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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. It may harm

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.

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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).

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.
• ACTH (tetracosactrin) (used to treat adrenal disorders).
• Sympathomimetics (used to treat heart failure and
shock).
• mTOR inhibitors used to treat kidney cancer (including
temsirolimus), certain antidiabetic drugs (DPP-4 inhibitors
e.g. vildagliptin) or certain drugs against heart
insufficiency and high blood pressure (neutral
endopeptidase inhibitor, e.g. racecadotril): the risk of an
angioedema (swelling of the face, eyes, tongue or throat)
can be elevated.
• Injectable gold treatments.

• If you have kidney disease.

Laboratory Tests

• If you have diabetes or impaired kidney function and you
are treated with a blood pressure lowering medicine
containing aliskiren.
• If you are taking sacubitril/valsartan, a medicine for heart
failure.

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.

Warnings and precautions

Accupro can be taken with or without food.

Talk to your doctor or pharmacist before taking Accupro if:

Pregnancy and breast-feeding
Pregnancy

• 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).
• You are undergoing major surgery or being given
anaesthesia in any treatment.
• You have intolerance to sugars such as lactose or
galactose.
• 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
• You are simultaneously receiving an mTOR (mammalian
target of Rapamycin) inhibitor (e.g. temsirolimus) or a
DPP-4 (dipeptidyl-peptidase-4) inhibitor (e.g. vildagliptin)
or a neutral endopeptidase inhibitor (e.g. racecadotril),
may have an increased risk for angioedema (swelling
of the face, eyes, tongue or throat). Special caution is
advised if treatment with an mTOR inhibitor or
DPP-4 inhibitor or a neutral endopeptidase inhibitor is
initiated in patients who are already receiving an ACE
inhibitor.
• You are taking medicines or have conditions which may
decrease sodium levels in your blood.
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:

UNITED KINGDOM

Accupro with food and drink

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.
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

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

More information on Accupro
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
Pfizer Limited,
Sandwich, England.

• 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)
• decreased sodium concentrations in the blood
• 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:

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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 08/2017
Ref: 24_0

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