ZABEP 20 rabeprazole sodium 20 mg enteric coated tablets blister pack

Main information

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

Documents

Localization

  • Available in:
  • ZABEP 20 rabeprazole sodium 20 mg enteric coated tablets blister pack
    Australia
  • Language:
  • English

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization status:
  • Registered
  • Authorization number:
  • 191867
  • Last update:
  • 21-05-2019

Public Assessment Report

Public Summary

Summary for ARTG Entry:

191867

ZABEP 20 rabeprazole sodium 20 mg enteric coated tablets blister pack

ARTG entry for

Medicine Registered

Sponsor

Medis Pharma Pty Ltd

Postal Address

PO Box 6127,North Sydney, NSW, 2059

Australia

ARTG Start Date

6/03/2013

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. ZABEP 20 rabeprazole sodium 20 mg enteric coated tablets blister pack

Product Type

Single Medicine Product

Effective date

26/07/2017

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

Rabeprazole is 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.,Rabeprazole 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

PA/Al/PVC/Al -

polyamide-aluminium

foil-polyvinylchloride/al

uminium foil

24 Months

Store below 25

degrees Celsius

Not recorded

Not recorded

Pack Size/Poison information

Pack Size

Poison Schedule

30 tablets

(S4) Prescription Only Medicine

Components

1. ZABEP 20 rabeprazole sodium 20 mg enteric coated tablets blister pack

Dosage Form

Tablet, enteric coated

Route of Administration

Oral

Visual Identification

Yellow, elliptical, biconvex shaped tablet with no markings

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 09:46:41 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

Zabep/180215/CMI-08

ZABEP 20

contains the active ingredient rabeprazole sodium

CONSUMER MEDICINE INFORMATION

What is in this leaflet

This leaflet answers some common

questions about ZABEP 20.

It does not contain all of the 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 the risks of

you taking ZABEP 20 against the

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 ZABEP 20 is used

for

ZABEP 20 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 the

throat, also known as heartburn.

help stop reflux oesophagitis from

coming back or relapsing

treat peptic ulcers. Depending on

the position of the ulcer it is called

a gastric or duodenal 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 amoxicillin) for

you. When ZABEP 20 is taken with

antibiotics, the combination therapy

will kill the Helicobacter pylori and

let your ulcer heal.

The presence of the bacteria

Helicobacter pylori may cause the

stomach to become inflamed,

resulting in pain, nausea and

vomiting. When ZABEP 20 is taken

with antibiotics, they will help kill

Helicobacter pylori and allow the

stomach to heal.

ZABEP 20 belongs to a group of

medicines called proton pump

inhibitors (PPIs). ZABEP 20 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

ZABEP 20 for another reason. Ask

your doctor if you have any questions

about why ZABEP 20 has been

prescribed for you.

ZABEP 20 is available only with a

doctor's prescription.

Before you take ZABEP

20

When you must not take it

Do not take ZABEP 20 if you are

allergic to medicines containing

rabeprazole sodium, or any other

proton inhibitors (omeprazole,

esomeprazole, lansoprazole,

pantoprazole) or any of the

ingredients listed at the end of this

leaflet.

Some of the symptoms of an allergic

reaction may include skin rash, itching

or hives, swelling of the face, lips or

tongue which may cause difficulty in

swallowing or breathing, wheezing or

shortness of breath.

Do not take ZABEP 20 if the expiry

date (Exp.) printed on the pack has

passed.

Do not take ZABEP 20 if the

packaging is torn or shows signs of

tampering.

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 are pregnant

or plan to become pregnant.

Tell your doctor if you are

breastfeeding or wish to breastfeed.

Your doctor will discuss the risks and

benefits of taking ZABEP 20 when

breastfeeding.

Tell your doctor if you have, or ever

have had, liver disease.

Zabep/180215/CMI-08

If you have not told your doctor

about any of the above, tell them

before you start taking ZABEP 20.

Taking other medicines

Tell your doctor if you are taking any

other medicines, including any that

you buy without a prescription from

a pharmacy, supermarket or health

food shop.

Some medicines may be affected by

ZABEP 20, or may affect how well it

works. These include:

digoxin, a medicine used to treat

heart problems.

ketoconazole, a medicine used to

treat fungal infections.

atazanavir, a medicine used (with

other antiretrovirals) to treat HIV-1

infection.

Your doctor can tell you what to do if

you are taking any of these medicines.

If you are not sure whether you are

taking any of these medicines, check

with your doctor or pharmacist.

Your doctor and pharmacist have more

information on medicines to be careful

with or avoid while taking ZABEP 20.

How to take ZABEP 20

How much to take

The usual dose is one tablet at the same

time each day. For treating

Helicobacter pylori infections in

combinations with antibiotics

(clarithromycin and amoxicillin), the

dose is one tablet twice each day,

morning and evening.

Your doctor may advise you to take a

different dose. This depends on your

condition and whether or not you are

taking any other medicines.

Follow all directions given to you by

your doctor and pharmacist

carefully.

How to take ZABEP 20

Swallow the tablets with a glass of

water.

Do not crush or chew the tablets.

They have a special coating, which

protects them from the acid in your

stomach. If you crush or chew ZABEP

20 tablets, they will not work as well. It

does not matter if you take ZABEP 20

with food or on an empty stomach.

If you forget to take ZABEP 20

If it is almost time for your next dose,

skip the dose you missed and take

your next dose when you are meant

to.

Otherwise, take the missed dose as

soon as you remember, and then go

back to taking your tablets as you

would normally.

Do not take a double dose to make up

for the dose you missed.

If you are not sure what to do, ask

your doctor or pharmacist.

How long to take ZABEP 20

for

Keep taking ZABEP 20 for as long as

your doctor recommends.

If you take too much ZABEP

20 (overdose)

Immediately telephone your doctor,

or the Poisons Information Centre

(telephone 13 11 26), or go to

Accident and Emergency at the

nearest hospital, if you think you or

anyone else may have taken too much

ZABEP 20. Do this even if there are

no signs of discomfort or poisoning.

You may need urgent medical attention.

While you are taking

ZABEP 20

Things you must do

Before starting any new medicine,

tell your doctor or pharmacist that

you are taking ZABEP 20.

Always swallow ZABEP 20 tablets

whole.

Tell all the doctors, dentists and

pharmacists who are treating you

that you are taking ZABEP 20.

Tell your doctor if you become

pregnant while taking ZABEP 20.

If you plan to have surgery, including

dental surgery, tell your doctor or

dentist that you are taking ZABEP

20.

Things you must not do

Do not use ZABEP 20 to treat any

other conditions unless your doctor

tells you to.

Do not give ZABEP 20 to anyone

else, even if they have the same

condition as you.

Do not crush or chew the tablets.

Do not give ZABEP 20 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.

Zabep/180215/CMI-08

Side effects

Tell your doctor or pharmacist as

soon as possible if you do not feel well

while you are taking ZABEP 20.

Like all other medicines, ZABEP 20

may have unwanted side effects in

some people. Sometimes they are

serious, most of the time they are not.

You may need medical treatment if you

get some of the 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 notice any of

the following and they worry you:

headache

dizziness

diarrhoea

constipation

stomach pain

muscle weakness

flatulence

dry mouth

breast enlargement in men

itchy rash accompanied by skin

eruption.

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.

Tell your doctor immediately and do

not take your next dose of ZABEP 20

if you notice any of the following:

signs of allergy such as skin rash,

reddening, blister 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 patients. Tell

your doctor if you notice anything

that is making you feel unwell.

Other problems are more likely to

arise from the ulcer itself rather than

the treatment.

For these reasons 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.

After using ZABEP 20

Storage

Keep ZABEP 20 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.

Keep the tablets in their 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 ZABEP 20 or any other

medicine in the bathroom or near a

sink.

Do not leave ZABEP 20 in the car or

on window sills.

Heat and dampness can destroy some

medicines.

Disposal

If your doctor tells you to stop taking

ZABEP 20, 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

ZABEP 20 - elliptical yellow tablet

with no markings.

Each carton of ZABEP 20 contains 30

enteric coated tablets.

Ingredients

The active ingredient in ZABEP 20 is

rabeprazole sodium:

Each ZABEP 20 enteric coated tablet

contains 20 mg of rabeprazole sodium.

The tablets also contain:

povidone

hydroxypropyl cellulose

magnesium oxide

mannitol

magnesium stearate

ethylcellulose

methacrylic acid-ethyl acrylate

copolymer (1:1)

polysorbate 80

sodium lauryl sulphate

propylene glycol

purified talc

iron oxide yellow (E172)

titanium dioxide (E171).

The tablets do not contain gluten,

lactose, sucrose, tartrazine or any other

azo dyes.

Supplier

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:

ZABEP 20 - AUST R 191867

Date of preparation: May 2015.