Risperdal Consta 50mg powder and solvent for prolonged-release suspension for intramuscular injection

Quốc gia: Malta

Ngôn ngữ: Tiếng Anh

Nguồn: Medicines Authority

Thành phần hoạt chất:

RISPERIDONE

Sẵn có từ:

Janssen-Cilag International NV Turnhoutsewes 30, B-2340 Beerse, Belgium

Mã ATC:

N05AX08

INN (Tên quốc tế):

RISPERIDONE 50 mg

Dạng dược phẩm:

POWDER AND SOLVENT FOR SUSPENSION FOR INJECTION

Thành phần:

RISPERIDONE 50 mg

Loại thuốc theo toa:

POM

Khu trị liệu:

PSYCHOLEPTICS

Tình trạng ủy quyền:

Authorised

Ngày ủy quyền:

2007-08-22

Tờ rơi thông tin

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
RISPERDAL CONSTA 25, 37.5 AND 50 MG POWDER AND SOLVENT FOR
PROLONGED-RELEASE SUSPENSION FOR
INJECTION
risperidone
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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 Risperdal Consta is and what it is used for
2.
What you need to know before you use Risperdal Consta
3.
How to use Risperdal Consta
4.
Possible side effects
5.
How to store Risperdal Consta
6.
Contents of the pack and other information
1.
WHAT RISPERDAL CONSTA IS AND WHAT IT IS USED FOR
Risperdal Consta belongs to a group of medicines called
‘antipsychotics’.
Risperdal Consta is used to maintain the treatment of 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.
Risperdal Consta is intended for patients who are currently treated
with oral (e.g. tablets, capsules)
antipsychotics.
Risperdal Consta can help alleviate the symptoms of your disease and
stop your symptoms from
coming back.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE RISPERDAL CONSTA
DO NOT USE RISPERDAL CONSTA
●
If you are allergic to risperidone or any of the other ingredients of
this medicine (listed in
section 6).
WARNINGS AND PRECAUTIONS
●
If you have never taken any form of Risperdal, you should begin with
oral Risperdal before
beginning treatment with Risperdal Consta.
Talk to your doctor or pharmacist before using Risperdal Consta if:
●
You have a heart problem. Examples include an irregular heart rhythm
or if you ar

Đặc tính sản phẩm

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
RISPERDAL CONSTA 25 mg powder and solvent for prolonged-release
suspension for injection
RISPERDAL CONSTA 37.5 mg powder and solvent for prolonged-release
suspension for injection
RISPERDAL CONSTA 50 mg powder and solvent for prolonged-release
suspension for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 vial contains 25 mg risperidone.
1 vial contains 37.5 mg risperidone.
1 vial contains 50 mg risperidone.
1 ml reconstituted suspension contains 12.5 mg of risperidone.
1 ml reconstituted suspension contains 18.75 mg of risperidone.
1 ml reconstituted suspension contains 25 mg of risperidone.
Excipients with known effect
1 ml reconstituted suspension contains 3 mg sodium.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder and solvent for prolonged-release suspension for injection.
_Vial with powder _
White to off-white free flowing powder.
_Prefilled syringe of solvent for reconstitution _
Clear, colourless aqueous solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
RISPERDAL CONSTA
is indicated for the maintenance treatment of schizophrenia in
patients
currently stabilised with oral antipsychotics.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults _
Starting dose
For most patients the recommended dose is 25 mg intramuscular every
two weeks. For those patients
on a fixed dose of oral risperidone for two weeks or more, the
following conversion scheme should be
considered. Patients treated with a dosage of 4 mg or less oral
risperidone should receive 25 mg
2
RISPERDAL CONSTA, while patients treated with higher oral doses should
be considered for the
higher RISPERDAL CONSTA dose of 37.5 mg.
Where patients are not currently taking oral risperidone, the oral
pre-treatment dosage should be
considered when choosing the I.M. starting dose. The recommended
starting dose is 25 mg
RISPERDAL CONSTA every two weeks. Patients on higher dosages of the
used oral antipsychotic
should be considered for the