ZESTORETIC 10

Active substance: LISINOPRIL DIHYDRATE

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P039102

Package leaflet: Information for the user

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 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 Zestoretic is and what it is used for
2. What you need to know before you take
Zestoretic
3. How to take Zestoretic
4. Possible side effects
5. How to store Zestoretic
6. Contents of the pack and other information
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.
• Lisinopril belongs to a group of medicines
called ACE inhibitors. It works by making
your blood vessels widen.
• Hydrochlorothiazide belongs to a group of
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. What you need to know before you take
Zestoretic
Do not take Zestoretic:
• if you are allergic to lisinopril or
hydrochlorothiazide or any of the other
ingredients of Zestoretic (listed in section 6).
• if you are allergic to ACE inhibitor or
sulphonamide medicines. If you are not sure
if this applies to you, please ask your doctor.
• if you have ever had sudden swelling of the
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.
• if you have hereditary angioedema
(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.
• if you have severe kidney problems.
• if you have stopped passing water (urine).
• if you have severe liver problems.
• if you are more than 3 months pregnant.
(It is also better to avoid Zestoretic in early
pregnancy - see the sections on ‘Pregnancy
and breast-feeding’).
• if you have diabetes or impaired kidney
function and you are treated with a blood
pressure lowering medicine containing
aliskiren.
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.
Warnings and precautions
Talk to your doctor or pharmacist before taking
Zestoretic:
• if you have a narrowing (stenosis) of the
aorta (an artery in your heart), the heart
valves (mitral valves) or 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 or you have had a
kidney transplant.
• 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 Zestoretic”.
• 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’.
• if you have ever had a condition called
systemic lupus erythematosus (SLE).
• if you are of black origin as Zestoretic may
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.

Other medicines and Zestoretic
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 and herbal
medicines. This is because Zestoretic can
affect the way some medicines work and some
medicines can have an effect on Zestoretic.
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 for treatment of high blood
pressure (antihypertensives).
• An angiotensin II receptor blocker (ARB)
or aliskiren, (see also information under
the headings “Do not take Zestoretic” and
“Warnings and precautions”).
• Water tablets (diuretic medicines).
• Non-steroidal anti‑inflammatory drugs
(NSAIDs) such as indomethacin, used to
treat pain and arthritis.
• Medicines for depression (tricyclic and
tetracyclic antidepressants).
• Medicines for mental problems, including
lithium.
• Aspirin (acetylsalicylic acid), if you are
taking more than 3 grams each day.
• Medicines that can increase the amount of
potassium in the blood such as potassium
tablets, potassium sparing diuretics or salt
substitutes that have potassium in them.
• Calcium salts.
• Insulin or medicines that you take by mouth
for diabetes.
• Medicines 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, such as
ciclosporin).
• Allopurinol (for gout).
• Medicines for uneven heart beat problems
(such as procainamide).
• Cardiac glycosides (to treat heart failure).
• Medicines that contain gold, such as sodium
aurothiomalate, which may be given to you
as an injection.
• Amphotericin B injection (to treat fungal
infections).
• Carbenoxolone (to treat ulcers or inflammation
in the gullet or in and around the mouth).
• Corticosteroids (steroid medicines).
• Corticotropin (a hormone).
• Medicines to treat constipation (stimulant
laxatives).
• Colestyramine and colestipol (to lower
cholesterol, prevent diarrhoea or reduce
itching).
• Muscle relaxants such as tubocurarine.
• Trimethoprim (an antibiotic).
• Sotalol (a beta-blocker).
• Lovastatin (to lower cholesterol).
• Dextran sulphate (used in the treatment
called ‘LDL apheresis’ to lower cholesterol).
• Chemotherapy for cancer (cytostatics).
• Other medicines known to have an effect
on the heart called Torsades de pointes.
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 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
Tell your doctor if you are breast-feeding
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
• This medicine may cause occasional
dizziness or tiredness which may have an
effect on your 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.
• You must wait to see how your medicine
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
• 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
Zestoretic before or after food.
• Keep taking Zestoretic for as long as
your doctor tells you to, it is a long term
treatment. It is important to keep taking
Zestoretic every day.
Taking your first dose
• Take special care when you have your
first dose of Zestoretic 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
• The recommended dose is one tablet once
a day. Your doctor will prescribe the tablet
that is the right strength for you.
• If necessary, your doctor may increase your
dose to two tablets once a day.
Use in children
• Zestoretic is not recommended for use in
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.

443273-A01
24-09-14
P039102

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Technical Info

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Zestoretic 10mg/12.5mg,
20mg/12.5mg Leaflet: Patient UK
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If you forget to take Zestoretic
• 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 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, this medicine 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, may affect up
to 1 in 1,000 people)
If you have a severe allergic reaction, stop taking
Zestoretic and see a doctor immediately. 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 or ankles.
• Difficulty breathing.
• Severe itching of the skin (with raised lumps).
Severe liver problems (very rare, may affect
up to 1 in 10,000 people)
The signs may include:
• Yellowing of your skin or eyes, dark coloured
urine or a loss of appetite.
If this happens to you, see a doctor immediately.
Other possible side effects:
Common (may affect up to 1 in 10 people)
• Headache.
• Feeling dizzy or light‑headed, especially if
you stand up quickly.
• Fainting.
• Diarrhoea.
• Being sick (vomiting).
• Cough.
• Kidney problems (shown in a blood test).
Uncommon (may affect up to 1 in 100 people)
• Mood changes including feeling depressed.
• Tingling feeling such as ‘pins and needles’.
• Spinning feeling (vertigo).
• Changes in the way things taste.
• Difficulty in sleeping.
• Heart attack or stroke.
• Unusual heart beat.
• Change of colour in your fingers or toes.
• Runny nose.
• Feeling sick (nausea).
• Stomach pain and indigestion.
• Changes in blood tests that check how the
liver is working.
• Rash.
• Itching.
• Being unable to get an erection (impotence).
• Feeling weak.
• Feeling tired.
• Increased levels of certain substances in
your blood (urea, creatinine or potassium).
Rare (may affect up to 1 in 1,000 people)
• Changes to some of the cells or other parts
of your blood. The signs may include feeling
tired and pale skin.
• Feeling confused.
• Changes in the way things smell.
• Dry mouth.
• Skin rash with dark red, raised, itchy
bumps (hives).
• Hair loss (alopecia).
• Psoriasis (a skin problem).
• Infection of the blood.
• Kidney failure.
• Enlarged breasts in men.
• Syndrome of inappropriate antidiuretic
hormone secretion (SIADH).
• Low levels of sodium in the blood, which
may cause weakness, tiredness, headache,
feeling sick, being sick (vomiting) and cramps.
Very rare (may affect up to 1 in 10,000 people)
• Problems with your bone marrow or a
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.
• Swollen glands (lymph nodes).
• Increased immune response (autoimmune
disease).
• Low levels of sugar in your blood
(hypoglycaemia). The signs may include
feeling hungry or weak, sweating and a fast
heart beat.
• Suddenly feeling wheezy or short of breath
(bronchospasm).
• Lung inflammation (which may make you
feel breathless).
• Sinusitis (a feeling of pain and fullness
behind your cheeks and eyes).
• Eosinophilic pneumonia. The signs include
a combination of the following:
- sinusitis
- feeling like you have flu
- feeling more and more breathless
- pain in the area of your stomach or gut
- skin rash
- a feeling of ‘pins and needles’ or
numbness of your arms or legs.
• Inflammation of the pancreas. This causes
moderate to severe pain in the stomach.
• Swelling of the lining of the gut. This may
cause sudden stomach pain, diarrhoea or
make you be sick (vomit).
• Sweating.
• Severe skin disorder or rash. The symptoms
include redness, blistering and peeling of
the skin which may develop quickly and may
include blistering in the mouth and nose.
• Passing less water (urine) than normal or
passing no water.
Not known (frequency cannot be estimated
from the available data)
• Seeing, feeling or hearing things that are
not there (hallucinations).
• Flushing of your skin.
Possible side effects with
hydrochlorothiazide (frequency not known)
• Inflammation of a salivary gland.
• A 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.
• Loss of appetite.

• An increase in the amount of sugar (glucose)
in your blood (hyperglycaemia).
• Sugar in your urine.
• An increase in the amount of uric acid in
your blood.
• Altered levels of substances in your blood
(for example low sodium and potassium).
You may notice muscle weakness, thirst,
‘pins and needles’, cramps or feeling sick.
• Raised or high levels of fats in your blood
(including cholesterol).
• Feeling restless.
• Depression.
• Difficulty sleeping.
• Tingling feelings such as ‘pins and needles’.
• Feeling light headed.
• Changes to your vision that can make things
look yellow.
• Problems with your sight for a short time.
• Severe 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).
• Feeling faint (especially when standing up).
• Damage to blood vessels causing red or
purple spots in the skin.
• Difficulty breathing. You may feel breathless if
your lungs get inflamed or have fluid on them.
• Stomach irritation.
• Diarrhoea.
• Constipation.
• Inflammation of the pancreas. This causes
moderate to severe pain in the stomach.
• Yellowing of your skin or the whites of your
eyes (jaundice).
• Skin 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, activating or worsening of existing
lupus conditions or appearance of unusual
skin reactions.
• Allergic reactions.
• Muscle cramps and muscle weakness.
• Kidney problems which may be severe
(shown in blood tests).
• Fever.
• Weakness.
Do not be concerned by this list of possible
side effects. You may not get any of them.
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 the 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.
5. How to store Zestoretic
• Keep this medicine out of the sight and
reach of children.
• Do not use this medicine after the expiry date
which is stated on the blister strip and the
carton. The expiry date refers to the last day
of that month.
• Store your tablets below 30°C. Always
keep the blister strip in the carton to protect
your tablets from light.
• 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 protect the environment.
6. Contents of the pack and other
information
What Zestoretic contains
The active substances are lisinopril
(as dihydrate) and hydrochlorothiazide.
Two strengths of tablets are available:
• Zestoretic 10 mg/12.5 mg Tablets contain
10 mg of lisinopril and 12.5 mg of
hydrochlorothiazide.
• Zestoretic 20 mg/12.5 mg Tablets contain
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.
This leaflet was last revised in September 2014
© AstraZeneca 2014
Zestoretic is a trade mark of the AstraZeneca
group of companies.
CV 14 0158

P039102

443273-A01
24-09-14
P039102

Black

Technical Info

630170L4
1209

Profile

Zestoretic 10mg/12.5mg,
20mg/12.5mg Leaflet: Patient UK
KL

Body text size

Smallest text size

9.5 pt

6.0 pt

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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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