RISPERDAL QUICKLET 3 MG ORODISPERSIBLE TABLETS

Active substance: RISPERIDONE

View full screen / Print PDF » Download PDF ⇩

Transcript
PATIENT INFORMATION LEAFLET

2441
27.12.13[4]

Risperdal® Quicklet® 3 mg Orodispersible
Tablets
Risperidone 3 mg Orodispersible Tablets
(risperidone)
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.
This medicine is available using any one of the above names but will be
referred to as Risperdal throughout this leaflet.
Risperdal Quicklet Orodispersible Tablets are also available in other
strengths.
Risperdal are also available as Risperdal film-coated tablets.
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
(nondrug) treatments should have been used previously
- Short-term treatment (up to 6 weeks) of longterm, 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.
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.
Risperdal may cause you to gain weight. Significant weight gain may
adversely affect your health. Your doctor should regularly measure your
body weight.
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.
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 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.
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
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:
- 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 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
- 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.
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 or aspartame
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.
The 2 mg and 6 mg film-coated 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.
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.
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.
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.
Risperdal Quicklet orodispersible 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.
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 if 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
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 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, Stuff y 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.

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
- 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 fl uttering 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 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 gammaglutamyltransferase) in
your blood, Increased liver enzymes in your blood
- Procedural pain.
Rare (affects 1 to 10 users in 10,000):
- 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 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).
Very rare (affects less than 1 user in 10,000):
- Life threatening complications of uncontrolled diabetes.
- Serious allergic reaction with swelling that may involve the throat and
lead to difficulty breathing.
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.
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects not listed in this leaflet.
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 the tablets above 30°C. Store in the original package
- Do not use Risperdal tablets after the expiry date which is stated on the
carton and blister strip. The expiry date refers to the last day of that
month.
- If your tablets become discoloured or show any other signs of
deterioration, consult your doctor or pharmacist who will tell you what to
do.
- Always return any left-over medicine to your pharmacist. Only keep it if
your doctor tells you to.
- Medicines should not be disposed of via wastewater or household
waste. These measures will help protect the environment. Return any
leftover Risperdal tablets to your pharmacist. Only keep it if your doctor
tells you to.
6. Contents of the pack and other information
What Risperdal contains
Each orodispersible tablet contains 3 mg risperidone.
The tablets are orodispersible, which means that they break up in the
mouth and can be taken with or without water.
Risperdal also contains several inactive ingredients which allow it to be
made. These are: polacrilex resin, gelatin, mannitol, glycine, simethicone,
carbomer, sodium hydroxide, aspartame E951, peppermint oil, xanthan
gum and red ferric oxide (E172).
What Risperdal look like and contents of the pack
Risperdal tablets are round, coral coloured biconvex orodispersible
tablets embossed with "R3" on one side and plain on the other.
Available in blister strip packs of 28 and 56 tablets.
Manufacturer and Product Licence Holder
Risperdal is manufactured by Janssen-Cilag S.p.A, Via C. Janssen,
04010 Borgo de San Michele, Latina, Italy and procured from within the
EU by Product Licence holder Star Pharmaceuticals Ltd., 5 Sandridge
Close, Harrow, Middlesex HA1 1XD. Repackaged by Servipharm Ltd.
POM

PL No: 20636/2441

Leaflet revision and issue date (Ref) 27.12.13[4]
®

Risperdal is a trademark of Johnson & Johnson.

Expand view ⇕

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.

Hide
(web1)