RISPERDAL QUICKLET 3 MG ORODISPERSIBLE TABLETS

Active substance: RISPERIDONE

View full screen / Print PDF » Download PDF ⇩

Transcript
Risperdal® Quicklet® 3 mg
Orodispersible Tablets
Risperidone 3 mg Orodispersible Tablets

2441
20.02.13[2]

(risperidone)
PATIENT INFORMATION LEAFLET
This medicine is available using any one of the above names but will be
referred to as Risperdal throughout this leaflet. This medicine is also
available in different strengths.
Read all of this leaflet carefully before you start using this medicine.
- 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. Do not pass it on to others. It
may harm them, even if their symptoms are the same as yours.
- If you get side effects and they become serious or if you notice any side
effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet
1. What Risperdal is and what it is are used for
2. Before you take Risperdal
3. How to take Risperdal
4. Possible side effects
5. How to store Risperdal
6. Further information
1. WHAT RISPERDAL IS AND WHAT IT IS USED FOR
Risperdal belongs to a group of medicines called ‘anti-psychotics’.
Risperdal is used to treat the following:
- Schizophrenia, where you may see, hear or feel things that are not there,
believe things that are not true or feel unusually suspicious, or confused
- Mania, where you may feel very excited, elated, agitated, enthusiastic or
hyperactive. Mania occurs in an illness called “bipolar disorder”
- Short-term treatment (up to 6 weeks) of long-term aggression in people
with Alzheimer’s dementia, who harm themselves or others. Alternative
(non-drug) treatments should have been used previously
- Short-term treatment (up to 6 weeks) of long-term aggression in
intellectually disabled children (at least 5 years of age) and adolescents
with conduct disorder.
2. BEFORE YOU TAKE RISPERDAL
Do not take Risperdal if:
- You are allergic (hypersensitive) to risperidone or any of the other
ingredients of Risperdal (listed in Section 6 below).
If you are not sure if the above applies to you, talk to your doctor or
pharmacist before using Risperdal.
Take special care with Risperdal
Check with 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 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 tumour, which is possibly dependent on prolactin
- You or someone else in your family has a history of blood clots, as
antipsychotics have been associated with formation of blood clots.
If you are not sure if any of the above applies to you, talk to your doctor or
pharmacist before using Risperdal.
Risperdal may cause you to gain weight.
Significant weight gain may adversely affect your health. Your doctor
should regularly measure your body weight.
As 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.
Elderly people with dementia
In elderly patients with dementia, there is an increased risk of stroke. You
should not take risperidone if you have dementia caused by stroke.
During treatment with risperidone you should frequently see your doctor.
Medical treatment should be sought straight away if you or your care-giver
notice a sudden change in your mental state or sudden weakness or
numbness of your face, arms or legs, especially on one side, or slurred
speech, even for a short period of time. These may be signs of a stroke.
Children and adolescents
Before treatment is started for conduct disorder, other causes of aggressive
behaviour should have been ruled out.
If during treatment with risperidone tiredness occurs, a change in the time
of administration might improve attention difficulties.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently
taken any other medicines, including medicines obtained without a
prescription and herbal 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 (anti-histamines),
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.
Taking Risperdal with food and drink
You can take this medicine with or without food. You should avoid drinking
alcohol when taking Risperdal.
Pregnancy and breast-feeding
- Talk to your doctor before using Risperdal if you are pregnant, trying to
become pregnant or breast-feeding. 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.
Ask your doctor or pharmacist for advice before taking any medicine.
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.
Important information about some of the ingredients of Risperdal
Risperdal contains aspartame, a source of phenylalanine which may be
harmful for people with phenylketonuria. Risperdal Quicklet also contains
mannitol (E421). This may cause a mild stomach upset or diarrhoea.
3. HOW TO TAKE RISPERDAL
How much to take
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.
Children and adolescents
- Children and adolescents under 18 years old should not be treated with
Risperdal for schizophrenia.
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.
Children and adolescents
- Children and adolescents under 18 years old should not be treated with
Risperdal for mania.
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.
For the treatment of conduct disorder in children and adolescents
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.

How to take Risperdal
Always take Risperdal 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.
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 product, ask your doctor
or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Risperdal 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
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
- Tremor, 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
- Diabetes mellitus, high blood sugar
- 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
- Liver enzymes increased, white blood cell count decreased (including
those that help to protect you against bacterial infection), 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), increased
blood cholesterol and triglycerides (blood fats)
- 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 discolouration, 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,
abnormal taste.
- 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.
- Inability to urinate or incomplete emptying of the bladder.
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,
decreased body temperature
- 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 fibres and pain in muscles (rhabdomyolysis),
movement disorder
- Tremor of the head.
- Coma due to uncontrolled diabetes
- Yellowing of the skin and the eyes (jaundice)
- Inflammation of the pancreas.
- Low blood sugar
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.
Risperdal CONSTA
The following side effects have been reported with the use of Risperdal
CONSTA, a long acting injection. Even if you are not being treated with
long acting injections of Risperdal CONSTA but you experience any of the
following, talk to your doctor.
- Infection of the intestine
- Abscess under the skin, tingling pricking or numbness of skin,
inflammation of the skin
- Depression
- Convulsion
- Eye blinking
- Sensation of spinning or swaying
- Slow beating heart, high blood pressure
- Toothache, tongue spasm
- Buttock pain
- Weight decreased.
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 RISPERDAL
- Keep out of the sight and reach of children.
- Do not store 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. FURTHER INFORMATION
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.
Product Licence Holder and Manufacturer
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) 20.02.13[2]
®

Risperdal and Quicklet are trademarks 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)