AURO-RISEDRONATE 30 risedronate sodium 30mg tablet blister pack

Main information

  • Trade name:
  • AURO-RISEDRONATE 30 risedronate sodium 30mg tablet blister pack
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • AURO-RISEDRONATE 30 risedronate sodium 30mg tablet blister pack
    Australia
  • Language:
  • English

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization status:
  • Registered
  • Authorization number:
  • 190156
  • Last update:
  • 21-05-2019

Public Assessment Report

Public Summary

Summary for ARTG Entry:

190156

AURO-RISEDRONATE 30 risedronate sodium 30mg tablet blister pack

ARTG entry for

Medicine Registered

Sponsor

Aurobindo Pharma Australia Pty Ltd

Postal Address

5 / 148 Spit Road,Mosman, NSW, 2088

Australia

ARTG Start Date

4/10/2012

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. AURO-RISEDRONATE 30 risedronate sodium 30mg tablet blister pack

Product Type

Single Medicine Product

Effective date

27/06/2014

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

Treatment of PagetÆs disease of bone

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Blister Pack

PVC/PE/PVDC/Al

2 Years

Store below 25

degrees Celsius

Not recorded

Not recorded

Pack Size/Poison information

Pack Size

Poison Schedule

(S4) Prescription Only Medicine

(S4) Prescription Only Medicine

Components

1. AURO-RISEDRONATE 30 risedronate sodium 30mg tablet blister pack

Dosage Form

Tablet, film coated

Route of Administration

Oral

Visual Identification

White to off-white coloured, circular shaped film coated biconvex tablets

debossed with 'L' on one side and '30' on the other side

Active Ingredients

Risedronate sodium hemipentahydrate

34.43 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 28.11.2017 at 11:35:35 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: composition, indications, side effects, dosage, interactions, adverse reactions, pregnancy, lactation

AURO-RISEDRONATE

CONSUMER MEDICINE INFORMATION

Ver 1.1

Page 1 of 4

AURO-RISEDRONATE 5, 30 & 35

Risedronate Sodium (as hemipentahydrate)

Consumer Medicine Information

What is in this leaflet

This

leaflet

answers some

common

questions

about

AURO-

RISEDRONATE.

It does not contain all the available

information. It does not take the place

talking

your

doctor

pharmacist.

All medicines have risks and benefits.

Your doctor has weighed the risks of

taking

AURO-RISEDRONATE

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 with the medicine.

You may need to read it again.

What

AURO-RISEDRONATE is

used for

AURO-RISEDRONATE

used

treat bone disease and belongs to a

group

medicines

called

bisphosphonates.

AURO-RISEDRONATE

works

directly on your bones to make them

stronger and therefore less likely to

break or fracture.

AURO-RISEDRONATE 5mg daily &

35mg Once-a- Week tablets are used

to treat:

osteoporosis (brittle or fragile

bones that may fracture easily)

osteoporosis caused by taking

steroids

AURO-RISEDRONATE

30mg

tablets are used to treat:

Paget's disease of the bone.

These

conditions

caused

changes in the way bone is normally

maintained.

Understanding bone

Bone is a living tissue consisting of

calcium

other

minerals.

Throughout

life,

bone

constantly broken down and replaced

with new bone. After the age of 35,

bone loss may occur faster than your

body can replace it. If you lose too

much bone then they become weaker

and are more likely to break.

Osteoporosis

Osteoporosis (brittle bone disease) is

a disease that causes bones to become

weaker. Weak bones break (fracture)

easily.

Many patients with osteoporosis have

no symptoms and may not even know

that they have osteoporosis. However

osteoporosis makes you more likely to

break bones when you have a fall or

bump. The spine, hip and wrist are the

most likely bones to break, although

this can happen to any bone in your

body.

Osteoporosis

also

cause

back pain, height loss and a curved

back.

Osteoporosis

common

women

after the menopause (change of life)

and is also more likely to occur in

women

have

reached

menopause

early.

Osteoporosis

also occur in women who have not yet

reached menopause, and in men.

Long term steroid treatment can also

lead to osteoporosis in both men and

women.

AURO-RISEDRONATE

works

slowing down the process of old bone

being removed.

This

allows

bone-forming

cells

time to rebuild normal bone.

AURO-RISEDRONATE also helps to

rebuild

bone

mass.

This

creates

stronger bone which is less likely to

fracture.

Therefore

AURO-

RISEDRONATE can help reverse the

progression of osteoporosis.

Paget's disease of the bone

Paget's

disease

occurs

when

process of bone remodelling happens

too quickly and in a disordered way.

bone

that

produced

weaker than normal and the affected

bones

become

enlarged,

deformed, painful and may fracture.

The skull, spine, legs, collar bone and

pelvic bone are the most commonly

affected.

Do

not

give

AURO-

RISEDRONATE

to

children

or

adolescents under 18 years of age.

There

have

been

studies

effects in this age group.

There

evidence

that

AURO-

RISEDRONATE is addictive.

This medicine is available only with a

doctor's prescription.

Before you take

AURO-RISEDRONATE

When you must not take

AURO-RISEDRONATE

Do

not

take

AURO-

RISEDRONATE if:

have

allergy

AURO-

RISEDRONATE

ingredients listed at the end of this

leaflet

unable

stand

upright for at least 30 minutes

have

condition

called

hypocalcaemia

level

calcium in the blood)

Do

not

take

AURO-

RISEDRONATE

if

you

are

pregnant.

AURO-RISEDRONATE

recommended

during

pregnancy,

unless

your

doctor have discussed the risks and

benefits involved.

AURO-RISEDRONATE

CONSUMER MEDICINE INFORMATION

Ver 1.1

Page 2 of 4

Do

not

take

AURO-

RISEDRONATE

if

you

are

breastfeeding.

known

whether

AURO-

RISEDRONATE

passes

into

breast

milk.

Do

not

take

AURO-

RISEDRONATE

after

the

expiry

date printed on the pack.

If you take this medicine after the

expiry date has passed, it may not

work as well.

Do

not

take

AURO-

RISEDRONATE if the packaging is

torn or shows signs of tampering.

Talk to your doctor or pharmacist

if

you

are

not

sure

whether

you

should

start

taking

AURO-

RISEDRONATE.

Before you start to take it

Tell your doctor or pharmacist if

you have allergies to:

any other medicines

any other substances, such as

foods, preservatives or dyes

Tell your doctor if you are pregnant

or intend to become pregnant.

Your doctor will discuss the possible

risks and benefits of using AURO-

RISEDRONATE during pregnancy.

Tell your doctor or pharmacist if

you

are

breastfeeding

or

plan

to

breastfeed.

Tell your doctor if you have or have

had

any

medical

conditions,

especially the following:

disturbances of bone and mineral

metabolism (for example vitamin D

deficiency,

parathyroid

hormone

abnormalities)

problems with the tube that takes

food

from

your

mouth

your

stomach

(oesophagus)

such

ulcers

Check with your doctor or dentist

to

see

if

a

dental

check-up

is

required

before

starting

AURO-

RISEDRONATE.

This is especially important if you are

receiving medicines or therapy used

treat

cancer

taking

corticosteroids, such as prednisone or

cortisone.

Tell your doctor about any of the

above,

before

you

start

taking

AURO-RISEDRONATE.

Taking other medicines

Tell your doctor or pharmacist if

you are taking any other medicines,

including any that you buy without

prescription from your pharmacy,

supermarket or health food shop.

Some

medicines

AURO-

RISEDRONATE may interfere with

each other if taken at the same time.

These include:

Antacids, medicines used to treat

indigestion eg Gaviscon, Mylanta

Other products containing

Calcium

Iron supplements

Check

with

your

doctor

or

pharmacist

if

you

are

not

sure

whether you are taking any of these

products.

You may need to stop taking these

products or take them at a different

time

AURO-

RISEDRONATE.

You can take aspirin while you are

being

treated

with

AURO-

RISEDRONATE.

Your doctor and pharmacist may have

more information on medicines to be

careful

with

while

taking

AURO-

RISEDRONATE.

How

to

take

AURO-

RISEDRONATE

How much to take

For osteoporosis, the usual dose is one

tablet

each

day,

AURO-

RISEDRONATE 35mg tablet once a

week.

For Paget's disease of the bone, the

usual dose is one 30 mg tablet each

day for 2 months.

Follow all directions given to you by

your doctor or pharmacist.

If

you

do

not

understand

the

instructions on the box, ask your

doctor or pharmacist for help.

How to take it

Take your AURO-RISEDRONATE

tablet in the morning, at least 30

minutes

before

your

first

meal,

drink or medication of the day.

AURO-RISEDRONATE

most

effective

when

your

stomach

empty.

Take your AURO-RISEDRONATE

tablet

while

sitting

or

standing

upright.

Do

not

lie

down

immediately after swallowing it.

important

stay

upright,

example, sitting, standing or walking

around, for at least 30 minutes after

swallowing your tablet. It is also very

important to stay upright until after

you have eaten your first food of the

day.

This

will

help

make

sure

tablet reaches your stomach quickly

helps

avoid

irritation

your

oesophagus.

Swallow

your

AURO-

RISEDRONATE tablet whole with

a glass of plain water. Do not chew

or suck the tablet.

important

take

AURO-

RISEDRONATE

with

plain

water

only,

mineral

water.

Mineral

water and other drinks, including fruit

juices, coffee and tea, will reduce the

effect of AURO-RISEDRONATE.

When to take it

Take

AURO-RISEDRONATE

in

the morning, 30 minutes to 1 hour

before

your

first

meal,

drink

or

medication of the day.

Take your AURO-RISEDRONATE

5mg and 30mg tablet at the same

time of day every day.

Taking your tablets at the same time

each day will have the best effect. It

will also help you remember when to

take the tablets.

AURO-RISEDRONATE

CONSUMER MEDICINE INFORMATION

Ver 1.1

Page 3 of 4

Take your AURO-RISEDRONATE

35mg Once-a- Week tablet on the

same day each week.

This

tablet

should

taken

each

week. Choose a day of the week that

suits you the best.

If

you

forget

to

take

your

tablet

For

AURO-RISEDRONATE

5mg

and 30mg tablets:

If it is almost time for your next

tablet

skip

the

tablet

you

missed

and take your next tablet when you

are meant to.

Do not take a double dose to make

up for the tablet that you missed.

This may increase the chance of you

getting an unwanted side effect.

For AURO-RISEDRONATE 35mg

Once-a-Week tablets:

If you have forgotten to take your

35mg tablet, just take your tablet

on the day you remember.

Do not take two tablets in one day

to

make

up

for

the

tablet

you

missed. Return to taking one tablet

once a week, as originally scheduled

on your chosen day.

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.

How long to take it

Continue

taking

AURO-

RISEDRONATE for as long as your

doctor recommends it.

Do

not

stop

taking

AURO-

RISEDRONATE without checking

with your doctor or pharmacist.

If

you

take

too

much

(overdose)

Immediately telephone your doctor

or

pharmacist

or

the

Poisons

Information Centre (13 11 26) or go

to accident and emergency at your

nearest hospital.

If

you

or

somebody

else

has

accidentally taken a large number

of tablets, drink a full glass of milk

or antacids. Do this even if here are

no signs of discomfort or poisoning.

need

urgent

medical

attention.

While

you

are

using

AURO-RISEDRONATE

Things you must do

Tell any other doctors, dentists, and

pharmacists who are treating you

that

you

are

taking

AURO-

RISEDRONATE.

If you require a dental procedure,

tell your dentist that you are taking

AURO-RISEDRONATE.

Invasive

dental

procedures

should

be

avoided where possible.

This type of medicine may cause jaw-

bone problems in some people. Jaw-

bone problems may include infection,

delayed

healing

after

teeth

pulled out or other work that involves

drilling into the jaw.

If

you

develop

a

toothache,

jaw

pain,

painful

exposed

bone

or

swelling, especially following dental

work,

tell

your

doctor

or

dentist

immediately.

Speak to your doctor and dentist

about

good

oral

hygiene

and

regular dental check-ups while you

are using AURO-RISEDRONATE.

If you are about to be started on

any new medicine, tell your doctor,

dentist or pharmacist that you are

taking AURO-RISEDRONATE.

If

you

become

pregnant

while

taking AURO-RISEDRONATE tell

your doctor or pharmacist.

If you develop new or unusual pain in

your hip or thigh, tell your doctor.

Rarely,

patients

have

experienced

fracture in a specific part of the thigh

bone.

Things you must not do

Do not lie down for 30 minutes after

taking AURO-RISEDRONATE.

Do

not

have

any

food

or

drink,

except

for

plain

water

for

30

minutes

after

taking

AURO-

RISEDRONATE.

Do

not

give

AURO-

RISEDRONATE

to

anyone

else,

even if they have the same condition

as you.

Do

not

take

AURO-

RISEDRONATE to treat any other

complaints

unless

your

doctor

or

pharmacist tells you to.

Do

not

stop

taking

AURO-

RISEDRONATE without checking

with your doctor or pharmacist.

Side Effects

Tell your doctor or pharmacist as

soon as possible if you do not feel

well while you are taking AURO-

RISEDRONATE.

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.

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:

stomach pain

diarrhoa

aching muscles, joints or bones

headache

nausea

runny nose

sore throat

dizziness

These side effects are usually mild.

Tell your doctor immediately if you

notice any of the following:

skin rash or redness of the skin,

sometimes

made

worse

by

sunlight, itchiness

AURO-RISEDRONATE

CONSUMER MEDICINE INFORMATION

Ver 1.1

Page 4 of 4

blurred vision, pain or redness in

the eyes

problems with your jaw or teeth,

associated

with

delayed

healing

and/or infection often following a

tooth

extraction

or

invasive

dental work

These side-effects are rare.

If any of the following happen, stop

taking

AURO-RISEDRONATE

and tell your doctor immediately:

difficulty or pain on swallowing

chest discomfort

new or worsening heartburn

These

side

effects

irritation

ulceration

food

pipe.

They

worsen

continue taking the tablets. These side

effects are rare.

If any of the following happen, stop

taking

AURO-RISEDRONATE

and tell your doctor immediately or

go

to

accident

and

emergency

at

your nearest hospital:

swelling of the face, lips, mouth,

throat or tongue

severe skin reactions

These

serious

side

effects.

need

urgent

medical

attention.

Other

side

effects

listed

above

may occur in some patients.

Tell your doctor or pharmacist if

you notice anything that is making

you feel unwell.

Do not be alarmed by this list of

possible side effects.

You may not experience any of them.

After using

AURO-RISEDRONATE

Storage

Keep your tablets in the pack until

it is time to take them.

If you take the tablets out of the pack

they may not keep well.

Keep

your

tablets

in

a

cool

dry

place where the temperature stays

below 25°C.

Do

not

store

AURO-

RISEDRONATE

or

any

other

medicine in the bathroom or near a

sink.

Do not leave medicines in the car on

hot days or on window sills.

Heat and dampness can destroy some

medicines.

Keep

medicines

where

children

cannot reach it.

A locked cupboard at least one-anda-

half

metres

above

ground

good place to store medicines.

Disposal

If your doctor or pharmacist tells

you

to

stop

taking

AURO-

RISEDRONATE

or

the

tablets

have passed their expiry date, ask

your pharmacist what to do with

any tablets that are left over.

Product description

What

AURO-RISEDRONATE

looks like

AURO-RISEDRONATE 5, 30 & 35

(5 mg, 30 mg & 35 mg) is presented

in blister pack.

AURO-RISEDRONATE 5 mg & 30

mg tablets are available in pack sizes

&

tablets.

AURO-

RISEDRONATE

tablets

available in pack size of 4 tablets..

AURO-RISEDRONATE 5 (AUST R

190155)

Yellow

colored,

circular

shaped,

beveled

edge,

film-coated

biconvex

tablets debossed with ‘X’ on one side

and ‘61’ on the other side.

AURO-RISEDRONATE

30

(AUST

R 190156)

White to off-white colored, circular

shaped film coated biconvex tablets

debossed with ‘L’ on one side and

‘30’ on the other side.

AURO-RISEDRONATE

35

(AUST

R 190158)

Light orange colored, circular shaped

film coated biconvex tablets debossed

with ‘F27’ on one side and plain on

the other side.

Ingredients

Active ingredient

Risedronate Sodium

Hemipentahydrate

Inactive ingredients

microcrystalline cellulose

lactose

crospovidone

magnesium stearate

hydroxypropylcellulose

Each

AURO-RISEDRONATE

tablet

also

contains Opadry

Yellow

20C82695 (PI ARTG-106484).

Each

AURO-RISEDRONATE

tablet

also

contains

hypromellose,

macrogol 400 & titanium dioxide.

Each

AURO-RISEDRONATE

tablet

also

contains

Opadry

Brown

20C86893 (PI ARTG-106485).

AURO-RISEDRONATE

does

contain sucrose, gluten, tartrazine or

any other azo dyes.

Name and Address of the Sponsor

Aurobindo Pharma Australia Pty Ltd

Unit 3, North Rydelink

277-283 Lane Cove Road

Macquarie Park

NSW 2113

Australia

Date of Approval

20 September 2012