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QUINAPRIL 10MG FILM-COATED TABLETS

Active substance(s): QUINAPRIL HYDROCHLORIDE / QUINAPRIL HYDROCHLORIDE / 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 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 of the side effects talk to your doctor
or pharmacist. This includes any possible side
effects not listed in this leaflet. See section 4..

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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

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EAS1108b LEA QUINAPRIL A/S F/C TAB TUK ZINC Ref:

WHAT QUINAPRIL IS AND WHAT IT IS USED
FOR

Quinapril belongs to a group of drugs called
Angiotensin Converting Enzyme (ACE) Inhibitors,
which are vasodilators (drugs which widen the blood
vessels, reduce blood pressure and make it easier for
the heart to pump blood around the body).
Quinapril is used to treat:
• high blood pressure
• congestive heart failure (a condition where the heart
no longer pumps blood as effectively as it should).

WHAT YOU NEED TO KNOW BEFORE YOU
TAKE QUINAPRIL

DO NOT take Quinapril and contact your doctor
immediately if you :
• are allergic (hypersensitive) to quinapril or any of
the other ingredients of this medicine
• have suffered an allergic reaction to any other ACE
inhibitors e.g. captopril, enalapril, which has led to
swelling of the face, lips, tongue and/or throat
• have a condition known as hereditary angioedema
which is a serious allergic reaction which causes
swelling of the face or throat, or have ever had a
similar unexplained allergic reaction
• are more than 3 months pregnant. (It is also better
to avoid Quinapril in early pregnancy – see
pregnancy section.)
• 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 before you start to take this
medicine if you:
• have any of the following heart problems: narrowing
of your heart valves, a condition called hypertrophic
cardiomyopathy (inflammation of the heart muscle
fibres leading to less efficient pumping of blood
around the body), or ischaemic heart disease (a
disease characterised by lack of blood flow and
oxygen to the heart)
• have kidney problems, or disease of the arteries to
the kidneys, or you are undergoing dialysis
• recently had a kidney transplant or are suffering
from primary hyperaldosteronism (a condition in
which too much aldosterone hormone is produced),
as Quinapril is not recommended.
• have cerebrovascular disease which is a disorder of
the blood vessels of the brain and its covering
membranes
• have collagen vascular disease e.g. rheumatoid
arthritis, SLE (systemic lupus erythematosus) which
is an autoimmune condition which causes joint pain,
skin rashes and fever
• have been on a low salt diet
• are recently suffered vomiting or diarrhoea
• 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
• are taking any of the following medicines, the risk of
angioedema (rapid swelling under the skin in area
such as the throat) is increased:
-sirolimus, everolimus and other medicines
belonging to the class of mTOR inhibitors (used to
avoid rejection of transplanted organs)
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 and contact your doctor immediately if you”
You must tell your doctor if 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).
Tell your doctor or pharmacist if you:
• are to have haemodialysis, as a different dialysis
membrane may be needed
• are about to have a treatment called ‘LDL apheresis’,
which is the removal of cholesterol from your blood
by a machine. The doctor treating you may wish to
stop your medicine temporarily to prevent a
possible allergic reaction.
• are to have desensitising therapy to prevent allergy
to wasps, ants or bees
• are to have an operation requiring an anaesthetic
(including treatment at the dentist); tell the doctor or
dentist that you are taking Quinapril.

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.
Other medicines and Quinapril
Tell your doctor or pharmacist if you are taking, have
recently taken or might take any of the following
medicines:
• 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
• non-steroidal anti-inflammatory drugs (NSAIDs) e.g.
aspirin, diclofenac, ibuprofen, piroxicam, as the
effectiveness of Quinapril may be reduced
• antacids (used to treat indigestion and heartburn)
e.g. aluminium hydroxide, dimeticone, as the
effectiveness of Quinapril may be reduced
• tetracycline (an antibiotic), as Quinapril may reduce
its effectiveness
• procainamide (used to treat an abnormal heartbeat)
and cytostatic agents e.g. mercaptopurine, as there
is an increased risk of leucopenia
• medicines for diabetes, including insulin, as your
dosage may need to be adjusted
• lithium (used to help treat mood swings and severe
depression), as levels of lithium may be increased
• barbiturates (sleeping pills) e.g. phenobarbital, as
the risk of low blood pressure may be increased
• narcotic drugs (used to treat moderate or severe
pain) e.g. diamorphine, morphine, pethidine, as the
risk of low blood pressure may be increased
• allopurinol (used to treat gout), as there is an
increased risk of the blood disorder leucopenia, a
reduction in the number of white blood cells which
makes infections more likely
• immunosuppressant drugs e.g. azathioprine,
ciclosporin and corticosteroids e.g. prednisolone
and hydrocortisone, as there is an increased risk of
leucopenia, a reduction in white blood cells which
makes infections more likely
• sympathomimetics e.g. dopamine, terbutaline,
salmeterol, salbutamol, ephedrine, adrenaline, or
phenylpropanolamine. Phenylpropanolamine and
ephedrine may be present in medicines for colds
and nasal stuffiness.
• Medicines which are most often used to avoid
rejection of transplanted organs (sirolimus,
everolimus and other medicines belonging to the
class of mTOR inhibitors). See section “Warnings
and precautions”.
• Potassium supplements or salt substitutes
containing potassium, diuretics (water tablets, in
particular those so called potassium sparing), other
drugs which can increase potassium in your body
(such as heparin and co-trimoxazole also known as
trimethoprim/sulfamethoxazole).
Your doctor may need to change your dose and/or to
take other precautions:
If you are taking an angiotensin II receptor blocker (ARB)
or aliskiren (see also information under the headings
“DO NOT take Quinapril and contact your doctor
immediately if you” and “Warnings and precautions”)”
Please tell your doctor or pharmacist if you are taking
or have recently taken any other medicines, including
medicines obtained without a prescription.
Taking Quinapril with food and drink
• DO NOT take alcohol whilst being treated with
Quinapril.
Pregnancy, breast-feeding and fertility
Pregnancy
If you are pregnant or breastfeeding, think you may be
pregnant or are planning to have a baby, ask your
doctor or pharmacist for advise before taking this
medicine.
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.
Breastfeeding
• 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.
Driving and using machines
• Quinapril may cause dizziness or drowsiness,
especially at the beginning of treatment or if taken
with alcohol. If you are affected, DO NOT drive or
operate machinery.

3

HOW TO TAKE QUINAPRIL

Always take this medicine exactly as your doctor has
told you. Check with your doctor or pharmacist if you
are not sure.
In some cases, your treatment may be started in
hospital so that you can be closely monitored.
The tablets should be swallowed preferably with a
glass of water. The usual dose is:
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.

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PAGE 2: REAR FACE (OUTSIDE OF REEL)

Colours Used:
YES
360 mm
160 mm
N/A
N/A

Very rare (may affect up to 1 in 10,000 people):
• jaundice (yellowing of the skin and whites of the
eyes), inflammation of the liver
• kidney failure
• serious allergic reaction which causes difficulty in
breathing or dizziness
• inflammation of the lungs
Reporting of side effects:
If you get any side effects, talk to your doctor or
pharmacist . 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 QUINAPRIL

Keep this medicine out of the sight and reach of
children.
Do not store above 25oC.
Store in the original package.
Do not use this medicine after the expiry date that is
stated on the outer packaging. The expiry date refers to
the last day of that month.
Do not throw away any medicine 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 Tablets contain:
• The active ingredient is quinapril (as quinapril
hydrochloride), 5mg, 10mg, 20mg or 40 mg.
• The other ingredients are magnesium carbonate
POSSIBLE SIDE EFFECTS
heavy, calcium hydrogen phosphate, anhydrous
gelatin, crospovidone Type A, magnesium stearate,
Like all medicines, this medicine can cause side
film coat, hypromellose titanium dioxide (E171) and
effects, although not everybody gets them.
macrogol 600, macrogol 400.
Stop taking the tablets and tell your doctor
• Quinapril 40mg also includes iron oxide yellow
immediately or go to the casualty department at your
(E172).
nearest hospital if the following happens:
• an allergic reaction (swelling of the lips, face or neck What Quinapril Tablets look like and contents of the
pack:
leading to severe difficulty in breathing; skin rash or
• Quinapril 5mg Tablets are white oval film-coated
hives).
tablets, debossed “5” on one side and breakline on
This is a very serious side effect. You may need urgent
both sides
medical attention or hospitalisation.
• Quinapril 10mg Tablets are white oval film-coated
The following side effects have been reported at the
tablets, debossed “10” on one side and scoreline on
approximate frequencies shown:
the other
Common (may affect up to 1 in 10 people):
• Quinapril 20mg Tablets are white oval film-coated
• dizziness
tablets, debossed “20” on one side and scoreline on
• very low blood pressure
the other
• cough
• Quinapril 40mg Tablets are yellow oval film-coated
• nausea, vomiting or diarrhoea
tablets, debossed “40” on one side and scoreline on
• headache
the other
• fatigue
• Quinapril is available in pack sizes of 28, 28
(calendar), 30, 50, 50 (hospital pack), 56, 100, or 300
Uncommon (may affect up to 1 in 100 people):
(10x30) tablets.
• serious allergic reactions causing swelling of the
Not all pack sizes may be marketed.
face and throat (may be more common in AfroCaribbean patients)
Marketing Authorisation Holder and Manufacturer
• blood disorders that may be characterised by fever
The Marketing Authorisation holder is TEVA UK
or chills, sore throat or ulcers in the mouth or throat, Limited, Eastbourne, BN22 9AG and the company
unusual tiredness or weakness, unusual bleeding or responsible for manufacture is Teva Pharmaceutical
unexplained bruising
Works Co. Ltd, Debrecen, Hungary.
• dry mouth or throat, indigestion and/or heartburn,
This leaflet was last revised: June 2017
abdominal pain or flatulence
PL 00289/0462-0465
• pins and needles,
• asthenia which is weakness or loss of strength,
• nervousness
• palpitations (sensation of the heart beating) or chest
pain
• very low blood pressure on standing, leading to
dizziness and possibly fainting
• pain in the sinuses, throat or upper chest (possibly
with pain or difficulty in swallowing) earache and
swollen glands,
• itching, rash, skin reaction causing skin peeling,
increased perspiration, or nettle rash
• protein in the urine, impotence which is difficulty in
getting or maintaining an erection
• difficulty sleeping, sleepiness lethargy or a feeling of
weakness,
• vertigo which is a sensation that your surroundings
are spinning either up and down or from side to
side
Rare (may affect up to 1 in 1,000 people):
• 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
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• 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.
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.
Please take this leaflet, any remaining tablets and the
container with you to the hospital or doctor so that
they know which tablets were consumed.
If you forget to take Quinapril
If you forget to take a dose, take one as soon as you
remember, unless it is nearly time to take the next one.
DO NOT take a double dose to make up for a forgotten
dose.
If you stop taking Quinapril
DO NOT stop taking your medicine without talking to
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.

Expand Transcript

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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