Skip to Content

UK Edition. Click here for US version.

ZESTORETIC 20MG/12.5MG TABLETS

Active substance(s): HYDROCHLOROTHIAZIDE / LISINOPRIL DIHYDRATE

View full screen / Print PDF » Download PDF ⇩
Transcript
Patient Information Leaflet
Zestoretic 20mg/12.5mg 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.
The name of your medicine is Zestoretic 20mg/12.5mg Tablets,
but will be referred to as Zestoretic throughout the remainder of
the leaflet.
Your medicine is also available in the following strength
10mg/12.5mg Tablets.
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’).


























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.



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.
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.

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.

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.

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.

Breast-feeding
Tell your doctor if you are breast-feeding or about to start breastfeeding. 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.

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.

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.

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).

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.

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.

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.

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.

If you are not sure if any of the above applies to you, talk to your
doctor or pharmacist before taking Zestoretic.

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.






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 out of the sight and reach of children.
Do not take your tablets after the expiry date that is stated on the
blister strip and the carton. The expiry date refers to the last day
of that month.
Do not store above 30°C. Protect from light.
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.
If the tablets show any signs of deterioration or discolouration,
consult your pharmacist for advice. If damaged please tell your
doctor or pharmacist.
6. Contents of the pack and other information
What Zestoretic contains
Each tablet contains 20mg of lisinopril as the dihydrate and
12.5mg of hydrochlorothiazide.
Also contains: magnesium stearate, maize starch, mannitol,
pregelatinised starch and calcium hydrogen phosphate.
What Zestoretic looks like and contents of the pack
Zestoretic 20 mg/12.5 mg Tablets are white, round uncoated with
markings ‘20 12.5’ on one side and a break line on the other.
The break line is not intended for breaking the tablets.
Zestoretic tablets are available in calendar blister packs of 28 and
56 tablets.
Zestoretic 20mg/12.5mg Tablets

PL 20774/1359

POM

Manufactured by: AstraZeneca UK Ltd, Silk Road Business Park,
SK10 2NA Macclesfield, Cheshire, 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.
Leaflet revision date: 16th February 2015
Zestoretic is a registered trademark of AstraZeneca UK Limited.
PP2/1359/V3

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