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ACCUPRO 20MG TABLETS

Active substance: QUINAPRIL

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S205 LEAFLET Accupro 20120730



PATIENT INFORMATION LEAFLET

ACCUPRO™ 20mg TABLETS
(quinapril hydrochloride)

You must tell your doctor if you think you are (or might become)
pregnant. Accupro 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).

Important things that you SHOULD know about your medicine:


Accupro is a treatment for high blood pressure and to help treat
heart failure.

Taking other medicines



Read all of this leaflet carefully before you start taking this
medicine



Other blood pressure treatments and diuretics (water tablets).



Keep this leaflet. You may need to read it again.



Medicines to treat infections called tetracyclines.



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.



Potassium supplements (this includes salt substitutes which
often contain potassium).



Lithium (used to treat to depression).



Non-steroidal anti-inflammatory pain killers (for example aspirin
or ibuprofen).



Steroids (for example hydrocortisone, dexamethasone or
prednisolone).



Procainamide (used to correct irregular heartbeats), cytostatic
drugs (cancer therapy), immunosuppressants (for the treatment
of autoimmune diseases e.g. Crohn’s disease and rheumatoid
arthritis), allopurinol (for the treatment of chronic gout).

Taking other medicines may sometimes cause problems.
Check with your doctor or pharmacist before taking this or any
other medicines.



Indigestion and heartburn medicines (antacids).



Drugs that have a sedative effect. This includes alcoholic
drinks and sleeping pills.

If you think you are (or might become) pregnant, you must tell
your doctor. Do not take Accupro if you are more than 3 months
pregnant.



Drugs to treat diabetes.



ACTH (tetracosactrin) (used to treat adrenal disorders)



Sympathomimetics (used to treat heart failure and shock.)



You should take Accupro regularly to get the maximum benefit,
even if you are feeling well.



Most people do not have serious problems when taking
Accupro but side effects can occur – see Section 4 for details.
If you experience swelling of the face, tongue or throat, see
your doctor immediately. 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.





This leaflet also contains information about other strengths i.e.
Accupro 5mg tablets, Accupro 10mg tablets and Accupro 40mg
tablets.
Please read the rest of this leaflet. It includes other important
information on the safe and effective use of this medicine that might
be especially important to you. If you have any further questions,
ask your doctor or pharmacist.
In this leaflet:

There are some medicines that may interact with Accupro:

You should always tell your doctor if you are taking or have recently
taken any other medicine, even those not prescribed, because they
might interact with Accupro.
Laboratory Tests
Accupro may affect the results of some laboratory tests. Tell your
doctor or hospital you are taking Accupro if you need to have any
tests carried out by your doctor or in hospital.

1. What Accupro is and what it is used for
2. Before you take Accupro

Taking Accupro with food and drink

3. How to take Accupro

Accupro can be taken with or without food.

4. Possible side effects
5. How to store Accupro

Pregnancy and breast feeding

6. Further information

Pregnancy

1. WHAT ACCUPRO IS AND WHAT IT IS USED FOR

You must tell your doctor if you think you are (or might become)
pregnant. Your doctor will normally advise you to stop taking
Accupro before you become pregnant or as soon as you know you
are pregnant and will advise you to take another medicine instead
of Accupro. Accupro 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.

Accupro is one of a group of medicines called angiotensin
converting enzyme (ACE) inhibitors. ACE inhibitors work by
widening blood vessels in the body, which can reduce the pressure
in the vessels.
It is used to treat high blood pressure, or to help treat heart failure.
2. BEFORE YOU TAKE ACCUPRO
Do not take Accupro:


If you have had an allergic reaction in the past to Accupro, the
active ingredient quinapril hydrochloride, or any of the other
ingredients listed in Section 6. This may have been itching, a
rash on the skin or difficulty in breathing.



If you are more than 3 months pregnant. (It is also better to
avoid Accupro in early pregnancy – see pregnancy section.)



If you have a condition called angioeurotic oedema (a swelling
of the face, tongue or throat which causes difficulty breathing).



If you have aortic stenosis (narrowing of the main blood vessel
from the heart).

Take special care with Accupro
If any of the following statements applies to you, and you have not
already discussed the matter with your doctor, you must contact
your doctor before taking ACCUPRO, as this medicine may not be
suitable for you:


You have kidney disease or use a haemodialysis machine (an
artificial kidney)



You have liver disease



You have heart disease



You have collagen vascular disease (deposits of collagen in
your blood vessels)



You are having, or about to have, low density lipoprotein
apheresis treatment (removal of cholesterol from your blood by
machine).



You suffer from allergies or asthma.



If you are having, or about to have, desensitisation treatment,
i.e. to reduce the effects of an allergy to a bee or wasp sting.



You have diabetes.



You are also taking other medicines

Breast-feeding
Tell your doctor if you are breast-feeding or about to start breastfeeding. Breast-feeding newborn babies (first few weeks after birth),
and especially premature babies, is not recommended whilst taking
Accupro. In the case of an older baby your doctor should advise
you on the benefits and risks of taking Accupro whilst breastfeeding, compared with other treatments.
Driving and using machinery
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 and contact your doctor immediately.
Important information about some of the ingredients in
Accupro
Accupro contains lactose (a type of sugar), if you have been told by
your doctor that you have an intolerance to some sugars, contact
your doctor before taking this medicinal product.
3. HOW TO TAKE ACCUPRO
For treatment of hypertension (high blood pressure) the starting
dose is usually 10 mg a day, which may be increased gradually up
to a maximum of 80 mg a day.
For the treatment of heart failure, if you are also taking water tablets
(diuretics) to treat your high blood pressure, you are aged 65 or
over, or you have kidney disease, the starting dose is usually 2.5
mg, which may be increased up to a maximum of 40 mg a day.
Accupro should not be used in children and adolescents under 18
years of age.
Accupro tablets should be taken either once or twice a day.
Whatever dose you have been prescribed, follow your doctor's
instructions exactly and never change the dose yourself.
Swallow the tablets whole with water. Do not chew, divide or
crush the tablets.

If you are still not sure, ask your doctor or pharmacist.

Other side effects of Accupro:

It is important to keep taking your tablets. They help to control your
blood pressure.



ringing or noise in the ears, disorders of balance



fainting

Don't wait until your tablets are finished before seeing your doctor.



bronchitis; narrowing of the airways in the lungs
(bronchospasm)

If you take more Accupro than you should



constipation; obstruction of the digestive system (bowel)

Taking too many tablets at once may make you unwell. Tell your
doctor or go to your nearest hospital casualty department
immediately.



dry mouth; taste disturbances



lazy eye



confusion

If you miss a dose of Accupro



hair loss

Do not worry. If you forget to take a dose, miss out the forgotten
dose completely and take the next dose at the normal time. Do not
take a double dose to make up for a missed dose.



hepatitis (liver inflammation)



increased numbers of white blood cells or decrease in blood
platelets which may result in bruising or easy bleeding; low
numbers of red blood cells (anaemia).

If you have any further questions on the use of this product, ask
your doctor or pharmacist
4. POSSIBLE SIDE EFFECTS

Accupro may cause certain changes in your blood and your doctor
may do blood tests to monitor this. If you notice bruising, feeing
very tired or if you are diabetic and notice sugar levels rising let
your doctor know so blood tests can be arranged if necessary.

Like all medicines, Accupro can cause side effects although not
everybody gets them.

If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet, please tell your doctor.
5. HOW TO STORE ACCUPRO

STOP taking Accupro and call an ambulance immediately if you
experience any of the following symptoms. Although they are very
rare, they can be serious.



KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.



Do not use after the expiry date printed on the carton label or
blister strip.



Accupro Tablets should not be stored above 25°C.



If your doctor tells you to stop using the medicine, please take it
back to the pharmacist for safe disposal. Only keep the
medicine if your doctor tells you to.



If the medicine becomes discoloured or shows any other signs
of deterioration, you should seek the advice of your pharmacist
who will tell you what to do.



Swelling of the face, tongue and throat which cause great
difficulty breathing (angioedema)



Severe abdominal pain causing you to be sick (intestinal
angioedema)



Heart attack, speeding up of the heart rate



Weakness of arms, legs or problems speaking which may be
symptoms of a possible stroke



Intense skin rash including hives, severe itching, blistering,
peeling and swelling of the skin, inflammation of mucous
membranes (Stevens Johnson Syndrome)

6. FURTHER INFORMATION



Severe allergic (anaphylactoid) reaction to this medicine.



Each film-coated Accupro 20mg Tablet contains 20mg of the
active ingredient, quinapril (as the hydrochloride).



Accupro Tablets also contain the following: magnesium
carbonate heavy, lactose, gelatin, crospovidone, magnesium
stearate, candelilla wax, hydroxypropylcellulose, macrogol 400,
hypromellose, titanium dioxide (E171) and red iron oxide
(E172).

Tell your doctor immediately if you experience any of the following
symptoms after taking this medicine. Although they are very rare,
these symptoms can be serious.






Feeling faint, particularly when standing. This may mean your
blood pressure is too low (hypotension). This is more likely to
occur if you have been taking diuretics (water tablets), other
blood pressure medication in addition to Accupro, alcohol or if
you are dehydrated or on dialysis. If you feel light headed or
faint, lie down until this feeling passes.
Severe sore throat or severe mouth ulcers, particularly if you
suffer from kidney problems or collagen vascular disease. This
may mean you do not have enough of certain white blood cells
(neutropenia/agranulocytosis), which may lead to increased risk
of infection or fever.
Chest pain, tightness of the chest, shortness of breath,
wheezing or trouble breathing, irregular or strong heartbeat
(palpitations).



Severe abdominal and back pain accompanied with feeling very
unwell (pancreatitis)



Yellowing of the skin or the eyes (jaundice)

The following side-effects have also been reported in patients with
high blood pressure being treated with Accupro. If any of these
side-effects gets serious, or if you notice any side-effects not listed
in this leaflet, please tell your doctor:
The most common side effects are:


feeling or being sick



headache; dizziness



tiredness



coughing; chest infection



nasal stuffiness and/or runny nose (rhinitis)

Less common side effects are:


diarrhoea, indigestion; wind



painful muscles; muscle weakness; back pain; joint pain (gout)



feeling weak; sleeplessness



kidney and urinary problems



numbness or tingling sensation in your limbs



depression; nervousness



fluid retention in the body



inflammation of your sinuses (sinusitis)



blurred vision



failure/ inability to achieve erection in males

What Accupro contains

What Accupro looks like and contents of the pack
Accupro 20mg tablets are reddish-brown circular tablets marked
‘20’ on one side and scored on both sides
Accupro Tablets are available as blister packs of 14 or 28 tablets.
Product Licence holder
Procured from within the EU and repackaged by the
Product Licence holder: S&M Medical Ltd, Chemilines House,
Alperton Lane, Wembley, HA0 1DX.
Manufacturer
This product is manufactured by


Goedecke GmbH, 79090 Freiburg, Germany.



Pfizer Manufacturing Deutschland GmbH, 79090 Freiburg,
Germany.

POM

PL No. 19488/0205 Accupro 20mg Tablets

Leaflet revision date: 30 July 2012
Accupro is a registered trade mark of Parke, Davis & Co, USA.
S205 LEAFLET Accupro 20120730

S204 LEAFLET Quinapril 20120730



PATIENT INFORMATION LEAFLET

QUINAPRIL 20mg TABLETS
(quinapril hydrochloride)

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).

Important things that you SHOULD know about your medicine:


Quinapril is a treatment for high blood pressure and to help treat
heart failure.

Taking other medicines



Read all of this leaflet carefully before you start taking this
medicine



Other blood pressure treatments and diuretics (water tablets).



Keep this leaflet. You may need to read it again.



Medicines to treat infections called tetracyclines.



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.



Potassium supplements (this includes salt substitutes which
often contain potassium).



Lithium (used to treat to depression).



Non-steroidal anti-inflammatory pain killers (for example aspirin
or ibuprofen).



Steroids (for example hydrocortisone, dexamethasone or
prednisolone).



Procainamide (used to correct irregular heartbeats), cytostatic
drugs (cancer therapy), immunosuppressants (for the treatment
of autoimmune diseases e.g. Crohn’s disease and rheumatoid
arthritis), allopurinol (for the treatment of chronic gout).

Taking other medicines may sometimes cause problems.
Check with your doctor or pharmacist before taking this or any
other medicines.



Indigestion and heartburn medicines (antacids).



Drugs that have a sedative effect. This includes alcoholic
drinks and sleeping pills.

If you think you are (or might become) pregnant, you must tell
your doctor. Do not take Quinapril if you are more than 3
months pregnant.



Drugs to treat diabetes.



ACTH (tetracosactrin) (used to treat adrenal disorders)

This leaflet also contains information about other strengths i.e.
Quinapril 5mg tablets, Quinapril 10mg tablets and Quinapril 40mg
tablets.



Sympathomimetics (used to treat heart failure and shock.)



You should take Quinapril regularly to get the maximum benefit,
even if you are feeling well.



Most people do not have serious problems when taking
Quinapril but side effects can occur – see Section 4 for details.
If you experience swelling of the face, tongue or throat, see
your doctor immediately. 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.





Please read the rest of this leaflet. It includes other important
information on the safe and effective use of this medicine that might
be especially important to you. If you have any further questions,
ask your doctor or pharmacist.
In this leaflet:

There are some medicines that may interact with Quinapril:

You should always tell your doctor if you are taking or have recently
taken any other medicine, even those not prescribed, because they
might interact with Quinapril.
Laboratory Tests
Quinapril may affect the results of some laboratory tests. Tell your
doctor or hospital you are taking Quinapril if you need to have any
tests carried out by your doctor or in hospital.

1. What Quinapril is and what it is used for
2. Before you take Quinapril

Taking Quinapril with food and drink

3. How to take Quinapril

Quinapril can be taken with or without food.

4. Possible side effects
5. How to store Quinapril

Pregnancy and breast feeding

6. Further information

Pregnancy

1. WHAT QUINAPRIL IS AND WHAT IT IS USED FOR

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.

Quinapril is one of a group of medicines called angiotensin
converting enzyme (ACE) inhibitors. ACE inhibitors work by
widening blood vessels in the body, which can reduce the pressure
in the vessels.
It is used to treat high blood pressure, or to help treat heart failure.
2. BEFORE YOU TAKE QUINAPRIL
Do not take Quinapril:


If you have had an allergic reaction in the past to Quinapril, the
active ingredient quinapril hydrochloride, or any of the other
ingredients listed in Section 6. This may have been itching, a
rash on the skin or difficulty in breathing.



If you are more than 3 months pregnant. (It is also better to
avoid Quinapril in early pregnancy – see pregnancy section.)



If you have a condition called angioeurotic oedema (a swelling
of the face, tongue or throat which causes difficulty breathing).



If you have aortic stenosis (narrowing of the main blood vessel
from the heart).

Take special care with Quinapril
If any of the following statements applies to you, and you have not
already discussed the matter with your doctor, you must contact
your doctor before taking QUINAPRIL, as this medicine may not be
suitable for you:


You have kidney disease or use a haemodialysis machine (an
artificial kidney)



You have liver disease



You have heart disease



You have collagen vascular disease (deposits of collagen in
your blood vessels)



You are having, or about to have, low density lipoprotein
apheresis treatment (removal of cholesterol from your blood by
machine).



You suffer from allergies or asthma.



If you are having, or about to have, desensitisation treatment,
i.e. to reduce the effects of an allergy to a bee or wasp sting.



You have diabetes.



You are also taking other medicines

Breast-feeding
Tell your doctor if you are breast-feeding or about to start breastfeeding. 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 breastfeeding, compared with other treatments.
Driving and using machinery
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 and contact your doctor immediately.
Important information about some of the ingredients in
Quinapril
Quinapril contains lactose (a type of sugar), if you have been told
by your doctor that you have an intolerance to some sugars, contact
your doctor before taking this medicinal product.
3. HOW TO TAKE QUINAPRIL
For treatment of hypertension (high blood pressure) the starting
dose is usually 10 mg a day, which may be increased gradually up
to a maximum of 80 mg a day.
For the treatment of heart failure, if you are also taking water tablets
(diuretics) to treat your high blood pressure, you are aged 65 or
over, or you have kidney disease, the starting dose is usually 2.5
mg, which may be increased up to a maximum of 40 mg a day.
Quinapril should not be used in children and adolescents under 18
years of age.
Quinapril tablets should be taken either once or twice a day.
Whatever dose you have been prescribed, follow your doctor's
instructions exactly and never change the dose yourself.
Swallow the tablets whole with water. Do not chew, divide or
crush the tablets.

If you are still not sure, ask your doctor or pharmacist.

Other side effects of Quinapril:

It is important to keep taking your tablets. They help to control your
blood pressure.



ringing or noise in the ears, disorders of balance



fainting

Don't wait until your tablets are finished before seeing your doctor.



bronchitis; narrowing of the airways in the lungs
(bronchospasm)

If you take more Quinapril than you should



constipation; obstruction of the digestive system (bowel)

Taking too many tablets at once may make you unwell. Tell your
doctor or go to your nearest hospital casualty department
immediately.



dry mouth; taste disturbances



lazy eye



confusion

If you miss a dose of Quinapril



hair loss

Do not worry. If you forget to take a dose, miss out the forgotten
dose completely and take the next dose at the normal time. Do not
take a double dose to make up for a missed dose.



hepatitis (liver inflammation)



increased numbers of white blood cells or decrease in blood
platelets which may result in bruising or easy bleeding; low
numbers of red blood cells (anaemia).

If you have any further questions on the use of this product, ask
your doctor or pharmacist
4. POSSIBLE SIDE EFFECTS

Quinapril may cause certain changes in your blood and your doctor
may do blood tests to monitor this. If you notice bruising, feeing
very tired or if you are diabetic and notice sugar levels rising let
your doctor know so blood tests can be arranged if necessary.

Like all medicines, Quinapril can cause side effects although not
everybody gets them.

If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet, please tell your doctor.
5. HOW TO STORE QUINAPRIL

STOP taking Quinapril and call an ambulance immediately if
you experience any of the following symptoms. Although they are
very rare, they can be serious.



KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.



Do not use after the expiry date printed on the carton label or
blister strip.



Quinapril Tablets should not be stored above 25°C.



If your doctor tells you to stop using the medicine, please take it
back to the pharmacist for safe disposal. Only keep the
medicine if your doctor tells you to.



If the medicine becomes discoloured or shows any other signs
of deterioration, you should seek the advice of your pharmacist
who will tell you what to do.



Swelling of the face, tongue and throat which cause great
difficulty breathing (angioedema)



Severe abdominal pain causing you to be sick (intestinal
angioedema)



Heart attack, speeding up of the heart rate



Weakness of arms, legs or problems speaking which may be
symptoms of a possible stroke



Intense skin rash including hives, severe itching, blistering,
peeling and swelling of the skin, inflammation of mucous
membranes (Stevens Johnson Syndrome)

6. FURTHER INFORMATION



Severe allergic (anaphylactoid) reaction to this medicine.



Each film-coated Quinapril 20mg Tablet contains 20mg of the
active ingredient, quinapril (as the hydrochloride).



Quinapril Tablets also contain the following: magnesium
carbonate heavy, lactose, gelatin, crospovidone, magnesium
stearate, candelilla wax, hydroxypropylcellulose, macrogol 400,
hypromellose, titanium dioxide (E171) and red iron oxide
(E172).

Tell your doctor immediately if you experience any of the following
symptoms after taking this medicine. Although they are very rare,
these symptoms can be serious.






Feeling faint, particularly when standing. This may mean your
blood pressure is too low (hypotension). This is more likely to
occur if you have been taking diuretics (water tablets), other
blood pressure medication in addition to Quinapril, alcohol or if
you are dehydrated or on dialysis. If you feel light headed or
faint, lie down until this feeling passes.
Severe sore throat or severe mouth ulcers, particularly if you
suffer from kidney problems or collagen vascular disease. This
may mean you do not have enough of certain white blood cells
(neutropenia/agranulocytosis), which may lead to increased risk
of infection or fever.
Chest pain, tightness of the chest, shortness of breath,
wheezing or trouble breathing, irregular or strong heartbeat
(palpitations).



Severe abdominal and back pain accompanied with feeling very
unwell (pancreatitis)



Yellowing of the skin or the eyes (jaundice)

The following side-effects have also been reported in patients with
high blood pressure being treated with Quinapril. If any of these
side-effects gets serious, or if you notice any side-effects not listed
in this leaflet, please tell your doctor:
The most common side effects are:


feeling or being sick



headache; dizziness



tiredness



coughing; chest infection



nasal stuffiness and/or runny nose (rhinitis)

Less common side effects are:


diarrhoea, indigestion; wind



painful muscles; muscle weakness; back pain; joint pain (gout)



feeling weak; sleeplessness



kidney and urinary problems



numbness or tingling sensation in your limbs



depression; nervousness



fluid retention in the body



inflammation of your sinuses (sinusitis)



blurred vision



failure/ inability to achieve erection in males

What Quinapril contains

What Quinapril looks like and contents of the pack
Quinapril 20mg tablets are a reddish-brown circular tablets marked
‘20’ on one side and scored on both sides
Quinapril Tablets are available as blister packs of 14 or 28 tablets.
Product Licence holder
Procured from within the EU and repackaged by the
Product Licence holder: S&M Medical Ltd, Chemilines House,
Alperton Lane, Wembley, HA0 1DX.
Manufacturer
This product is manufactured by


Goedecke GmbH, 79090 Freiburg, Germany.



Pfizer Manufacturing Deutschland GmbH, 79090 Freiburg,
Germany.

POM

PL No. 19488/0205 Quinapril 20mg Tablets

Leaflet revision date: 30 July 2012.
S204 LEAFLET Quinapril 20120730

Expand view ⇕

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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