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SELEGILINE HYDROCHLORIDE 1.25MG ORAL LYOPHILISATE

Active substance(s): SELEGILINE HYDROCHLORIDE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Zelapar® 1.25mg Oral Lyophilisate
(selegiline hydrochloride)
Read all of this leaflet carefully before you start taking this
medicine.
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or
pharmacist.
This medicine has been prescribed for you. Do not pass it on to
others. It may harm them, even if their symptoms are the same
as yours.
If 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
The name of your medicine is Zelapar® 1.25mg Oral Lyophilisate
but will be referred to as Zelapar throughout this leaflet.
In this leaflet:
1. What Zelapar is and what it is used for
2. Before you take Zelapar
3. How to take Zelapar
4. Possible side effects
5. How to store Zelapar
6. Further information

1. WHAT ZELAPAR IS AND WHAT IT IS USED FOR
Zelapar contains a medicine called selegiline hydrochloride. This
belongs to a group of medicines called "monoamine oxidase B
inhibitors". An oral lyophilisate looks like a tablet.
Zelapar is used to treat Parkinson's disease. It can be used with
another medicine called Levodopa or on its own.

2. BEFORE YOU TAKE ZELAPAR
Do not take Zelapar if:
You are allergic (hypersensitive) to selegiline hydrochloride or
any of the other ingredients of Zelapar (listed in Section 6)
You have a stomach ulcer or ulcer in your gut
You have a problem called „phenylketonuria‟
You have a movement or muscle problem („extrapyramidal‟)
which is not caused by a lack of dopamine.
Do not take Zelapar if any of the above apply to you. If you are not
sure, talk to your doctor or pharmacist before taking Zelapar.
Also, you must look in the „Taking other medicines‟ section below
as Zelapar cannot be taken with some medicines.

Levodopa, a medicine used for your Parkinson's disease and
you have any of the following:
- High blood pressure or a major heart problem, such as
chest pain (angina) or an uneven or fast heart beat
- A tumour of your prostate gland
- A tumour of your adrenal gland (phaeochromocytoma)
- An eye problem called 'narrow angle glaucoma'
- An overactive thyroid gland (hyper-thyroid disease)
- Major mental health problems such as schizophrenia
- Severe dementia.
Do not take Zelapar and talk to your doctor or pharmacist if any of
the above apply to you.
Also tell your doctor or pharmacist if you are taking any of the
following:
Levodopa (used for Parkinson's disease). If you take the
maximum dose of Levodopa and Zelapar together you can feel
agitated. Your doctor may lower your Levodopa dose slightly
when you start Zelapar
Oral contraceptives (the pill)
HRT (hormone replacement therapy)
Altretamine (used for ovarian cancer)
Amantadine (used for Parkinson's disease)
Dopamine or Digoxin (used for heart problems)
Medicines for heart problems
Medicines to relax the gut muscles
Medicines for anxiety or sleep problems
Medicines for high or low blood pressure
Medicines for asthma such as a salbutamol inhaler
Medicines for depression
Medicines to thin your blood.
Please tell your doctor if you are due to have a general anaesthetic.
If any of the above apply to you (or you are not sure), talk to your
doctor or pharmacist before taking Zelapar.
Also, talk to your doctor or pharmacist if you need to take any of the
medicines shortly after stopping Zelapar. Wait at least 14 days
between stopping Zelapar and starting to take any of the medicines
listed in this „Taking other medicines‟ section. Wait at least 24 hours
between stopping Zelapar and starting to take any serotonin
agonists (such as triptan medicines used to treat migraine).

Take special care with Zelapar
Check with your doctor or pharmacist before taking your medicine
if:
You have a liver or kidney problem
You have sudden and repeated increases in blood pressure
You have chest pain (angina) or an uneven heart beat
You have severe dementia
You have any mental health problem
You have ever had a stomach ulcer or ulcer in your gut
You are taking any other medicines. Make sure you look in the
„Taking other medicines‟ section below.
If any of the above apply to you (or you are not sure), talk to your
doctor or pharmacist before taking Zelapar.

Taking Zelapar with food and drink
Do not eat, drink or rinse your mouth for 5 minutes after taking
Zelapar.
Do not drink alcohol when you are taking Zelapar.
If you are taking Zelapar with another 'monoamine oxidase
inhibitor' (MAOI), your doctor may ask you to restrict your diet.

The use of Zelapar may produce positive results in anti-doping
tests.

The medicine can affect your ability to drive as it may make you
sleepy or dizzy.

Taking other medicines
Please tell your doctor or pharmacist if you are taking or have
recently taken any other medicines. This includes medicines
obtained without a prescription, including herbal medicines. This is
because Zelapar can affect the way some other medicines work.
Also some other medicines can affect the way Zelapar works.
Do not take this medicine and talk to your doctor or pharmacist if
you are taking any of the following:
pethidine or any other morphine-like painkiller
medicines for depression, including tricyclic antidepressants,
'selective serotonin reuptake inhibitors' (SSRIs), such as
fluoxetine, and venlafaxine.
Do not start Zelapar until at least 5 weeks after stopping fluoxetine.
Do not start Zelapar until at least 2 weeks after stopping sertraline.
If you have taken any other SSRI, wait at least 1 week after
stopping this SSRI before starting Zelapar.
medicines called „monoamine oxidase inhibitors‟ or MAOls used
to treat depression and also the antibiotic linezolid
medicines called sympathomimetics, such as medicines for
nasal congestion, ephedrine
medicines for migraine such as rizatriptan

Pregnancy and breast-feeding
Do not take Zelapar if you are pregnant, breast-feeding or planning
to become pregnant.
Driving and using machines
You may feel slow, dizzy or sleepy or have blurred vision while
taking Zelapar. If this happens, do not drive or use any tools or
machines.

Do not drive while taking this medicine until you know how it
affects you.
It is an offence to drive if this medicine affects your ability to
drive.
However, you would not be committing an offence if:
The medicine has been prescribed to treat a medical or dental
problem and
You have taken it according to the instructions given by the
prescriber or in the information provided with the medicine and
It was not affecting your ability to drive safely
Talk to your doctor or pharmacist if you are not sure whether it is
safe for you to drive while taking this medicine.
Important information about some of the ingredients of Zelapar
Zelapar contains a source of phenylalanine. This may be harmful
for people with phenylketonuria.

3. HOW TO TAKE ZELAPAR
Always take Zelapar exactly as your doctor has told you. You
should check with your doctor or pharmacist if you are not sure.
Your doctor will monitor you during your treatment to see how you
respond.
Taking this medicine
The usual dose is 1.25mg (1 tablet) once a day, before
breakfast.
Do not push the tablet through the foil blister.
To get the tablet out of the packaging, peel back the foil and
carefully take out the tablet.
Place it on your tongue and let it dissolve. The tablet will
dissolve quickly (in less than 10 seconds).
Do not eat, drink or rinse your mouth out for 5 minutes after
taking it.
If you take more Zelapar than you should
If you take more Zelapar than you should, talk to a doctor or go to a
hospital straight away.
Take the packet and this leaflet with you so that the doctor will know
what you have taken.
If you forget to take Zelapar
If you forget a dose of Zelapar in the morning, take it as soon as
you remember later that day.
Do not eat, drink or rinse your mouth out for 5 minutes after
taking it.
Do not take a double dose to make up for a forgotten dose.
If you stop taking Zelapar
You should continue taking Zelapar for as long as your doctor has
advised. Do not stop taking Zelapar without talking to your doctor.
Do not stop Zelapar suddenly. If you have any further questions on
the use of this product, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS
Like all medicines, Zelapar can cause side effects, although not
everybody gets them.
Stop taking Zelapar and talk to a doctor straight away, if you
notice any of the following:
Difficulty breathing or your mouth or throat begins to swell. Also
if you start to get a severe rash, itching or other skin reactions.
These may be signs of a serious allergic reaction. Stop taking
Zelapar and talk to a doctor straight away if any of the above apply
to you.
Talk to a doctor straight away, if you notice any of the
following:
Seeing, feeling or hearing things that are not there
(hallucinations) or being confused - these are common and
affect less than 1 in 10 patients treated
Serious mental health problems - these are uncommon and
affect less than 1 in 100 patients treated
Chest pains (angina) - these are uncommon and affect less
than 1 in 100 patients treated.
Talk to a doctor straight away if any of the above apply to you.
Other side effects include:
Very common (affects more than 1 in 10 patients treated)
Sore mouth
Common (affects less than 1 in 10 patients treated)
Mouth ulcers
Blocked nose, sore throat
Sweating more than usual
High or low blood pressure, low heart rate
Joint pains, back pain and muscle cramps
Problems sleeping, depression, feeling tired
Feeling dizzy or like you are spinning (vertigo)
Falls, loss of balance, tremor, feeling dizzy, headache
Constipation or diarrhoea, feeling sick (nausea), dry mouth
Abnormal liver tests (seen in a blood test)
Strange movements including lack of movement and slow
movement
Uncommon (affects less than 1 in 100 patients treated)
Feeling faint
Blurred vision
Loss of appetite
Muscle weakness
Pounding heart beat (palpitations), uneven or fast heart
beat
Hair loss, skin rashes or spots
Strange dreams, feeling agitated, anxious or irritable, mood
changes
Swollen ankles

Throat infections
Problems passing urine
Low blood pressure when standing. This may make you feel
dizzy or faint
Low levels of white blood cells (leukocytopenia) and
platelets Ithrombocytopenia) in the blood. This may make
you more likely to get infections or bruising. Tell your doctor
if you bruise or bleed easily, or often get sore throats or
fever.
Rare (affects less than 1 in 1000 patients treated)
Skin reactions
The following side effects have also been reported with the use of
Zelapar but it is not known how often they may occur: being
excessively interested or involved in sexual activity and inability to
pass urine.
Side effects if you take Zelapar with Levodopa
Zelapar increases the effect of Levodopa. This means the side
effects you get with Levodopa may also be increased. Your doctor
may want to reduce your dose of Levodopa while you are taking
Zelapar. If you take Zelapar with Levodopa you may also notice the
following side effects:
Difficulty controlling your movements. This is common and
affects less than 1 in 10 patients treated.
Feeling restless
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 ZELAPAR
Keep out of the sight and reach of children.
Do not take your medicine after the expiry date which is stated
on the label after „Exp‟. The expiry date refers to the last day of
that month.
Do not store above 25°C.
Store for a maximum of 3 months after opening the sachet.
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.

6. FURTHER INFORMATION
What Zelapar contains
Each oral lyophilisate (tablet) contains 1.25mg selegiline
hydrochloride equivalent to 1.05mg selegiline base.
The other ingredients are gelatin, mannitol, glycine, aspartame,
anhydrous citric acid, grapefruit flavour, yellow iron oxide
(E172), hypromellose (E464).
What Zelapar looks like and contents of the pack
Zelapar are round, pale yellow oral lyophilisates with the letter “A”
on one side and plain on the reverse.
Each pack contains 3 sachets. Each sachet contains 10 oral
lyophilisates (tablets) in blister packs.
Manufactured by:
Teva Pharmaceuticals Europe B.V., Swensweg 5, 2031 GA
Haarlem, The Netherlands.
Procured from within the EU and repackaged by the
Product Licence holder: B&S Healthcare, Unit 4, Bradfield Road,
Ruislip, Middlesex, HA4 0NU, UK.
Zelapar®1.25mg Oral Lyophilisate
PL 18799/2321

POM

Leaflet date: 29.03.2016
Zelapar is a registered trademark of Cephalon (UK) limited.

PACKAGE LEAFLET: INFORMATION FOR THE USER

Selegiline hydrochloride 1.25mg Oral
Lyophilisate
Read all of this leaflet carefully before you start taking this
medicine.
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or
pharmacist.
This medicine has been prescribed for you. Do not pass it on to
others. It may harm them, even if their symptoms are the same
as yours.
If 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
The name of your medicine is Selegiline hydrochloride 1.25mg Oral
Lyophilisate but will be referred to as Selegiline throughout this
leaflet.
In this leaflet:
1. What Selegiline is and what it is used for
2. Before you take Selegiline
3. How to take Selegiline
4. Possible side effects
5. How to store Selegiline
6. Further information

1. WHAT SELEGILINE IS AND WHAT IT IS USED FOR
Selegiline contains a medicine called selegiline hydrochloride. This
belongs to a group of medicines called "monoamine oxidase B
inhibitors". An oral lyophilisate looks like a tablet.
Selegiline is used to treat Parkinson's disease. It can be used with
another medicine called Levodopa or on its own.

2. BEFORE YOU TAKE SELEGILINE
Do not take Selegiline if:
You are allergic (hypersensitive) to selegiline hydrochloride or
any of the other ingredients of Selegiline (listed in Section 6)
You have a stomach ulcer or ulcer in your gut
You have a problem called „phenylketonuria‟
You have a movement or muscle problem („extrapyramidal‟)
which is not caused by a lack of dopamine.
Do not take Selegiline if any of the above apply to you. If you are
not sure, talk to your doctor or pharmacist before taking Selegiline.
Also, you must look in the „Taking other medicines‟ section below
as Selegiline cannot be taken with some medicines.
Take special care with Selegiline
Check with your doctor or pharmacist before taking your medicine
if:
You have a liver or kidney problem
You have sudden and repeated increases in blood pressure
You have chest pain (angina) or an uneven heart beat
You have severe dementia
You have any mental health problem
You have ever had a stomach ulcer or ulcer in your gut
You are taking any other medicines. Make sure you look in the
„Taking other medicines‟ section below.
If any of the above apply to you (or you are not sure), talk to your
doctor or pharmacist before taking Selegiline.
The use of Selegiline may produce positive results in anti-doping
tests.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have
recently taken any other medicines. This includes medicines
obtained without a prescription, including herbal medicines. This is
because Selegiline can affect the way some other medicines work.
Also some other medicines can affect the way Selegiline works.
Do not take this medicine and talk to your doctor or pharmacist if
you are taking any of the following:
pethidine or any other morphine-like painkiller
medicines for depression, including tricyclic antidepressants,
'selective serotonin reuptake inhibitors' (SSRIs), such as
fluoxetine, and venlafaxine.
Do not start Selegiline until at least 5 weeks after stopping
fluoxetine. Do not start Selegiline until at least 2 weeks after
stopping sertraline. If you have taken any other SSRI, wait at least 1
week after stopping this SSRI before starting Selegiline.
medicines called „monoamine oxidase inhibitors‟ or MAOls used
to treat depression and also the antibiotic linezolid
medicines called sympathomimetics, such as medicines for
nasal congestion, ephedrine

medicines for migraine such as rizatriptan
Levodopa, a medicine used for your Parkinson's disease and
you have any of the following:
- High blood pressure or a major heart problem, such as
chest pain (angina) or an uneven or fast heart beat
- A tumour of your prostate gland
- A tumour of your adrenal gland (phaeochromocytoma)
- An eye problem called 'narrow angle glaucoma'
- An overactive thyroid gland (hyper-thyroid disease)
- Major mental health problems such as schizophrenia
- Severe dementia.
Do not take Selegiline and talk to your doctor or pharmacist if any of
the above apply to you.
Also tell your doctor or pharmacist if you are taking any of the
following:
Levodopa (used for Parkinson's disease). If you take the
maximum dose of Levodopa and Selegiline together you can
feel agitated. Your doctor may lower your Levodopa dose
slightly when you start Selegiline
Oral contraceptives (the pill)
HRT (hormone replacement therapy)
Altretamine (used for ovarian cancer)
Amantadine (used for Parkinson's disease)
Dopamine or Digoxin (used for heart problems)
Medicines for heart problems
Medicines to relax the gut muscles
Medicines for anxiety or sleep problems
Medicines for high or low blood pressure
Medicines for asthma such as a salbutamol inhaler
Medicines for depression
Medicines to thin your blood.
Please tell your doctor if you are due to have a general anaesthetic.
If any of the above apply to you (or you are not sure), talk to your
doctor or pharmacist before taking Selegiline.
Also, talk to your doctor or pharmacist if you need to take any of the
medicines shortly after stopping Selegiline. Wait at least 14 days
between stopping Selegiline and starting to take any of the
medicines listed in this „Taking other medicines‟ section. Wait at
least 24 hours between stopping Selegiline and starting to take any
serotonin agonists (such as triptan medicines used to treat
migraine).
Taking Selegiline with food and drink
Do not eat, drink or rinse your mouth for 5 minutes after taking
Selegiline.
Do not drink alcohol when you are taking Selegiline.
If you are taking Selegiline with another 'monoamine oxidase
inhibitor' (MAOI), your doctor may ask you to restrict your diet.
Pregnancy and breast-feeding
Do not take Selegiline if you are pregnant, breast-feeding or
planning to become pregnant.
Driving and using machines
You may feel slow, dizzy or sleepy or have blurred vision while
taking Selegiline. If this happens, do not drive or use any tools or
machines.
The medicine can affect your ability to drive as it may make you
sleepy or dizzy.
Do not drive while taking this medicine until you know how it
affects you.
It is an offence to drive if this medicine affects your ability to
drive.
However, you would not be committing an offence if:
The medicine has been prescribed to treat a medical or dental
problem and
You have taken it according to the instructions given by the
prescriber or in the information provided with the medicine and
It was not affecting your ability to drive safely
Talk to your doctor or pharmacist if you are not sure whether it is
safe for you to drive while taking this medicine.
Important information about some of the ingredients of
Selegiline
Selegiline contains a source of phenylalanine. This may be harmful
for people with phenylketonuria.

3. HOW TO TAKE SELEGILINE
Always take Selegiline exactly as your doctor has told you. You
should check with your doctor or pharmacist if you are not sure.
Your doctor will monitor you during your treatment to see how you
respond.
Taking this medicine
The usual dose is 1.25mg (1 tablet) once a day, before
breakfast.
Do not push the tablet through the foil blister.
To get the tablet out of the packaging, peel back the foil and
carefully take out the tablet.
Place it on your tongue and let it dissolve. The tablet will
dissolve quickly (in less than 10 seconds).
Do not eat, drink or rinse your mouth out for 5 minutes after
taking it.
If you take more Selegiline than you should
If you take more Selegiline than you should, talk to a doctor or go to
a hospital straight away.
Take the packet and this leaflet with you so that the doctor will know
what you have taken.
If you forget to take Selegiline
If you forget a dose of Selegiline in the morning, take it as soon
as you remember later that day.
Do not eat, drink or rinse your mouth out for 5 minutes after
taking it.
Do not take a double dose to make up for a forgotten dose.
If you stop taking Selegiline
You should continue taking Selegiline for as long as your doctor has
advised. Do not stop taking Selegiline without talking to your doctor.
Do not stop Selegiline suddenly. If you have any further questions
on the use of this product, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS
Like all medicines, Selegiline can cause side effects, although not
everybody gets them.
Stop taking Selegiline and talk to a doctor straight away, if you
notice any of the following:
Difficulty breathing or your mouth or throat begins to swell. Also
if you start to get a severe rash, itching or other skin reactions.
These may be signs of a serious allergic reaction.Stop taking
Selegiline and talk to a doctor straight away if any of the above
apply to you.
Talk to a doctor straight away, if you notice any of the
following:
Seeing, feeling or hearing things that are not there
(hallucinations) or being confused - these are common and
affect less than 1 in 10 patients treated
Serious mental health problems - these are uncommon and
affect less than 1 in 100 patients treated
Chest pains (angina) - these are uncommon and affect less
than 1 in 100 patients treated.
Talk to a doctor straight away if any of the above apply to you.
Other side effects include:
Very common (affects more than 1 in 10 patients treated)
Sore mouth
Common (affects less than 1 in 10 patients treated)
Mouth ulcers
Blocked nose, sore throat
Sweating more than usual
High or low blood pressure, low heart rate
Joint pains, back pain and muscle cramps
Problems sleeping, depression, feeling tired
Feeling dizzy or like you are spinning (vertigo)
Falls, loss of balance, tremor, feeling dizzy, headache
Constipation or diarrhoea, feeling sick (nausea), dry mouth
Abnormal liver tests (seen in a blood test)
Strange movements including lack of movement and slow
movement
Uncommon (affects less than 1 in 100 patients treated)
Feeling faint
Blurred vision
Loss of appetite
Muscle weakness
Pounding heart beat (palpitations), uneven or fast heart
beat
Hair loss, skin rashes or spots
Strange dreams, feeling agitated, anxious or irritable, mood
changes
Swollen ankles

Throat infections
Problems passing urine
Low blood pressure when standing. This may make you feel
dizzy or faint
Low levels of white blood cells (leukocytopenia) and
platelets Ithrombocytopenia) in the blood. This may make
you more likely to get infections or bruising. Tell your doctor
if you bruise or bleed easily, or often get sore throats or
fever.
Rare (affects less than 1 in 1000 patients treated)
Skin reactions
The following side effects have also been reported with the use of
Selegiline but it is not known how often they may occur: being
excessively interested or involved in sexual activity and inability to
pass urine.
Side effects if you take Selegiline with Levodopa
Selegiline increases the effect of Levodopa. This means the side
effects you get with Levodopa may also be increased. Your doctor
may want to reduce your dose of Levodopa while you are taking
Selegiline. If you take Selegiline with Levodopa you may also notice
the following side effects:
Difficulty controlling your movements. This is common and
affects less than 1 in 10 patients treated.
Feeling restless
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 SELEGILINE
Keep out of the sight and reach of children.
Do not take your medicine after the expiry date which is stated
on the label after „Exp‟. The expiry date refers to the last day of
that month.
Do not store above 25°C.
Store for a maximum of 3 months after opening the sachet.
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.

6. FURTHER INFORMATION
What Selegiline contains
Each oral lyophilisate (tablet) contains 1.25mg selegiline
hydrochloride equivalent to 1.05mg selegiline base.
The other ingredients are gelatin, mannitol, glycine, aspartame,
anhydrous citric acid, grapefruit flavor, yellow iron oxide (E172),
hypromellose (E464).
What Selegiline looks like and contents of the pack
Selegiline are round, pale yellow oral lyophilisates with the letter “A”
on one side and plain on the reverse.
Each pack contains 3 sachets. Each sachet contains 10 oral
lyophilisates (tablets) in blister packs.
Manufactured by:
Teva Pharmaceuticals Europe B.V., Swensweg 5, 2031 GA
Haarlem, The Netherlands.
Procured from within the EU and repackaged by the
Product Licence holder: B&S Healthcare, Unit 4, Bradfield Road,
Ruislip, Middlesex, HA4 0NU, UK.
Selegiline hydrochloride 1.25mg Oral Lyophilisate
PL 18799/2321
POM
Leaflet date: 29.03.2016

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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