RALOXIFENE

Main information

  • Trade name:
  • RALOXIFENE AN Raloxifene hydrochloride 60 mg tablets, blister pack
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • RALOXIFENE AN Raloxifene hydrochloride 60 mg tablets, blister pack
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 207899
  • Last update:
  • 10-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

207899

RALOXIFENE AN Raloxifene hydrochloride 60 mg tablets, 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

14/01/2014

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. RALOXIFENE AN Raloxifene hydrochloride 60 mg tablets, blister pack

Product Type

Single Medicine Product

Effective date

9/10/2015

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

Raloxifene is indicated for the prevention and treatment of osteoporosis in post-menopausal women.,Raloxifene is indicated for the reduction in the risk

of invasive breast cancer in postmenopausal women with osteoporosis.Raloxifene is indicated for the reduction in the risk of invasive breast cancer in

postmenopausal women at high risk of invasive breast cancer.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Blister Pack

Al/Al

24 Months

Store below 25

degrees Celsius

Not recorded

Store in Original

Container

Pack Size/Poison information

Pack Size

Poison Schedule

28 tablets

(S4) Prescription Only Medicine

Components

1. RALOXIFENE AN Raloxifene hydrochloride 60 mg tablets, blister pack

Dosage Form

Tablet, film coated

Route of Administration

Oral

Visual Identification

White to off-white, oval, biconvex, film coated tablets with 'C' on one side

and '12' on other side.

Active Ingredients

Raloxifene hydrochloride

60 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 27.11.2017 at 11:49:40 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

RALOXIFENE AN

RALOXIFENE AN

Raloxifene hydrochloride

Consumer Medicine Information

What is in this leaflet

This leaflet is designed to provide

you with answers to some common

questions about this medicine. It

does not contain all the available

information and does not take the

place of talking with your doctor.

All medicines have risks and

benefits. Your doctor has more

information about this medicine than

is contained in this leaflet. Also,

your doctor has had the benefit of

taking a full and detailed history

from you and is in the best position

to make an expert judgement to meet

your individual needs.

If you have any concerns about

taking this medicine, talk to your

doctor or pharmacist.

Keep this leaflet with this

medicine.

You may need to read it again.

What RALOXIFENE

AN is used for

RALOXIFENE AN belongs to a

group of non-hormonal medicines

called Selective Estrogen Receptor

Modulators (SERMs). When a

woman reaches menopause, the level

of the female sex hormone,

oestrogen, goes down.

RALOXIFENE AN mimics some of

the beneficial effects of oestrogen

after menopause.

RALOXIFENE AN is used to

prevent and treat osteoporosis in

women after menopause.

Osteoporosis causes your bones to

become thin and fragile - it is

especially common in women after

menopause. While osteoporosis may

have no symptoms at first, it makes

your bones more likely to break,

especially in your spine, hips and

wrists. Osteoporosis may also cause

back pain, loss of height and a curved

back.

Fractures may occur during normal,

everyday activity, such as lifting, or

from minor injury that would not

ordinarily fracture normal bone.

RALOXIFENE AN is also used to

reduce the risk of invasive breast

cancer in women with osteoporosis

after menopause and reduce the

risk of invasive breast cancer in

women at high risk of invasive

breast cancer after menopause.

Breast cancer is invasive when it has

spread outside the milk duct or

milk-making glands and has grown

into normal tissue inside the breast.

Invasive cancers can spread cancer to

other parts of the body through the

bloodstream and lymphatic system.

Your doctor may have prescribed

RALOXIFENE AN for another

reason.

Ask your doctor if you have any

questions about why

RALOXIFENE AN has been

prescribed for you.

This medicine is available only with

a doctor's prescription.

Before you take

RALOXIFENE AN

Tell your doctor if you have any of

the following conditions or if you

have ever experienced any of these

conditions.

When you must not take

RALOXIFENE AN

Do not take

RALOXIFENE AN

* if you have not been through

menopause. RALOXIFENE AN

is only for use by women after

menopause and must not be

taken by women who could still

have a baby.

* if you have had an allergic

reaction to RALOXIFENE AN or

any of the ingredients listed at the

end of

this leaflet (see 'Product

Description'). Signs of an

allergic reaction may include a

skin rash, itching, shortness of

breath or swelling of the face,

lips or tongue.

* if you are being treated or have

been treated for blood clots.

* if the packaging is torn or shows

signs of tampering, or if the

tablets do not look quite right.

* if the expiry date on the pack has

passed. If you take this medicine

after the expiry date has passed, it

may not work as well.

If you are not sure whether you

should start taking

RALOXIFENE AN, talk to your

doctor or pharmacist.

RALOXIFENE AN

Before you start taking

RALOXIFENE AN

You must tell your doctor:

* if you have any unexplained

vaginal bleeding.

* if you are at risk of blood clots.

* if you are, or know you will be

immobilised for some time, e.g.,

being wheel-chair bound or

having to stay in bed while

recovering from an operation or

illness.

* if you have liver disease.

* if you are intolerant of lactose.

RALOXIFENE AN contains a

small amount of lactose (about

150 mg) which

is unlikely to affect you.

* if you have menopausal

symptoms, such as hot flushes.

RALOXIFENE AN does not

treat hot flushes.

* if you are breastfeeding.

* if you are on oestrogen or

hormone replacement therapy

(HRT).

* if you have or have had high

blood fats (triglycerides) caused

by oestrogen.

* if you have previously had a

stroke, or if you have ever had

other risk factors for stroke such

as a mini-stroke (transient

ischaemic attack) or a type of

irregular heartbeat called atrial

fibrillation

* if you have had breast cancer.

RALOXIFENE AN has not

been fully studied in women

who have a history of breast

cancer.

Before starting and while taking

RALOXIFENE AN you should have

breast examinations and

mammograms, as directed by your

Doctor. RALOXIFENE AN does not

eliminate the chance of developing

breast cancers, you need these

examinations to find any breast

cancers as early as possible.

RALOXIFENE AN is not intended

to be taken by men.

RALOXIFENE AN has no

known effect on driving or the

ability to use machinery.

Taking other medicines

Tell your doctor if you are taking

any other medicines, including any

that you buy without a

prescription from your pharmacy,

supermarket or health food shop.

Some medicines and

RALOXIFENE AN may interfere

with each other. These include:

* medicines for your heart such as

digitalis drugs (e.g. digoxin) or

blood thinning drugs such as

warfarin. Your doctor may need

to adjust the dose of these

medicines.

* hormone replacement therapy

(HRT) or oestrogens.

* lipid-lowering drugs including

cholestyramine.

Your doctor or pharmacist has more

information on medicines to be

careful with or avoid while taking

RALOXIFENE AN.

Tell your doctor about these things

before taking RALOXIFENE AN.

How to take

RALOXIFENE AN

Carefully follow all directions

given to you by your doctor or

pharmacist.

These may differ from the

information contained in this leaflet.

How much to take

The usual dose of RALOXIFENE

AN is one tablet per day.

How to take it

RALOXIFENE AN tablets should be

swallowed whole with a glass of

water.

When prescribed for the treatment or

prevention of osteoporosis,

RALOXIFENE AN should be taken

in conjunction with supplementary

calcium if daily calcium intake is

inadequate.

When to take it

It does not matter what time of day

you take your tablet. However, it is

best to take it at the same time each

day as this will help you remember to

take it.

The days of the week are printed on

the blister foil to help you take your

tablet each day.

You may take RALOXIFENE

AN with or without food.

How long do I take it

For maximum benefit,

RALOXIFENE AN is intended

for long-term use.

Do

not

stop

taking

RALOXIFENE AN without

first talking to your doctor.

If you forget to take it

If it is almost time for your next

dose, skip the tablet you missed

and take your next dose when you

are meant to.

Otherwise, take it as soon as you

remember then go back to taking

your medicine as you would

normally.

Do not take a double dose to make

up for the dose that you missed.

If you are not sure what to do, ask

your doctor or pharmacist.

If you take too much

Immediately telephone your doctor

or the Australian Poisons

Information Centre (13 11 26), or

the New Zealand National Poisons

Information Centre (0800 POISON

or 0800 764 766), or go to the

Accident and Emergency

Department at your nearest

hospital, if you think that you or

anyone else has taken too much

RALOXIFENE AN.

Do this even if there are no signs of

discomfort or poisoning.

In adults, symptoms of an overdose

may include leg cramps and

dizziness.

RALOXIFENE AN

In children, symptoms of an

overdose may include coordination

problems, dizziness, vomiting, rash,

diarrhoea, repetitive shaking, and

flushing.

While you are taking

RALOXIFENE AN

Things you must do

It is important that you remember

to take RALOXIFENE AN daily

and at the dose prescribed by your

doctor.

Tell all doctors and pharmacists

who are treating you that you are

taking RALOXIFENE AN.

While you are taking

RALOXIFENE AN, tell your

doctor or pharmacist before you

start any new medicine.

If you become pregnant while

taking RALOXIFENE AN, tell

your doctor.

Tell your doctor if you are

immobilised for some time, e.g.,

being wheel-chair bound or having

to stay in bed while recovering

from an operation or illness.

If you are going on a long plane or

car trip, you should move about

periodically.

Tell your doctor if you have any

vaginal bleeding.

Things you must not do

Do not stop taking

RALOXIFENE AN without first

checking with your doctor.

Do not give RALOXIFENE AN to

anyone else, your doctor has

prescribed it specifically for you.

Side effects

Tell your doctor or pharmacist as

soon as possible if you experience

any undesirable effect or feel

unwell while you are taking

RALOXIFENE AN.

Like other medicines,

RALOXIFENE AN may cause some

unwanted side effects. These are

likely to vary from patient to patient.

The majority of side effects seen with

RALOXIFENE AN have been mild.

Tell your doctor if you notice any

of the following side effects and

they worry you:

* hot flushes

* leg cramps

* muscle spasms

* swelling of hands, feet and legs

* flu-like symptoms

These are the more common side

effects of RALOXIFENE AN.

Tell your doctor immediately or go

to the Accident and Emergency

Department at your nearest

hospital if you notice any of the

following:

* severe pain or swelling in your

legs

* severe stomach pain

* problems with your eyesight

* shortness of breath or pain on

breathing

In clinical trials of RALOXIFENE

some

women

experienced

blood clots in the veins (venous

thromboembolic

events).

This

occurred in less than

1% of RALOXIFENE AN

patients. This is a serious side

effect. You may need urgent

medical attention or

hospitalisation.

Tell your doctor if you notice

anything unusual or if you are

concerned about any aspect of your

health, even if you think the

problems are not associated with

this medicine and are not referred

to in this leaflet.

Clinical trials using RALOXIFENE

AN have shown that:

* Women taking RALOXIFENE

AN have less swelling, tenderness

and pain in their breasts than

women

receiving oestrogen.

* Unlike oestrogen,

RALOXIFENE AN has no effect

on the uterus and is unlikely to

cause vaginal bleeding or

spotting.

After taking

RALOXIFENE AN

Storage

Keep your tablets in the blister

pack until it is time to take them.

Keep your tablets in a cool, dry

place where the temperature stays

below 25 degrees C.

All medicines should be kept where

young children cannot reach them.

There will be an expiry date (month,

year) on your RALOXIFENE AN

pack.

The medicine should not be taken

after this date because it may have

lost some of its strength.

Disposal

If your doctor tells you to stop taking

RALOXIFENE AN or you find that

the tablets have passed their expiry

date, please return any leftover

tablets to your pharmacist.

Product Description

What it looks like

RALOXIFENE AN tablets are

white to off-white,oval, biconvex,

film coated tablets with ‘C’ on one

side and ‘12’ on the other side.

In Australia RALOXIFENE AN

tablets come in packs of 28 tablets.

Ingredients

Active Ingredient – raloxifene.

Each

RALOXIFENE

tablet

contains

raloxifene

hydrochloride which is equivalent to

56 mg raloxifene.

RALOXIFENE AN

Inactive Ingredients -,

povidone, polysorbate 80,

crospovidone, microcrystalline

cellulose, colloidal anhydrous

silica, magnesium stearate,

opadry white 12B580000

(ARTG 108743).

Sponsor

RALOXIFENE AN is a product of:

Amneal Pharma Australia Pty Ltd

12 River Street

South Yarra VIC 3141

Australia

Australian Registration

Number:

AUST R 207899

This document was prepared in

February 2015.

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Janumet (Merck Sharp and Dohme Limited)

Janumet (Merck Sharp and Dohme Limited)

Janumet (Active substance: sitagliptin / metformin hydrochloride) - PSUSA - Modification - Commission Decision (2018)3260 of Thu, 24 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/PSUSA/2003/201708

Europe -DG Health and Food Safety

24-5-2018

Efficib (Merck Sharp and Dohme Limited)

Efficib (Merck Sharp and Dohme Limited)

Efficib (Active substance: sitagliptin / metformin hydrochloride) - PSUSA - Modification - Commission Decision (2018)3276 of Thu, 24 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/PSUSA/2003/201708

Europe -DG Health and Food Safety

21-5-2018

EU/3/14/1353 (Lupin Europe GmbH)

EU/3/14/1353 (Lupin Europe GmbH)

EU/3/14/1353 (Active substance: Mexiletine hydrochloride) - Transfer of orphan designation - Commission Decision (2018)3134 of Mon, 21 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/074/14/T/03

Europe -DG Health and Food Safety

21-5-2018

EU/3/14/1421 (Incyte Biosciences Distribution B.V.)

EU/3/14/1421 (Incyte Biosciences Distribution B.V.)

EU/3/14/1421 (Active substance: Ponatinib hydrochloride) - Transfer of orphan designation - Commission Decision (2018)3141 of Mon, 21 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/212/14/T/02

Europe -DG Health and Food Safety

15-5-2018

Votrient (Novartis Europharm Limited)

Votrient (Novartis Europharm Limited)

Votrient (Active substance: Pazopanib hydrochloride) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)3062 of Tue, 15 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/1141/T/46

Europe -DG Health and Food Safety

21-3-2018

EU/3/11/919 (Monopar Therapeutics SARL)

EU/3/11/919 (Monopar Therapeutics SARL)

EU/3/11/919 (Active substance: Clonidine hydrochloride) - Transfer of orphan designation - Commission Decision (2018)1817 of Wed, 21 Mar 2018 European Medicines Agency (EMA) procedure number: EMA/OD/069/11/T/02

Europe -DG Health and Food Safety