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PROGANDOL XL 8MG TABLETS

Active substance(s): DOXAZOSIN MESILATE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

®

CARDURA XL 8mg Tablets
(doxazosin mesilate)
Important things that you SHOULD know about your
medicine:
CARDURA XL is a treatment for high blood pressure, or the
symptoms caused by enlargement of the prostate gland in
men.
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.
You should take CARDURA XL regularly to get the maximum
benefit, even if you are feeling well.
Most people do not have serious problems when taking
CARDURA XL but side effects can occur – see Section 4 for
details. If you experience swelling of the face, tongue or
windpipe, 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.
Taking other medicines may sometimes cause problems.
Check with your doctor or pharmacist before taking this or
any other medicines.
If you are, or are trying to become pregnant, do not take
CARDURA XL and tell your doctor.
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.
®

The name of your medicine is CARDURA XL 8mg Tablets but it
will be referred as CARDURA XL throughout this leaflet. Please
note that this leaflet also contains information about other strengths
CARDURA XL 4mg Tablets.
In this leaflet:
1. What CARDURA XL is and what it is used for
2. Before you take CARDURA XL
3. How to take CARDURA XL
4. Possible side effects
5. Storing CARDURA XL
6. Further information

1. What CARDURA XL is and what it is
used for
CARDURA XL is one of a group of medicines called alpha-blockers.
It is used to treat high blood pressure, or the symptoms caused by
enlargement of the prostate gland in men.
CARDURA XL can be used to treat high blood pressure
(hypertension), by relaxing blood vessels so that blood passes
through them more easily. This helps to lower blood pressure.
In patients with an enlarged prostate gland, CARDURA XL is taken
to treat poor and/or frequent passing of urine. This is common in
patients with an enlarged prostate gland. CARDURA XL works by
relaxing muscle around the bladder exit and prostate gland so urine
is passed more easily.

2. Before you take CARDURA XL
Do not take CARDURA XL:
If you have had an allergic reaction in the past to
CARDURA XL, the active ingredient doxazosin, other types of
quinazolines (such as prazosin or terazosin), or any of the other
ingredients listed in section 6. This may have been itching,
reddening of the skin or difficulty in breathing.
If you are breast-feeding.
If you have any form of obstruction of the digestive tract.
If you are under 18 years of age.
If you have an enlarged prostate gland (benign prostatic
hyperplasia) and have low blood pressure.
If you have a history of a condition known as ‘orthostatic
hypotension’ which is a form of low blood pressure that causes
you to feel dizzy or light-headed when you stand up from sitting
or lying down.
If you have an enlarged prostate gland with one of the following:
any kind of congestion or blockage in your urinary tract, a
longstanding infection of the urinary tract or you have bladder
stones.
If you have overflow incontinence (you do not feel the urge to
urinate), or anuria (your body is not producing any urine) with or
without kidney problems.
Take special care with CARDURA XL:
The following are reasons why CARDURA XL may not be suitable
for you:
If you are pregnant or trying to become pregnant
If you have liver disease
If you have heart disease
If you are also taking other medicines

If you are undergoing eye surgery because of cataract (cloudiness
of the lens of the eye) please inform your eye specialist before the
operation that you are using or have previously used
CARDURA XL. This is because CARDURA XL may cause
complications during the surgery which can be managed if your
specialist is prepared in advance.
If any of these apply to you speak to your doctor before taking this
medicine.
When you start to take CARDURA XL you may experience
faintness or dizziness caused by low blood pressure, when getting
up from sitting or lying down. If you feel faint or dizzy, you should sit
or lie down until you feel better and avoid situations where you
might fall or hurt yourself. Your doctor may want to measure your
blood pressure regularly at the start of therapy to reduce the
possibility of these effects happening.
Taking other medicines:
There are some medicines that may interact with CARDURA XL:
Some patients who take alpha-blocker therapy for the treatment
of high blood pressure or prostate enlargement may experience
dizziness or light-headedness, which may be caused by low
blood pressure upon sitting or standing up quickly. Certain
patients have experienced these symptoms when taking drugs
for erectile dysfunction (impotence) with alpha-blockers. In order
to reduce the likelihood that these symptoms occur, you should
be on a regular daily dose of your alpha blocker before you start
drugs for erectile dysfunction.
Cardura XL may lower your blood pressure even more if you are
already taking other medicines to treat your high blood pressure
such as terazosin and prazosin.
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 CARDURA XL.
Taking CARDURA XL with food and drink:
CARDURA XL can be taken with or without food.
Pregnancy:
The safety of using CARDURA XL during pregnancy has not been
established. If you are pregnant or trying to become pregnant speak
to your doctor and he/she will decide if CARDURA XL is suitable for
you.
Breast-feeding:
Do not take CARDURA XL if you are breast-feeding.
Driving and using machinery:
Take care if you drive or operate machinery. Your tablets may affect
your ability to drive or operate machinery safely, particularly when
you first start to take them. They may make you feel weak or dizzy.
If affected, do not drive or operate machinery and contact your
doctor immediately.

3. How to take CARDURA XL
CARDURA XL is a modified release tablet. The medicine is
contained within a non-absorbable shell that has been specially
designed to slowly release the medicine. Once swallowed,
doxazosin is slowly released into the body from the tablet, until the
tablet is empty.
Since the empty tablet is eliminated from the body in bowel
movements, you may occasionally observe in the stools, something
that looks like a tablet. This is to be expected and you should not be
concerned.

How to take your medicine









The usual dose of CARDURA XL is one 4mg modified release
tablet taken as a single daily dose each day.
Your doctor may wish to increase your dose to 8mg.This is the
maximum dose of CARDURA XL.
Swallow CARDURA XL whole with water. Do not chew, divide
or crush the tablets.
Take your tablets as your doctor told you or by following the
days and arrows on the blister foil.
If you are still not sure, ask your doctor or pharmacist.
It is important to keep taking your tablets. They help to control
your blood pressure.
Don't change the dose or stop taking the tablets without first
checking with your doctor.
Don't wait until your tablets are finished before seeing your
doctor.

If you take more CARDURA XL than you should:
Taking too many tablets at once may make you unwell.
If several tablets are taken it may be dangerous. Tell your doctor
immediately or go to your nearest hospital casualty department
immediately.
If you forget to take CARDURA XL:
Do not worry. If you forget to take a tablet, leave that dose out
completely. Then go on as before.

4. POSSIBLE SIDE EFFECTS
Like all medicines, CARDURA XL can cause side effects although
not everybody gets them.
STOP taking CARDURA XL and call an ambulance immediately
if you experience any of the following:
Heart attack
Weakness of arms, legs or problems speaking which may be
symptoms of a stroke
Swelling of the face, tongue or throat which may be the result of
an allergic reaction to this medicine
Tell your doctor immediately if you experience any of the following
symptoms after taking CARDURA XL:
Chest pain, angina
Shortness of breath, difficulty breathing, wheezing
Increased, decreased or irregular heart beat
Feeling your heart beat (palpitation)
Skin rash or itching (especially the whole body)
Fainting
Yellowing of the skin or the eyes (jaundice)
Low numbers of white blood cells or blood platelets, which may
result in bruising or easy bleeding
The following events have been reported in patients being treated
with CARDURA XL. If any of these side effects get serious, or if you
notice any side effects not listed in this leaflet, please tell your
doctor.
Common side effects
These can affect between 1 in 10 and 1 in 100 patients:
dizziness, feeling of spinning or rotation of surroundings
(vertigo), headache
low blood pressure
swelling of feet, ankles or fingers
bronchitis, coughing, respiratory tract (nose, throat, lungs)
infection
nasal stuffiness, sneezing and/or runny nose caused by
inflammation of the lining of the nose (rhinitis)
stomach/ abdominal pains, feeling/being sick
urinary tract infection, urinary incontinence (inability to control
passing urine), inflammation of the bladder (cystitis)
sleepiness, general weakness
indigestion, heartburn, dry mouth
back pain, painful muscles
flu-like symptoms
Uncommon side effects:
These can affect between 1 in 100 and 1 in 1,000 patients:
constipation, wind, inflammation of the stomach and intestines
(gastroenteritis) which can cause diarrhoea and vomiting
pain or discomfort on passing urine, needing to pass urine more
often than usual, blood in urine
inflammation of the joints (gout), painful joints, general pain
swelling of the face
sleeplessness, anxiety, depression
reduced or altered sense of touch or sensation of the hands and
feet
increased appetite or loss of appetite, weight gain
nose bleeds
ringing in the ears, tremor
failure/ inability to achieve penile erection
abnormal results for blood tests which show changes in the way
the liver is working
Very Rare side effects
These can affect less than 1 in 10,000 patients:
faintness or dizziness caused by low blood pressure when
getting up from a sitting or lying position
hepatitis (liver inflammation) or bile disorder
hives, hair loss, red or purple patches on the skin, bleeding
under the skin
tingling or numbness of the hands and feet
agitation, nervousness.
tiredness, generally feeling unwell
aggravated wheezing
muscle cramps, muscle weakness
blurred vision
flushing
disorder in passing urine, needing to pass urine at night,
increased volume of urine passed, increased production of urine
causing an increase in the number of times of passing urine
discomfort or enlargement of the breasts in men
painful persistent erection of the penis
Other side effects
The frequency of these side effects is unknown:
little or no semen ejaculated at sexual climax, cloudy urine
following sexual climax
eye problems may occur during eye surgery for cataract
(cloudiness of the lens of the eye). See section ‘Take special
care with CARDURA XL’.
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 CARDURA XL
CARDURA XL should not be stored above 30°C. Store in the
original container.
Do not use after the expiry date printed on the carton label or
blister strip. The expiry date refers to the last day of that month.
The tablet should be swallowed whole to work effectively,
however if you notice any defects (such as broken tablets)
consult your pharmacist immediately.
KEEP ALL MEDICINES OUT OF THE SIGHT AND REACH OF
CHILDREN.
If your doctor tells you to stop taking the tablets, please take
them back to the pharmacist for safe disposal. Only keep the
tablets if your doctor tells you to.
If the tablets become discoloured or show any other signs of
deterioration, you should seek the advice of your pharmacist.

6. Further information
CARDURA XL contains 9.70mg of the active ingredient doxazosin
mesilate, equivalent to 8mg of Doxazosin in a white, round modified
release tablet, which is, marked ‘CXL 8’ on one side and plain on
the reverse. The tablets are designed to slowly release the drug.
CARDURA XL 8mg tablets also contain the following:
Polyethylene oxide, sodium chloride, hypromellose, cellulose
acetate, magnesium stearate, macrogol, ammonium hydroxide,
titanium dioxide (E171), black iron oxide (E172), red iron oxide
(E172), shellac, n-butyl alocohol, isopropyl alcohol, and propylene
glycol.
CARDURA XL are available in calendar blister packs of 28 tablets.
Manufactured by: Industrias Farmaceuticas Almirall, S.L., Ctra.
Nacional II, Km. 593 08740 Sant Andreu de la barca – Barcelona,
Spain.
Procured from within the EU and repackaged by the Product
Licence holder: B&S Healthcare, Unit 4, Bradfield Road, Ruislip,
Middlesex, HA4 0NU, UK
®

CARDURA XL 8mg Tablets; PL No: 18799/2640
Leaflet date: 16.09.2015

POM

PACKAGE LEAFLET: INFORMATION FOR THE USER

®

PROGANDOL XL 8mg Tablets
(doxazosin mesilate)
Important things that you SHOULD know about your
medicine:
PROGANDOL XL is a treatment for high blood pressure, or
the symptoms caused by enlargement of the prostate gland
in men.
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.
You should take PROGANDOL XL regularly to get the
maximum benefit, even if you are feeling well.
Most people do not have serious problems when taking
PROGANDOL XL but side effects can occur – see Section 4
for details. If you experience swelling of the face, tongue or
windpipe, 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.
Taking other medicines may sometimes cause problems.
Check with your doctor or pharmacist before taking this or
any other medicines.
If you are, or are trying to become pregnant, do not take
PROGANDOL XL and tell your doctor.
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.
®

The name of your medicine is PROGANDOL XL 8mg Tablets but it
will be referred as PROGANDOL XL throughout this leaflet. Please
note that this leaflet also contains information about other strengths
PROGANDOL XL 4mg Tablets.
In this leaflet:
1. What PROGANDOL XL is and what it is used for
2. Before you take PROGANDOL XL
3. How to take PROGANDOL XL
4. Possible side effects
5. Storing PROGANDOL XL
6. Further information

1. What PROGANDOL XL is and what it
is used for
PROGANDOL XL is one of a group of medicines called
alpha-blockers. It is used to treat high blood pressure, or the
symptoms caused by enlargement of the prostate gland in men.
PROGANDOL XL can be used to treat high blood pressure
(hypertension), by relaxing blood vessels so that blood passes
through them more easily. This helps to lower blood pressure.
In patients with an enlarged prostate gland, PROGANDOL XL is
taken to treat poor and/or frequent passing of urine. This is common
in patients with an enlarged prostate gland. PROGANDOL XL
works by relaxing muscle around the bladder exit and prostate
gland so urine is passed more easily.

2. Before you take PROGANDOL XL
Do not take PROGANDOL XL:
If you have had an allergic reaction in the past to
PROGANDOL XL, the active ingredient doxazosin, other types
of quinazolines (such as prazosin or terazosin), or any of the
other ingredients listed in section 6. This may have been itching,
reddening of the skin or difficulty in breathing.
If you are breast-feeding.
If you have any form of obstruction of the digestive tract.
If you are under 18 years of age.
If you have an enlarged prostate gland (benign prostatic
hyperplasia) and have low blood pressure.
If you have a history of a condition known as ‘orthostatic
hypotension’ which is a form of low blood pressure that causes
you to feel dizzy or light-headed when you stand up from sitting
or lying down.
If you have an enlarged prostate gland with one of the following:
any kind of congestion or blockage in your urinary tract, a
longstanding infection of the urinary tract or you have bladder
stones.
If you have overflow incontinence (you do not feel the urge to
urinate), or anuria (your body is not producing any urine) with or
without kidney problems.
Take special care with PROGANDOL XL:
The following are reasons why PROGANDOL XL may not be
suitable for you:
If you are pregnant or trying to become pregnant
If you have liver disease
If you have heart disease
If you are also taking other medicines

If you are undergoing eye surgery because of cataract (cloudiness
of the lens of the eye) please inform your eye specialist before the
operation that you are using or have previously used
PROGANDOL XL. This is because PROGANDOL XL may cause
complications during the surgery which can be managed if your
specialist is prepared in advance.
If any of these apply to you speak to your doctor before taking this
medicine.
When you start to take PROGANDOL XL you may experience
faintness or dizziness caused by low blood pressure, when getting
up from sitting or lying down. If you feel faint or dizzy, you should sit
or lie down until you feel better and avoid situations where you
might fall or hurt yourself. Your doctor may want to measure your
blood pressure regularly at the start of therapy to reduce the
possibility of these effects happening.
Taking other medicines:
There are some medicines that may interact with PROGANDOL XL:
Some patients who take alpha-blocker therapy for the treatment
of high blood pressure or prostate enlargement may experience
dizziness or light-headedness, which may be caused by low
blood pressure upon sitting or standing up quickly. Certain
patients have experienced these symptoms when taking drugs
for erectile dysfunction (impotence) with alpha-blockers. In order
to reduce the likelihood that these symptoms occur, you should
be on a regular daily dose of your alpha blocker before you start
drugs for erectile dysfunction.
PROGANDOL XL may lower your blood pressure even more if
you are already taking other medicines to treat your high blood
pressure such as terazosin and prazosin.
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 PROGANDOL XL.
Taking PROGANDOL XL with food and drink:
PROGANDOL XL can be taken with or without food.
Pregnancy:
The safety of using PROGANDOL XL during pregnancy has not
been established. If you are pregnant or trying to become pregnant
speak to your doctor and he/she will decide if PROGANDOL XL is
suitable for you.
Breast-feeding:
Do not take PROGANDOL XL if you are breast-feeding.
Driving and using machinery:
Take care if you drive or operate machinery. Your tablets may affect
your ability to drive or operate machinery safely, particularly when
you first start to take them. They may make you feel weak or dizzy.
If affected, do not drive or operate machinery and contact your
doctor immediately.

3. How to take PROGANDOL XL
PROGANDOL XL is a modified release tablet. The medicine is
contained within a non-absorbable shell that has been specially
designed to slowly release the medicine. Once swallowed,
doxazosin is slowly released into the body from the tablet, until the
tablet is empty.
Since the empty tablet is eliminated from the body in bowel
movements, you may occasionally observe in the stools, something
that looks like a tablet. This is to be expected and you should not be
concerned.

How to take your medicine









The usual dose of PROGANDOL XL is one 4mg modified
release tablet taken as a single daily dose each day.
Your doctor may wish to increase your dose to 8mg.This is the
maximum dose of PROGANDOL XL.
Swallow PROGANDOL XL whole with water. Do not chew,
divide or crush the tablets.
Take your tablets as your doctor told you or by following the
days and arrows on the blister foil.
If you are still not sure, ask your doctor or pharmacist.
It is important to keep taking your tablets. They help to control
your blood pressure.
Don't change the dose or stop taking the tablets without first
checking with your doctor.
Don't wait until your tablets are finished before seeing your
doctor.

If you take more PROGANDOL XL than you should:
Taking too many tablets at once may make you unwell.
If several tablets are taken it may be dangerous. Tell your doctor
immediately or go to your nearest hospital casualty department
immediately.
If you forget to take PROGANDOL XL:
Do not worry. If you forget to take a tablet, leave that dose out
completely. Then go on as before.

4. POSSIBLE SIDE EFFECTS
Like all medicines, PROGANDOL XL can cause side effects
although not everybody gets them.
STOP taking PROGANDOL XL and call an ambulance
immediately if you experience any of the following:
Heart attack
Weakness of arms, legs or problems speaking which may be
symptoms of a stroke
Swelling of the face, tongue or throat which may be the result of
an allergic reaction to this medicine
Tell your doctor immediately if you experience any of the following
symptoms after taking PROGANDOL XL:
Chest pain, angina
Shortness of breath, difficulty breathing, wheezing
Increased, decreased or irregular heart beat
Feeling your heart beat (palpitation)
Skin rash or itching (especially the whole body)
Fainting
Yellowing of the skin or the eyes (jaundice)
Low numbers of white blood cells or blood platelets, which may
result in bruising or easy bleeding
The following events have been reported in patients being treated
with PROGANDOL XL. If any of these side effects get serious, or if
you notice any side effects not listed in this leaflet, please tell your
doctor.
Common side effects
These can affect between 1 in 10 and 1 in 100 patients:
dizziness, feeling of spinning or rotation of surroundings
(vertigo), headache
low blood pressure
swelling of feet, ankles or fingers
bronchitis, coughing, respiratory tract (nose, throat, lungs)
infection
nasal stuffiness, sneezing and/or runny nose caused by
inflammation of the lining of the nose (rhinitis)
stomach/ abdominal pains, feeling/being sick
urinary tract infection, urinary incontinence (inability to control
passing urine), inflammation of the bladder (cystitis)
sleepiness, general weakness
indigestion, heartburn, dry mouth
back pain, painful muscles
flu-like symptoms
Uncommon side effects:
These can affect between 1 in 100 and 1 in 1,000 patients:
constipation, wind, inflammation of the stomach and intestines
(gastroenteritis) which can cause diarrhoea and vomiting
pain or discomfort on passing urine, needing to pass urine more
often than usual, blood in urine
inflammation of the joints (gout), painful joints, general pain
swelling of the face
sleeplessness, anxiety, depression
reduced or altered sense of touch or sensation of the hands and
feet
increased appetite or loss of appetite, weight gain
nose bleeds
ringing in the ears, tremor
failure/ inability to achieve penile erection
abnormal results for blood tests which show changes in the way
the liver is working
Very Rare side effects
These can affect less than 1 in 10,000 patients:
faintness or dizziness caused by low blood pressure when
getting up from a sitting or lying position
hepatitis (liver inflammation) or bile disorder
hives, hair loss, red or purple patches on the skin, bleeding
under the skin
tingling or numbness of the hands and feet
agitation, nervousness.
tiredness, generally feeling unwell
aggravated wheezing
muscle cramps, muscle weakness
blurred vision
flushing
disorder in passing urine, needing to pass urine at night,
increased volume of urine passed, increased production of urine
causing an increase in the number of times of passing urine
discomfort or enlargement of the breasts in men
painful persistent erection of the penis
Other side effects
The frequency of these side effects is unknown:
little or no semen ejaculated at sexual climax, cloudy urine
following sexual climax
eye problems may occur during eye surgery for cataract
(cloudiness of the lens of the eye). See section ‘Take special
care with PROGANDOL XL’.
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 PROGANDOL XL
PROGANDOL XL should not be stored above 30°C. Store in the
original container.
Do not use after the expiry date printed on the carton label or
blister strip. The expiry date refers to the last day of that month.
The tablet should be swallowed whole to work effectively,
however if you notice any defects (such as broken tablets)
consult your pharmacist immediately.
KEEP ALL MEDICINES OUT OF THE SIGHT AND REACH OF
CHILDREN.
If your doctor tells you to stop taking the tablets, please take
them back to the pharmacist for safe disposal. Only keep the
tablets if your doctor tells you to.
If the tablets become discoloured or show any other signs of
deterioration, you should seek the advice of your pharmacist.

6. Further information
PROGANDOL XL contains 9.70mg of the active ingredient
doxazosin mesilate, equivalent to 8mg of Doxazosin in a white,
round modified release tablet, which is, marked ‘CXL 8’ on one side
and plain on the reverse. The tablets are designed to slowly release
the drug.
PROGANDOL XL 8mg tablets also contain the following:
Polyethylene oxide, sodium chloride, hypromellose, cellulose
acetate, magnesium stearate, macrogol, ammonium hydroxide,
titanium dioxide (E171), black iron oxide (E172), red iron oxide
(E172), shellac, n-butyl alocohol, isopropyl alcohol, and propylene
glycol.
PROGANDOL XL are available in calendar blister packs of
28 tablets.
Manufactured by: Industrias Farmaceuticas Almirall, S.L., Ctra.
Nacional II, Km. 593 08740 Sant Andreu de la barca – Barcelona,
Spain.
Procured from within the EU and repackaged by the Product
Licence holder: B&S Healthcare, Unit 4, Bradfield Road, Ruislip,
Middlesex, HA4 0NU, UK
®

PROGANDOL XL 8mg Tablets; PL No: 18799/2640
Leaflet date: 16.09.2015

POM

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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