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Risperat

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PACKAGE LEAFLET: INFORMATION FOR THE USER


Risperat 0.5 mg orodispersible tablets

Risperat 1 mg orodispersible tablets

Risperat 2 mg orodispersible tablets


Risperidone


Read all of this leaflet carefully before you start taking this medicinebecause it contains important information for you.

What is inthis leaflet:

1. What Risperat is and what it is used for

2. What you need to know beforeyou take Risperat

3. How to take Risperat

4. Possible side effects

5. How to store Risperat

6. Contents of the pack and otherinformation


1. What Risperatis and what it is used for

Risperat contains the active substance risperidone. Itbelongs to a group of medicines called ‘anti-psychotics’.


Risperat is used to treat the following:


Risperat can help alleviate the symptoms of your disease and stop your symptoms from coming back.


2. What you need to know before you take Risperat


Do not take Risperat if:

You are allergic 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 Risperat.


Warnings and precautions

Talk toyour doctor or pharmacist before taking Risperat if:

You have ever experienced involuntary movements of the tongue, mouth and face


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


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 Risperat, your doctor may check your white blood cell counts.


Risperat 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 Risperat, 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.


Olderpeople with dementia

In older people 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 forconduct disorder, other causes of aggressive behaviour should have been ruled out. Before treatment is started your or your child’s 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.


Othermedicines and Risperat

Tellyour 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:


The following medicines may reduce the effect of risperidone

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

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 Risperat.


Risperat with food, drink and alcohol

You can take this medicine with or without food. You should avoid drinking alcohol when taking Risperat.


Pregnancy,breast-feedingand fertility


Driving and using machines

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


Risperatcontainsaspartame and sorbitol

Aspartame (E951) is a source of phenylalanineand maybe harmful for people with phenylketonuria.

Sorbitol is 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.


3. How to takeRisperat


Always take this medicine exactly as your doctor has told you. Checkwith 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 recommended dose is as follows:


For the treatment of schizophrenia


Adults


Olderpeople


For the treatment of mania


Adults


Olderpeople


For the treatment of long-standing aggression in people with Alzheimer’s dementia


Adults (including olderpeople)


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.


Use in children and adolescents

For children who weigh less than 50 kg


For children who weigh 50 kg or more


Treatment duration in patients with conduct disorder should be not more than 6 weeks.


Children under 5 years old should not be treated with Risperat for conduct disorder.


Method of administration

Risperatis for oral use.


Risperatorodispersible 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 with dry hands as follows:

Hold the blister at the edges and separate one blister cell from the rest of the blister by gently tearing along the perforations around it.

Pull up the edge of the foil and peel foil off completely.

Tip the tablet out onto your hand.

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.

Risperatorodispersible tablets can be taken with a meal or between meals.


If you take more Risperat than you should


If you forget to take Risperat


If you stop taking Risperat

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 any of the following serious side effects:


Uncommon: may affect up to 1in 100 people


Rare: may affect up to 1 in 1,000 people


Very rare: may affect up to1 in 10,000people


Not known:frequency cannot be estimated from the available data

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.


The following other side effects may happen:


Very common: may affect more than 1 in 10 people


Common: may affect up to 1 in 10 people


Uncommon: may affect up to 1 in 100 people


Rare: may affect up to 1 in 1,000 people


The following side effect has been seen with the use of another medicine called paliperidone that is very similar to risperidone, so it can also be expected with Risperat: 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.


Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.


5. How to store Risperat

Keep this medicine out of the sight and reach of children.


Do not usethis medicineafter the expiry date which is stated on the blister and outer carton. The expiry date refers to the last day of that month.


This medicinal product does not require any special storage conditions.


Donot throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.


6. Contents of the pack and other information


What RISPERAT contains

The active substance is risperidone


Each RISPERAT orodispersible tablet contains 0.5 mg, 1 mg or 2 mg of risperidone.


The other ingredients are mannitol, basic butylated methacrylate copolymer, povidone K25, microcrystalline cellulose, low-substituted hydroxypropylcellulose, aspartame (E951), crospovidone, red iron oxide (E172), spearmint flavour (containing in particular sorbitol (E420)), peppermint flavour (containing in particular sorbitol (E420), levomenthol), calcium silicate, magnesium stearate.


What RISPERAT looks like and contents of the pack

Round, slightly convex, pink marbled orodispersible tablets.


RISPERAT 0,5 mg orodispersible tablets

Pack sizes: 10, 20, 28, 30, 56, 60, 98 and 100 orodispersible tablets.


RISPERAT 1 mg orodispersible tablets

RISPERAT 2 mg orodispersible tablets

Pack sizes: 7, 10, 14, 20, 28, 30, 56, 60, 98 and 100 orodispersible tablets.


Not all pack sizes may be marketed.


Marketing Authorisation Holder and Manufacturer:

<[To be completed nationally]>



This medicinal product is authorised in the Member States of the EEA under the following names:


Austria:

RISPERIDON SANDOZ 0,5 MG - SCHMELZTABLETTEN

RISPERIDON SANDOZ 1 MG - SCHMELZTABLETTEN

RISPERIDON SANDOZ 2 MG – SCHMELZTABLETTEN


Belgium:

Risperidon Sandoz 0.5 mg orodisperbeerbare tabletten

Risperidon Sandoz 1 mg orodisperbeerbare tabletten

Risperidon Sandoz 2 mg orodisperbeerbare tabletten


France:

RISPERIDONE SANDOZ 0,5 MG, COMPRIMÉ ORODISPERSIBLE

RISPERIDONE SANDOZ 1 MG, COMPRIMÉ ORODISPERSIBLE

RISPERIDONE SANDOZ 2 MG, COMPRIMÉ ORODISPERSIBLE


Germany:

RISPERIDON SANDOZ 0,5 MG SCHMELZTABLETTEN

RISPERIDON SANDOZ 1 MG SCHMELZTABLETTEN

RISPERIDON SANDOZ 2 MG SCHMELZTABLETTEN


Sweden:

Risperat0.5 MG MUNSÖNDERFALLANDE TABLETT

Risperat1 MG MUNSÖNDERFALLANDE TABLETT

Risperat2 MG MUNSÖNDERFALLANDE TABLETT


United Kingdom:

RISPERIDONE 0.5 MG ORODISPERSIBLE TABLET

RISPERIDONE 1 MG ORODISPERSIBLE TABLET

RISPERIDONE 2 MG ORODISPERSIBLE TABLET


This leaflet was last revisedin19 March 2014

<[to be completed nationally]>.