RISPERIDONE 2 MG ORODISPERSIBLE TABLETS

Active substance: RISPERIDONE

View full screen / Print PDF » Download PDF ⇩

Transcript
PACKAGE LEAFLET: INFORMATION FOR THE USER

Risperidone 2 mg orodispersible tablets
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 is and what it is used for
2. Before you take Risperidone
3. How to take Risperidone
4. Possible side effects
5. How to store Risperidone
6. Further information
1. WHAT Risperidone IS AND WHAT IT IS USED FOR
Risperidone belongs to a group of medicines called antipsychotics.
Risperidone is used:
• to treat schizophrenia (a severe mental illness characterised by symptoms such as delusional ideas, perceiving things that
are not there (hallucinations) and a gradual change of personality).
• to keep schizophrenia under control after the previous symptoms have declined, to prevent the illness from returning in
its full intensity.
2. BEFORE YOU TAKE Risperidone
Do not take Risperidone
• if you are allergic (hypersensitive) to risperidone or any of the other ingredients of Risperidone tablets.
An allergic reaction may manifest as rash, pruritus, oedema of the face and lips or dyspnoea.
• if you have an abnormally high concentration of the hormone prolactin in the blood.
Take special care with Risperidone
Tell your doctor if you suffer from the following conditions:
• heart or vascular disease (e.g. low blood pressure)
• Parkinson’s disease
• dementia or you have previously had a stroke or a disorder of blood supply to the brain (because treatment with
Risperidone can cause impaired cerebral blood flow possibly leading to stroke, particularly in elderly patients)
• Lewy body dementia (a special form of dementia)
• epilepsy
• liver or kidney disease. Your treatment may need to be adjusted (see section 3)
• diabetes mellitus
• breast cancer (and other specific tumors which can be correlated to the hormone prolactin, e.g. hypophysal
prolactinoma)
Tell your doctor immediately if you experience:
• involuntary rhythmic movements of the tongue, mouth and facial muscles
• fever, severe muscular stiffness, sweating or a lowered level of consciousness
• signs and symptoms such as sudden weakness, numbness in the face, arms or legs, particularly on one side, or
indistinct speech.
If you are of an advanced age:
In elderly people, dizziness, excessively low blood pressure and injury as a result of a tendency to fall occurs more often than
in younger people.
If signs such as agitation, restlessness and aggressiveness are exacerbated: Antipsychotics can sometimes cause this, in
which case a reduction of the dose or discontinuation of treatment may be necessary.
Please also tell your doctor if you have a factor increasing susceptibility to cardiovascular diseases, such as high blood
pressure, diabetes, cardiac dysfunction called atrial fibrillation or if you smoke.Your doctor will decide whether you can take
Risperidone tablets and if the dosage should be adjusted.
Be cautious taking Risperidone if you are exposed to temperature extremes, because abnormally changes in body
temperature can occur.
Avoid dehydration. Refrain from excessive eating to avoid weight gain during Risperidone treatment.
Using other medicines
Please tell your doctor or pharmacist, if you are taking or have recently taken any other medicines, including medicines or
herbal and natural products obtained without a prescription.
Some medicines can cause problems if you take them with Risperidone. These include:
• medicines acting upon the central nervous system (e.g. levodopa, used to treat Parkinson’s disease): risperidone may
weaken the effect of levodopa
• opiates (used to treat severe pain), antihistamines (used to treat allergies) and benzodiazepines (tranquilizing
medicines): their effect is increased by risperidone
• other antipsychotic medicines (used to treat psychiatric disorders), lithium and antidepressants (used to treat
depressions), medicines to treat Parkinson’s disease and other medicinal products with a specific effect on the central
nervous system: the risk that movement disturbances (tardive dyskinesia) occur as side effect is increased
• neuroleptics (used to treat psychiatric disorders), antiarrhythmics class IA or III (used to treat heart disease), antibiotics
(used to treat bacterial infections), medicines to treat malaria, antihistamines (used to treat allergies) and
antidepressants (used to treat depressions): cardiac disorders may occur
• certain diuretics (like chlorothiazide and furosemide),used to treat swellings (oedema) caused by water retention in the
body: the body may lose too much water and minerals (sodium, chloride) and especially with furosemide when used in
elderly patients with dementia cardiac disorders may occur. Thus concomitant use of furosemide with Risperidone is
not recommended
• certain blood pressure lowering medicines, e.g. phenoxybenzamine, labetalol, methyldopa, reserpine: risperidone can
increase their effect
• guanethidine, used to treat high blood pressure: risperidone blocks the effect
• carbamazepine, phenytoin and phenobarbital (used to treat epilepsy), barbiturates (used for sedation), rifampicin (used
to treat tuberculosis), the herbal remedy St. John’s wort (Hypericum perforatum, used to treat depressive mood changes):
they may weaken the effect of risperidone
• antacida (used to treat stomach problems, e.g. heartburn): they may reduce the amount of Risperidone which is taken up
by the body
• medicines which may increase the concentration of Risperidone in the blood so that your doctor might need to adjust
the dose of Risperidone:
• phenothiazines, used to treat psychiatric disorders
• fluoxetine, paroxetine and tricyclic antidepressants, used to treat depressive conditions
• quinidine, used to treat heart disease
• terbinafine, used to treat certain fungal infections
• beta-blockers, used to treat high blood pressure
• cimetidine and ranitidine, used to treat certain stomach problems
Using Risperidone with food and drink
The tablets can be taken with or without meals. Your mouth should be empty before taking the tablet. Abundant use of
alcohol should be avoided during therapy with Risperidone since concomitant use may cause somnolence.
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking any medicine.Insufficient information is known about the use of
risperidone during pregnancy in humans to assess the possible harmfulness. Long term use until birth can result in
movement disorders and withdrawal symptoms in the newborn child. Risperidone may only be used during pregnancy
if your doctor has carefully weighed up the benefits against the risks.
If you are pregnant or are planning to become pregnant, discuss with your doctor who will decide whether you can
use Risperidone.
Risperidone passes into the breast milk in small quantities. Your doctor will carefully weigh up the benefits of breast feeding
against the possible risks to the infant.
Driving and using machines
Risperidone therapy may impair alertness and affect the ability to drive or use machines. It is recommended to avoid driving
and using machines requiring precision until the doctor has ensured that Risperidone does not impair your attention.
Important information about some of the ingredients of Risperidone
Risperidone orodispersible tablets contain aspartame (E951) which is a source of phenylalanine.
Aspartame may be harmful for people with phenylketonuria.
3. HOW TO TAKE Risperidone
Risperidone orodispersible tablets are fragile. They should not be pushed through the foil in the blister pack as this will cause
damage to the tablet. Remove a tablet from the package as follows:
1. Hold the blister strip at the edges and separate one blister cell from the rest of the strip by gently tearing along the
perforations around it.
2. Pull up the edge of the foil and peel foil off completely.
3. Tip the tablet out onto your hand.
4. Put the tablet on the tongue as soon as it is removed from the packaging.

In a few seconds it begins disintegrating in the mouth and subsequently can be swallowed with or without water.
The mouth should be empty before placing the tablet on the tongue.
Your doctor prescribes the correct dose and duration of treatment. These are individual and the doctor checks and adjusts
the dosage until a dose suitable for you is achieved.
Always take Risperidone exactly as your doctor has told you. You should check with your doctor or pharmacist if you are
not sure.
Important - Never take more than 16 mg per day.

Treatment of psychosis in adults and adolescents over 15 years of age:
Treatment is started gradually, e.g. 2 mg on the first day and 4 mg on the second day.
The daily dose can be taken in one dose or divided into two subdoses, one taken in the morning and another one in the
evening. However, your doctor may recommend to increase the dose more slowly.
Thereafter, the dosage may remain the same or it can be adjusted, if necessary. The usual dose is 4-6 mg daily, but a dose less
than 4 mg may be adequate for some patients.
Children and adolescents
Use of the product is not recommended for children and adolescents below the age of 15 years due to lacking experience.
Elderly patients
The recommended starting dose is 0.5 mg twice daily. This dose can be adjusted, in steps of 0.5 mg twice daily, to a dose
of 1 to 2 mg twice daily. Caution should be exercised because little experience has been acquired in the treatment of
elderly patients.
Patients with cardiovascular disease
The doctor will prescribe the dosage which is appropriate for you. Dependent on the kind of disease and its severity the
dosage can be lower as described above.
Patients with impaired liver or kidney function
The doctor will prescribe the dosage which is appropriate for you. Dependent on the kind of impairment and its severity the
dosage can be as described above or only half of that.
Follow carefully the instructions from your doctor and do not change the dosage or discontinue the medicine without
discussing with your doctor first.
Tell your doctor or pharmacist if you feel that the efficacy of Risperidone tablets is too strong or too weak.
If you take more Risperidone than you should
If you have taken too much of Risperidone contact your doctor or a hospital straight away. Signs of an overdose needing
medical care straight away are: fatigue, accelerated heart beat (tachycardia), low blood pressure (hypotension) and
extrapyramidal symptoms like tremor, muscular stiffness, increased salivation, slowness of movements, restless legs and
sudden muscular contractions.
If you forget to take Risperidone
Skip the forgotten dose and continue taking the medicine normally as instructed by the doctor.
If you stop taking Risperidone
Do not stop treatment without talking to your doctor first because abrupt stopping of therapy can cause so called withdrawal
symptoms such as nausea, vomiting, sweating and insomnia. Therefore therapy needs to be discontinued by slowly reducing
the dose of Risperidone over a certain period of time, exactly according to your doctor’s recommendations.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Risperidone tablets can cause side effects, although not everybody gets them.
Common (in more than 1 in 100, but in less than 1 in 10 patients)
Uncommon (in more than 1 in 1,000, but in less than 1 in 100 patients)
Rare (in more than 1 in 10,000, but in less than 1 in 1,000 patients)
Very rare (in less than 1 in 10,000 patients)
Blood
Very rare: slight decrease in the amount of certain blood cells (neutrophils and thrombocytes)
Endocrine disorders
Uncommon: elevated blood levels of the hormone prolactin leading to abnormal milk discharge from the breasts, disturbances
of the menstrual cycle and even absence of menstruation.
Rare: enlargement of breasts in men
Metabolism
Very rare: high blood sugar (hyperglycaemia), exacerbation of preexisting diabetes
Mental disorders
Common: agitation, anxiety
Nervous system
Common: sleeplessness, headache, sedation (sedation has been reported more frequently in children and adolescents than in
adults. Sedation is usually mild and transient),
Uncommon: drowsiness, fatigue, dizziness, concentration difficulties, extrapyramidal symptoms: involuntary shaking (tremor),
muscular stiffness (rigidity), increased salivation, slowness of movements (bradykinesia), restless legs (akathisia), sudden
muscular contractions (acute dystonia) (these symptoms are usually mild and are reversible upon dose reduction and/or
administration of antiparkinson drugs, if necessary)
Very rare: movement disorders (tardive dyskinesia), neuroleptic malignant syndrome with symptoms such as fever, muscular
stiffness, lowering of the level of consciousness, fits (seizures), panic reactions
Eye disorders
Uncommon: blurred vision
Heart
Uncommon: increased heart rate (tachycardia)
Very rare: specific cardiac arrhythmias (QT prolongation, torsades de pointes)
Blood vessels
Uncommon: low blood pressure (hypotension) including dizziness on getting up (orthostatic hypotension) or high blood
pressure (hypertension)
Rare: strokes or temporary reduction of blood flow to the brain (TIA’s)
Respiration and chest
Uncommon: cold (rhinitis)
Stomach and intestine
Uncommon: constipation, digestive disorders (dyspepsia), nausea/vomiting, stomach ache, weight increase
Liver
Very rare: rise in liver values (hepatic enzymes)
Skin and subcutaneous tissue
Uncommon: rash and other allergic reactions
Very rare: swelling, itching and inflamed skin (pruritus, exanthema), photosensitivity
Kidney and urinary tract
Uncommon: urinary incontinence
Sex organs and breasts
Uncommon: erectile dysfunction, dysfunctional ejaculation and orgasm disturbances, impotence in men who previously did
not have any sexual disturbances
Rare: prolonged painful erection (priapism)
Muscles
Very rare: muscle weakness
Others
Very rare: abnormally lowered body temperature (hypothermia), abnormally elevated body temperature (hyperthermia)
In rare cases Risperidone may cause disturbances of the water balance due to overdrinking or disturbances in the secretion of
a specific hormone (antidiuretic hormone).
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 Risperidone
Keep out of the reach and sight of children.
Do not use after the expiry date stated on the package.
This medicinal product does not require any special storage conditions.
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. FURTHER INFORMATION
What Risperidone contains
• The active ingredient is risperidone. Each tablet contains 2 mg risperidone.
• Other ingredients are mannitol (E421), basic butylated methacrylate copolymer, povidone K-25, microcrystalline cellulose,
hydroxypropylcellulose, aspartame (E951), crospovidone, red iron oxide (E172), spearmint flavour, peppermint flavour,
calcium silicate, magnesium stearate.
What Risperidone looks like and contents of the pack
Orodispersible Tablets:
Tablets are round, slightly convex, pink marbled tablets.
Contents of the packs: 28 or 56 in blister pack.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer :
Marketing Authorisation Holder: KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
Manufacturer: KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
Distributed by Consilient Health (UK) Ltd, 500 Chiswick High Road, London, W4 5RG.
This medicinal product is authorised in the Member States of the EEA under the following names:
Czech Republic
Rorendo Oro Tab 2 mg, orodispersible tablets
Germany
Risperidon Krka 2 mg Schmelztabletten
Denmark
Risperidon Krka
Estonia
Torendo Q-Tab 2 mg
Finland
Risperidon Norpharm 2 mg Orodispersible Tablets
Hungary
Torendo Q-Tab 2 mg
Lithuania
Torendo Q-Tab 2 mg, orodispersible tablets
Latvia
Torendo Q-Tab 2 mg
Norway
Risperidon Krka 2 mg Orodispersible Tablets
Poland
Torendo Q-Tab 2 mg
Portugal
Risperidon Krka
Sweden
Risperidon Krka 2 mg ODT tablet
Slovak Republic
Torendo Q-Tab 2 mg
Spain
Risperidon Krka 2 mg Orodispersible Tablets
UK
Risperidone 2 mg Orodispersible Tablets
This leaflet was last revised in: May 2007











P0029

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
(web2)