Sulpiride 200mg tablets

Negara: Inggris

Bahasa: Inggris

Sumber: MHRA (Medicines & Healthcare Products Regulatory Agency)

Bahan aktif:

Sulpiride

Tersedia dari:

Medreich Plc

Kode ATC:

N05AL01

INN (Nama Internasional):

Sulpiride

Dosis:

200mg

Bentuk farmasi:

Oral tablet

Rute administrasi :

Oral

Kelas:

No Controlled Drug Status

Jenis Resep:

Valid as a prescribable product

Ringkasan produk:

BNF: 04020100; GTIN: 05060292740553

Selebaran informasi

READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING 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 TABLETS ARE AND WHAT THEY ARE USED FOR
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE SULPIRIDE TABLETS
3.
HOW TO TAKE SULPIRIDE TABLETS
4.
POSSIBLE SIDE EFFECTS
5.
HOW TO STORE SULPIRIDE TABLETS
6.
CONTENTS OF THE PACK AND OTHER INFORMATION
1. WHAT SULPIRIDE TABLETS ARE AND WHAT THEY ARE USED FOR
Sulpiride belongs to a group of medicines called ‘benzamides’. It
works by
blocking the effect of a chemical in the brain. Sulpiride tablets are
used to
treat Schizophrenia.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE SULPIRIDE TABLETS
DO NOT TAKE SULPIRIDE TABLETS:
•
If you are allergic (hypersensitive) to sulpiride or any other
ingredients
in this product (_see Section 6 and end of Section_ 2). Signs of an
allergic
reaction include: a rash, swallowing or breathing problems, swelling
of
your lips, face, throat or tongue.
•
If
you
have
a
rare
illness
called
‘porphyria’
which
affects
your
metabolism.
•
If you have tumour on the adrenal gland called ‘phaeochromocytoma’
•
If you have breast cancer or cancer in the pituitary gland.
•
You are taking levodopa or ropinirole used for Parkinson’s disease
(see
‘Taking other medicines’ below)
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 Sulpiride
Tablets.
TAKE SPECIAL CARE AND TELL TO YOUR DOCTOR OR PHARMACIST IF YOU:
•
have kidney problems
•
have high blood pressure
•
have epilepsy or have

Karakteristik produk

1. NAME OF THE MEDICINAL PRODUCT
Sulpiride 200mg Tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 200mg of the active substance sulpiride.
Also contains 128mg of Lactose Monohydrate
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Tablet.
White,
c
ircular tablet marked S200 on one face and plain on the reverse.
4. CLINICAL PARTICULARS
4.1. THERAPEUTIC INDICATIONS
This medicinal product is for
the
treatment of acute and chronic schizophrenia.
4.2. POSOLOGY AND METHOD OF ADMINISTRATION
Adults:
The initial dose depends on the nature of the symptoms.
In patients with predominantly negative symptoms (flattening of
affect, poverty of speech,
anergia, apathy, as well as depression) the usual starting dose is 400
mg twice daily. This can
be reduced to 200mg twice daily as a response occurs, increasing the
alerting effect of
sulpiride that occurs at lower doses.
In patients with predominantly positive symptoms (formal thought
disorder, hallucinations,
delusions, incongruity of affect) the usual starting dose is 400mg
twice daily increasing if
necessary to a suggested maximum of 1200mg twice daily.
In patients with positive and negative symptoms, with neither
predominating, a dose of
400mg-600mg twice daily is recommended.
Elderly:
Initially one quarter to one half of the adult dose.
Children:
Clinical experience in children under 14 years of age is insufficient
to permit specific
recommendations.
Renal impairment:
The dosage should be reduced or the dosage interval increased.
4.3 CONTRAINDICATIONS
Phaeochromocytoma
Acute porphyria
Hypersensitivity to sulpiride or to any of the excipients listed in
section 6.1.
Concomitant prolactin-dependent tumours e.g. pituitary gland
prolactinomas and
breast cancer (See section 4.8 Undesirable effects).
Association with levodopa or antiparkinsonian drugs (including
ropinirole) (See
section 4.5 Interactions with other medicinal products and other forms
of interaction).
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
WARNINGS:
Increased motor