SALOFALK

Main information

  • Trade name:
  • SALOFALK mesalazine 3g modified release granules sachet
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • SALOFALK mesalazine 3g modified release granules sachet
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 214810
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

214810

SALOFALK mesalazine 3g modified release granules sachet

ARTG entry for

Medicine Registered

Sponsor

Orphan Australia Pty Ltd

Postal Address

34-36 Chandos Street,ST LEONARDS, NSW, 2065

Australia

ARTG Start Date

2/07/2014

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. SALOFALK mesalazine 3g modified release granules sachet

Product Type

Single Medicine Product

Effective date

21/09/2017

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

SALOFALK granules are indicated in the treatment of acute ulcerative colitis of mild to moderate severity, and for the maintenance of remission and/or

the long term treatment of ulcerative colitis.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Sachet

Other plastic

laminate/Al

3 Years

Store below 25

degrees Celsius

Not recorded

Protect from Light

Pack Size/Poison information

Pack Size

Poison Schedule

(S4) Prescription Only Medicine

(S4) Prescription Only Medicine

(S4) Prescription Only Medicine

Components

1. SALOFALK mesalazine 3g modified release granules sachet

Dosage Form

Granules, modified release

Route of Administration

Oral

Visual Identification

Greyish white granules

Active Ingredients

Mesalazine

3000 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 26.11.2017 at 09:19:46 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

SALOFALK

(500 mg, 1 g, 1.5 g, 3 g) granules – Consumer Medicine Information

Page 1 of 4

SALOFALK

®

granules

mesalazine

Consumer Medicine Information (CMI)

What is in this

leaflet

This leaflet answers some

common questions about

SALOFALK. It does not

contain all of the available

information. Reading this

leaflet does not take the place

of talking to your doctor or

pharmacist.

All medicines have risks and

benefits. Your doctor has

weighed the possible risks of

taking SALOFALK against the

expected benefits.

Ask your doctor or

pharmacist if you have any

concerns about taking

SALOFALK.

Keep this leaflet with the

medicine.

You may want to read it

again.

What SALOFALK is

used for

SALOFALK granules contain

the active ingredient

mesalazine (5-aminosalicylic

acid), which is used to treat,

and prevent relapse of, mild

to moderate attacks of

ulcerative colitis (inflammation

of the large bowel).

Ask your doctor if you have

any questions about why

SALOFALK granules have

been prescribed for you.

Your doctor may have

prescribed it for another

reason.

SALOFALK is not addictive.

SALOFALK is not expected to

affect your ability to drive a

car or operate machinery.

SALOFALK is only available

on a doctor’s prescription.

Before you take it

When you must not take it

Do not take SALOFALK if:

you are allergic to

mesalazine or aspirin-like

medicines, or any of the

ingredients listed at the

end of this leaflet.

Signs of allergic reactions

may include itchy skin

rash, shortness of breath

and swelling of the face or

tongue.

you suffer from a severe

kidney or liver problem

the expiry date (EXP)

printed on the pack has

passed. If you use this

medicine after the expiry

date has passed, it may

not work as well.

the package is torn or

shows signs of tampering.

Do not give SALOFALK

granules to a child below 6

years of age.

The safety and effectiveness

of SALOFALK in this group

have not been established.

Before you start to take it

Tell your doctor if:

you have any allergies

you are pregnant or

intend to become

pregnant or are

breastfeeding or wish to

breastfeed.

Your doctor will discuss

the risks and benefits of

taking SALOFALK if you

are pregnant or

breastfeeding.

you have or have had

any medical conditions,

especially the following:

lung or breathing

problems such as

asthma

phenylketonuria.

SALOFALK granules

contain aspartame.

If you have not told your

doctor about any of the

above, tell them before you

start to take SALOFALK.

Taking other medicines

Tell your doctor if you are

taking any other medicines,

including any that you buy

without a prescription from

your pharmacy,

supermarket or health food

shop.

SALOFALK may interfere with

the action of the following

types of medicines:

anticoagulants, medicines

used to stop blood clots,

e.g. warfarin.

glucocorticoids, medicines

used to treat inflammation

or swelling, e.g.

prednisolone

sulphonylureas, medicines

used to lower blood sugar

methotrexate, medicine

used to treat some types

of cancer and arthritis

SALOFALK

(500 mg, 1 g, 1.5 g, 3 g) granules – Consumer Medicine Information

Page 2 of 4

probenecid/

sulphinpyrazone,

medicines used to treat

gout

spironolactone/frusemide,

medicines which lower

blood pressure or increase

volume of urine

rifampicin, medicine used

to treat tuberculosis

azathioprine, medicine

used to suppress the

immune system

mercaptopurine or

thioguanine, medicines

used to treat leukaemia

lactulose or similar

preparations, medicines

which can change the

acidity of the content of

the bowels.

You may need to use different

amounts of these medicines,

or you may need to take

different medicines when you

are taking SALOFALK. Your

doctor or pharmacist will

advise you.

How to take it

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

Adults and the elderly:

For acute ulcerative colitis,

take 1.5 g to 3 g SALOFALK

once a day or in 2-3 divided

doses.

For long term treatment of

ulcerative colitis, take 1.5 g

SALOFALK once a day or in

2-3 divided doses.

Children over 6 years old:

The dose of SALOFALK for

your child depends on

disease severity and body

weight. Your doctor will tell

you how much SALOFALK

your child should take.

For acute ulcerative colitis,

the usual dose for a child is

30-50 mg SALOFALK/kg/day

in one single or 2-3 divided

doses.

For long term treatment of

ulcerative colitis, the usual

dose for a child is 15-30 mg

SALOFALK/kg/day in one

single or 2 divided doses.

For some conditions, your

doctor may prescribe a

different dose.

How to take it

1. Tear open the sachet

along the end with the

triangular mark.

2. Pour contents of sachet

onto tongue.

3. Swallow the SALOFALK

granules whole without

chewing or crushing.

4. Drink some water to

wash down the granules.

When to take it

Take SALOFALK the same

time each day.

This will help you remember

when to take SALOFALK.

How long to take it

SALOFALK helps control your

condition but does not cure it.

Therefore, you must continue

to take SALOFALK for as

long as your doctor tells you

If you forget to take it

If you forget to take a dose of

SALOFALK, leave out that

dose completely. Take your

next dose at the normal time

it is due.

Do not take a double dose

to make up for the dose

that you missed.

If you are not sure what to do,

ask your doctor or

pharmacist.

If you have trouble

remembering when to take

SALOFALK, 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 taken too

much SALOFALK granules.

Do this even if there are no

SALOFALK

(500 mg, 1 g, 1.5 g, 3 g) granules – Consumer Medicine Information

Page 3 of 4

signs of discomfort or

poisoning.

Possible symptoms of

overdose may include feeling

sick, vomiting and diarrhoea.

While you are

taking it

Things you must do

Make sure that all of your

doctors and pharmacists

know you are taking

SALOFALK. Remind them if

any new medicines are

about to be started.

Things that you must not

do

Do not take SALOFALK to

treat any complaint other

than that directed by your

doctor.

It may not be safe to use

SALOFALK for another

complaint.

Do not give your medicine

to anyone else, even if they

have the same condition as

you.

It may not be safe for another

person to take SALOFALK.

Do not stop taking your

SALOFALK or change the

dosage without checking

with your doctor.

Side effects

Tell your doctor or

pharmacist as soon as

possible if you do not feel

well while you are taking

SALOFALK.

Like all medicines,

SALOFALK may have some

side effects. Most side effects

are mild and may disappear

without stopping SALOFALK.

However, some may be

serious and need medical

attention.

Mild effects:

Tell your doctor or

pharmacist if you notice

any of the following that are

troublesome or ongoing:

headache

mild stomach pains

excessive gas in the

stomach or bowel

increased number of

bowel motions

nausea (feeling sick)

rash or itchy skin

dizziness

common cold.

More serious effects:

Tell your doctor

immediately if you notice

any of the following:

fever, muscle aches and

pains, painful joints and

chest pain (sometimes

spreading to the neck and

shoulders, and sometimes

fever)

mild skin rash, itching or

hives

numbness or weakness of

the arms and legs

pain in the upper belly

(may be due to

inflammation of the

pancreas)

worsening of ulcerative

colitis.

Stop taking SALOFALK and

contact your doctor or go

to Accident and Emergency

at your nearest hospital if

any of the following

happens:

allergic reaction including

swelling of limbs, face,

lips, mouth or throat which

may cause difficulty

swallowing or breathing.

Other rare events, which have

been reported with

mesalazine, include:

changes in kidney function

and inflammation of the

kidney

changes in blood test

results such as low white

blood cell and/or platelet

counts

changes in liver function

tests

liver disease with nausea,

vomiting, loss of appetite,

feeling generally unwell,

fever, itching, yellowing of

the skin and eyes, and

dark coloured urine

changes relating to your

heart

allergic, inflammatory or

other lung conditions

shortness of breath,

difficulty breathing, cough,

wheezing, chest pain that

worsens when breathing.

As a precaution, your doctor

may have your blood, liver

and kidney tested regularly

during treatment with

SALOFALK.

Tell your doctor if you

notice anything else that is

making you feel unwell.

Other side effects not listed

above may also occur in

some patients.

Do not be alarmed by this

list of possible side effects.

You may not experience any

of them.

After taking it

Storage

Keep SALOFALK granules

in their original package

until it is time to take them.

SALOFALK

(500 mg, 1 g, 1.5 g, 3 g) granules – Consumer Medicine Information

Page 4 of 4

If you take them out of their

packaging, they may not keep

as well.

Keep SALOFALK in a cool

dry place, protected from

light where the temperature

stays below 25

C.

Do not store SALOFALK or

any other medicine in the

bathroom or near a sink. Do

not leave SALOFALK on a

window sill or in the car.

Heat and dampness can

destroy some medicines.

Keep SALOFALK where

children cannot reach them.

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 SALOFALK 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

SALOFALK granules are

greyish-white cylindrical to

round granules. It is available

in 4 different strengths,

500 mg, 1 g, 1.5 g and 3 g.

SALOFALK 500 mg granules

are available in packs of 100

sachets.

SALOFALK 1 g granules are

available in packs of 100

sachets.

SALOFALK 1.5 g granules

are available in packs of 60

sachets.

SALOFALK 3 g granules are

available in packs of 30

sachets.

Ingredients

Each SALOFALK sachet

contains 500 mg, 1 g, 1.5 g or

3 g of the active ingredient,

mesalazine.

They also contain the

following inactive ingredients:

microcrystalline cellulose

hypromellose

anhydrous colloidal silica

methacrylic acid

copolymer

nonoxinol 100

magnesium stearate

simethicone emulsion

(containing sorbic acid,

methylcellulose)

triethyl citrate

talc

carmellose sodium

aspartame

anhydrous citric acid

vanilla custard flavour

75016-31 (containing

propylene glycol)

povidone

titanium dioxide.

Sponsor

SALOFALK granules are

made in Germany by:

Dr. Falk Pharma GmbH

Leinenweberstr. 5

79108 Freiburg

Germany

and are supplied in Australia

Orphan Australia Pty Ltd

(a member of the Aspen

Australia group of companies)

34-36 Chandos Street

St Leonards NSW 2065

SALOFALK granules

Australian Registration

Numbers:

500 mg: AUST R 80648

1 g: AUST R 80649

1.5 g: AUST R 143611

3 g: AUST R 214810.

SALOFALK

is a registered

trademark of Dr. Falk Pharma

GmbH, Germany, used under

licence by Orphan Australia

Pty Ltd.

This leaflet was revised in

July 2014.