Nodiril

Šalis: Malta

kalba: anglų

Šaltinis: Medicines Authority

Veiklioji medžiaga:

RISPERIDONE

Prieinama:

Actavis Group PTC ehf Revkjavikurvegi 76-78, 220 Hafnarfjordur, Iceland

ATC kodas:

N05AX08

INN (Tarptautinis Pavadinimas):

RISPERIDONE 3 mg

Vaisto forma:

FILM-COATED TABLET

Sudėtis:

RISPERIDONE 3 mg

Recepto tipas:

POM

Gydymo sritis:

PSYCHOLEPTICS

Autorizacija statusas:

Withdrawn

Leidimo data:

2005-10-18

Pakuotės lapelis

 
NODIRIL 
Risperidone 
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE.
-  Keep this leaflet. You may need to read it again.
-  If you have further questions, please ask your doctor or your
pharmacist.
-  This medicine has been prescribed for you personally and you
should not pass it on to others. It may harm them, even if their  
   symptoms are the same as yours.

IN THIS LEAFLET: 
1.  What Nodiril is and what it is used for
2.  Before you use Nodiril
3.  How to use Nodiril
4.  Possible side effects
5  Storing Nodiril
6.  Further information.

NODIRIL
0.5, 1, 2, 3 and 4mg film-coated tablets 

-  The active substance is risperidone. Each film-coated tablet
contains 0.5, 1, 2, 3, or 4  mg of risperidone.
-  The other ingredients are anhydrous lactose, microcrystalline
cellulose, pregelatinised starch, magnesium stearate, 
  hypromellose, Macrogol 6000 and titanium dioxide (colouring agent
E171).
MARKETING AUTHORISATION HOLDER:
Actavis Group PTC ehf., Reykjavikurvegur 76-78, 220 Hafnarfjördur,
Iceland. 

MANUFACTURER:
Actavis hf, Reykjavikurvegur 78, IS-220 Hafnarfjördur,
Iceland. _(Responsible for batch release in Malta)_
Actavis hf, Karsnesbraut 108, IS-200 Kopavogur, Iceland. 

1. WHAT NODIRIL IS AND WHAT IT IS USED FOR
Nodiril is a medicinal product intended for treatment of psychosis,
easing off or eliminating the symptoms of the disease. 
Psychosis is a dysfunction in the brain, which affects the way you
think, feel and/or act. People with these conditions may for 
example feel they are being followed by somebody, hear voices or have
difficulties in controlling their thoughts.

Nodiril may be taken for both sudden (acute) and long-lasting
(chronic) psychotic symptoms. After the symptoms have been 
alleviated, Nodiril may also be used for prevention of relapses.

The tablets are supplied in blister packs of 6, 20, 28, 30, 50, 60, 98
or 100 film-coated tablets. 
Not all pack sizes may be marketed.

2. BEFORE YOU USE NODI

Prekės savybės

 
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SUMMARY OF PRODUCT CHARACTERISTICS 

1. NAME OF THE MEDICINAL PRODUCT 

Nodiril 0.5 mg film-coated tablets  
Nodiril 1 mg film-coated tablets  
Nodiril 2 mg film-coated tablets  
Nodiril 3 mg film-coated tablets  
Nodiril 4 mg film-coated tablets  

2. QUALITATIVE AND QUANTITATIVE COMPOSITION 

Nodiril 0.5 mg: Each film-coated tablet contains 0.5 mg risperidone

Nodiril 1 mg: Each film-coated tablet contains 1 mg risperidone. 
Nodiril 2 mg: Each film-coated tablet contains 2 mg risperidone. 
Nodiril 3 mg: Each film-coated tablet contains 3 mg risperidone. 
Nodiril 4 mg: Each film-coated tablet contains 4 mg risperidone. 

For excipients, see section 6.1. 

3. PHARMACEUTICAL FORM 

Film-coated tablet. 

0.5 mg tablet: white, film-coated, round, biconvex tablet, diameter
6 mm. 
1 mg tablet: white, film-coated, oval, biconvex, scored tablet, size
8 mm x 5 mm. 
2 mg tablet: white, film-coated, oval, biconvex, scored tablet, size
10 mm x 5 mm. 
3 mg tablet: white, film-coated, oval, biconvex, scored tablet, size
11 mm x 6.5 mm. 
4 mg tablet: white, film-coated, oval, biconvex, scored tablet, size
14 mm x 7.5 mm. 

4. CLINICAL PARTICULARS 

4.1 THERAPEUTIC INDICATIONS 

Nodiril tablets are indicated for the treatment of acute and
chronic schizophrenic psychoses, and 
other psychotic conditions, in which positive symptoms (such as
hallucinations, delusions, thought 
disturbances, hostility, suspiciousness), and/or negative
symptoms (such as blunted affect, 
emotional and social withdrawal, poverty of speech) are prominent. 

Nodiril tablets also alleviate affective symptoms (such as
depression, guilt feelings, anxiety) 
associated with schizophrenia.  

Nodiril tablets are also effective in maintaining the
clinical improvement during continuation 
therapy in patients who have shown an initial treatment response. 

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