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ACCUPRO TABLETS 40MG

Active substance(s): QUINAPRIL HYDROCHLORIDE

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Package leaflet: Information for the user

Accupro®
5 mg, 10 mg, 20 mg and 40 mg Tablets
quinapril hydrochloride
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.

What is in this leaflet:
1. What Accupro is and what it is used for
2. What you need to know before you
take Accupro
3. How to take Accupro
4. Possible side effects
5. How to store Accupro
6. Contents of the pack and other
information

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1. What Accupro is
and what it is
used for

This medicine contains quinapril, which is one
of a group of medicines called angiotensin
converting enzyme (ACE) inhibitors. ACE
inhibitors work by widening blood vessels in
the body, which can reduce the pressure in the
vessels.
It is used to treat high blood pressure, or to
help treat heart failure.
You must talk to a doctor if you do not feel
better or if you feel worse.

!

2. What you need to
know before you
take Accupro

Do not take Accupro
• If you are allergic to quinapril hydrochloride
or any of the other ingredients of this
medicine (listed in section 6). Signs of
allergic reaction include itching, a rash on
the skin or difficulty in breathing.
• If you are more than 3 months pregnant. (It is
also better to avoid Accupro in early
pregnancy – see pregnancy section).
• If you have a condition called angioneurotic
oedema (a swelling of the face, tongue or
throat which causes difficulty breathing).
• If you have aortic stenosis (narrowing of the
main blood vessel from the heart).
• If you have kidney disease.
• If you have diabetes or impaired kidney
function and you are treated with a blood
pressure lowering medicine containing
aliskiren.

Warnings and precautions
Talk to your doctor or pharmacist before taking
Accupro if:
• You have kidney disease or use a
haemodialysis machine (an artificial kidney).
• You experience jaundice or any other
symptoms of liver disease, then contact your
doctor immediately.
• You have heart disease or heart failure.
• You have previously had a sudden drop in
blood pressure after taking medicines to
treat high blood pressure.
• You have collagen vascular disease
(deposits of collagen in your blood vessels).
• You are having, or about to have, low density
lipoprotein apheresis treatment (removal of
cholesterol from your blood by machine).
• You suffer from allergies or asthma.
• You are having, or about to have,
desensitisation treatment, i.e. to reduce the
effects of an allergy to a bee or wasp sting.
• You have diabetes.
• You are also taking other medicines.
• You are of child bearing potential (see
pregnancy section).
• If you are undergoing major surgery or being
given anaesthesia in any treatment.
• If you have intolerance to sugars such as
lactose or galactose.
• 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 Accupro’.

Other medicines and Accupro
Tell your doctor or pharmacist if you are taking,
have recently taken or might take any other
medicines including medicines obtained
without a prescription. There are some
medicines that may interact with Accupro. Your
doctor may need to change your dose and/or
to take other precautions:

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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.
• Angiotensin II receptor blocker (ARB) or
aliskiren (see also information under the
headings ‘Do not take Accupro’ and
‘Warnings and precautions’).
• Other blood pressure treatments and diuretics
(including aliskiren and water tablets).
• Medicines to treat infections called
tetracyclines.
• Antibiotics like sulfamethoxazole and
trimethoprim.
• Potassium supplements (this includes salt
substitutes which often contain potassium).
• Lithium (used to treat depression).
• Non-steroidal anti-inflammatory pain killers
(including aspirin or ibuprofen).
• Steroids (including hydrocortisone,
dexamethasone or prednisolone).
• Procainamide (used to correct irregular
heartbeats), cytostatic drugs (cancer
therapy), immunosuppressants (for the
treatment of autoimmune diseases e.g.
Crohn’s disease and rheumatoid arthritis),
allopurinol (for the treatment of chronic gout).
• Indigestion and heartburn medicines
(antacids).
• Medicines that have a sedative effect. This
includes alcoholic drinks and sleeping pills.
• Medicines to treat diabetes (including
vildagliptin).
• ACTH (tetracosactrin) (used to treat adrenal
disorders).
• Sympathomimetics (used to treat heart
failure and shock).
• mTOR inhibitors used to treat kidney cancer
(including temsirolimus).
• Injectable gold treatments.

Laboratory Tests
Accupro may affect the results of some
laboratory tests. Tell your doctor or hospital
you are taking Accupro if you need to have any
tests carried out by your doctor or in hospital.

Accupro with food and drink
Accupro can be taken with or without food.

Pregnancy and breast-feeding
Pregnancy
If you are pregnant think you may be pregnant
or are planning to have a baby, ask your doctor
or pharmacist for advice before taking this
medicine. Your doctor will normally advise you
to stop taking Accupro before you become
pregnant or as soon as you know you are
pregnant and will advise you to take another
medicine instead of Accupro. Accupro 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
If you are breast-feeding or about to start
breast-feeding, ask your doctor or pharmacist
for advice before taking this medicine.
Breast-feeding newborn babies (first few weeks
after birth), and especially premature babies, is
not recommended whilst taking Accupro.
In the case of an older baby your doctor should
advise you on the benefits and risks of
taking Accupro whilst breast-feeding,
compared with other treatments.

Driving and using machines
Your tablets may affect your ability to drive or
operate machines safely. They may make you
feel dizzy or weary. If affected, do not drive or
operate machines and contact your doctor
immediately.

Accupro contains lactose
Lactose is a type of sugar, if you have been
told by your doctor that you have an
intolerance to some sugars, contact your
doctor before taking this medicinal product.

3. How to take
Accupro

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Always take this medicine exactly as your
doctor or pharmacist has told you. Check with
your doctor or pharmacist if you are not sure.
Do not wait until your tablets are finished
before seeing your doctor.

Adults
For treatment of hypertension (high blood
pressure) the starting dose is usually 10 mg a
day, which may be increased gradually up to a
maximum of 80 mg a day.

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You will find more about Accupro
on the back of this leaflet

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More information on Accupro
For the treatment of heart failure, if you are also
taking water tablets (diuretics) to treat your
high blood pressure, you are aged 65 or over,
or you have kidney disease, the starting dose is
usually 2.5 mg, which may be increased up to a
maximum of 40 mg a day.
Accupro tablets should be taken either once or
twice a day. Whatever dose you have been
prescribed, follow your doctor’s instructions
exactly and never change the dose yourself.
Swallow the tablets whole with water. Do not
chew, divide or crush the tablets.

Use in children and adolescents
Accupro should not be used in children and
adolescents under 18 years of age.

If you take more Accupro than you
should
Taking too many tablets at once may make you
unwell. Tell your doctor or go to your nearest
hospital casualty department immediately.

If you forget to take Accupro
Do not worry. If you forget to take a dose, miss
out the forgotten dose completely and take the
next dose at the normal time. Do not take a
double dose to make up for a missed dose.

If you stop taking Accupro
Do not stop taking your tablets or alter the dose
you are currently taking without seeing your
doctor first. It is important to keep taking your
tablets. They help to control your blood pressure.
If you have any further questions on the use of
this medicine, ask your doctor or pharmacist.

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4. Possible side
effects

Like all medicines, this medicine can cause
side effects although not everybody gets them.
STOP taking Accupro and tell your doctor
immediately if you experience any of the
following symptoms after taking this medicine.
These symptoms can be serious.
• Severe allergic (anaphylactoid) reaction to
this medicine. The symptoms include
swelling of the face, tongue and throat which
cause great difficulty breathing and
angioedema (swelling of the deeper layer of
the skin caused by a build-up of fluid).
• Severe abdominal pain causing you to be
sick, resulting from inflammation of the wall
of the bowel (intestinal angioedema).
• Severe abdominal pain that may spread to the
back accompanied with feeling very unwell
which may be a symptom of pancreatitis.
• Chest pain, tightness of the chest, shortness of
breath, wheezing or trouble breathing, which
may be a symptom of angina or a heart attack
and an irregular or rapid heartbeat (palpitations).
• Weakness of arms, legs or face or problems
speaking and visual disturbance which may
be symptoms of a possible stroke.
• Sudden severe headache, seizures, loss of
coordination, loss of balance
(cerebrovascular accident).
• Skin rash, rawness, irritation, itching, hives,
blistering, peeling and scaling.
• Red or purple skin rash, skin pain, hives,
blistering of the skin and mouth, nose, eyes,
genitals, facial and tongue swelling
developing after a fever, flu like symptoms
(Stevens Johnson Syndrome).
• Feeling faint, particularly when suddenly
standing up. This may mean your blood
pressure is too low (hypotension). This is
more likely to occur if you have been taking
diuretics (water tablets), other blood
pressure medication in addition to Accupro,
alcohol or if you are dehydrated or on
dialysis. If you feel light headed or faint, lie
down until this feeling passes.
• Severe sore throat or severe mouth ulcers,
particularly if you suffer from kidney problems
or collagen vascular disease. This may mean
you do not have enough of certain white blood
cells (neutropenia/agranulocytosis), which may
lead to increased risk of infection or fever.
• Tightness of the chest, shortness of breath,
wheezing or trouble breathing.
• Yellowing of the skin or the whites of the
eyes (jaundice).
The following side-effects have also been reported
in patients with high blood pressure being treated
with Accupro. If any of these side-effects gets
serious, or if you notice any side-effects not listed
in this leaflet, please tell your doctor:
Common: may affect up to 1 in 10 people:
• increased potassium levels in the blood
• sleeplessness
• coughing; throat infection
• nasal stuffiness and/or runny nose (rhinitis)
• diarrhoea
• indigestion
• feeling or being sick
• tiredness; weakness; lack of energy
• headache
• dizziness
• sensation of tickling, pricking or burning on
the skin
• back pain
• low blood pressure
• pain in the muscle
• increased creatinine and urea nitrogen in the
blood
Uncommon: may affect up to 1 in 100 people:
• depression; nervousness; confusion
• widening of the blood vessels
• fluid retention in the body
• rapid heartbeat (tachycardia)
• drowsiness
• reduced vision (not correctable by glasses or
contact lenses)
• ringing or noises in the ears

• spinning of the head or dizziness due to
problems with the inner ear
• dry mouth or throat
• wind
• excessive sweating
• rash on the skin
• failure/inability to achieve erection in males
• protein in urine, urinary tract infection,
reduced kidney function
• inflammation of your sinuses (sinusitis),
bronchitis, upper respiratory tract infection
• fever
Rare: may affect up to 1 in 1,000 people:
• taste disturbances
• constipation
• soreness of the tongue
• disorders of balance
• swelling of the lungs from an increase in
eosinophils, a type of white blood cell
(eosinophilic pneumonitis)
Very rare: may affect up to 1 in 10,000 people:
• blurring of vision
• swelling of the walls of the bowels
(intestines). Symptoms include abdominal
pain, nausea, vomiting and intestinal cramps
(intestinal angioedema)
Not known: frequency cannot be estimated
from the available data:
• abnormal breakdown of red blood cells
• bruising or a purple or red rash – purpura
• abdominal pain caused by inflammation of
the liver or blocked bile ducts
• decreased numbers of white blood cells or
decrease in blood platelets (thrombocytopenia)
which may result in bruising or easy bleeding;
low numbers of red blood cells (anaemia)
• hair loss
• sensitivity of the skin to light
Accupro may cause certain changes in your
blood and your doctor may do blood tests to
monitor this. If you notice bruising, feeling very
tired or if you are diabetic and notice sugar
levels rising let your doctor know so blood
tests can be arranged if necessary.

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
Accupro

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Keep this medicine out of the sight and reach
of children.
Do not use your medicine after the expiry date
which is stated on carton after EXP. The expiry
date refers to the last day of that month.
Do not store above 25°C.
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 Accupro contains:
Accupro tablets contain 5, 10, 20 or 40 mg of
the active ingredient quinapril.
The other ingredients are magnesium
carbonate, lactose, gelatin, crospovidone and
magnesium stearate.
The tablet coating contains candelilla wax and
opadry Y-5-9020G, which is
hydroxypropylmethylcellulose,
hydroxypropylcellulose, polyethylene glycol,
red iron oxide (E172) and titanium dioxide
(E171).

What Accupro looks like and
contents of the pack:
The 5 mg tablets are brown, oval and stamped
with the strength on both sides and have a line
dividing them in half on both sides.
The 10 mg tablets are brown, triangular, stamped
with the strength on one side only and have a
line dividing them in half on both sides.
The 20 mg tablets are brown, round, stamped
with the strength on one side only and have a
line dividing them in half on both sides.
The 40 mg tablets are reddish-brown, stamped
with the strength on one side and “PD 535” on
the other side.
Each strength of Accupro is supplied in blister
packs of 7, 28, 56 and 100 tablets and
tampertainers of 56 and 100 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Pfizer Limited, Sandwich, Kent, CT13 9NJ,
United Kingdom.

Manufacturer
Pfizer Manufacturing Deutschland GmbH
Betriebsstätte Freiburg
Mooswaldallee 1
79090 Freiburg
Germany

Company Contact address
For further information on this medicine, please
contact Medical Information at Pfizer Limited in
Walton Oaks, Tadworth, Surrey,
Tel: +44 1304 616161
This leaflet was last revised in: 12/2015
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Ref: AC 21_0 UK

Pfizer Limited,
Sandwich, England.

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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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