Risperidone Mylan 1mg orodispersible Tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

RISPERIDONE

Available from:

Mylan Pharmaceuticals Limited Damastown Industrial Park Mulhuddart Dublin15 Dublin, Ireland

ATC code:

N05AX08

INN (International Name):

RISPERIDONE 1 mg

Pharmaceutical form:

ORODISPERSIBLE TABLET

Composition:

RISPERIDONE 1 mg

Prescription type:

POM

Therapeutic area:

PSYCHOLEPTICS

Authorization status:

Authorised

Authorization date:

2012-07-13

Patient Information leaflet

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PACKAGE LEAFLET
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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
RISPERIDONE MYLAN 0.5 MG ORODISPERSIBLE TABLETS
RISPERIDONE MYLAN 1 MG ORODISPERSIBLE TABLETS
RISPERIDONE MYLAN 2 MG ORODISPERSIBLE TABLETS
RISPERIDONE MYLAN 3MG ORODISPERSIBLE TABLETS
RISPERIDONE MYLAN 4 MG ORODISPERSIBLE TABLETS
risperidone
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
•
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 only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
•
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What Risperidone Mylan is and what it is used for
2.
What you need to know before you take Risperidone Mylan
3.
How to take Risperidone Mylan
4.
Possible side effects
5.
How to store Risperidone Mylan
6.
Contents of the pack and other information.
1.
WHAT RISPERIDONE MYLAN IS AND WHAT IT IS USED FOR
This medicine belongs to a group of medicines called
‘anti-psychotics’.
Risperidone Mylan 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.
Risperidone Mylan can help alleviate the sy

Summary of Product characteristics

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SUMMARY OF PRODUCT CHARACTERISTICS
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1.
NAME OF THE MEDICINAL PRODUCT
Risperidone Mylan 0.5 mg orodispersible tablets
Risperidone Mylan 1 mg orodispersible tablets
Risperidone Mylan 2 mg orodispersible tablets
Risperidone Mylan 3 mg orodispersible tablets
Risperidone Mylan 4 mg orodispersible tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 0.5 mg orodispersible tablet contains 0.5 mg of risperidone
Each 1 mg orodispersible tablet contains 1 mg of risperidone
Each 2 mg orodispersible tablet contains 2 mg of risperidone
Each 3 mg orodispersible tablet contains 3 mg of risperidone
Each 4 mg orodispersible tablet contains 4 mg of risperidone
Excipient with known effect
Each 0.5 mg orodispersible tablet contains 2.5 mg aspartame (E951)
Each 1 mg orodispersible tablet contains 5 mg aspartame (E951)
Each 2 mg orodispersible tablet contains 10 mg aspartame (E951)
Each 3 mg orodispersible tablet contains 15 mg aspartame (E951)
Each 4 mg orodispersible tablet contains 20 mg aspartame (E951)
For the full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Orodispersible tablet.
Risperidone 0.5 mg orodispersible tablet: Light pink coloured, plain
to mottled, round, flat faced,
bevelled edged tablets debossed with ‘M’ on one side and ‘R05’
on the other side.
Risperidone 1 mg orodispersible tablet: Light pink coloured, plain to
mottled, round, flat faced,
bevelled edged tablets debossed with ‘M’ on one side and ‘R1’
on the other side.
Risperidone 2 mg orodispersible tablet: Light pink coloured, plain to
mottled, round, flat faced,
bevelled edged tablets debossed with ‘M’ on one side and ‘R2’
on the other side.
Risperidone 3 mg orodispersible tablet: Light pink coloured, plain to
mottled, round, flat faced,
bevelled edged tablets debossed with ‘M’ on one side and ‘R3’
on the other side.
Risperidone 4 mg orodispersible tablet: Light pink coloured, plain to
mottled, round, flat faced,
bevelled edged tablets debossed with ‘M’ on one side and ‘R4’
on th