QUINAPRIL 20MG FILM-COATED TABLETS

Active substance: QUINAPRIL HYDROCHLORIDE

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PAGE 1: FRONT FACE (INSIDE OF REEL)

QUINAPRIL 5 mg, 10 mg, 20 mg
AND 40 mg FILM-COATED TABLETS
PACKAGE LEAFLET: INFORMATION FOR THE USER
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.

Other important information:
• Quinapril may not work as well in Afro-Caribbean
patients, and they may be at greater risk of certain
side effects (see section 4, Possible side effects)
• Your doctor may monitor you when you first start
taking Quinapril. This may involve urine and blood
tests.

Taking other medicines
Talk to your doctor if you are taking any of the
following:
• diuretics (”water tablets”), as the risk of low blood
pressure may be increased
• other medicines for high blood pressure e.g.
atenolol, diltiazem, as the effects of Quinapril may
be increased
• potassium supplements (this includes salt
substitutes that often replace potassium), as
IN THIS LEAFLET:
potassium may increase above expected levels
1. What Quinapril is and what it is used for
• non-steroidal anti-inflammatory drugs (NSAIDs)
2. Before you take Quinapril
e.g. aspirin, diclofenac, ibuprofen, piroxicam, as
3. How to take Quinapril
the effectiveness of Quinapril may be reduced
4. Possible side effects
• antacids (used to treat indigestion and heartburn)
5. How to store Quinapril
e.g. aluminium hydroxide, dimeticone, as the
6. Further information
effectiveness of Quinapril may be reduced
• tetracycline (an antibiotic), as Quinapril may
WHAT QUINAPRIL IS AND WHAT IT IS USED
reduce its effectiveness
FOR
• trimethoprim (an antibiotic), as your blood
Quinapril belongs to a group of drugs called
potassium level may be raised
Angiotensin Converting Enzyme (ACE) Inhibitors
• procainamide (used to treat an abnormal heartbeat)
which are vasodilators (drugs which widen the blood
and cytostatic agents e.g. mercaptopurine, as there
vessels, reduce blood pressure and make it easier for
is an increased risk of leucopenia
the heart to pump blood around the body).
• medicines for diabetes, including insulin, as your
Quinapril is used to treat:
dosage may need to be adjusted
• high blood pressure
• lithium (used to help treat mood swings and
• congestive heart failure (a condition where the
severe depression), as levels of lithium may be
heart no longer pumps blood as effectively as it
increased
should).
• barbiturates (sleeping pills) e.g. phenobarbital, as
the risk of low blood pressure may be increased
BEFORE YOU TAKE QUINAPRIL
• narcotic drugs (used to treat moderate or severe
pain) e.g. diamorphine, morphine, pethidine, as
DO NOT take Quinapril and contact your doctor
the risk of low blood pressure may be increased
immediately if you:
• allopurinol (used to treat gout), as there is an
• are allergic (hypersensitive) to quinapril or any of
increased risk of the blood disorder leucopenia, a
the other ingredients of this medicine
reduction in the number of white blood cells which
• have suffered an allergic reaction to any other ACE
makes infections more likely
inhibitors e.g. captopril, enalapril, which has led to • immunosuppressant drugs e.g. azathioprine,
swelling of the face, lips, tongue and/or throat
ciclosporin and corticosteroids e.g. prednisolone
• have a condition known as hereditary angioedema
and hydrocortisone, as there is an increased risk of
which is a serious allergic reaction which causes
leucopenia, a reduction in white blood cells which
swelling of the face or throat, or have ever had a
makes infections more likely
similar unexplained allergic reaction
• sympathomimetics e.g. dopamine, terbutaline,
• are more than 3 months pregnant. (It is also better
salmeterol, salbutamol, ephedrine, adrenaline, or
to avoid Quinapril in early pregnancy - see
phenylpropanolamine. Phenylpropanolamine and
pregnancy section).
ephedrine may be present in medicines for colds
Take special care with Quinapril
and nasal stuffiness.
Tell your doctor before you start to take this
Please tell your doctor or pharmacist if you are taking
medicine if you have:
or have recently taken any other medicines, including
• any of the following heart problems: narrowing of medicines obtained without a prescription.
your heart valves, a condition called hypertrophic
Taking Quinapril with food and drink
cardiomyopathy (inflammation of the heart muscle • DO NOT take alcohol whilst being treated with
fibres leading to less efficient pumping of blood
Quinapril.
around the body), or ischaemic heart disease (a
Pregnancy and breast-feeding
disease characterised by lack of blood flow and
Pregnancy
oxygen to the heart)
• You must tell you doctor if you think you are (or
• kidney problems, or disease of the arteries to the
might become) pregnant. Your doctor will normally
kidneys, or you are undergoing dialysis
advise you to stop taking Quinapril before you
• recently had a kidney transplant or are suffering
become pregnant or as soon as you know you are
from primary hyperaldosteronism (a condition in
pregnant and will advise you to take another
which too much aldosterone hormone is
medicine instead of Quinapril. Quinapril is not
produced), as Quinapril is not recommended
recommended in early pregnancy, and must not be
• cerebrovascular disease which is a disorder of the
taken when more than 3 months pregnant, as it
blood vessels of the brain and its covering
may cause serious harm to your baby if used after
membranes
the third month of pregnancy.
• collagen vascular disease e.g. rheumatoid arthritis,
Breast-feeding
SLE (systemic lupus erythematosus) which is an
• Tell your doctor if you are breast-feeding or about
autoimmune condition which causes joint pain,
to start breast-feeding. Breast-feeding newborn
skin rashes and fever
babies (first few weeks after birth), and especially
• been on a low salt diet
premature babies, is not recommended whilst
• recently suffered vomiting or diarrhoea.
taking Quinapril.
You must tell your doctor if you think you are (or
• In the case of an older baby your doctor should
might become) pregnant. Quinapril is not
advise you on the benefits and risks of taking
recommended in early pregnancy, and must not be
Quinapril whilst breast-feeding, compared with
taken if you are more than 3 months pregnant, as it
other treatments.
may cause serious harm to your baby if used at that
Driving and using machines
stage (see pregnancy section).
• Quinapril may cause dizziness or drowsiness,
Tell your doctor you are taking Quinapril if you:
especially at the beginning of treatment or if taken
• are to have haemodialysis, as a different dialysis
with alcohol. If you are affected, DO NOT drive or
membrane may be needed
operate machinery.
• are about to have a treatment called ‘LDL
apheresis’, which is the removal of cholesterol
HOW TO TAKE QUINAPRIL
from your blood by a machine. The doctor treating
you may wish to stop your medicine temporarily
Always take Quinapril exactly as your doctor has told
to prevent a possible allergic reaction
you. You should check with your doctor or pharmacist
• are to have desensitising therapy to prevent
if you are not sure.
allergy to wasps, ants or bees
In some cases, your treatment may be started in
• are to have an operation requiring an anaesthetic
(including treatment at the dentist): tell the doctor hospital so that you can be closely monitored.
or dentist that you are taking Quinapril.

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PAGE 2: REAR FACE (OUTSIDE OF REEL)

The tablets should be swallowed preferably with a
glass of water. The usual dose is:

• vertigo which is a sensation that your surroundings
are spinning either up and down or from side to side.

Adults including the elderly
• High blood pressure
10 mg once daily. Your doctor may, if necessary,
increase your dose to 20 to 40 mg a day, taken as
one or two doses.
If you are already taking a diuretic (”water tablet”),
your doctor may recommend an initial dose of
2.5 mg once daily, gradually increasing this as
necessary. Your doctor may have told you to stop
taking your diuretic medicine 2 or 3 days before
starting Quinapril.
• Heart failure
The usual recommended dose is 2.5 mg once
daily. Your doctor will then gradually increase your
dose usually to 10 or 20 mg a day, taken as one or
two doses. The maximum dose that may be taken
is 40 mg a day.

Rare (affecting less than one person in 1,000 but
more than one person in 10,000):
• depression, confusion
• disturbances of balance, nerve problems causing
numbness
• blurred vision or squint
• ringing in the ears
• fast heart beat, fainting, heart attack, severe chest
pain, bleeding in the brain or transient stroke-like
symptoms
• changes in blood test results
• agranulocytosis which is a severe reduction in the
number of white blood cells which makes
infections more likely
• wheezing, breathlessness, bronchitis, worsening of
asthma, runny and itchy nose
• taste disturbances, constipation, inflammation of
the pancreas, inflammation of the tongue, spasm
of the intestine
• disturbance of liver or kidney function
• skin redness, blisters/bleeding of the lips, eyes,
nose, mouth and genitals, severe blistering rash,
patches of thickened and sore skin, skin
photosensitivity and hair loss
• joint, muscle and back pain
• a condition which includes fever, inflammation of the
blood vessels, muscle pain, joint pain or arthritis and
changes in blood chemistry has been reported
• gynaecomastia which is a condition in which one
or both breasts in males enlarge
• inflammation of blood vessels have been reported
with other ACE inhibitors.

Patients with liver or kidney problems
Your doctor may give you a lower dose if you have
liver or kidney problems.
Children
Quinapril is not recommended for use in children
under 18 years of age.

If you take more Quinapril than you should
If you (or someone else) swallow a lot of the tablets
all together, or if you think a child has swallowed any
of the tablets, contact your nearest hospital casualty
department or your doctor immediately.
An overdose is likely to cause very low blood
pressure leading to dizziness and fainting, weak
pulse and clammy skin, stupor (a condition of near
unconsciousness) a slow heart beat and kidney failure. Very rare (affecting less than one person in 10,000):
Please take this leaflet, any remaining tablets and the • jaundice (yellowing of the skin and whites of the
container with you to the hospital or doctor so that
eyes), inflammation of the liver
they know which tablets were consumed.
• kidney failure
• serious allergic reaction which causes difficulty in
If you forget to take Quinapril
breathing or dizziness
If you forget to take a tablet, take one as soon as you
• inflammation of the lungs.
remember, unless it is nearly time to take the next
one. DO NOT take a double dose to make up for a
If any of the side effects get serious, or if you notice
forgotten dose.
any side effects not listed in this leaflet, please tell
your doctor or pharmacist.
If you stop taking Quinapril
DO NOT stop taking your medicine without talking to
HOW TO STORE QUINAPRIL
your doctor first even if you feel better.
If you have any further questions on the use of this
product, ask your doctor or pharmacist.

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Keep out of the reach and sight of children.
Do not store above 25ºC.
Store in the original package. Do not use Quinapril
POSSIBLE SIDE EFFECTS
after the expiry date that is stated on the outer
packaging. The expiry date refers to the last day of
Like all medicines, Quinapril can cause side effects,
that month.
although not everybody gets them.
Medicines should not be disposed of via wastewater
Stop taking the tablets and tell your doctor
or household waste. Ask your pharmacist how to
immediately or go to the casualty department at your dispose of medicines no longer required. These
nearest hospital if the following happens:
measures will help to protect the environment.
• an allergic reaction (swelling of the lips, face or
neck leading to severe difficulty in breathing; skin
FURTHER INFORMATION
rash or hives).
This is a very serious side effect. You may need
What Quinapril Tablets contain:
urgent medical attention or hospitalisation.
• The active ingredient is quinapril (as quinapril
hydrochloride), 5 mg, 10 mg, 20 mg or 40 mg.
The following side effects have been reported at the
• The other ingredients are magnesium carbonate
approximate frequencies shown:
heavy, calcium hydrogen phosphate, anhydrous
Common (affecting less than one person in 10 but
gelatin, crospovidone Type A, magnesium stearate,
more than one person in 100):
film coat, hypromellose titanium dioxide (E171)
• dizziness
and macrogol 600, macrogol 400.
• very low blood pressure
• Quinapril 40 mg also includes iron oxide yellow
• cough
(E172).
• nausea, vomiting or diarrhoea
• headache
What Quinapril Tablets look like and contents of the
• fatigue.
pack:
• Quinapril 5 mg Tablets are white oval film-coated
Uncommon (affecting less than one person in 100
tablets debossed “5” on one side and breakline on
but more than one person in 1,000):
both sides.
• serious allergic reactions causing swelling of the
• Quinapril 10 mg Tablets are white, oval film-coated
face and throat (may be more common in
tablets debossed “10” on one side and scoreline
Afro-Caribbean patients)
on the other.
• blood disorders that may be characterised by fever
• Quinapril 20 mg Tablets are white oval film-coated
or chills, sore throat or ulcers in the mouth or
tablets debossed “20” on one side and scoreline
throat, unusual tiredness or weakness, unusual
on the other.
bleeding or unexplained bruising
• dry mouth or throat, indigestion and/or heartburn, • Quinapril 40 mg Tablets are yellow, oval
film-coated tablets debossed “40” on one side and
abdominal pain or flatulence
scoreline on the other.
• pins and needles
• Quinapril is available in pack sizes of 28, 28
• asthenia which is weakness or loss of strength
(calendar), 30, 50, 50 (hospital pack), 56, 100, or
• nervousness
300 (10 x 30) tablets.
• palpitations (sensation of the heart beating) or
Not all pack sizes may be marketed.
chest pain
• very low blood pressure on standing, leading to
Marketing Authorisation Holder and Manufacturer
dizziness and possibly fainting
The Marketing Authorisation holder is TEVA UK
• pain in the sinuses, throat or upper chest (possibly Limited, Eastbourne, BN22 9AG and the company
with pain or difficulty in swallowing), earache and responsible for manufacture is Teva Pharmaceutical
swollen glands
Works Co. Ltd, Debrecen, Hungary.
• itching, rash, skin reaction causing skin peeling,
This leaflet was last revised: July 2010
increased perspiration, or nettle rash
• protein in the urine, impotence which is difficulty
PL 00289/0462-0465
in getting or maintaining an erection
• difficulty sleeping, sleepiness, lethargy or a feeling
of weakness
35958-V

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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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