PRABEZ rabeprazole sodium 20mg enteric coated tablet blister pack

Main information

  • Trade name:
  • PRABEZ rabeprazole sodium 20mg enteric coated tablet blister pack
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • PRABEZ rabeprazole sodium 20mg enteric coated tablet blister pack
    Australia
  • Language:
  • English

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization status:
  • Registered
  • Authorization number:
  • 196572
  • Last update:
  • 21-05-2019

Public Assessment Report

Public Summary

Summary for ARTG Entry:

196572

PRABEZ rabeprazole sodium 20mg enteric coated tablet blister pack

ARTG entry for

Medicine Registered

Sponsor

Alphapharm Pty Ltd

Postal Address

PO Box R1462,ROYAL EXCHANGE, NSW, 1225

Australia

ARTG Start Date

27/05/2013

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. PRABEZ rabeprazole sodium 20mg enteric coated tablet blister pack

Product Type

Single Medicine Product

Effective date

16/06/2016

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

? 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

antiinflammatory,drugs (NSAIDs) usually require treatment with antimicrobial agents in addition to,antisecretory drugs whether on first presentation or on

recurrence.,It is 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

Blister Pack

Al/Al

24 Months

Store below 25

degrees Celsius

Neither child resistant

closure nor restricted

flow insert

Do not Freeze

Do not Refrigerate

Pack Size/Poison information

Pack Size

Poison Schedule

2,7, 10, 28, 30 tablets

(S4) Prescription Only Medicine

Components

1. PRABEZ rabeprazole sodium 20mg enteric coated tablet blister pack

Dosage Form

Tablet, enteric coated

Route of Administration

Oral

Visual Identification

Light yellow, round, biconvex coated tablets and plain on both sides.

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 28.11.2017 at 01:37:11 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

PRABEZ Tablets

Rabeprazole sodium

CONSUMER MEDICINE INFORMATION

What is in this leaflet

This leaflet answers some common

questions about PRABEZ tablets. It

does not contain all the available

information. It does not take the

place of talking to your doctor or

pharmacist.

All medicines have risks and

benefits. Your doctor has weighed

the risks of you taking PRABEZ

against the benefits this medicine is

expected to have for you.

If you have any concerns about

using PRABEZ ask your doctor or

pharmacist.

Keep this leaflet with your

medicine.

You may need to read it again.

What PRABEZ is used

for

The name of your medicine is

PRABEZ. It contains the active

ingredient rabeprazole sodium.

Reflux Oesophagitis:

PRABEZ 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.

PRABEZ is also used to help stop

reflux oesophagitis from coming

back or relapsing.

Peptic Ulcers:

PRABEZ is used to treat peptic

ulcers. Depending on the position of

the ulcer it is called a gastric or

duodenal ulcer. A gastric ulcer

occurs in the stomach. A duodenal

ulcer occurs in the duodenum which

is the tube leading out of the

stomach.

These ulcers can be caused by too

much acid being made in the

stomach.

Most people who have a peptic ulcer

also have a bacteria called

Helicobacter pylori in their stomach.

Your doctor may also prescribe a

course of antibiotics (clarithromycin

and amoxycillin) for you. When

PRABEZ is taken with antibiotics,

the combination therapy will kill the

Helicobacter pylori and let your ulcer

heal.

Chronic Gastritis:

The presence of the bacteria

Helicobacter pylori may cause the

stomach to become inflamed,

resulting in pain, nausea and

vomiting.

When PRABEZ tablets are taken

with antibiotics, they will help kill

Helicobacter pylori and allow the

stomach to heal.

How PRABEZ works

PRABEZ belongs to a group of

medicines called proton pump

inhibitors (PPIs). PRABEZ works by

decreasing the amount of acid the

stomach makes, to give relief from

the symptoms and allow healing to

take place. Your food will still be

digested in the normal way.

Your doctor may have prescribed

PRABEZ for another reason. Ask

your doctor if you have any questions

about why PRABEZ has been

prescribed for you.

PRABEZ is only available with a

doctor's prescription.

Before you take

PRABEZ

When you must not take it

Do not take PRABEZ if you have

an allergy to:

rabeprazole sodium

any of the ingredients listed at the

end of this leaflet.

other proton pump inhibitors

(omeprazole, esomeprazole,

lansoprazole, pantoprazole).

Symptoms of an allergic reaction

may include:

rash, itching or hives on the skin

shortness of breath, wheezing or

difficulty breathing

swelling of the face, lips, tongue

or other parts of the body

Do not take PRABEZ if:

the packaging is torn or shows

signs of tampering.

the expiry date (month and year)

printed on the pack has passed. If

you take PRABEZ after the

expiry date it may not work.

Before you start to take it:

You must tell your doctor if:

you are pregnant or intend to

become pregnant.

PRABEZ

you are breast-feeding or intend

to breast-feed. It is not known if

PRABEZ passes into breast milk.

you have or have ever had liver

disease.

Taking other medicines:

Tell your doctor or pharmacist if

you are taking any other

medicines, including medicines you

can buy without a prescription

from a pharmacy, supermarket or

health food shop.

Do not take PRABEZ 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 PRABEZ

while taking these medicines.

Also tell your doctor or pharmacist

if you are taking any of the

following:

cyclosporin, a medicine used to

treat several conditions including

prevention of graft rejection

following kidney, liver or 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.

These medicines may be affected by

PRABEZ or may affect how well

PRABEZ works. Your doctor or

pharmacist can tell you what to do if

you are taking any other medicines.

If you have not told your doctor or

pharmacist about any of the above,

tell them before you start taking

PRABEZ.

Your doctor will advise you whether

or not to take

PRABEZ or if you need to have your

dose adjusted.

Taking PRABEZ

Follow the directions given to you

by your doctor and pharmacist.

How much to take:

Adults

The usual dose is one tablet at the

same time each day. For treating

Helicobacter pylori infections in

combination with antibiotics

(clarithromycin and amoxycillin), the

dose is one tablet twice each day,

morning and evening.

The dose of PRABEZ 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

PRABEZ should not be given to

children.

How to take it:

PRABEZ should be swallowed

whole, with a 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.

It does not matter if you take

PRABEZ 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.

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.

If you are not sure what to do, check

with your doctor or pharmacist.

If you have trouble remembering

when to take your medicine, ask your

pharmacist for some hints.

If you have taken too much

(overdose):

Immediately telephone your doctor

or the Poisons Information Centre for

advice, or go to Accident and

Emergency at your nearest hospital.

Do this even if there are no signs of

discomfort or poisoning. You may

need urgent medical attention.

Poisons Information Centre

telephone numbers:

Australia: 13 11 26

While you are using

PRABEZ

Things you must do

Use PRABEZ exactly as your

doctor has prescribed.

Always swallow PRABEZ tablets

whole.

Tell your doctor if you become

pregnant while you are taking

PRABEZ

Tell your doctor or pharmacist

that you are taking PRABEZ if you

are about to start taking a new

medicine.

Things you must not do

Do not use PRABEZ to treat

any other complaint unless

your doctor says to.

Do not give this medicine to

anyone else, even if they have

the same symptoms as you.

PRABEZ

Do not crush or chew the

tablets.

Do not give PRABEZ to

children.

Things that may help your

condition

Some self help measures suggested

below may help your condition. Talk

to your doctor or pharmacist for 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 may irritate the

stomach and may make your

condition worse. Your doctor or

pharmacist may suggest other

medicines you can take.

Caffeine - your doctor may advise

you to limit the number of drinks

which contain caffeine, such as

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

PRABEZ is usually well tolerated

but tell your doctor or pharmacist as

soon as possible if you do not feel

well while you are taking PRABEZ.

PRABEZ helps most people with

peptic ulcers or reflux disease, but it

may have unwanted side effects in a

few people.

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

side effects.

Do not be alarmed by this list of

possible side effects. You may not

experience any of them.

Ask your doctor or pharmacist to

answer any questions you may have.

Tell your doctor if you experience

any of the following and they

worry you:

headache

diarrhoea

abdominal pain

unusual weakness

wind

rash

dry mouth

dizziness

nausea

vomiting

constipation

runny or blocked nose

sore throat and discomfort when

swallowing

cough

infection

chest pain

back pain

muscle weakness

insomnia

breast enlargement in men

itchy rash accompanied by skin

eruption

These side effects are usually mild.

People who take proton pump

inhibitor (PPI) medicines at high

doses for a long period of time (1

year or longer) may have an

increased risk of fractures of the hip,

wrist, or spine.

Tell your doctor immediately 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.

These are serious side effects. You

may need urgent medical attention.

Serious side effects are rare.

Tell your doctor immediately and

do not take your next dose of

PRABEZ if you experience:

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.

Other side effects not listed above

may also occur in some people. Tell

your doctor if you notice anything

making you feel unwell when you are

taking, or soon after you have

finished taking PRABEZ.

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

you pass black (blood-stained)

motions.

Ask your doctor or pharmacist if

you do not understand anything in

this list.

After using PRABEZ

Storage

Do not take PRABEZ tablets out of

the blister pack until it is time to

take them. If you take them out of

the blister they may not keep well.

Keep PRABEZ tablets in a cool

dry place where the temperature is

below 25°C. Do not keep PRABEZ

in the refrigerator.

Do not store PRABEZ, or any

other medicine, in the bathroom or

near a sink. Do not leave medicines

in the car or on window sills. Heat

and dampness can destroy some

medicines.

Keep your medicines where

children cannot reach them. A

PRABEZ

locked cupboard at least one-and-

a-half metres (1.5 m) above the

ground is a good place to store

medicines.

Disposal

If your doctor tells you to stop

taking PRABEZ tablets, or the

tablets have passed their expiry

date, ask your pharmacist what to

do with any tablets that are left

over.

Product description

What it looks like

PRABEZ 10 mg tablets are pink,

round, biconvex coated tablets and

plain on both sides.

This is available in a blister pack of

28 tablets.

PRABEZ 20 mg tablets are light

yellow, round, biconvex coated

tablets and plain on both sides.

This is available in a blister pack of

30 tablets.

Ingredients

Each PRABEZ tablet contains 10 mg

or 20 mg of rabeprazole sodium as

the active ingredient.

Each tablet also contains the

following other ingredients:

mannitol, light magnesium oxide,

hypromellose, magnesium

stearate, ethylcellulose,

hypromellose phthalate,

diacetylated monoglycerides,

purified talc, titanium dioxide and

carnauba wax

The 20 mg tablets also contain

iron oxide yellow

The 10 mg tablets contain iron

oxide red

The tablets do not contain lactose

or gluten.

Sponsor

Alphapharm Pty Limited

(ABN 93 002 359 739)

Level 1, 30 The Bond

30-34 Hickson Road

Millers Point NSW 2000

Phone: (02) 9298 3999

www.alphapharm.com.au

Australian registration numbers:

AUST R 196564

AUST R 196572

This leaflet was prepared on

15 June 2016.

Prabez_cmi\Jun16/01

PRABEZ