Acamprosate 333mg gastro-resistant tablets

देश: यूनाइटेड किंगडम

भाषा: अंग्रेज़ी

स्रोत: MHRA (Medicines & Healthcare Products Regulatory Agency)

सक्रिय संघटक:

Acamprosate calcium

थमां उपलब्ध:

Waymade Healthcare Plc

ए.टी.सी कोड:

N07BB03

INN (इंटरनेशनल नाम):

Acamprosate calcium

डोज़:

333mg

फार्मास्यूटिकल फॉर्म:

Gastro-resistant tablet

प्रशासन का मार्ग:

Oral

वर्ग:

No Controlled Drug Status

प्रिस्क्रिप्शन प्रकार:

Valid as a prescribable product

उत्पाद समीक्षा:

BNF: 04100100

सूचना पत्रक

Myriad Pro
10.5 pt
10.5 pt
Acamprosate_333mg_168
Leaflet
1936962
N/A
1936962
PL 04569/1610
Mylan Laboratories
Ltd (Aurangabad - IN)
75068816
TBC
N/A
102864316/0020
3
United Kingdom
KLD_Acamprosate Tabs 333mg_
Leaflet (Blister Pack)_170 x 320mm
N/A
1
170 x 320 mm
BLACK
1 / 2
N/A
v3/Jul 2017
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15:57
19 Sep 19
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ACAMPROSATE 333 MG
GASTRO-RESISTANT TABLETS
acamprosate calcium
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 Acamprosate is and what it is used for
2.
What you need to know before you take
Acamprosate
3.
How to take Acamprosate
4.
Possible side effects
5.
How to store Acamprosate
6.
Contents of the pack and other information
1. WHAT ACAMPROSATE IS AND WHAT IT IS
USED FOR
Acamprosate is a medicine which acts on the
central nervous system (the brain and the
spinal cord).
Acamprosate is used for the treatment of alcohol
dependence. It helps to maintain abstinence in
alcohol-dependent patients.
Acamprosate in combination with counselling
will help you to not drink alcohol. It does this by
acting on the chemical changes that have taken
place in the bra

उत्पाद विशेषताएं

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Acamprosate 333 mg Gastro-resistant Tablets.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gastro-resistant tablet contains acamprosate calcium 333.0 mg as
the active
ingredient.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Gastro-resistant tablet.
White, round, biconvex coated tablet with “M” over “AC”
printed in black ink on one
side of the tablet and blank on the other side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Acamprosate is indicated as therapy to maintain abstinence in
alcohol-dependent
patients. It should be combined with counselling.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults within the age range 18-65 years _
- 2 tablets three times daily with meals (2 tablets in the morning,
noon and night) in
subjects weighing 60kg or more.
- In subjects weighing less than 60kg, 4 tablets divided into three
daily doses with
meals (2 tablets in the morning, 1 at noon and 1 at night).
_Paediatric population and older people _
Acamprosate should not be administered to children, adolescents and
the elderly.
_Duration of treatment _
The recommended treatment period is one year. Treatment with
acamprosate should
be initiated as soon as possible after the withdrawal period and
should be maintained
if the patient relapses.
Acamprosate does not prevent the harmful effects of continuous alcohol
abuse.
Continued alcohol abuse negates the therapeutic benefit; therefore
acamprosate
treatment should only be initiated after weaning therapy, once the
patient is abstinent
from alcohol.
Method of administration
For oral use.
Swallow this tablet whole. Do not chew or crush the tablet as this may
damage the
gastro-resistant coating.
4.3
CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients
listed in section
6.1.
Breast-feeding women (see section 4.6)
Patients with renal impairment (serum creatinine >120 micromol/l)
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
The safety and