PARBEZOL

Main information

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

Documents

Localization

  • Available in:
  • PARBEZOL rabeprazole sodium 20mg enteric-coated tablet bottle
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 216110
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

216110

PARBEZOL rabeprazole sodium 20mg enteric-coated tablet bottle

ARTG entry for

Medicine Registered

Sponsor

Arrow Pharma Pty Ltd

Postal Address

15 - 17 Chapel Street,Cremorne, VIC, 3121

Australia

ARTG Start Date

26/08/2014

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. PARBEZOL rabeprazole sodium 20mg enteric-coated tablet bottle

Product Type

Single Medicine Product

Effective date

13/07/2017

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

Store in Original

Container

Do not Refrigerate

Do not Freeze

Pack Size/Poison information

Pack Size

Poison Schedule

(S4) Prescription Only Medicine

Components

1. PARBEZOL rabeprazole sodium 20mg enteric-coated tablet bottle

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 10.11.2017 at 05:56:22 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

PARBEZOL

CONSUMER MEDICINE INFORMATION

Ver 1.1

Page 1 of 5

PARBEZOL 10 & 20

Rabeprazole sodium

Consumer Medicine Information

What is in this leaflet

This leaflet answers some common

questions about PARBEZOL tablets.

It does not contain all the available

information.

does

take

place of talking to your doctor or

pharmacist.

medicines

have

risks

benefits. Your doctor has weighed

the risks of you taking PARBEZOL

against the benefits it 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 PARBEZOL is used for

name

your

medicine

PARBEZOL

contains

active

ingredient

rabeprazole sodium.

What it does

This

medicine

used

treat,

- Reflux Oesophagitis

- Peptic Ulcers

- Chronic Gastritis

Reflux Oesophagitis:

This medicine is used to treat reflux

oesophagitis or reflux disease. This

can be caused by food and acid from

the stomach flowing the wrong way

(reflux) back up the food pipe, also

known as the oesophagus.

Reflux can cause a burning sensation

in the chest rising up to the throat,

also known as heartburn.

This medicine is also used to help

stop

reflux

oesophagitis

from

coming back or relapsing.

Peptic Ulcers:

This medicine is used to treat peptic

ulcers. Depending on the position of

the ulcer, it is called a gastric or

duodenal

ulcer.

gastric

ulcer

occurs in the stomach. A duodenal

ulcer occurs in the duodenum which

tube

leading

stomach. These ulcers can be caused

by too much acid being made in the

stomach.

Most people who have a peptic ulcer

also

have

bacteria

called

Helicobacter pylori in their stomach.

Your

doctor

also

prescribe

course of antibiotics (clarithromycin

amoxycillin)

you.

When

PARBEZOL

taken

with

antibiotics, the combination therapy

will kill the Helicobacter pylori and

let your ulcer heal.

Chronic Gastritis:

presence

bacteria

Helicobacter

pylori

cause

stomach

become

inflamed,

resulting

pain,

nausea

vomiting.

When PARBEZOL tablets are taken

with antibiotics, they will help kill

Helicobacter

pylori

allow

stomach to heal.

How it works

PARBEZOL belongs to a group of

medicines

called

proton

pump

inhibitors (PPIs).

It works by decreasing the amount of

acid

stomach

makes,

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 may 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

PARBEZOL

TM

When you must not take it

Do not take

PARBEZOL

if you

have an allergy to:

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

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 on 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.

expired

damaged,

return

your

pharmacist

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

have

allergies to any other

medicines,

foods, preservatives or dyes.

Tell your doctor if you have or

have

had

any

of

the

following

medical conditions:

liver disease

PARBEZOL

CONSUMER MEDICINE INFORMATION

Ver 1.1

Page 2 of 5

Tell your doctor if you are pregnant

or plan to become pregnant or are

breast-feeding.

Your doctor can discuss with you the

risks and benefits involved.

If you have not told your doctor

about

any

of

the

above,

tell

him/her

before

you

start

taking

this medicine.

Taking other medicines

Tell your doctor or pharmacist if

you

are

taking

any

other

medicines, including:

all prescription medicines

medicines,

vitamins,

herbal

supplements

natural

therapies

without

prescription

from

pharmacy,

supermarket,

naturopath or health food shop.

Some medicines may be affected by

PARBEZOL or may affect how well

works.

need

different

amounts of your medicines, or you

need

take

different

medicines. Your doctor will advise

you.

Do not take PARBEZOL and tell

your doctor or pharmacist if you

are taking any of the following:

atazanavir,

a

medicine

used

(with

other

antiretrovirals)

to

treat HIV-1 infection.

clopidogrel,

an

antiplatelet

medicine.

You should not take PARBEZOL

while taking these medicines.

Also

tell

your

doctor

or

pharmacist if you are taking any

of the following:

cyclosporin,

medicine

used

treat several conditions including

prevention

graft

rejection

following

kidney,

liver

heart

transplantation;

severe,

active

rheumatoid

arthritis;

severe

skin

diseases;

kidney

disease

where

other treatments have failed.

methotrexate, a medicine used to

treat some kinds of cancer. It is

also used to treat psoriasis (skin

disease) and rheumatoid arthritis.

digoxin, a medicine used to treat

heart problems.

ketoconazole, a medicine used to

treat fungal infections.

clarithromycin, a medicine used to

treat infections.

Your

doctor

pharmacist

have

more information on medicines to be

careful with or avoid while taking

this medicine.

How to take PARBEZOL

TM

Follow all directions given to you

by

your

doctor

or

pharmacist

carefully.

They

differ

from

information contained in this leaflet.

If

you

do

not

understand

the

instructions on the box/bottle, ask

your

doctor

or

pharmacist

for

help.

How much to take

Your doctor will tell you how many

tablets you need to take each day.

This may depend on your age, your

condition and whether or not you are

taking any other medicines.

Adults

The usual dose is one tablet at the

same time each day. For treating

Helicobacter

pylori

infections

combination

with

antibiotics

(clarithromycin

amoxycillin),

the dose is one tablet twice each day,

morning and evening.

The dose of PARBEZOL 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

This medicine should not be given to

children.

How to take it

Swallow the tablets whole with a full

glass of water or other liquid.

Do NOT crush or chew the tablets.

They have a special coating, which

protects them from the acid in your

stomach. If the coating is broken by

chewing, the tablets may not 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 you remember when to take it.It

does

matter

take

this

medicine with food or on an empty

stomach.

Ask your doctor or pharmacist for

help if you do not understand the

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 of

getting an 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)

Immediately

telephone

your

doctor,

or

Poisons

Information

Centre (telephone Australia 13 11

26 or New Zealand 0800 POISON

or 0800 764 766) for advice, or go

to Accident and Emergency at the

nearest hospital, if you think that

PARBEZOL

CONSUMER MEDICINE INFORMATION

Ver 1.1

Page 3 of 5

you or anyone else may have taken

too much PARBEZOL

TM

.

Do this even if there are no signs of

discomfort or poisoning.

need

urgent

medical

attention.

While

you

are

using

PARBEZOL

TM

Things you must do

Use this medicine exactly as your

doctor has prescribed.

Always swallow the tablets whole.

If you are about to be started on

any

new

medicine,

remind

your

doctor

and

pharmacist

that

you

are taking this medicine.

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.

It may affect other medicines used

during surgery.

If you become pregnant while taking

this

medicine,

tell

your

doctor

immediately.

Things you must not do

Do not take PARBEZOL 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

this

medicine

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

PARBEZOL affects you.

This medicine may cause dizziness

some

people.

have

this

symptom,

drive,

operate

machinery or do anything else that

could be 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

help

your

condition.

Your doctor or pharmacist can give

more

information

about

these

measures.

Alcohol

- your doctor may advise

you to limit your alcohol intake.

Aspirin

and

many

other

medicines

used

to

treat

arthritis/period pain/headaches

these

medicines

irritate

stomach

make

your

condition worse. Your doctor or

pharmacist

suggest

other

medicines you can take.

Caffeine

- your doctor may advise

you to limit the number of 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. Eat 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

PARBEZOL

is

usually

well

tolerated but tell your doctor or

pharmacist as soon as possible if

you do not feel well while you are

taking this medicine.

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.

It can be difficult to tell whether side

effects are the result of taking this

medicine, effects of your condition

side

effects

other

medicines

you may be taking. For this reason, it

is important to tell your doctor of

any change in your condition.

Do not be alarmed by this list of

possible side effects.

experience

them.

Ask your doctor or pharmacist to

answer

any

questions

you

may

have.

Tell your doctor if:

Tell your doctor or pharmacist if

you notice any of the following and

they worry you:

headache

dizziness

diarrhoea

constipation

nausea

vomiting

abdominal pain

unusual weakness

wind

rash

muscle weakness

dry mouth

runny or blocked nose

sore throat and discomfort when

swallowing

cough

infection

chest pain

back pain

insomnia

breast enlargement in men

itchy

rash

accompanied

skin

eruption

These side effects are usually mild.

PARBEZOL

CONSUMER MEDICINE INFORMATION

Ver 1.1

Page 4 of 5

People

take

proton

pump

inhibitor

(PPI)

medicines

high

doses for a long period of time (1

year

longer)

have

increased risk of fractures of the hip,

wrist, or spine.

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

usually

mild

short-

lived.

Tell

your

doctor

as

soon

as

possible if:

Tell

your

doctor

as

soon

as

possible if you notice any of the

following:

bleeding or bruising more easily

than normal

signs of frequent infections such

as 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

rare.

Go to hospital if:

Tell your doctor immediately (and

do

not

take

your

next

dose

of

PARBEZOL

TM

) 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 of breath or wheezing

The above list includes very serious

side effects. You may need urgent

medical attention or hospitalisation.

These side effects are very rare.

Other problems are more likely to

arise from the 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

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 using PARBEZOL

TM

Storage

Keep

your

tablets

in

the

pack/bottle until it is time to take

them.

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

PARBEZOL

TM

,

or

any

other

medicine,

in

the

bathroom or near a sink. Do not

leave it on a window sill or in the

car.

Heat

dampness

destroy

some medicines.

Keep

it

where

children

cannot

reach it.

A locked cupboard at least one-and-

a-half metres above the ground is a

good place to store medicines.

Disposal

If

your

doctor

tells

you

to

stop

taking this medicine, or the expiry

date

has

passed,

ask

your

pharmacist what to do with any

medicine that is left over.

Product Description

What it looks like

PARBEZOL

tablets

round, white, enteric coated tablets.

PARBEZOL

tablets

round, yellow, enteric coated tablets.

PARBEZOL tablets are supplied in

blister

packs,

pack

sizes

tablets (10 mg) & 30 tablets (20 mg)

and HDPE plastic bottles, in pack

sizes of 90 tablets (20 mg).

Ingredients

Each PARBEZOL tablet contains 10

mg or 20 mg of rabeprazole sodium

as the active ingredient.

Each

tablet

also

contains

following other ingredients:

- mannitol

- heavy magnesium oxide

- light magnesium oxide

- magnesium stearate

- hypromellose

- crospovidone

- hydroxypropylcellulose

- ethylcellulose

- hypromellose phthalate

- diacetylatedmonoglycerides

- purified talc

- titanium dioxide

PARBEZOL

tablets

also

contain:

- Iron oxide yellow (colouring)

This

medicine

does

contain

lactose, sucrose, gluten, tartrazine or

any other azo dyes.

Sponsor

Arrow Pharma Pty Ltd

15 – 17 Chapel Street

Cremorne VIC 3121

Australian registration numbers

10 mg tablet (in blister packs):

AUST R 216107

20 mg tablet (in blister packs):

AUST R 216109

20 mg tablet (in HDPE bottles):

PARBEZOL

CONSUMER MEDICINE INFORMATION

Ver 1.1

Page 5 of 5

AUST R 216110

This leaflet was prepared in July

2017

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26-9-2018

Kexxtone (Elanco GmbH)

Kexxtone (Elanco GmbH)

Kexxtone (Active substance: Monensin sodium) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6324 of Wed, 26 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/2235/T/10

Europe -DG Health and Food Safety

24-9-2018

Inhixa (Techdow Europe AB)

Inhixa (Techdow Europe AB)

Inhixa (Active substance: enoxaparin sodium) - Centralised - Variation - Commission Decision (2018)6101 of Mon, 24 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4264/X/18, 26

Europe -DG Health and Food Safety

27-8-2018

Arixtra (Aspen Pharma Trading Limited)

Arixtra (Aspen Pharma Trading Limited)

Arixtra (Active substance: Fondaparinux sodium) - PSUSA - Modification - Commission Decision (2018)5708 of Mon, 27 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/403/PSUSA/1467-201712

Europe -DG Health and Food Safety

3-8-2018

Sodium oxybate

Sodium oxybate

Sodium oxybate (Active substance: Sodium oxybate) - Centralised - Art 28 - (PSUR - Commission Decision (2018)5381 of Fri, 03 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/PSUSA/10612/201710

Europe -DG Health and Food Safety

2-8-2018

EU/3/18/2043 (Dr Ulrich Granzer)

EU/3/18/2043 (Dr Ulrich Granzer)

EU/3/18/2043 (Active substance: Combination of carboplatin and sodium valproate) - Orphan designation - Commission Decision (2018)5275 of Thu, 02 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/036/18

Europe -DG Health and Food Safety

11-7-2018

Fosavance (Merck Sharp and Dohme B.V.)

Fosavance (Merck Sharp and Dohme B.V.)

Fosavance (Active substance: Alendronate Sodium / Colecalciferol) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)4518 of Wed, 11 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/619/T/42

Europe -DG Health and Food Safety

10-7-2018

Adrovance (Merck Sharp and Dohme B.V.)

Adrovance (Merck Sharp and Dohme B.V.)

Adrovance (Active substance: Alendronate sodium / Colecalciferol) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)4477 of Tue, 10 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/759/T/39

Europe -DG Health and Food Safety

10-7-2018

Ammonaps (Swedish Orphan Biovitrum International AB)

Ammonaps (Swedish Orphan Biovitrum International AB)

Ammonaps (Active substance: Sodium phenylbutyrate) - Centralised - Yearly update - Commission Decision (2018)4483 of Tue, 10 Jul 2018

Europe -DG Health and Food Safety

5-7-2018

Withdrawn application:  Prohippur, sodium benzoate, Initial authorisation

Withdrawn application: Prohippur, sodium benzoate, Initial authorisation

Europe - EMA - European Medicines Agency

19-6-2018

Xyrem (UCB Pharma S.A.)

Xyrem (UCB Pharma S.A.)

Xyrem (Active substance: Sodium oxybate) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)3912 of Tue, 19 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/593/T/74

Europe -DG Health and Food Safety

1-6-2018

Valproate

Valproate

Valproate (Active substance: medicinal products containing substances related to valproate (sodium valproate, valproic acid, valproate semisodium, valpromide, valproate magnesium)) - Community Referrals - Art 31 - Commission Decision (2018)3623 of Fri, 01 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/H/A-31/1454

Europe -DG Health and Food Safety

28-3-2018

EU/3/17/1876 (FGK Representative Service GmbH)

EU/3/17/1876 (FGK Representative Service GmbH)

EU/3/17/1876 (Active substance: Sodium (1R,3R,4R,5S)-3-({2-N-acetylamino-2-deoxy-3-O-[(1S)-1-carboxylato-2-cyclohexylethyl]-beta-D-galactopyranosyl}oxy)-4-({6-deoxy-alpha-L-galactopyranosyl}oxy)-5-ethyl-cyclohexan-1-yl-(38-oxo-2,5,8,11,14,17,20,23,26,29,32,35-dodecaoxa-39-azahentetracontan-41-yl)carboxamide) - Transfer of orphan designation - Commission Decision (2018)2011 of Wed, 28 Mar 2018 European Medicines Agency (EMA) procedure number: EMA/OD/010/17/T/01

Europe -DG Health and Food Safety

21-3-2018

EU/3/16/1711 (Akcea Therapeutics UK Ltd)

EU/3/16/1711 (Akcea Therapeutics UK Ltd)

EU/3/16/1711 (Active substance: Volanesorsen sodium) - Transfer of orphan designation - Commission Decision (2018)1822 of Wed, 21 Mar 2018 European Medicines Agency (EMA) procedure number: EMA/OD/082/16/T/01

Europe -DG Health and Food Safety