Solian 400 mg film-coated tablets

Страна: Ирландия

Език: английски

Източник: HPRA (Health Products Regulatory Authority)

Активна съставка:

Amisulpride

Предлага се от:

Originalis B.V.

АТС код:

N05AL05

INN (Международно Name):

Amisulpride

дозиране:

400 milligram(s)

Лекарствена форма:

Film-coated tablet

Терапевтична област:

amisulpride

Дата Оторизация:

2019-08-23

Листовка

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 ‘anti-
psychotics’. 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:
x
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
x
You are pregnant or might become pregnant (see 'Pregnancy and
breast-feeding section)
x
You have breast cancer or something called ‘a prolactin dependent
tumour’
x
You have a pituitary tumour
x
You have a tumour on the adrenal gland (called phaeochromocytoma)
x
You are taking other medicines which could change your heart rate such
as medicines which are
used to control your heart beat (see ‘Taking other medicines’
section)
x
You are taking levodopa, a medicine to treat Parkinson’s disease
(see ‘Taking other medicines’
section)
x
The patient is under 15 years old
Do not take this medicine if any of the above apply to you. If you are
not sure, talk to your doctor or
pharmacist before taking Solian.
WARNINGS AND PRECAUTIONS
Severe liver problems have been reported with Solian. Talk to your
doctor immediately if you experience
fatigue, loss of appetite, nausea, vom

Данни за продукта

Health Products Regulatory Authority
23 August 2019
CRN0092CM
Page 1 of 2
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Solian 400 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 400 mg amisulpride.
Excipient with known effect
Lactose (as monohydrate)
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet
_Product imported from Greece_
Oblong,white scored tablet engraved "AMI 400" on one side of it.
The score line is only to faciliate breaking for ease of swallowing
and not to divide into equal doses.
4 CLINICAL PARTICULARS
As per PA0540/158/004
5 PHARMACOLOGICAL PROPERTIES
As per PA0540/158/004
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Tablet core
Sodium carboxymethyl starch
Lactose monohydrate
Cellulose, microcrystalline
Hypromellose
Magnesium stearate
Coating
Hypromellose
Cellulose, microcrystalline
Polyoxyl 40 stearate
Titanium dioxide (E171)
6.2 INCOMPATIBILITIES
Not applicable.
6.3 SHELF LIFE
The shelf life expiry date for this product shall be the date shown on
the blister and outer package of the product on the
market in the country of origin.
Health Products Regulatory Authority
23 August 2019
CRN0092CM
Page 2 of 2
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Do not store above 30 °C.
6.5 NATURE AND CONTENTS OF CONTAINER
Blisters of 60 film-coated tablets.
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL OF A USED MEDICINAL PRODUCT OR
WASTE MATERIALS DERIVED FROM SUCH MEDICINAL
PRODUCT AND OTHER HANDLING OF THE PRODUCT
No special requirements.
7 PARALLEL PRODUCT AUTHORISATION HOLDER
Originalis B.V.
Joop Geesinkenweg 901
1114 AB Amsterdam-Duivendrecht
Netherlands
8 PARALLEL PRODUCT AUTHORISATION NUMBER
PPA2306/019/001
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 23
rd
August 2019
10 DATE OF REVISION OF THE TEXT