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CARDICOR 2.5 MG FILM-COATED TABLETS

Active substance(s): BISOPROLOL HEMIFUMARATE

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PACKAGE LEAFLET- INFORMATION FOR THE USER
CARDICOR® 2.5 mg film-coated tablets
(bisoprolol hemifumarate)
Your medicine is available as the above name but will be referred to
as Cardicor throughout this leaflet
Read all of this leaflet carefully before you start taking this
medicine because it contains important information for you.
 Keep this leaflet. You may need to read it again.
 If you have any further questions, ask your doctor or your
pharmacist.
 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 or pharmacist. This
includes any possible side effects not listed in this leaflet. See
section 4.
What is in this leaflet:
1. What Cardicor is and what it is used for
2. What you need to know before you take Cardicor
3. How to take Cardicor
4. Possible side effects
5. How to store Cardicor
6. Contents of the pack and other information
1.

What Cardicor is and what it is used for

The active substance in Cardicor is bisoprolol.
Bisoprolol belongs to a group of medicines called beta-blockers.
These medicines work by affecting the body`s response to some
nerve impulses, especially in the heart. As a result, bisoprolol slows
down the heart rate and makes the heart more efficient at pumping
blood around the body.
Heart failure occurs when the heart muscle is weak and unable to
pump enough blood to supply the body’s needs. Cardicor is used to
treat stable chronic heart failure.
It is used in combination with other medicines suitable for this
condition (such as ACE-inhibitors, diuretics, and heart glycosides).
2.

What you need to know before you take Cardicor

Do not take Cardicor
Do not take Cardicor if one of the following conditions applies to you:
 allergy (hypersensitivity) to bisoprolol or to any of the other
ingredients (see section 6 ‘What Cardicor contains’)
 severe asthma
 severe blood circulation problems in your limbs (such as
Raynaud’s syndrome), which may cause your fingers and toes to
tingle or turn pale or blue
 untreated phaeochromocytoma, which is a rare tumour of the
adrenal gland
 metabolic acidosis, which is a condition when there is too much
acid in the blood.
Do not take Cardicor if you have one of the following heart problems:
 acute heart failure
 worsening heart failure requiring injection of medicines into a
vein, that increase the force of contraction of the heart
 slow heart rate
 low blood pressure
 certain heart conditions causing a very slow heart rate or
irregular heartbeat
 cardiogenic shock, which is an acute serious heart condition
causing low blood pressure and circulatory failure.
Warnings and precautions
If you have any of the following conditions tell your doctor before
taking Cardicor; he or she may want to take special care (for
example give additional treatment or perform more frequent checks):
 diabetes
 strict fasting
 certain heart diseases such as disturbances in heart rhythm, or
severe chest pain at rest (Prinzmetal’s angina)
 kidney or liver problems
 less severe blood circulation problems in your limbs
 chronic lung disease or less severe asthma
 history of a scaly skin rash (psoriasis)
 tumour of the adrenal gland (phaeochromocytoma)
 thyroid disorder.

In addition, tell your doctor if you are going to have:
desensitization therapy (for example for the prevention of hay
fever), because Cardicor may make it more likely that you
experience an allergic reaction, or such reaction may be more
severe
 anaesthesia (for example for surgery), because Cardicor may
influence how your body reacts to this situation.


If you have chronic lung disease or less severe asthma please inform
your doctor immediately if you start to experience new difficulties in
breathing, cough, wheezing after exercise, etc. when using Cardicor.

3.

How to take Cardicor

Always take this medicine exactly as your doctor has told you. Check
with your doctor or pharmacist if you are not sure.
Treatment with Cardicor requires regular monitoring by your doctor.
This is particularly necessary at the start of treatment, during dose
increase and when you stop treatment.
Take the tablet with some water in the morning, with or without food.
Do not crush or chew the tablet. The scored tablets can be divided
into two equal doses.

Children and adolescents
Cardicor is not recommended for use in children or adolescents

Treatment with Cardicor is usually long-term.

Other medicines and Cardicor
Tell your doctor or pharmacist if you are taking, have recently taken
or might take any other medicines.

Adults including the elderly:
Treatment with bisoprolol must be started at a low dose and
increased gradually.

Do not take the following medicines with Cardicor without special
advice from your doctor:
 certain medicines used to treat irregular or abnormal heartbeat
(Class I antiarrhythmic medicines such as quinidine,
disopyramide, lidocaine, phenytoin; flecainide, propafenone)
 certain medicines used to treat high blood pressure, angina
pectoris or irregular heartbeat (calcium antagonists such as
verapamil and diltiazem)
 certain medicines used to treat high blood pressure such as
clonidine, methyldopa, moxonodine, rilmenidine. However, do
not stop taking these medicines without checking with your
doctor first.

Your doctor will decide how to increase the dose, and this will
normally be done in the following way:
 1.25 mg bisoprolol once daily for one week
 2.5 mg bisoprolol once daily for one week
 3.75 mg bisoprolol once daily for one week
 5 mg bisoprolol once daily for four weeks
 7.5 mg bisoprolol once daily for four weeks
 10 mg bisoprolol once daily for maintenance (ongoing) therapy.
The maximum recommended daily dose is 10 mg bisoprolol.

Check with your doctor before taking the following medicines with
Cardicor; your doctor may need to check your condition more
frequently:
 certain medicines used to treat high blood pressure or angina
pectoris (dihydropyridine-type calcium antagonists such as
felodipine and amlodipine)
 certain medicines used to treat irregular or abnormal heartbeat
(Class III antiarrhythmic medicines such as amiodarone)
 beta-blockers applied locally (such as timolol eye drops for
glaucoma treatment)
 certain medicines used to treat for example Alzheimer’s disease
or glaucoma (parasympathomimetics such as tacrine or
carbachol) or medicines that are used to treat acute heart
problems (sympathomimetics such as isoprenaline and
dobutamine)
 antidiabetic medicines including insulin
 anaesthetic agents (for example during surgery)
 digitalis, used to treat heart failure
 non-steroidal anti-inflammatory medicines (NSAIDs) used to treat
arthritis, pain or inflammation (for example ibuprofen or
diclofenac)
 any medicine, which can lower blood pressure as a desired or
undesired effect such as antihypertensives, certain medicines for
depression (tricyclic antidepressants such as imipramine or
amitriptyline), certain medicines used to treat epilepsy or during
anaesthesia (barbiturates such as phenobarbital), or certain
medicines to treat mental illness characterized by a loss of
contact with reality (phenothiazines such as levomepromazine)
 mefloquine, used for prevention or treatment of malaria
 depression treatment medicines called monoamine oxidase
inhibitors (except MAO-B inhibitors) such as moclobemide.
Pregnancy and breast-feeding
Pregnancy
There is a risk that use of Cardicor during pregnancy may harm the
baby. If you are pregnant or planning to become pregnant, tell your
doctor. He or she will decide whether you can take Cardicor during
pregnancy.
Breast-feeding
It is not known whether bisoprolol passes into human breast milk.
Therefore, breastfeeding is not recommended during therapy with
Cardicor.
Driving and using machines
Your ability to drive or use machinery may be affected depending on
how well you tolerate the medicine.
Please be especially cautious at the start of treatment, when the
dose is increased or the medication is changed, as well as in
combination with alcohol.

Uncommon (may affect up to 1 in 100 people):
sleep disturbances
depression
dizziness when standing up
breathing problems in patients with asthma or chronic lung
disease
 muscle weakness, muscle cramps.





Rare (may affect up to 1 in 1,000 people):
 hearing problems
 allergic runny nose
 reduced tear flow
 inflammation of the liver which can cause yellowing of the skin or
whites of the eyes
 certain blood test results for liver function or fat levels differing
from normal
 allergy-like reactions such as itching, flush, rash
 impaired erection
 nightmares, hallucinations
 fainting.
Very rare (may affect up to 1 in 10,000 people):
 irritation and redness of the eye (conjunctivitis)
 hair loss
 appearance or worsening of scaly skin rash (psoriasis);
psoriasis-like rash.

Depending on how well you tolerate the medicine, your doctor may
also decide to lengthen the time between dose increases. If your
condition gets worse or you no longer tolerate the drug, it may be
necessary to reduce the dose again or to interrupt treatment. In
some patients a maintenance dose lower than 10 mg bisoprolol may
be sufficient.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects not listed in this leaflet. You can
also report side effects directly via the Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more information on
the safety of this medicine.

Your doctor will tell you what to do.

5.

If you have to stop treatment entirely, your doctor will usually advise
you to reduce the dose gradually, as otherwise your condition may
become worse.

KEEP ALL MEDICINES OUT OF THE SIGHT AND REACH OF
CHILDREN.
Do not store Cardicor tablets above 25°C.
Do not use any tablets after the expiry date on the carton or blister
label. Unused tablets or tablets older than their expiry date should be
returned to a pharmacy for disposal.
If your Cardicor tablets become discolored or show any signs of
deterioration, consult your pharmacist who will tell you what to do.
Medicines should not be disposed of via wastewater or household
waste. Ask your pharmacist how to dispose of medicines no longer
required. These measures will help to protect the environment.

If you take more Cardicor than you should
If you have taken more Cardicor tablets than you should, tell your
doctor immediately. Your doctor will decide what measures are
necessary.
Symptoms of an overdose may include slowed heart rate, severe
difficulty in breathing, feeling dizzy, or trembling (due to decreased
blood sugar).
If you forget to take Cardicor
Do not take a double dose to make up for a forgotten dose. Take
your usual dose the next morning.
If you stop taking Cardicor
Never stop taking Cardicor unless on your doctor’s advice. Otherwise
your condition could become much worse.
If you have any further questions on the use of this product, ask your
doctor or pharmacist.
4.

Possible side effects

Like all medicines, this medicine can cause side effects, although not
everybody gets them.
To prevent serious reactions, speak to a doctor immediately if a side
effect is severe, occurred suddenly or gets worse rapidly.
The most serious side effects are related to the heart function:
 slowing of heart rate (may affect more than 1 in 10 people)
 worsening of heart failure (may affect up to 1 in 10 people)
 slow or irregular heartbeat (may affect up to 1 in 100 people)
If you feel dizzy or weak, or have breathing difficulties please contact
your doctor as soon as possible.
Further side effects are listed below according to how frequently they
may occur:
Common (may affect up to 1 in 10 people):
 tiredness, feeling weak, dizziness, headache
 feeling of coldness or numbness in hands or feet
 low blood pressure
 stomach or intestine problems such as nausea, vomiting,
diarrhoea, or constipation.

6.

How to store Cardicor

Contents of the pack and other information

What Cardicor contains
Cardicor 2.5 mg film-coated tablets:
The active ingredient in Cardicor tablets is bisoprolol. Each
film-coated tablet contains 2.5 mg of bisoprolol hemifumarate.
Cardicor 2.5 mg film-coated tablets also contain the following inactive
ingredients: colloidal anhydrous silica, magnesium stearate,
crospovidone, microcrystalline cellulose, maize starch, calcium
hydrogen phosphate anhydrous, dimethicone, macrogol 400,
titanium dioxide (E171) and hypromellose.
What Cardicor looks like and contents of the pack
Cardicor 2.5 mg film-coated tablets are white, heart-shaped,
film-coated tablets with a score line on both sides
Cardicor 2.5 mg film-coated tablets are available in blister packs of
30 or 100 tablets.
Manufacturer and Product Licence holder
Cardicor is manufactured by Merck KGaA, Frankfurter Strasse 250,
64293 Darmstadt, Germany.
Or
Merck KGaA & Co, Werk Spittal Hösslgasse 20, 9800 Spittal/Drau,
Austria.
Procured from within the EU and repackaged by the Product Licence
holder: G-Pharma Ltd., Dakota Avenue, Salford M50 2PU.
PL 16369/1364
Cardicor 2.5 mg film-coated tablets

POM

Date of revision of this leaflet: 5th December 2013
‘Cardicor’ is a registered trademark of Merck.

PACKAGE LEAFLET- INFORMATION FOR THE USER
CARDICOR® 2.5 mg film-coated tablets
(bisoprolol hemifumarate)
Your medicine is available as the above name but will be referred to
as Cardicor throughout this leaflet
Read all of this leaflet carefully before you start taking this
medicine because it contains important information for you.
 Keep this leaflet. You may need to read it again.
 If you have any further questions, ask your doctor or your
pharmacist.
 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 or pharmacist. This
includes any possible side effects not listed in this leaflet. See
section 4.
What is in this leaflet:
1. What Cardicor is and what it is used for
2. What you need to know before you take Cardicor
3. How to take Cardicor
4. Possible side effects
5. How to store Cardicor
6. Contents of the pack and other information
1.

What Cardicor is and what it is used for

The active substance in Cardicor is bisoprolol.
Bisoprolol belongs to a group of medicines called beta-blockers.
These medicines work by affecting the body`s response to some
nerve impulses, especially in the heart. As a result, bisoprolol slows
down the heart rate and makes the heart more efficient at pumping
blood around the body.
Heart failure occurs when the heart muscle is weak and unable to
pump enough blood to supply the body’s needs. Cardicor is used to
treat stable chronic heart failure.
It is used in combination with other medicines suitable for this
condition (such as ACE-inhibitors, diuretics, and heart glycosides).
2.

What you need to know before you take Cardicor

Do not take Cardicor
Do not take Cardicor if one of the following conditions applies to you:
 allergy (hypersensitivity) to bisoprolol or to any of the other
ingredients (see section 6 ‘What Cardicor contains’)
 severe asthma
 severe blood circulation problems in your limbs (such as
Raynaud’s syndrome), which may cause your fingers and toes to
tingle or turn pale or blue
 untreated phaeochromocytoma, which is a rare tumour of the
adrenal gland
 metabolic acidosis, which is a condition when there is too much
acid in the blood.
Do not take Cardicor if you have one of the following heart problems:
 acute heart failure
 worsening heart failure requiring injection of medicines into a
vein, that increase the force of contraction of the heart
 slow heart rate
 low blood pressure
 certain heart conditions causing a very slow heart rate or
irregular heartbeat
 cardiogenic shock, which is an acute serious heart condition
causing low blood pressure and circulatory failure.
Warnings and precautions
If you have any of the following conditions tell your doctor before
taking Cardicor; he or she may want to take special care (for
example give additional treatment or perform more frequent checks):
 diabetes
 strict fasting
 certain heart diseases such as disturbances in heart rhythm, or
severe chest pain at rest (Prinzmetal’s angina)
 kidney or liver problems
 less severe blood circulation problems in your limbs
 chronic lung disease or less severe asthma
 history of a scaly skin rash (psoriasis)
 tumour of the adrenal gland (phaeochromocytoma)
 thyroid disorder.

In addition, tell your doctor if you are going to have:
desensitization therapy (for example for the prevention of hay
fever), because Cardicor may make it more likely that you
experience an allergic reaction, or such reaction may be more
severe
 anaesthesia (for example for surgery), because Cardicor may
influence how your body reacts to this situation.


If you have chronic lung disease or less severe asthma please inform
your doctor immediately if you start to experience new difficulties in
breathing, cough, wheezing after exercise, etc. when using Cardicor.

3.

How to take Cardicor

Always take this medicine exactly as your doctor has told you. Check
with your doctor or pharmacist if you are not sure.
Treatment with Cardicor requires regular monitoring by your doctor.
This is particularly necessary at the start of treatment, during dose
increase and when you stop treatment.
Take the tablet with some water in the morning, with or without food.
Do not crush or chew the tablet. The scored tablets can be divided
into two equal doses.

Children and adolescents
Cardicor is not recommended for use in children or adolescents

Treatment with Cardicor is usually long-term.

Other medicines and Cardicor
Tell your doctor or pharmacist if you are taking, have recently taken
or might take any other medicines.

Adults including the elderly:
Treatment with bisoprolol must be started at a low dose and
increased gradually.

Do not take the following medicines with Cardicor without special
advice from your doctor:
 certain medicines used to treat irregular or abnormal heartbeat
(Class I antiarrhythmic medicines such as quinidine,
disopyramide, lidocaine, phenytoin; flecainide, propafenone)
 certain medicines used to treat high blood pressure, angina
pectoris or irregular heartbeat (calcium antagonists such as
verapamil and diltiazem)
 certain medicines used to treat high blood pressure such as
clonidine, methyldopa, moxonodine, rilmenidine. However, do
not stop taking these medicines without checking with your
doctor first.

Your doctor will decide how to increase the dose, and this will
normally be done in the following way:
 1.25 mg bisoprolol once daily for one week
 2.5 mg bisoprolol once daily for one week
 3.75 mg bisoprolol once daily for one week
 5 mg bisoprolol once daily for four weeks
 7.5 mg bisoprolol once daily for four weeks
 10 mg bisoprolol once daily for maintenance (ongoing) therapy.
The maximum recommended daily dose is 10 mg bisoprolol.

Check with your doctor before taking the following medicines with
Cardicor; your doctor may need to check your condition more
frequently:
 certain medicines used to treat high blood pressure or angina
pectoris (dihydropyridine-type calcium antagonists such as
felodipine and amlodipine)
 certain medicines used to treat irregular or abnormal heartbeat
(Class III antiarrhythmic medicines such as amiodarone)
 beta-blockers applied locally (such as timolol eye drops for
glaucoma treatment)
 certain medicines used to treat for example Alzheimer’s disease
or glaucoma (parasympathomimetics such as tacrine or
carbachol) or medicines that are used to treat acute heart
problems (sympathomimetics such as isoprenaline and
dobutamine)
 antidiabetic medicines including insulin
 anaesthetic agents (for example during surgery)
 digitalis, used to treat heart failure
 non-steroidal anti-inflammatory medicines (NSAIDs) used to treat
arthritis, pain or inflammation (for example ibuprofen or
diclofenac)
 any medicine, which can lower blood pressure as a desired or
undesired effect such as antihypertensives, certain medicines for
depression (tricyclic antidepressants such as imipramine or
amitriptyline), certain medicines used to treat epilepsy or during
anaesthesia (barbiturates such as phenobarbital), or certain
medicines to treat mental illness characterized by a loss of
contact with reality (phenothiazines such as levomepromazine)
 mefloquine, used for prevention or treatment of malaria
 depression treatment medicines called monoamine oxidase
inhibitors (except MAO-B inhibitors) such as moclobemide.
Pregnancy and breast-feeding
Pregnancy
There is a risk that use of Cardicor during pregnancy may harm the
baby. If you are pregnant or planning to become pregnant, tell your
doctor. He or she will decide whether you can take Cardicor during
pregnancy.
Breast-feeding
It is not known whether bisoprolol passes into human breast milk.
Therefore, breastfeeding is not recommended during therapy with
Cardicor.
Driving and using machines
Your ability to drive or use machinery may be affected depending on
how well you tolerate the medicine.
Please be especially cautious at the start of treatment, when the
dose is increased or the medication is changed, as well as in
combination with alcohol.

Uncommon (may affect up to 1 in 100 people):
sleep disturbances
depression
dizziness when standing up
breathing problems in patients with asthma or chronic lung
disease
 muscle weakness, muscle cramps.





Rare (may affect up to 1 in 1,000 people):
 hearing problems
 allergic runny nose
 reduced tear flow
 inflammation of the liver which can cause yellowing of the skin or
whites of the eyes
 certain blood test results for liver function or fat levels differing
from normal
 allergy-like reactions such as itching, flush, rash
 impaired erection
 nightmares, hallucinations
 fainting.
Very rare (may affect up to 1 in 10,000 people):
 irritation and redness of the eye (conjunctivitis)
 hair loss
 appearance or worsening of scaly skin rash (psoriasis);
psoriasis-like rash.

Depending on how well you tolerate the medicine, your doctor may
also decide to lengthen the time between dose increases. If your
condition gets worse or you no longer tolerate the drug, it may be
necessary to reduce the dose again or to interrupt treatment. In
some patients a maintenance dose lower than 10 mg bisoprolol may
be sufficient.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects not listed in this leaflet. You can
also report side effects directly via the Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more information on
the safety of this medicine.

Your doctor will tell you what to do.

5.

If you have to stop treatment entirely, your doctor will usually advise
you to reduce the dose gradually, as otherwise your condition may
become worse.

KEEP ALL MEDICINES OUT OF THE SIGHT AND REACH OF
CHILDREN.
Do not store Cardicor tablets above 25°C.
Do not use any tablets after the expiry date on the carton or blister
label. Unused tablets or tablets older than their expiry date should be
returned to a pharmacy for disposal.
If your Cardicor tablets become discolored or show any signs of
deterioration, consult your pharmacist who will tell you what to do.
Medicines should not be disposed of via wastewater or household
waste. Ask your pharmacist how to dispose of medicines no longer
required. These measures will help to protect the environment.

If you take more Cardicor than you should
If you have taken more Cardicor tablets than you should, tell your
doctor immediately. Your doctor will decide what measures are
necessary.
Symptoms of an overdose may include slowed heart rate, severe
difficulty in breathing, feeling dizzy, or trembling (due to decreased
blood sugar).
If you forget to take Cardicor
Do not take a double dose to make up for a forgotten dose. Take
your usual dose the next morning.
If you stop taking Cardicor
Never stop taking Cardicor unless on your doctor’s advice. Otherwise
your condition could become much worse.
If you have any further questions on the use of this product, ask your
doctor or pharmacist.
4.

Possible side effects

Like all medicines, this medicine can cause side effects, although not
everybody gets them.
To prevent serious reactions, speak to a doctor immediately if a side
effect is severe, occurred suddenly or gets worse rapidly.
The most serious side effects are related to the heart function:
 slowing of heart rate (may affect more than 1 in 10 people)
 worsening of heart failure (may affect up to 1 in 10 people)
 slow or irregular heartbeat (may affect up to 1 in 100 people)
If you feel dizzy or weak, or have breathing difficulties please contact
your doctor as soon as possible.
Further side effects are listed below according to how frequently they
may occur:
Common (may affect up to 1 in 10 people):
 tiredness, feeling weak, dizziness, headache
 feeling of coldness or numbness in hands or feet
 low blood pressure
 stomach or intestine problems such as nausea, vomiting,
diarrhoea, or constipation.

6.

How to store Cardicor

Contents of the pack and other information

What Cardicor contains
Cardicor 2.5 mg film-coated tablets:
The active ingredient in Cardicor tablets is bisoprolol. Each
film-coated tablet contains 2.5 mg of bisoprolol hemifumarate.
Cardicor 2.5 mg film-coated tablets also contain the following inactive
ingredients: colloidal anhydrous silica, magnesium stearate,
crospovidone, microcrystalline cellulose, maize starch, calcium
hydrogen phosphate anhydrous, dimethicone, macrogol 400,
titanium dioxide (E171) and hypromellose.
What Cardicor looks like and contents of the pack
Cardicor 2.5 mg film-coated tablets are white, heart-shaped,
film-coated tablets with a score line on both sides
Cardicor 2.5 mg film-coated tablets are available in blister packs of
30 or 100 tablets.
Manufacturer and Product Licence holder
Cardicor is manufactured by Merck KGaA, Frankfurter Strasse 250,
64293 Darmstadt, Germany.
Or
Merck KGaA & Co, Werk Spittal Hösslgasse 20, 9800 Spittal/Drau,
Austria.
Procured from within the EU and repackaged by the Product Licence
holder: G-Pharma Ltd., Dakota Avenue, Salford M50 2PU.
PL 16369/1364
Cardicor 2.5 mg film-coated tablets

POM

Date of revision of this leaflet: 2nd December 2015
‘Cardicor’ is a registered trademark of Merck.

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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