Solian 50mg Tablets

Land: Irland

Sprog: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

Aktiv bestanddel:

Amisulpride

Tilgængelig fra:

Imbat Limited

ATC-kode:

N05AL; N05AL05

INN (International Name):

Amisulpride

Dosering:

50 milligram(s)

Lægemiddelform:

Tablet

Recept type:

Product subject to prescription which may be renewed (B)

Terapeutisk område:

Benzamides; amisulpride

Autorisation status:

Authorised

Autorisation dato:

2014-06-13

Indlægsseddel

Page 1 of 2
PACKAGE LEAFLET: INFORMATION FOR THE USER
SOLIAN
® 50MG TABLETS
(amisulpride)
Your medicine is available using the name Solian 50mg Tablets
but will be referred to as Solian throughout this leaflet.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU
START TAKING THIS MEDICINE

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.
IN THIS LEAFLET:
1.
What Solian is and what it is used for
2.
What you need to know before you take Solian
3.
How to take Solian
4.
Possible side effects
5.
How to store Solian
6.
Contents of the pack and other information
1.
WHAT SOLIAN IS AND WHAT IT IS USED FOR
Solian contains a medicine called amisulpride.
This belongs to a group of medicines called ‘antipsychotics’.
It is used to treat an illness called schizophrenia.
Schizophrenia can make you feel, see or hear things which do not
exist, have strange and frightening thoughts, change how you act,
and make you feel alone. Sometimes people with these symptoms
may also feel tense, anxious or depressed. Solian works by
improving disturbed thoughts, feelings and behaviour. It is used
to treat schizophrenia when it starts and also over the long term.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE
SOLIAN
DO NOT TAKE THIS MEDICINE AND TELL YOUR DOCTOR IF:

You are allergic (hypersensitive) to amisulpride or any of the
other ingredients of Solian (listed in Section 6). Signs of an
allergic reaction include: a rash, swallowing or breathing
problems, swelling of your lips, face, throat or tongue

You are pregnant, might become pregnant or are breast-
feeding (see ‘Pregnancy and breastfeeding’ section)

You have breast cancer or something called ‘a prolactin
dependent tumo

Produktets egenskaber

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Solian 50mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 50mg of amisulpride.
Excipient of known effect: lactose monohydrate.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet
_Product imported from the UK:_
White to off-white, round, flat faced tablets engraved with ‘AMI
50’ on one face and plain on the reverse.
4 CLINICAL PARTICULARS
As per PA0540/158/001.
5 PHARMACOLOGICAL PROPERTIES
As per PA0540/158/001.
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
sodium starch glycolate
lactose monohydrate
microcrystalline cellulose
hypromellose
magnesium stearate
6.2 INCOMPATIBILITIES
Not applicable.
6.3 SHELF LIFE
The shelf life expiry date of this product shall be the date shown on
the container and outer package of the product on
the market in the country of origin.
6.4 SPECIAL PRECAUTIONS FOR STORAGE
This medicinal product does not require any special storage
conditions.
H
E
A
L
T
H
P
R
O
D
U
C
T
S
R
E
G
U
L
A
T
O
R
Y
A
U
T
H
O
R
I
T
Y
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
_D_
_a_
_t_
_e_
_ _
_P_
_r_
_i_
_n_
_t_
_e_
_d_
_ _
_1_
_3_
_/_
_0_
_2_
_/_
_2_
_0_
_1_
_5_
_C_
_R_
_N_
_ _
_2_
_1_
_5_
_3_
_6_
_3_
_3_
_p_
_a_
_g_
_e_
_ _
_n_
_u_
_m_
_b_
_e_
_r_
_:_
_ _
_1_
6.5 NATURE AND CONTENTS OF CONTAINER
Cardboard outer containing blister strips.
Pack size: 60 tablets
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL AND OTHER HANDLING
No special requirements.
7 PARALLEL PRODUCT AUTHORISATION HOLDER
Imbat Limited
Unit L2
North Ring Business Park
Santry
Dublin 9
Ireland
8 PARALLEL PR