RESOTRANS

Main information

  • Trade name:
  • RESOTRANS
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • RESOTRANS
    Australia
  • Language:
  • English

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization status:
  • Registered
  • Authorization number:
  • 176747
  • Last update:
  • 22-05-2019

Public Assessment Report

Public Summary

Summary for ARTG Entry:

176747

RESOTRANS prucalopride (as succinate) 1mg tablet blister pack

ARTG entry for

Medicine Registered

Sponsor

Janssen-Cilag Pty Ltd

Postal Address

Locked Bag 2070,NORTH RYDE, NSW, 1670

Australia

ARTG Start Date

7/10/2011

Product category

Medicine

Status

Active

Approval area

Drug Safety Evaluation Branch

Conditions

Conditions applicable to all therapeutic goods as specified in the document "Standard Conditions Applying to Registered or Listed Therapeutic Goods

Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Conditions applicable to the relevant category and class of therapeutic goods as specified in the document "Standard Conditions Applying to Registered

or Listed Therapeutic Goods Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Products

1. RESOTRANS

Product Type

Single Medicine Product

Effective date

22/05/2017

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

RESOTRANS is indicated for the treatment of chronic functional constipation in adults in whom laxatives fail to provide adequate relief

-Before RESOTRANS is considered, patients must have tried at least two different types of laxatives from different classes (at the highest tolerated

recommended doses) for at least six months, but have not had adequate relief from constipation.

- If treatment with RESOTRANS is not effective within four weeks, the benefit of continuing treatment should be reconsidered

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Blister Pack

PA/Al/PVC/Al -

polyamide-aluminium

foil-polyvinylchloride/al

uminium foil

3 Years

Store below 30

degrees Celsius

Not recorded

Protect from Moisture

Pack Size/Poison information

Pack Size

Poison Schedule

28 film-coated tablets

(S4) Prescription Only Medicine

7 film-coated tablets

(S4) Prescription Only Medicine

Components

1.

Dosage Form

Tablet, film coated

Route of Administration

Oral

Visual Identification

White to off-white, round, biconvex tablets marked "PRU 1" on one side

Active Ingredients

prucalopride succinate

1.321 mg

© Commonwealth of Australia.This work is copyright.You are not permitted to re-transmit, distribute or commercialise the material without obtaining prior

written approval from the Commonwealth.Further details can be found at http://www.tga.gov.au/about/website-copyright.htm.

Public Summary

Page 1 of

Produced at 29.11.2017 at 12:33:41 AEDT

This is not an ARTG Certificate document.

The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.

Visit www.tga.gov.au for contact information

Patient Information leaflet: composition, indications, side effects, dosage, interactions, adverse reactions, pregnancy, lactation

RESOTRANS

RESOTRANS

®

1 mg and 2 mg tablets

Prucalopride succinate

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

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.

RESOTRANS contains the active

ingredient prucalopride succinate. 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 listed at the

end of this leaflet.

RESOTRANS contains lactose. If

you have been told by your doctor

that you have an intolerance to some

sugars, contact your doctor before

taking this medicine.

Symptoms of an allergic reaction

may include rash, itching or hives on

the skin, shortness of breath,

wheezing or difficulty breathing,

swelling of the face, lips, tongue or

other parts of the body.

Do not take RESOTRANS if:

you are on kidney dialysis (a

procedure used to remove waste

products from the blood of a

person with kidney failure)

if you suffer from perforation or

obstruction of the gut wall, or

severe inflammation of the

intestines

if you had recent bowel surgery.

If you are not sure whether you

should take this medicine, talk to

your doctor.

Before you start to take

RESOTRANS:

Tell your doctor if you have or

have had any medical conditions,

especially the following:

severe kidney disease

severe liver disease

any other serious medical

problem such as lung or heart

disease, neurological or

psychiatric disorders or other

endocrine disorders, cancer or

AIDS for which you are currently

under supervision by your doctor

You must tell your doctor if you:

are pregnant or planning to

become pregnant. It is

recommended not to take

RESOTRANS if you are pregnant

or if you intend to become

pregnant, unless your doctor

advises you to do so.

are breastfeeding or wish to

breastfeed. When breast-feeding,

prucalopride can pass into breast

milk, and although there is no

RESOTRANS

evidence that this is harmful, it is

better not to use this medicine

while breastfeeding unless your

doctor advises you to do so.

If you have not told your doctor

about any of the above, tell them

before you start taking

RESOTRANS.

Do not take this medicine if the

packaging is torn or shows signs of

tampering.

Do not take this medicine beyond

the expiry date (month and year)

printed on the pack.

The medicine must not be given to

children or adolescents (under 18

years of age).

Taking other medicines:

Tell your doctor or pharmacist if you

are taking or have recently taken any

other medicines, including medicines

that you can buy without a

prescription from a pharmacy,

supermarket or health food shop.

In particular, tell your doctor if you

are taking the following medicines:

ketoconazole (an antifungal

agent)

erythromycin, an antibiotic used

to treat infections

medicines known to cause

irregular heart beat or other heart

problems

atropine-like substances

These medicines may be affected by

RESOTRANS or may affect how

well it works. You may need

different amounts of your medicines,

or you may need to take different

medicines.

You doctor or pharmacist will have

more information on medicines to be

careful with or avoid while taking

this medicine.

RESOTRANS does not interact with

the following medicines: warfarin,

digoxin, paroxetine and oral

contraceptives.

How to take

RESOTRANS

Follow all directions given to you by

your doctor or pharmacist carefully.

They may differ from the

information contained in this leaflet.

How much to take

The usual dose for most patients is

one 2 mg tablet once a day. If you are

older than 65 years, the starting dose

is one 1 mg tablet once a day, which

your doctor may increase to 2 mg

once a day if needed. Your doctor

may also recommend a lower dose of

one 1 mg tablet daily if you have

severe kidney or liver disease.

How to take it

This medicine can be taken with or

without food and drinks, at any time

of the day.

When to take it

This medicine should be taken once a

day. You must take this medicine

every day for as long as your doctor

prescribes it.

Your doctor may want to reassess

your condition and the benefit of

continued treatment after the first 4

weeks and thereafter at regular

intervals.

If you forget to take it

If it is almost time for your next

dose, skip the dose you missed and

take your next dose when you are

meant to. Otherwise, take it as

soon as you remember, and then go

back to taking it as you would

normally.

Do not take a double dose to make

up for the dose that you missed.

This may increase the chance of you

getting an unwanted side effect.

If you have trouble remembering to

take your medicine, ask your

pharmacist for some hints.

If you stop taking it

If you stop taking RESOTRANS,

your constipation symptoms may

come back again.

If you have taken too much

(overdose)

Immediately telephone your doctor

or the Poisons Information Centre

for advice or go to Accident and

Emergency at your nearest

hospital, if you think that you or

anyone else may have taken too

much RESOTRANS. Do this even

if there are no signs of discomfort

or poisoning. You may need urgent

medical attention.

Poisons Information Centre

telephone numbers:

Australia: 13 11 26

New Zealand: 0800 POISON or

0800 764 766.

Keep these telephone numbers

handy.

It is important to keep to the dose as

prescribed by your doctor. If you

have taken more RESOTRANS than

you should, it is possible that you

will get diarrhoea, headache and/or

nausea. In case of diarrhoea, make

sure that you drink enough water.

If you have any further questions on

the use of this medicine, ask your

doctor or pharmacist.

While you are taking

RESOTRANS

If you experience severe diarrhoea

after taking RESOTRANS, certain

medicines such as the oral

contraceptive pill may not work

properly and the use of an extra

method of contraception is

recommended.

Things you must do

Always follow your doctor's

instructions carefully

RESOTRANS

Tell your doctor immediately if

you become pregnant while you

are taking this medicine

Tell your doctor or pharmacist

that you are taking this medicine

if you are about to be started on

any new medicines.

Things you must not do

Do not give your medicine to

anyone else, even if they have the

same condition as you.

Do not use this medicine to treat

any other complaints unless your

doctor tells you to.

Do not stop taking your medicine

or lower the dose without

checking with your doctor.

Things to be careful of

Be careful driving or operating

machinery until you know how

RESOTRANS affects you.

RESOTRANS has been associated

with dizziness and fatigue

particularly during the first day of

treatment which may have an effect

on driving and using machines.

If you have any of these symptoms,

do not drive, operate machinery or do

anything else that could be

dangerous.

Side Effects

All medicines can have side effects.

Sometimes they are serious, most of

the time they are not. You may need

medical attention if you get some

side effects.

Do not be alarmed by this list of

possible side effects. You may not

experience any of them.

Ask your doctor or pharmacist to

answer any questions you may have.

Tell your doctor if you experience

any of the following and they

worry you:

headache

nausea

weakness

dizziness

fatigue

abnormal bowel sounds

flatulence

general feeling of discomfort or

uneasiness (malaise)

Tell your doctor as soon as possible

if you have any of the following as

you may need medical attention:

anorexia

fever

diarrhoea

vomiting

disturbed digestion (dyspepsia)

increase in frequency of passing

urine (pollakiuria)

abdominal pain

Tell your doctor immediately if

you notice any of the following:

tremors

pounding heart

rectal bleeding.

Other side effects not listed above

may also occur in some people. Tell

your doctor if you notice any other

effects.

After using

RESOTRANS

Storage

Keep your tablets in their blister pack

until it is time to take them.

If you take the tablet out of the blister

pack, they may not keep well.

Keep RESOTRANS in a cool dry

place where the temperature stays

below 30°C. Do not store this

medicine or any other medicines in a

bathroom or near a sink. Do not leave

it in the car or on window sills.

Heat and dampness can destroy some

medicines.

Keep this medicine where children

cannot reach it.

A locked cupboard at least one-and-

a-half metres above the ground is a

good place to store medicines.

Disposal

If your doctor tells you to stop taking

RESOTRANS or the tablets have

passed their expiry date, ask your

pharmacist what to do with any

tablets that are left over.

Product Description

What it looks like

RESOTRANS 1 mg tablets are white

to off-white, round, biconvex tablets

marked PRU 1 on one side.

RESOTRANS 2 mg tablets are pink,

round, biconvex shaped tablets

marked PRU 2 on one side.

Ingredients

The active ingredient in

RESOTRANS tablets is prucalopride

succinate. The 1 mg tablet contains 1

mg of prucalopride and the 2 mg

tablet contains 2 mg of prucalopride

in pack sizes of 7 and 28 enteric

coated tablets.

The other ingredients in the 1 mg

tablet are lactose, cellulose -

microcrystalline, magnesium

stearate, silica - colloidal anhydrous,

hypromellose, titanium dioxide,

macrogol 3000 and glycerol

triacetate.

The other ingredients in the 2 mg

tablet are lactose , cellulose -

microcrystalline, magnesium

stearate, silica - colloidal anhydrous,

hypromellose, titanium dioxide,

macrogol 3000, glycerol triacetate,

iron oxide red, iron oxide yellow and

indigo carmine CI73015.

Sponsor

JANSSEN-CILAG Pty Ltd

1-5 Khartoum Rd

Macquarie Park NSW 2113 Australia

Telephone: 1800 226 334

RESOTRANS

This leaflet was prepared in January

2015.

TGA registration number:

1mg tablet - AUST R 176747

2mg tablet - AUST R 176746

RESOTRANS

is a registered

trademark of Ortho-McNeil-Janssen

Pharmaceuticals, Inc. for

prucalopride oral tablets.