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S381 LEAFLET Mobiflex 20120723

PACKAGE LEAFLET: INFORMATION FOR THE USER

MOBIFLEX 20MG TABLETS
(tenoxicam)
The name of your medicine is Mobiflex 20mg Tablets but will be
referred to as Mobiflex throughout the following leaflet.

Taking other medicines
Tell your doctor or pharmacist if you are taking or have recently
taken any other medicines.
This includes medicines that you buy without a prescription and
herbal medicines. In particular, tell your doctor or pharmacist if you
are taking:


Other NSAIDs, like aspirin, ibuprofen or diclofenac.

Please read all of this leaflet carefully before you start taking
this medicine.



Medicines to stop your blood clotting, like warfarin, heparin or
clopidogel.



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





If you have any further questions, ask your doctor or
pharmacist.

Sulfonamide medicines, like hydrochlorothiazide,
acetazolamide, indapamide and including sulfonamide
antibiotics (for infections).



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.



A sulfonylurea (for diabetes), like glimepiride or glipizide.



An ‘ACE inhibitor’ or any other medicine for high blood pressure
like cilazapril, enalapril or propranolol.

If any of the side effects become serious or troublesome, or if
you notice any side effects not listed in this leaflet, please tell
your doctor or pharmacist.



A diuretic (water tablet) for high blood pressure, like
furosemide.



A ‘cardiac glycoside’ (for heart problems), like digitoxin.



A steroid (for swelling and inflammation), like hydrocortisone,
prednisolone and dexamethasone.



A ‘quinolone antibiotic’ (for infections), like ciprofloxacin or
moxifloxacin.

3. How to take Mobiflex



Lithium (for mental health problems).

4. Possible side effects?



Methotrexate (used to treat skin problems, arthritis or cancer).

5. How to store Mobiflex?



Ciclosporin or tacrolimus (for skin problems or after an organ
transplant).



In this leaflet:
1. What Mobiflex is and what it is used for
2. Before you take Mobiflex

6. Further information


Zidovudine (used to treat AIDS and HIV infections).

1. WHAT MOBIFLEX IS AND WHAT IT IS USED FOR



Mobiflex contains a medicine called tenoxicam. This is a ‘Non
Steroidal Anti Inflammatory Drug’ or NSAID.

Mifepristone (used to end pregnancy or to bring on labour if the
baby has died).



Mobiflex can lessen pain, swelling, redness and heat (inflammation)
in:

SSRI’s (medicines used to treat depression such as fluoxetine,
citalopram, paroxetine, fluvoxamine).



Antacids (used to treat conditions such as indigestion,
heartburn).



Problems with your muscles, joints and tendons, like strains,
sprains or injuries.



Arthritis.

2. BEFORE YOU TAKE MOBIFLEX
Do not take Mobiflex if you are allergic (hypersensitive) to:


Tenoxicam or any of the other ingredients of Mobiflex (see
Section 6).



Aspirin, or any other NSAIDs (such as ibuprofen or diclofenac).

If any of the above apply to you, or if you are not sure, talk to your
doctor or pharmacist before you take Mobiflex.
Pregnancy and breast-feeding


Do not take Mobiflex if you are in the last three months of
pregnancy, as it can harm your baby.



Talk to your doctor before taking Mobiflex if you are pregnant,
think you are pregnant, plan to get pregnant or are breastfeeding. Your doctor will decide if you should take Mobiflex.



Mobiflex may make it more difficult to become pregnant. You
should tell your doctor if you are planning to become pregnant
or if you have problems becoming pregnant.

Do not take Mobiflex if:


You now have or have ever had any problems with your
stomach or gut (intestine) like an ulcer or bleeding.



You have previously experienced bleeding or perforation in your
stomach while taking NSAIDs.



You have severe problems with your kidneys, liver or heart.



You are in the last three months of pregnancy.

Do not take Mobiflex if any of the above apply to you. If you are not
sure, talk to your doctor or pharmacist before taking Mobiflex.
Take special care with Mobiflex
If you have heart problems, previous stroke or think that you might
be at risk of these conditions (for example if you have high blood
pressure, diabetes or high cholesterol or are a smoker) you should
discuss your treatment with your doctor or pharmacist.
Check with your doctor or pharmacist before taking Mobiflex if any
of the following apply to you:


Asthma or allergies (like hayfever) or have had swelling of the
face, lips, eyes or tongue in the past.



You are elderly (you are more likely to suffer problems).



Problems with your kidneys or liver.



Problems with the way that your blood clots.



Low blood volume (caused by bleeding or severe dehydration).



Problems with the blood vessels (arteries) anywhere in your
body.



Too much fat (lipid) in your blood (hyperlipidaemia).



An autoimmune condition, such as ‘systemic lupus
erythematosus’ (SLE, causes joint pain, skin rashes and fever)
and ulcerative colitis or Crohn’s disease (conditions causing
inflammation of the bowel, bowel pain, diarrhoea, vomiting and
weight loss).



You are going to have an operation, such as a replacement hip
or other major surgery.

If any of the above apply to you, or if you are not sure, talk to your
doctor or pharmacist before you take Mobiflex.

Driving and using machines:
Mobiflex may make you tired, drowsy, dizzy, have problems with
your eyesight and balance, depressed or have difficulty sleeping.
Talk to your doctor if any of these happen to you and do not drive or
use any tools or machines.
Important information about some of the ingredients of
Mobiflex:
This medicine contains lactose, which is a type of sugar. If you have
been told by your doctor that you cannot tolerate or digest some
sugars (have an intolerance to some sugars), talk to your doctor
before taking this medicine.
3. HOW TO TAKE MOBIFLEX
Medicines such as Mobiflex may be associated (linked) with a small
increased risk of heart attack (‘myocardial infarction’) or stroke. Any
risk is more likely with higher doses and prolonged (longer term)
treatment. Do not exceed (take more than) the recommended
dose or duration (length) of treatment. Check with your doctor if
you are not sure.
Swallow the tablets whole with a little water, preferably with or after
food, at the same time each day.
While you are taking Mobiflex your doctor will want to see you to
check you are on the right dose for you and look for any side
effects. This is particularly important if you are elderly.
Children
Mobiflex is not recommended for use in children.
Adults


The usual dose is 1 tablet each day.



For sprains and strains, the usual length of treatment is up to 7
days (maximum 14 days).
The elderly and people with liver and kidney problems
Your doctor will decide your dose, it will usually be lower than that
for other adults.

If you take more Mobiflex than you should

Nervous system

If you take more Mobiflex than you should, talk to a doctor or go to
a hospital straight away. Take the medicine pack with you.
If you forget to take Mobiflex



Headache.



Feeling dizzy, light-headed or sleepy.



If you forget to take a dose, skip the missed dose. Then take
your next dose as normal.



Do not take a double dose to make up for a forgotten dose.

4. POSSIBLE SIDE EFFECT
Like all medicines Mobiflex can cause side effects, although not
everyone will get them. Medicines such as Mobiflex may be
associated with a small increased risk of heart attack (‘myocardial
infarction’) or stroke.

 Pins and needles or numbness of your hands and feet.
Eyes and ears


Changes to your eyesight, swollen or irritated eyes.



Ringing in the ears (tinnitus).

 Dizziness that causes problems with your balance.
Heart and circulation


Swelling of your hands, feet or legs (oedema). This may be with
chest pains, tiredness, shortness of breath (cardiac failure).



A fluttering feeling in your heart (palpitations), slow heart beat
or high blood pressure.

Important side effects to look out for:
Stop taking Mobiflex and tell a doctor straight away if any of
the following side effects happen. You may need urgent
medical treatment:



Serious stomach or gut problems, signs include:

Difficulty breathing, including shortness of breath, wheezing or
coughing.
Skin and hair

Problems with the way your heart pumps blood around the
body. Signs may include tiredness, shortness of breath, feeling
faint, general pain.
Chest



Bleeding from the stomach, seen as vomit which has blood in it,
or bits that look like coffee grounds.



Bleeding from your back passage (anus), seen as passing
black sticky bowel motions (stools) or bloody diarrhoea.



Skin rashes including redness, hives, pimples and blisters on
your hand, body or face.



Ulcers or holes forming in your stomach or gut. Signs include
upset stomach, stomach pain, fever, feeling or being sick.



Itching, skin being more sensitive to the sun or hair loss
(alopecia).



Problems with your pancreas. Signs include severe stomach
pain which spreads to your back.

 Changes to your nails.
Urinary



Worsening of ulcerative colitis or Crohn’s disease, seen as
pain, diarrhoea, vomiting and weight loss.

 Kidney problems.
Other

Allergic reactions, signs include:


Sudden swelling of your throat, face, hands or feet.



Difficulty breathing, tightness in your chest.

 Skin rashes, blisters or itching.
Severe skin rashes, signs include:


A severe rash that develops quickly, with blisters or peeling of
your skin and possibly blisters in your mouth, throat or eyes.
Fever, headache, cough and aching body may happen at the
same time.



Feeling generally unwell.



A sore mouth or mouth ulcers.



Loss of appetite.



Weight loss or gain.



Problems for women in getting pregnant



Nosebleeds.

If any of the side effects become serious, or if you notice any side
effects not listed in this leaflet, please tell your doctor or pharmacist.

Liver problems, signs include:


Yellowing of your skin or the whites of your eyes (jaundice).

5. HOW TO STORE MOBIFLEX



Feeling tired, loss of appetite, feeling or being sick and pale
coloured stools (hepatitis) and problems (including hepatitis),
shown in blood tests.



KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.



Mobiflex should not be stored above 30°C.



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



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.

Heart attack, signs include:


Chest pain which may spread to your neck and shoulders and
down your left arm.

Stroke, signs include:


Muscle weakness and numbness. This may only be on one side
of your body.



A suddenly altered sense of smell, taste, hearing or vision,
confusion.

Meningitis, signs include:


Fever, feeling or being sick, a stiff neck, headache, sensitivity to
bright light and confusion (most likely in people with
autoimmune conditions such as ‘systemic lupus
erythematosus’.

If you notice any of the serious side effects mentioned above, stop
taking Mobiflex and tell your doctor straight away.
Other possible side effects:

6. FURTHER INFORMATION
What Mobiflex contains


Each tablet contains 20mg of the active ingredient tenoxicam.



Mobiflex also contains the following inactive ingredients:
lactose, talc, magnesium stearate, maize starch, hypromellose,
titanium dioxide (E171) and yellow iron oxide (E172).
What Mobiflex looks like and contents of the pack

Stomach and gut

Mobiflex Tablets are greyish yellow, film-coated oval tablets
imprinted ‘ROCHE” on one face with a breakline on the other.



Mobiflex Tablets are available as blister packs of 30 tablets.

Heartburn, indigestion, stomach ache, feeling sick, constipation,
diarrhoea, wind.

Blood


Blood problems, like anaemia or changes to the numbers of
white blood cells.

 High blood sugar (hyperglycaemia).
Mental illness


Having difficulty sleeping or changes in your patterns of
dreaming.



Depression.



Seeing or possibly hearing things that are not there
(hallucinations).



Confusion or nervousness.

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 Roche SpA, via Morelli 2 Segrate,
Italy.
POM

PL No. 19488/0381

Leaflet revision date: 23 July 2012
Mobiflex is a registered trademark of Roche products Ltd UK.
S381 LEAFLET Mobiflex 20120723

S381 LEAFLET Tenoxicam 20120723

PACKAGE LEAFLET: INFORMATION FOR THE USER

TENOXICAM 20MG TABLETS

Taking other medicines
Tell your doctor or pharmacist if you are taking or have recently
taken any other medicines.

The name of your medicine is Tenoxicam 20mg Tablets but will be
referred to as Tenoxicam Tablets throughout the following leaflet.

This includes medicines that you buy without a prescription and
herbal medicines. In particular, tell your doctor or pharmacist if you
are taking:

Please read all of this leaflet carefully before you start taking
this medicine.



Other NSAIDs, like aspirin, ibuprofen or diclofenac.



Medicines to stop your blood clotting, like warfarin, heparin or
clopidogel.



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.

Sulfonamide medicines, like hydrochlorothiazide,
acetazolamide, indapamide and including sulfonamide
antibiotics (for infections).



A sulfonylurea (for diabetes), like glimepiride or glipizide.



An ‘ACE inhibitor’ or any other medicine for high blood pressure
like cilazapril, enalapril or propranolol.



A diuretic (water tablet) for high blood pressure, like
furosemide.



A ‘cardiac glycoside’ (for heart problems), like digitoxin.



A steroid (for swelling and inflammation), like hydrocortisone,
prednisolone and dexamethasone.



A ‘quinolone antibiotic’ (for infections), like ciprofloxacin or
moxifloxacin.

5. How to store Tenoxicam Tablets?



Lithium (for mental health problems).

6. Further information



Methotrexate (used to treat skin problems, arthritis or cancer).



Ciclosporin or tacrolimus (for skin problems or after an organ
transplant).



If any of the side effects become serious or troublesome, or if
you notice any side effects not listed in this leaflet, please tell
your doctor or pharmacist.

In this leaflet:
1. What Tenoxicam Tablets are and what they are used for
2. Before you take Tenoxicam Tablets
3. How to take Tenoxicam Tablets
4. Possible side effects?

1. WHAT TENOXICAM TABLETS ARE AND WHAT THEY ARE
USED FOR



Zidovudine (used to treat AIDS and HIV infections).

Tenoxicam Tablets contain a medicine called tenoxicam. This is a
‘Non Steroidal Anti Inflammatory Drug’ or NSAID.



Mifepristone (used to end pregnancy or to bring on labour if the
baby has died).

Tenoxicam Tablets can lessen pain, swelling, redness and heat
(inflammation) in:



SSRI’s (medicines used to treat depression such as fluoxetine,
citalopram, paroxetine, fluvoxamine).
Antacids (used to treat conditions such as indigestion,
heartburn).



Problems with your muscles, joints and tendons, like strains,
sprains or injuries.





Arthritis.

If any of the above apply to you, or if you are not sure, talk to your
doctor or pharmacist before you take Tenoxicam Tablets.
Pregnancy and breast-feeding

2. BEFORE YOU TAKE TENOXICAM TABLETS
Do not take Tenoxicam Tablets if you are allergic (hypersensitive) to:



Do not take Tenoxicam Tablets if you are in the last three
months of pregnancy, as it can harm your baby.





Talk to your doctor before taking Tenoxicam Tablets if you are
pregnant, think you are pregnant, plan to get pregnant or are
breast-feeding. Your doctor will decide if you should take
Tenoxicam Tablets.

Tenoxicam or any of the other ingredients of Tenoxicam Tablets
(see Section 6).

 Aspirin, or any other NSAIDs (such as ibuprofen or diclofenac).
Do not take Tenoxicam Tablets if:


You now have or have ever had any problems with your
stomach or gut (intestine) like an ulcer or bleeding.



You have previously experienced bleeding or perforation in your
stomach while taking NSAIDs.



You have severe problems with your kidneys, liver or heart.



You are in the last three months of pregnancy.

Do not take Tenoxicam Tablets if any of the above apply to you. If
you are not sure, talk to your doctor or pharmacist before taking
Tenoxicam Tablets.
Take special care with Tenoxicam Tablets
If you have heart problems, previous stroke or think that you might
be at risk of these conditions (for example if you have high blood
pressure, diabetes or high cholesterol or are a smoker) you should
discuss your treatment with your doctor or pharmacist.
Check with your doctor or pharmacist before taking Tenoxicam
Tablets if any of the following apply to you:


Asthma or allergies (like hayfever) or have had swelling of the
face, lips, eyes or tongue in the past.



You are elderly (you are more likely to suffer problems).



Problems with your kidneys or liver.



Problems with the way that your blood clots.



Low blood volume (caused by bleeding or severe dehydration).



Problems with the blood vessels (arteries) anywhere in your
body.



Too much fat (lipid) in your blood (hyperlipidaemia).



An autoimmune condition, such as ‘systemic lupus
erythematosus’ (SLE, causes joint pain, skin rashes and fever)
and ulcerative colitis or Crohn’s disease (conditions causing
inflammation of the bowel, bowel pain, diarrhoea, vomiting and
weight loss).



You are going to have an operation, such as a replacement hip
or other major surgery.

If any of the above apply to you, or if you are not sure, talk to your
doctor or pharmacist before you take Tenoxicam Tablets.



Tenoxicam Tablets may make it more difficult to become
pregnant. You should tell your doctor if you are planning to
become pregnant or if you have problems becoming pregnant.
Driving and using machines:
Tenoxicam Tablets may make you tired, drowsy, dizzy, have
problems with your eyesight and balance, depressed or have
difficulty sleeping. Talk to your doctor if any of these happen to you
and do not drive or use any tools or machines.
Important information about some of the ingredients of
Tenoxicam Tablets:
This medicine contains lactose, which is a type of sugar. If you have
been told by your doctor that you cannot tolerate or digest some
sugars (have an intolerance to some sugars), talk to your doctor
before taking this medicine.
3. HOW TO TAKE TENOXICAM TABLETS
Medicines such as Tenoxicam Tablets may be associated (linked)
with a small increased risk of heart attack (‘myocardial infarction’) or
stroke. Any risk is more likely with higher doses and prolonged
(longer term) treatment. Do not exceed (take more than) the
recommended dose or duration (length) of treatment. Check
with your doctor if you are not sure.
Swallow the tablets whole with a little water, preferably with or after
food, at the same time each day.
While you are taking Tenoxicam Tablets your doctor will want to
see you to check you are on the right dose for you and look for any
side effects. This is particularly important if you are elderly.
Children
Tenoxicam Tablets are not recommended for use in children.
Adults


The usual dose is 1 tablet each day.



For sprains and strains, the usual length of treatment is up to 7
days (maximum 14 days).

The elderly and people with liver and kidney problems
Your doctor will decide your dose, it will usually be lower than that
for other adults.

If you take more Tenoxicam Tablets than you should

Nervous system

If you take more Tenoxicam Tablets than you should, talk to a
doctor or go to a hospital straight away. Take the medicine pack
with you.



Headache.



Feeling dizzy, light-headed or sleepy.

If you forget to take Tenoxicam Tablets



If you forget to take a dose, skip the missed dose. Then take
your next dose as normal.
Do not take a double dose to make up for a forgotten dose.

4. POSSIBLE SIDE EFFECT
Like all medicines Tenoxicam Tablets can cause side effects,
although not everyone will get them. Medicines such as Tenoxicam
Tablets may be associated with a small increased risk of heart
attack (‘myocardial infarction’) or stroke.
Important side effects to look out for:

 Pins and needles or numbness of your hands and feet.
Eyes and ears


Changes to your eyesight, swollen or irritated eyes.



Ringing in the ears (tinnitus).

 Dizziness that causes problems with your balance.
Heart and circulation


Swelling of your hands, feet or legs (oedema). This may be with
chest pains, tiredness, shortness of breath (cardiac failure).



A fluttering feeling in your heart (palpitations), slow heart beat
or high blood pressure.



Stop taking Tenoxicam Tablets and tell a doctor straight away
if any of the following side effects happen. You may need
urgent medical treatment:

Problems with the way your heart pumps blood around the
body. Signs may include tiredness, shortness of breath, feeling
faint, general pain.
Chest

Serious stomach or gut problems, signs include:

Difficulty breathing, including shortness of breath, wheezing or
coughing.
Skin and hair



Bleeding from the stomach, seen as vomit which has blood in it,
or bits that look like coffee grounds.



Bleeding from your back passage (anus), seen as passing
black sticky bowel motions (stools) or bloody diarrhoea.



Ulcers or holes forming in your stomach or gut. Signs include
upset stomach, stomach pain, fever, feeling or being sick.



Problems with your pancreas. Signs include severe stomach
pain which spreads to your back.



Worsening of ulcerative colitis or Crohn’s disease, seen as
pain, diarrhoea, vomiting and weight loss.



Skin rashes including redness, hives, pimples and blisters on
your hand, body or face.



Itching, skin being more sensitive to the sun or hair loss
(alopecia).

 Changes to your nails.
Urinary
 Kidney problems.
Other

Allergic reactions, signs include:



Feeling generally unwell.



Sudden swelling of your throat, face, hands or feet.



A sore mouth or mouth ulcers.



Difficulty breathing, tightness in your chest.



Loss of appetite.

Skin rashes, blisters or itching.



Weight loss or gain.

Severe skin rashes, signs include:



Problems for women in getting pregnant





Nosebleeds.



A severe rash that develops quickly, with blisters or peeling of
your skin and possibly blisters in your mouth, throat or eyes.
Fever, headache, cough and aching body may happen at the
same time.
Liver problems, signs include:


Yellowing of your skin or the whites of your eyes (jaundice).



Feeling tired, loss of appetite, feeling or being sick and pale
coloured stools (hepatitis) and problems (including hepatitis),
shown in blood tests.

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


KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.



Tenoxicam Tablets should not be stored above 30°C.



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



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.

Heart attack, signs include:


Chest pain which may spread to your neck and shoulders and
down your left arm.
Stroke, signs include:


Muscle weakness and numbness. This may only be on one side
of your body.



A suddenly altered sense of smell, taste, hearing or vision,
confusion.
Meningitis, signs include:

6. FURTHER INFORMATION



What Tenoxicam Tablets contain

Fever, feeling or being sick, a stiff neck, headache, sensitivity to
bright light and confusion (most likely in people with
autoimmune conditions such as ‘systemic lupus
erythematosus’.

If you notice any of the serious side effects mentioned above, stop
taking Tenoxicam Tablets and tell your doctor straight away.



Each tablet contains 20mg of the active ingredient tenoxicam.



Tenoxicam Tablets also contain the following inactive
ingredients: lactose, talc, magnesium stearate, maize starch,
hypromellose, titanium dioxide (E171) and yellow iron oxide
(E172).

What Tenoxicam Tablets look like and contents of the pack
Other possible side effects:
Stomach and gut

Tenoxicam Tablets are greyish yellow, film-coated oval tablets
imprinted ‘ROCHE” on one face with a breakline on the other.



Tenoxicam Tablets are available as blister packs of 30 tablets.

Heartburn, indigestion, stomach ache, feeling sick, constipation,
diarrhoea, wind.
Blood


Blood problems, like anaemia or changes to the numbers of
white blood cells.

 High blood sugar (hyperglycaemia).
Mental illness


Having difficulty sleeping or changes in your patterns of
dreaming.



Depression.



Seeing or possibly hearing things that are not there
(hallucinations).



Confusion or nervousness.

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 Roche SpA, via Morelli 2 Segrate,
Italy.
POM

PL No. 19488/0381

Leaflet revision date: 23 July 2012
S381 LEAFLET Tenoxicam 20120723

Expand Transcript

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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