for genital herpes simplex
Contains the active ingredient valaciclovir hydrochloride monohydrate
Consumer Medicine Information
NOTICE: This Consumer Medicine Information (CMI) is intended for persons
living in Australia. This page contains answers to some common
. It does
not contain all the information that is known about
. It does not take the
place of talking to your doctor or pharmacist. All medicines have risks
and benefits. Your doctor has weighed the risk of you using this medicine
against the benefits he/she expects it will have for you. If you have
any concerns about using this medicine, ask your doctor or pharmacist.
Bookmark or print this page, you may need to read it again.
What this medicine is used for
The name of your medicine is APO-Valaciclovir. It contains the active ingredient valaciclovir hydrochloride monohydrate. It
is used to treat:
genital herpes simplex infection
Ask your doctor if you have any questions about why this medicine has been prescribed for you. Your doctor may have prescribed
this medicine for another reason.
This medicine is available only with a doctor's prescription.
How it works
Valaciclovir belongs to a group of medicines called antivirals.
Valaciclovir works by stopping the multiplication of the virus which causes herpes. It can reduce the length and severity
of an outbreak of herpes, the duration of pain and shorten the time to healing of crusts associated with herpes. They do not
eliminate the herpes virus from the body. The herpes virus is also known as the Herpes Simplex Virus, or HSV.
Valaciclovir helps 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.
In immunocompromised patients, valaciclovir can also be taken long term to help prevent the HSV infection coming back.
Valaciclovir (or any other antiviral) is not a cure for genital herpes. Because genital herpes is a sexually transmitted disease,
you should minimise having intercourse and always use condoms when you have an outbreak of herpes or show any symptoms. This
will avoid the risk of spreading herpes to your partner.
Valaciclovir is more effective in patients 50 years of age and older.
There is no evidence that this medicine is addictive.
Use in children
There is not enough information to recommend the use of this medicine in children.
Before you take this medicine
When you must not take it
Do not take this medicine if you have had an allergic reaction to aciclovir, valaciclovir or any of the ingredients listed
at the end of this leaflet.
Symptoms of an allergic reaction may include: shortness of breath, wheezing or difficulty breathing; swelling of the face,
lips, tongue, throat or other parts of the body; muscle pain or tenderness or joint pain or rash, itching or hives on the
Do not take this medicine if you are pregnant, trying to become pregnant or are breastfeeding, unless your doctor says you
Your doctor will discuss with you the risks and benefits of using valaciclovir when pregnant and during breastfeeding.
Do not take this medicine after the expiry date (EXP) printed on the pack.
If you take this medicine after the expiry date has passed, it may not work as well.
Do not take this medicine if the packaging is torn, shows signs of tampering or if it does not look quite right.
If it has expired or is damaged, return it to your pharmacist for disposal.
If you are not sure whether you should start taking this medicine, talk to your doctor or pharmacist.
Before you start to take it
Before you start taking this medicine, tell your doctor if:
You have allergies to:
any other medicines.
any other substances, such as foods, preservatives or dyes.
You have or have had any medical conditions, especially the following:
a kidney or liver condition
you are anaemic (reduced red blood cells or iron stores)
You are currently pregnant or you plan to become pregnant. Do not take this medicine whilst pregnant until you and your doctor
have discussed the risks and benefits involved.
You are currently breastfeeding or you plan to breastfeed. Do not take this medicine whilst breastfeeding until you and your
doctor have discussed the risks and benefits involved.
You are taking or are planning to take any other medicines; this includes vitamins and supplements that are available from
your pharmacy, supermarket or health food shop.
Some medicines may interact with valaciclovir:
Mofetil, cylclosporin and tacrolimus are medicines commonly taken by transplant patients and require close attention.
These medicines may be affected by valaciclovir or may affect how well it works. You may need different amounts of your medicines,
or you may need to take different medicines.
Other medicines not listed above may also interact with valaciclovir.
How to take this medicine
Follow carefully all directions given to you by your doctor or pharmacist.
Their instructions may be different to the information in this leaflet.
If you do not understand any written instructions, ask your doctor or pharmacist for help.
How much to take
Your doctor or pharmacist will tell you how many tablets you will need to take. This depends on your condition and whether
or not you are taking any other medicines.
Acute (short term) treatment of genital herpes:
Dosing should ideally start just before, or straight after the first signs of HSV infection appear. The usual dose is one
500 mg tablet with water, two times a day.
Suppressive (long term) treatment of genital herpes in immunocompromised patients:
The usual dose is one 500 mg tablet with water, two times a day.
How to take it
Swallow the tablets with a glass of water. You should drink plenty of fluids whilst taking valaciclovir, especially if you
When to take it
For genital herpes infection, the usual times to take the tablets are in the morning and evening.
How long to take it for
For the treatment of genital 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 the prevention of genital herpes infections in immunocompromised patients, you should continue to take this medicine every
day as prescribed by your doctor.
Continue taking your medicine for as long as your doctor tells you.
Do not stop taking it unless your doctor tells you to - even if you feel better.
Make sure you have enough to last over weekends and holidays.
If you forget to take it
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.
If you miss more than one dose, or you are not sure what to do, ask your doctor or pharmacist.
Do not take a double dose to make up for missed doses. This may increase the chance of side effects.
If you have trouble remembering to take your medicine, ask your pharmacist for some hints to help you remember.
If you take too much (overdose)
If you think that you or anyone else may have taken too much of this medicine, immediately telephone your doctor or the Poisons
Information Centre (Tel: 13 11 26 in Australia) for advice. Alternatively go to the Accident and Emergency Department at your
Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention.
Signs of an overdose with valaciclovir may include:
acute renal failure
neurological symptoms including confusion, hallucinations, agitation, decreased consciousness and coma.
nausea and vomiting
While you are taking this medicine
Things you must do
Tell any other doctors, dentists, and pharmacists who are treating you that you are taking valaciclovir.
Tell your doctor immediately if you become pregnant or are trying to become pregnant, or intend to breastfeed while you are
If you are about to have any blood tests, tell your doctor that you are taking this medicine.
Go to your doctor regularly for a check-up.
Your doctor may occasionally do tests to make sure the medicine is working and to prevent side effects.
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.
Things you must not do
Give this medicine to anyone else, even if their symptoms seem similar to yours.
Take your medicine to treat any other condition unless your doctor or pharmacist tells you to
Stop taking your medicine, or change the dosage, without first checking with your doctor.
Things to be careful of
Be careful when driving or operating machinery until you know how valaciclovir affects you.
Possible side effects
All medicines may have some side effects. Sometimes they are serious, but most of the time, they are not. Your doctor has
weighed the risks of using this medicine against the benefits they expect it will have for you.
Following is a list of possible side effects. Do not be alarmed by this list. You may not experience any of them.
The most commonly reported side effects are listed below, please tell your doctor or pharmacist if you notice any of them:
gastrointestinal discomfort (vomiting, nausea, diarrhoea, constipation, abdominal pain, indigestion)
Please also tell your doctor or pharmacist if you notice any of the following:
skin rash which may be itchy
Some rare side effects of valaciclovir are listed below, please tell your doctor if you notice any of them:
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 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 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:
confusion or imagining sights or sounds (hallucinations)
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.
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.
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: shortness of breath, wheezing or difficulty breathing; swelling of the face, lips, tongue, throat or
other parts of the body; muscle pain or tenderness or joint pain or rash, itching or hives on the skin.
If you think you are having an allergic reaction to valaciclovir, stop taking the tablets and tell your doctor immediately
or go to the Accident and Emergency department at your nearest hospital.
Storage and disposal
Keep your medicine in its original packaging until it is time to take it.
If you take your medicine out of its original packaging it may not keep well.
Keep your medicine in a cool dry place where the temperature will stay below 25°C.
Do not store your medicine, or any other medicine, in the bathroom or near a sink. Do not leave it on a window sill or in
the car. Heat and dampness can destroy some medicines.
Keep this medicine 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.
If your doctor or pharmacist tells you to stop taking this medicine or they have passed their expiry date, your pharmacist
can dispose of the remaining medicine safely.
What APO-Valaciclovir looks like
500 mg tablets
The 500 mg tablets are dark blue, capsule-shaped, biconvex film-coated tablets, engraved "APO" on one side, "VAL 500" on the
Blisters of 2, 4, 6, 8, 10, 20, 30, 42, 60, 80, 90, 100, 240, 480 tablets and bottles of 100, 240, 480, 500 tablets.
Not all strengths, pack types and/or pack sizes may be available.
Each tablet contains valaciclovir as the active ingredient.
It also contains the following inactive ingredients:
Colloidal Anhydrous Silica
Indigo Carmine Aluminium Lake
This medicine is gluten-free, lactose-free, sucrose-free, tartrazine-free and free of other azo dyes.
Australian Registration Numbers
APO-Valaciclovir 500 mg tablets (blister pack): AUST R 158911
APO-Valaciclovir 500 mg tablets (bottle): AUST R 158910
Apotex Pty Ltd
66 Waterloo Road
North Ryde, NSW 2113
Apotex Pty Ltd is the licensee of the registered trademarks APO and APOTEX from the registered proprietor, Apotex Inc.
This leaflet was prepared in December 2010.