RESOTRANS

País: Austrália

Língua: inglês

Origem: Department of Health (Therapeutic Goods Administration)

Ingredientes ativos:

Prucalopride succinate; Prucalopride

Disponível em:

Janssen-Cilag Pty Ltd

Classe:

Medicine Registered

Folheto informativo - Bula

RESOTRANS™  
1 MG AND 2 MG TABLETS 
_Prucalopride_
_ _
CONSUMER MEDICINE INFORMATION 
WHAT IS IN THIS LEAFLET 
This leaflet answers some common questions 
about RESOTRANS.  It does not contain all the 
available information.  It does not take the place 
of talking to your doctor or pharmacist. 
All medicines have risks and benefits.  Your 
doctor has weighed the risks of you taking 
RESOTRANS against the benefits this medicine 
is expected to have for you. 
If you have any concerns about taking this 
medicine, ask your doctor or pharmacist. 
Keep this leaflet while being treated. You may 
need to read it again. 
WHAT RESOTRANS IS USED FOR 
The name of your medicine is RESOTRANS. It 
contains the active ingredient called prucalopride. 

RESOTRANS tablets are used for the treatment 
of long-standing constipation in adults in whom 
conventional medicines used to treat 
constipation (laxatives) fail to provide adequate 
relief. 

RESOTRANS is not used to treat constipation 
due to other medical conditions including 
disorders which involve the over-production or 
under-production of hormones from the 
endocrine gland, disorders that involve an 
alteration in normal metabolism, disorders of the 
nervous system and constipation due to use of 
medicines including opioid medicines such as 
codeine, oxycodone and morphine. 

It belongs to a group of medicines called 
enterokinetics. It acts on the muscle wall of the 
gut, helping to restore the normal functioning of 
the bowel.  

Your doctor may have prescribed this medicine 
for another reason. Ask your doctor if you have 
any questions about why it has been prescribed 
for you. 

There is no evidence that this medicine is 
addictive. 

This medicine is available only with a doctor’s 
prescription. 

BEFORE YOU TAKE RESOTRANS 
WHEN YOU MUST NOT TAKE IT 
DO NOT TAKE RESOTRANS IF YOU HAVE AN 
ALLERGY TO: 
•  prucalopride, the active ingredient in the 
medicine 
•  any of the ingredients

Características técnicas

_ _

1

 PRUCALOPRIDE (111004)API.doc

RESOTRANS
TM

TABLETS 
PRODUCT INFORMATION

NAME OF THE MEDICINE 
Prucalopride 

The chemical name for prucalopride is
4-amino-5-chloro-2,3-dihydro-N-[1-(3-methoxypropyl)-
4-piperidinyl]-7-benzofurancarboxamide butanedioate (1:1).
Prucalopride has the following 
chemical structure: 

NH
2
O
NH
Cl
N
CH
2
CH
2
CH
2
O
C
CH
3
CH
2
CH
2
COOH
COOH
.
C
18
H
26
ClN
3
O
3
.C
4
H
6
O
4
Molecular weight: 485.96
O

CAS Registry No: 179474-85-2 
DESCRIPTION 
Prucalopride succinate is a white to almost white powder. 

RESOTRANS is available as film-coated tablets containing 1 mg or 2
mg of prucalopride as the 
succinate salt. 

RESOTRANS tablets contain the following inactive ingredients: 
Tablet core: lactose, cellulose - microcrystalline, magnesium
stearate and silica – colloidal 
anhydrous.  
Coating: hypromellose, titanium dioxide, lactose, macrogol 3000
and glycerol triacetate. 
Additionally, in the coating, the 2 mg tablet
contains iron oxide red, iron oxide yellow and indigo 
carmine C173015.  

SOLUBILITY 
In organic media, prucalopride succinate is soluble
in _N,N-_dimethylformamide, 
sulfinylbismethane and _N, N_-dimethylacetamide and sparingly soluble
in methanol. In 
aqueous media, prucalopride succinate is freely soluble in acidic
aqueous media. However, 
this solubility decreases with increasing pH.  

_ _

 2 
PRUCALOPRIDE 
(111004)API.doc 

DISSOCIATION CONSTANT 
The pKa for the piperidine moiety of prucalopride succinate is 8.5,
determined at 20°C by 
potentiometric titration of an aqueous solution
of prucalopride succinate. The pKa for the 
amino moiety of prucalopride succinate is less than 3, determined at
20°C by spectrometric 
measurements of solutions of prucalopride succinate in water at
different pH-values. 

PARTITION COEFFICIENT 
The partition coefficients are determined at 20°C between n-octan