
RISPERDAL 1 mg TABLETS /
RISPERIDONE l mg TABLETS /
RISPERDAL 2mg TABLETS /
RISPERIDONE 2mg TABLETS
(risperidone)
This product is available using any of the above names but will
be referred to as Risperidone 1mg / 2mg Tablets throughout
the following:
Patient Information Leaflet
Please read this information about Risperidone 1mg / 2mg Tablets
carefully before you start taking your tablets.
It contains all the information you should need to know.
If you have any further questions or are not sure about anything,
ask your doctor or pharmacist.
Please keep this information in a safe place, you may wish to refer
to it again.
The medicine is called Risperidone Tablets. Each film-coated
tablet contains 1 mg of the active ingredient risperidone, and is
oblong and white. It is coded 'RIS 1' with a breakline on one side
and plain on the reverse.
OR
The medicine is called Risperidone 2mg Each film-coated tablet
contains 2 mg of the active ingredient risperidone, and is oblong
and white. It is coded 'RIS 2' with a breakline on one side and
plain on the reverse.
Risperidone 1mg Tablets also contain the following:
lactose, maize starch, microcrystalline cellulose, hypromellose,
magnesium stearate, colloidal anhydrous silica, sodium lauryl sulphate
and propylene glycol.
Risperidone 2mg Tablets also contain the following:
lactose, maize starch, microcrystalline cellulose, hypromellose,
magnesium stearate, colloidal anhydrous silica, sodium lauryl sulphate,
propylene glycol, titanium dioxide (E171), talc and sunset yellow
FCF aluminium lake (E110).
Risperidone l mg / 2mg Tablets are available in blister
packs containing 60 tablets.
Risperidone belongs to a group of medicines called antipsychotics
and is used to improve thoughts, feeling andlor behaviour when these
are disturbed In certain medical conditions.
Why you need to take this medicine:
Risperidone Tablets are used to treat conditions which affect
the way you think, feel and/or act. These conditions may cause symptoms
such as confusion, hallucinations (eg hearing, sensing or seeing
things, which are not there), delusions, paranoia (unusual suspiciousness),
and emotional and social withdrawal. People with these conditions
may also feel depressed, guilty or anxious or tense.
Risperidone Tablets may be taken for acute (sudden) and chronic
(long-lasting) disorders.
Before you take your medicine:
Make sure it is safe for you to take Risperidone Tablets
If you answer YES to any of the following questions DO NOT use
Risperidone l mg / 2mg Tablets. Tell your doctor.
-
Have you ever had an allergic reaction to Risperidone Tablets,
risperidone or any of the other ingredients of these tablets?
(an allergic reaction may include rash, itching, swollen lips
or face, shortness of breath).
-
Are you breast feeding?
Check to see if any of the following apply to you, and consult
your doctor before starting to take the medicine if the answer is
YES to any of them:
-
Are you pregnant, think you might be pregnant or are you trying
to become pregnant? If so you should talk to your doctor who
will decide if you should take Risperidone 1mg / 2mg Tablets.
-
It you suffer from any of the following problems, you may need
to be more closely supervised during treatment and the dosage
may need to be altered.
-
Do you suffer from heart or blood vessel disease?
-
Do you suffer from kidney or liver disease?
-
Do you suffer from Parkinson's disease or epilepsy?
-
Are you taking carbamazepine (used to treat epilepsy or facial
neuralgia - severe pain attacks in the face)? This may change
the effect of Risperidone l mg / 2mg Tablets. Tell your doctor
if you start or stop taking this drug as you may need a different
dose of Risiperidione 1mg 1 2mg Tablets.
-
Are you taking any medicines for anxiety, medicines to help
you sleep (tranquillisers), certain painkillers, antidepressants
or some antihistamines (e.g. chiorpheniramine)? Taking Risperidone
1mg / 2rng Tablets as well may make you feel drowsy. Only take
any of these as well as Risperidone Tablets if your doctor tells
you that you can.
Are you taking any medicines for Parkinson's disease?
You should tell your doctor if you are taking any other medicines
whether prescribed for or bought without prescription.
If you are not sure what to do, check with your doctor or pharmacist.
Warnings:
Risperidone 1mg / 2mg Tablets may make you put on weight, so
you should try to eat moderately while taking these tablets.
You should be careful how much alcohol you drink whilst taking
Risperidone Tablets. The combined effect of alcohol and the tablets
may make you feel drowsy.
As with other drugs of this type, Risperidone Tablets could cause
uncontrollable movements, mainly of the face or tongue. If this
happens, consult your doctor.
Very rarely Risperidone Tablets might also cause fever, faster
breathing, sweating, muscle stiffness and reduced consciousness.
If any of these occur, STOP taking the tablets and contact
your doctor immediately.
Risperidone Tablets may affect your alertness so you should not
drive or operate machinery until the doctor sees how the tablets
affect you.
Sunset yellow FCF aluminium lake (E110) can cause allergic type
reactions including asthma.
Allergy is more common in those people who are allergic to aspirin.
When to take your tablets:
Follow the doctor's instructions, and check the directions on
the pharmacy label, which should tell you how many tablets to take
in a day. If it does not or you are unsure, ask your doctor or pharmacist.
It does not matter whether you take Risperidone Tablets with or
without food. Swallow the correct number of tablets with some liquid.
This will vary from person to person and your doctor will adjust
the number and strength of the tablets to suit you.
Do not be surprised therefore if you are given differently-coloured
tablets from time to time.
It is very important that you take the correct amount.
The dose for adults and the elderly should be individually set
by your doctor and if necessary increased only gradually.
Always read the label on your medicine and follow your doctor's
instructions carefully. Ask your pharmacist or nurse if you are
not sure about anything.
Risperidone Tablets is only for those aged 15 years and over.
The dose of Risperidone Tablets will be started gradually over
the first days of treatment. Your doctor will probably recommend
the following dosage to start with:
Day 1: 2mg (as a single dose or as 1 mg in the morning and 1 mg
in the evening);
Day 2: 4mg (as a single dose or as 2mg in the morning and 2mg in
the evening).
However, if you have not used Risperidone Tablets before, your
doctor may recommend a more gradual increase.
The dosage will then be set to suit your needs but will normally
be 4mg to 6mg a day, either as a single dose or split into two doses,
one to be taken in the morning and one to be taken in the evening.
Some patients may require less than 4mg for a good effect.
Important:
Never take more than a total of 16mg per day.
If you are elderly or have a liver or kidney disorder you should
take half the above doses. You will be told how many tablets you
need to take.
Do not stop your treatment just because you feet better. It is
important that you carry on taking Risperidone Tablets for as long
as your doctor tells you to.
What to do if an overdose is taken:
If too many tablets are taken consult your doctor or get someone
to take you to your nearest hospital casualty department IMMEDIATELY.
Do not drive yourself. Remember to take the leaflet and any tablets
with you, so that the doctor in charge knows what you have taken.
What to do if you miss a dose:
If you miss a dose in the initial treatment period, take it
as soon as possible instead of your next dose and then take the
remaining doses in the order described above. Then continue at whatever
dose your doctor has prescribed for you.
If you miss a tablet after the first few days, do not take the
missed dose but take your next dose as usual and continue your course.
If you are not sure what to do, ask your doctor or Pharmacist
Side-Effects:
As with all medicines Risperidone Tablets can cause unwanted
side-effects in some patients. The tablets are generally well-tolerated.
There are usually few side-effects when Risperidone Tablets are
taken in the way your doctor, nurse or pharmacist has prescribed.
Sometimes Risperidone Tablets may cause side effects such as:
sleeplessness, agitation, anxiety and headache.
Occasionally the following effects may occur:
sleepiness, tiredness, concentration difficulties, blurred vision,
dizziness, indigestion, nausea (feeling sick), vomiting (being sick),
stomach ache, constipation, sexual potency problems, leakage of
urine, runny or blocked nose, liver problems, local skin rash or
swelling, or other allergic reactions suck as itching, swollen face
or lips, shortness of breath. Swelling of the ankles may occur.
Some people may feel dizzy in the early stages of treatment, especially
when getting up from a lying or sitting position. This will usually
pass off on its own but if it does not, tell your doctor.
Sometimes trembling, pronounced muscle stiffness or spasm, slowness
of movement, excess saliva or restlessness can occur but this will
usually disappear if your dose of Risperidone Tablets is reduced
by your doctor or if your doctor prescribes an additional medicine.
After prolonged use, women may suffer from milk secretion, an absence
of their monthly period or changes in the regularity of their periods.
Men may experience breast swelling. If these persist, tell your
doctor. Risperidone Tablets may make you put on weight so you should
try to eat moderately while taking this medicine.
Occasionally mild blood cell changes have been reported.
In some cases,
the blood pressure may fall slightly in the early stages of treatment,
resulting in dizziness. This will usually pass off automatically.
Somewhat later in treatment increased blood pressure may occur,
but this is very rare.
In rare cases,
Risperidone Tablets may cause a desire to drink large amounts of
water. You might also experience marked changes in your body temperature.
Rare cases of convulsions have also occurred. If any of these occurs
contact your doctor as soon as possible.
Very rarely,
Risperidone Tablets might cause fever, faster breathing, sweating,
muscle stiffness and reduced consciousness. If this occurs, stop
taking the tablets and contact a doctor at once.
As with other drugs of this type, Risperidone Tablets could cause
uncontrollable movements, mainly of the face or tongue. Should this
occur, talk to your doctor.
You should also see your doctor if you feel any other unusual or
unexpected side effects not mentioned above during or after taking
Risperidone Tablets. He or she (or it?) will have more information
about Risperidone Tablets and will tell you what to do.
Expiry Date:
Do not use after the expiry date printed on the carton label
or blister strip.
Storage:
Risperidone Tablets should be stored below30*C in a dry place
and protected from light. The tablets should be kept in the original
container.
KEEP ALL MEDICINES OUT OF THE REACH OF CHILDREN.
If your doctor tells you to stop taking the tablets, please take
them back to the pharmacist for safe disposal. Only keep the tablets
if your doctor tells you to.
If the tablets become discoloured or show signs of any deterioration,
you should seek the advice of your pharmacist who will advise you
what to do.
IMPORTANT.
This medicine is for YOUR use only. It can only be prescribed
by a doctor. Never give it to anyone else. It may harm them even
if their symptoms are the same as yours.
This is not the complete information about Risperidone. If you
have any questions, or are not sure about anything, ask your doctor
or pharmacist who has access to additional information.
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