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PROZAC 20MG HARD CAPSULES

Active substance(s): FLUOXETINE HYDROCHLORIDE

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Package leaflet:
Information for the user

How Prozac works
Everyone has a substance called serotonin in their
brain. People who are depressed or have obsessivecompulsive disorder or bulimia nervosa have lower
levels of serotonin than others. It is not fully understood
how Prozac and other SSRIs work but they may help
by increasing the level of serotonin in the brain.
Treating these conditions is important to help you
get better. If it’s not treated, your condition may not
go away and may become more serious and more
difficult to treat.
You may need to be treated for a few weeks or
months to ensure that you are free from symptoms.

PROZAC® 20 mg hard capsules
fluoxetine
EIGHT IMPORTANT THINGS YOU NEED TO KNOW
ABOUT PROZAC
Prozac treats depression and anxiety disorders.
Like all medicines it can have unwanted effects. It is
therefore important that you and your doctor weigh
up the benefits of treatment against the possible
unwanted effects, before starting treatment.

2. What you need to know before you take Prozac
hard capsules

Prozac is not for use In children and adolescents
under 18. See section 2, Children and adolescents
aged 8 to 18 years.

Do not take Prozac if you are:
• allergic to fluoxetine or any of the other
ingredients of this medicine (listed in section 6). If
you develop a rash or other allergic reactions
(like itching, swollen lips or face or shortness
of breath), stop taking the capsules straight
away and contact your doctor immediately.
• taking other medicines known as irreversible,
non-selective monoamine oxidase inhibitors
(MAOIs), since serious or even fatal reactions can
occur (e.g. iproniazid used to treat depression).

Prozac won’t work straight away. Some people
taking antidepressants feel worse before feeling
better. Your doctor should ask to see you again a
couple of weeks after you first start treatment. Tell
your doctor if you haven’t started feeling better. See
section 3, How to take Prozac hard capsules.
Some people who are depressed or anxious
think of harming or killing themselves. If you start
to feel worse, or think of harming or killing yourself,
see your doctor or go to a hospital straight away.
See section 2.

Treatment with Prozac should only be started at
least 2 weeks after discontinuation of an irreversible,
non-selective MAOI.

Don’t stop taking Prozac without talking to your
doctor. If you stop taking Prozac suddenly or miss
a dose, you may get withdrawal effects. See section
3 for further information.

Do not take any irreversible, non-selective MAOIs
for at least 5 weeks after you stop taking Prozac.
If Prozac has been prescribed for a long period
and/or at a high dose, a longer interval needs to be
considered by your doctor.
• taking metoprolol (to treat heart failure) since
there is an increased risk of your heart beat
becoming too slow.

If you feel restless and feel like you can’t sit or
stand still, tell your doctor. Increasing the dose
of Prozac may make these feelings worse. See
section 4, Possible side-effects.
Taking some other medicines with Prozac can
cause problems. You may need to talk to your doctor.
See section 2, Taking other medicines.

Warnings and precautions
Talk to your doctor or pharmacist before taking Prozac
if any of the following applies to you:
• heart problems;
• appearance of fever, muscle stiffness or tremor,
changes in your mental state like confusion,
irritability and extreme agitation; you may suffer
from the so-called “serotonin syndrome” or
“neuroleptic malignant syndrome”. Although
this syndrome occurs rarely it may result in
potentially life threatening conditions; contact
your doctor immediately, since Prozac might
need to be discontinued.
• mania now or in the past; if you have a manic
episode, contact your doctor immediately
because Prozac might need to be discontinued;
• history of bleeding disorders or appearance of
bruises or unusual bleeding;
• ongoing treatment with medicines that thin the
blood (see ‘Other medicines and Prozac’);
• epilepsy or fits. If you have a fit (seizures) or
experience an increase in seizure frequency,
contact your doctor immediately; Prozac might
need to be discontinued;
• ongoing ECT (electro-convulsive therapy);
• ongoing treatment with tamoxifen (used to
treat breast cancer) (see ‘Other medicines and
Prozac’);
• starting to feel restless and cannot sit or stand
still (akathisia). Increasing your dose of Prozac
may make this worse;
• diabetes (your doctor may need to adjust your
dose of insulin or other antidiabetic treatment);
• liver problems (your doctor may need to adjust
your dosage);
• low resting heart-rate and/or if you know that
you may have salt depletion as a result of
prolonged severe diarrhoea and vomiting (being
sick) or usage of diuretics (water tablets);
• ongoing treatment with diuretics (water tablets),
especially if you are elderly;
• glaucoma (increased pressure in the eye).

If you are pregnant or planning to get pregnant,
talk to your doctor. See section 2, Pregnancy,
breast-feeding and fertility.
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 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 Prozac hard capsules are and what they
are used for
2. What you need to know before you take Prozac
hard capsules
3. How to take Prozac hard capsules
4. Possible side effects
5. How to store Prozac hard capsules
6. Content of the pack and other information
1. What are Prozac hard capsules and what they
are used for
Prozac 20 mg hard capsules contain the active
substance fluoxetine which is one of a group of
medicines called selective serotonin re-uptake
inhibitors (SSRI) antidepressants.
This medicine is used to treat the following conditions:
Adults:
• Major depressive episodes
• Obsessive-compulsive disorder
• Bulimia nervosa: Prozac is used alongside
psychotherapy for the reduction of binge-eating
and purging
Children and adolescents aged 8 years and above:
• Moderate to severe major depressive disorder, if
the depression does not respond to psychological
therapy after 4-6 sessions. Prozac should be
offered to a child or young person with moderate
to severe major depressive disorder only in
combination with psychological therapy.

Thoughts of suicide and worsening of your
depression or anxiety disorder.
If you are depressed and/or have anxiety disorders
you can sometimes have thoughts of harming or
killing yourself. These may be increased when first
starting antidepressants, since these medicines

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all take time to work, usually about two weeks but
sometimes longer.
You may be more likely to think like this:
- If you have previously had thoughts about killing
or harming yourself.
- If you are a young adult. Information from
clinical trials has shown an increased risk of
suicidal behaviour in adults aged less than
25 years with psychiatric conditions who were
treated with an antidepressant.
If you have thoughts of harming or killing yourself at
any time, contact your doctor or go to a hospital
straight away.
You may find it helpful to tell a relative or close
friend that you are depressed or have an anxiety
disorder, and ask them to read this leaflet. You might
ask them to tell you if they think your depression or
anxiety is getting worse, or if they are worried about
changes in your behaviour.








Children and adolescents aged 8 to 18 years:
Patients under 18 have an increased risk of sideeffects such as suicide attempt, suicidal thoughts
and hostility (predominantly aggression, oppositional
behaviour and anger) when they take this class of
medicines. Prozac should only be used in children
and adolescents aged 8 to 18 years for the treatment
of moderate to severe major depressive episodes
(in combination with psychological therapy) and it
should not be used to treat other conditions.



Additionally, only limited information concerning
the long-term safety of Prozac on growth, puberty,
mental, emotional and behavioural development in
this age group is available. Despite this, and if you
are a patient under 18, your doctor may prescribe
Prozac for moderate to severe major depressive
episodes, in combination with psychological therapy,
because he/she decides that this is in your best
interests. If your doctor has prescribed Prozac for
a patient under 18 and you want to discuss this,
please go back to your doctor. You should inform your
doctor if any of the symptoms listed above develop or
worsen when patients under 18 are taking Prozac.




Prozac should not be used in the treatment of children
under the age of 8 years.



Other medicines and Prozac
Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines.
Do not take Prozac with:
• Certain irreversible, non-selective
monoamine oxidase inhibitors (MAOIs), some
used to treat depression. Irreversible, nonselective MAOIs must not be used with Prozac
as serious or even fatal reactions (serotonin
syndrome) can occur (see section “Do not take
Prozac”). Treatment with Prozac should only be
started at least 2 weeks after discontinuation of
an irreversible, non-selective MAOI (for instance
tranylcypromine). Do not take any irreversible,
non-selective MAOIs for at least 5 weeks after
you stop taking Prozac. If Prozac has been
prescribed for a long period and/or at a high
dose, a longer interval than 5 weeks may need
to be considered by your doctor.
• metoprolol when used for heart failure; there is
an increased risk of your heart beat becoming
too slow.



monitor you carefully and use a lower dose of
the MAOI-A drug.
mequitazine (for allergies); because taking
this drug with Prozac may increase the risk of
changes in the electrical activity of the heart.
phenytoin (for epilepsy); because Prozac may
influence the blood levels of this drug, your doctor
may need to introduce phenytoin more carefully
and carry out check-ups when given with Prozac.
lithium, selegiline, St. John’s Wort, tramadol
(a painkiller), triptans (for migraine) and
tryptophan; there is an increased risk of mild
serotonin syndrome when these drugs are taken
with Prozac. Your doctor will carry out more
frequent check-ups.
medicines that may affect the heart’s rhythm,
e.g. Class IA and III antiarrhythmics,
antipsychotics (e.g. phenothiazine
derivatives, pimozide, haloperidol), tricyclic
antidepressants, certain antimicrobial
agents (e.g. sparfloxacin, moxifloxacin,
erythromycin IV, pentamidine), anti-malaria
treatment particularly halofantrine or certain
antihistamines (astemizole, mizolastine),
because taking one or more of these drugs with
Prozac may increase the risk of changes in the
electrical activity of the heart.
Anti-coagulants (such as warfarin), NSAID
(such as ibruprofen, diclofenac), aspirin and
other medicines which can thin the blood
(including clozapine, used to treat certain mental
disorders). Prozac may alter the effect of these
medicines on the blood. If Prozac treatment is
started or stopped when you are taking warfarin,
your doctor will need to perform certain tests,
adjust your dose and check on you more
frequently.
cyproheptadine (for allergies); because it may
reduce the effect of Prozac.
drugs that lower sodium levels in the
blood (including, drug that causes increase in
urination, desmopressin, carbamazepine and
oxcarbazepine); because these drugs may
increase the risk of sodium levels in the blood
becoming too low when taken with Prozac.
anti-depressants such as tricyclic
anti-depressants, other selective serotonin
reuptake inhibitors (SSRIs) or bupropion,
mefloquine or chloroquine (used to treat
malaria), tramadol (used to treat severe pain)
or anti-psychotics such as phenothiazines or
butyrophenones; because Prozac may increase
the risk of seizures when taken with these
medicines.
flecainide, propafenone, nebivolol or
encainide (for heart problems), carbamazepine
(for epilepsy), atomoxetine or tricyclic
antidepressants (for example imipramine,
desipramine and amitriptyline) or risperidone
(for schizophrenia); because Prozac may
possibly change the blood levels of these
medicines, your doctor may need to lower their
dose when administered with Prozac.

Prozac with food, drink and alcohol
• You can take Prozac with or without food,
whatever you prefer.
• You should avoid alcohol while you are taking
this medicine.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may
be pregnant or are planning to have a baby, ask
your doctor or pharmacist for advice before taking
this medicine.

Prozac may affect the way the following medicines
work (interaction):
• tamoxifen (used to treat breast cancer);
because Prozac may change the blood levels
of this drug, resulting in the possibility of a
reduction in the effect of tamoxifen, your doctor
may need to consider prescribing a different
antidepressant treatment.
• monoamine oxidase inhibitors A (MAOI-A)
including moclobemide, linezolid (an antibiotic)
and methylthioninium chloride (also called
methylene blue, used for the treatment
of medicinal or chemical product induced
methemoglobinemia): due to the risk of serious
or even fatal reactions (called serotonin
syndrome). Treatment with fluoxetine can be
started the day after stopping treatment with
reversible MAOIs but the doctor may wish to

Pregnancy
Talk to your doctor as soon as possible if you’re
pregnant, if you might be pregnant, or if you’re
planning to become pregnant.
In babies whose mothers took fluoxetine during
the first few months of pregnancy, there have been
some studies describing an increased risk of birth
defects affecting the heart. In the general population,
about 1 in 100 babies are born with a heart defect.
This increased to about 2 in 100 babies in mothers
who took fluoxetine.
When taken during pregnancy, particularly in the last
3 months of pregnancy, medicines like fluoxetine

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may increase the risk of a serious condition in
babies, called persistent pulmonary hypertension
of the newborn (PPHN), making the baby breathe
faster and appear bluish. These symptoms usually
begin during the first 24 hours after the baby is born.
If this happens to your baby you should contact your
midwife and/or doctor immediately.

exceed 2 capsules (40 mg). The maximum dose is
3 capsules (60 mg) daily.
Liver impairment:
If you have a liver problem or are using other
medication that might affect Prozac, your doctor
may decide to prescribe a lower dose or tell you to
use Prozac every other day.

It is preferable not to use this treatment during
pregnancy unless the potential benefit outweighs
the potential risk. Thus, you and your doctor may
decide to gradually stop taking Prozac while you
are pregnant or before being pregnant. However,
depending on your circumstances, your doctor may
suggest that it is better for you to keep taking Prozac.

If you take more Prozac than you should
• If you take too many capsules, go to your nearest
hospital emergency department (or casualty) or
tell your doctor straight away.
• Take the pack of Prozac with you if you can.
Symptoms of overdose include: nausea, vomiting,
seizures, heart problems (like irregular heart beat
and cardiac arrest), lung problems and change in
mental condition ranging from agitation to coma.

Caution should be exercised when used during
pregnancy, especially during late pregnancy or
just before giving birth since the following effects
have been reported in new born children: irritability,
tremor, muscle weakness, persistent crying, and
difficulty in sucking or in sleeping.

If you forget to take Prozac
• If you miss a dose, do not worry. Take your next
dose the next day at the usual time. Do not take
a double dose to make up for a forgotten dose.
• Taking your medicine at the same time each day
may help you to remember to take it regularly.

Breast-feeding
Fluoxetine is excreted in breast milk and can cause
side effects in babies. You should only breast-feed if
it is clearly necessary. If breast-feeding is continued,
your doctor may prescribe a lower dose of fluoxetine.

If you stop taking Prozac
• Do not stop taking Prozac without asking your
doctor first, even when you start to feel better. It
is important that you keep taking your medicine.
• Make sure you do not run out of capsules.

Fertility
Fluoxetine has been shown to reduce the quality
of sperm in animal studies. Theoretically, this could
affect fertility, but impact on human fertility has not
been observed as yet.

You may notice the following effects (withdrawal
effects) when you stop taking Prozac: dizziness;
tingling feelings like pins and needles; sleep
disturbances (vivid dreams, nightmares, inability to
sleep); feeling restless or agitated; unusual tiredness
or weakness; feeling anxious; nausea/vomiting (feeling
sick or being sick); tremor (shakiness); headaches.

Driving and using machines
Psychotropic drugs such as Prozac may affect
your judgment or co-ordination. Do not drive or use
machinery until you know how Prozac affects you.
3. How to take Prozac hard capsules

Most people find that any symptoms on stopping
Prozac are mild and disappear within a few weeks.
If you experience symptoms when you stop treatment,
contact your doctor.

Always take this medicine exactly as your doctor or
pharmacist has told you. Check with your doctor or
pharmacist if you are not sure. Do not take more
capsules than your doctor tells you.

When stopping Prozac, your doctor will help you to
reduce your dose slowly over one or two weeks –
this should help reduce the chance of withdrawal
effects.

Swallow the capsules with a drink of water. Do not
chew the capsules.
Adults:
The recommended dose is:
• Depression: The recommended dose is 1
capsule (20 mg) daily. Your doctor will review
and adjust your dosage if necessary within 3
to 4 weeks of the start of treatment. If required,
the dosage can be gradually increased up to
a maximum of 3 capsules (60 mg) daily. The
dose should be increased carefully to ensure
that you receive the lowest effective dose. You
may not feel better immediately when you first
start taking your medicine for depression. This
is usual because an improvement in depressive
symptoms may not occur until after the first
few weeks. Patients with depression should be
treated for at least 6 months.
• Bulimia nervosa: The recommended dose is 3
capsules (60 mg) daily.
• Obsessive-compulsive disorder: The
recommended dose is 1 capsule (20 mg) daily.
Your doctor will review and adjust your dosage
if necessary after 2 weeks of treatment. If
required, the dosage can be gradually increased
up to a maximum of 3 capsules (60 mg) daily. If
no improvement is noted within 10 weeks, your
doctor will reconsider your treatment.

If you have any further questions on the use of this
medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side
effects, although not everybody gets them.
• If you have thoughts of harming or killing yourself
at any time, contact your doctor or go to a
hospital straight away (see Section 2).
• If you get a rash or allergic reaction such as
itching, swollen lips/tongue or wheezing/shortness
of breath, stop taking the capsules straight
away and tell your doctor immediately.
• If you feel restless and cannot sit or stand still,
you may have akathisia; increasing your dose of
Prozac may make you feel worse. If you feel like
this, contact your doctor.
• Tell your doctor immediately if your skin starts
to turn red or you develop a varied skin reaction or
your skin starts to blister or peel. This is very rare.
The most frequent sides effects (very common
side effects that may affect more than 1 user in 10)
are insomnia, headache, diarrhoea, feeling sick
(nausea) and fatigue.
Some patients have had:
• a combination of symptoms (known as “serotonin
syndrome”) including unexplained fever with
faster breathing or heart rate, sweating, muscle
stiffness or tremor, confusion, extreme agitation
or sleepiness (only rarely);
• feelings of weakness, drowsiness or confusion
mostly in elderly people and in (elderly) people
taking diuretics (water tablets);
• prolonged and painful erection;
• irritability and extreme agitation;
• heart problems, such as fast or irregular heart
rate, fainting, collapsing or dizziness upon
standing which may indicate abnormal functioning
of the heart rate.
If you have any of the above side effects, you
should tell your doctor immediately.

Use in children and adolescents aged 8 to 18
years with depression:
Treatment should be started and be supervised
by a specialist. The starting dose is 10 mg/day
(given as 2.5 ml of Prozac oral solution). After 1
to 2 weeks, your doctor may increase the dose to
20 mg/day. The dose should be increased carefully
to ensure that you receive the lowest effective dose.
Lower weight children may need lower doses. If
there is a satisfactory response to treatment, your
doctor will review the need for continuing treatment
beyond 6 months. If you have not improved within 9
weeks, your doctor will reassess your treatment.
Elderly:
Your doctor will increase the dose with more
caution and the daily dose should generally not

3

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 following side effects have also been reported
in patients taking Prozac:
Common (may affect up to 1 in 10 people)
• not feeling hungry, weight loss
• nervousness, anxiety
• restlessness, poor concentration
• feeling tense
• decreased sex drive or sexual problems (including
difficulty maintaining an erection for sexual activity)
• sleep problems, unusual dreams, tiredness or
sleepiness
• dizziness
• change in taste
• uncontrollable shaking movements
• blurred vision
• rapid and irregular heartbeat sensations
• flushing
• yawning
• indigestion, vomiting
• dry mouth
• rash, urticaria, itching
• excessive sweating
• joint pain
• passing urine more frequently
• unexplained vaginal bleeding
• feeling shaky or chills

United Kingdom
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard
Ireland
HPRA Pharmacovigilance
Earlsfort Terrace
IRL - Dublin 2
Tel: +353 1 6764971
Fax: +353 1 6762517
Website: www.hpra.ie
e-mail: medsafety@hpra.ie
Malta
ADR Reporting
Website: www.medicinesauthority.gov.mt/adrportal
By reporting side effects you can help provide more
information on the safety of this medicine.
5. How to store Prozac hard capsules
Keep out of the sight and reach of children.
Do not use this medicine after the expiry date which
is stated on the carton after EXP. The expiry date
refers to the last day of that month.
Do not store your capsules above 30°C.

Uncommon (may affect up to 1 in 100 people)
• feeling detached from yourself
• strange thinking
• abnormally high mood
• orgasm problems
• thoughts of suicide or harming yourself
• teeth grinding
• muscle twitching, involuntary movements or
problems with balance or co-ordination
• memory impairment
• enlarged (dilated) pupils
• ringing in the ears
• low blood pressure
• shortness of breath
• nose bleeds
• difficulty swallowing
• hair loss
• increased tendency to bruising
• unexplained bruising or bleeding
• cold sweat
• difficulty passing urine
• feeling hot or cold
• abnormal liver test results

Do not throw away any medicines via wastewater
or household waste. Ask your pharmacist how to
throw away medicines you no longer use. These
measures will help to protect the environment.
6. Content of the pack and other information
What Prozac hard capsules contains
The active substance is fluoxetine hydrochloride.
Each capsule contains 20 milligram (mg) of fluoxetine
(as fluoxetine hydrochloride).
The other ingredients are: maize starch flowable
and dimeticone.
The capsule shell is made of gelatin, patent
blue V (E131), yellow iron oxide (E172), titanium
dioxide (E171) and black edible printing ink, which
contains shellac, black iron oxide (E172), propylene
glycol and may contain ammonium hydroxide and
potassium hydroxide.
What Prozac hard capsules looks like and
contents of the pack
The capsules are yellow and green, and marked
‘Lilly 3105’. The capsules are available in PVC/
aluminium blister packs of 2, 7, 12, 14, 20, 28, 30,
50, 56, 70, 98, 100 and 500. Not all pack sizes may
be marketed.

Rare (may affect up to 1 in 1,000 people)
• low levels of salt in the blood
• reduction in blood platelets, which increases risk
of bleeding or bruising
• reduction in white blood cell count
• untypical wild behaviour
• hallucinations
• agitation
• panic attacks
• confusion
• stuttering
• aggression
• fits
• vasculitis (inflammation of a blood vessel)
• rapid swelling of the tissues around the neck,
face, mouth and/or throat
• pain in the tube that takes food or water to your
stomach
• hepatitis
• lung problems
• sensitivity to sunlight
• muscle pain
• problems urinating
• producing breast milk

Marketing Authorisation Holder and Manufacturer
The marketing authorisation holder is Eli Lilly and
Company Limited, Lilly House, Priestley Road,
Basingstoke, Hampshire, RG24 9NL, U.K.
The manufacturer is Patheon France, 40, boulevard
de Champaret, 38300 Bourgoin-Jallieu, France.
This medicinal product is authorised in the
Member States of the EEA under the following
names:
Austria: Fluctine
Belgium: Prozac, Fontex
Czech Republic: Prozac
France: Prozac
Greece: Ladose
Ireland: Prozac
Italy: Prozac
Luxembourg: Prozac, Fontex
Malta: Prozac
Portugal: Prozac
Spain: Prozac
Slovenia: Prozac
United Kingdom: Prozac

Bone fractures – an increased risk of bone
fractures has been observed in patients taking this
type of medicines.
Most of these side effects are likely to disappear
with continued treatment.

This leaflet was last revised in February 2016.
Detailed information on this medicine is available
on the web site of: UK/MHRA, Ireland/HPRA,
Malta/The Medicines Authority

In children and adolescents (8-18 years) – In
addition to the possible side effects listed above,
Prozac may slow growth or possibly delay sexual
maturity. Suicide-related behaviours (suicide attempt
and suicidal thoughts), hostility, mania, and nose
bleeds were also commonly reported in children.

4

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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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