RISEDRONATE AN risedronate sodium 35mg tablet blister pack

Main information

  • Trade name:
  • RISEDRONATE AN risedronate sodium 35mg tablet blister pack
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • RISEDRONATE AN risedronate sodium 35mg tablet blister pack
    Australia
  • Language:
  • English

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization status:
  • Registered
  • Authorization number:
  • 190157
  • Last update:
  • 21-05-2019

Public Assessment Report

Public Summary

Summary for ARTG Entry:

190157

RISEDRONATE AN risedronate sodium 35mg tablet blister pack

ARTG entry for

Medicine Registered

Sponsor

Amneal Pharma Australia Pty Ltd

Postal Address

12 River Street,SOUTH YARRA, VIC, 3141

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. RISEDRONATE AN risedronate sodium 35mg tablet blister pack

Product Type

Single Medicine Product

Effective date

25/06/2015

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

? Treatment of osteoporosis,? Treatment of glucocorticoid-induced osteoporosis,? Preservation of bone mineral density in patients on long term

corticosteroid therapy

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Blister Pack

PVC/PE/PVDC/Al

36 Months

Store below 25

degrees Celsius

Not recorded

Store in a Dry Place

Pack Size/Poison information

Pack Size

Poison Schedule

(S4) Prescription Only Medicine

Components

1. RISEDRONATE AN risedronate sodium 35mg tablet blister pack

Dosage Form

Tablet, film coated

Route of Administration

Oral

Visual Identification

Light orange coloured, circular shaped film coated biconvex tablets

debossed with 'F27' on one side and plain on the other side

Active Ingredients

Risedronate sodium hemipentahydrate

40.17 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 11:34:56 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

Risedronate AN CMI v 2.0

Page 1 of 4

RISEDRONATE AN

Risedronate Sodium (as hemipentahydrate)

Consumer Medicine Information

What is in this leaflet

This

leaflet

answers

some

common

questions

about

RISEDRONATE AN.

It does not contain all the available

information. It does not take the

place of talking to your doctor or

pharmacist.

medicines

have

risks

benefits. Your doctor has weighed

risks

taking

RISEDRONATE

against

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 RISEDRONATE AN

is used for

RISEDRONATE

used

treat bone disease and belongs to

group

medicines

called

bisphosphonates.

RISEDRONATE AN works directly

your

bones

make

them

stronger and therefore less likely

to break or fracture.

RISEDRONATE AN 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

RISEDRONATE AN 30mg tablets

are used to treat:

Paget's disease of the bone.

These conditions are caused by

changes

bone

normally maintained.

Understanding bone

Bone is a living tissue consisting

calcium

other

minerals.

Throughout

life,

bone

constantly

broken

down

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

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

more

likely to break bones when

have a fall or bump. The spine, hip

and wrist are the most likely bones

to break, although this can happen

bone

your

body.

Osteoporosis can also cause back

pain,

height

loss

curved

back.

Osteoporosis

common

women

after

menopause

(change of life) and is also more

likely to occur in women who have

reached

menopause

early.

Osteoporosis

also

occur

women who have not yet reached

menopause, and in men.

Long term steroid treatment can

also lead to osteoporosis in both

men and women.

RISEDRONATE

works

slowing down the process of old

bone being removed.

This allows the bone-forming cells

time to rebuild normal bone.

RISEDRONATE AN also helps to

rebuild bone mass. This creates

stronger bone which is less likely

fracture.

Therefore

RISEDRONATE

help

reverse

progression

osteoporosis.

Paget's disease of the bone

Paget's disease occurs when the

process

bone

remodelling

happens

quickly

disordered

way.

bone

that is produced is weaker than

normal

affected

bones

may become enlarged, deformed,

painful

fracture.

skull, spine, legs, collar bone and

pelvic

bone

most

commonly affected.

Do not give RISEDRONATE AN

to

children

or

adolescents

under 18 years of age.

There have been no studies of its

effects in this age group.

There

evidence

that

RISEDRONATE AN is addictive.

This

medicine

available

only

with a doctor's prescription.

Before you take

RISEDRONATE AN

When you must not take

RISEDRONATE AN

Do not take RISEDRONATE AN

if:

have

allergy

RISEDRONATE

AN or

any of

the ingredients listed at the end

of this leaflet

you are unable to stand or sit

upright for at least 30 minutes

have

condition

called

hypocalcaemia (a low

level of

calcium in the blood)

Do not take RISEDRONATE AN

if you are pregnant.

RISEDRONATE

recommended

during

pregnancy, unless you and your

Risedronate AN CMI v 2.0

Page 2 of 4

doctor

have

discussed

risks

and benefits involved.

Do not take RISEDRONATE AN

if you are breastfeeding.

known

whether

RISEDRONATE

passes

into

breast milk.

Do not take RISEDRONATE AN

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 RISEDRONATE AN

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

RISEDRONATE AN.

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

possible

risks

benefits

using RISEDRONATE AN 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

bone

mineral metabolism (for example

vitamin D deficiency, parathyroid

hormone abnormalities)

problems

with

tube

that

takes food from your mouth to

your

stomach

(oesophagus)

such as ulcers

Check

with

your

doctor

or

dentist to see if a dental check-

up

is

required

before

starting

RISEDRONATE AN.

This is especially important if you

are receiving medicines or therapy

used

treat

cancer

taking

corticosteroids,

such

prednisone or cortisone.

Tell your doctor about any of

the

above,

before

you

start

taking RISEDRONATE AN.

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

RISEDRONATE AN may interfere

with

each

other

taken

same time. These include:

Antacids,

medicines

used

treat

indigestion

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

take

them

different

time

RISEDRONATE AN.

You can take aspirin while you are

being treated with RISEDRONATE

Your doctor and pharmacist may

have

more

information

medicines to be careful with while

taking RISEDRONATE AN.

How

to

take

RISEDRONATE AN

How much to take

For osteoporosis, the usual dose

is one 5mg tablet each day, one

RISEDRONATE AN 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

RISEDRONATE

AN

tablet in the morning, at least 30

minutes before your first meal,

drink or medication of the day.

RISEDRONATE

most

effective

when

your

stomach

empty.

Take

your

RISEDRONATE

AN

tablet while sitting or standing

upright.

Do

not

lie

down

immediately after swallowing it.

It is important to stay upright, for

example,

sitting,

standing

walking

around,

least

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 the tablet

reaches your stomach quickly and

helps

avoid

irritation

your

oesophagus.

Swallow

your

RISEDRONATE

AN tablet whole with a glass of

plain

water.

Do

not

chew

or

suck the tablet.

important

take

RISEDRONATE

with

plain

water only (120 mL), not mineral

water.

Mineral

water

other

drinks, including fruit juices, coffee

and tea, will reduce the effect of

RISEDRONATE AN.

When to take it

Take RISEDRONATE AN in the

morning, 30 minutes to 1 hour

before your first meal, drink or

medication of the day.

Risedronate AN CMI v 2.0

Page 3 of 4

Take

your

RISEDRONATE

AN

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.

will

also

help

remember

when

take

tablets.

Take

your

RISEDRONATE

AN

35mg

Once-a-

Week

tablet

on

the same day each week.

This tablet should be taken each

week. Choose a day of the week

that suits you the best.

If you forget to take your tablet

For RISEDRONATE AN 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

getting

unwanted

side

effect.

For

RISEDRONATE

AN

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

RISEDRONATE

long

your

doctor

recommends it.

Do

not

stop

taking

RISEDRONATE

AN

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

RISEDRONATE AN

Things you must do

Tell any other doctors, dentists,

and

pharmacists

who

are

treating you that you are taking

RISEDRONATE AN.

If

you

require

a

dental

procedure, tell your dentist that

you

are

taking

RISEDRONATE

AN. Invasive dental procedures

should

be

avoided

where

possible.

This type of medicine may cause

jaw-bone

problems

some

people. Jaw-bone problems may

include

infection,

delayed

healing after teeth are 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

RISEDRONATE AN.

If you are about to be started on

any

new

medicine,

tell

your

doctor,

dentist

or

pharmacist

that

you

are

taking

RISEDRONATE AN.

If you become pregnant while

taking

RISEDRONATE

AN

tell

your doctor or pharmacist.

develop

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 RISEDRONATE AN.

Do not have any food or drink,

except

for

plain

water

for

30

minutes

after

taking

RISEDRONATE AN.

Do not give RISEDRONATE AN

to

anyone

else,

even

if

they

have the same condition as you.

Do not take RISEDRONATE AN

to

treat

any

other

complaints

unless

your

doctor

or

pharmacist tells you to.

Do

not

stop

taking

RISEDRONATE

AN

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 RISEDRONATE AN.

medicines

have

side

effects.

Sometimes

they

serious, most of the time they are

not.

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

Risedronate AN CMI v 2.0

Page 4 of 4

dizziness

These

side

effects

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

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 RISEDRONATE AN

and

tell

your

doctor

immediately:

difficulty

or

pain

on

swallowing

chest pain

new or worsening heartburn

These side effects may be due to

irritation or ulceration of the food

pipe.

They

worsen

continue taking the tablets. These

side effects are rare.

If any of the following happen,

stop taking RISEDRONATE AN

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 not 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

RISEDRONATE AN

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 RISEDRONATE AN

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 is a good place to store

medicines.

Disposal

If

your

doctor

or

pharmacist

tells

you

to

stop

taking

RISEDRONATE

AN

or

the

tablets have passed their expiry

date, ask your pharmacist what

to do with any tablets that are

left over.

Product description

What RISEDRONATE AN looks

like

RISEDRONATE AN 5 mg, 30 mg

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

presented in a blister pack.

RISEDRONATE AN 5 mg & 30 mg

tablets are available in pack sizes

&

tablets.

RISEDRONATE AN 35 mg tablets

available

pack

size

tablets.

RISEDRONATE AN 5 mg (AUST

R 190160)

Yellow

colored,

circular

shaped,

beveled

edge,

film-coated

biconvex tablets debossed with ‘X’

on one side and ‘61’ on the other

side.

RISEDRONATE

AN

30

mg

(AUST R 190159)

White to off-white colored, circular

shaped

film

coated

biconvex

tablets debossed with ‘L’ on one

side and ‘30’ on the other side.

RISEDRONATE

AN

35

mg

(AUST R 190157)

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

RISEDRONATE

tablet also contains Opadry Yellow

20C82695 (PI ARTG-106484).

Each RISEDRONATE AN 30 mg

tablet also contains hypromellose,

macrogol 400 & titanium dioxide.

Each RISEDRONATE AN 35 mg

tablet also contains Opadry Brown

20C86893 (PI ARTG-106485).

RISEDRONATE

does

contain sucrose, gluten, tartrazine

or any other azo dyes.

Name

and

Address

of

the

Sponsor

Amneal Pharma Australia Pty Ltd

12 River Street, South Yarra

VIC 3141

Australia

Date of Preparation: October

2014