RENVELA

Main information

  • Trade name:
  • RENVELA sevelamer carbonate 800 mg tablet bottle
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • RENVELA sevelamer carbonate 800 mg tablet bottle
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 220892
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

220892

RENVELA sevelamer carbonate 800 mg tablet bottle

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. RENVELA sevelamer carbonate 800 mg tablet bottle

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

Renvela 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

Bottle

HDPE

3 Years

Store below 25

degrees Celsius

Child resistant closure

Do not Refrigerate

Protect from Moisture

Keep Container

Tightly Closed/Airtight

Pack Size/Poison information

Pack Size

Poison Schedule

(S4) Prescription Only Medicine

(S4) Prescription Only Medicine

(S4) Prescription Only Medicine

Components

1. RENVELA sevelamer carbonate 800 mg tablet bottle

Dosage Form

Tablet, film coated

Route of Administration

Oral

Visual Identification

white oval film-coated tablets imprinted with RENVELA 800 on one side

and are blank on the other side

Active Ingredients

sevelamer carbonate

800 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 01:53:06 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

RENVELA

Renvela

Sevelamer carbonate

Consumer Medicine Information

What is in this leaflet

This leaflet answers some common

questions about Renvela.

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 Renvela

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 Renvela is used

for

Renvela 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.

Renvela 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 Renvela 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

Renvela

When you must not take

Renvela

Do not take Renvela 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 Renvela if you :

have hypophosphatemia, a

condition where you do not have

enough phosphorus in your body

have a bowel obstruction

Renvela should not be used after

the expiry date (exp) printed on the

pack.

If you take this medicine after

the expiry date it may have no effect

at all, or worse, an unexpected effect.

Renvela should not be used if the

packaging is torn or shows signs of

tampering.

Do not give Renvela to children.

The safety and efficacy of Renvela 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

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

RENVELA

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 Renvela.

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

Renvela 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

Renvela or may affect how well

Renvela 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 Renvela. Your doctor will

advise you if you are taking these

medicines.

Renvela 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

Renvela. 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 Renvela.

How to take Renvela

How much to take

The recommended starting dose of

Renvela 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 Renvela tablets whole with

a glass of water. Do not crush, chew

or break into pieces.

If you are having difficulty

swallowing Renvela tablets, speak to

you doctor. You may be prescribed

Renvela 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

Renvela 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 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 Renvela,

your phosphate levels may rise again.

It is important to keep taking your

medicines even if you feel well.

Do not stop taking Renvela. Your

doctor may need to change the dose

of your other medicines if you stop

taking Renvela, 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 Renvela as

prescribed by your doctor.

RENVELA

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 Renvela. 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

Renvela

Things you must do

If you become pregnant while you

are taking Renvela, 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

Renvela.

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 Renvela.

Things you must not do

Do not give Renvela to anyone else,

even if they have the same condition

as you.

Do not use Renvela 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

Renvela.

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 Renvela 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 Renvela.

After using Renvela

Storage

Keep Renvela in a cool dry place

where the temperature stays below

25°C. Do not put Renvela 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 Renvela 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.

Disposal

If your doctor tells you to stop taking

Renvela or your Renvela 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 Renvela looks like

Renvela is available as tablets or

powder.

Renvela tablets are white oval film-

coated tablets imprinted with

‘RENVELA 800’ on one side and are

blank on the other side.

Renvela 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

RENVELA

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

Renvela is supplied in Australia by:

sanofi-aventis australia pty ltd

12-24 Talavera Road

Macquarie Park NSW 2113

Renvela is supplied in New Zealand

sanofi-aventis new zealand ltd

56 Cawley St

Ellerslie, Auckland,

New Zealand

Australian registration numbers:

Renvela 800mg tablet, AUSTR

220892

Renvela 1.6g powder, AUSTR

220889

Renvela 2.4g powder, AUSTR

220890

This leaflet was prepared on August

2017

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