Nodiril 1 mg film-coated tablets

Quốc gia: Malta

Ngôn ngữ: Tiếng Anh

Nguồn: Medicines Authority

Thành phần hoạt chất:

RISPERIDONE

Sẵn có từ:

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

Mã ATC:

N05AX08

INN (Tên quốc tế):

RISPERIDONE 1 mg

Dạng dược phẩm:

FILM-COATED TABLET

Thành phần:

RISPERIDONE 1 mg

Loại thuốc theo toa:

POM

Khu trị liệu:

PSYCHOLEPTICS

Tình trạng ủy quyền:

Withdrawn

Ngày ủy quyền:

2005-10-18

Tờ rơi thông tin

Page 1 of 11
PACKAGE LEAFLET: INFORMATION FOR THE USER
NODIRIL 1 AND 2 MG FILM-COATED 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 Nodiril is and what it is used for
2.
What you need to know before you take Nodiril
3.
How to take Nodiril
4.
Possible side effects
5.
How to store Nodiril
6.
Contents of the pack and other information
1.
WHAT NODIRIL IS AND WHAT IT IS USED FOR
Nodiril belongs to a group of medicines called “anti-psychotics”.
Nodiril 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.
Nodiril can help alleviate the symptoms of your disease and stop your
symptoms from coming
back.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE NODIRIL
DO NOT TAKENODIRIL:
-
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

Đặc tính sản phẩm

Page 1 of 22
1.
NAME OF THE MEDICINAL PRODUCT
Nodiril 1 mg film-coated tablets
Nodiril 2 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Nodiril 1 mg film coated tablet contains 1 mg risperidone
Each Nodiril 2 mg film coated tablet contains 2 mg risperidone
Excipient with known effect:
Each Nodiril 1 mg film coated tablet contains 61 mg anhydrous lactose
Each Nodiril 2 mg film coated tablet contains 123 mg anhydrous lactose
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet
Nodiril 1 mg tablets: White, oval, biconvex tablets with a break
score, 8x5 mm, marked “T1” on
one side. The tablet can be divided into equal doses.
Nodiril 2 mg tablets: White, oval, biconvex tablets, with a break
score, 10x5 mm, marked “T2” on
one side. The tablet can be divided into equal doses.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Nodiril is indicated for the treatment of schizophrenia.
Nodiril is indicated for the treatment of moderate to severe manic
episodes associated with bipolar
disorders.
Nodiril is indicated for the short-term treatment (up to 6 weeks) of
persistent aggression in patients
with moderate to severe Alzheimer’s dementia unresponsive to
non-pharmacological approaches
and when there is a risk of harm to self or others.
Nodiril is indicated for the short-term symptomatic treatment (up to 6
weeks) of persistent
aggression in conduct disorder in children from the age of 5 years and
adolescents with subaverage
intellectual functioning or mental retardation diagnosed according to
DSM-IV criteria, in whom the
severity of aggressive or other disruptive behaviours require
pharmacologic treatment.
Pharmacological treatment should be an integral part of a more
comprehensive treatment
programme, including psychosocial and educational intervention. It is
recommended that
risperidone be prescribed by a specialist in child neurology and child
and adolescent psychiatry or
physicians well familiar with the treatment of conduct disorder of
children