UBRETID TABLET 5 mg

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

DISTIGMINE BROMIDE

Available from:

CELLTRION HEALTHCARE SINGAPORE PRIVATE LIMITED

ATC code:

N07AA03

Dosage:

5 mg

Pharmaceutical form:

TABLET

Composition:

DISTIGMINE BROMIDE 5 mg

Administration route:

ORAL

Prescription type:

Prescription Only

Manufactured by:

Globopharm

Authorization status:

ACTIVE

Authorization date:

1989-05-22

Patient Information leaflet

PACKAGE INSERT 

UBRETID
®
 5 MG TABLETS

COMPOSITION
Each tablet UBRETID
®
 5 mg contains 5 mg distigmine bromide 

PROPERTIES AND EFFICACY
UBRETID
® 
increases the activity of the musculature of the gastrointestinal
tract and the tonicity 
of the urinary bladder, the sphincteric tonicity, the tonicity of the
ureter and of the skeletal 
muscles. 

CLINICAL APPLICATION 
The use of the drug in therapy is based on both its
parasympathomimetic as well as its muscle 
tone increasing effect on the skeletal muscle. 

INDICATIONS 
Functional insufficiency of the vesical sphincteral apparatus 
Hypotonia of the urinary bladder 
Chronic hypotonic constipation and megacolon 
In various neurological indications (peripheral paralyses of the
striated muscles, 
myasthenia gravis pseudoparalytica) a functional improvement can be
obtained. 

GENERAL INSTRUCTION FOR DOSAGE
The long duration of effects of UBRETID
® 
might allow dosage interval of 2 to 3 days. As a rule, 
UBRETID
® 
5 mg tablets are taken in the morning half an hour before breakfast on
an empty 
stomach. If however, due to preceding or simultaneous food intake a
dose of UBRETID
® 
does 
not take effect, this should by no means be compensated by repeating
the medication within a 
few hours as this might lead to an uncontrolled accumulation.
The dosage level has to be individualized for each patient, dependent
upon the condition.  
The strong and prolong effects of UBRETID
® 
have to be taken into account with special caution 
in the treatment of vagotonic patient. 

FUNCTIONAL INSUFFICIENCY OF THE VESICOSPHINCTERAL SYSTEM
Oral therapy will be sufficient; it is recommended that UBRETID
® 
5 mg (one tablet), be given 
daily at the commencement of treatment until an improvement is
observed. Usually the effect 
can be maintained by administering one to two tablets every other or
third day. The tablets 
should always be taken in the morning on an empty stomach, half an
hour before breakfast. 

CHRONIC HYPOTONIC CON

Summary of Product characteristics

PACKAGE INSERT
UBRETID
®
5 MG TABLETS
COMPOSITION
Each tablet UBRETID
®
5 mg contains 5 mg distigmine bromide
PROPERTIES AND EFFICACY
UBRETID
®
increases the activity of the musculature of the gastrointestinal
tract and the tonicity of the
urinary bladder, the sphincteric tonicity, the tonicity of the ureter
and of the skeletal muscles.
CLINICAL APPLICATION
The use of the drug in therapy is based on both its
parasympathomimetic as well as its muscle tone
increasing effect on the skeletal muscle.
INDICATIONS
Functional insufficiency of the vesical sphincteral apparatus
Hypotonia of the urinary bladder
Chronic hypotonic constipation and megacolon
In various neurological indications (peripheral paralyses of the
striated muscles, myasthenia gravis
pseudoparalytica) a functional improvement can be obtained.
GENERAL INSTRUCTION FOR DOSAGE
Method of administration
For oral administration with some fluid in the morning on empty
stomach about half an hour before
breakfast.
Duration of use
Duration of treatment will depend on the course of the disease and
will be determined by the physician.
Ubretid 5mg tablets are principally suitable for long-term treatment.
When using UBRETID
®
, its slow onset of action and its long duration of action as well as
the individual
response of the patient should be considered. The dosage level has to
be individualized for each patient,
dependent upon the patient´s weight, clinical status, response to
therapy, and the drug´s long duration
of action.
Posology
As a rule,
the initial oral dose is usually one
UBRETID
®
5 mg tablet taken daily in the morning, half
an hour before breakfast on an empty stomach. If however, due to
preceding or simultaneous food intake
a dose of UBRETID
®
does not take effect, this should by no means be compensated by
repeating the
medication within a few hours as this might lead to an uncontrolled
accumulation. The long duration of
effects of UBRETID
®
might allow dosage interval of 2 to 3 days.
The strong and prolong effects of UBRETID
®
have to be taken