RISPERIDONE 1MG FILM-COATED TABLETS

Active substance: RISPERIDONE

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360 mm
160 mm
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L:
W:
D:
Foil Width:
Perforated:

Dimensions:

231-10-01601, 01611, 01621, 01631,
01641 and 01651.
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TBC
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Univers
F. P. Code:

PL 00289/0652-57. Teva UK Limited Licence, Teva Regulatory Team.
Packed at Teva Debrecen, Hungary.
Tablets scoring/breakline text updated.
PL Number(s),
MA Holder & Packer:
Reason for revision:

Trackwise Parent:

223206

1
Version:

Child:

223210

Colours:
(PANTONE® is a registered
trademark of Pantone, Inc.)

PANTONE® GREEN C

19 September 2013

231-30-69703-ZC LEA RISPERIDONE A/S F/C TAB TUK Ref:

RISPERIDONE 0.5 mg, 1 mg, 2 mg, 3 mg,
4 mg and 6 mg FILM-COATED TABLETS

• 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).
PACKAGE LEAFLET: INFORMATION FOR THE USER
Risperidone taken by itself or with furosemide, may
have an increased risk of stroke or death in elderly
Read all of this leaflet carefully before you start taking this
people with dementia.
medicine.
• Keep this leaflet. You may need to read it again.
The following medicines may reduce the effect of
• If you have any further questions, ask your doctor or
Risperidone
pharmacist.
• Rifampicin (a medicine for treating some infections)
• This medicine has been prescribed for you. Do not pass it • Carbamazepine, phenytoin (medicines for epilepsy)
on to others. It may harm them, even if their symptoms • Phenobarbital.
are the same as yours.
If you start or stop taking such medicines you may need a
• If any of the side effects get serious, or if you notice any different dose of Risperidone.
side effects not listed in this leaflet, please tell your
The following medicines may increase the effect of
doctor or pharmacist.
Risperidone
• Quinidine (used for certain types of heart disease)
IN THIS LEAFLET:
• Antidepressants such as paroxetine, fluoxetines,
1. What Risperidone is and what it is used for
tricyclic antidepressants
2. Before you take Risperidone
• Medicines known as beta blockers (used to treat high
3. How to take Risperidone
blood pressure)
4. Possible side effects
• Phenothiazines (e.g. used to treat psychosis or to calm
5. How to store Risperidone
down)
6. Further Information
• Cimetidine, ranitidine (blockers of the acidity of stomach).
If you start or stop taking such medicines you may need a
WHAT RISPERIDONE IS AND WHAT IT IS USED FOR different dose of Risperidone.
If you are not sure if any of the above applies to you, talk
Risperidone belongs to a group of medicines called
to your doctor or pharmacist before using Risperidone.
‘anti-psychotics’.
Taking Risperidone with food and drink
Risperidone is used to treat the following:
You can take this medicine with or without food. You
• Schizophrenia, where you may see, hear or feel things
that are not there, believe things that are not true or feel should avoid drinking alcohol when taking Risperidone.
Pregnancy and breast-feeding
unusually suspicious, or confused
• Mania, where you may feel very excited, elated, agitated, • Talk to your doctor before using Risperidone if you are
pregnant, trying to become pregnant or breast-feeding.
enthusiastic or hyperactive. Mania occurs in an illness
Your doctor will decide if you can take it.
called “bipolar disorder”
.
• The following symptoms may occur in newborn babies,
• Short-term treatment (up to 6 weeks) of long-term
of mothers that have used Risperidone in the last
aggression in people with Alzheimer’s dementia, who
trimester (last three months of their pregnancy): shaking,
harm themselves or others. Alternative (non-drug)
muscle stiffness and/or weakness, sleepiness, agitation,
treatments should have been used previously.
breathing problems, and difficulty in feeding. If your
• Short-term treatment (up to 6 weeks) of long-term,
baby develops any of these symptoms you may need to
aggression in intellectually disabled children (at least
contact your doctor.
5 years of age) and adolescents with conduct disorder.
Ask your doctor or pharmacist for advice before taking
any medicine.
BEFORE YOU TAKE RISPERIDONE
Driving and using machines
Do NOT take Risperidone:
Dizziness, tiredness, and vision problems may occur
• If you are allergic (hypersensitive) to Risperidone or any during treatment with Risperidone. Do not drive or use
of the other ingredients of this medicine (see section 6
any tools or machines without talking to your doctor first.
‘Further information’).
Important information about some of the ingredients of
If you are not sure if the above applies to you, talk to your
Risperidone
doctor or pharmacist before using Risperidone.
If you have been told by your doctor that you have
intolerance to some sugars, contact your doctor before
Take special care with Risperidone:
taking this medicine.
Check with your doctor or pharmacist before taking
Risperidone if you:
• have a heart problem. Examples include an irregular
HOW TO TAKE RISPERIDONE
heart rhythm or if you are prone to low blood pressure
or if you are using medicines for your blood pressure.
How much to take
Risperidone may cause low blood pressure. Your dose
For the treatment of schizophrenia
may need to be adjusted.
Adults
• know of any factors which would favour you having a
• The usual starting dose is 2 mg per day, this may be
stroke, such as high blood pressure, cardiovascular
increased to 4 mg per day on the second day
disorder or blood vessel problems in the brain
• Your dose may then be adjusted by your doctor
• have Parkinson’s disease or dementia
depending on how you respond to the treatment
• are diabetic
• Most people feel better with daily doses of 4 mg to 6 mg
• have epilepsy
• This total daily dose can be divided into either one or
• are a man and you have ever had a prolonged or painful
two doses a day. Your doctor will tell you which is the
erection. If you experience this while taking Risperidone,
best for you.
contact your doctor straight away.
Elderly people
• have problems controlling your body temperature or
• Your starting dose will normally be 0.5 mg twice a day
overheating
• Your dose may then be gradually increased by your
• have kidney problems
doctor to 1 mg to 2 mg twice a day
• have liver problems
• Your doctor will tell you which is the best for you.
• have an abnormally high level of the hormone prolactin
in your blood or if you have a tumour, which is possibly Children and adolescents
dependent on prolactin
• Children and adolescents under 18 years old should not
• have or someone else in your family has a history of
be treated with Risperidone for schizophrenia.
blood clots, as medicines like these have been associated For the treatment of mania
with formation of blood clots.
Adults
Tell your doctor immediately if you experience
• Your starting dose will usually be 2 mg once a day
• involuntary rhythmic movements of the tongue, mouth
• Your dose may then be gradually adjusted by your
and face. Withdrawal of Risperidone may be needed.
doctor depending on how you respond to the treatment
• fever, severe muscle stiffness, sweating or a lowered
• Most people feel better with doses of 1 mg to 6 mg once
level of consciousness (a disorder called neuroleptic
a day.
malignant syndrome). Immediate medical treatment
Elderly people
may be needed.
• Your starting dose will usually be 0.5 mg twice a day
If you are not sure if any of the above applies to you, talk
• Your dose may then be gradually adjusted by your
to your doctor or pharmacist before using Risperidone.
doctor to 1 mg to 2 mg twice a day depending on how
much you respond to the treatment.
Risperidone may cause you to gain weight.
Children and adolescents
Elderly people with dementia
In elderly patients with dementia, there is an increased risk • Children and adolescents under 18 years old should not
be treated with Risperidone for bipolar mania.
of stroke. You should not take Risperidone if you have
dementia caused by stroke.
For the treatment of long-standing aggression in people
During treatment with Risperidone you should frequently
with Alzheimer’s dementia
see your doctor.
Adults (including elderly people)
Medical treatment should be sought straight away if you
• Your starting dose will normally be 0.25 mg twice a day
or your care-giver notice a sudden change in your mental
• Your dose may then be gradually adjusted by your
state or sudden weakness or numbness of your face, arms
doctor depending on how you respond to the treatment
or legs, especially on one side, or slurred speech, even for • Most people feel better with 0.5 mg twice a day. Some
a short period of time. These may be signs of a stroke.
patients may need 1 mg twice a day.
• Treatment duration in patients with Alzheimer’s
Children and adolescents
dementia should be not more than 6 weeks.
Before treatment is started in conduct disorder, other
causes of aggressive behaviour should have been ruled out. For the treatment of conduct disorder in children and
Before treatment is started your, or your child’s body
adolescents
weight may be measured and it may be regularly
The dose will depend on your child’s weight:
monitored during treatment.
For children who weigh less than 50 kg
If during treatment with Risperidone tiredness occurs, a
• The starting dose will normally be 0.25 mg once a day
change in the time of administration might improve
• The dose may be increased every other day in steps of
attention difficulties.
0.25 mg per day
• The usual maintenance dose is 0.25 mg to 0.75 mg once
Taking other medicines
a day.
Please tell your doctor or pharmacist if you are taking or have
recently taken any other medicines, including medicines
For children who weigh 50 kg or more
obtained without a prescription and herbal medicines.
• The starting dose will normally be 0.5 mg once a day
• The dose may be increased every other day in steps of
It is especially important to talk to your doctor or
0.5 mg per day
pharmacist if you are taking any of the following:
• The usual maintenance dose is 0.5 mg to 1.5 mg once a
• Medicines that work on your brain such as to help you
day.
calm down (benzodiazepines) or some medicines for pain
(opiates), medicines for allergy (some antihistamines), as Treatment duration in patients with conduct disorder
Risperidone may increase the sedative effect of all of these should be not more than 6 weeks.
• Medicines that may change the electrical activity of your Children under 5 years old should not be treated with
heart, such as medicines for malaria, heart rhythm
Risperidone for conduct disorder.
problems (such as quinidine), allergies (antihistamines),
People with kidney or liver problems
some antidepressants or other medicines for mental
Regardless of the disease to be treated, all starting doses
problems
and following doses of Risperidone should be halved.
• Medicines that cause a slow heart beat
Dose increases should be slower in these patients.
• Medicines that cause low blood potassium (e.g. certain
Risperidone should be used with caution in this patient
diuretics)
group.
• Medicines to treat elevated blood pressure. Risperidone
can lower blood pressure.

1

2

3

7 Pt
Base Font Size:

IMPORTANT: Artwork, text and content must not be reset, remade, amended or altered. The only exceptions to this are: bleeds, chokes, spreads or other print related adjustments required for reproduction by the supplier.
We must receive a copy of any 3rd Party Supplier’s Proof before approval to print will be granted.

BLACK

360 mm
160 mm
N/A
N/A
N/A
EAN Code:
Pharma Code:
Edge Code:
Third party code:
Fonts:

L:
W:
D:
Foil Width:
Perforated:

231-10-01601, 01611, 01621, 01631,
01641 and 01651.
N/A
TBC
N/A
TBC
Univers
F. P. Code:

Dimensions:

PL 00289/0652-57. Teva UK Limited Licence, Teva Regulatory Team.
Packed at Teva Debrecen, Hungary.
Tablets scoring/breakline text updated.
PL Number(s),
MA Holder & Packer:
Reason for revision:

Trackwise Parent:

223206

1
Version:

Child:

223210

Colours:
(PANTONE® is a registered
trademark of Pantone, Inc.)

PANTONE® GREEN C

19 September 2013

231-30-69703-ZC LEA RISPERIDONE A/S F/C TAB TUK Ref:

How to take Risperidone
• Always take Risperidone exactly as your doctor has told
you. You should check with your doctor or pharmacist if
you are not sure.
• Your doctor will tell you how much medicine to take and
for how long. This will depend on your condition and
varies from person to person. The amount of medicine
you should take is explained under the ‘How much to
take’ sub-heading below.
Risperidone Film-Coated Tablets
• You should swallow your tablet with a drink of water.
If you take more Risperidone 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 heart beats or fits.
If you forget to take Risperidone
• 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 Risperidone
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 product,
ask your doctor or pharmacist.

4

POSSIBLE SIDE EFFECTS

Like all medicines, Risperidone can cause side effects,
although not everybody gets them.
Very common: affects more than 1 user in 10
Common: affects 1 to 10 users in 100
Uncommon: affects 1 to 10 users in 1,000
Rare: affects 1 to 10 users in 10,000
Very rare: affects less than 1 user in 10,000
Not known: frequency cannot be estimated from the
available data.
The following side effects may happen:
Very Common (affects more than 1 user in 10):
• Parkinsonism. This is a medical term that includes many
symptoms. Each individual symptom may occur less
frequently than in 1 in 10 people. Parkinsonism includes:
increase in saliva secretion or watery mouth, musculoskeletal
stiffness, drooling, jerks when bending the limbs, slow,
reduced or impaired body movements, no expression on
the face, muscle tightness, stiff neck, muscle stiffness,
small, shuffling, hurried steps and lack of normal arm
movements when walking, persistent blinking in
response to tapping of the forehead (an abnormal reflex).
• Headache, difficulty falling or staying asleep.
Common (affects 1 to 10 users in 100):
• Drowsiness, fatigue, restlessness, inability to sit still,
irritability, anxiety, sleepiness, dizziness, poor attention,
feeling exhausted, sleep disorder
• Vomiting, diarrhoea, constipation, nausea, increased
appetite, abdominal pain or discomfort, sore throat, dry
mouth
• Weight increased, increase in body temperature,
decreased appetite
• Difficulty breathing, lung infection (pneumonia), flu,
infection of the breathing passages, blurred vision, nose
congestion, nose bleeding, cough
• Urinary tract infection, bed wetting
• Muscle spasm, involuntary movements of face or arms
and legs, joint pain, back pain, swelling of arms and legs,
pain in arms and legs
• Rash, skin redness
• Fast beating heart, chest pain
• Blood prolactin hormone level increased.
Uncommon (affects 1 to 10 users in 1000):
• Excessive drinking of water, stool incontinence, thirsty,
very hard faeces, hoarseness or voice disorder
• Lung infection caused by inhaling of food into the
breathing passages, bladder infection, ‘pink eye’, sinus
infection, viral infection, ear infection, tonsil infection,
infection under the skin, eye infection, stomach infection,
eye discharge, yeast infection of nails
• Abnormal electrical conduction of the heart, drop in
blood pressure after standing, low blood pressure,
feeling dizzy after changing body position, abnormal
electric activity tracing of the heart (ECG), abnormal
heart rhythm, awareness of heart beating, heart rate
increased or decreased
• Urinary incontinence, pain when passing urine, frequent
passing of urine
• Confused, disturbance in attention, low level of
consciousness, excessive sleep, nervousness, elated
mood (mania), lack of energy and interest
• Blood sugar increased, liver enzymes increased, white
blood cell count decreased, low haemoglobin or red blood
cell count (anaemia), increase in eosinophils (special
white blood cells), blood creatinine phosphokinase
increased, decrease in platelets (blood cells that help
you stop bleeding)
• Muscle weakness, muscle pain, ear pain, neck pain, joint
swelling, abnormal posture, joint stiffness,
musculoskeletal chest pain, chest discomfort
• Skin lesion, skin disorder, dry skin, intense itching of skin,
acne, hair loss, skin inflammation caused by mites, skin
discoloration, thickening of skin, flushing, reduced skin
sensitivity to pain or touch, inflammation of oily skin
• No menstruation, sexual dysfunction, erectile
dysfunction, ejaculation disorder, breast discharge,
enlargement of breast in men, decreased sexual drive,
irregular menstruation, vaginal discharge
• Fainting, gait disturbance, sluggishness, decreased
appetite resulting in malnutrition and low body weight,
feeling ‘out of sorts’, balance disorder, allergy, oedema,
speech disorder, chills, abnormal coordination
• Painful oversensitivity to light, increased blood flow to
the eye, eye swelling, dry eye, increase in tears
• Breathing passage disorder, lung congestion, crackly
lung noise, congestion of breathing passages, trouble
speaking, difficulty swallowing, cough with sputum,
coarse/whistling sound during breathing, flu-like illness,
sinus congestion
• Unresponsive to stimuli, loss of consciousness, sudden
swelling of lips and eyes along with difficulty breathing,
sudden weakness or numbness of the face, arms, or legs,
especially on one side, or instances of slurred speech
that last for less than 24 hours (these are called
mini-strokes or strokes), involuntary movements of face,
arms, or legs, ringing in ears, face oedema.

Rare (affects 1 to 10 users in 10,000):
• Inability to reach orgasm, menstrual disorder
• Dandruff
• Drug allergy, coldness in arms and legs, lip swelling, lip
inflammation
• Glaucoma, reduced visual clarity, eyelid margin crusting,
eye rolling
• Lack of emotion
• Change in consciousness with increased body temperature
and twitching of muscles, oedema all over the body, drug
withdrawal syndrome, body temperature decreased
• Fast shallow breathing, trouble breathing during sleep,
chronic otitis media
• Obstruction of intestine
• Reduced blood flow to the brain
• Decrease in white blood cells, inappropriate secretion of
a hormone that controls urine volume
• Breakdown of muscle fibers and pain in muscles
(rhabdomyolysis), movement disorder
• Coma due to uncontrolled diabetes
• Yellowing of the skin and the eyes (jaundice)
• Inflammation of the pancreas.
Very rare (affects less than 1 user in 10,000):
• Life threatening complications of uncontrolled diabetes.
Unknown frequency of occurrence (frequency cannot be
estimated from the available data):
• Severe allergic reaction resulting in difficulty in breathing
and shock
• No granulocytes (a type of white blood cell to help you
against infection)
• Prolonged and painful erection
• Dangerously excessive intake of water
• 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 in breathing. If you notice any
of these symptoms seek medical advice immediately.
If any of the side effects gets serious, or if you notice any
side effects not listed in this leaflet, please tell your doctor
or pharmacist.

5

HOW TO STORE RISPERIDONE

Keep out of the reach and sight of children.
Do not use Risperidone after the expiry date which is
stated on the outer packaging or bottle. The expiry date
refers to the last day of the month.
Do not store above 30°C for 0.5 mg
Do not store above 25°C for 1.0 mg
This medicinal product does not require any special
storage conditions for 2 mg, 3 mg, 4 mg and 6 mg.
Medicines should not be disposed of via waste water 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 Risperidone contains:
• The active ingredient is risperidone.
• Other ingredients are lactose monohydrate, sodium
lauril sulfate, hypromellose (E464), macrogol 6000,
macrogol 400, colloidal anhydrous silica, microcrystalline
cellulose, pregelatinised starch, sodium starch glycolate
(Type A) and magnesium stearate. The tablets contain
the following colours:
• 0.5 mg tablets: iron oxide red (E172), iron oxide
yellow (E172) and titanium dioxide (E171)
• 1 mg tablets: titanium dioxide (E171)
• 2 mg tablets: iron oxide red (E172), Iron oxide yellow
(E172) and titanium dioxide (E171)
• 3 mg tablets: titanium dioxide (E171) and quinoline
yellow aluminium lake (E104)
• 4 mg tablets: titanium dioxide (E171), quinoline
yellow aluminium lake (E104), indigo carmine
aluminium lake (E132) and iron oxide yellow (E172)
• 6 mg tablets: titanium dioxide (E171), iron oxide red
(E172) and iron oxide yellow (E172).
What Risperidone looks like and the contents of the pack:
• Risperidone 0.5 mg Film-Coated Tablets are
brownish-red, round slightly arched tablets, with
approx. 6.5 mm diameter and 3 mm thickness, debossed
RIS 0.5 and scoreline on one side and scoreline on the
other side
• Risperidone 1 mg Film-Coated Tablets are white, round,
slightly arched tablets, with approx. 8 mm diameter and
3.5 mm thickness, debossed RIS 1 and scoreline on one
side and scoreline on the other side
• Risperidone 2 mg Film-Coated Tablets are tan, round,
slightly arched tablets, with approx. 8 mm diameter and
3.5 mm thickness, debossed RIS 2 and scoreline on one
side and scoreline on the other side
• Risperidone 3 mg Film-Coated Tablets are yellow, round,
slightly arched tablets, with approx. 9.5 mm diameter
and 4 mm thickness, debossed RIS 3 and scoreline on
one side and scoreline on the other side
• Risperidone 4 mg Film-Coated Tablets are green, round,
slightly arched tablets, with approx. 10.5 mm diameter
and 4.5 mm thickness, debossed RIS 4 and scoreline on
one side and scoreline on the other side
• Risperidone 6 mg Film-Coated Tablets are tan, round,
slightly arched tablets, with approx. 10.5 mm diameter
and 4.5 mm thickness, debossed RIS 6 and scoreline on
one side and scoreline on the other side.
• The 0.5 mg tablets are available in pack sizes of 10, 20
and 60 film-coated tablets
• The 1 mg tablets are available in pack sizes of 6, 10, 20, 50, 60,
100, 100 (5x20 hospital pack) and 500 film-coated tablets
• The 2 mg tablets are available in pack sizes of 10, 20, 50, 60,
100, 100 (5x20 hospital pack) and 500 film-coated tablets
• The 3 mg tablets are available in pack sizes of 10, 20, 50, 60,
100, 100 (5x20 hospital pack) and 500 film-coated tablets
• The 4 mg tablets are available in pack sizes of 10, 20, 30,
50, 60, 100, 100 (5x20 hospital pack) and 500 film-coated
tablets
• The 6 mg tablets are available in pack sizes of 7, 20, 28,
30, 50, 60, 100 and 100 (5x20 hospital pack) film-coated
tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
The Marketing Authorisation holder and company
responsible for manufacture is TEVA UK Limited,
Eastbourne, BN22 9AG.
This leaflet was last revised: September 2013.
PL 00289/0652-57
69703-ZC
360 x 160

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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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