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QUINHEXAL 10 MG TABLETS

Active substance(s): QUINAPRIL HYDROCHLORIDE

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Hexal AG
Quinhexal 5, 10, 20 & 40 mg Tablets

PL 10880/0066-0069

Patient Information Leaflet
06/06/2016

PACKAGE LEAFLET: INFORMATION FOR THE USER
Quinhexal 5mg Tablets
Quinhexal 10mg Tablets
Quinhexal 20mg Tablets
Quinhexal 40mg Tablets
Active substance: Quinapril hydrochloride
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 gets serious, or if you notice any side effects not
listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1 What Quinhexal is and what it is used for
2 Before you take Quinhexal
3 How to take Quinhexal
4 Possible side effects
5 How to store Quinhexal
6 Further information
1.

WHAT QUINHEXAL IS AND WHAT IT IS USED FOR

Quinhexal contains quinapril, which belongs to a group of medicines called ACE
inhibitors which reduces blood pressure and make the blood vessels become
wider. This makes the blood flow more easily and reduces the effort needed for
the heart to pump blood around the body.
Quinapril, can be used to treat high blood pressure (hypertension) on its own or
in combination with an other medicine. It can also help treat heart failure along
with an other medicine.
2.

BEFORE YOU TAKE QUINHEXAL

Do NOT take Quinhexal
 if you are allergic to quinapril or any of the tablet ingredients or any other
ACE inhibitor
 if you are more than 3 months pregnant (It is also better to avoid Quinhexal in
early pregnancy – see pregnancy section.)
PIL.10880.00660069.007.1d

V023: RAS Referral, WS + RFI

IS

Hexal AG
Quinhexal 5, 10, 20 & 40 mg Tablets

PL 10880/0066-0069

Patient Information Leaflet
06/06/2016

 if you have diabetes or impaired kidney function and you are treated with a
blood pressure lowering medicine containing aliskiren
 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
 if you have or any member of your family have suffered a similar severe
allergic skin reaction for any reason in the past where itchy swellings erupt
on the face, hands, genitals and/or in the mouth.
Warnings and precautions
Talk to your doctor or pharmacist before taking Quinhexal
 if you are dehydrated (lost water in your body) 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 lightheaded.
 if you suffer from a heart problem (other than the one being treated),
including valve problems, narrowing of blood vessels or thickening of the
heart muscle.
 if you have kidney problems or narrowing of the blood vessels to the kidney.
 if you have had a kidney transplant.
 if you receive dialysis treatment (with high flux membranes), blood
separation treatment to remove cholesterol from your blood by machine or
desensitisation treatment to reduce the effects of an allergy to a bee or
wasp sting. In these cases tell your doctor that you are taking Quinhexal. He
may wish to change your treatment to prevent a possible allergic reaction.
 if you have a history of allergy.
 if you have liver problems.
 if you suffer from a skin disease eg. scleroderma, SLE (lupus).
 if you need to have an operation with a general anaesthetic. Please tell your
doctor that you are taking Quinhexal.
 if you are diabetic, as the dose of anti-diabetic medicine may need adjusting.
 if your high blood pressure is caused by a hormone imbalance and water
retention.
 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, telmisartan, irbesartan), in particular if you have
diabetes-related kidney problems.
 aliskiren.
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 Quinhexal”.

PIL.10880.00660069.007.1d

V023: RAS Referral, WS + RFI

IS

Hexal AG
Quinhexal 5, 10, 20 & 40 mg Tablets

PL 10880/0066-0069

Patient Information Leaflet
06/06/2016

You must tell your doctor if you think you are (or might become) pregnant.
Quinhexal 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).
Please note
Your doctor will give you blood tests to check your kidney function and will also
check the levels of salts, sugar and blood cells in your blood from time to time.
This will happen more often if you have kidney problems, diabetes or a skin
disease.
Other medicines and Quinhexal
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
The effect of Quinhexal may be altered by other medicines. Quinhexal in turn,
may affect how well other medicines work.
This applies to the following medicines, among others:
 tetracycline (an antibiotic)
 water tablets (diuretics) e.g. triamterene, amiloride, furosemide and
spironolactone
 potassium supplements or salt substitutes containing potassium
 other medicines that lower blood pressure e.g. methyldopa, beta-blockers and
anaesthetic agents
 lithium, to treat mental illness
 painkillers called non-steroidal anti-inflammatory drugs (NSAIDs) e.g.
ibuprofen and aspirin
 gold (sodium aurothiomalate)
 allopurinol, often used to treat gout
 medicine to treat cancer e.g. azathioprine
 ciclosporin (used after transplant surgery or for autoimmune disorders such
as rheumatoid arthritis)
 corticosteroids e.g. prednisolone
 procainamide, to treat abnormal heart rhythms
 medicine to help you sleep e.g. barbiturates
 dobutamine, dopexamine and ephedrine (known as sympathomimetics)
 antacids, to relieve indigestion
 antidiabetic medicine such as insulin, gliclazide, metformin; doses of the
antidiabetic medicine may need to be adjusted
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 Quinhexal” and “Warnings and
precautions”).
PIL.10880.00660069.007.1d

V023: RAS Referral, WS + RFI

IS

Hexal AG
Quinhexal 5, 10, 20 & 40 mg Tablets

PL 10880/0066-0069

Patient Information Leaflet
06/06/2016

Taking Quinhexal with food and drink
Drinking alcohol may increase the risk for a larger drop in your blood pressure.
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 Quinhexal before you become
pregnant or as soon as you know you are pregnant and will advise you to take
another medicine instead of Quinhexal. Quinhexal 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. Breastfeeding newborn babies (first few weeks after birth), and especially premature
babies, is not recommended whilst taking Quinhexal.
In the case of an older baby your doctor should advise you on the benefits and
risks of taking Quinhexal whilst breast-feeding, compared with other treatments.
Driving and using machines
Your tablets may affect your ability to drive or operate machinery safely. They
may make you feel dizzy or weary. If affected, do not drive or operate machinery.
Important information about some of the ingredients of Quinhexal
This medicine contains Lactose.
If you have been told by your doctor that you have an intolerance to some
sugars, contact your doctor before taking this medicine.
3.

HOW TO TAKE QUINHEXAL

Always take Quinhexal exactly as your doctor has told you. You should
check with your doctor or pharmacist if you are not sure.
 Swallow your tablets with a glass of water.
 Try to take the tablets at the same time every day.
During treatment with Quinhexal you will be constantly undergoing blood tests by
your doctor (see also “Please note” in section 2). It is important that you do not
miss any blood test.
Adults
PIL.10880.00660069.007.1d

V023: RAS Referral, WS + RFI

IS

Hexal AG
Quinhexal 5, 10, 20 & 40 mg Tablets

PL 10880/0066-0069

Patient Information Leaflet
06/06/2016

To treat high blood pressure
The usual starting dose is 10 mg of Quinhexal once a day. If you are already
taking a water tablet (diuretic) the starting dose is 2.5 mg of Quinhexal 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
of Quinhexal, taken as a single dose or divided into two doses. A few patients
have been treated with doses up to 80 mg a day.
To treat heart failure
You will also be taking other medicine for your condition, such as a water tablet
(diuretic) or digoxin.
The usual starting dose is 2.5 mg of Quinhexal in the morning. Every 2 to 3
weeks your doctor may increase this, to a dose of between 10 mg and 40 mg of
Quinhexal 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.
Kidney problems
The usual starting dose of Quinhexal needs to be adjusted by your doctor
according to how well your kidneys are working.
Elderly
If you are elderly or have kidney problems, you may be more sensitive to the
effects of Quinhexal. 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.
Children (6-12 years)
Quinhexal should not be given to children.
If you take more Quinhexal than you should
Contact your doctor or nearest hospital casualty department immediately. Take
any remaining tablets and the package with you. If you have taken too many
tablets, you may feel particularly light-headed or faint, your heart rate may slow
down and your skin may feel cold and clammy.
If you forget to take Quinhexal
Take it as soon as you remember unless it is nearly time for your next dose.
Never take two doses at the same time.
If you stop taking Quinhexal
Do not stop taking this medicine unless your doctor tells you to.
PIL.10880.00660069.007.1d

V023: RAS Referral, WS + RFI

IS

Hexal AG
Quinhexal 5, 10, 20 & 40 mg Tablets

4.

PL 10880/0066-0069

Patient Information Leaflet
06/06/2016

POSSIBLE SIDE EFFECTS

Like all medicines, Quinhexal can cause side effects, although not everybody
gets them.
Stop taking Quinhexal and seek medical attention if you begin to itch, develop a
severe skin rash with blistering or peeling, get short of breath or wheezy, and
develop swelling of the face, hands, feet, mouth, throat or eyes. You may be
allergic to this medicine (anaphylactic reaction). The frequency of this effect is
not known.
Tell your doctor if you suffer from sore throats, mouth ulcers more frequent
infections or fever.
Tell your doctor if you notice yellowing of your skin or whites of your eyes or
have abdominal (tummy) pain. This is a very rare effect.
If any of the side effects gets serious, or if you notice any side effects not
listed in this leaflet, please tell your doctor or pharmacist.
The following undesirable effects have been observed during treatment with
quinapril and other ACE inhibitors with the following frequencies:
common: in less than 1 of 10 patients
 raised blood potassium levels
 insomnia
 dizziness
 low blood pressure
 cough
 sore throat
 breathlessness
 itchy and runny nose
 feeling or being sick
 diarrhoea
 indigestion
 stomach pain
 headache
 tingling or numbness in the fingers and toes
 muscle or back pain
 chest pain
 feeling unusually tired
 weakness
PIL.10880.00660069.007.1d

V023: RAS Referral, WS + RFI

IS

Hexal AG
Quinhexal 5, 10, 20 & 40 mg Tablets


PL 10880/0066-0069

Patient Information Leaflet
06/06/2016

increases in several blood components (creatinine, urea) are more likely
to occur in patients receiving water tablets as well as quinapril. These
observed increases will often reverse on continued therapy.

uncommon: in less than 1 of 100 patients





















feeling nervous
depression
confusion
sleepiness
weakness of arms, legs or problems speaking which may be symptoms of
a possible stroke
impaired vision
ringing in the ears (tinnitus)
spinning sensation
fast or irregular heart beat (palpitations), racing heart beat, severe short
lived chest pain that may move to the arms, throat, lower jaw or back,
heart attack
vasodilatation (expansion of the veins or arteries)
inflammation of the sinuses (sinusitis)
bronchitis, infection of the upper respiratory system
dry mouth or throat
flatulence (wind)
itchy skin, rash, sweating,
kidney problems, infection of the bladder
protein in the urine (worsening kidney function)
impotence
swelling of hands, feet, face, lips, tongue, throat and/or vocal chords
(angioedema). fever
oedema

rare: in less than 1 of 1,000 patients










loss of balance
tingling in the limbs (pins and needles)
fainting
inflammation of the lungs with cough, fever, difficulty breathing or
wheezing (eosinophilic pneumontits), worsening of asthma
taste changes
swollen or painful tongue
constipation
nettle rash (hives), erythema multiforme (acute inflammation of the skin)
skin lesions including blisters

PIL.10880.00660069.007.1d

V023: RAS Referral, WS + RFI

IS

Hexal AG
Quinhexal 5, 10, 20 & 40 mg Tablets

PL 10880/0066-0069

Patient Information Leaflet
06/06/2016

very rare: in less than 1 of 10,000 patients
 severe kidney problems
 blurred vision
 bowel blockage
 severe abdominal pain causing you to be sick (intestinal angioedema)
 thickened patches of red/silver skin
not known (cannot be estimated from the available data)
 stroke
 inflammation of the liver and the pancreas
 jaundice
 changes in blood cell count (white and red blood cells, thrombocytes,
haemoglobin, haematocrit)
 changes in liver function (may only be detected by blood tests)
 low blood pressure when standing up
 narrowing of the airways in the lungs
flaking skin, intense skin rash including hives, severe itching, blistering, peeling
and swelling of the skin, inflammation of mucous membranes, hair loss, skin
sensitivity to sunlight. Skin changes may be associated with fever, inflammation
of blood vessels and abdominal tissue, muscle or joint pain, arthritis with blood
test abnormalities
Development of breasts in men and inflammation of the blood vessels have been
reported with other ACE-inhibitors and may occur with quinapril.
5.

HOW TO STORE QUINHEXAL

Keep out of the reach and sight of children.
Do not use Quinhexal after the expiry date which is stated on the blister and 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.
6.

FURTHER INFORMATION

What Quinhexal contains
The active substance is quinapril hydrochloride, which is equivalent to 5mg,
10mg, 20mg or 40mg quinapril.
The other ingredients are:
PIL.10880.00660069.007.1d

V023: RAS Referral, WS + RFI

IS

Hexal AG
Quinhexal 5, 10, 20 & 40 mg Tablets

PL 10880/0066-0069

Patient Information Leaflet
06/06/2016

Tablet core
lactose monohydrate
microcrystalline cellulose
magnesium stearate
magnesium oxide
crospovidone type A
Coat
hypromellose
macrogol 400
polysorbate 80
iron oxide yellow (E172)
iron oxide black (E172)
titanium dioxide (E171).
What Quinhexal looks like and contents of the pack
Quinhexal 5mg Tablets:
Quinhexal 5mg film-coated tablets are beige and oval and marked QP/5 on one
side and G on the other.
Quinhexal 10mg Tablets:
Quinhexal 10 mg film-coated tablets are beige and oval and marked QP/10 on
one side and G on the other.
Quinhexal 20mg Tablets:
Quinhexal 20 mg film-coated tablets are beige and oval and marked QP/20 on
one side and G on the other.
Quinhexal 40mg Tablets:
Quinhexal 40 mg film-coated tablets are beige and oval and marked QP/40 on
one side and G on the other.
Quinhexal tablets are available in blister packs of 10, 14, 28, 30, 50, 60 and 100
film-coated tablets.
Not all pack sizes maybe marketed.
The pharmacist will dispense the number of tablets prescribed by your doctor.
Marketing Authorisation Holder
Hexal AG
Industriestrasse 25
83607 Holzkirchen
Germany
PIL.10880.00660069.007.1d

V023: RAS Referral, WS + RFI

IS

Hexal AG
Quinhexal 5, 10, 20 & 40 mg Tablets

PL 10880/0066-0069

Patient Information Leaflet
06/06/2016

Manufacturer
Generics (UK) Ltd, Station Close, Potters Bar, Hertfordshire, EN6 1 TL, United
Kingdom OR
Mc Dermott Laboratories t/a Gerard Laboratories, 35/36 Baldoyle Industrial
Estate, Grange Road, Dublin 13, Ireland OR
Merck Farma y Quimica S.A, Poligono MERCK, E-08100 Mollet Del Valles,
Barcelona, Spain OR
Salutas Pharma GmbH, Otto-von-Guericke-Allee 1, 39179 Barleben, Germany
This leaflet was last revised in 08/2014.

PIL.10880.00660069.007.1d

V023: RAS Referral, WS + RFI

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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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