RABEPRAZOLE AN rabeprazole sodium 20mg enteric coated tablet bottle

Main information

  • Trade name:
  • RABEPRAZOLE AN rabeprazole sodium 20mg enteric coated tablet bottle
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • RABEPRAZOLE AN rabeprazole sodium 20mg enteric coated tablet bottle
    Australia
  • Language:
  • English

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization status:
  • Registered
  • Authorization number:
  • 189218
  • Last update:
  • 22-05-2019

Public Assessment Report

Public Summary

Summary for ARTG Entry:

189218

RABEPRAZOLE AN rabeprazole sodium 20mg enteric coated tablet bottle

ARTG entry for

Medicine Registered

Sponsor

Amneal Pharma Australia Pty Ltd

Postal Address

12 River Street,SOUTH YARRA, VIC, 3141

Australia

ARTG Start Date

4/04/2012 11:00:00 PM

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. RABEPRAZOLE AN rabeprazole sodium 20mg enteric coated tablet bottle

Product Type

Single Medicine Product

Effective date

10/11/2014

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

Indicated for: ,?Treatment and prevention of relapse of gastro-oesophageal reflux disease ,?Symptomatic treatment of gastro-oesophageal reflux

disease ,?Treatment of duodenal ulcers ,?Treatment of gastric ulcers. ,Patients whose gastric and duodenal ulceration is not associated with

ingestion of non-steroidal anti-inflammatory drugs (NSAIDs) usually require treatment with antimicrobial agents in addition to antisecretory drugs whether

on first presentation or on recurrence. ,Also indicated, in combination with clarithromycin and amoxycillin, for: ,?Eradication of Helicobacter pylori in

patients with peptic ulcer disease or chronic gastritis ,?Healing of peptic ulcers in patients with Helicobacter pylori associated ulcers.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Bottle

HDPE

21 Months

Store below 25

degrees Celsius

Neither child resistant

closure nor restricted

flow insert

Do not Refrigerate

Do not Freeze

Store in Original

Container

Pack Size/Poison information

Pack Size

Poison Schedule

(S4) Prescription Only Medicine

(S4) Prescription Only Medicine

Components

1. RABEPRAZOLE AN rabeprazole sodium 20mg enteric coated tablets, bottles

Dosage Form

Tablet, enteric coated

Route of Administration

Oral

Visual Identification

Round, yellow, biconvex enteric-coated tablets

Active Ingredients

Rabeprazole sodium

20 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 29.11.2017 at 12:40:08 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

Rabeprazole AN tablets – Consumer Medicine Information

Doc ID: 92.AN.M.1.0

Page 1

Rabeprazole AN tablets

Rabeprazole sodium

Consumer Medicine Information

What is in this leaflet

This

leaflet

answers

some

common

questions

about

Rabeprazole AN.

does

contain

available information. It does not

take the place of talking to your

doctor or pharmacist.

All medicines have benefits and

risks. Your doctor has weighed

risks

taking

Rabeprazole

against

benefits they expect it will have

for you.

If

you

have

any

concerns

about

taking

this

medicine,

talk

to

your

doctor

or

pharmacist.

Keep

this

leaflet

with

your

medicine.

You may need to read it again.

What Rabeprazole AN

is used for

The name of your medicine is

Rabeprazole AN.

It contains the active ingredient

rabeprazole sodium.

Rabeprazole is used to treat

Reflux oesophagitis

Peptic ulcers

Chronic Gastritis

Reflux Oesophagitis:

Rabeprazole AN is used to treat

reflux

oesophagitis

reflux

disease. This can be caused by

food and acid from the stomach

flowing the wrong way (reflux)

back

food

pipe,

also

known as the oesophagus.

Reflux

cause

burning

sensation in the chest rising up

throat,

also

known

heartburn.

Rabeprazole AN is also used to

help

stop

reflux

oesophagitis

from coming back or relapsing

Peptic Ulcers

Rabeprazole AN is used to treat

peptic ulcers. Depending on the

position of the ulcer, it is called a

gastric ulcer or duodenal ulcer. A

gastric

ulcer

occurs

stomach.

duodenal

ulcer

occurs in the duodenum which is

tube

leading

stomach.

ulcers

caused by too much acid being

made in the stomach.

Most people who have a peptic

ulcer also have a bacteria called

Helicobacter

pylori

their

stomach. Your doctor may also

prescribe a course of antibiotics

(clarithromycin and amoxycillin)

for you. When Rabeprazole AN

taken

with

antibiotics,

combination therapy will kill the

Helicobacter pylori and let your

ulcer heal.

Chronic Gastritis

presence

bacteria

Helicobacter

pylori

cause

the stomach to become inflamed

resulting

pain,

nausea

vomiting.

When

Rabeprazole

tablets

taken with antibiotics, then will

help kill Helocobactor pylori and

allow the stomach to heal.

How Rabeprazole AN works

Rabeprazole

belongs

group of medicines called proton

pump inhibitors (PPIs).

works

decreasing

amount

acid

stomach

makes, to give relief from the

symptoms and allow healing to

take place. Your food will still be

digested in the normal way.

Ask your doctor if you have

any questions about why this

medicine has been prescribed

for you.

Your

doctor

have

prescribed it for another reason.

This medicine is only available

with a doctor’s prescription.

Use in children

There is not enough information

to recommend the use of this

medicine in children.

Before You Take

Rabeprazole AN

When you must not take

it:

Do not take Rabeprazole AN if

you have an allergy to:

Any medicine containing

rabeprazole sodium

any of the ingredients

listed at the end of this

leaflet

other proton pump

inhibitors (for example:

omeprazole,

esomeprazole,

lansoprazole,

pantoprazole)

Symptoms of an allergic reaction

may include:

shortness of breath

wheezing or difficulty

breathing

swelling of the face, lips,

tongue or other parts of

the body

rash, itching or hives of

the skin

Do not take this medicine after

the expiry date printed on the

pack

or

if

the

packaging

is

torn

or

shows

signs

of

tampering.

Rabeprazole AN tablets – Consumer Medicine Information

Doc ID: 92.AN.M.1.0

Page 2

If it has expired or is damaged,

return it to your pharmacist for

disposal.

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

if

you

are

allergic

to

any

other

medicines,

foods,

dyes

or

preservatives.

Tell your doctor if you have or

have had any of the following

medical conditions:

liver disease

Tell

your

doctor

if

you

are

pregnant

or

plan

to

become

pregnant or are breastfeeding

or wish to breastfeed.

Your doctor will discuss with you

the risks and benefits involved.

If you have not told your doctor

about

above,

tell

him/her before you start taking

Rabprazole AN.

Taking other medicines

Tell your doctor if you are taking

other

medicines,

including

that

without

prescription

from

pharmacy,

supermarket

health

food

shop.

Some

medicines

affected by Rabeprazole AN or

affect

well

works.

You may need different amounts

of your medicines, or you may

need to take different medicines.

Your doctor will advise you

Tell your doctor or pharmacist

if you are taking any of the

following:

digoxin, a medicine used

to treat heart problems

ketoconazole,

medicine

used

treat

fungal infections

atazanavir,

medicine

used

(with

other

antivirals) to treat HIV-1

infection

Your doctor and pharmacist will

more

information

medicines to be careful with or

avoid

taking

while

this

medicine.

How to take

Rabeprazole AN

Follow all directions given to

you

by

your

doctor

or

pharmacist carefully.

They

differ

from

information

contained

this

leaflet.

understand

instructions

box/bottle,

ask your doctor or pharmacist for

help.

How much to take

Your

doctor

will

tell

many tablets you need to take

each day. This may depend on

your

age,

your

condition

whether or not you are taking

any other medicines.

Adults

The usual dose is one tablet at

same

time

each

day.

treating

Helicobacter

pylori

infections

combination

with

antibiotics

(clarithromycin

amoxycillin),

dose

tablet twice each day, morning

and evening.

dose

Rabeprazole

tablets is usually 20 mg, but may

vary from 10 mg to 40 mg per

day depending on what condition

you are being treated for and

how severe it is.

Children

Rabeprazole AN should not be

given to children.

How to take it

Swallow the tablets whole with a

full glass of water or other liquid.

crush

chew

tablets.

They

have

special

coating,

which

protects

them

from the acid in your stomach. If

coating

broken

chewing,

tablets

work.

When to take it

Take your medicine at about

the same time each day.

Taking it at the same time each

day will have the best effect. It

will

also

help

remember

when

take

does

matter if you take Rabeprazole

AN with food or on an empty

stomach.

Ask your doctor or pharmacist

for help if you do not understand

instructions

provided

with

this medicine.

How long to take it

Continue taking your medicine

for as long as your doctor tells

you.

If you forget to take it

If

you

forget

to

take

your

tablet, take it as soon as you

remember, and then continue

to

take

it

as

you

would

normally.

However, if it is almost time

for your next dose, skip the

dose

you

missed

and

take

your next dose when you are

meant to.

Do not take a double dose to

make

up

for

the

dose

you

missed.

This may increase your chance

getting

unwanted

side

effect.

If you are not sure what to do,

check

with

your

doctor

or

pharmacist.

If

you

have

trouble

remembering

to

take

your

medicine, ask your pharmacist

for some hints.

If you take too much

(overdose)

Rabeprazole AN tablets – Consumer Medicine Information

Doc ID: 92.AN.M.1.0

Page 3

Immediately

telephone

your

doctor

or

the

Poisons

Information Centre (telephone

13 11 26) for advice, or go to

Accident

and

Emergency

at

the

nearest

hospital,

if

you

think you or anyone else may

have taken

too much RABEPRAZOLE AN.

Do this even if there are no

signs

of

discomfort

or

poisoning.

You may need urgent medical

attention.

While you are using

Rabeprazole AN

Things you must do

Use Rabeprazole exactly as

your doctor has prescribed.

Always swallow Rabeprazole

AN tablets whole.

If you are about to be started

on any new medicine, remind

your

doctor

and

pharmacist

that

you

are

taking

Rabeprazole AN.

Tell

any

other

doctors,

dentists, and pharmacists who

treat you that you are taking

this medicine.

If

you

are

going

to

have

surgery,

tell

the

surgeon

or

anaesthetist

that

you

are

taking this medicine.

affect

other

medicines

used during surgery.

become

pregnant

while

taking Rabeprazole AN, tell your

doctor immediately.

Things you must not do

Do not take Rabeprazole AN to

treat

any

other

complaints

unless your doctor tells you

to.

Do not give your medicine to

anyone else, even if they have

the same condition as you.

Do

not

crush

or

chew

the

tablets.

Do

not

give

Rabeprazole AN to children.

Do

not

stop

taking

your

medicine or lower the dosage

without

checking

with

your

doctor.

Things to be careful of

Be careful driving or operating

machinery until you know how

Rabeprazole AN affects you.

This

medicine

cause

dizziness in some people. If you

have this symptom, do not drive,

operate

machinery

anything

else

that

could

dangerous.

Be

careful

when

drinking

alcohol while you are taking

this medicine.

If you drink alcohol, symptoms

such as dizziness may be worse.

Things that would be helpful

for your condition

Some

self

help

measures

suggested below may help your

condition.

Your

doctor

pharmacist can give you more

information

about

these

measures.

Alcohol.

Your

doctor

advise

limit

your

alcohol intake

Asprin

and

many

other

medicines

used

to

treat

arthritis/period

pain/headaches

these

medicines

irritate

stomach

make

your condition worse. Your

doctor

pharmacist

suggest other medicines you

can take.

Caffeine – your doctor may

advise

limit

number

drinks

which

contain

caffeine,

such

coffee, tea, cocoa and cola

drinks because they contain

ingredients that may irritate

your stomach

Eating habits- eat smaller,

more

frequent

meals.

slowly and chew your food

carefully. Try not to rush at

meal times.

Smoking – your doctor may

advise you to stop smoking

or at least cut down

Weight – your doctor may

suggest losing some weight

to help your condition.

Side Effects

Rabeprazole

AN

is

usually

well

tolerated

but

tell

your

doctor or pharmacist as soon

as possible if you do not feel

well while you are taking it.

medicines

have

side

effects.

Sometimes

they

serious, most of the time they

are not. You may need medical

treatment if you get some of the

side effects.

It can be difficult to tell whether

side

effects

result

taking Rabeprazole AN, effects

of your condition or side effects

of other medicines you may be

taking.

this

reason,

important to tell your doctor of

any change in your condition.

Do not be alarmed by this list

of possible side effects.

You may not experience any of

them.

Ask your doctor of pharmacist

to answer any questions you

may have.

Tell your doctor if you notice

any of the following and they

worry you:

headache

dizziness

diarrhoea

constipation

nausea

vomiting

stomach pain

muscle weakness/pain

flatulence

dry mouth

itchy or /runny nose

sore throat

cough

trouble falling/staying asleep

breast enlargement in men

Rabeprazole AN tablets – Consumer Medicine Information

Doc ID: 92.AN.M.1.0

Page 4

itchy rash accompanied

by skin

eruption

Also tell your doctor if your

reflux/heartburn

symptoms

get worse.

The above list includes some of

the more common side effects of

your medicine.

They are usually mild and short-

lived.

Tell your doctor as soon as

possible if you notice any of

the following:

bleeding or bruising more

easily

than normal

signs

frequent

infections

such

fever,

severe

chills,

sore

throat

or mouth ulcers.

Yellow skin

Significant mood changes

Significant weight changes

Double or blurred vision

The above list includes serious

side

effects

that

require

medical attention. Serious side

effects are rare.

Tell your doctor immediately

(and

do

not

take

your

next

dose of Rabeprazole AN) or go

to Accident and Emergency at

the

nearest

hospital

if

you

notice any of the following:

signs of allergy such as

skin rash, reddening,

blisters or

itching,

swelling of the face, lips or

other

parts of the body

shortness

breath

wheezing

above

list

includes

very

serious

side

effects.

You may

need urgent

medical

attention

hospitalisation.

These

side

effects are very rare.

Other problems

are more likely

arise

from

ulcer

itself

rather than

the treatment.

For this reason, contact your

doctor

immediately

if

you

notice

any of the following:

pain or indigestion

you begin to vomit blood or

food

you pass black (blood-

stained)

motions.

Tell

your

doctor

if

you

notice

anything

else

that

is

making you

feel unwell.

Other side effects not listed

above

may also occur in

some people.

After taking

Rabeprazole AN

Storage

Keep

your

tablets

in

the

pack/bottle until it is time to

take them.

If you take the tablets out of the

pack/bottle they may not keep

well.

Keep your tablets in a cool dry

place where the temperature

stays below 25

o

C

Do not store Rabeprazole AN

or any other medicine in the

bathroom or near a sink. Do

not leave it in the car or on

window

sills.

Heat

dampness

destroy

some

medicines.

Keep Rabeprazole AN where

children cannot reach it.

A locked cupboard at least one-

and-a-half

metres

above

ground is a good place to store

medicines.

Disposal

If your doctor tells you to stop

taking this medicine, or your

tablets

have

passed

their

expiry

date,

ask

your

pharmacist

what

to

do

with

any that are left over.

Product description

What it looks like

Rabeprazole AN 10 mg and 20

mg tablets are supplied in blister

packs (in pack sizes of 28 and

30 tablets) and in HDPE plastic

bottles (in pack sizes of 30 and

90 tablets).

RABEPRAZOLE

AN

10

mg

Round, white, biconvex, enteric-

coated tablets

Blister pack AUST R 189244

Bottle pack AUST R 189233

RABEPRAZOLE AN 20 mg

Round,

yellow,

biconvex,

enteric-coated tablets

Blister pack AUST R 189226

Bottle pack AUST R 189218

Ingredients

Active Ingredient:

Rabeprazole sodium

Each

tablet

contains

either

rabeprazole

sodium as the active ingredient.

Other Ingredients:

Crospovidone

Diacetylated

monoglycerides

Ethylcellulose

Hydroxypropylcellulose

Hypromellose phthalate

Iron oxide yellow

Heavy magnesium oxide

Light magnesium oxide

Magnesium stearate

Mannitol

Purified talc

Titanium dioxide

Please read this leaflet carefully

before

start

taking

RABEPRAZOLE AN. You may

wish to keep it to read again.

Name

and

Address

of

the

Sponsor

Amneal Pharma Australia Pty

12 River Street

South Yarra 3141

Australia

Date of Preparation

January 2014

Doc ID: 92.AN.M.1.0