Solian 50mg Tablets

Land: Írland

Tungumál: enska

Heimild: HPRA (Health Products Regulatory Authority)

Virkt innihaldsefni:

Amisulpride

Fáanlegur frá:

LTT Pharma Limited

ATC númer:

N05AL; N05AL05

INN (Alþjóðlegt nafn):

Amisulpride

Skammtar:

50 milligram(s)

Lyfjaform:

Tablet

Gerð lyfseðils:

Product subject to prescription which may be renewed (B)

Lækningarsvæði:

Benzamides; amisulpride

Leyfisstaða:

Authorised

Leyfisdagur:

2014-09-19

Upplýsingar fylgiseðill

IN PARTICULAR, DO NOT TAKE THIS MEDICINE, AND TELL YOUR DOCTOR IF YOU
ARE
TAKING ANY OF THE FOLLOWING MEDICINES:
*
Medicines used to control your heart beat such as quinidine,
disopyramide,
procainamide, amiodarone and sotalol
*
Bepridil, used to treat heart disease
*
Cisapride, used to treat heartburn
*
Thioridazine or sultopride, used to treat mental illness
*
Methadone, used to treat pain and opiate addiction
*
Antibiotics such as erythromycin (given by injection) or sparfloxacin
*
Vincamine (given by injection), used for brain circulation problems
*
Halofantrine, used for malaria
*
Pentamidine used for pneumonia
*
Levodopa, a medicine to treat parkinson's disease
*
Clozapine, used to treat schizophrenia
TELL YOUR DOCTOR IF YOU ARE TAKING ANY OF THE FOLLOWING MEDICINES:
*
Medicines for depression or to calm emotional and mental illness such
as
pimozide, haloperidol, imipramine, and lithium
*
Medicines for severe pain called opiates such as morphine or pethidine
*
Medicines for high blood pressure and migraine such as clonidine,
diltiazem and verapamil, guanfacine and digitalis
*
Medicines which may lower potassium levels. This includes water
tablets
such as bendrofluazide or hydrochlorothiazide, some laxatives,
glucocorticoids (used to treat severe asthma and other inflammatory
disorders), tetracosactides and amphotericin (used to treat fungal
infections)
*
Medicines which help you sleep such as barbiturates and
benzodiazepines
*
Pain-killers such as tramadol and indometacin
*
Anaesthetics
*
Antihistamines such as promethazine which make you sleepy
If you are not sure if any of the above apply to you, talk to your
doctor or
pharmacist before taking Solian.
TAKING SOLIAN WITH FOOD AND DRINK
*
Swallow Solian tablets with plenty of water before a meal
*
Do not drink alcohol while you are taking Solian. This is because it
can
affect the way the medicine works
PREGNANCY AND BREAST-FEEDING
Do not take this medicine if:
*
You are breast-feeding or planning to breast-feed
The following symptoms may occur in newborn ba

Vara einkenni

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Solian 50mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Amisulpride 50mg per tablet.
Excipient(s) with known effect
Lactose monohydrate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet
_Product imported from the United Kingdom_
White to off-white, round flat-faced tablet engraved ‘AMI 50’ on
one face.
4 CLINICAL PARTICULARS
As per PA0540/158/001
5 PHARMACOLOGICAL PROPERTIES
As per PA0540/158/001
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Lactose monohydrate
Microcrystalline cellulose
Sodium starch glycolate
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
No special precautions for storage.
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6.5 NATURE AND CONTENTS OF CONTAINER
PVC/aluminium foil blister packs containing 60 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
LTT Pharma Limited
Unit 18
Oxleasow Road
East Moons Moat
Redd