IBAVYR

Main information

  • Trade name:
  • IBAVYR ribavirin 600 mg tablet bottle
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • IBAVYR ribavirin 600 mg tablet bottle
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 222628
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

222628

IBAVYR ribavirin 600 mg tablet bottle

ARTG entry for

Medicine Registered

Sponsor

Clinect Pty Ltd

Postal Address

PO Box 7300,Melbourne, VIC, 8004

Australia

ARTG Start Date

26/02/2015

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. IBAVYR ribavirin 600 mg tablet bottle

Product Type

Single Medicine Product

Effective date

12/09/2017

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

IBAVYR (ribavirin tablets) is indicated in combination with other oral agents for the treatment of chronic hepatitis C (CHC) in adults.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Bottle

HDPE

3 Years

Store below 25

degrees Celsius

Child resistant closure

Protect from Light

Pack Size/Poison information

Pack Size

Poison Schedule

28 tablets

(S4) Prescription Only Medicine

Components

1. IBAVYR ribavirin 600 mg tablet bottle

Dosage Form

Tablet

Route of Administration

Oral

Visual Identification

White, capsule-shaped coated tablet, debossed with "600" on one side and

nothing on the other side.

Active Ingredients

Ribavirin

600 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 26.11.2017 at 11:01:22 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

IBAVYR

200MG, 400 MG AND 600 MG TABLETS

IBAVYR

®

200mg, 400 mg, 600 mg ribavirin tablets

contains the active ingredient ribavirin

CONSUMER MEDICINE INFORMATION

What is in this leaflet

This leaflet answers some common

questions about IBAVYR.

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 risks and

benefits. Your doctor has weighed

the risks of you using IBAVYR

against the benefits they expect it

will 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 want to read it again.

What IBAVYR is used

for

IBAVYR Tablets contain the active

ingredient ribavirin. Ribavirin

belongs to a group of medicines

called antivirals.

IBAVYR is used in combination

with other oral agents for the

treatment of chronic hepatitis C

(CHC). CHC is a viral infection of

the liver. There are different types of

the hepatitis C virus, referred to as

genotypes. If this viral infection is

not managed in some people, the

liver becomes badly damaged and

scarred. This is called cirrhosis.

Cirrhosis can cause the liver to stop

working. CHC may also be

associated with the development of

hepatocellular carcinoma.

IBAVYR is not effective when used

alone and must only be used in

combination with other oral agents.

For more information please refer to

the respective Consumer Medicine

Information of the other oral agent

used during the treatment.

This medicine is available only with

a doctor's prescription.

Before you take

IBAVYR

When you must not take it

Do not take Ibavyr if you are

allergic to:

ribavirin, the active ingredient, or

to any of the other ingredients

listed at the end of this leaflet

under Product Description

any other similar medicines

Some of the 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 on the skin

Do not take Ibavyr if:

you or your partner is pregnant

or planning to become

pregnant.

IBAVYR may cause birth defects

and/or death of an unborn baby.

It is very important that you or

your partner avoid becoming

pregnant during treatment and for

6 months after treatment. This is

because IBAVYR Tablets can

affect the sperm as well as the

unborn child.

you are taking didanosine (a

medicine used to treat patients

with human immunodeficiency

virus (HIV).

you have blood disorders

including anaemia (low number

of red blood cells), thalassaemia

(Mediterranean anaemia) or

sickle-cell anaemia

the packaging is torn or shows

signs of tampering.

the expiry date (EXP) printed

on the packs has passed. If you

use it after the expiry date it

may not work as well.

If you are not sure whether you

should start taking IBAVYR, talk

to your doctor or pharmacist.

Before you start to take it

If you are or your partner is a

woman of childbearing age, you or

your partner must have a negative

pregnancy test before treatment

with IBAVYR Tablets starts.

You or your partner must also have a

negative pregnancy test each month

during treatment and for the 6

months after treatment is stopped.

Two effective forms of contraception

must be used, one by each partner,

male and female, during treatment

with IBAVYR Tablets and for the 6

months after treatment is completed.

IBAVYR Tablets can cause harm to

IBAVYR

200MG, 400 MG AND 600 MG TABLETS

the unborn child if a pregnant woman

takes IBAVYR Tablets herself

during pregnancy or has unprotected

sex (sex without using a condom)

with a man who is taking IBAVYR

Tablets. IBAVYR Tablets can

damage the sperm and the embryo

(unborn child).

Tell your doctor if you have

allergies to any other medicines,

foods, preservatives or dyes.

Do not use IBAVYR Tablets if you

are breastfeeding.

It is not known if IBAVYR passes

into breast milk. Therefore to avoid

any potential side effects in the

nursing infant, nursing mothers

should stop breast feeding when

taking IBAVYR.

Do not give IBAVYR to children

under 18 years of age.

Safety and effectiveness in children

has not been established.

Tell your doctor if you have, or

have ever had any of the following

medical conditions before you start

taking IBAVYR:

heart problems such as congestive

heart failure, irregular or very fast

heartbeat, heart disease, or you

have ever had a heart attack

anaemia (a low number of red

blood cells)

kidney problems

liver problems other than

hepatitis C

organ transplant

Also refer to the respective

Consumer Medicines Information

of the other oral agent used during

the treatment, for other things to

be careful of when IBAVYR is

taken in combination with other

oral agents.

Taking other medicines

Tell your doctor if you are taking

any other medicines including any

that you have bought from a

pharmacy, supermarket or health

food shop.

You must not take IBAVYR if you

are taking didanosine (a medicine

used to treat HIV).

You must tell your doctor if you

are taking:

stavudine, zidovudine or

lamivudine (medicines used to

treat HIV), azathioprine (a

medicine used to treat organ

transplant patients), severe

rheumatoid arthritis, systemic

lupus erythematosus,

dermatomyositis/polymyositis,

autoimmune chronic active

hepatitis, pemphigus vulgaris,

polyarteritis nodosa, autoimmune

haemolytic anaemia, chronic

refractory idiopathic

thrombocytopenic purpura

Some medicines may interfere with

IBAVYR or may affect how well it

works. You may need to use

different amounts of your medicine

or you may need to take different

medicines. Your doctor will advise

you.

Your doctor or pharmacist has more

information on medicines to be

careful of or avoid using while taking

IBAVYR.

Ask your doctor or pharmacist if

you are not sure about this list of

medicines.

How to use IBAVYR

Take IBAVYR exactly as your

doctor has directed.

Your doctor will tell you how many

tablets to take each day.

Do not exceed the recommended

dosage.

IBAVYR has a child resistant cap.

To open cap, push cap downward

and twist counter clockwise.

Please refer to illustration.

To close cap, place cap on bottle and

turn clockwise.

How much to take

The usual dose of IBAVYR depends

on your weight and genotype. This

can range from 600 mg to 1200 mg

daily, to be taken in two divided

doses (morning and evening).

Routine blood tests will help your

doctor to monitor your response to

treatment.

Your doctor may adjust your dose

during therapy according to your

response.

How to take IBAVYR

IBAVYR should be taken with food.

Do not crush or chew the tablets.

IBAVYR 200mg and 600mg tablets

should be swallowed whole with

water. IBAVYR 400mg tablets are

scored and can be split into two equal

halves as necessary and should be

swallowed with water.

When to take IBAVYR

Take IBAVYR during or

immediately after a meal, at about

the same times each day.

Taking IBAVYR at the same times

every day will have the best effect

and help you to remember to take

your tablets.

How long to take IBAVYR

Do not stop taking IBAVYR unless

your doctor tells you to stop.

Treatment is usually for at least 12

weeks and can go up to 24 weeks

depending on your response.

If you become pregnant while

using IBAVYR Tablets, you should

immediately stop taking IBAVYR

and tell your doctor. If you are

male and your partner becomes

IBAVYR

200MG, 400 MG AND 600 MG TABLETS

pregnant while you are taking

IBAVYR, ask your partner to tell

her doctor immediately.

If you forget to take it

If you miss a dose of IBAVYR do

not take a double dose to make up

for the tablet you missed.

Take the missed dose as soon as

possible during the same day.

If it is almost time for your next

dose, skip the dose you missed and

take your next dose when you are

meant to.

If you are not sure what to do, ask

your doctor or pharmacist.

If you have trouble remembering

when to use your medicine, ask your

pharmacist for some helpful hints.

If you take too much

(overdose)

Immediately telephone your doctor

or Poisons Information Centre

(telephone number for Australia:

13 11 26, or New Zealand: 0800

764 766 [0800 POISON]) for

advice, or go to Accident and

Emergency at your nearest

hospital if you think that you or

anyone else may have taken too

much IBAVYR, even if there are

no signs of discomfort or

poisoning. You may need urgent

medical attention.

Keep telephone numbers for these

places handy.

While you are taking

IBAVYR

Things you must do

Use IBAVYR Tablets exactly as

your doctor has prescribed.

Tell all doctors, dentists and

pharmacists who are treating you

that you are taking IBAVYR.

Use contraception in order to avoid

pregnancy.

Stop using IBAVYR Tablets if you

become pregnant and immediately

tell your doctor.

If you are male and your partner

becomes pregnant while you are

using IBAVYR, ask your partner

to tell her doctor immediately.

Keep all your doctor's

appointments so that your progress

can be checked. Your doctor will

carry out blood tests to monitor

your response to treatment.

If you are about to be started on

any new medicine, remind your

doctor and pharmacist that you

are taking IBAVYR.

Things you must not do

Do not stop taking IBAVYR or

change the dose without first

checking with your doctor.

Do not use it to treat any other

complaints unless your doctor says

to.

Do not give IBAVYR to anyone

else, even if their symptoms seem

similar to yours.

Do not let yourself run out of

medicine over weekends or holiday

periods.

Do not take any other medicines

whether they require a

prescription or not without first

telling your doctor or pharmacist.

Things to be careful of

Be careful driving or operating

machinery until you know how

IBAVYR affects you.

If you become drowsy from the

combination therapy, do not drive or

use machinery.

Side effects

Tell your doctor or pharmacist as

soon as possible if you do not feel

well while you are taking IBAVYR

in combination with other oral

agents.

The side effects listed below are

possible side effects.

For more information please refer to

the respective Consumer Medicine

Information of the other oral agent

used during the treatment.

All medicines can have side effects.

Sometimes they are serious, most of

the time they are not. You may need

medical attention if you get some of

the side effects.

Do not be alarmed by the following

lists of 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, fatigue, fever and chills

weakness

sleeplessness

stomach pain, discomfort or

constipation

muscular ache and pain or joint

pain

agitation, irritability, mood

swings, or disturbance in

attention

hair loss/change in hair texture,

itching, rash or dry or redness of

the skin

sore throat, cough, shortness of

breath

back pain.

These are mild side effects of the

medicine and are usually short-lived.

If they continue or are severe, tell

your doctor.

Tell your doctor as soon as possible

if you notice any of the following:

signs of anaemia such as

tiredness, being short of breath

and looking pale

signs of liver decompensation

such as a swollen abdomen lower

back or side pain

severe stomach pain

IBAVYR

200MG, 400 MG AND 600 MG TABLETS

fever or chills beginning after a

few weeks of treatment

persistent cough or shortness of

breath

depression

confusion, trouble sleeping,

thinking or concentrating

The above list includes serious side

effects that may require medical

attention.

If any of the following happen, tell

your doctor immediately or go to

Accident and Emergency at your

nearest hospital:

itchy rash,

swelling of the face, lips or

tongue,

wheezing or troubled breathing or

faintness.

These could be signs of a serious

allergic reaction.

Other side effects not listed above

may also occur in some patients. If

you notice any other side effects,

check with your doctor.

Check with your doctor as soon as

possible if you have any problems

while using the combination

therapy, even if you do not think

the problems are connected with

the medicines.

After taking IBAVYR

Storage

Always keep this medicine in the

bottle until it is time to take it.

Keep your medicine in a cool dry

place where the temperature stays

below 25°C.

Do not store IBAVYR or any other

medicine in the bathroom or near a

sink. Do not leave it on a window sill

or in the car. Keep bottle tightly

closed.

Heat and dampness can destroy some

medicines.

Keep IBAVYR where children

cannot reach.

A locked cupboard at least one-and-

a-half metres above the ground is a

good place to store medicines.

Disposal

Return any unused medicine to

your pharmacist.

Product description

What it looks like

IBAVYR 200 mg tablets are white,

capsule-shaped, coated tablet,

debossed with "200" on one side and

nothing on the other side.

IBAVYR 400 mg tablets are light

pink, capsule-shaped coated tablets,

debossed with "400" on one side and

scored on the other side.

IBAVYR 600 mg tablets are white,

capsule-shaped coated tablets,

debossed with "600" on one side and

nothing on the other side.

The tablets are packaged in HDPE

bottles of 28 tablets with a child

resistant closure.

Ingredients

Each IBAVYR tablet contains

ribavirin as the active ingredient.

The tablets also contain the following

inactive ingredients:

Povidone

Croscarmellose sodium

Microcrystalline cellulose

Crospovidone

Silicon dioxide

Magnesium stearate

The IBAVYR tablet coating

contains:

400 mg: Opadry Orange

04F93451 (PI 109445)

200mg and 600 mg: Opadry

White 03F180000 (PI 109444)

Supplier

In Australia and New Zealand:

Clinect Pty Ltd

120 - 132 Atlantic Drive

Keysborough VIC 3173

Australia

Free Call Australia:

1800 899 005

Free Call New Zealand:

0800 138 803

Australian Registration Number

AUST R 243632 - 200 mg tablets

AUST R 222627 - 400 mg tablets

AUST R 222628 - 600 mg tablets

Date of Preparation

14 November 2016

® Registered trademark of

PHARMASCIENCE Inc.

15-5-2018

Orphan designation:  Ribavirin,  for the: Treatment of Lassa fever

Orphan designation: Ribavirin, for the: Treatment of Lassa fever

Europe - EMA - European Medicines Agency

2-10-2018

Rebetol (Merck Sharp and Dohme B.V.)

Rebetol (Merck Sharp and Dohme B.V.)

Rebetol (Active substance: ribavirin) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6479 of Tue, 02 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/246/T83

Europe -DG Health and Food Safety

7-8-2018

Ribavirin Mylan (Mylan S.A.S.)

Ribavirin Mylan (Mylan S.A.S.)

Ribavirin Mylan (Active substance: Ribavirin ) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5423 of Tue, 07 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/1185/T/29

Europe -DG Health and Food Safety

23-3-2018

EU/3/18/2003 (Pharmadev Healthcare Ltd)

EU/3/18/2003 (Pharmadev Healthcare Ltd)

EU/3/18/2003 (Active substance: Ribavirin) - Orphan designation - Commission Decision (2018)1891 of Fri, 23 Mar 2018 European Medicines Agency (EMA) procedure number: EMA/OD/225/17

Europe -DG Health and Food Safety

23-3-2018

EU/3/18/2002 (Pharmadev Healthcare Ltd)

EU/3/18/2002 (Pharmadev Healthcare Ltd)

EU/3/18/2002 (Active substance: Ribavirin) - Orphan designation - Commission Decision (2018)1890 of Fri, 23 Mar 2018 European Medicines Agency (EMA) procedure number: EMA/OD/224/17

Europe -DG Health and Food Safety