Risperidon Mylan 0,5 mg Munsönderfallande tablett

Šalis: Švedija

kalba: švedų

Šaltinis: Läkemedelsverket (Medical Products Agency)

Veiklioji medžiaga:

risperidon

Prieinama:

Mylan S.A.S.

ATC kodas:

N05AX08

INN (Tarptautinis Pavadinimas):

risperidone

Dozė:

0,5 mg

Vaisto forma:

Munsönderfallande tablett

Sudėtis:

mannitol Hjälpämne; risperidon 0,5 mg Aktiv substans; aspartam Hjälpämne

Klasė:

Apotek

Recepto tipas:

Receptbelagt

Gydymo sritis:

Risperidon

Produkto santrauka:

Förpacknings: Blister, 30 tabletter; Blister, 28 tabletter; Blister, 56 tabletter; Blister, 60 tabletter; Blister, 10 tabletter; Blister, 14 tabletter

Autorizacija statusas:

Avregistrerad

Leidimo data:

2006-10-13

Pakuotės lapelis

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
RISPERIDON MYLAN 0.5 MG ORODISPERSIBLE TABLETS
RISPERIDON MYLAN 1 MG ORODISPERSIBLE TABLETS
RISPERIDON MYLAN 2 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 Risperidon Mylan
is and what it is used for
2.
What you need to know before you take Risperidon Mylan
3.
How to take Risperidon Mylan
4.
Possible side effects
5.
How to store Risperidon Mylan
6.
Contents of the pack and other information
1.
WHAT RISPERIDON MYLAN IS AND WHAT IT IS USED FOR
Risperidon Mylan belongs to a group of medicines called
‘anti-psychotics’.
Risperidon 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.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE RISPERIDON MYLAN
DO NOT TAKE RISPERIDON MYLAN

if you are allergic to risperidone or any of the other ingredients of
this medicine (listed in
se

Prekės savybės

1
Produktinformationen för Risperidon Mylan 0,5 mg, 1 mg, 2 mg
munsönderfallande tablett, MTnr 21767,
21768, 21769, gäller vid det tillfälle då läkemedlet godkändes.
Informationen kommer inte att uppdateras
eftersom läkemedlet inte marknadsförs i Sverige. Av samma anledning
finns inte någon svensk
produktinformation.
Den engelska produktinformationen kommer dock att uppdateras när
Sverige är referensland i proceduren.
Om läkemedelsnamnet i följande produktinformation inte stämmer med
namnet på dokumentet, beror det på
att läkemedlet i Sverige är godkänt under ett annat namn.
2
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
RISPERIDON MYLAN 0.5 mg orodispersible tablets
RISPERIDON MYLAN 1 mg orodispersible tablets
RISPERIDON MYLAN 2 mg orodispersible tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each orodispersible tablet 0.5 mg contains 0.5 mg risperidone.
Each orodispersible tablet 1 mg contains 1 mg risperidone.
Each orodispersible tablet 2 mg contains 2 mg risperidone.
EXCIPIENTS:
aspartame (E951), sorbitol (E420).
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Orodispersible tablet.
Round, slightly convex, pink marbled orodispersible tablets
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Risperidone is indicated for the treatment of schizophrenia.
Risperidone is indicated for the maintenance treatment in order to
prevent relapse in chronic
schizophrenia in patients having shown a response to initial
treatment.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Risperidon Mylan orodispersible tablets should not be divided. When
administration of 0.25 mg or
dose increments of 0.25 mg is necessary another preparation containing
risperidone should be used.
_Acute and chronic treatment of schizophrenia_
_Adults and adolescents ≥ 15 years_
The daily dose of risperidone may be taken once daily or twice daily.
For some patients, taking into
account the risk of orthostatic hypotension of risperidone, a twice
daily administration is preferable,
partic