RISPERIDONE 1 MG/ML ORAL SOLUTION

Active substance: RISPERIDONE

View full screen / Print PDF » Download PDF ⇩

Transcript
PACKAGE LEAFLET: INFORMATION FOR THE USER

SZ00000LT000

Risperidone 1 mg/ml Oral Solution

Risperidone
Read all of this leaflet carefully before you start taking 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 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.
In this leaflet:
1. What Risperidone Oral Solution is and what it is used for
2. Before you take Risperidone Oral Solution
3. How to take Risperidone Oral Solution
4. Possible side effects
5. How to store Risperidone Oral Solution
6. Further information

1

• Medicines known as beta blockers (used to treat high blood
pressure)
• Phenothiazines (e.g. 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.

What Risperidone Oral Solution is and what it
is used for

Risperidone Oral Solution belongs to a group of medicines called
ʻanti-psychoticsʼ.

If you are not sure if any of the above applies to you, talk to your
doctor or pharmacist before using Risperidone Oral Solution.

Risperidone Oral Solution 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 Alzheimerʼs 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

Taking Risperidone Oral Solution with food and drink
You can take this medicine with or without food. You should avoid
drinking alcohol when taking Risperidone Oral Solution.
Risperidone Oral Solution must not be mixed with tea.

Pregnancy and breast-feeding
• Talk to your doctor before using Risperidone Oral Solution 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 who have used Risperidone 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.

Before you take Risperidone Oral Solution

Ask your doctor or pharmacist for advice before taking any
medicine.

Do not take Risperidone Oral Solution if:
• You are allergic (hypersensitive) to risperidone or any of the
other ingredients of Risperidone Oral Solution (listed in Section
6 below).

Driving and using machines
Dizziness, tiredness, and vision problems may occur during
treatment with Risperidone Oral Solution. Do not drive or use any
tools or machines without talking to your doctor first.

If you are not sure if the above applies to you, talk to your doctor
or pharmacist before using Risperidone Oral Solution.

3

Take special care with Risperidone Oral Solution
Check with your doctor or pharmacist before taking Risperidone
Oral Solution 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. Risperidone Oral
Solution 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 or someone else in your family has a history of blood clots,
as medicines like this have been associated with formation of
blood clots
• You have Parkinsonʼs disease or dementia
• You are diabetic
• You have epilepsy
• You are a man and you have ever had a prolonged or painful
erection. If you experience this while taking Risperidone Oral
Solution, contact your doctor straight away
• 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.

How to take Risperidone Oral Solution

How much to take

For the treatment of schizophrenia
Adults
• The usual starting dose is 2 ml oral solution (2 mg risperidone)
per day, this may be increased to 4 ml oral solution (4 mg
risperidone) 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 ml oral
solution (4 to 6 mg risperidone).
• This total daily dose can be divided into either one or two doses
a day. Your doctor will tell you which is the best dose for you.

Elderly people
• Your starting dose will normally be 0.5 ml oral solution (0.5 mg
risperidone) twice a day.
• Your dose may then be gradually increased by your doctor to 1
to 2 ml oral solution (1 to 2 mg risperidone) 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 Risperidone Oral Solution for schizophrenia.

Tell your doctor immediately if you experience
• involuntary rhythmic movements of the tongue, mouth and face.
Withdrawal of risperidone may be needed
• fever, severe muscle stiffness, sweating or a lowered level of
consciousness (a disorder called “neuroleptic malignant
syndrome”). Immediate medical treatment may be needed.

For the treatment of mania
Adults
• Your starting dose will usually be 2 ml oral solution (2 mg
risperidone) 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 ml oral solution (1
to 6 mg risperidone) once a day.

If you are not sure if any of the above applies to you, talk to your
doctor or pharmacist before using Risperidone Oral Solution.

Elderly people
• Your starting dose will usually be 0.5 ml oral solution (0.5 mg
risperidone) twice a day.
• Your dose may then be gradually adjusted by your doctor to 1 to
2 ml oral solution (1 to 2 mg risperidone) twice a day depending
on how much you respond to the treatment.

Risperidone Oral Solution 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 Risperidone Oral Solution,
your doctor should check for signs of high blood sugar.
In patients with pre-existing diabetes mellitus blood glucose
should be monitored regularly.

Children and adolescents
• Children and adolescents under 18 years old should not be
treated with Risperidone Oral Solution for bipolar mania.

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.

For the treatment of long-standing aggression in people with
Alzheimerʼs dementia
Adults (including elderly people)
• Your starting dose will normally be 0.25 ml oral solution
(0.25 mg risperidone) 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 ml oral solution (0.5 mg
risperidone) twice a day. Some patients may need 1 ml oral
solution (1 mg risperidone) twice a day.
• Treatment duration in patients with Alzheimerʼs dementia should
be not more than 6 weeks.

Children and adolescents
Before treatment is started in conduct disorder, other causes of
aggressive behaviour should have been ruled out. Before
treatment is started your or your childʼs body weight may be
measured and it may be regularly monitored during treatment.
If during treatment with risperidone tiredness occurs, a change in
the time of administration might improve attention difficulties.

For the treatment of conduct disorder in children and
adolescents
The dose will depend on your childʼs weight:

For children who weigh less than 50 kg
• The starting dose will normally be 0.25 ml oral solution (0.25 mg
risperidone) once a day.
• The dose may be increased every other day in steps of 0.25 ml
oral solution (0.25 mg risperidone) per day.
• The usual maintenance dose is 0.25 to 0.75 ml oral solution
(0.25 to 0.75 mg risperidone) once a day.

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 (such as
quinidine), allergies (anti-histamines), some antidepressants or
other medicines for mental problems
• Medicines that cause a slow heart beat
• Medicines that cause low blood potassium (e.g. certain
diuretics)
• Medicines to treat elevated blood pressure. Risperidone Oral
Solution 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). Risperidone Oral Solution taken
by itself or with furosemide, may have an increased risk of
stroke or death in elderly people with dementia.

For children who weigh 50 kg or more
• The starting dose will normally be 0.5 ml oral solution (0.5 mg
risperidone) once a day.
• The dose may be increased every other day in steps of 0.5 ml
oral solution (0.5 mg risperidone) per day.
• The usual maintenance dose is 0.5 to 1.5 ml oral solution (0.5
to 1.5 mg risperidone) 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 Risperidone
Oral Solution 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 Risperidone Oral Solution
Always take Risperidone Oral Solution exactly as your doctor has
told you. You should check with your doctor or pharmacist if you
are not sure.

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.

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 ʻHow much to takeʼ sub-heading above.

The following medicines may increase the effect of risperidone
• Quinidine (used for certain types of heart disease)
• Antidepressants such as paroxetine, fluoxetine, tricyclic
antidepressants

Continued on the next page >>

Artwork Proof Box
Ref: V023 - SPC & PIL (Article 45) update

draft: 5200303
laetus code:
mat.no.:

Proof no.
008.0

Date prepared:
20/03/2013

Colours:
Black
Black 20%
Dimensions: 190 x 600 mm

Font size:
8pt
Fonts:
Helvetica

Risperidone Oral Solution is for oral use.

• 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 ʻout of
sortsʼ, balance disorder, allergy, oedema (swelling in body
tissues), 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.

Opening the bottle and handling the dosing pipette
A dosing pipette is supplied with each bottle. The bottle has a
child-proof screw cap.
1. Open the screw cap by pressing it firmly downwards and
turning it anticlockwise as shown in Figure 1.

2. Insert the pipette into the bottle. In order to measure the dose
hold the pipette tightly with one hand by the lower ring and with
the other hand pull the upper ring of the pipette until the correct
quantity of the medicine is visible from the barrel of the pipette
(ml or mg for example) as shown in Figure 2.

3. Draw the pipette carefully from the bottle holding it tightly by the
lower ring as shown in Figure 3. Transfer the quantity of
medicine drawn into the pipette into a glass containing a drink
(not alcohol or tea) by pressing the upper ring of the pipette.
Drink the contents of the glass.
4. Close the bottle and rinse the empty pipette with water.

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 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.

Fig. 1
1

Fig. 2

2

0
0.5
1
1.5
2
2.5
3

Fig. 3
0
0.5
1
1.5
2
2.5
3

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 (see beginning of this section
under “Tell your doctor immediately if you”)
• Dangerously excessive intake of water
• Blood clots in the veins especially in the legs (see beginning of
this section under “Tell your doctor immediately if you”).

If you take more Risperidone Oral Solution 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 Oral Solution
• 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.

Long-acting injectable risperidone
The following side effects have been reported with the use of a
long acting injectable risperidone. Even if you are not being
treated with long acting injections of risperidone but you
experience any of the following, talk to your doctor.

If you stop taking Risperidone Oral Solution
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.

• 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 you have any further questions on the use of this product, ask
your doctor or pharmacist.

4

Possible side effects

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.

Like all medicines, Risperidone Oral Solution can cause side
effects, although not everybody gets them.

5

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 in 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.

How to store Risperidone Oral Solution

Keep out of the reach and sight of children.
Do not use after the expiry date which is stated on the carton and
on the label of the bottle. The expiry date refers to the last day of
that month.

Do not freeze.
Do not use Risperidone Oral Solution after 6 months have elapsed
from first opening of the bottle.

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 to protect the
environment.

6

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.

Further information

What Risperidone Oral Solution contains
- The active substance is risperidone. Each 1 ml of Oral Solution
contains 1 mg risperidone.
- The other ingredients are benzoic acid (E 210); water, purified.

What Risperidone Oral Solution looks like and contents of the
pack
Risperidone 1 mg/ml Oral Solution is a clear, colourless Oral
Solution.
It is available in amber glass bottles with a white plastic child
resistant closure containing 30 ml, 60 ml, 100 ml or 120 ml Oral
Solution.
A dosing pipette including pipette holder is enclosed.
Not all pack sizes may be marketed.

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.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder
Sandoz Ltd,
Frimley Business Park, Frimley,
Camberley, Surrey, GU16 7SR, UK.
Manufacturers
Salutas Pharma GmbH,
Otto-von-Guericke-Allee 1,
39179 Barleben,
Germany
or

Uncommon (affects 1 to 10 users in 1,000):
• 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, ʻpink eyeʼ, 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

LEK Pharmaceuticals d.d.,
Verovškova 57,
1526 Ljubljana,
Slovenia.
This leaflet was last revised in 03/2013.

SZ00000LT000

Artwork Proof Box
Ref: V023 - SPC & PIL (Article 45) update

draft: 5200303
laetus code:
mat.no.:

Proof no.
008.0

Date prepared:
20/03/2013

Colours:
Black
Black 20%
Dimensions: 190 x 600 mm

Font size:
8pt
Fonts:
Helvetica

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
(web5)