VALACICLOVIR AN 500mg

Main information

  • Trade name:
  • VALACICLOVIR AN 500mg
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • VALACICLOVIR AN 500mg
    Australia
  • Language:
  • English

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization status:
  • Registered
  • Authorization number:
  • 173287
  • Last update:
  • 22-05-2019

Public Assessment Report

Public Summary

Summary for ARTG Entry:

173287

VALACICLOVIR AN 500mg valaciclovir (as hydrochloride) 500mg tablet blister pack

ARTG entry for

Medicine Registered

Sponsor

Amneal Pharma Australia Pty Ltd

Postal Address

12 River Street,SOUTH YARRA, VIC, 3141

Australia

ARTG Start Date

25/10/2011

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. VALACICLOVIR AN 500mg

Product Type

Single Medicine Product

Effective date

6/07/2017

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

For the treatment of herpes zoster (shingles) in adult patients who commence therapy within 72 hours of the onset of rash.,For the treatment of

ophthalmic zoster.,For the treatment of recurrent herpes labialis (cold sores),For the treatment of clinical episodes of genital herpes simplex

infections.,For the prevention of recurrent genital herpes.,Reduction of transmission of genital herpes in patients suffering from recurrent genital herpes.

In addition to therapy with Valaciclovir, it is recommended that patients use safer sex practices. ,Prophylaxis of cytomegalovirus (CMV) infection and

disease following solid organ transplantation in patients at risk of CMV disease.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Blister Pack

PVC/PVDC/Al

3 Years

Store below 25

degrees Celsius

Not recorded

Store in a Dry Place

Pack Size/Poison information

Pack Size

Poison Schedule

(S4) Prescription Only Medicine

(S4) Prescription Only Medicine

(S4) Prescription Only Medicine

(S4) Prescription Only Medicine

(S4) Prescription Only Medicine

Components

1.

Dosage Form

Tablet, film coated

Route of Administration

Oral

Visual Identification

Blue, film-coated, capsule shaped tablets with a partial scorebar on both

sides containing 'F' on one side and '9' and '3' on the other side

Active Ingredients

valaciclovir hydrochloride

556 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 04:26:19 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

Valaciclovir AN tablets – Consumer Medicine Information

Doc ID: 104.AN.CMI.1.0

Page 1

Valaciclovir AN tablets

valaciclovir (as hydrochloride)

Consumer Medicine Information

What is in this leaflet

This leaflet answers some

common questions about

VALACICLOVIR AN tablets. 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 taking

VALACICLOVIR AN tablets

against the benefits this

medicine 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

VALACICLOVIR AN

tablets are used for

How VALACICLOVIR AN

tablets work

VALACICLOVIR AN

tablets

belong to a group of medicines

called antivirals. VALACICLOVIR

AN tablets are used for the

treatment of genital herpes

infection, shingles (infection

zoster), ophthalmic zosters

(shingles affecting the eye

region), cold sores (herpes

labialis) and for the prevention of

Cytomegalovirus (CMV) infection

in people following an organ

transplant.

VALACICLOVIR AN tablets work

by stopping the multiplication of

the virus which causes herpes,

shingles and cold sores. They

can reduce the length and

severity of an outbreak of

herpes, shingles and cold sores

and the duration of pain and

shorten the time to healing of

crusts associated with herpes.

Genital herpes

VALACICLOVIR AN tablets do

not eliminate the herpes virus

from the body. The herpes virus

is also known as the Herpes

Simplex Virus, or HSV.

VALACICLOVIR AN tablets help

the blisters to heal more quickly.

If you start taking them as soon

as you feel an outbreak starting,

you may actually prevent the

blisters from developing.

VALACICLOVIR AN tablets can

also be taken long term to help

prevent the HSV infection

coming back.

VALACICLOVIR AN tablets can

also reduce the risk of

transmitting the virus that causes

genital herpes in patients who

are taking it continuously to

prevent or reduce recurrent

outbreaks. It does not cure

genital herpes or completely

eliminate the risk of

transmission. Therefore, in

addition to therapy with

VALACICLOVIR AN, it is

recommended that patients

avoid contact when symptoms

are present and always use

condoms.

VALACICLOVIR AN (or any

other antiviral) is not a cure for

genital herpes. Because genital

herpes is a sexually transmitted

disease, you should minimise

having intercourse when you

have an outbreak of herpes or

show any symptoms. This will

avoid the risk of spreading

herpes to your partner.

Shingles

It is important the treatment for

shingles is started within the first

three days of the shingles attack.

Cold sores

For the treatment of cold sores

the tablets should be taken at

the earliest symptom of a cold

sore (e.g. tingling, itching, or

burning).

Cytomegalovirus (CMV)

VALACICLOVIR AN is used to

prevent the cytomegalovirus

(CMV) infection in people

following an organ transplant.

CMV is a common viral infection

caused by human herpes virus.

It can be spread by contact with

infectious blood or body

secretions (e.g. saliva, urine,

cervical mucous, or semen).

CMV may cause symptoms

similar to glandular fever

(fatigue, fever, sore throat and

swollen glands).

VALACICLOVIR AN tablets are

more effective inpatients 50

years of age and older.

Ask your doctor if you have any

questions about why

VALACICLOVIR AN tablets have

been prescribed for you.

VALACICLOVIR AN tablets are

not addictive.

Before you take

VALACICLOVIR AN

tablets

When you must not take them

Do not take VALACICLOVIR

AN tablets if you have ever

had an allergic reaction to

valaciclovir, aciclovir or any

of the ingredients listed at

the end of this leaflet.

Valaciclovir AN tablets – Consumer Medicine Information

Doc ID: 104.AN.CMI.1.0

Page 2

Refer to "Side Effects"

section for some common

symptoms of an allergic

reaction.

Do not take VALACICLOVIR

AN tablets if you are

pregnant, trying to become

pregnant or breastfeeding,

unless your doctor says you

should.

Your doctor will discuss the

risks and benefits of using

VALACICLOVIR AN tablets

when pregnant and during

breastfeeding.

Do not take VALACICLOVIR

AN tablets after the expiry

date (EXP) printed on the

pack.

If you take it after the expiry

date has passed, it may not

work as well.

Do not take VALACICLOVIR

AN tablets if the packaging

is torn or shows signs of

tampering.

If you are not sure whether

you should be taking

VALACICLOVIR AN, talk to

your doctor.

Before you start to take them

You must tell your doctor if:

you are allergic to foods,

dyes, preservatives or any

other medicines.

you have a kidney or liver

condition.

If you have not told your

doctor about any of the above,

please do so before you take

VALACICLOVIR AN

Taking other medicines

Tell your doctor if you are

taking any other medicines,

including medicines you buy

without a prescription from a

pharmacy, supermarket or

health food shop.

Some medicines may affect the

way others work. Your doctor or

pharmacist will be able to tell you

what to do when taking

VALACICLOVIR AN tablets with

other medicines.

Use in children

There is not enough information

to recommend the use of

VALACICLOVIR AN in children.

How to take

VALACICLOVIR AN

tablets

Take VALACICLOVIR AN tablets

exactly as your doctor has

prescribed. Your doctor or

pharmacist will tell you:

how many tablets to take at

each dose

how many doses to take each

when to take your doses each

day.

The label on the pack will give

the same information. If there is

something you do not

understand, ask your doctor or

pharmacist.

How much to take for the

treatment of genital herpes

Your doctor will decide what

dose you should take, how often

you should take it and what

strength VALACICLOVIR AN

tablets you should use. The

dosage may vary depending on

your medical history.

Acute (short term) treatment

of genital herpes:

If you have had a herpes

infection before, you should start

to take VALACICLOVIR AN

tablets as early as possible if you

think you are about to have

another recurrence (attack).

Dosing should ideally start just

before, or straight after the first

signs of HSV infection appear.

If you have been prescribed

VALACICLOVIR AN 500 mg

tablets for, the treatment of HSV

infection, the usual dose to take

is one tablet with water twice

daily.

Suppressive (long term)

treatment of genital herpes:

If you have been prescribed

VALACICLOVIR AN 500 mg

tablets to prevent the herpes

infection appearing again, the

usual dose to take is 500 mg

once daily. Your doctor may

recommend that you take this as

a divided dose (i.e.250 mg twice

daily).

If you previously have had more

than10 recurrences (attacks) in

one year, your doctor may

recommend that you take 1000

mg of VALACICLOVIR AN once

daily to prevent recurrences.

If you think you have been

advised to take a different dose,

talk to your doctor or pharmacist.

How much to take for the

treatment of shingles

If you have been prescribed

VALACICLOVIR AN 500 mg

tablets, the normal dose to take

is two tablets with water three

times a day.

If you have been prescribed

VALACICLOVIR AN 1000 mg

tablets, the normal dose to take

is one tablet with water three

times a day.

If you think you have been

advised to take a different dose,

talk to your doctor or pharmacist.

How much to take for the

treatment of cold sores

If you have been prescribed

VALACICLOVIR AN 500 mg

tablets, the normal dose to take

for the one day regimen is four

tablets with water twice a day,

with the second dose taken

about 12 hours after the first

dose.

If you have been prescribed

VALACICLOVIR AN 1000 mg

tablets, the normal dose to take

for one day regimen is two

tablets with water twice a day,

with the second dose taken

about 12 hours after the first

dose.

How much to take for the

treatment of CMV

Valaciclovir AN tablets – Consumer Medicine Information

Doc ID: 104.AN.CMI.1.0

Page 3

The usual dose for adults and

children over 12 years of age is

2000 mg (two 1000 mg tablets or

four 500 mg tablets) taken four

times a day.

If you have a kidney disease

your doctor may reduce your

dose.

Ask your doctor or pharmacist

if you are unsure of the

correct dose for you.

They will tell you exactly how

much to take.

Follow the instructions they

give

you.

How to take them

Swallow the tablets with a glass

of water.

You should drink plenty of fluids

while taking VALACICLOVIR AN

tablets, especially if you are

elderly.

When to take them

Genital herpes

The usual times to take the

tablets are in the morning and

evening.

Shingles

The shingles packs are designed

to help you to remember to take

the tablets at the correct times.

For the treatment of shingles

the usual times to take the

tablets are in the morning,

afternoon and evening.

Cold sores

The cold sore packs are

designed to help you to

remember to take the tablets at

the correct times.

For the treatment of cold

sores the tablets should be

taken at the earliest symptom

of a cold sore (e.g. tingling,

itching, or burning).

Treatment for cold sores

should not exceed 1 day (2

doses) and the doses should

be taken 12 hours apart.

CMV

Unless your doctor tells you

otherwise, take

VALACICLOVIR AN four times

a day (i.e. morning, noon,

afternoon and evening).

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.

How long to take them

Genital herpes

For the treatment of herpes

infections, the usual course of

treatment is five days. However

in some instances your doctor

may want you to take your

tablets for ten days.

For prevention of herpes

infections, you should continue

to take this medicine every day

as prescribed by your doctor.

Do not stop taking

VALACICLOVIR AN tablets

just because you feel better.

The herpes outbreak may not

be completely over.

Shingles

For shingles the usual course of

treatment is seven days

Do not stop taking

VALACICLOVIR AN tablets

before the course of treatment

is finished just because you

feel better. The shingles may

not be completely over.

Cold sores

For cold sores the course of

treatment should not exceed 1

day (2 doses) and the doses

should be taken 12 hours apart.

CMV

Continue taking this medicine

four times daily for the full course

of the treatment.

The usual course of treatment is

90 days.

Do not stop taking your

medicine before the course of

treatment is finished unless

advised by your doctor.

If you forget to take them

For treatment of genital herpes,

shingles and CMV, 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 it as soon as

you remember, then go back to

taking it as you would normally.

For the treatment of cold sores,

take the second dose as soon as

possible once 12 hours have

passed.

Do not take a double dose to

makeup for the dose that you

missed.

If you take too much

(overdose)

Immediately telephone your

doctor or Poisons Information

Centre (telephone 131126) for

advice, if you think you or

anyone else may have taken

too much VALACICLOVIR AN,

even if there are no signs of

discomfort or poisoning. You

may need urgent medical

attention.

Keep telephone numbers for

these places handy.

If you are not sure what to do,

contact your doctor or

pharmacist.

While you are taking

VALACICLOVIR AN

tablets

Things you must do

Tell your doctor or pharmacist

that you are taking

VALACICLOVIR AN tablets if

you are about to be started on

any new medicines.

Tell your doctor if you become

pregnant or are trying to

become pregnant or intend to

breastfeed while you are

taking VALACICLOVIR AN

tablets.

Valaciclovir AN tablets – Consumer Medicine Information

Doc ID: 104.AN.CMI.1.0

Page 4

Tell your doctor if, for any

reason, you have not taken

your medicine exactly as

prescribed.

Otherwise, your doctor may think

that it was not effective and

change your treatment

unnecessarily.

Be careful driving or operating

machinery until you know how

VALACICLOVIR AN tablets

affect you.

Things you must not do

Do not stop taking

VALACICLOVIR AN tablets, or

alter the dose, without first

checking with your doctor.

Do not give this medicine to

anyone else, even if their

symptoms seem similar to

yours.

Do not use VALACICLOVIR AN

tablets to treat any other

complaints unless your doctor

says to.

Side Effects

Check with your doctor as

soon as possible if you have

any problems while taking

VALACICLOVIR AN tablets,

even if you do not think the

problems are connected with

the medicine or are not listed

in this leaflet.

Like all medicines,

VALACICLOVIR AN tablets can

cause some side effects. If they

occur, they are most likely to be

minor and temporary. However,

some may be serious and need

medical attention.

The most commonly reported

side effects are:

headache

gastrointestinal discomfort

(vomiting, nausea, diarrhoea,

constipation, abdominal pain,

indigestion)

sensitivity to UV light, such as

the development of a rash or

sunburn, even after short

exposure

For patients taking

VALACICLOVIR AN for the

prevention of CMV infection and

disease, you should report the

above side effects to the doctor

or pharmacist if they are severe

or become troublesome.

Ask your doctor or pharmacist

to answer any questions you

may have.

Tell your doctor or pharmacist

if you notice any of the

following and they worry you:

dry mouth

fever

difficulty sleeping

chills

back pain

nervousness

skin rash which may be itchy

weakness

Some people are allergic to

medicines. Symptoms of an

allergic reaction may be mild

or severe. They usually

include some or all of the

following: wheezing, swelling

of the lips/mouth, difficulty in

breathing, hayfever, lumpy

rash ("hives") or fainting.

If you think you are having an

allergic reaction to

VALACICLOVIR AN tablets,

stop taking the tablets and tell

your doctor immediately or go

to the casualty department at

your nearest hospital.

This is not a complete list of all

possible side effects. Others

may occur in some people and

there may be some side effects

not yet known.

Some rare side effects of

VALACICLOVIR AN tablets

include:

sensitivity to UV light, such as

development of a rash like

sunburn even after short

exposure to UV light.

damage to the kidney, which

gets better when

VALACICLOVIR AN treatment

is stopped.

unusual bruising or bleeding.

Tell your doctor immediately if

you notice any bruising or

bleeding, as it may indicate

that the number of platelets (a

type of blood cell responsible

for blood clotting) in your blood

are reduced.

Damage to the liver, which

gets better when

VALACICLOVIR AN treatment

is stopped.

You should contact your doctor if

you experience any of the

following side effects which are

more common in patients with

kidney disease or in those taking

high doses of VALACICLOVIR

Dizziness

Confusion or imagining sights

or sounds (hallucinations)

Drowsiness.

Tell your doctor if you notice

anything else that is making

you feel unwell, even if it is

not on this list.

Ask your doctor or pharmacist

if

you don't understand anything

in

this list.

Do not be alarmed by this list

of possible side-effects. You

may not experience any of

them.

After taking

VALACICLOVIR AN

tablets

Storage

Keep this medicine where

young children cannot reach

it.

Valaciclovir AN tablets – Consumer Medicine Information

Doc ID: 104.AN.CMI.1.0

Page 5

A locked cupboard at least one-

and-a half metres above the

ground is a good place to store

medicines.

Keep VALACICLOVIR AN

tablets in a cool, dry place

where it stays below 25°C. Do

not store them, or any other

medicine, in a bathroom or

near a sink.

Do not leave them in the car or

on window sills.

Heat and dampness can destroy

some medicines.

Keep your tablets in their pack

until it is time to take them.

If you take the tablets out of their

pack they may not keep well.

Disposal

If your doctor tells you to stop

taking VALACICLOVIR AN, or

the tablets have passed their

expiry date, ask your

pharmacist what to do with

any tablets left over.

Product Description

What VALACICLOVIR AN

tablets look like

VALACICLOVIR AN 500 mg is

presented in pack size of 10, 30

& 42 tablets in blister pack.

VALACICLOVIR AN 500mg

Blue, film-coated, capsule

shaped tablets with a partial

scorebar on both sides

containing ‘F’ on one side and ‘9’

and ‘3’ on the other side.

Ingredients

Active Ingredient:

Valaciclovir (as hydrochloride)

Each tablet contains 500 mg of

valaciclovir as hydrochloride.

Other Ingredients:

microcrystalline cellulose

crospovidone

povidone

magnesium stearate

opadry blue 13B50578 (PI-

ARTG No. 106487).

Please read this leaflet carefully

before you start taking

VALACICLOVIR 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

VIC – 3141

Australia

Australian Registration

Number

500 mg tablets:

AUST R 173287 (blister pack)

500 mg tablets:

AUST R 173292 (bottle pack)

1000 mg tablets:

AUST R 173291 (blister pack)

1000 mg tablets:

AUST R 173284 (bottle pack)

Date of Preparation

October 2014