RISPERIDONE 1MG TABLETS

Active substance: RISPERIDONE

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What Risperdal® Tablets looks like and the contents of the pack

 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® Tablets. 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 apnea), 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 fibers 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, A decrease in body temperature,
Coldness in arms and legs
 Symptoms of drug withdrawal
 Yellowing of the skin and the eyes (jaundice).

PACKAGE LEAFLET: INFORMATION FOR THE USER
®

Each oblong white film coated tablet is coded `Ris 1`with a scoreline on
one side, plain on the reverse.
Risperdal® Tablets are available in blister packs of 20 or 60 tablets.
Who manufactured your medicine
Manufactured by Janssen Cilag Spa., Via C Janssen, 04010 Borgo, San
Michele, Latina, Italy and is procured from within the EU and repackaged
by Product Licence Holder: Beachcourse Limited, 20 Alliance Court,
Alliance Road, London W3 0RB.
PL
16378/0094
POM
Revision date: 07.05.2014
Leaflet Reference: RISP1
Risperdal® is a registered trademark.

RISPERDAL 1mg TABLETS/ RISPERIDONE 1mg TABLETS

Revision date: 07.05.2014
Leaflet reference: RISP1

(Risperidone)
 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
Read all of this leaflet carefully before you start taking this medicine
pharmacist before using Risperdal® Tablets.
because it contains important information for you.
As dangerously low numbers of a certain type of white blood cell needed
 Keep this leaflet. You may need to read it again.
to fight infection in your blood has been seen very rarely with patients
 If you have any further questions, ask your doctor or pharmacist.
taking Risperdal® Tablets, your doctor may check your white blood cell
 This medicine has been prescribed for you only. Do not pass it on to
counts.
others. It may harm them, even if their signs of illness are the same as
Risperdal® Tablets may cause you to gain weight. Significant weight gain
yours.
may adversely affect your health. Your doctor should regularly measure
 If you get any side effects, talk to your doctor or pharmacist. This
your body weight.
includes any possible side effects not listed in this leaflet. See section
As diabetes mellitus or worsening of pre-existing diabetes mellitus have
4.
been seen with patients taking Risperdal® Tablets, your doctor should
check for signs of high blood sugar. In patients with pre-existing diabetes
What is in this leaflet:
mellitus blood glucose should be monitored regularly.
1. What Risperdal® Tablets are and what they are used for
During an operation on the eye for cloudiness of the lens (cataract), the
®
2. What you need to know before you take Risperdal Tablets
pupil (the black circle in the middle of your eye) may not increase in size
3. How to take Risperdal® Tablets
as needed. Also, the iris (the coloured part of the eye) may become floppy
4. Possible side effects
during surgery and that may lead to eye damage. If you are planning to
®
5. How to store Risperdal Tablets
have an operation on your eye, make sure you tell your eye doctor that
6. Contents of the pack and other information
you are taking this medicine.
This product is also available in other strengths and orodispersible tablets
(Quicklet).
Your medicine is known by the above names, but will be referred to as
Risperdal® Tablets throughout this leaflet.

1. WHAT RISPERDAL® TABLETS ARE AND WHAT THEY ARE

Elderly people with dementia

USED FOR

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 caregiver 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.

Very rare (affects less than 1 user in 10,000):

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.

Risperdal® Tablets belong to a group of medicines called ‘anti-psychotics’.
Risperdal® Tablets are 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® Tablets can help alleviate the symptoms of your disease and
stop your symptoms from coming back.

Reporting of side effects

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE

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 Yellow Card Scheme (Website:
www.mhra.gov.uk/yellowcard). By reporting side effects you can help
provide more information on the safety of this medicine.

RISPERDAL® TABLETS

 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.
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® Tablets: Rapid heartbeat upon standing.
Additional side effects in children and adolescents

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 your, or your child’s body weight may be
measured and it may be regularly monitored during treatment.
Other medicines and Risperdal® Tablets
Tell your doctor or pharmacist if you are taking, have recently taken or
might take any other medicines.
It is especially important to talk to your doctor or pharmacist if you
are taking any of the following:

®

Do not take Risperdal Tablets if:

 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® Tablets 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® Tablets taken by themselves or with
furosemide, may have an increased risk of stroke or death in elderly
people with dementia.

 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® Tablets.

5. HOW TO STORE RISPERDAL® TABLETS

Warnings and precautions

Keep out of the sight and reach of children.
Store below 30°C, in a dry place away from direct sunlight.
Do not take your tablets out of the blister strip until it is time to take your
dose.
Do not use this medicine after the expiry date (This is printed on both the
carton and blister label).
If your doctor tells you to stop taking this medicine, return any unused
medicine to your pharmacist for safe disposal. Only keep this medicine, if
your doctor tells you to.
If your tablets show signs of deterioration or discolouration, you should
seek the advice of your pharmacist who will tell you what to do.
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 protect the environment.

Talk to your doctor or pharmacist before taking Risperdal® Tablets 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® Tablets 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

6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Risperdal® Tablets contain
Each tablet contains 1mg of the active ingredient risperidone.
Each tablet also contains lactose, maize starch, microcrystalline cellulose,
hypromellose, magnesium stearate, colloidal anhydrous silica, sodium
lauryl sulphate, and propylene glycol.

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.

Continued overleaf

4

1

The following medicines may increase the effect of risperidone

For the treatment of long-standing aggression in people with
Alzheimer’s dementia

 Quinidine (used for certain types of heart disease)
 Antidepressants such as paroxetine, fluoxetine, tricyclic
antidepressants
 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)
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® Tablets.

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

Risperdal® Tablets with food, drink and alcohol

 Children and adolescents under 18 years old should not be treated with
Risperdal® Tablets for schizophrenia or mania.

You can take this medicine with or without food. You should avoid
drinking alcohol when taking Risperdal® Tablets.

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® Tablets
for conduct disorder.

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® Tablets 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® Tablets 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® Tablets. Do not drive or use any tools or machines without
talking to your doctor first.

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.

Risperdal® Tablets contains lactose or aspartame
Risperdal® 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. The 2 mg and 6 mg filmcoated tablets contain sunset yellow (E110) that may cause allergic
reactions.
The orodispersible tablets contain aspartame, a source of phenylalanine
which may be harmful for people with phenylketonuria.

®

Risperdal 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.
Risperdal® Quicklet® orodispersible tablets

3. HOW TO TAKE RISPERDAL® TABLETS

Only remove a tablet from the blister when it is time to take your medicine.
 Peel open a blister to expose the tablet
 Do not push the tablet through the foil because it may break
 Remove the tablet from the blister with dry hands
 Place the tablet on your tongue straight away
 The tablet will begin disintegrating within seconds
 It can then be swallowed with or without water.

Always take this medicine exactly as your doctor has told you. Check with
your doctor or pharmacist if you are not sure.
The recommended dose is as follows:
For the treatment of schizophrenia
Adults

If you take more Risperdal® Tablets than you should

 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.

 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® Tablets
 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

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

If you stop taking Risperdal Tablets

Adults

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.

 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

4. POSSIBLE SIDE EFFECTS

 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® Tablets 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® Tablets 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 win
 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 stiffness, 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 gamma-glutamyltransferase) in your blood, Increased
liver enzymes in your blood
 Procedural pain.

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 (affects more than 1 user in 10):
 Difficulty falling or staying asleep
 Parkinsonism: This condition may include: slow or impaired movement,
sensation of stiffness 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 (affects 1 to 10 users in 100):
 Pneumonia, Infection of the chest (bronchitis), Common cold
symptoms, Sinus infection Urinary tract infection Ear infection, Feeling
like you have the flu
 Risperdal® Tablets can raise your levels of a hormone called "prolactin"
found on a blood test (which may or may not cause symptoms). When
symptoms of high prolactin occur, they may include in men breast
swelling, difficulty in getting or maintaining erections, 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.
 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, Diarrhea, 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.

Rare (affects 1 to 10 users in 10,000):






Uncommon (affects 1 to 10 users in 1000):
 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






 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.

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
Continued overleaf

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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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