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RISPERIDONE 6MG ORODISPERSIBLE TABLETS

Active substance(s): RISPERIDONE / RISPERIDONE / RISPERIDONE

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TEVA UK Ref:

Version:

231-30-86518-X LEA RISPERIDONE OD TABS A/S TUK
3

02 June 2014

RISPERIDONE
2 mg, 3 mg, 4 mg and 6 mg
ORODISPERSIBLE TABLETS

RISPERIDONE
2 mg, 3 mg, 4 mg and 6 mg
ORODISPERSIBLE TABLETS

$UMMY 0HARMA #ODES SHOWN NUMBER  WILL
be replaced by the real ones prior to production.

RISPERIDONE
2 mg, 3 mg, 4 mg and 6 mg
ORODISPERSIBLE TABLETS

4HE FOLLOWING MEDICINES MAY REDUCE THE EFFECT OF RISPERIDONE
s 2IFAMPICIN A MEDICINE FOR TREATING SOME INFECTIONS
s #ARBAMAZEPINE PHENYTOIN MEDICINES FOR EPILEPSY
s 0HENOBARBITAL

0!#+!'% ,%!&,%4 ).&/2-!4)/.
&/2 4(% 53%2

)F YOU START OR STOP TAKING SUCH MEDICINES YOU MAY NEED A
different dose of risperidone.

Read all of this leaflet carefully before you start taking this
medicine because it contains important information for you.
s +EEP THIS LEAFLET9OU MAY NEED TO READ IT AGAIN
s )F YOU HAVE ANY FURTHER QUESTIONS ASK YOUR DOCTOR OR
pharmacist.
s 4HIS MEDICINE HAS BEEN PRESCRIBED FOR YOU ONLY $O NOT PASS
IT ON TO OTHERS )T MAY HARM THEM EVEN IF THEIR SIGNS OF
illness are the same as yours.
s )F YOU GET ANY SIDE EFFECTS TALK TO YOUR DOCTOR OR PHARMACIST

4HE FOLLOWING MEDICINES MAY INCREASE THE EFFECT OF
risperidone.
s 1UINIDINE USED FOR CERTAIN TYPES OF HEART DISEASE
s !NTIDEPRESSANTS SUCH AS PAROXETINE FLUOXETINES TRICYCLIC
antidepressants
s -EDICINES KNOWN AS BETA BLOCKERS USED TO TREAT HIGH BLOOD
PRESSURE
s 0HENOTHIAZINES EG USED TO TREAT PSYCHOSIS OR TO CALM
DOWN

4HIS INCLUDES ANY POSSIBLE SIDE EFFECTS NOT LISTED IN THIS
LEAFLET 3EE SECTION 

7(!4 )3 ). 4()3 ,%!&,%4
1. What Risperidone is and what it is used for
2. What you need to know before you take Risperidone
3. How to take Risperidone
4. Possible side effects
5. How to store Risperidone
6. Contents of the pack and other information

1

)F YOU START OR STOP TAKING SUCH MEDICINES YOU MAY NEED A
different dose of risperidone.
)F YOU ARE NOT SURE IF ANY OF THE ABOVE APPLIES TO YOU TALK TO
YOUR DOCTOR OR PHARMACIST BEFORE USING 2ISPERIDONE
Risperidone with food and drink
YOU CAN TAKE THIS MEDICINE WITH OR WITHOUT FOOD9OU SHOULD
AVOID DRINKING ALCOHOL WHEN TAKING 2ISPERIDONE

WHAT RISPERIDONE IS AND WHAT IT IS USED FOR

2ISPERIDONE BELONGS TO A GROUP OF MEDICINES CALLED
@ANTI PSYCHOTICS
2ISPERIDONE IS USED TO TREAT THE FOLLOWING
s 3CHIZOPHRENIA WHERE YOU MAY SEE HEAR OR FEEL THINGS THAT
ARE NOT THERE believe things that are not true or feel
UNUSUALLY SUSPICIOUS OR CONFUSED
s -ANIA WHERE YOU MAY FEEL VERY EXCITED ELATED AGITATED
enthusiastic or hyperactive. Mania occurs in an illness
CALLED hBIPOLAR DISORDERv
s 3HORT TERM TREATMENT UP TO  WEEKS OF LONG TERM
AGGRESSION IN PEOPLE WITH !LZHEIMERS DEMENTIA WHO HARM
THEMSELVES OR OTHERS !LTERNATIVE NON DRUG TREATMENTS
should have been used previously.
s 3HORT TERM TREATMENT UP TO  WEEKS OF LONG TERM
AGGRESSION IN INTELLECTUALLY DISABLED CHILDREN AT LEAST
 YEARS OF AGE AND ADOLESCENTS WITH CONDUCT DISORDER

2

s #IMETIDINE RANITIDINE BLOCKERS OF THE ACIDITY OF THE STOMACH 

WHAT YOU NEED TO KNOW BEFORE YOU TAKE
RISPERIDONE

Do not take Risperidone:
s )F YOU ARE ALLERGIC HYPERSENSITIVE TO RISPERIDONE OR ANY OF
THE OTHER INGREDIENTS OF THIS MEDICINE LISTED IN SECTION  
)F YOU ARE NOT SURE IF THE ABOVE APPLIES TO YOU TALK TO YOUR
DOCTOR OR PHARMACIST BEFORE USING 2ISPERIDONE
Warnings and precautions
4ALK TO YOUR DOCTOR OR PHARMACIST BEFORE TAKING 2ISPERIDONE IF
s 9OU HAVE A HEART PROBLEM %XAMPLES INCLUDE AN IRREGULAR
HEART RHYTHM OR IF YOU ARE PRONE TO LOW BLOOD PRESSURE OR IF
you are using medicines for your blood pressure.
2ISPERIDONE MAY CAUSE LOW BLOOD PRESSURE9OUR DOSE MAY
need to be adjusted.
s 9OU 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
s 9OU HAVE 0ARKINSONS DISEASE OR DEMENTIA
s 9OU 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
s 9OU ARE DIABETIC
s 9OU HAVE EPILEPSY
s 9OU ARE A MAN AND YOU HAVE EVER HAD A PROLONGED OR
PAINFUL ERECTION )F YOU EXPERIENCE THIS WHILE TAKING
2ISPERIDONE CONTACT YOUR DOCTOR STRAIGHT AWAY
s 9OU HAVE PROBLEMS CONTROLLING YOUR BODY TEMPERATURE OR

Pregnancy and breast-feeding
s )F 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
s 4HE FOLLOWING SYMPTOMS MAY OCCUR IN NEWBORN BABIES OF
MOTHERS THAT HAVE USED 2ISPERIDONE IN THE LAST TRIMESTER
LAST THREE MONTHS OF THEIR PREGNANCY  SHAKING MUSCLE
STIFFNESS ANDOR WEAKNESS SLEEPINESS AGITATION BREATHING
PROBLEMS AND DIFFICULTY IN FEEDING )F YOUR BABY DEVELOPS
any of these symptoms you may need to contact your
doctor.
s 2ISPERIDONE CAN RAISE YOUR LEVELS OF A HORMONE CALLED
PROLACTIN THAT MAY IMPACT FERTILITY SEE 0OSSIBLE SIDE
EFFECTS 
!SK YOUR DOCTOR OR PHARMACIST FOR ADVICE BEFORE TAKING ANY
medicine.
Driving and using machines
$IZZINESS TIREDNESS AND VISION PROBLEMS MAY OCCUR DURING
TREATMENT WITH 2ISPERIDONE $O NOT DRIVE OR USE ANY TOOLS OR
MACHINES WITHOUT TALKING TO YOUR DOCTOR FIRST
Risperidone 3 mg contains tartrazine
2ISPERIDONE  MG /RODISPERSIBLE4ABLETS CONTAINS TARTRAZINE
and may cause allergic reactions.

3

HOW TO TAKE RISPERIDONE

!LWAYS TAKE THIS MEDICINE EXACTLY AS YOUR DOCTOR HAS TOLD YOU
#HECK WITH YOUR DOCTOR OR PHARMACIST IF YOU ARE NOT SURE
The recommended dose is as follows:
For the treatment of schizophrenia
Adults
s 4HE USUAL STARTING DOSE IS  MG PER DAY THIS MAY BE
increased to 4 mg per day on the second day
s 9OUR DOSE MAY THEN BE ADJUSTED BY YOUR DOCTOR DEPENDING
ON HOW YOU RESPOND TO THE TREATMENT
s -OST PEOPLE FEEL BETTER WITH DAILY DOSES OF  TO  MG
s 4HIS TOTAL DAILY DOSE CAN BE DIVIDED INTO EITHER ONE OR TWO
DOSES A DAY9OUR DOCTOR WILL TELL YOU WHICH IS THE BEST FOR
you.
Elderly people

overheating
s 9OU HAVE KIDNEY PROBLEMS
s 9OU HAVE LIVER PROBLEMS
s 9OU HAVE AN ABNORMALLY HIGH LEVEL OF THE HORMONE
PROLACTIN IN YOUR BLOOD OR IF YOU HAVE A TUMOUR WHICH IS
possibly dependent on prolactin
s 9OU OR SOMEONE ELSE IN YOUR FAMILY HAS A HISTORY OF BLOOD
CLOTS AS MEDICINES LIKE THESE HAVE BEEN ASSOCIATED WITH
formation of blood clots.

9OUR STARTING DOSE WILL NORMALLY BE  MG TWICE A DAY
s 9OUR DOSE MAY THEN BE GRADUALLY INCREASED BY YOUR DOCTOR
TO  MG TO  MG TWICE A DAY
s 9OUR DOCTOR WILL TELL YOU WHICH IS THE BEST FOR YOU
Use in children and adolescents
s #HILDREN AND ADOLESCENTS UNDER  YEARS OLD SHOULD NOT BE
TREATED WITH 2ISPERIDONE FOR SCHIZOPHRENIA
For the treatment of mania

Tell your doctor immediately if you experience
s INVOLUNTARY RHYTHMIC MOVEMENTS OF THE TONGUE MOUTH and
FACE 7ITHDRAWAL OF RISPERIDONE MAY BE NEEDED
s FEVER SEVERE MUSCLE STIFFNESS SWEATING OR A LOWERED LEVEL
OF CONSCIOUSNESS A DISORDER CALLED hNEUROLEPTIC MALIGNANT
SYNDROMEv  )MMEDIATE MEDICAL TREATMENT MAY BE NEEDED

Adults
s 9OUR STARTING DOSE WILL USUALLY BE  MG ONCE A DAY
s 9OUR DOSE MAY THEN BE GRADUALLY ADJUSTED BY YOUR DOCTOR
DEPENDING ON HOW YOU RESPOND TO THE TREATMENT
s -OST PEOPLE FEEL BETTER WITH DOSES OF  TO  MG ONCE A DAY

Elderly people
)F YOU ARE NOT SURE IF ANY OF THE ABOVE APPLIES TO YOU TALK TO
s 9OUR STARTING DOSE WILL USUALLY BE  MG TWICE A DAY
YOUR DOCTOR OR PHARMACIST BEFORE USING 2ISPERIDONE
!S DANGEROUSLY LOW NUMBERS OF A CERTAIN TYPE OF WHITE BLOOD s 9OUR DOSE MAY THEN BE GRADUALLY ADJUSTED BY YOUR DOCTOR
TO  MG TO  MG TWICE A DAY DEPENDING ON HOW MUCH YOU
cell needed to fight infection in your blood has been seen very
respond to the treatment.
RARELY WITH PATIENTS TAKING 2ISPERIDONE YOUR DOCTOR MAY CHECK
YOUR WHITE BLOOD CELL COUNTS
Use in children and adolescents
2ISPERIDONE MAY CAUSE YOU TO GAIN WEIGHT 3IGNIFICANT WEIGHT s #HILDREN AND ADOLESCENTS UNDER  YEARS OLD SHOULD NOT BE
TREATED WITH 2ISPERIDONE FOR BIPOLAR MANIA
gain may adversely affect your health. Your doctor should
REGULARLY MEASURE YOUR BODY WEIGHT
For the treatment of long-standing aggression in people with
Alzheimer’s dementia
!S DIABETES MELLITUS OR WORSENING OF PRE EXISTING DIABETES
MELLITUS HAVE BEEN SEEN WITH PATIENTS TAKING 2ISPERIDONE
Adults (including elderly people)
YOUR DOCTOR SHOULD CHECK FOR SIGNS OF HIGH BLOOD SUGAR )N
s 9OUR STARTING DOSE WILL NORMALLY BE  MG TWICE A DAY
PATIENTS WITH PRE EXISTING DIABETES MELLITUS BLOOD GLUCOSE
s 9OUR DOSE MAY THEN BE GRADUALLY ADJUSTED BY YOUR DOCTOR
should be monitored regularly.
DEPENDING ON HOW YOU RESPOND TO THE TREATMENT
s -OST PEOPLE FEEL BETTER WITH  MG TWICE A DAY 3OME
During an operation on the eye for cloudiness of the lens
PATIENTS MAY NEED  MG TWICE A DAY
CATARACT THE PUPIL THE BLACK CIRCLE IN THE MIDDLE OF YOUR EYE
MAY NOT INCREASE IN SIZE AS NEEDED !LSO THE IRIS THE COLOURED s 4REATMENT DURATION IN PATIENTS WITH !LZHEIMERS DEMENTIA
SHOULD BE NOT MORE THAN  WEEKS
PART OF THE EYE MAY BECOME FLOPPY DURING SURGERY AND THAT
MAY LEAD TO EYE DAMAGE )F YOU ARE PLANNING TO HAVE AN
For the treatment of conduct disorder in children and
OPERATION ON YOUR EYE MAKE SURE YOU TELL YOUR EYE DOCTOR
adolescents
that you are taking this medicine.
4HE DOSE WILL DEPEND ON YOUR CHILDS WEIGHT
Elderly people with dementia
)N ELDERLY PATIENTS WITH DEMENTIA THERE IS AN INCREASED RISK OF &OR CHILDREN WHO WEIGH LESS THAN  KG
stroke. You should not take risperidone if you have dementia s 4HE STARTING DOSE WILL NORMALLY BE  MG ONCE A DAY
s 4HE DOSE MAY BE INCREASED EVERY OTHER DAY IN STEPS OF
caused by stroke.
 MG PER DAY
$URING TREATMENT WITH RISPERIDONE YOU SHOULD FREQUENTLY SEE
s 4HE USUAL MAINTENANCE DOSE IS  MG TO  MG ONCE A
your doctor.
day.
-EDICAL TREATMENT SHOULD BE SOUGHT STRAIGHT AWAY IF YOU or
YOUR CARE GIVER NOTICE A SUDDEN CHANGE IN YOUR MENTAL state or
&OR CHILDREN WHO WEIGH  KG OR MORE
SUDDEN WEAKNESS OR NUMBNESS OF YOUR FACE ARMS OR LEGS
s 4HE STARTING DOSE WILL NORMALLY BE  MG ONCE A DAY
ESPECIALLY ON ONE SIDE OR SLURRED SPEECH EVEN FOR A SHORT
s 4HE DOSE MAY BE INCREASED EVERY OTHER DAY IN STEPS OF
PERIOD OF TIME4HESE MAY BE SIGNS OF A STROKE
 MG PER DAY
s 4HE USUAL MAINTENANCE DOSE IS  MG TO  MG ONCE A DAY
Children and adolescents
"EFORE TREATMENT IS STARTED IN CONDUCT DISORDER OTHER CAUSES of
4REATMENT DURATION IN PATIENTS WITH CONDUCT DISORDER SHOULD
aggressive behaviour should have been ruled out.
BE NOT MORE THAN  WEEKS
"EFORE TREATMENT IS STARTED YOUR OR YOUR CHILDS BODY WEIGHT
#HILDREN UNDER  YEARS OLD SHOULD NOT BE TREATED WITH
may be measured and it may be regularly monitored during

treatment.

2ISPERIDONE FOR CONDUCT DISORDER

)F DURING TREATMENT WITH RISPERIDONE TIREDNESS OCCURS A
change in the time of administration might improve attention
difficulties.

People with kidney or liver problems
2EGARDLESS OF THE DISEASE TO BE TREATED ALL STARTING DOSES AND
FOLLOWING DOSES OF RISPERIDONE SHOULD BE HALVED $OSE
INCREASES SHOULD BE SLOWER IN THESE PATIENTS
2ISPERIDONE SHOULD BE USED WITH CAUTION IN THIS PATIENT GROUP

Other medicines and Risperidone
4ELL YOUR DOCTOR OR PHARMACIST IF YOU ARE TAKING HAVE RECENTLY
taken or might take any other medicines.

Take the tablets as follows
/NLY REMOVE A TABLET FROM THE BLISTER WHEN IT IS TIME TO TAKE
)T IS ESPECIALLY IMPORTANT TO TALK TO YOUR DOCTOR OR PHARMACIST IF your medicine.
YOU ARE TAKING ANY OF THE FOLLOWING
s -EDICINES THAT WORK ON YOUR BRAIN SUCH AS TO HELP YOU CALM s $O NOT PUSH THE TABLET OUT OF THE POCKET AS THIS WILL CRUSH IT
s %ACH STRIP CONTAINS TABLETS SEPARATED IN POCKETS BY
DOWN BENZODIAZEPINES OR SOME MEDICINES FOR PAIN
PERFORATIONS4EAR OFF ONE TABLET POCKET ALONG THE DOTTED
OPIATES MEDICINES FOR ALLERGY SOME ANTIHISTAMINES AS
LINES &IGURE  
risperidone may increase the sedative effect of all of these
s -EDICINES THAT MAY CHANGE THE ELECTRICAL ACTIVITY OF YOUR
HEART SUCH AS MEDICINES FOR MALARIA HEART RHYTHM
PROBLEMS SUCH AS QUINIDINE ALLERGIES ANTI HISTAMINES
some antidepressants or other medicines for mental
problems

s -EDICINES THAT CAUSE A SLOW HEART BEAT
s #AREFULLY PEEL OFF THE LIDDING FOIL STARTING IN THE CORNER
s -EDICINES THAT CAUSE LOW BLOOD POTASSIUM EG CERTAIN
INDICATED BY THE ARROW &IGURES  AND  
DIURETICS
s -EDICINES TO TREAT ELEVATED BLOOD PRESSURE 2ISPERIDONE CAN
LOWER BLOOD PRESSURE
s -EDICINES FOR 0ARKINSONS DISEASE SUCH AS LEVODOPA
s 7ATER 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  2ISPERIDONE TAKEN
BY ITSELF OR WITH FUROSEMIDE MAY have an increased risk of s +EEP YOUR HANDS DRY AND TAKE THE TABLET OUT OF THE STRIP
s 4HE TABLET SHOULD BE PLACED ON TOP OF THE TONGUE WHERE IT
STROKE OR DEATH IN ELDERLY PEOPLE WITH DEMENTIA
WILL DISPERSE WITHIN SECONDS AND CAN THEN BE SWALLOWED
WITH OR WITHOUT WATER

TEVA UK Ref:

231-30-86518-X LEA RISPERIDONE OD TABS A/S TUK
Do not break or divide the tablets. Your mouth should be
empty before placing the tablet on the tongue.
If you take more Risperidone than you should
s 3EE A DOCTOR RIGHT AWAY4AKE THE MEDICINE PACK WITH YOU
s )N 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 heart beats or fits.
If you forget to take Risperidone
s )F YOU FORGET TO TAKE A DOSE TAKE IT AS SOON AS YOU REMEMBER
IT (OWEVER IF IT IS ALMOST TIME FOR YOUR NEXT DOSE SKIP THE
MISSED DOSE AND CONTINUE AS USUAL )F YOU MISS TWO OR
MORE DOSES CONTACT YOUR DOCTOR
s $O NOT TAKE A DOUBLE DOSE TWO DOSES AT THE SAME TIME TO
make up for a forgotten dose.

Version:

3

02 June 2014

s !BNORMAL POSTURE JOINT STIFFNESS JOINT SWELLING MUSCLE
WEAKNESS NECK PAIN
s &REQUENT PASSING OF URINE INABILITY TO PASS URINE PAIN WHEN
passing urine
s %RECTILE DYSFUNCTION EJACULATION DISORDER
s ,OSS OF MENSTRUAL PERIODS MISSED MENSTRUAL PERIODS OR
OTHER PROBLEMS WITH YOUR CYCLE FEMALES
s $EVELOPMENT OF BREASTS IN MEN LEAKAGE OF MILK FROM THE
BREASTS SEXUAL DYSFUNCTION BREAST PAIN BREAST DISCOMFORT
vaginal discharge
s 3WELLING OF THE FACE MOUTH EYES OR LIPS
s #HILLS AN INCREASE IN BODY TEMPERATURE
s ! CHANGE IN THE WAY YOU WALK
s &EELING THIRSTY FEELING UNWELL CHEST DISCOMFORT FEELING
OUT OF SORTS DISCOMFORT
s )NCREASED LIVER TRANSAMINASES IN YOUR BLOOD INCREASED ''4
A LIVER ENZYME CALLED GAMMA GLUTAMYLTRANSFERASE IN YOUR

If you stop taking Risperidone
You should not stop taking this medicine unless told to do so
BY YOUR DOCTOR9OUR SYMPTOMS MAY RETURN )F YOUR DOCTOR
DECIDES TO STOP THIS MEDICINE YOUR DOSE MAY BE DECREASED
GRADUALLY OVER A FEW DAYS

BLOOD INCREASED LIVER ENZYMES IN YOUR BLOOD
s 0ROCEDURAL PAIN

Rare (may affect up to 1 in 1,000 people):
s )NFECTION
s )NAPPROPRIATE SECRETION OF A HORMONE THAT CONTROLS URINE
volume
)F YOU HAVE ANY FURTHER QUESTIONS ON THE USE OF THIS MEDICINE s 3UGAR IN THE URINE LOW BLOOD SUGAR HIGH BLOOD
TRIGLYCERIDES A FAT
ask your doctor or pharmacist.
s ,ACK OF EMOTION INABILITY TO REACH ORGASM
s .EUROLEPTIC MALIGNANT SYNDROME CONFUSION REDUCED OR
4 POSSIBLE SIDE EFFECTS
LOSS OF CONSCIOUSNESS HIGH FEVER AND SEVERE MUSCLE
STIFFNESS
,IKE ALL MEDICINES THIS MEDICINE CAN CAUSE SIDE EFFECTS
s "LOOD VESSEL PROBLEMS IN THE BRAIN
although not everybody gets them.
s #OMA DUE TO UNCONTROLLED DIABETES
s 3HAKING OF THE HEAD
4ELL YOUR DOCTOR IMMEDIATELY IF YOU
s 'LAUCOMA INCREASED PRESSURE WITHIN THE EYEBALL
s %XPERIENCE BLOOD CLOTS IN THE VEINS ESPECIALLY IN THE LEGS
PROBLEMS WITH MOVEMENT OF YOUR EYES EYE ROLLING EYELID
SYMPTOMS INCLUDE SWELLING PAIN AND REDNESS IN THE LEG
margin crusting
WHICH MAY TRAVEL THROUGH BLOOD VESSELS TO THE LUNGS
s %YE PROBLEMS DURING CATARACT SURGERY $URING CATARACT
CAUSING CHEST PAIN AND DIFFICULTY BREATHING )F YOU NOTICE
SURGERY A CONDITION CALLED INTRAOPERATIVE FLOPPY IRIS
any if these symptoms seek medical advice immediately.
SYNDROME )&)3 CAN HAPPEN IF YOU TAKE OR HAVE TAKEN
s (AVE DEMENTIA AND EXPERIENCE A SUDDEN CHANGE IN YOUR
2ISPERIDONE )F YOU NEED TO HAVE CATARACT SURGERY BE SURE
MENTAL STATE OR SUDDEN WEAKNESS OR NUMBNESS OF YOUR
to tell your eye doctor if you take or have taken this
FACE ARMS OR LEGS ESPECIALLY ON ONE SIDE OR SLURRED
medicine.
SPEECH EVEN FOR A SHORT PERIOD OF TIME4HESE MAY BE SIGNS
s $ANGEROUSLY LOW NUMBERS OF A CERTAIN TYPE OF WHITE BLOOD
of a stroke.
cell needed to fight infection in your blood
s %XPERIENCE FEVER MUSCLE STIFFNESS SWEATING OR A LOWERED
s 3EVERE ALLERGIC REACTION CHARACTERISED BY FEVER SWOLLEN
LEVEL OF CONSCIOUSNESS A DISORDER CALLED h.EUROLEPTIC
MOUTH FACE LIP OR TONGUE SHORTNESS OF BREATH ITCHING SKIN
-ALIGNANT 3YNDROMEv  )MMEDIATE MEDICAL TREATMENT MAY
rash and sometimes drop in blood pressure
be needed.
s $ANGEROUSLY EXCESSIVE INTAKE OF WATER
s !RE A MAN AND EXPERIENCE PROLONGED OR PAINFUL ERECTION
4HIS IS CALLED PRIAPISM )MMEDIATE MEDICAL TREATMENT MAY s )RREGULAR HEART BEAT
s "LOOD CLOT IN THE LEGS BLOOD CLOT IN THE LUNGS
be needed.
s %XPERIENCE INVOLUNTARY RHYTHMIC MOVEMENTS OF THE TONGUE s 4ROUBLE BREATHING DURING SLEEP SLEEP APNEA FAST SHALLOW
breathing
MOUTH AND FACE 7ITHDRAWAL OF RISPERIDONE MAY BE NEEDED
s )NFLAMMATION OF THE PANCREAS A BLOCKAGE IN THE BOWELS
s %XPERIENCE SEVERE ALLERGIC REACTION CHARACTERIZED BY FEVER
s 3WOLLEN TONGUE CHAPPED LIPS RASH ON SKIN RELATED TO DRUG
SWOLLEN MOUTH FACE LIP OR TONGUE SHORTNESS OF BREATH
s $ANDRUFF
ITCHING SKIN RASH OR DROP IN BLOOD PRESSURE
s "REAKDOWN OF MUSCLE FIBERS AND PAIN IN MUSCLES
RHABDOMYOLYSIS
4HE FOLLOWING SIDE EFFECTS MAY HAPPEN
s ! DELAY IN MENSTRUAL PERIODS ENLARGEMENT OF THE GLANDS IN
YOUR BREASTS BREAST ENLARGEMENT DISCHARGE FROM THE
Very Common (may affect more than 1 in 10 people):
breasts
s 0ARKINSONISM4HIS IS A MEDICAL TERM THAT INCLUDES MANY
s )NCREASED INSULIN A HORMONE THAT CONTROLS BLOOD SUGAR
SYMPTOMS %ACH INDIVIDUAL SYMPTOM MAY OCCUR LESS
LEVELS IN YOUR BLOOD
FREQUENTLY THAN IN  IN  PEOPLE 0ARKINSONISM INCLUDES
s 0RIAPISM A PROLONGED PENILE ERECTION THAT MAY REQUIRE
increase in saliva secretion OR WATERY MOUTH
SURGICAL TREATMENT
MUSCULOSKELETAL STIFFNESS DROOLING JERKS WHEN BENDING THE
s (ARDENING OF THE SKIN
LIMBS SLOW REDUCED OR IMPAIRED BODY MOVEMENTS NO
EXPRESSION ON THE FACE MUSCLE TIGHTNESS STIFF NECK MUSCLE s $ECREASED BODY TEMPERATURE A DECREASE IN BODY
TEMPERATURE COLDNESS IN ARMS AND LEGS
STIFFNESS SMALL SHUFFLING HURRIED STEPS AND LACK OF NORMAL
s 3YMPTOMS OF DRUG WITHDRAWAL
ARM MOVEMENTS WHEN WALKING PERSISTENT BLINKING IN
s 9ELLOWING OF THE SKIN AND THE EYES JAUNDICE 
RESPONSE TO TAPPING OF THE FOREHEAD AN ABNORMAL REFLEX 
s (EADACHE DIFFICULTY FALLING OR STAYING ASLEEP FEELING SLEEPY
Very rare (may affect up to 1 in 10,000 people):
or less alert.
s ,IFE THREATENING COMPLICATIONS OF UNCONTROLLED DIABETES
s 3ERIOUS ALLERGIC REACTION WITH SWELLING THAT MAY INVOLVE THE
Common (may affect up to 1 in 10 people):
throat and lead to difficulty breathing
s 0NEUMONIA INFECTION OF THE CHEST BRONCHITIS COMMON COLD
s ,ACK OF BOWEL MUSCLE MOVEMENT THAT CAUSES BLOCKAGE
SYMPTOMS SINUS INFECTION URINARY TRACT INFECTION EAR
INFECTION FEELING LIKE YOU HAVE THE FLU
4HE FOLLOWING SIDE EFFECT HAS BEEN SEEN WITH THE USE OF
s 2ISPERIDONE CAN RAISE YOUR LEVELS OF A HORMONE CALLED

s
s
s

s
s
s
s
s
s
s
s
s
s
s
s

PROLACTIN FOUND ON A BLOOD TEST WHICH MAY OR MAY NOT
CAUSE SYMPTOMS  7HEN SYMPTOMS OF HIGH PROLACTIN OCCUR
THEY MAY INCLUDE IN MEN BREAST SWELLING DIFFICULTY IN GETTING
OR MAINTAINING ERECTIONS OR OTHER SEXUAL DYSFUNCTION )N
WOMEN THEY MAY INCLUDE BREAST DISCOMFORT LEAKAGE OF MILK
FROM THE BREASTS MISSED MENSTRUAL PERIODS OR OTHER
PROBLEMS WITH YOUR CYCLE
7EIGHT GAIN INCREASED APPETITE DECREASED APPETITE
3LEEP DISORDER IRRITABILITY DEPRESSION ANXIETY RESTLESSNESS
$YSTONIA 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
$IZZINESS
$YSKINESIA4HIS IS A CONDITION INVOLVING INVOLUNTARY MUSCLE
MOVEMENTS AND CAN INCLUDE REPETITIVE SPASTIC OR WRITHING
MOVEMENTS OR TWITCHING
4REMOR SHAKING
"LURRY VISION EYE INFECTION OR PINK EYE
2APID HEART RATE HIGH BLOOD PRESSURE SHORTNESS OF BREATH
3ORE THROAT COUGH NOSEBLEEDS STUFFY NOSE
!BDOMINAL PAIN ABDOMINAL DISCOMFORT VOMITING NAUSEA
CONSTIPATION DIARRHOEA INDIGESTION DRY MOUTH TOOTHACHE
2ASH SKIN REDNESS
-USCLE SPASMS BONE OR MUSCLE ACHE BACK PAIN JOINT PAIN
)NCONTINENCE LACK OF CONTROL OF URINE
3WELLING OF THE BODY ARMS OR LEGS FEVER CHEST PAIN
WEAKNESS FATIGUE TIREDNESS PAIN
&ALL

Uncommon (may affect up to 1 in 100 people):
s )NFECTION 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
s $ECREASE 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 ANAEMIA DECREASE IN RED BLOOD CELLS
INCREASE IN EOSINOPHILS A TYPE OF WHITE BLOOD CELL IN YOUR
blood
s !LLERGIC REACTION
s $IABETES OR WORSENING OF DIABETES HIGH BLOOD SUGAR
EXCESSIVE DRINKING OF WATER
s 7EIGHT LOSS LOSS OF APPETITE RESULTING IN MALNUTRITION AND
LOW BODY WEIGHT
s )NCREASED CHOLESTEROL IN YOUR BLOOD
s %LATED MOOD MANIA CONFUSION DECREASED SEXUAL DRIVE
NERVOUSNESS NIGHTMARES
s 4ARDIVE DYSKINESIA TWITCHING OR JERKING MOVEMENTS THAT
YOU CANNOT CONTROL IN YOUR FACE TONGUE OR OTHER PARTS OF
YOUR BODY 4ELL YOUR DOCTOR IMMEDIATELY IF YOU EXPERIENCE
INVOLUNTARY RHYTHMIC MOVEMENTS OF THE TONGUE MOUTH AND
FACE 7ITHDRAWAL OF 2ISPERIDONE MAY BE NEEDED
s 3UDDEN LOSS OF BLOOD SUPPLY TO BRAIN STROKE OR MINI
STROKE
s 5NRESPONSIVE TO STIMULI LOSS OF CONSCIOUSNESS LOW LEVEL OF
consciousness

another medicine called paliperidone that is very similar to
2ISPERIDONE SO THESE CAN ALSO BE EXPECTED WITH 2ISPERIDONE
2APID HEARTBEAT UPON STANDING
Additional side effects in children and adolescents
)N GENERAL SIDE EFFECTS IN CHILDREN ARE EXPECTED TO BE SIMILAR
to those in adults.
4HE FOLLOWING SIDE EFFECTS WERE REPORTED MORE OFTEN IN
CHILDREN AND ADOLESCENTS  TO  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
)F YOU GET ANY SIDE EFFECTS TALK TO YOUR DOCTOR PHARMACIST OR
NURSE4HIS INCLUDES ANY POSSIBLE SIDE EFFECTS NOT LISTED IN THIS
LEAFLET9OU CAN ALSO REPORT SIDE EFFECTS DIRECTLY VIA THE9ELLOW
#ARD 3CHEME AT WWWMHRAGOVUKYELLOWCARD
"Y REPORTING SIDE EFFECTS YOU CAN HELP PROVIDE MORE
information on the safety of this medicine.

5

HOW TO STORE RISPERIDONE

Keep this medicine out of the sight and reach of children.
$O NOT USE THIS MEDICINE AFTER THE EXPIRY DATE WHICH IS STATED
ON THE BLISTER AND CARTON4HE EXPIRY DATE REFERS TO THE LAST DAY
of the month.
4HIS MEDICINE DOES NOT REQUIRE ANY SPECIAL STORAGE
conditions.
$O NOT THROW AWAY ANY MEDICINES VIA WASTE WATER OR
HOUSEHOLD WASTE !SK YOUR PHARMACIST HOW TO THROW AWAY
MEDICINES YOU NO LONGER USE4HESE MEASURES WILL HELP
protect the environment.

6

CONTENTS OF THE PACK AND OTHER INFORMATION

What Risperidone contains
s 4HE ACTIVE SUBSTANCE IS RISPERIDONE %ACH ORODISPERSIBLE
TABLET CONTAINS    OR  MG OF RISPERIDONE
s 4HE OTHER INGREDIENTS ARE MANNITOL SODIUM STARCH GLYCOLATE
TYPE ! AND PEPPERMINT FLAVOUR4HE TABLETS ALSO CONTAIN
THE FOLLOWING COLOURS
 MG TARTRAZINE %
 MG ERYTHROSINE %
 MG INDIGO CARMINE % 
What Risperidone looks like and the contents of the pack
s /RODISPERSIBLE TABLET
s 2ISPERIDONE  MG /RODISPERSIBLE4ABLETS ARE WHITE FLAT
ROUND TABLETS PLAIN ON BOTH SIDES ROUGH ON BORDERS AND
face
s 2ISPERIDONE  MG /RODISPERSIBLE4ABLETS ARE LIGHT YELLOW
FLAT ROUND TABLETS PLAIN ON BOTH SIDES ROUGH ON BORDERS
and face
s 2ISPERIDONE  MG /RODISPERSIBLE4ABLETS ARE MOTTLED LIGHT

s #ONVULSION FITS FAINTING
s ! 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 OF
skin
s /VERSENSITIVITY OF THE EYES TO LIGHT DRY EYE INCREASED TEARS
redness of the eyes
s 3ENSATION OF SPINNING VERTIGO RINGING IN THE EARS EAR PAIN
s !TRIAL 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 14 INTERVAL FROM YOUR HEART SLOW
HEART RATE ABNORMAL ELECTRICAL TRACING OF THE HEART
ELECTROCARDIOGRAM OR %#' A FLUTTERING OR POUNDING FEELING
IN YOUR CHEST PALPITATIONS
s ,OW BLOOD PRESSURE LOW BLOOD PRESSURE UPON STANDING
CONSEQUENTLY SOME PEOPLE TAKING 2ISPERIDONE MAY FEEL
FAINT DIZZY OR MAY PASS OUT WHEN THEY STAND UP OR SIT UP
SUDDENLY FLUSHING
s 0NEUMONIA CAUSED BY INHALING FOOD LUNG CONGESTION
CONGESTION OF BREATHING PASSAGES CRACKLY LUNG SOUNDS
WHEEZING VOICE DISORDER BREATHING PASSAGE DISORDER
s 3TOMACH OR INTESTINAL INFECTION STOOL INCONTINENCE VERY
HARD STOOL DIFFICULTY SWALLOWING EXCESSIVE PASSING OF GAS
OR WIND
s (IVES OR NETTLE RASH ITCHING HAIR LOSS THICKENING OF SKIN
ECZEMA DRY SKIN SKIN DISCOLORATION ACNE FLAKY ITCHY SCALP
OR SKIN SKIN DISORDER SKIN LESION
s !N INCREASE OF #0+ CREATINE PHOSPHOKINASE IN YOUR BLOOD
AN ENZYME WHICH IS SOMETIMES RELEASED WITH MUSCLE
BREAKDOWN

s
s
s
s
s

PINK FLAT ROUND TABLETS PLAIN ON BOTH SIDES ROUGH ON
borders and face
2ISPERIDONE  MG /RODISPERSIBLE4ABLETS ARE BLUE FLAT
ROUND TABLETS PLAIN ON BOTH SIDES ROUGH ON BORDERS AND
face
4HE  MG TABLETS ARE AVAILABLE IN PACK SIZES OF    
        TABLETS HOSPITAL PACK   
   ORODISPERSIBLE TABLETS
4HE  MG TABLETS ARE AVAILABLE IN PACK SIZES OF    
        TABLETS HOSPITAL PACK    
  ORODISPERSIBLE TABLETS
4HE  MG TABLETS ARE AVAILABLE IN PACK SIZES OF    
        TABLETS HOSPITAL PACK    
  ORODISPERSIBLE TABLETS
4HE  MG TABLETS ARE AVAILABLE IN PACK SIZES OF    
       TABLETS HOSPITAL PACK     
 ORODISPERSIBLE TABLETS

.OT ALL PACK SIZES MAY BE MARKETED
Marketing Authorisation Holder:
4%6! 5+ ,IMITED %ASTBOURNE ". !'
Manufacturer:
4EVA /PERATIONS 0OLAND 3P ZOO 3IENKIEWICZA  3TR  
+UTNO 0OLAND
This leaflet was last revised in 05/2014.
0,  

 X 
 8

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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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