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QUINAPRIL 5MG TABLETS

Active substance(s): QUINAPRIL HYDROCHLORIDE

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Package leaflet: Information for the patient

Quinapril 5mg, 10mg, 20mg and 40mg Tablets
Read all of this leaflet carefully before you start taking this medicine because it contains important
information for you.
• Keep this leaflet you may nee to read it again.
• If you have any further questions, ask your doctor, pharmacist or nurse.
• 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, pharmacist or nurse. This includes any possible
side effects not listed in this leaflet. See section 4.

What is in this leaflet
1. What Quinapril tablets are and what they are used for
2. What you need to know before you take
3. How to take Quinapril tablets
4. Possible side effects
5. How to store Quinapril tablets
6. Contents of the pack and other information

1. What Quninapril Tablets are and what they are used for
Quinapril is one of a group of medicines called angiotensin converting enzyme (ACE) inhibitors. These
medicines work by widening blood vessels in the body, which can lower pressure in the blood vessels.
Quinapril may be used for treating:
• High blood pressure
• Heart failure
2. What you need to know before you take
Do not take Quinapril Tablets if you:
• are more than 3 months pregnant.(It is also better to avoid Quinapril Tablets in early pregnancy – see
‘Pregnancy and breast feeding’.)
• are allergic Quinapril Tablets, any of the ingredients of this medicine (listed in section 6) or any other
ACE inhibitor treatment. (An allergic reaction may include swelling, a rash, itching or difficulty
breathing)
• have ever experienced angioedema (a puffy swollen face, tongue or body) either without knowing the
cause, because the condition runs in your family or after taking previous ACE inhibitor treatments
• suffer from obstruction of the left side of the heart (dynamic left ventricular out flow obstruction)
• 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, pharmacist or nurse before taking Quinapril Tablets if you:
• have aortic stenosis (narrowing of the main blood vessel from the heart), heart valve problems (mitral
valve stenosis) or an enlarged heart, heart failure
• have kidney problems, have had a kidney transplant or you use a haemodialysis machine (an artificial
kidney), have kidney artery stenosis (narrowing of the main blood vessel to the kidney)










low blood, high blood pressure
have liver problems
have diabetes mellitus, hyperaldosteronism (an overproduction of aldosterone) or collagen vascular
disease (deposits of collagen in the blood vessels)
are having desensitisation treatment e.g. with snake venom
are due to have an operation that may involve use of an anaesthetic
If you 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,
telmesartan, irbesartan), in particular if you have diabetes-related kidney problems.
Aliskerin

Your doctor may check your kidney function, blood pressure, and the amount of electrolytes (e.g.
potassium) in your blood at regular intervals.
Other medicines and Quinapril Tablets
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Especially:
• Tetracycline-an antibiotic used to treat various infections
• Diuretics (“water tablets”) e.g. amiloride-used to remove excess fluid or treat high blood pressure or
other drugs used to lower blood pressure e.g. atenolol, methyldopa
• Potassium supplements or potassium-containing salt substitutes e.g. Lo-Salt, used to increase
potassium levels in the body
• Heparin to dissolve blood clots such as deep vein thrombosis (DVT)
• Lithium-used to moderate mood in certain conditions including depression and mania
• NSAIDs-Drugs used to calm inflammation and pain associated with conditions like arthritis e.g.
ibuprofen, diclofenac and high doses of aspirin
• “Sympathomimetic” medicines such as salbutamol for asthma; the decongestant pseudoephedrine;
phenylephrine, brimonidine or dipivefrine used in eye drops; ephedrine or noradrenaline
(norepinephrine) used in heart surgery
• Allopurinol- for prevention of attacks of gout
• Drugs used to calm the immune or inflammatory responses of the body e.g. azathioprine, ciclosporin,
prednisolone
• Procainamide-used to treat irregular heart rhythm
• Barbiturates-used for treating epilepsy e.g. phenobarbital
• Strong pain-killers containing codeine, dihydrocodeine or morphine
• Indigestion remedies e.g. magnesium trisilicate, aluminium hydroxide
• Insulin or tablets to treat diabetes e.g. metformin, tolbutamide, glibenclamide
• Sodium aurothiomalate (injectable gold) for treatment of progressive rheumatoid arthritis
• Atorvastatin used to treat symptomatic cardiovascular disease
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 Tablets’ and ‘Warnings and precautions’)
Quinapril Tablets and alcohol
You should take care drinking alcohol with this medication as the combination might cause your blood
pressure to fall too far. Please discuss with your doctor if in doubt.

Pregnancy and breast-feeding
Pregnancy
If you are pregnant, think you may be pregnant or are planning to have a baby ask your doctor or
pharmacist for advice before taking this medicine. Your doctor will normally advise you to stop taking
Quinapril Tablets before you become pregnant or as soon as you know you are pregnant and will advise
you to take another medicine instead of Quinapril Tablets. Quinapril Tablets are not recommended in
early pregnancy, and must not be taken when more than 3 months pregnant, as they 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 Tablets. In the case of an older baby your doctor should advise you on the benefits and risks of
taking Quinapril Tablets whilst breast-feeding, compared with other treatments.
Driving and using machines
Quinapril Tablets may make you feel dizzy or tiredness. Make sure you are not affected before you drive
or operate machinery.
Other precautions you should take
If you see another doctor or go into hospital, let them know what medicines you are taking. An
anaesthetist needs to know you are taking Quinapril Tablets before an operation.
3. How to take Quinapril tablets
Always take this medicine exactly as your doctor or pharmacist has told you. Check with you doctor or
pharmacist if you are not sure.
The recommended dose is
Adult
High Blood Pressure
If no other medicines are being taken to treat high blood pressure the usual starting dose is 10mg
Quinapril once daily. This may be increased gradually according to response to 20mg to 40mg daily,
taken as either one single or two doses per day.
If diuretics are already being taken to treat high blood pressure, your doctor may tell you to stop taking
them two to three days before starting treatment with Quinapril Tablets. The starting dose is usually
2.5mg Quinapril once daily. The dose may be increased or adjusted as above.
Heart Failure
The usual starting dose is 2.5mg Quinapril once daily. This may be increased or adjusted as above to a
maximum of 40mg Quinapril per day, taken as a single or twice daily dose. The usual maintenance dose
is 10mg to 20mg Quinapril as either one single or two doses per day, usually with an additional drug e.g.
a diuretic.
Elderly
The doctor may prescribe a lower starting dose for high blood pressure of 2.5mg once daily in certain
patients.
Reduced Kidney Function
Your doctor may prescribe a lower starting dose.

Children
Not recommended.
Swallow these tablets with water. Take them at the same time each day. This medicine should be taken
for as long as your doctor tells you to; it may be dangerous to stop without their advice.
If you take more Quinapril Tablets than you should
Do not take more tablets than your doctor tells you to. If you (or someone else) swallow a lot of tablets at
the same time, or you think a child may have swallowed any, contact your nearest hospital casualty
department or tell you doctor immediately. Signs of an overdose include feeling faint due to low blood
pressure. Take the container and any remaining tablets with you to show to the doctor.
If you forget to take Quinapril tablets
If you forget to take a dose, take one as soon as you remember. Then go on as before. Do not take a
double dose to make up for a forgotten tablet. If you are worried ask your pharmacist or doctor for
advice.
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking Quinapril tablets and contact your doctor at once if you experience the following allergic
reaction: skin rash, swelling of the face, lips, tongue or throat, or difficulty or shallow breathing (i.e.
asthma)
Tell your doctor if you notice and of the following side effects or notice any other side effects not
listed:
Common (may affect up to 1 in 10 people)
Raised blood potassium levels, sleeping problems, dizziness, headache, tingling or pins and needles, low
blood pressure, persistent dry cough, sore throat, difficulty breathing, runny nose, feeling or being sick,
diarrhoea, indigestion, stomach pain, muscle or back pain, chest pain, tiredness, weakness and loss of
strength, changes in the blood seen in tests.
Uncommon (may affect up to 1 in 100 people)
Changes in sleep pattern, nervousness, numbness, depression, confusion, sleepiness or drowsiness,
temporary blockage of blood supply (e.g. stroke), poor eyesight, irregular heart beat, angina pectoris (a
crushing pain often radiating from the chest and down the left arm), racing heart beat, heart attack,
widening of the blood vessels, inflammation of the sinus, throat and nose infections, inflammation of the
airways (bronchitis), Dry mouth or throat, wind, itching, rash (including exanthema), increased sweating,
bladder infections, protein in the urine (detected by urine test), reduced sexual potency in men, rise in
body temperature (fever), water retention in the hands, body and feet, vertigo, ringing in the ear (tinnitus)
Rare (may affect up to 1 in 1,000 people)
Unsteady balance, nervous system problems, fainting, bleeding on the brain, inflammation in the lung,
worsening of asthma, taste disturbance, constipation, inflammation of the tongue, altered liver function,
itchy skin rash caused by allergic reaction-pale or red irregular raised patches with severe itching (hives),
severe skin rashes including erythema multiforme, serious blistering (pemphigus), joint pain, changes in
the amount or the need to pass water.

Very Rare (may affect up to 1 in 10,000 people)
Blurred vision, inflammation of the lungs, intestinal blockage, swelling of the wall of the bowels
(intestines), a rash resembling psoriasis, kidney failure
Not Known (frequency cannot be estimated from the available data)
Reduction in white blood cell count (detected in blood tests or through getting infections),
agranulocytosis (symptoms include fever, joint or muscle pain, and mouth or throat ulcers) reduction in
red blood cells which cause pale yellow skin, weakness and breathlessness, reduction in platelets in the
blood, stroke, feeling faint on standing or sitting up due to low blood pressure, inflammation of the
pancreas causing pain and tenderness in the abdomen and back, jaundice (yellow of the skin and eyes),
inflammation of the liver, Stevens Johnson syndrome (localised or widespread reddening with lumps or
blisters), exfoliative dermatitis (reddening, scaling and peeling of the skin), hair loss, breakdown of the
surface layer of the skin, oversensitivity to light, changes in the blood seen in test,
Changes to that skin may also be caused by fever, muscle and joint pain, vascular inflammation,
inflammations of serous tissues and certain changes in laboratory values.
Quinapril Tablets can cause changes to results of blood tests for certain naturally occurring substances.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. 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
Keep out of sight and reach of children
Do not use this medicine after the expiry date which is stated on the label/carton/bottle. The expiry date
refers to the last day of the month.
Do not store above 25°C
Do not throw away medicines via water or household waste. Ask you pharmacist how to throw away
medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What Quinapril Tablets contain
The active ingredient is quinapril
Quinapril Tablets come in four strengths.
Each 5mg film-coated tablet contains 5.415mg of the active ingredient quinapril hydrochloride,
equivalent to 5mg quinapril.
Each 10mg film-coated tablet contains 10.83mg of the active ingredient quinapril hydrochloride,
equivalent to 10mg quinapril.
Each 20mg film-coated tablet contains 21.66mg of the active ingredient quinapril hydrochloride,
equivalent to 20mg quinapril.

Each 40mg film-coated tablet contains 43.32mg of the active ingredient quinapril hydrochloride,
equivalent to 40mg quinapril.
The other ingredients are:
magnesium carbonate heavy, calcium hydrogen phosphate anhydrous (E341), starch pregelatinised,
croscarmellose sodium and magnesium stearate.
The tablet coating contains:
hypromellose 6cP (E464), hydroxypropylcellulose (E464), titanium dioxide (E171), macrogol and iron
oxide red (E172).
What Quinapril Tablets looks like and contents of the pack
5mg tablets:
Film-coated tablet.
Red brown, 4.5 x 8.7 mm, oval, biconvex, film-coated tablets with breakline on both sides. Marked I.
10mg tablets:
Film-coated tablet.
Red brown, 5.8 x 11.3 mm, oval, biconvex, film-coated tablets with breakline on both sides. Marked L
20mg tablets:
Film-coated tablet.
Red brown, 7.0 mm, round, biconvex, film-coated tablets with breakline on both sides. Marked I.
40mg tablets:
Film-coated tablet.
Red brown, 6.5 x 12.7 mm, oval, biconvex, film-coated tablets with breakline on both sides. Marked I
Quinapril tablets are available in pack sizes of 14, 28, 30, 50, 56, 60, 84, 90, 100.*
*only the marketed pack size will appear on the final leaflet
Marketing Authorisation Holder
Actavis, Barnstaple, EX32 8NS, UK.
Manufacturer
Actavis hf, Reykjavikurvegur 78, IS-220 Hafnarfjordur, Iceland
This leaflet was last revised in September 2015

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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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