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

Pregnancy and breast-feeding

What is in this leaflet:
1. What Quinapril is and what it is used for.
2. What you need to know before you take Quinapril.
3. How to take Quinapril.
4. Possible side effects.
5. How to store Quinapril.
6. Contents of the pack and other information.
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:
• lower your blood pressure if it is too high (a condition called
hypertension)
• help your heart pump blood around your body if you have a
condition known as congestive heart failure (along with other
medicines).
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE QUINAPRIL
Do not take Quinapril:
• if you are allergic to quinapril or any of the other ingredients
of this medicine (listed in Section 6). Symptoms of an allergic
reaction include itching, a rash on the skin or difficulty breathing.
• if you have taken an ACE inhibitor before and had an allergic
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)
• if you suffer from a severe allergic skin reaction called hereditary/
idiopathic angioneurotic oedema, where itchy swellings erupt on
the face, hands and/or genitals and in the mouth
• if you are more than 3 months pregnant (it is also better to
avoid Quinapril in early pregnancy – see 'Pregnancy' section)
• if you have a condition causing obstruction to blood flow from
the heart like heart valve disease.
Warnings and precautions

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Code reading direction

Talk to your doctor or pharmacist before taking Quinapril if:
• you suffer from a heart problem (other than the one being
treated) or narrowing of the main artery carrying blood out of
the heart (aortic stenosis)
• you have liver problems
• you suffer from kidney problems, narrowing of the blood
vessels to the kidney (renal artery stenosis), have had a kidney
transplant or need haemodialysis treatment
• you suffer from a collagen vascular disease (deposits of collagen
in your blood vessels) e.g. lupus erythematosus or scleroderma
• you are dehydrated (dry) due to treatment with diuretics ('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
• you have excessive production of aldosterone causing high
blood pressure also called primary hyperaldosteronism
• you have a history of allergy or asthma
• you are diabetic, as the dose of anti-diabetic medicine may
need adjusting
• you are having treatment to remove cholesterol from your
blood by machine also called low density lipoprotein apheresis
• you are having or about to have treatment to reduce the effects
of an allergy to a bee or wasp sting also called desensitisation
treatment
• you think you are (or might become) pregnant. Quinapril 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 'Pregnancy' section)
• you are going to have an operation or need an anaesthetic.
You should be aware that this medicine may be less effective
at lowering the blood pressure in black patients than in
non-black 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:
• other medicines to lower blood pressure e.g. methyldopa,
atenolol
• other diuretics e.g. triamterene, amiloride, furosemide,
spironolactone
• potassium supplements (or salt substitutes containing potassium)
• procainamide, to treat abnormal heart rhythms
• lithium, to treat mental illness
• other medicines that interact with magnesium salts e.g. the
antibiotic tetracycline
• antidiabetic medicines such as insulin, gliclazide, metformin;
doses may need to be adjusted
• painkillers called non-steroidal anti-inflammatory drugs
(NSAIDs) e.g. ibuprofen and aspirin
• allopurinol, often used to treat gout
• medicine to treat cancer
• immunosuppressive agents e.g. ciclosporin, used after
transplant surgery or for autoimmune disorders such as
rheumatoid arthritis
• corticosteroids e.g. prednisolone
• antacids, to relieve indigestion and heartburn
• medicines that act on your nervous system e.g. barbiturates,
alcohol and narcotics
• medicines used to treat stiffness and inflammation of your
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.

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.

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Rare: may affect up to 1 in 1,000 people:
• skin rash, which may blister, and looks like small targets (central
dark spots surrounded by a paler area, with dark ring around
the edge) (erythema multiforme)
• blistering of the skin and surrounding surfaces (pemphigus).
Very rare: may affect up to 1 in 10,000 people:
• severe abdominal pain causing you to be sick (intestinal
angioedema).
Not known: frequency cannot be estimated from the
available data:
• sudden signs of allergy such as rash, itching or hives on
the skin, swelling of the face, lips, tongue or other parts of
the body, shortness of breath, wheezing or trouble
breathing (anaphylaxis)
• severe headache, eyesight changes, numbness or weakness,
and difficulty speaking (symptoms of a stroke)
• severe abdominal and back pain accompanied by feeling very
unwell (pancreatitis)
• skin condition with severe blisters and bleeding in the lips,
eyes, mouth, nose and genitals (Stevens-Johnson syndrome)
• severe skin reaction that starts with painful red areas, then 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)
• feel unusually tired, look pale, notice unusual bleeding, bruise
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)
• yellowing of your skin or whites of your eyes, dark urine,
pale stools.

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

These are serious side effects. You may need medical attention.

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.

It is very important that you stop taking Quinapril
immediately and see your doctor if you feel dizzy,
light-headed 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).

Code reading direction

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.

TBC

(quinapril hydrochloride)

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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.

PACKAGE LEAFLET: INFORMATION FOR THE USER

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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.

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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.

Other side effects include:
Common side effects (may affect up to 1 in 10 people):
• sore throat and discomfort when swallowing
• runny or blocked nose, sneezing, facial pressure or pain
• high potassium levels in the blood
• difficulty sleeping
• dizziness
• headache
• tingling or numbness in the fingers and toes
• low blood pressure
• shortness of breath
• coughing
• nausea
• vomiting
• diarrhoea
• indigestion
• abdominal pain
• back pain
• muscle pain
• tiredness (fatigue)
• feeling of weakness
• chest pain
• increase of creatinine and urea in your blood.

Method of administration:
• Try to take the tablets at the same time every day.
• Swallow the tablets with a glass of water.
• Do not chew or crush the tablets.
• The score lines on the 10 mg and 20 mg tablets are not
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.
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.

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 Komarom, Mylan utca 1, Hungary.
This medicinal product is authorised in the Member States of
the EEA under the following names:

Uncommon side effects (may affect up to 1 in 100 people):
• inflammation of the airways (bronchitis)
• nose or throat infections
• urinary tract infection
• feeling of tension or fullness in the nose, cheeks and behind
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
• feeling of spinning around
• buzzing, hissing, whistling, ringing or other persistent noise in
the ears
• fast heart rate
• widening of blood vessels
• dry throat
• wind (flatulence)
• dry mouth
• increase in liver blood test values
• itchy skin or rash
• excessive sweating
• protein in the urine, kidney problems
• inability to get or maintain an erection
• fluid retention in the body
• fever
• swelling of hands, ankles or feet
• illness resulting from the destruction of red blood cells
(haemolytic anaemia) in patients with a congenital
glucose-6-phosphate dehydrogenase deficiency
• a decrease in the oxygen carrying substance in the blood.

Use in children and adolescents
Quinapril tablets are not recommended for children and
adolescents under 18 years of age.

Not known side effects (frequency cannot be estimated from
the available data):
• illness resulting from the destruction of red blood cells
(haemolytic anaemia), low blood platelet count
(thrombocytopenia)
• constriction of the airways
• yellowing of the skin and/or eyes
• skin sensitive to light
• severe flaking or peeling of the skin (exfoliative dermatitis)
• hair loss
• narrowing or blockage of blood vessels (vasculitis) and breast
enlargement in men (gynaecomastia) have been reported with
other ACE inhibitors.

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

Rare side effects (may affect up to 1 in 1,000 people):
• loss of balance
• fainting or loss of consciousness
• inflammation of the lungs which can cause breathlessness,
cough and raise temperature (eosinophilic pneumonia)
• inflammation of the tongue
• constipation
• taste changes
• hives, skin eruption.

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:

Very rare side effects (may affect up to 1 in 10,000 people):
• blurred vision
• obstruction of the digestive system (bowel)
• skin rash with white, silvery coloured appearance.

Uncommon: may affect up to 1 in 100 people:
• allergic reactions causing swelling of the face, lips, tongue
and/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)
• tightness of the chest, shortness of breath, wheezing or trouble
breathing, irregular or strong heartbeat (palpitations).

This leaflet was last revised in: January 2013.

16-JAN-2013

Job No. 37006964v2

23-JAN-2013

product category QUINAPRIL
market UK 2013
packing site Komarom
product Quinapril 5, 10, 20, 40mg FCTab x28
component type Leaflet

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artwork code 10004744
superseded code 10003798

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MA no. 04569/0537, 0538, 0539, 0540
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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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