QUINAPRIL 40 MG TABLETS

Active substance: QUINAPRIL HYDROCHLORIDE

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PL 00289/0481-0484

Patient Information Leaflet
Quinapril 5 mg, 10 mg, 20 mg and 40 mg Film-Coated Tablets
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 further questions, please ask your doctor or pharmacist.
This medicine has been prescribed for you personally and you should not pass it on to
others. It may harm them, even if their symptoms are the same as yours.

In this leaflet:
1.

Quinapril; what it is and what it’s used for
2. Before you take Quinapril
3. How to take Quinapril
4. Possible side effects
5. Storing Quinapril

The name of your medicine is Quinapril 5 mg, 10 mg, 20 mg or 40 mg Film-Coated
Tablets.
The active ingredient is quinapril (as hydrochloride).
Other ingredients are magnesium carbonate, calcium hydrogen phosphate, gelatin,
crospovidone, magnesium stearate, hypromellose (E464), titanium dioxide (E171) and
macrogol. The 40 mg tablets also contain iron oxide yellow (E172).

The Marketing Authorisation holder and company responsible for manufacture: Approved
Prescription Services Limited, Eastbourne, BN22 9AG.
OR
The Marketing Authorisation holder is Approved Prescription Services Limited,
Eastbourne, BN22 9AG England. The company responsible for manufacture is Teva
Pharmaceutical Works Company Ltd, Debrecen, Hungary*.
OR
The Marketing Authorisation holder and company responsible for manufacture is
Pharmachemie BV, Swensweg 5, PO Box 552, 2003 RN Haarlem, The Netherlands*.
OR
The Marketing Authorisation holder and company responsible for manufacture is Teva
Pharmaceutical Works Company Ltd, Debrecen, Hungary*.
OR
The company responsible for manufacture is Teva Operations Poland Sp. z o.o.,
Mogilska 80 Str. 31-546 Kraków, Poland*.
1. Quinapril; what it is and what it’s used for

Only the paragraph containing the details of the current batch release site will be included
in the printed version of the PIL
** Only marketed pack sizes will be included in the printed version of the PIL
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Each tablet contains 5, 10, 20 or 40 mg of quinapril (as hydrochloride). Quinapril
belongs to a group of drugs called Angiotensin Converting Enzyme (ACE) Inhibitors
which are vasodilators (drugs which widen the blood vessels).
The product is available in pack sizes** of 28, 30, 50, 56, 100, or 300 film-coated
tablets.
The 5 mg and 20 mg tablets are also available in packs of 14 tablets.
Your medicine is used to treat high blood pressure and a condition known as
congestive heart failure where the heart no longer pumps blood as effectively as it
should.

2. Before you take Quinapril
Do not take Quinapril if you:
Are sensitive to any of the ingredients in your medicine
If you are more than 3 months pregnant. (It is also better to avoid Quinapril in early
pregnancy – see pregnancy section.)
Have suffered an unexplained allergic reaction, or 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 been diagnosed with a condition known as hereditary angioedema.

Take special care with Quinapril if you have:
To have haemodialysis, a different dialysis membrane may be needed
Have narrowing of your heart valves or a condition called hypertrophic cardiomyopathy
in which there is an abnormality of the heart muscle fibres leading to less efficient
pumping of blood around the body
Kidney problems, disease of the arteries to the kidneys
A collagen vascular disease e.g. systemic lupus erythematosus
Been on a low salt diet
Recently suffered vomiting or diarrhoea
To have desensitising therapy to prevent allergy to wasps, ants or bees
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 if you are also taking:
Tetracycline (an antibiotic), as Quinapril may reduce its effectiveness
Diuretics (water tablets), as the risk of low blood pressure may be increased
Lithium (used to help treat mood swings and severe depression), as levels of lithium
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
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Other medicine for high blood pressure e.g. atenolol, diltiazem, methyldopa as the
effects of Quinapril may be increased
Barbiturates (sleeping pills) e.g. phenobarbital, tricyclic antidepressants e.g.
amitriptyline or neuroleptics e.g. haloperidol, as the risk of low blood pressure may be
increased
Medicine for diabetes, including insulin, as your dosage may need to be adjusted
Narcotic drugs (used to treat moderate or severe pain) e.g. diamorphine, morphine,
pethidine, as the risk of low blood pressure may be increased
Potassium supplements (this includes salt substitutes that often replace potassium), as
potassium may increase above expected levels
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) occurring
Immunosuppressant drugs e.g. azathioprine, ciclosporin and corticosteroids e.g.
prednisolone, hydrocortisone, as there is an increased risk of leucopenia
Procainamide (used to treat an abnormal heartbeat) and cytostatic agents e.g.
mercaptopurine, as there is an increased risk of leucopenia
Sympathomimetics e.g. dopamine, terbutaline, salmeterol, salbutamol, ephedrine,
adrenaline, or phenylpropanolamine. Phenylpropanolamine and ephedrine may be
present in medicines for colds and nasal stuffiness
Trimethoprim (an antibiotic) if given with Quinapril may raise your blood potassium
level.
Other precautions you should take:
Tell the hospital or dentist you are taking Quinapril if you are to have an operation or
require an anaesthetic
Quinapril treatment is not recommended in patients who have recently received a
kidney transplant or for those suffering from primary hyperaldosteronism, a condition in
which too much aldosterone hormone is produced
If you are about to have a treatment called ‘LDL apheresis’, which is the removal of
cholesterol from your blood by a machine, you should tell the doctor who is treating you
that you are taking Quinapril. The doctor may wish to stop your medicine to prevent a
possible allergic reaction.
Taking Quinapril with food and drink:
Drinking alcohol is not recommended whilst being treated with Quinapril.
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.
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
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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 make you feel dizzy or tired. Do not drive or operate machinery until you
are sure you are not affected.
3. How to take Quinapril
Your doctor has decided the dose which is suited to you. Always follow your doctor's
instructions and those which are on the pharmacy label. If you do not understand these
instructions, or you are in any doubt, ask your doctor or pharmacist.
The tablets should be swallowed with a drink of water.
The usual dosage instructions are given below:
For high blood pressure the usual starting dose is 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. Your
doctor will adjust your dose to suit you.
For heart failure the usual starting dose is 2.5 mg once daily. Your doctor will increase
your dose up to a maximum of 40 mg a day, taken as one or two doses.
Occasionally some people need higher doses than those stated above.
If necessary your treatment will be started in hospital.
Children: Quinapril is not recommended for use in children.
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.
Overdose can cause very low blood pressure leading to dizziness and fainting; weak pulse
and clammy skin; stupor, a slow heart beat, chemical imbalance in the body fluids and
kidney failure.

If you forget to take Quinapril
If you forget to take a tablet, take one as soon as you remember, unless it is nearly time to
take the next one. Never take two doses together. Take the remaining doses at the
correct time.
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4. Possible side effects
Like all medicines, Quinapril can have side effects.
If the following occurs, stop taking Quinapril and tell your doctor immediately or go to the
casualty department at your nearest hospital:
Difficulty breathing and swelling of the lips, face and neck.
This is a very serious but rare side effect. You may need urgent medical attention or
hospitalisation. Rare means the effect occurs in more than one in 10, 000 people, but
fewer than one in 1000 people.
The most common (i.e. occur in more than one in 100 people, but fewer than one in ten
people) side effects of Quinapril are:
Dizziness
Very low blood pressure
Cough
Nausea, vomiting or diarrhoea
Headache
Fatigue.
The following uncommon side effects have been reported. These occur in more than one
in 1000 people, but fewer than one in 100 people:
Blood disorders that may be characterised by fever or chills, sore throat or ulcers in the
mouth or throat, unusual tiredness or weakness, unusual bleeding or unexplained
bruising
Dry mouth or throat, indigestion and/or heartburn, abdominal pain or flatulence
Pins-and-needles
Nervousness, palpitations (a sensation of the heart beating) or chest pain
Very low blood pressure leading to dizziness and possibly fainting on standing
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, skin infection, increased perspiration,
or nettle rash
Protein in the urine, impotence
Difficulty sleeping, sleepiness or lethargy
Vertigo (a sensation that your surroundings are spinning either up and down or from
side to side).
The following side effects have been reported rarely (i.e. occurring in more than one in
10, 000 people, but fewer than one in 1000):
Depression, confusion
Disturbances of balance, numbness
Blurred vision or squint, ringing in the ears
Fast heart beat, fainting, heart attack, severe chest pain, bleeding in the brain or
stroke-like symptoms
Wheezing, breathlessness, bronchitis, worsening of asthma, runny and itchy nose
Taste disturbances, constipation, pancreatitis (inflammation of the pancreas),
inflammation of the tongue, spasm of the intestine
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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 syndrome including fever, inflammation of the blood vessels, muscle pain, joint pain
or arthritis and changes in blood chemistry has been reported
Gynaecomastia (a condition in which one or both breasts in males enlarge) and
inflammation of blood vessels have been reported with other ACE inhibitors
Changes in blood test results may occur while being treated with Quinapril.

The following side effects have been reported very rarely (i.e. fewer than one person in
10, 000 or isolated cases):
Dry cough and breathing difficulty on exertion
Jaundice (yellowing of the skin and whites of the eyes), inflammation of the liver or
kidney failure.

If you notice any side effects not mentioned in this leaflet, please inform your doctor or
pharmacist.

5. Storing Quinapril
Keep Quinapril out of the reach and sight of children. Do not store above 25 oC. Store in
the original package. Do not transfer to another container. Do not use Quinapril after the
expiry date shown on the blister and carton. The expiry date refers to the last day of that
month.
Return all unused medicines to your pharmacist for safe disposal.

Revised April 2012
Distributed by TEVA UK Ltd, Leeds, LS27 0JG

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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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