Skip to Content

UK Edition. Click here for US version.

ZESTRIL 20MG TABLETS

Active substance(s): LISINOPRIL / LISINOPRIL DIHYDRATE

View full screen / Print PDF » Download PDF ⇩
Transcript
Package leaflet: Information for the patient

P041556

Zestril 5 mg Tablets
Zestril 10 mg Tablets
Zestril 20 mg Tablets
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 Zestril is and what it is used for
2. What you need to know before you take
Zestril
3. How to take Zestril
4. Possible side effects
5. How to store Zestril
6. Contents of the pack and other information
1. What Zestril is and what it is used for
Zestril contains a medicine called lisinopril. This
belongs to a group of medicines called ACE
inhibitors.
Zestril 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.
Zestril 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
Zestril
Do not take Zestril:
• if you are allergic 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 Zestril 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.
If you are not sure if any of these apply to you,
talk to your doctor or pharmacist before taking
Zestril.
If you develop a dry cough which is persistent
for a long time after starting treatment with
Zestril, talk to your doctor.
Warnings and precautions
Talk to your doctor or pharmacist before taking
Zestril:
• 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 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 Zestril”.
• 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. Zestril 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 Zestril 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 these apply to you,
talk to your doctor or pharmacist before taking
Zestril.
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 Zestril 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 Zestril. This is because you can
get low blood pressure (hypotension) if you
are given certain local or general anaesthetics
while you are taking Zestril.

Children and adolescents
Zestril has been studied in children. For more
information, talk to your doctor. Zestril is not
recommended in children under 6 years of age
or in any child with severe kidney problems.
Other medicines and Zestril
Tell your doctor or pharmacist if you are taking,
have recently taken, or might take any other
medicines. This is because Zestril can affect
the way some medicines work and some
medicines can have an effect on Zestril. Your
doctor may need to change your dose and/or to
take other precautions.
In particular, tell your doctor or pharmacist if
you are taking any of the following medicines:
• O
 ther medicines to help lower your blood
pressure.
• A
 n angiotensin II receptor blocker (ARB)
or aliskiren, (see also information under
the headings “Do not take Zestril” and
“Warnings and precautions”).
• W
 ater tablets (diuretic medicines).
• M
 edicines to break up blood clots (usually
given in hospital).
• B
 eta-blocker medicines, such as atenolol
and propranolol.
• N
 itrate medicines (for heart problems).
• N
 on-steroidal anti‑inflammatory drugs
(NSAIDs) used to treat pain and arthritis.
• A
 spirin (Acetylsalicylic acid), if you are
taking more than 3 grams each day.
• M
 edicines for depression and for mental
problems, including lithium.
• P
 otassium supplements, salt substitutes that
have potassium in them or other drugs that
may increase serum potassium in your body.
• Insulin or medicines that you take by mouth
for diabetes.
• M
 edicines used to treat asthma.
• M
 edicines to treat nose or sinus congestion
or other cold remedies (including those you
can buy in the pharmacy).
• M
 edicines to suppress the body’s immune
response (immunosuppressants).
• A
 llopurinol (for gout).
• P
 rocainamide (for heart beat problems).
• M
 edicines 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 Zestril
before you become pregnant or as soon as you
know you are pregnant and will advise you to
take another medicine instead of Zestril. Zestril
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. Zestril 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
• S
 ome people feel dizzy or tired when taking
this medicine. If this happens to you, do not
drive or use any tools or machines.
• Y
 ou must wait to see how your medicine
affects you before trying these activities.
3. How to take Zestril
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 Zestril 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
• S
 wallow the tablet with a drink of water.
 ry to take your tablets at the same time
• T
each day. It does not matter if you take
Zestril before or after food.
 eep taking Zestril for as long as your doctor
• K
tells you to, it is a long term treatment. It is
important to keep taking Zestril every day.
Taking your first dose
• T
 ake special care when you have your first
dose of Zestril or if your dose is increased.
It may cause a greater fall in blood pressure
than later doses.
• T
 his 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.
For high blood pressure
• T
 he recommended starting dose is 10 mg
once a day.
• The usual long‑term dose is 20 mg once a day.
For heart failure
• T
 he recommended starting dose is 2.5 mg
once a day.
• T
 he long‑term dose is 5 to 35 mg once a day.
After a heart attack
• T
 he 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
• T
 he 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.
Use in children and adolescents
(6 to 16 years old) with high blood pressure
• Z
 estril is not recommended for children
under 6 years or in any children with severe
kidney problems.
• T
 he doctor will work out the correct dose for
your child. The dose depends on the child’s
body weight.
• F
 or children who weigh between 20 kg and
50 kg, the recommended starting dose is
2.5 mg once a day.
• F
 or children who weigh more than 50 kg, the
recommended starting dose is 5 mg once a day.

If you take more Zestril than you should
If you take more Zestril 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 Zestril
• 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 Zestril
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, this medicine can cause
side effects, although not everybody gets them.
If you experience any of the following reactions,
stop taking Zestril 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 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
Zestril 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.

Ireland
HPRA Pharmacovigilance
Earlsfort Terrace
IRL - Dublin 2
Tel: +353 1 6764971
Fax: +353 1 6762517
Website: www.hpra.ie
e-mail: medsafety@hpra.ie
Malta
ADR Reporting
Website: www.medicinesauthority.gov.mt/adrportal
5. How to store Zestril
• K
 eep this medicine out of the sight and
reach of children.
• Do not use this medicine after the expiry
date (EXP) which is stated on the blister strip
and the carton. The expiry date refers to the
last day of that month.
• 5 mg, 10 mg and 20 mg tablets: Do not
store above 30°C. 
• 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 Zestril contains
• The active substance is lisinopril (as dihydrate).
• The other ingredients are mannitol, calcium
hydrogen phosphate dihydrate, maize starch,
pregelatinised starch and magnesium stearate.
In addition, the pink and brownish-red tablets
contain red iron oxide (E172).
Zestril is supplied in 3 strengths containing 5 mg,
10 mg or 20 mg of lisinopril (as dihydrate).
What Zestril looks like and contents of
the pack
Zestril 5 mg Tablets: round, pink, uncoated,
biconvex tablet with “♥ 5” on one side and
bisected on the other side. Diameter 6 mm.
The tablet can be divided into equal doses.
Zestril 10 mg Tablets: round, pink, uncoated,
biconvex tablet with “♥ 10” on one side and
plain on the other side. Diameter 8 mm.
Zestril 20 mg Tablets: round, brownish-red,
uncoated, biconvex tablet with “♥ 20” on one
side and plain on the other side. Diameter 8 mm.
Zestril tablets are available in aluminium foil
blister packs of 14, 20, 28, 28x1, 30, 42, 50,
56, 56x1, 60, 84, 98, 100, 400 and 500 tablets.
Blister packs containing multiples of 7 tablets
may also be available with weekday marks.
Zestril tablets are also available in bottle packs
of 20, 30, 50, 100 and 400 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and
Manufacturer
The Marketing Authorisations for Zestril in
United Kingdom, Ireland and Malta are held
by AstraZeneca UK Ltd, 600 Capability Green,
Luton, LU1 3LU, UK.
Zestril is manufactured by AstraZeneca UK Limited,
Silk Road Business Park, Macclesfield,
Cheshire SK10 2NA, UK. (for Austria, Belgium,
Ireland, France, Germany, Greece, Italy,
Luxembourg, Netherlands, Norway, Portugal,
Spain, Sweden and UK)
AndersonBrecon Pharmaceuticals Ltd.,
Wye Valley Business Park, Brecon Road,
Hay-on-Wye, Hereford, Herefordshire,
HR3 5PG, UK.
(Austria, Belgium, Ireland, France, Germany,
Greece, Italy, Luxembourg, Netherlands,
Norway, Portugal, Spain, Sweden and UK)
Corden Pharma, GmbH, Otto-Hahn Strasse,
68723 Plankstadt, Germany.
(for Austria, Germany, Greece, Italy, Norway
and Sweden)
Biofabri, S.L., La Relva, s/n, Porriño,
36400 Pontevedra, Spain.
(for Portugal, Spain and Sweden)
AstraZeneca, Reims, Parc Industriel Pompelle,
Chemin de Vrilly, B.P. 1050, 51689 Reims,
Cedex 2, France.
(Austria, France, Greece, Italy and Sweden)
This medicine is authorised in the Member
States of the EEA under the following names:
ACEMIN (AT), ACERBON (DE), ZESTRIL
(BE, ES, IE, FR, IT, EL, LU, NO, NL, PT, SE, UK).

To listen to or request a
copy of this leaflet in Braille,
large print or audio please
call, free of charge:
0800 198 5000 (UK only)
Please be ready to give the
following information:
Product name
Reference Number
Zestril 5 mg Tablets
PL 17901/ 0061
Zestril 10 mg Tablets
PL 17901/ 0062
Zestril 20 mg Tablets
PL 17901/ 0063
This is a service provided by
the Royal National Institute
of Blind People.
This leaflet was last revised in March 2016
© AstraZeneca 2016
Zestril is a trade mark of the AstraZeneca
group of companies.
CV 15 0138

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
or pharmacist. This includes any possible side
effects not listed in this leaflet. You can also
report side effects directly (see details below).
By reporting side effects you can help provide
more information on the safety of this medicine.
United Kingdom
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard

22 March 2016

08:23

P041556

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.

Hide