonged bleeding after injury,
bleed from the gums or elsewhere, pale
appearance and feel tired. Contact your doctor.
! Fever, mouth and throat ulcers. Contact your
doctor or local hospital accident and emergency
department as soon as possible.
! One or more of the following symptoms
occurring together: fever, patchy swelling of small
blood vessels (symptoms: rash, bleeding into the
skin, arthritis and kidney failure); muscle pain;
joint pain or inflammation; changes to your blood;
rash; sensitivity to sunlight; or other skin
conditions.
! Yellowing of the skin and the whites of the eyes
(jaundice) and sickness caused by inflammation of
the liver (hepatitis).
! Low or no urine to pass, or blood in the urine
caused by kidney problems.
! Sinusitis (inflammation of the internal areas of the
nose).
! Wheezing, runny nose or sinusitis.
! Hair loss, excessive sweating, a scaly rash
(psoriasis) and an itchy or raised rash may occur.
! loss of sense of smell
! Depression
Frequency not known: Syncope (fainting).
If you develop any of these serious conditions, contact
your doctor as soon as possible.
If you experience any adverse effects and they
become severe or upsetting, or you have any other
unpleasant effects which you think could be due to
taking Lisinopril Tablets, contact your doctor or
pharmacist for advice.
5. How to store Lisinopril Tablets
Keep out of the reach and sight of children.
Do not use Lisinopril Tablets after the expiry date
which is stated on the carton.
Do not keep the tablets above 25°C.
6. Further information
What Lisinopril Tablets contain
Each tablet contains 2.5mg, 5mg, 10mg, or 20mg of
lisinopril as the active ingredient lisinopril dihydrate.
The other ingredients are mannitol, calcium
hydrogen phosphate dihydrate, pregelatinised maize
starch, croscarmellose sodium and magnesium
stearate. The 10mg and 20mg tablets also contain
red, black and yellow oxide colourings (E172).
What Lisinopril Tablets look like and contents of
the pack
Lisinopril 2.5mg and 5.0mg Tablets are white circular
biconvex tablets. The Lisinopril 10mg and 20mg
Tablets are light pink circular biconvex tablets.
The tablets are supplied in packs of 28 or 50 tablets.
Marketing Authorisation Holder and
Manufacturer
Relonchem Limited, Cheshire House, Gorsey Lane
Widnes, Cheshire, WA8 0RP, UK
Date leaflet last revised: September 2011
POM
PL 20395/0019 - 0022

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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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