SEVELAMER

Main information

  • Trade name:
  • SEVELAMER CARBONATE WINTHROP sevelamer carbonate 2.4 g powder for oral suspension sachet
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • SEVELAMER CARBONATE WINTHROP sevelamer carbonate 2.4 g powder for oral suspension sachet
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 220887
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

220887

SEVELAMER CARBONATE WINTHROP sevelamer carbonate 2.4 g powder for oral suspension sachet

ARTG entry for

Medicine Registered

Sponsor

Sanofi-Aventis Australia Pty Ltd

Postal Address

Locked Bag 2227,NORTH RYDE BC, NSW, 1670

Australia

ARTG Start Date

20/04/2015

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. SEVELAMER CARBONATE WINTHROP sevelamer carbonate 2.4 g powder for oral suspension sachet

Product Type

Single Medicine Product

Effective date

4/09/2017

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

SEVELAMER CARBONATE WINTHROP is indicated for the management of hyperphosphataemia in adult patients with stage 4 and 5 chronic kidney

disease.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Sachet

Other composite

material

3 Years

Store below 25

degrees Celsius

Child resistant closure

Protect from Moisture

Do not Refrigerate

Pack Size/Poison information

Pack Size

Poison Schedule

(S4) Prescription Only Medicine

(S4) Prescription Only Medicine

(S4) Prescription Only Medicine

Components

1. SEVELAMER CARBONATE WINTHROP sevelamer carbonate 2.4 g powder for oral suspension sachet

Dosage Form

Suspension, powder for

Route of Administration

Oral

Visual Identification

pale yellow powder free from foreign particles

Active Ingredients

sevelamer carbonate

2400 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 23.11.2017 at 08:24:24 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

SEVELAMER CARBONATE WINTHROP

Sevelamer Carbonate

Winthrop

Sevelamer carbonate

Consumer Medicine Information

What is in this leaflet

This leaflet answers some common

questions about Sevelamer Carbonate

Winthrop.

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 Sevelamer

Carbonate Winthrop 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

. You may need to

read it again.

What Sevelamer

Carbonate Winthrop is

used for

Sevelamer Carbonate Winthrop

contains the active substance

sevelamer carbonate and is used to

treat hyperphosphatemia, a condition

caused by too much dietary

phosphorus being retained in your

body due to a diseased kidney.

Increased levels of serum phosphorus

can lead to hard deposits in your

body called calcification. These

deposits can stiffen your blood

vessels and make it harder for blood

to be pumped around the body.

Sevelamer Carbonate Winthrop helps

to remove excess phosphorus that has

built up in your body by binding the

phosphorus that is in the food that

you eat.

Your doctor, however, may have

prescribed Sevelamer Carbonate

Winthrop for another purpose.

Ask your doctor if you have any

questions about why it has been

prescribed for you

This medicine is only available with

a doctor's prescription.

Before you take

Sevelamer Carbonate

Winthrop

When you must not take

Sevelamer Carbonate

Winthrop

Do not take Sevelamer Carbonate

Winthrop if you have an allergy to:

any medicine containing

sevelamer carbonate (the active

ingredient)

any of the ingredients listed at

the end of this leaflet

any other similar medicine, such

as sevelamer hydrochloride.

Symptoms that may indicate an

allergic reaction 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

Tell your doctor if you are

experiencing these symptoms.

Do not take Sevelamer Carbonate

Winthrop if you:

have hypophosphatemia, a

condition where you do not have

enough phosphorus in your body

have a bowel obstruction

Sevelamer Carbonate Winthrop

should not be used after the expiry

date (exp) printed on the pack.

you take this medicine after the

expiry date it may have no effect at

all, or worse, an unexpected effect.

Sevelamer Carbonate Winthrop

should not be used if the packaging

is torn or shows signs of

tampering.

Do not give Sevelamer Carbonate

Winthrop to children.

The safety

and efficacy of Sevelamer Carbonate

Winthrop in children under the age of

18 years as not been established.

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 or pharmacist if

you have:

allergies to any other medicines

or substances such as foods,

preservatives or dyes.

swallowing problems

SEVELAMER CARBONATE WINTHROP

severe constipation

problems with movement in

your stomach and bowel

active inflammation of the bowel

undergone major surgery on

your stomach or bowel

you have or have had any other

medical conditions, including a

bowel obstruction or

hypophosphatemia

thyroid problems

If you are pregnant or breast-

feeding, think you may be

pregnant or are planning to have

a baby.

Tell your doctor about any of the

above before you take Sevelamer

Carbonate Winthrop.

Additional Information

Due to either your kidney

condition or your dialysis

treatment you may:

Develop low or high levels of

calcium in your blood. Since

Sevelamer Carbonate Winthrop

does not contain calcium your

doctor might prescribe additional

calcium tablets

Have a low amount of vitamin D

in your blood. Therefore your

doctor may monitor the levels of

vitamin D in your blood and

prescribe additional vitamin D as

necessary. If you do not take

multivitamin supplements you

may also develop low levels of

vitamins A, E, K and folic acid

in your blood and therefore your

doctor may monitor these levels

and prescribe supplemental

vitamins as necessary.

Develop peritonitis (infection of

your abdominal fluid) associated

with your peritoneal dialysis.

This risk can be reduced by

careful adherence to sterile

techniques during bag changes.

You should tell your doctor

immediately if you experience

any new signs or symptoms of

abdominal distress, abdominal

swelling, abdominal tenderness,

constipation, fever, chills,

nausea or vomiting.

Taking other medicines

Tell your doctor or pharmacist if you

are taking, have recently taken, or

might take any other medicines

(including vaccinations), medicines

that you buy without a prescription

from your pharmacy, supermarket or

health food shop.

Some medicines may be affected by

Sevelamer Carbonate Winthrop or

may affect how well Sevelamer

Carbonate Winthrop works. You may

need different amounts of your

medicine, or you may need to take

different medicines. Your doctor will

advise you.

The effects of medicines such as

cyclosporin, mycophenolate mofetil

and tacrolimus (medicines used to

suppress the immune system) may be

reduced by Sevelamer Carbonate

Winthrop. Your doctor will advise

you if you are taking these

medicines.

Sevelamer Carbonate Winthrop

should not be taken at the same time

as ciprofloxacin (an antibiotic).

Thyroid hormone deficiency may

uncommonly be observed in certain

people taking levothyroxine (used to

treat low thyroid hormone levels) and

Sevelamer Carbonate Winthrop.

Therefore your doctor may monitor

the levels of thyroid stimulating

hormone in your blood more closely.

If you are taking medicines for heart

rhythm problems or for epilepsy, you

should consult your doctor before

taking Sevelamer Carbonate

Winthrop.

How to take

Sevelamer Carbonate

Winthrop

How much to take

The recommended starting dose of

Sevelamer Carbonate Winthrop is 2.4

g to 4.8 g per day to be taken over 3

meals.

For tablets, this means one to two

800 mg tablets with each meal three

times a day. For powder this means

up to one full sachet (1.6 g) with

each meal, three times a day.

The dose will depend on your serum

phosphorus level.

Follow all directions given to you

by your doctor or pharmacist

carefully.

These directions may differ from the

information contained in this leaflet.

How to take it

Tablets

Swallow Sevelamer Carbonate

Winthrop tablets whole with a glass

of water. Do not crush, chew or

break into pieces.

If you are having difficulty

swallowing Sevelamer Carbonate

Winthrop tablets, speak to you

doctor. You may be prescribed

Sevelamer Carbonate Winthrop

powder as an alternative.

Powder

The 1.6g powder for oral suspension

should be dispersed in 40 ml of water

per sachet.

The 2.4g powder for oral suspension

should be dispersed in 60 ml of water

per sachet.

The powder isn’t expected to fully

dissolve in water. When dispersed it

creates a cloudy white suspension in

which small particles are visible.

Drink within 30 minutes of being

prepared. It is important to drink all

of the dose and it may be necessary

to rinse the glass with water and

drink this as well to ensure that all of

the powder is swallowed.

How long to take it

Sevelamer Carbonate Winthrop helps

lower your dietary phosphate. It does

not cure your condition. Therefore,

you must continue to take it as

directed by you doctor if you expect

SEVELAMER CARBONATE WINTHROP

to lower your phosphate level and

keep it down. You may have to take

phosphate-lowering medicines for

the rest of your life. If you stop

taking Sevelamer Carbonate

Winthrop, your phosphate levels may

rise again. It is important to keep

taking your medicines even if you

feel well.

Do not stop taking Sevelamer

Carbonate Winthrop. Your doctor

may need to change the dose of your

other medicines if you stop taking

Sevelamer Carbonate Winthrop, so

you should only stop when your

treating physician tells you to.

If you forget to take it

If you miss a dose, do not take an

extra dose to make up for the one you

missed. Take the next dose at the

usual time with your meal.

It is important to take Sevelamer

Carbonate Winthrop as prescribed by

your doctor.

If you take too much

(overdose)

Immediately telephone your

treating physician or Poisons

Information Centre [Australia

telephone 13 11 26; in New

Zealand telephone 0800 POISON

or 0800 764 766], or go to accident

and emergency at your nearest

hospital, if you think that you or

anyone else may have taken too

much Sevelamer Carbonate

Winthrop. Do this even if there

are no signs of discomfort or

poisoning.

You may need urgent

medical attention. Keep telephone

numbers of these places handy.

While you are taking

Sevelamer Carbonate

Winthrop

Things you must do

If you become pregnant while you

are taking Sevelamer Carbonate

Winthrop, tell your doctor.

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.

If you are about to be started on any

new medicine, tell your doctor and

pharmacist that you are taking

Sevelamer Carbonate Winthrop.

Be sure to keep all your doctor's

appointments so your progress can be

checked.

Your doctor will check your progress

and monitor your phosphorus levels

from time to time. This helps to

ensure you are getting the right dose

of Sevelamer Carbonate Winthrop.

Things you must not do

Do not give Sevelamer Carbonate

Winthrop to anyone else, even if they

have the same condition as you.

Do not use Sevelamer Carbonate

Winthrop to treat any other

complaints unless your doctor tells

you to.

Do not stop taking your medicine or

lower the dosage without checking

with your doctor.

Side Effects

Tell your doctor, pharmacist or

nurse as soon as possible if you do

not feel well while you are taking

Sevelamer Carbonate Winthrop.

All medicines can have side effects.

Sometimes they are serious, most of

the time they are not. You may need

medical treatment if you get some of

the side effects.

If any of the following happen after

you have taken Sevelamer

Carbonate Winthrop tell your

doctor or pharmacist:

vomiting

nausea

constipation

diarrhoea

flatulence

indigestion

abdominal pain.

These side effects are usually mild.

Tell your doctor immediately if

you notice any of the following

symptoms:

rash, itching or hives on the skin

severe

constipation

If any of the following happen, tell

your doctor immediately or go to

the Accident and Emergency at

your nearest hospital:

shortness of breath

wheezing or difficulty in

breathing

swelling of the face, lips, tongue

or other parts of the body

Other side effects not listed above

may occur in some patients. Tell

your doctor if you notice anything

making you feel unwell when you

are taking, or soon after you have

finished taking Sevelamer Carbonate

Winthrop.

After using Sevelamer

Carbonate Winthrop

Storage

Keep Sevelamer Carbonate Winthrop

in a cool dry place where the

temperature stays below 25°C. Do

not put Sevelamer Carbonate

Winthrop in the refrigerator. Do not

put it in the bathroom or near the

sink. Do not leave it in the car or on

window sills. Heat and dampness can

destroy some medicines.

Keep Sevelamer Carbonate Winthrop

where young children cannot reach it.

A locked cupboard at least one and a

half meters above the ground is a

good place to store medicines.

SEVELAMER CARBONATE WINTHROP

Disposal

If your doctor tells you to stop taking

Sevelamer Carbonate Winthrop or

your Sevelamer Carbonate Winthrop

tablets or powder have passed their

expiry date, ask your pharmacist

what to do with any tablet or powder

that is left over.

Product description

What Sevelamer Carbonate

Winthrop looks like

Sevelamer Carbonate Winthrop is

available as tablets or powder.

Sevelamer Carbonate Winthrop

tablets are white oval film-coated

tablets imprinted with

‘SEVELAMER CARBONATE

WINTHROP 800’ on one side and

are blank on the other side.

Sevelamer Carbonate Winthrop

powder is pale yellow in colour.

Ingredients

Tablet

Active ingredients:

Sevelamer carbonate

Other ingredients:

Microcrystalline cellulose

Sodium chloride

Zinc stearate

Hypromellose

Diacetylated monoglycerides

Iron oxide black (E172)

Isopropyl alcohol

Propylene glycol

Purified water

Powder

Active ingredients:

Sevelamer carbonate

Other ingredients:

Propylene glycol alginate

Sodium chloride

Sucralose

Iron oxide yellow

Citrus cream flavour (RB26

Genzyme N&A citrus cream

24660)

Supplied by

Sevelamer Carbonate Winthrop is

supplied in Australia by:

sanofi-aventis australia pty ltd

12-24 Talavera Road

Macquarie Park NSW 2113

Sevelamer Carbonate Winthrop is

supplied in New Zealand by:

sanofi-aventis new zealand ltd

56 Cawley St

Ellerslie, Auckland,

New Zealand

Australian registration numbers:

Sevelamer Carbonate Winthrop

800mg tablet, AUSTR 220891

Sevelamer Carbonate Winthrop 1.6g

powder, AUSTR 220894

Sevelamer Carbonate Winthrop 2.4g

powder, AUSTR 220887

This leaflet was prepared on August

2017

sev-carb-winth-ccdsv4-cmiv2-aug17

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