APO-Valaciclovir (genital herpes) (valaciclovir hydrochloride monohydrate) Drug / Medicine Information

for genital herpes simplex

Contains the active ingredient valaciclovir hydrochloride monohydrate

Consumer Medicine Information

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 skin.

Do not take this medicine if you are pregnant, trying to become pregnant or are breastfeeding, unless your doctor says you should.

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:

1. You have allergies to:

any other medicines.

any other substances, such as foods, preservatives or dyes.

2. 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)

3. 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.

4. 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.

5. 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 are elderly.

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 nearest hospital.

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 taking valaciclovir.

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

Do not:

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:

headache

gastrointestinal discomfort (vomiting, nausea, diarrhoea, constipation, abdominal pain, indigestion)

Please also tell your doctor or pharmacist if you notice any of the following:

dry mouth

fever

difficulty sleeping

chills

back pain

nervousness

skin rash which may be itchy

weakness

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:

dizziness

confusion or imagining sights or sounds (hallucinations)

drowsiness

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

Storage

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.

Disposal

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.

Product description

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 other side.

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.

Ingredients

Each tablet contains valaciclovir as the active ingredient.

It also contains the following inactive ingredients:

Stearic Acid

Colloidal Anhydrous Silica

Hypromellose

Macrogol 8000

Titanium Dioxide

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

Sponsor

Apotex Pty Ltd

66 Waterloo Road

North Ryde, NSW 2113

Australia

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.