PENTASA

Main information

  • Trade name:
  • PENTASA mesalazine 4 g prolonged release granules sachet
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • PENTASA mesalazine 4 g prolonged release granules sachet
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 216259
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

216259

PENTASA mesalazine 4 g prolonged release granules sachet

ARTG entry for

Medicine Registered

Sponsor

Ferring Pharmaceuticals Pty Ltd

Postal Address

PO Box 315,NORTH RYDE BC, NSW, 1670

Australia

ARTG Start Date

14/08/2014

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. PENTASA mesalazine 4 g prolonged release granules sachet

Product Type

Single Medicine Product

Effective date

10/07/2017

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

Treatment of mild to moderate ulcerative colitis and Crohn's disease and maintenance of remission.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Sachet

Al/Al

2 Years

Store below 25

degrees Celsius

Not recorded

Store in Original

Container

Pack Size/Poison information

Pack Size

Poison Schedule

30 sachets

(S4) Prescription Only Medicine

Components

1. PENTASA mesalazine 4 g prolonged release granules sachet

Dosage Form

Granules, modified release

Route of Administration

Oral

Visual Identification

white-grey to pale white-brown cylindrical shaped granules

Active Ingredients

Mesalazine

4 g

© 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 23.11.2017 at 08:30:20 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

PENTASA

(MESALAZINE) SACHETS

PENTASA

®

Sachets

mesalazine

Consumer Medicine Information

What is in this leaflet

This leaflet answers some common

questions about PENTASA.

It does not contain all the available

information. It does not take the

place of talking to your doctor or

pharmacist.

Please read this leaflet before you

start using PENTASA.

All medicines have risks and

benefits. Your doctor has weighed

the risks of you using PENTASA

against the benefits they expect it

will have for you.

If you have any concerns about

using this medicine, ask your

doctor or pharmacist.

Keep this leaflet with the medicine.

You may need to read it again.

What PENTASA is

used for

This medicine is used to treat Crohn's

disease and ulcerative colitis,

diseases associated with

inflammation, ulcers and sores in the

bowel causing bleeding, stomach

pain, and diarrhoea.

The active ingredient in PENTASA

is mesalazine. It is an anti-

inflammatory agent, similar to

aspirin, and is thought to work by

reducing inflammation in the bowel.

Ask your doctor if you have any

questions about why this medicine

has been prescribed for you.

Your doctor may have prescribed it

for another reason.

There is no evidence that PENTASA

is addictive.

It is available only with a doctor's

prescription.

It is not expected to affect your

ability to drive a car or operate

machinery.

Before you take

PENTASA

When you must not take it

Do not take PENTASA if you have

an allergy to:

any medicine containing

mesalazine or aspirin-like

medicines

any of the ingredients listed at

the end of this leaflet.

Some of the symptoms of an allergic

reaction may include:

shortness of breath, wheezing or

difficulty breathing

swelling of the face, lips, tongue

or other parts of the body

rash, itching or hives on the skin.

Do not take PENTASA if you have

a severe kidney or liver problem.

Do not take PENTASA after the

expiry date printed on the pack or

if the packaging is torn or shows

signs of tampering.

If it has expired or is damaged, return

it to your pharmacist for disposal.

Do not give PENTASA to a child

12 years old or under.

The safety and effectiveness of

PENTASA in this age group have not

been established.

Before you start to take it

Tell your doctor if you have

allergies to any other medicines,

foods, preservatives or dyes.

Tell your doctor if you have or

have had any of the following

medical conditions:

a known allergy to PENTASA,

sulfasalazine or aspirin-like

medicines, or any of the

ingredients listed at the end of

this leaflet

a kidney or liver problem

a bleeding disorder

a history of asthma.

Tell your doctor if you are

pregnant or plan to become

pregnant or are breast-feeding.

Your doctor can discuss with you the

risks and benefits involved.

PENTASA should be used with

caution during pregnancy and breast-

feeding and only if the potential

benefits outweigh the possible risks

in the opinion of the doctor. The

underlying condition itself

(inflammatory bowel disease) may

increase risks for the pregnancy

outcome.

If you have not told your doctor

about any of the above, tell

him/her before you start using

PENTASA.

PENTASA

(MESALAZINE) SACHETS

Taking other medicines

Tell your doctor or pharmacist if

you are using any other medicines,

including any that you get without

a prescription from your

pharmacy, supermarket or health

food shop.

There is no information available on

interactions between PENTASA and

other medicines. However,

mesalazine belongs to a group of

medicines called salicylates that may

interfere with the following types of

medicines:

anti-coagulants, used to thin

blood or stop blood clots (e.g.

warfarin)

glucocorticoids, used to treat

inflammation, swelling or

allergies (e.g. prednisolone)

sulphonylureas, used to lower

blood sugar and treat diabetes

(e.g. glibenclamide, glipizide)

methotrexate, used to treat some

kinds of cancers and arthritis

probenicid or sulfinpyrazone,

used to treat gout

spirinolactone or frusemide, used

to increase the amount of urine

produced, and to lower blood

pressure

rifampicin, used to treat

tuberculosis

azathioprine, used to suppress the

immune system

mercaptopurine and thioguanine,

used to treat leukaemia.

Ask your doctor or pharmacist if you

are unsure about taking any of these

medicines.

Your doctor and pharmacist have

more information on medicines to be

careful with or avoid while taking

this medicine.

How to take PENTASA

Follow all directions given to you

by your doctor or pharmacist

carefully.

They may differ from the

information contained in this leaflet.

If you do not understand the

instructions on the packaging, ask

your doctor or pharmacist for

help.

How much to take

Adults:

Ulcerative Colitis

For active ulcerative colitis, take up

to 4 g PENTASA once a day or in

divided doses.

For long term treatment of ulcerative

colitis, take 2 g PENTASA once a

day or in divided doses.

Crohn's Disease

For active Crohn's disease, take up to

4 g PENTASA daily in divided

doses.

For long term treatment of Crohn's

disease, take up to 4 g PENTASA

daily in divided doses.

For some conditions, your doctor

may prescribe a different dose.

How to take it

Tear or cut to open the sachet along

the dotted line.

Empty the contents (granules) of the

sachet onto the tongue and wash

down with water or juice.

Swallow the PENTASA granules

whole without chewing or crushing.

When to take it

Take your medicine the same time

each day. This will help you

remember when to take it.

You can take PENTASA with or

without food.

How long to take it

Continue using your medicine for

as long as your doctor tells you.

This medicine helps to control your

condition, but does not cure it. It is

important to keep using your

medicine even if you feel well.

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 PENTASA as you would

normally.

If you are not sure what to do, ask

your doctor or pharmacist.

If you have trouble remembering to

take PENTASA, ask your pharmacist

for some hints.

If you take too much

(overdose)

Immediately telephone your doctor

or the Poisons Information Centre

(telephone 13 11 26) for advice, or

go to Accident and Emergency at

the nearest hospital, if you think

that you or anyone else may have

used too much PENTASA. Do this

even if there are no signs of

discomfort or poisoning.

You may need urgent medical

attention.

While you are taking

PENTASA

Things you must do

If you are about to be started on

any new medicine, remind your

doctor and pharmacist that you

are taking PENTASA.

Have all blood tests recommended

by your doctor.

PENTASA may cause kidney, liver

or blood problems in a few people.

You should have regular blood tests

to check your kidney function.

Tell any other doctors, dentists,

and pharmacists who treat you

that you are using this medicine.

If you are going to have surgery,

tell the surgeon or anaesthetist that

you are using this medicine.

PENTASA

(MESALAZINE) SACHETS

It may affect other medicines used

during surgery.

If you become pregnant while

using this medicine, tell your

doctor immediately.

Things you must not do

Do not take PENTASA to treat any

other complaints unless your

doctor tells you to.

Do not give your medicine to

anyone else, even if they have the

same condition as you.

Do not stop using your medicine or

lower the dosage without checking

with your doctor.

If you stop taking it suddenly, your

condition may worsen.

Side effects

Tell your doctor or pharmacist as

soon as possible if you do not feel

well while you are taking

PENTASA.

This medicine helps most people but

it may have unwanted side effects in

a few people. All medicines can

have side effects. Sometimes they are

serious, most of the time they are not.

You may need medical attention if

you experience some of the side

effects.

Do not be alarmed by the following

lists of side effects. You may not

experience any of them.

Ask your doctor or pharmacist to

answer any questions you may

have.

Tell your doctor or pharmacist if

you notice any of the following and

they worry you:

headache

diarrhoea

abdominal or stomach pain

flatulence (stomach discomfort or

fullness, relieved by passing

wind)

nausea (feeling sick)

vomiting,

mild skin rash.

The above list includes the more

common side effects of your

medicine (affecting between 1 in 10

and 1 in 100 patients). They are

usually mild and short-lived.

Tell your doctor as soon as possible

if you notice any of the following:

dizziness

bruising easily, unusual bleeding

(e.g. nosebleeds), signs of

infection such as fever, chills,

sore throat and mouth ulcers

muscle aches and pains

painful or swollen joints

severe upper stomach pain,

nausea and vomiting

changes in kidney

function/kidney disease, and or

urine discolouration

numbness, tingling or weakness

of the arms and legs

yellowing of the skin or eyes,

dark coloured urine

hair loss (this is reversible)

worsening of your condition.

The above list includes serious side

effects which may require medical

attention. Serious side effects are

usually rare or very rare (affecting

less than 1 in 1,000 patients).

If you notice any of the following,

tell your doctor immediately or go

to Accident and Emergency at

your nearest hospital:

sudden signs of allergic reactions

such as rash, itching or hives,

shortness of breath, wheezing,

coughing, or swelling of limbs,

face, lips, mouth, tongue or throat

which may cause difficulty

swallowing or breathing

severe stomach cramps and/or

pain, bloody diarrhoea, fever,

severe headache and skin rash

rash with severe blisters and

bleeding of the eyes, mouth, lips,

nose and genitals e.g. erythema

multiforme or Stevens-Johnson

Syndrome (SJS)

lupus erythematosus-like

reactions (a disease affecting the

skin, joints and kidneys with

symptoms such as joint pain,

fever and skin rash)

chest pain and/or pain behind the

breast bone sometimes spreading

to the neck and shoulders, or with

fever.

The above list includes very serious

side effects, which may need urgent

medical attention or hospitalisation.

These side effects are usually rare or

very rare (affecting less than 1 in

1,000 patients).

Other very rare side effects that

have been reported with

PENTASA include:

changes in kidney function

changes in liver function e.g.

raised liver enzymes

changes in the blood e.g. a

decrease in the number of

red/white blood cells, and/or

platelets

low sperm count (this is

reversible).

As a precaution, your doctor may do

blood tests to check if there are any

changes in your blood, kidney or

liver function.

Very rare side effects occur in less

than 1 in 10,000 patients.

Other side effects not listed above

may also occur in some people.

Tell your doctor or pharmacist if

you notice anything that is making

you feel unwell.

After taking PENTASA

Storage

Keep your PENTASA in the

packaging until it is time to take

your next dose.

If you take PENTASA out of the

packaging it may not keep well.

PENTASA

(MESALAZINE) SACHETS

Keep your PENTASA in a cool dry

place where the temperature stays

below 25°C.

Do not store PENTASA or any

other medicine in the bathroom or

near a sink. Do not leave it on a

window sill or in the car.

Heat and dampness can damage

some medicines.

Keep PENTASA 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 PENTASA or the expiry

date has passed, ask your

pharmacist what to do with any

granules that are left over.

Product description

What it looks like

PENTASA Sachets contain short and

cylindrical (or tube) shaped granules

that are white-grey to pale white

brown in colour.

PENTASA 1 g Sachets are supplied

in packs of 30 and 120.

PENTASA 2 g Sachets are supplied

in packs of 15 and 60.

PENTASA 4 g Sachets are supplied

in packs of 8 and 30.

Not all pack sizes are being

distributed in Australia.

Ingredients

PENTASA Sachets contain 1 g , 2 g

or 4 g of mesalazine as the active

ingredient, as well as the following

inactive ingredients:

ethylcellulose

povidone.

This medicine does not contain

sucrose, gluten, tartrazine or any

other azo dyes.

Sponsor

PENTASA Sachets are supplied in

Australia by:

Ferring Pharmaceuticals Pty Ltd

Suite 2, Level 1, Building 1

20 Bridge Street

Pymble, NSW 2073, Australia

AUST R 161063 - PENTASA

mesalazine 1 g prolonged release

granules sachet

AUST R 161064 - PENTASA

mesalazine 2 g prolonged release

granules sachet

AUST R 216259 - PENTASA

mesalazine 4 g prolonged release

granules sachet

This leaflet was prepared in

September 2016.

#14662-v13A

PENTASA

is a registered trade

mark of Ferring B.V.

® = Registered trade mark

By scanning the QR code with your

smart phone or tablet, you can access

a video on how to administer

PENTASA

Sachets. Alternative

access via www.myibd.com.au

Access available only within

Australia.