VELPHORO

Main information

  • Trade name:
  • VELPHORO sucroferric oxyhydroxide 2500 mg (equivalent to iron 500 mg) chewable tablet blister
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • VELPHORO sucroferric oxyhydroxide 2500 mg (equivalent to iron 500 mg) chewable tablet blister
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 216701
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

216701

VELPHORO sucroferric oxyhydroxide 2500 mg (equivalent to iron 500 mg) chewable tablet blister

ARTG entry for

Medicine Registered

Sponsor

Fresenius Medical Care Australia Pty Ltd

Postal Address

Level 17 / 61 Lavender Street,MILSONS POINT, NSW, 2061

Australia

ARTG Start Date

27/11/2014

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. VELPHORO sucroferric oxyhydroxide 2500 mg (equivalent to iron 500 mg) chewable tablet blister

Product Type

Single Medicine Product

Effective date

7/02/2017

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

Velphoro is indicated for the control of serum phosphorus levels in adult patients with chronic kidney disease (CKD) on dialysis.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Blister Pack

Al/Al

36 Months

Store below 30

degrees Celsius

Not recorded

Protect from Moisture

Pack Size/Poison information

Pack Size

Poison Schedule

(S4) Prescription Only Medicine

30 (as both sale and starter packs)

(S4) Prescription Only Medicine

Components

1. VELPHORO sucroferric oxyhydroxide 2500 mg (equivalent to iron 500 mg) chewable tablet blister

Dosage Form

Tablet, chewable

Route of Administration

Oral

Visual Identification

VELPHORO chewable tablets are brown, round, flat faced tablets

embossed with PA500 on one side.

Active Ingredients

sucroferric oxyhydroxide

2500 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 07:16:53 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

VELPHORO

®

500 mg chewable tablets

sucroferric oxyhydroxide (500 mg iron)

Consumer Medicine Information

WHAT IS IN THIS

LEAFLET

This leaflet answers some

common questions about

VELPHORO.

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

this medicine against the

benefits they expect it will have

for you.

If you have any concerns

about taking this medicine,

ask your doctor or

pharmacist.

Keep this leaflet.

You may need to read it again.

WHAT VELPHORO IS

USED FOR

VELPHORO is used to control

the phosphorus levels in the

blood of patients with chronic

kidney disease (CKD) on

dialysis.

It contains 2.5 g of the active

substance sucroferric

oxyhydroxide which

corresponds to 500 mg iron.

This medicine belongs to a

group of drugs used when the

levels of phosphorus in blood

are too high (a condition called

hyperphosphataemia).

The active ingredient works by

binding phosphate from food in

the digestive tract. This reduces

how much is absorbed and the

levels of phosphorus in the

blood.

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.

BEFORE YOU TAKE

VELPHORO

When you must not take it

Do not take this medicine if

you have an allergy to:

the active substance

sucroferric oxyhydroxide, or

to any of the other

ingredient(s) listed at the end

of this leaflet

any other similar medicines

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 this medicine if

you have too much iron in

your body

(haemochromatosis) or any

other problems with the iron

levels in your body.

Do not take this medicine after

the expiry date printed on the

pack or 45 days after opening

(whichever is earlier) 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.

If you are not sure whether

you should start taking this

medicine, talk to your doctor.

Before you start to take it

Tell your doctor if you have

allergies to any other

medicines, foods, preservatives

or dyes.

Tell your doctor or pharmacist

before taking VELPHORO if

you have:

inflammation of the thin

tissue (serous membrane)

that lines the inner wall of

the abdomen (peritonitis),

significant stomach and/or

liver disorders,

had major surgery on your

stomach and/or intestines,

a history of abnormal iron

accumulation in your bodily

organs (haemochromatosis)

or other iron disorders

an intolerance to some

sugars

Tell your doctor if you are

pregnant or plan to become

pregnant or are breastfeeding.

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Your doctor will discuss with

you the risks and benefits

involved.

If you have not told your

doctor about any of the above,

tell him/her before you start

taking VELPHORO.

Taking other medicines

Tell your doctor or pharmacist

if you are taking any other

medicines, including any that

you get without a prescription

from your pharmacy,

supermarket or health food

shop.

Some medicines and

VELPHORO may interfere with

each other. These include:

alendronate (a medicine used

to treat or prevent

osteoporosis)

doxycycline (antibiotics to

treat infections)

levothyroxine (a medicine

used to treat thyroid

problems)

These medicines may be

affected by VELPHORO or may

affect how well it works. You

may need different amounts of

your medicines. It is

recommended that these drugs

should be administrated at least

1 hour before or at least 2 hours

after intake of Velphoro.

Your doctor and pharmacist

have more information on

medicines to be careful with or

avoid while taking this

medicine.

HOW TO TAKE

VELPHORO

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, ask your doctor

or pharmacist for help.

How much to take

The standard dose for this

medicine is one tablet three

times a day.

The usual recommended starting

dose is 1,500 mg per day (1

tablet, 3 times a day).

The maximum recommended

dose is 3,000 mg (2 tablets, 3

times a day).

Your doctor may adjust the dose

during the treatment course

depending on the phosphorus

level in your blood.

Your doctor may have

prescribed a different dose.

Ask your doctor or pharmacist

if you are unsure of the correct

dose for you.

They will tell you exactly how

much to take.

Follow the instructions they

give you.

If you take the wrong dose,

VELPHORO may not work as

well and your problem may not

improve.

How to take it

VELPHORO chewable tablets

should only be taken by

mouth.

Take the tablet during a meal

and chew it. DO NOT swallow

it whole.

If necessary, the tablet may be

crushed to make this easier for

you.

The amount of tablets taken per

day should be divided across the

three largest meals of the day.

No additional fluid above the

amount usually taken due to

your kidney disease is required.

Additional information for the

blister pack:

Separate the blister pack at

perforations.

Peel back the paper foil at

the corner.

Push the tablet through the

aluminium foil.

When to take VELPHORO

Take your medicine at about

the same time each day.

Taking it at the same time each

day will have the best effect. It

will also help you remember

when to take it.

Take your medicine during or

immediately after a meal, at

about the same time each day.

If you take it on an empty

stomach, it may cause stomach

upset.

How long to take

VELPHORO

Continue taking 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 taking

your medicine even if you feel

well.

If you forget to take it

Skip the dose you missed and

take your next dose when you

are meant to.

Do not take a double dose to

make up for the dose that you

missed.

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This may increase the chance of

you getting an unwanted side

effect.

If you are not sure what to do,

ask your doctor or pharmacist.

If you have trouble remembering

to take your medicine, ask your

pharmacist for some hints.

If you take too much

(overdose)

Immediately telephone your

doctor or the Poisons

Information Centre (telephone

Australia 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 VELPHORO. Do

this even if there are no signs

of discomfort or poisoning.

You may need urgent medical

attention.

WHILE YOU ARE

TAKING VELPHORO

Things you must do

If you are about to be started

on any new medicine, remind

your doctor and pharmacist

that you are taking

VELPHORO.

Tell any other doctors, dentists

and pharmacists who treat you

that you are taking this

medicine.

If you become pregnant while

taking this medicine, tell your

doctor immediately.

Keep all of your doctor’s

appointments so that your

progress can be checked.

Your doctor may do some tests

from time to time to make sure

the medicine is working and to

prevent unwanted side effects.

Things you must not do

Do not take VELPHORO 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 taking your

medicine or lower the dosage

without checking with your

doctor or pharmacist.

If you stop taking it suddenly,

your condition may worsen.

Things to be careful of

Be careful driving or

operating machinery until you

know how VELPHORO

affects you.

It is unlikely that this medicine

will affect your ability to drive

or to operate tools or machines.

Ask your doctor if you are not

sure.

SIDE EFFECTS

Tell your doctor or pharmacist

as soon as possible if you do

not feel well while you are

taking VELPHORO.

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 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.

Like all medicines, this

medicine can cause side effects,

although not everybody gets

them.

The following side effects have

been reported in patients taking

VELPHORO:

Very common

(may affect more

than 1 in 10 people):

diarrhoea,

discoloured faeces*.

Common (may affect up to 1 in

10 people): nausea, constipation,

vomiting, indigestion,

abdominal pain, flatulence,

discolouration of teeth and/or

tongue.

Uncommon (may affect up to 1

in 100 people): abdominal

distension (bloating), gastritis,

abdominal discomfort, difficulty

swallowing, gastro-oesophageal

reflux disorder (GORD), fatigue,

itching skin, rash, headache,

shortness of breath.

*As is often seen with oral iron

preparations, discoloured (black)

stools may occur very

commonly in patients taking

VELPHORO

. This may

visually hide gastrointestinal

bleeding. If you also have

symptoms like increasing

fatigue and breathlessness

contact your doctor

immediately.

If you get any side effects, talk

to your doctor or pharmacist.

This includes any possible side

effects not listed in this leaflet.

Tell your doctor or pharmacist

if you notice anything else that

is making you feel unwell.

Other side effects not listed

above may also occur in some

people.

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AFTER TAKING

VELPHORO

Storage

Keep your medicine in the

original container.

If you take it out of its original

container it may not keep well.

Keep your medicine in a cool

dry place where the

temperature stays below 30°C.

Do not store VELPHORO 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 destroy

some medicines.

Keep it 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 this medicine or the

expiry date has passed, ask

your pharmacist what to do

with any medicine that is left

over.

PRODUCT

DESCRIPTION

What it looks like

VELPHORO chewable tablets

are brown, circular, bi-planar

tablets embossed with PA500 on

one side.

The tablets are packed in high

density polyethylene bottles

with a child resistant

polypropylene cap and a foil

induction seal, or in child

resistant aluminium blister

packs.

VELPHORO is available in

packs containing 30 or 90

chewable tablets.

Ingredients

Active ingredients:

2.5 g sucroferric

oxyhydroxide (equivalent to

500 mg iron)

The active ingredient sucroferric

oxyhydroxide contains 750 mg

sucrose and 700 mg starches.

Inactive ingredients:

woodberry flavour

neohesperidin

dihydrochalcone

magnesium stearate

silica (colloidal, anhydrous)

Sponsor

Fresenius Medical Care

Australia Pty Ltd

Level 17/61 Lavender Street

Milsons Point NSW 2061

Australia

Telephone:

1800 481 392.

Australian Registration Number:

AUST R 216701

AUST R 216702

This leaflet was prepared in June

2015.

Fresenius Medical Care Australia Pty Ltd

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22-10-2018

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