ZESTORETIC 10

Active substance: LISINOPRIL DIHYDRATE

View full screen / Print PDF » Download PDF ⇩

Transcript
PACKAGE LEAFLET: INFORMATION FOR THE USER

P037673

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.
• 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. Do not pass it on to others. It may
harm them, even if their symptoms are
the same as yours.
• 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.
In this leaflet:
1. What Zestoretic is and what it is used for
2. Before you take Zestoretic
3. How to take Zestoretic
4. Possible side effects
5. How to store Zestoretic
6. Further 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. Before you take Zestoretic
Do not take Zestoretic if:
• You are allergic (hypersensitive) to
lisinopril or hydrochlorothiazide or any of
the other ingredients of Zestoretic (listed
in Section 6: Further information).
• You are allergic to ACE inhibitor or
sulphonamide medicines. If you are not
sure if this applies to you, please ask your
doctor.
• 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.
• 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.
• You have severe kidney problems.
• You have stopped passing water (urine).
• You have severe liver problems.
• 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’).
• You are taking a blood pressure medicine
containing aliskiren and you have
diabetes mellitus.
• You are taking a blood pressure medicine
containing aliskiren and you have kidney
problems.
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:
• You have a narrowing (stenosis) of the
aorta (an artery in your heart), the heart
valves (mitral valves) or the kidney artery.
• You have an increase in the thickness of
the heart muscle (known as hypertrophic
cardiomyopathy).
• You have problems with your blood
vessels (collagen vascular disease).
• You have low blood pressure. You may
notice this as feeling dizzy or light-headed,
especially when standing up.
• You have kidney problems or you are
having kidney dialysis or you have had a
kidney transplant.
• You have liver problems.
• You have diabetes.
• You have recently had diarrhoea or
vomiting (being sick).
• Your doctor has told you to control the
amount of salt in your diet.
• You have high levels of cholesterol and
you are having a treatment called ‘LDL
apheresis’.
• You have ever had a condition called
systemic lupus erythematosus (SLE).
• 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.
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:
• Other medicines for treatment of high
blood pressure (antihypertensives),
including those containing aliskiren.
• 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
• 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 usual 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.
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.
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:
• 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, affect less
than 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 (affect less than 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 (affect less than 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 (affect less than 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 (affect less than 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.
Frequency not known
• 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 reach and sight 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.
• Store your tablets below 30°C. Always
keep the blister strip in the carton to
protect your tablets 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.
6. Further 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.
Leaflet prepared: January 2014
© AstraZeneca 2014
Zestoretic is a trade mark of the
AstraZeneca group of companies.
CV 14 0003

P037673

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
(web2)