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ZESTRIL 5MG TABLETS

Active substance(s): LISINOPRIL

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Package leaflet: Information for the patients
Zestril® 5mg Tablets
(lisinopril)
The name of your medicine is Zestril 5mg Tablets, but will be
referred to as Zestril throughout the remainder of the leaflet.
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.
Your medicine is also available in the following strengths:
2.5mg, 10mg and 20mg.
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, the risk of
angioedema (rapid swelling under the skin in area such as
the throat) is increased:
- sirolimus, everolimus and other medicines belonging to
the class of mTOR inhibitors (used to avoid rejection of
transplanted organs).
• 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:
• Other medicines to help lower your blood pressure.
• An angiotensin II receptor blocker (ARB) or aliskiren, (see also
information under the headings “Do not take Zestril” and
“Warnings and precautions”).
• Water tablets (diuretic medicines).
• 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 supplements, salt substitutes that have potassium in
them or other drugs that may increase serum potassium in your
body (such as heparin, and co-trimoxazole also known as
trimethoprim/sulfamethoxazole).
• 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.
The following medicines may increase the risk of angioedema
(signs of angioedema include swelling of the face, lips, tongue
and/or throat with difficulty in swallowing or breathing):

Medicines to break up blood clots (tissue plasminogen
activator), usually given in hospital

Medicines which are most often used to avoid rejection of
transplanted organs (sirolimus, everolimus and other
medicines belonging to the class of mTOR inhibitors). See
section 2 “Warnings and precautions”.

Racecadotril used to treat diarrhoea.
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.

• 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 many
tablets to take each day. Check with your doctor or pharmacist if
you are unsure.
For high blood pressure
• The recommended starting dose is 10 mg once a day.
• The usual long‑term dose is 20 mg once a day.
For heart failure
• The recommended starting dose is 2.5 mg once a day.
• The long‑term dose is 5 to 35 mg once a day.
After a heart attack
• The 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
• The 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
• Zestril 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
recommended starting dose is 2.5 mg once a day.
• For 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.

Breast-feeding:
Tell your doctor if you are breast-feeding or about to start breastfeeding. Zestril is not recommended for mothers who are breastfeeding, 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.

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.

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.

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.

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.

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).

Taking your medicine
• 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 Zestril before or after food.
• Keep taking Zestril for as long as your doctor tells you to, it is a
long term treatment. It is important to keep taking Zestril every
day.
Taking your first dose
• Take 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.

PP3/1437/V2

• 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.
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.
Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or
search for MHRA Yellow Card in the Google Play or Apple App
Store.
5. How to store Zestril
Keep out of the sight and reach of children.
Do not use after the expiry date (EXP) which is stated on the
blister strip and the carton.
Do not store above 30°C.
Medicines should not be disposed of via waste water or
household waste. Ask your pharmacist how to dispose of
medicines no longer required. This will help to protect the
environment.
6. Contents of the pack and other information
Zestril Tablets are round, pink, uncoated, biconvex tablet with “♥
5” on one side and bisected on the other side.
Each tablet contains 5mg of the active ingredient lisinopril (as
dihydrate).
Also contains: mannitol, calcium hydrogen phosphate dihydrate,
maize starch, pregelatinised starch, magnesium stearate and red
iron oxide (E172).
Zestril Tablets are available in blister packs of 28 or 56 tablets.
Manufactured by: AndersonBrecon Pharmaceuticals Ltd, Wye
Valley Business Park, Brecon Road, Hay-on-Wye Hereford,
Herefordshire
HR3 5PG, UK or AstraZeneca UK Ltd, Silk Road Business Park,
Macclesfield, Cheshire SK10 2NA, UK or Biofabri, S.L. La Relva,
s/n Porrino 36400 Pontevedra, Spain. Procured from within the
EU. Product Licence holder: Quadrant Pharmaceuticals Ltd.
Lynstock House, Lynstock Way, Lostock, Bolton, BL6 4SA.
Repackaged by Maxearn Ltd. Bolton BL6 4SA.
PL 20774/1437

Zestril 5mg Tablets

POM

Zestril is a registered trademark of AstraZeneca UK Ltd.
th

Leaflet prepared: 5 March 2018

Blind or partially sighted?
Is this leaflet hard to see?
Contact Quadrant Pharmaceuticals
Ltd. Tel:01204 473081
PP3/1437/V2

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