ZESTORETIC 10

Active substance: LISINOPRIL DIHYDRATE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

P035909

Zestoretic 10 mg/12.5 mg and 20 mg/12.5 mg Tablets
lisinopril, hydrochlorothiazide

Read all of this leaflet carefully before
you start taking this medicine.
•  eep this leaflet. You may need to read it
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again.
• f you have any further questions, ask your
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doctor or pharmacist.
•  his medicine has been prescribed for
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you. Do not pass it on to others. It may
harm them, even if their symptoms are the
same as yours.
• f any of the side effects get serious, or
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if you notice any side effects not listed
in this leaflet, please tell your doctor or
pharmacist.
In this leaflet:
1.  hat Zestoretic is and what it is used for
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2.  efore you take Zestoretic
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3.  ow to take Zestoretic
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4.  ossible side effects
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5.  ow to store Zestoretic
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6.  urther information
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1. What Zestoretic is and what it is
used for
Zestoretic is used to treat high blood
pressure (hypertension). It contains
two medicines called lisinopril and
hydrochlorothiazide.
•  isinopril belongs to a group of medicines
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called ACE inhibitors. It works by making
your blood vessels widen.
•  ydrochlorothiazide belongs to a group of
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medicines called diuretics (water tablets).
It helps your body to get rid of water and
salts like sodium in your urine.
These medicines work together to lower your
blood pressure.
2. Before you take Zestoretic
Do not take Zestoretic if:
•  ou are allergic (hypersensitive) to lisinopril
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or hydrochlorothiazide or any of the
other ingredients of Zestoretic (listed in
Section 6: Further information).
•  ou are allergic to ACE inhibitor or
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sulphonamide medicines. If you are not
sure if this applies to you, please ask your
doctor.
•  ou have ever had sudden swelling of the
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hands, feet, ankles, face, lips, tongue or
throat, especially if this followed treatment
with an ACE inhibitor. It may also have
been difficult to swallow or breathe.
•  ou have hereditary angioedema
Y
(a condition that makes you more prone to
the swelling described above). If you are
not sure if this applies to you, please ask
your doctor.
•  ou have severe kidney problems.
Y
•  ou have stopped passing water (urine).
Y
•  ou have severe liver problems.
Y
•  ou are more than 3 months pregnant.
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(It is also better to avoid Zestoretic in
early pregnancy - see the sections on
‘Pregnancy and breast-feeding’).
Do not take Zestoretic if any of the above
applies to you. If you are not sure, talk to
your doctor or pharmacist before taking
Zestoretic.
Take special care with Zestoretic
Check with your doctor or pharmacist before
taking Zestoretic if:
•  ou have a narrowing (stenosis) of the
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aorta (an artery in your heart) or the
kidney artery.
•  ou have an increase in the thickness of
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the heart muscle (known as hypertrophic
cardiomyopathy).
•  ou have problems with your blood
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vessels (collagen vascular disease).
•  ou have low blood pressure. You may
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notice this as feeling dizzy or light-headed,
especially when standing up.
•  ou have kidney problems or you are
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having kidney dialysis or you have had a
kidney transplant.
•  ou have liver problems.
Y
•  ou have diabetes.
Y
•  ou have recently had diarrhoea or
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vomiting (being sick).
•  our doctor has told you to control the
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amount of salt in your diet.
•  ou have high levels of cholesterol and
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you are having a treatment called ‘LDL
apheresis’.
•  ou have ever had a condition called
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systemic lupus erythematosus (SLE).
•  ou are of black origin as Zestoretic may
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be less effective. You may also more
readily get the side effect ‘angioedema’
(a severe allergic reaction with swelling of
the hands, feet, ankles, face, lips, tongue
or throat).
You must tell your doctor if you think you
are (or might become) pregnant. Zestoretic
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 the sections on ‘Pregnancy and
breast-feeding’).
If you are not sure if any of the above applies
to you, talk to your doctor or pharmacist
before taking Zestoretic.
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 Zestoretic 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 Zestoretic. This
is because you can get low blood pressure
(hypotension) if you are given certain local
or general anaesthetics while you are taking
Zestoretic.
Taking other medicines
Tell your doctor if you are taking, or have
recently taken, any other medicines. This
includes medicines that you buy without a
prescription and herbal medicines. This is
because Zestoretic can affect the way some
medicines work and some medicines can
have an effect on Zestoretic.
In particular, tell your doctor or pharmacist if
you are taking any of the following medicines:
•  ther medicines to help lower your blood
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pressure.
•  ater tablets (diuretic medicines).
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•  on-steroidal anti‑inflammatory drugs
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(NSAIDs) such as indomethacin, used to
treat pain and arthritis.
•  edicines for depression (tricyclic and
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tetracyclic antidepressants).
•  edicines for mental problems, including
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lithium.
•  spirin (acetylsalicylic acid), if you are
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taking more than 3 grams each day.
•  edicines that can increase the amount of
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potassium in the blood such as potassium
tablets, potassium sparing diuretics or salt
substitutes that have potassium in them.
•  alcium salts.
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• nsulin or medicines that you take by
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mouth for diabetes.
•  edicines to treat asthma.
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•  edicines to treat nose or sinus
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congestion or other cold remedies
(including those you can buy in the
pharmacy).
•  edicines to suppress the body’s immune
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response (immunosuppressants, such as
ciclosporin).
•  llopurinol (for gout).
A
•  edicines for uneven heart beat problems
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(such as procainamide).
•  ardiac glycosides (to treat heart failure).
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•  edicines that contain gold, such as
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sodium aurothiomalate, which may be
given to you as an injection.
•  mphotericin B injection (to treat fungal
A
infections).
•  arbenoxolone (to treat ulcers or
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inflammation in the gullet or in and around
the mouth).
•  orticosteroids (steroid medicines).
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•  orticotropin (a hormone).
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•  edicines to treat constipation (stimulant
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laxatives).
•  olestyramine and colestipol (to lower
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cholesterol, prevent diarrhoea or reduce
itching).
•  uscle relaxants such as tubocurarine.
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•  rimethoprim (an antibiotic).
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•  otalol (a beta-blocker).
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•  ovastatin (to lower cholesterol).
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•  extran sulphate (used in the treatment
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called ‘LDL apheresis’ to lower
cholesterol).
•  hemotherapy for cancer (cytostatics).
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•  ther medicines known to have an effect
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on the heart called Torsades de pointes.
Pregnancy
•  ou must tell your doctor if you think you
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are (or might become) pregnant. Your
doctor will normally advise you to stop
taking Zestoretic before you become
pregnant or as soon as you know you
are pregnant and will advise you to take
another medicine instead of Zestoretic.
Zestoretic 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
•  ell your doctor if you are breast-feeding
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or about to start breast-feeding. Zestoretic
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
•  his medicine may have an effect on your
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ability to drive or use machines, especially
at the start of treatment or when the dose
is adjusted, or in combination with alcohol.
If this happens to you, do not drive or use
any tools or machines.
•  ou must wait to see how your medicine
Y
affects you before trying these activities.
3. How to take Zestoretic
Always take Zestoretic 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 Zestoretic 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
•  wallow the tablet with a drink of water.
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•  ry to take your tablets at the same time
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each day. It does not matter if you take
Zestoretic before or after food.
•  eep taking Zestoretic for as long as
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your doctor tells you to, it is a long term
treatment. It is important to keep taking
Zestoretic every day.
Taking your first dose
•  ake special care when you have your
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first dose of Zestoretic or if your dose is
increased. It may cause a greater fall in
blood pressure than later doses.
•  his may make you feel dizzy or
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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
•  he usual dose is one tablet once a day.
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Your doctor will prescribe the tablet that is
the right strength for you.
• f necessary, your doctor may increase
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your dose to two tablets once a day.
Children
•  estoretic is not recommended for use in
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children.
If you take more Zestoretic than you
should
If you take more Zestoretic than prescribed
by your doctor, talk to a doctor or go to a
hospital immediately. Take the medicine pack
with you so that the tablets can be identified.
If you forget to take Zestoretic
• f you forget to take a dose, take it as
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soon as you remember. However, if it is
nearly time for the next dose, skip the
missed dose.
•  o not take a double dose to make up for
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a forgotten dose.
If you stop taking Zestoretic
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, Zestoretic can cause side
effects, although not everybody gets them.
Zestoretic contains two medicines: lisinopril
and hydrochlorothiazide. The following side
effects have been seen with these individual
medicines. This means they could also
happen with Zestoretic.
Your doctor may take blood samples from
time to time to check whether Zestoretic has
had any effect on your blood.
Possible side effects with lisinopril
Severe allergic reactions (rare, affect less
than 1 in 1000 people)
If you have a severe allergic reaction,
stop taking Zestoretic and see a doctor
immediately. The signs may include sudden
onset of:
•  welling of your face, lips, tongue or
S
throat. This may make it difficult to
swallow.
•  evere or sudden swelling of your hands,
S
feet or ankles.
•  ifficulty breathing.
D
•  evere itching of the skin (with raised
S
lumps).





















Severe liver problems (very rare, affect less
than 1 in 10,000 people)
The signs may include:
•  ellowing of your skin or eyes, dark
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coloured urine or a loss of appetite.
If this happens to you, see a doctor
immediately.
Other possible side effects:
Common (affect less than 1 in 10 people)
•  eadache.
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•  eeling dizzy or light‑headed, especially
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if you stand up quickly.
•  ainting.
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•  iarrhoea.
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•  eing sick (vomiting).
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•  ough.
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•  idney problems (shown in a blood test).
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Uncommon (affect less than 1 in
100 people)
•  ood changes including feeling
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depressed.
•  ingling feeling such as ‘pins and needles’.
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•  pinning feeling (vertigo).
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•  hanges in the way things taste.
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•  ifficulty in sleeping.
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•  eart attack or stroke.
H
•  nusual heart beat.
U
•  hange of colour in your fingers or toes.
C
•  unny nose.
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•  eeling sick (nausea).
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•  tomach pain and indigestion.
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•  hanges in blood tests that check how the
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liver is working.
•  ash.
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• tching.
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•  eing unable to get an erection
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(impotence).
•  eeling weak.
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•  eeling tired.
F
• ncreased levels of certain substances in
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your blood (urea, creatinine or potassium).
Rare (affect less than 1 in 1,000 people)
•  hanges to some of the cells or other
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parts of your blood. The signs may include
feeling tired and pale skin.
•  eeling confused.
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•  hanges in the way things smell.
C
•  ry mouth.
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•  kin rash with dark red, raised, itchy
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bumps (hives).
•  air loss (alopecia).
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•  soriasis (a skin problem).
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• nfection of the blood.
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•  idney failure.
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•  nlarged breasts in men.
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•  ow levels of sodium in the blood,
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which may cause weakness, tiredness,
headache, feeling sick, being sick
(vomiting) and cramps.
Very rare (affect less than 1 in
10,000 people)
•  roblems with your bone marrow or a
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reduced number of blood cells and/or
platelets in your blood. You may notice
tiredness, an infection (which may be
serious), fever, feeling breathless or that
you bruise or bleed more easily.
•  wollen glands (lymph nodes).
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• ncreased immune response (autoimmune
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disease).
•  ow levels of sugar in your blood
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(hypoglycaemia). The signs may include
feeling hungry or weak, sweating and a
fast heart beat.
•  uddenly feeling wheezy or short of breath
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(bronchospasm).
•  ung inflammation (which may make you
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feel breathless).
•  inusitis (a feeling of pain and fullness
S
behind your cheeks and eyes).
•  osinophilic pneumonia. The signs include
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a combination of the following:
--  inusitis
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-- eeling like you have flu
f
-- eeling more and more breathless
f
--  ain in the area of your stomach or gut
p
--  kin rash
s
--  feeling of ‘pins and needles’ or
a
numbness of your arms or legs.
• nflammation of the pancreas. This causes
I
moderate to severe pain in the stomach.
•  welling of the lining of the gut. This may
S
cause sudden stomach pain, diarrhoea or
make you be sick (vomit).
•  weating.
S
•  evere skin disorder or rash. The
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symptoms include redness, blistering and
peeling of the skin which may develop
quickly and may include blistering in the
mouth and nose.
•  assing less water (urine) than normal or
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passing no water.
Possible side effects with
hydrochlorothiazide (frequency not
known)
• nflammation of a salivary gland.
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•  reduced number of blood cells and/or
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platelets in your blood. You may notice
tiredness, an infection (which may be
serious), fever, feeling breathless or that
you bruise or bleed more easily.
•  oss of appetite.
L
•  n increase in the amount of sugar
A
(glucose) in your blood.
•  ugar in your urine.
S
•  n increase in the amount of uric acid in
A
your blood.
•  ltered levels of substances in your blood
A
(for example low sodium and potassium).
You may notice muscle weakness, thirst,
‘pins and needles’, cramps or feeling sick.
•  aised or high levels of fats in your blood
R
(including cholesterol).







F
 eeling restless.
D
 epression.
D
 ifficulty sleeping.
T
 ingling feelings such as ‘pins and
needles’.
F
 eeling light headed.
C
 hanges to your vision that can make
things look yellow.
P
 roblems with your sight for a short time.
S
 evere eye pain with redness and
sudden blurred vision. If you have a
suddenly painful red eye tell your doctor
immediately; you may need treatment to
avoid permanent loss of vision.
A
 spinning feeling (vertigo).
F
 eeling faint (especially when standing up).
D
 amage to blood vessels causing red or
purple spots in the skin.
D
 ifficulty breathing. You may feel
breathless if your lungs get inflamed or
have fluid on them.
S
 tomach irritation.
D
 iarrhoea.
C
 onstipation.
I
nflammation of the pancreas. This causes
moderate to severe pain in the stomach.
Y
 ellowing of your skin or the whites of your
eyes (jaundice).
S
 kin problems including rash caused by
sensitivity to sunlight, rash, severe rash
that develops quickly with blistering or
peeling of the skin and possibly blistering
in the mouth, worsening of existing
lupus erythematosus-like reactions or
appearance of unusual skin reactions.
A
 llergic reactions.
M
 uscle cramps and muscle weakness.
K
 idney problems which may be severe
(shown in blood tests).
F
 ever.
W
 eakness.

Do not be concerned by this list of possible
side effects. You may not get any of them.
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.
5. How to store Zestoretic
•  eep out of the reach and sight of
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children.
•  o not take your tablets after the expiry
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date that is stated on the blister strip and
the carton. The expiry date refers to the
last day of that month.
•  tore your tablets below 30°C. Always
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keep the blister strip in the carton to
protect your tablets from light.
•  edicines should not be disposed of via
M
waste water or household waste. Ask your
pharmacist how to dispose of medicines
no longer required. This will help to protect
the environment.
6. Further information
What Zestoretic contains
The active substances are lisinopril
(as dihydrate) and hydrochlorothiazide.
Two strengths of tablets are available:
•  estoretic 10 mg/12.5 mg Tablets contain
Z
10 mg of lisinopril and 12.5 mg of
hydrochlorothiazide.
•  estoretic 20 mg/12.5 mg Tablets contain
Z
20 mg of lisinopril and 12.5 mg of
hydrochlorothiazide.
The other ingredients are calcium hydrogen
phosphate dihydrate, magnesium stearate,
maize starch, mannitol and pregelatinised
starch. Zestoretic 10 mg/12.5 mg Tablets also
contain iron oxide (E172).
What Zestoretic looks like and contents of
the pack
Zestoretic 10 mg/12.5 mg Tablets are peach
coloured and round. They have ‘Zt’ and ‘10’
on one side.
Zestoretic 20 mg/12.5 mg Tablets are white
and round. They have ‘20 12.5’ on one side
and a break line on the other. The break line
is not intended for breaking the tablets.
They are supplied in cartons containing
blister strips of 28 tablets.
Marketing Authorisation Holder and
Manufacturer
The Marketing Authorisations for Zestoretic
are held by AstraZeneca UK Ltd,
600 Capability Green, Luton, LU1 3LU, UK.
Zestoretic is manufactured by AstraZeneca
UK Ltd, Silk Road Business Park,
Macclesfield, Cheshire, SK10 2NA, 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
Zestoretic 10 mg/12.5 mg
Tablets
17901/0058
Zestoretic 20 mg/12.5 mg
Tablets
17901/0059
This is a service provided by
the Royal National Institute
of Blind People.

Leaflet prepared: November 2011
© AstraZeneca 2011
Zestoretic is a trade mark of the AstraZeneca
group of companies.
CV 11 0158

P035909

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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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