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RISPERDAL 4MG TABLETS

Active substance(s): RISPERIDONE / RISPERIDONE / RISPERIDONE

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Risperdal® 2mg Tablets
Risperdal® 3mg Tablets
Risperdal® 4mg Tablets
(risperidone)

Patient Information 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 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.
Risperdal Tablets are also available in the following strengths: 0.5mg,
1mg and 6mg.
What is in this leaflet:
1. What Risperdal is and what it is used for
2. What you need to know before you take Risperdal
3. How to take Risperdal
4. Possible side effects
5. How to store Risperdal
6. Contents of the pack and other information
1. What Risperdal is and what it is used for
Risperdal belongs to a group of medicines called ‘anti-psychotics’.
Risperdal is used to treat the following:





Schizophrenia, where you may see, hear or feel things that are not
there, believe things that are not true or feel unusually suspicious, or
confused
Mania, where you may feel very excited, elated, agitated,
enthusiastic or hyperactive. Mania occurs in an illness called “bipolar
disorder”
Short-term treatment (up to 6 weeks) of long-term aggression in
people with Alzheimer’s dementia, who harm themselves or others.
Alternative (non-drug) treatments should have been used previously
Short-term treatment (up to 6 weeks) of long-term aggression in
intellectually disabled children (at least 5 years of age) and
adolescents with conduct disorder.

Risperdal can help alleviate the symptoms of your disease and stop your
symptoms from coming back.
2. What you need to know before you take Risperdal
Do not take Risperdal if:
You are allergic (hypersensitive) to risperidone or any of the other
ingredients of this medicine (listed in Section 6).
If you are not sure if the above applies to you, talk to your doctor or
pharmacist before using Risperdal.
Warnings and precautions
Talk to your doctor or pharmacist before taking Risperdal if:

You have a heart problem. Examples include an irregular heart
rhythm or if you are prone to low blood pressure or if you are using
medicines for your blood pressure. Risperdal may cause low blood
pressure. Your dose may need to be adjusted

You know of any factors which would favour you having a stroke,
such as high blood pressure, cardiovascular disorder or blood vessel
problems in the brain

You have ever experienced involuntary movements of the tongue,
mouth and face

You have ever had a condition whose symptoms include high
temperature, muscle stiffness, sweating or a lowered level of
consciousness (also known as Neuroleptic Malignant Syndrome)

You have Parkinson’s disease or dementia

You know that you have had low levels of white blood cells in the
past (which may or may not have been caused by other medicines)

You are diabetic

You have epilepsy

You are a man and you have ever had a prolonged or painful
erection

You have problems controlling your body temperature or overheating

You have kidney problems

You have liver problems

You have an abnormally high level of the hormone prolactin in your
blood or if you have a possible prolactin-dependent tumour

You or someone else in your family has a history of blood clots, as
antipsychotics have been associated with formation of blood clots.

If you are not sure if any of the above applies to you, talk to your doctor or
pharmacist before using Risperdal.
Risperdal may cause you to gain weight. Significant weight gain may
adversely affect your health. Your doctor should regularly measure your
body weight.
As dangerously low numbers of a certain type of white blood cell needed
to fight infection in your blood has been seen very rarely with patients
taking Risperdal, your doctor may check your white blood cell counts.
As diabetes mellitus or worsening of pre-existing diabetes mellitus have
been seen with patients taking Risperdal, your doctor should check for
signs of high blood sugar. In patients with pre-existing diabetes mellitus
blood glucose should be monitored regularly.
Risperdal commonly raises levels of a hormone called “prolactin”. This
may cause side effects such as menstrual disorders or fertility problems in
women, breast swelling in men (see Possible side effects). If such side
effects occur, evaluation of the prolactin level in the blood is
recommended.
During an operation on the eye for cloudiness of the lens (cataract), the
pupil (the black circle in the middle of your eye) may not increase in size
as needed. Also, the iris (the coloured part of the eye) may become floppy
during surgery and that may lead to eye damage. If you are planning to
have an operation on your eye, make sure you tell your eye doctor that
you are taking this medicine.
Elderly people with dementia
In elderly patients with dementia, there is an increased risk of stroke. You
should not take risperidone if you have dementia caused by stroke.
During treatment with risperidone you should frequently see your doctor.
Medical treatment should be sought straight away if you or your care-giver
notice a sudden change in your mental state or sudden weakness or
numbness of your face, arms or legs, especially on one side, or slurred
speech, even for a short period of time. These may be signs of a stroke.
Children and adolescents
Before treatment is started for conduct disorder, other causes of
aggressive behaviour should have been ruled out.
If during treatment with risperidone tiredness occurs, a change in the time
of administration might improve attention difficulties.
Before treatment is started you, or your child’s body weight may be
measured and it may be regularly monitored during treatment.



Medicines known as beta blockers (used to treat high blood
pressure)

Phenothiazines (such as medicines used to treat psychosis or to
calm down)

Cimetidine, ranitidine (blockers of the acidity of stomach)

Itraconazole and ketoconazole (medicines for treating fungal
infections)

Certain medicines used in the treatment of HIV/AIDS, such as
ritonavir

Verapamil a medicine used to treat high blood pressure and/or
abnormal heart rhythm

Sertraline and fluvoxamine, medicines used to treat depression and
other psychiatric disorders.
If you start or stop taking such medicines you may need a different dose
of risperidone.
If you are not sure if any of the above applies to you, talk to your doctor or
pharmacist before using Risperdal.
Risperdal with food, drink and alcohol
You can take this medicine with or without food. You should avoid drinking
alcohol when taking Risperdal.
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. Your doctor will decide if you can take it.

The following symptoms may occur in newborn babies, of mothers
that have used Risperdal in the last trimester (last three months of
their pregnancy); shaking, muscle stiffness, and/or weakness,
sleepiness, agitation, breathing problems, and difficulty in feeding. If
your baby develops any of these symptoms you may need to contact
your doctor.

Risperdal can raise your levels of a hormone called “prolactin” that
may impact fertility (see Possible side effects).
Driving and using machines
Dizziness, tiredness, and vision problems may occur during treatment with
Risperdal. Do not drive or use any tools or machines without talking to
your doctor first.
Risperdal contains lactose
The film-coated tablets contain lactose, a type of sugar. If you have been
told by your doctor that you have an intolerance to some sugars, contact
your doctor before taking this medicinal product.

A small and inconclusive study has reported an increase in height in
children who took risperidone, but whether this is an effect of the drug or
due to some other reason is not known.

The 2 mg and 6 mg film-coated tablets also contain sunset yellow (E110)
that may cause allergic reactions.

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

3. How to take Risperdal
Always take this medicine exactly as your doctor has told you. Check with
your doctor or pharmacist if you are not sure.

It is especially important to talk to your doctor or pharmacist if you
are taking any of the following:

Medicines that work on your brain such as to help you calm down
(benzodiazepines) or some medicines for pain (opiates), medicines
for allergy (some antihistamines), as risperidone may increase the
sedative effect of all of these

Medicines that may change the electrical activity of your heart, such
as medicines for malaria, heart rhythm problems, allergies (antihistamines), some antidepressants or other medicines for mental
problems

Medicines that cause a slow heart beat

Medicines that cause low blood potassium (such as certain diuretics)

Medicines to treat raised blood pressure. Risperdal can lower blood
pressure

Medicines for Parkinson's disease (such as levodopa)

Water tablets (diuretics) used for heart problems or swelling of parts
of your body due to a build up of too much fluid (such as furosemide
or chlorothiazide). Risperdal taken by itself or with furosemide, may
have an increased risk of stroke or death in elderly people with
dementia.

The recommended dose is as follows:
For the treatment of schizophrenia
Adults

The usual starting dose is 2 mg per day, this may be increased to 4
mg per day on the second day

Your dose may then be adjusted by your doctor depending on how
you respond to the treatment

Most people feel better with daily doses of 4 to 6 mg

This total daily dose can be divided into either one or two doses a
day. Your doctor will tell you which is the best for you.

The following medicines may reduce the effect of risperidone

Rifampicin (a medicine for treating some infections)

Carbamazepine, phenytoin (medicines for epilepsy)

Phenobarbital
If you start or stop taking such medicines you may need a different dose
of risperidone.
The following medicines may increase the effect of risperidone

Quinidine (used for certain types of heart disease)

Antidepressants such as paroxetine, fluoxetine, tricyclic
antidepressants

Elderly people

Your starting dose will normally be 0.5 mg twice a day

Your dose may then be gradually increased by your doctor to 1 mg to
2 mg twice a day

Your doctor will tell you which is the best for you.
For the treatment of mania
Adults

Your starting dose will usually be 2 mg once a day

Your dose may then be gradually adjusted by your doctor depending
on how you respond to the treatment

Most people feel better with doses of 1 to 6 mg once a day.
Elderly people

Your starting dose will usually be 0.5 mg twice a day

Your dose may then be gradually adjusted by your doctor to 1 mg to
2 mg twice a day depending on how much you respond to the
treatment.

For the treatment of long-standing aggression in people with
Alzheimer’s dementia
Adults (including elderly people)

Your starting dose will normally be 0.25 mg twice a day

Your dose may then be gradually adjusted by your doctor depending
on how you respond to the treatment

Most people feel better with 0.5 mg twice a day. Some patients may
need 1 mg twice a day

Treatment duration in patients with Alzheimer’s dementia should be
not more than 6 weeks.
Use in children and adolescents

Children and adolescents under 18 years old should not be treated
with Risperdal for schizophrenia or mania.
For the treatment of conduct disorder
The dose will depend on your child’s weight:
For children who weigh less than 50 kg

The starting dose will normally be 0.25 mg once a day

The dose may be increased every other day in steps of 0.25 mg per
day.

The usual maintenance dose is 0.25 mg to 0.75 mg once a day.
For children who weigh 50 kg or more

The starting dose will normally be 0.5 mg once a day

The dose may be increased every other day in steps of 0.5 mg per
day.

The usual maintenance dose is 0.5 mg to 1.5 mg once a day.
Treatment duration in patients with conduct disorder should be not more
than 6 weeks.
Children under 5 years old should not be treated with Risperdal for
conduct disorder.
People with kidney or liver problems
Regardless of the disease to be treated, all starting doses and following
doses of risperidone should be halved. Dose increases should be slower
in these patients.
Risperidone should be used with caution in this patient group.
Method of administration
For oral use.
Risperdal film-coated tablets

You should swallow your tablet with a drink of water

The score line is only there to help you break the tablet if you have
difficulty swallowing it whole.
If you take more Risperdal than you should

See a doctor right away. Take the medicine pack with you

In case of overdose you may feel sleepy or tired, or have abnormal
body movements, problems standing and walking, feel dizzy due to
low blood pressure, or have abnormal heartbeats or fits.
If you forget to take Risperdal

If you forget to take a dose, take it as soon as you remember it.
However, if it is almost time for your next dose, skip the missed dose
and continue as usual. If you miss two or more doses, contact your
doctor

Do not take a double dose (two doses at the same time) to make
up for a forgotten dose
If you stop taking Risperdal
You should not stop taking this medicine unless told to do so by your
doctor. Your symptoms may return. If your doctor decides to stop this
medicine, your dose may be decreased gradually over a few days.
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.
Tell your doctor immediately if you:

Experience blood clots in the veins, especially in the legs (symptoms
include swelling, pain, and redness in the leg), which may travel
through blood vessels to the lungs causing chest pain and difficulty
breathing. If you notice any of these symptoms seek medical advice
immediately.

Have dementia and experience a sudden change in your mental
state or sudden weakness or numbness of your face, arms or legs,
especially on one side, or slurred speech, even for a short period of
time. These may be signs of a stroke






Experience fever, muscle stiffness, sweating or a lowered level of
consciousness (a disorder called “Neuroleptic Malignant Syndrome”).
Immediate medical treatment may be needed
Are a man and experience prolonged or painful erection. This is
called priapism. Immediate medical treatment may be needed
Experience involuntary rhythmic movements of the tongue, mouth
and face. Withdrawal of risperidone may be needed
Experience severe allergic reaction characterised by fever, swollen
mouth, face, lip or tongue, shortness of breath, itching, skin rash or
drop in blood pressure.

The following side effects may happen:
Very Common (may affect more than 1 in 10 people):

Difficulty falling or staying asleep

Parkinsonism: This condition may include: slow or impaired
movement, sensation of stiff ness or tightness of the muscles
(making your movements jerky), and sometimes even a sensation of
movement “freezing up” and then restarting. Other signs of
parkinsonism include a slow shuffling walk, a tremor while at rest,
increased saliva and/or drooling, and a loss of expression on the
face.

Feeling sleepy, or less alert

Headache
Common (may affect up to 1 in 10 people):

Pneumonia, Infection of the chest (bronchitis),
Common cold symptoms, Sinus infection Urinary tract infection Ear
infection, Feeling like you have the flu

Raised levels of a hormone called “prolactin” found in a blood test
(which may or may not cause symptoms). Symptoms of high
prolactin occur uncommonly and may include in men breast swelling,
difficulty in getting or maintaining erections, decreased sexual desire
or other sexual dysfunction. In women they may include breast
discomfort, leakage of milk from the breasts, missed menstrual
periods, or other problems with your cycle or fertility problems.

Weight gain, Increased appetite, Decreased appetite

Sleep disorder, Irritability, Depression, Anxiety,

Restlessness

Dystonia: This is a condition involving slow or sustained involuntary
contraction of muscles.
While it can involve any part of the body (and may result in abnormal
posture), dystonia often involves muscles of the face, including
abnormal movements of the eyes, mouth, tongue or jaw.

Dizziness

Dyskinesia: This is a condition involving involuntary muscle
movements, and can include repetitive, spastic or writhing
movements, or twitching.

Tremor (shaking)

Blurry vision, Eye infection or “pink eye”

Rapid heart rate, High blood pressure, Shortness of breath

Sore throat, Cough, Nosebleeds, Stuffy nose

Abdominal pain, Abdominal discomfort, Vomiting, Nausea,
Constipation, Diarrhoea, Indigestion, Dry mouth, Toothache

Rash, Skin redness

Muscle spasms, Bone or muscle ache, Back pain, Joint pain

Incontinence (lack of control) of urine

Swelling of the body, arms or legs, Fever, Chest pain, Weakness,
Fatigue (tiredness), Pain

Fall.
Uncommon (may affect up to 1 in 100 people):

Infection of the breathing passages, Bladder infection, ‘Eye infection,
Tonsillitis, Fungal infection of the nails, Infection of the skin, An
infection confined to a single area of skin or part of the body, Viral
infection, Skin inflammation caused by mites

Decrease in the type of white blood cells that help to protect you
against infection, White blood cell count decreased Decrease in
platelets (blood cells that help you stop bleeding), Anemia, Decrease
in red blood cells, Increase in eosinophils (a type of white blood cell)
in your blood

Allergic reaction

Diabetes or worsening of diabetes, High blood sugar, Excessive
drinking of water

Weight loss, Loss of appetite resulting in malnutrition and low body
weight

Increased cholesterol in your blood

Elated mood (mania), Confusion, Decreased sexual drive,
Nervousness, Nightmares

Tardive dyskinesia (twitching or jerking movements that you cannot
control in your face, tongue, or other parts of your body). Tell your
doctor immediately if you experience involuntary rhythmic
movements of the tongue, mouth and face. Withdrawal of Risperdal
may be needed,

Sudden loss of blood supply to brain (stroke or “mini” stroke)

Unresponsive to stimuli, Loss of consciousness, Low level of
consciousness

























Convulsion (fits), Fainting
A restless urge to move parts of your body, Balance disorder,
Abnormal coordination, Dizziness upon standing, Disturbance in
attention, Problems with speech, Loss or abnormal sense of taste,
Reduced sensation of skin to pain and touch, A sensation of tingling,
pricking, or numbness skin
Oversensitivity of the eyes to light, Dry eye, Increased tears,
Redness of the eyes
Sensation of spinning (vertigo), Ringing in the ears, Ear pain
Atrial fibrillation (an abnormal heart rhythm), An interruption in
conduction between the upper and lower parts of the heart, Abnormal
electrical conduction of the heart, Prolongation of the QT interval
from your heart, Slow heart rate, Abnormal electrical tracing of the
heart (electrocardiogram or ECG), A fluttering or pounding feeling in
your chest (palpitations)
Low blood pressure, Low blood pressure upon standing
(consequently, some people taking Risperdal may feel faint, dizzy, or
may pass out when they stand up or sit up suddenly, Flushing
Pneumonia caused by inhaling food, Lung congestion, Congestion of
breathing passages, Crackly lung sounds, Wheezing, Voice disorder,
Breathing passage disorder
Stomach or intestinal infection, Stool incontinence, Very hard stool,
Difficulty swallowing, Excessive passing of gas or wind
Hives (or “nettle rash”), Itching, Hair loss, Thickening of skin,
Eczema, Dry skin, Skin discoloration, Acne, Flaky, itchy scalp or skin,
Skin disorder, Skin lesion
An increase of CPK (creatine phosphokinase) in your blood, an
enzyme which is sometimes released with muscle breakdown
Abnormal posture, Joint stiff ness, Joint swelling, Muscle weakness,
Neck pain
Frequent passing of urine, Inability to pass urine, Pain when passing
urine
Erectile dysfunction, Ejaculation disorder
Loss of menstrual periods, Missed menstrual periods or other
problems with your cycle (females),
Development of breasts in men, Leakage of milk from the breasts,
Sexual dysfunction, Breast pain, Breast discomfort, Vaginal
discharge
Swelling of the face, mouth, eyes, or lips
Chills, An increase in body temperature
A change in the way you walk
Feeling thirsty, Feeling unwell, Chest discomfort, Feeling “out of
sorts”, Discomfort
Increased liver transaminases in your blood, Increased GGT (a liver
enzyme called gammaglutamyltransferase) in your blood, Increased
liver enzymes in your blood
Procedural pain

Rare (may affect up to 1 in 1,000 people):

Infection

Inappropriate secretion of a hormone that controls urine volume

Sugar in the urine, Low blood sugar, High blood triglycerides (a fat)

Lack of emotion, Inability to reach orgasm

Neuroleptic malignant syndrome (confusion, reduced or loss of
consciousness, high fever, and severe muscle stiffness)

Blood vessel problems in the brain

Coma due to uncontrolled diabetes

Shaking of the head

Glaucoma (increased pressure within the eyeball), Problems with
movement of your eyes, Eye rolling, Eyelid margin crusting

Eye problems during cataract surgery. During cataract surgery, a
condition called intraoperative floppy iris syndrome (IFIS) can happen
if you take or have taken Risperdal. If you need to have cataract
surgery, be sure to tell your eye doctor if you take or have taken this
medicine.

Dangerously low numbers of a certain type of white blood cell
needed to fight infection in your blood,

Severe allergic reaction characterised by fever, swollen mouth, face,
lip or tongue, shortness of breath, itching, skin rash and sometimes
drop in blood pressure

Dangerously excessive intake of water

Irregular heart beat

Blood clot in the legs, Blood clot in the lungs

Trouble breathing during sleep (sleep apnoea), Fast, shallow
breathing

Inflammation of the pancreas, A blockage in the bowels

Swollen tongue, Chapped lips, Rash on skin related to drug

Dandruff

Breakdown of muscle fibres and pain in muscles (rhabdomyolysis)

A delay in menstrual periods, Enlargement of the glands in your
breasts, Breast enlargement, Discharge from the breasts

Increased insulin (a hormone that controls blood sugar levels) in your
blood

Priapism (a prolonged penile erection that may require surgical
treatment)







Hardening of the skin
Decreased body temperature,
Coldness in arms and legs
Symptoms of drug withdrawal
Yellowing of the skin and the eyes (jaundice).

Very rare (may affect up to 1 in 10,000 people):

Life threatening complications of uncontrolled diabetes.

Serious allergic reaction with swelling that may involve the throat and
lead to difficulty breathing.

Lack of bowel muscle movement that causes blockage.

Blind or partially sighted?
Is this leaflet hard to see or read?
Contact Quadrant Pharmaceuticals
Ltd – 01204 473081

The following side effect has been seen with the use of another medicine
called paliperidone that is very similar to risperidone, so these can also be
expected with Risperdal: Rapid heartbeat upon standing.
Additional side effects in children and adolescents
In general, side effects in children are expected to be similar to those in
adults.
The following side effects were reported more often in children and
adolescents (5 to 17 years) than in adults: feeling sleepy, or less alert,
fatigue (tiredness), headache, increased appetite, vomiting, common cold
symptoms, nasal congestion, abdominal pain, dizziness, cough, fever,
tremor (shaking), diarrhoea, and incontinence (lack of control) of urine.
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 Risperdal
KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.
Do not store above 30°C.
Do not use after the expiry date which is stated on the blister, foil, carton,
or bottle. The expiry date refers to the last day of that month.
If the tablets show any signs of discolouration or deterioration consult your
pharmacist for advice.
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. Contents of the pack and other information
What Risperdal contains
The active substance is risperidone.
Each film-coated tablet contains 2 mg, 3 mg or 4 mg risperidone.
The other ingredients are: lactose, maize starch, microcrystalline
cellulose, hypromellose, magnesium stearate, colloidal anhydrous silica,
sodium lauryl sulphate and propylene glycol.
The tablets also contain:
2 mg: orange yellow S (E110), titanium dioxide (E171) and talc.
3 mg: quinoline yellow (E104), titanium dioxide (E171) and talc.
4 mg: quinoline yellow (E104), indigo carmine (E132), titanium dioxide
(E171) and talc.
What Risperdal tablets look like and contents of the pack
The 2mg tablets are orange, oblong shaped, marked ‘Ris’ scoreline ‘2’ on
one side and plain on the reverse and contain 2mg of the active ingredient
risperidone.
The 3mg tablets are yellow, oblong shaped, marked ‘Ris’ scoreline ‘3’ on
one side and plain on the reverse and contain 3mg of the active ingredient
risperidone.
The 4mg tablets are green, oblong shaped, marked ‘Ris’ scoreline ‘4’ on
one side and plain on the reverse and contain 4mg of the active ingredient
risperidone.
Risperdal are available in blister packs of 20 and 60 tablets.
Manufactured by Janssen Cilag S.P.A, Via C. Janssen, Borgo S. Michele,
04010-Latina, Italy. Procured from within the EU: Product Licence Holder:
Quadrant Pharmaceuticals Ltd, Lynstock House, Lynstock Way, Lostock,
Bolton BL6 4SA. Repackaged by Maxearn Ltd, BL6 4SA.
Risperdal 2mg Tablets
Risperdal 3mg Tablets
Risperdal 4mg Tablets

PL 20774/0930
PL 20774/0931
PL 20774/0932

POM

Risperdal is a registered trademark of Janssen Cilag.
th

Date of Preparation of Leaflet: 26 May 2017

PP9/0930/31/32/V1

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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