Sulpiride Grindeks 200 mg tablets

Maa: Malta

Kieli: englanti

Lähde: Medicines Authority

Saatavilla:

AS GRINDEKS Krustpils iela 53 Riga, LV-1057 , Latvia

ATC-koodi:

N05AL01

INN (Kansainvälinen yleisnimi):

SULPIRIDE 300 mg

Lääkemuoto:

TABLET

Koostumus:

SULPIRIDE 300 mg

Prescription tyyppi:

POM

Terapeuttinen alue:

PSYCHOLEPTICS

Tuoteyhteenveto:

Licence number in the source country: NOT APPLICAPABLE

Valtuutuksen tilan:

Authorised

Valtuutus päivämäärä:

2022-05-13

Pakkausseloste

PACKAGE LEAFLET: INFORMATION FOR THE USER
SULPIRIDE GRINDEKS 50 MG TABLETS
SULPIRIDE GRINDEKS 100 MG TABLETS
SULPIRIDE GRINDEKS 200 MG TABLETS
sulpiride
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 Sulpiride Grindeks is and what it is used for
2.
What you need to know before you use Sulpiride Grindeks
3.
How to use Sulpiride Grindeks
4.
Possible side effects
5.
How to store Sulpiride Grindeks
6.
Contents of the pack and other information
1.
WHAT SULPIRIDE GRINDEKS
IS AND WHAT IT IS USED FOR
Sulpiride Grindeks contains a medicine called sulpiride. This belongs
to a group of medicines called
‘benzamides’. It works by blocking the effect of a chemical in the
brain. Sulpiride Grindeks are used
to treat schizophrenia.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE SULPIRIDE GRINDEKS
DO NOT USE SULPIRIDE GRINDEKS
–
If you are allergic to sulpiride or any of the other ingredients of
this medicine (listed in section 6).
Signs of an allergic reaction include: a rash, swallowing or breathing
problems, swelling of your
lips, face, throat or tongue.
–
If you have a tumour of the adrenal gland called 'phaeochromocytoma'.
–
If you have a rare illness called ‘porphyria’ which affects your
metabolism.
–
If you have breast cancer or cancer in the pituitary gland.
–
If you are taking levodopa or ropinirole used for Parkinson’s
disease (see section
_Other _
_medicines and Sulpiride Grindeks _
below).
Do not take this medicine if any of the above apply to you. If you are
not sure, talk to your docto

Valmisteyhteenveto

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Sulpiride Grindeks 50 mg tablets
Sulpiride Grindeks 100 mg tablets
Sulpiride Grindeks 200 mg tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 50 mg, 100 mg or 200 mg sulpiride.
_ _
Excipient with known effect:
Each 50 mg tablet contains 5.5 mg lactose (as monohydrate);
Each 100 mg tablet contains 11.0 mg lactose (as monohydrate);
Each 200 mg tablet contains 22.0 mg lactose (as monohydrate).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet.
Sulpiride Grindeks 50 mg are white or almost white round tablets with
bevelled edges. Dimension of
tablet: diameter approximately 6.0 mm.
Sulpiride Grindeks 100 mg are white or almost white round tablets with
bevelled edges. Dimension of
tablet: diameter approximately 7.0 mm.
Sulpiride Grindeks 200 mg are white or almost white round tablets with
bevelled edges and single
score line on one side. Dimension of tablet: diameter approximately
10.0 mm. The score line is only to
facilitate breaking for ease of swallowing and not to divide into
equal doses.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Acute and chronic schizophrenia.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults _
A starting dose of 400 mg to 800 mg, given twice daily (morning and
early evening) is recommended.
Predominantly positive symptoms (formal thought disorder,
hallucinations, delusions, incongruity of
affect) respond to higher doses, and a starting dose of at least 400
mg twice daily is recommended,
increasing if necessary up to a suggested maximum of 1200 mg twice
daily. Increasing the dose
beyond this level has not been shown to produce further improvement.
Predominantly negative symptoms (flattening of affect, poverty of
speech, anergia, apathy, as well as
depression) respond to doses below 800 mg daily; therefore, a starting
dose of 400 mg twice daily is
recommended. Reducing this dose towards 200 mg twice daily will
normally increase the alerting
effect of Sulpiride