QUINAPRIL 20 MG FILM-COATED TABLETS

Active substance: QUINAPRIL HYDROCHLORIDE

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QUINAPRIL 5 MG FILM-COATED TABLETS
QUINAPRIL 10 MG FILM-COATED TABLETS
QUINAPRIL 20 MG FILM-COATED TABLETS
QUINAPRIL 40 MG FILM-COATED TABLETS
(quinapril hydrochloride)
Read all of this leaflet carefully before you start taking this
medicine because it contains important information for you.
-  eep this leaflet. You may need to read it again.
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-  f you have any further questions, ask your doctor
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or pharmacist.
-  his medicine has been prescribed for you only. Do not pass
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it on to others. It may harm them, even if their signs of illness
are the same as yours.
- f you get any side effects, talk to your doctor or pharmacist.
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This includes any possible side effects not listed in this leaflet.
What is in this leaflet:
1.  hat Quinapril is and what it is used for.
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2.  hat you need to know before you take Quinapril.
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3.  ow to take Quinapril.
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4.  ossible side effects.
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5.  ow to store Quinapril.
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6.  ontents of the pack and other information.
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1. WHAT quinapril IS AND WHAT IT IS USED FOR
Quinapril belongs to a group of medicines called angiotensin
converting enzyme (ACE) inhibitors, which make the blood
vessels become wider, reducing the pressure in the vessels. This
makes blood flow more easily and reduces the effort needed for
the heart to pump blood around the body.
Quinapril can be used to:
• ower your blood pressure if it is too high (a condition
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called hypertension)
•  elp your heart pump blood around your body if you have a
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condition known as congestive heart failure (along with
other medicines).
2. what you need to know BEFORE YOU take QUINAPRIL
Do not take Quinapril:
• f you are allergic to quinapril or any of the other ingredients
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of this medicine (listed in section 6). Symptoms of an allergic
reaction include itching, a rash on the skin or difficulty breathing
• f you have taken an ACE inhibitor before and had an allergic
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reaction to it resulting in swelling of the face, lips, tongue and/
or throat with difficulty swallowing or breathing, or you or any
member of your family have suffered a similar allergic reaction
for any reason in the past (angioedema)
• f you suffer from a severe allergic skin reaction called hereditary/
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idiopathic angioneurotic oedema, where itchy swellings erupt
on the face, hands and/or genitals and in the mouth
• f you are more than 3 months pregnant (it is also better to
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avoid Quinapril in early pregnancy – see pregnancy section)
• f you have a condition causing obstruction to blood flow from
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the heart like heart valve disease.
• f you have diabetes or impaired kidney function and you
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are treated with a blood pressure lowering medicine
containing aliskiren.
Warnings and precautions

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Talk to your doctor or pharmacist before taking Quinapril if:
•  ou suffer from a heart problem (other than the one being
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treated) or narrowing of the main artery carrying blood out of
the heart (aortic stenosis)
•  ou have liver problems
y
•  ou suffer from kidney problems, narrowing of the blood
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vessels to the kidney (renal artery stenosis), have had a kidney
transplant or need haemodialysis treatment
•  ou suffer from a collagen vascular disease (deposits of collagen
y
in your blood vessels) e.g. lupus erythematosus or scleroderma
•  ou are dehydrated (dry) due to treatment with diuretics
y
(‘water tablets’), dialysis, a low salt diet, vomiting or diarrhoea.
You may be more likely to suffer from a very large drop in your
blood pressure (hypotension) when you start taking the tablets
and may feel faint or light-headed
•  ou have excessive production of aldosterone causing high
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blood pressure also called primary hyperaldosteronism
•  ou have a history of allergy or asthma
y
•  ou are diabetic, as the dose of anti-diabetic medicine may
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need adjusting
•  ou are having treatment to remove cholesterol from your
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blood by machine also called low density lipoprotein apheresis
•  ou are having or about to have treatment to reduce the
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effects of an allergy to a bee or wasp sting also called
desensitisation treatment
•  ou think you are (or might become) pregnant. Quinapril is not
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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 pregnancy section)
•  ou are going to have an operation or need an anaesthetic
y
•  ou are taking any of the following medicines used to treat
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high blood pressure:
-  n angiotensin II receptor blocker (ARBs) (also known as
a
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 Quinapril”.
You should be aware that this medicine may be less effective
at lowering the blood pressure in black patients than in nonblack patients.
Other medicines and Quinapril
Tell your doctor or pharmacist if you are taking, have recently
taken or might take any other medicines, including medicines
obtained without a prescription, or the following:
•  ther medicines to lower blood pressure e.g. methyldopa, atenolol
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•  ther diuretics e.g. triamterene, amiloride, furosemide,
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spironolactone
•  otassium supplements (or salt substitutes containing potassium)
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•  rocainamide, to treat abnormal heart rhythms
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• ithium, to treat mental illness
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•  ther medicines that interact with magnesium salts e.g. the
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antibiotic tetracycline
•  ntidiabetic medicines such as insulin, gliclazide, metformin;
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doses may need to be adjusted
•  ainkillers called non-steroidal anti-inflammatory drugs
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(NSAIDs) e.g. ibuprofen and aspirin
•  llopurinol, often used to treat gout
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•  edicine to treat cancer
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• mmunosuppressive agents e.g. ciclosporin, used after
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transplant surgery or for autoimmune disorders such as
rheumatoid arthritis
•  orticosteroids e.g. prednisolone
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•  ntacids, to relieve indigestion and heartburn
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•  edicines that act on your nervous system e.g. barbiturates,
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alcohol and narcotics
•  edicines used to treat stiffness and inflammation of your
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muscles, bones and joints including gold therapy such as
sodium aurothiomalate, which can lead to flushing of your
face, feeling sick (nausea), being sick (vomiting) and low
blood pressure.
Your doctor may need to change your dose and/or to take
other precautions:
• f you are taking an angiotensin II receptor blocker (ARB) or
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aliskiren (see also information under the headings “Do not take
Quinapril” and “Warnings and precautions”).
Quinapril with food, drink and alcohol
Quinapril can be taken with or without food. Drinking alcohol
while being treated with this medicine may make you dizzy
or sleepy.
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
Quinapril before you become pregnant or as soon as you know
you are pregnant and will advise you to take another medicine
instead of Quinapril. Quinapril 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 breastfeeding. Breast-feeding newborn babies (first few weeks after
birth), and especially premature babies, is not recommended
whilst taking Quinapril.
In the case of an older baby your doctor should advise you on
the benefits and risks of taking Quinapril whilst breast-feeding,
compared with other treatments.
Ask your doctor or pharmacist for advice before taking
any medicine.
Driving and using machines
This medicine may affect your ability to drive a car or operate
machinery. However, do not perform these tasks if you suffer
from side effects such as dizziness or feeling tired. These effects
can sometimes occur at the start of treatment, and may become
worse if you drink alcohol at the same time.
Quinapril contains lactose monohydrate
This medicine contains lactose, a type of sugar. If you have been
told by your doctor that you have an intolerance to some sugars,
such as lactose, contact your doctor before taking this
medicinal product.
3. HOW TO TAKE QUINAPRIL
Always take this medicine exactly as your doctor or pharmacist
has told you. Check with your doctor or pharmacist if you are
not sure.
Adults
To treat high blood pressure
The recommended starting dose is 10 mg once a day. If you
are already taking a diuretic (‘water’ tablet) the starting dose is
2.5 mg a day.
After 3 to 4 weeks, your doctor may increase this to a dose that
best controls your blood pressure. The usual daily dose needed
is between 20 mg and 40 mg, taken as a single dose or divided
into two doses. A few patients have been treated with doses up
to 80 mg a day.
To treat heart failure
You will also be taking other medicine for your condition, such
as a diuretic (‘water’ tablet) or digoxin.
The recommended starting dose is 2.5 mg in the morning. Every
2 to 3 weeks your doctor may increase this to a dose of between
10 mg and 40 mg a day. Most patients will only need 10-20 mg
per day, when given with water tablets or digoxin. This may be
taken as a single dose or divided into two doses. The maximum
daily dose is 40 mg and this dose should not be exceeded. At
the start of treatment your doctor will monitor your condition
closely. In some cases your doctor may wish to take the
precaution of placing you in hospital just for the start of therapy.
Use in the elderly or people with kidney problems
If you are elderly or have kidney problems, you may be more
sensitive to the effects of Quinapril. The usual starting dose for
treating high blood pressure is 2.5 mg. Your doctor will slowly
increase the dose until your condition is under control.
Use in children and adolescents
Quinapril tablets are not recommended for children and
adolescents under 18 years of age.
Method of administration
•  ry to take the tablets at the same time every day.
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•  wallow the tablets with a glass of water.
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•  o not chew or crush the tablets.
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•  he score lines on the 10 mg and 20 mg tablets are not
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intended for breaking the tablet.
If you take more Quinapril than you should
Contact your doctor or nearest hospital emergency department
immediately. Take the container and any remaining tablets with
you. Symptoms of overdose include severe low blood pressure,
shock, feeling disorientated, a slow heart rate and kidney failure.

Date: 14 Aug 2014
Description Quinapril Hydrochloride 5/10/20/40mg ALL
Component Type Leaflet
Affiliate Item Code 433479

Pharma Code 2970
SAP No. N/A

Superceded Affiliate Item Code 10004744

Vendor Job No. 231377

TrackWise PR No. 433479

Proof No. 2

MA No. 04569/0537-0540
Packing Site/Printer N/A
Supplier Code 50057272
Sign-offs

Client Market UK
Keyline/Drawing No. N/A
Barcode Info N/A

No. of colours
Colours

1

Time: 14:35
Page Count

1/2

Black

Non-Print
Colours
Equate CMYK
with
Main Font Myriad Pro
Dimensions 200 x 480mm

Body Text Size 9 pt

12221122122

PACKAGE LEAFLET: INFORMATION FOR THE USER

If you forget to take Quinapril
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
forgotten dose.
If you stop taking Quinapril
Do not stop taking Quinapril without talking to your doctor first.
It is important to keep taking your tablets. They help to control
your blood pressure. Do not wait until your tablets are finished
before seeing your doctor.
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.
If any of the following happen, stop taking Quinapril and
tell your doctor immediately or go to your nearest hospital
emergency department:
Uncommon: may affect up to 1 in 100 people:
•  llergic reactions causing swelling of the face, lips, tongue and/
a
or throat which may cause difficulty breathing or swallowing.
Swelling is more likely to occur in black patients (angioedema)
severe chest pain which may spread to the neck and shoulders
(symptoms of a heart attack or angina)
•  ightness of the chest, shortness of breath, wheezing or trouble
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breathing, irregular or strong heartbeat (palpitations).
Rare: may affect up to 1 in 1,000 people:
•  kin rash, which may blister, and looks like small targets (central
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dark spots surrounded by a paler area, with dark ring around
the edge) (erythema multiforme)
•  listering of the skin and surrounding surfaces (pemphigus).
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Very rare: may affect up to 1 in 10,000 people:
•  evere abdominal pain causing you to be sick
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(intestinal angioedema).
Not known: frequency cannot be estimated from the
available data:
•  udden signs of allergy such as rash, itching or hives on the
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skin, swelling of the face, lips, tongue or other parts of the body,
shortness of breath, wheezing or trouble breathing (anaphylaxis)
•  evere headache, eyesight changes, numbness or weakness,
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and difficulty speaking (symptoms of a stroke)
•  evere abdominal and back pain accompanied by feeling very
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unwell (pancreatitis)
•  kin condition with severe blisters and bleeding in the lips,
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eyes, mouth, nose and genitals (Stevens- Johnson syndrome)
•  evere skin reaction that starts with painful red areas, then
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large blisters and ends with peeling of layers of skin. This is
accompanied by fever and chills, aching muscles and generally
feeling unwell (toxic epidermal necrolysis)
•  eel unusually tired, look pale, notice unusual bleeding, bruise
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easily, or suffer from frequent nosebleeds, sore throats or fever
(these may occur due to a decrease in the number of blood
cells, known as neutropenia and agranulocytosis)
•  ellowing of your skin or whites of your eyes, dark urine,
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pale stools.
These are serious side effects. You may need medical attention.
It is very important that you stop taking Quinapril
immediately and see your doctor if you feel dizzy, lightheaded or faint (especially at the start of treatment or when
the dose has increased or when you stand up). These side
effects are caused by a large drop in your blood pressure
and could lead to a heart attack (severe chest pain) or
stroke. This is more likely to occur if you have been taking
diuretics (water tablets), other blood pressure medication in
addition to Quinapril or if you are dehydrated or on dialysis.
The frequency of this side effect is not known (cannot be
estimated from the available data).
Other side effects include:
Common side effects (may affect up to 1 in 10 people):
•  ore throat and discomfort when swallowing
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•  unny or blocked, sneezing, facial pressure or pain
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•  igh potassium levels in the blood
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• difficulty sleeping
• dizziness
• headache
•  ingling or numbness in the fingers and toes
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• ow blood pressure
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•  hortness of breath
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• coughing
• nausea
• vomiting
• diarrhoea
• indigestion
• abdominal pain
• back pain
• muscle pain
• tiredness (fatigue)
•  eeling of weakness
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• chest pain
• ncrease of creatinine and urea in your blood.
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Uncommon side effects (may affect up to 1 in 100 people):
• nflammation of the airways (bronchitis)
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•  ose or throat infections
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•  rinary tract infection
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•  eeling of tension or fullness in the nose, cheeks and behind
f
your eyes, sometimes with a throbbing ache, fever, stuffy nose
and loss of the sense of smell (sinusitis)
• confusion
• depression
• feeling nervous
• lazy eye
• drowsiness
• mini-stroke
•  eeling of spinning around
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•  uzzing, hissing, whistling, ringing or other persistent noise in
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the ears
•  ast heart rate
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•  idening of blood vessels
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• dry throat
• wind (flatulence)

• dry mouth
• ncrease in liver blood test values
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• tchy skin or rash
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• excessive sweating
•  rotein in the urine, kidney problems
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• nability to get or maintain an erection
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•  luid retention in the body
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• fever
•  welling of hands, ankles or feet
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• llness resulting from the destruction of red blood cells
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(haemolytic anaemia) in patients with a congenital glucose6-phosphate dehydrogenase deficiency, a decrease in the
oxygen carrying substance in the blood.
Rare side effects (may affect up to 1 in 1,000 people):
• oss of balance
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•  ainting or loss of consciousness
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• nflammation of the lungs which can cause breathlessness,
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cough and raise temperature (eosinophilic pneumonia)
• nflammation of the tongue
i
• constipation
•  aste changes, hives, skin eruption.
t
Very rare side effects (may affect up to 1 in 10,000 people):
• blurred vision
•  bstruction of the digestive system (bowel)
o
•  kin rash with white, silvery coloured appearance.
s
Not known side effects (frequency cannot be estimated from
the available data):
• llness resulting from the destruction of red blood
i
cells (haemolytic anaemia), low blood platelet count
(thrombocytopenia)
•  onstriction of the airways
c
•  ellowing of the skin and/or eyes
y
•  kin sensitive to light
s
•  evere flaking or peeling of the skin (exfoliative dermatitis)
s
• hair loss
•  arrowing or blockage of blood vessels (vasculitis) and breast
n
enlargement in men (gynaecomastia) have been reported with
other ACE inhibitors.
If you get any side effects, talk to your doctor or pharmacist.
This includes any possible side effects not listed in this leaflet.
5. HOW TO STORE quinapril
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 carton after EXP. The expiry date refers to the last day of that
month. Do not store above 25°C. Store in the original package.
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 to
protect the environment.
6. contents of the pack and oTHER INFORMATION
What Quinapril contains
The active substance is quinapril hydrochloride. Each tablet
contains either 5 mg, 10 mg, 20 mg or 40 mg of quinapril
hydrochloride.
The other ingredients are lactose monohydrate; cellulose,
microcrystalline; magnesium stearate; magnesium oxide and
crospovidone. The coating includes hypromellose, macrogol 400,
polysorbate 80, iron oxide yellow (E172), iron oxide black (E172)
and titanium dioxide (E171).
What Quinapril looks like and contents of the pack
The 5 mg, 10 mg and 40 mg tablets are beige and oval. The
20 mg tablets are beige and round.
The 5 mg tablets are scored on both sides and marked QP/5 on
one side and “G” on the other. The 10 mg tablets are marked
QP/10 on one side and “G” on the other. The 20 mg tablets are
marked QP/20 on one side and “G” on the other. The 40 mg
tablets are marked QP/40 on one side and “G” on the other.
Quinapril is available in blister packs of 10, 14, 28, 30, 50, 60 or
100 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Mylan, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom.
Manufacturers
Gerard Laboratories, 35/36 Baldoyle Industrial Estate, Grange
Road, Dublin 13, Ireland.
Mylan Hungary Kft, H-2900 Komárom, Mylan útca.1, Hungary.
This medicinal product is authorised in the Member States of
the EEA under the following names:
Belgium: Quinapril Mylan 5 mg, 20 mg & 40 mg
filmomhulde tabletten
Greece: QUINAPRIL/GENERICS fctabs
Italy: Quinapril Mylan Generics 5 mg & 20 mg compresse
rivestite con film
The Netherlands: Quinapril Mylan 5 mg, 10 mg, 20 mg & 40 mg
Poland: AprilGen 5 mg, 10 mg, 20 mg & 40 mg
Portugal: Quinapril Mylan 5 mg, 20 mg & 40 mg Comprimidos
Slovakia: Quinpres 5 mg, 10 mg & 20 mg

This leaflet was last revised in
August 2014.

Date: 14 Aug 2014
Description Quinapril Hydrochloride 5/10/20/40mg ALL
Component Type Leaflet
Affiliate Item Code 433479

Pharma Code 2970
SAP No. N/A

Superceded Affiliate Item Code 10004744

Vendor Job No. 231377

TrackWise PR No. 433479

Proof No. 2

MA No. 04569/0537-0540
Packing Site/Printer N/A
Supplier Code 50057272
Sign-offs

Client Market UK
Keyline/Drawing No. N/A
Barcode Info N/A

No. of colours
Colours

1

433479
50057272

Time: 14:35
Page Count

2/2

Black

Non-Print
Colours
Equate CMYK
with
Main Font Myriad Pro
Dimensions 200 x 480mm

Body Text Size 9 pt

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.

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