Consumer medicine information

Valaciclovir GA 500 mg and 1000 Tablets for herpes simplex

Valaciclovir


Consumer Medicine Information

Please read this leaflet carefully before you start Valaciclovir GA.

What is in this leaflet

This leaflet answers some common questions about Valaciclovir GA 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 GA 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 GA tablets are used for

Valaciclovir GA tablets belong to a group of medicines called antivirals. Valaciclovir GA tablets are used for the treatment of genital herpes infection.

Valaciclovir GA tablets work by stopping the multiplication of the virus which causes herpes. They 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 GA 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 GA tablets can also be taken long term to help prevent the HSV infection coming back.

Valaciclovir GA is more effective in patients 50 years of age and older.

Valaciclovir GA 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 GA, it is recommended that patients avoid contact when symptoms are present and always use condoms.

Valaciclovir GA (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.

Ask your doctor if you have any questions about why Valaciclovir GA tablets have been prescribed for you.

Valaciclovir GA tablets are not addictive.

Before you take Valaciclovir GA tablets

When you must not take them

  • Do not take Valaciclovir GA tablets if you have ever had an allergic reaction to valaciclovir, aciclovir or any of the ingredients listed at the end of this leaflet.
    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.
  • Do not take Valaciclovir GA 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 GA tablets when pregnant and during breastfeeding.
  • Do not take Valaciclovir GA 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 GA tablets if the packaging is torn or shows signs of tampering.
  • If you are not sure whether you should be taking Valaciclovir GA, 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.

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 GA tablets with other medicines.

Use in children

There is not enough information to recommend the use of Valaciclovir GA in children.

How to take Valaciclovir GA tablets

Take Valaciclovir GA 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 day
  • 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

Your doctor will decide what dose you should take, how often you should take it and what strength Valaciclovir GA 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 GA 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 GA 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 GA 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 (ie 250 mg twice daily).

If you previously have had more than 10 recurrences (attacks) in one year, your doctor may recommend that you take 1000 mg of Valaciclovir GA once daily to prevent recurrences.

If you think you have been advised to take a different dose, talk to your doctor or pharmacist.

How to take them

Swallow the tablets whole with a glass of water.

You should drink plenty of fluids while taking Valaciclovir GA tablets.

When to take them

The usual times to take the tablets are in the morning and evening.

How long to take them

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 GA tablets just because you feel better. The herpes outbreak may not be completely over.

If you forget to take them

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.

Do not take a double dose to make up for the dose that you missed.

If you take too much (overdose)

Immediately telephone your doctor or Poisons Information Centre (telephone 13 11 26) for advice, if you think you or anyone else may have taken too much Valaciclovir GA, 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 GA tablets

Things you must do

Tell your doctor or pharmacist that you are taking Valaciclovir GA 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 GA tablets.

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 GA tablets affect you.

Things you must not do

Do not stop taking Valaciclovir GA 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 GA 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 GA 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 GA 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)

Ask your doctor or pharmacist to answer any questions you may have.

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

If you think you are having an allergic reaction to Valaciclovir GA tablets, tell your doctor immediately or go to your casualty department at your nearest hospital. Symptoms usually include some or all of the following:

  • wheezing
  • swelling of the lips/smouth
  • difficulty in breathing
  • hayfever
  • lumpy rash (“hives”)
  • fainting

Some rare side effects of Valaciclovir GA 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 GA 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 GA 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 GA:

  • 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.

Do not be alarmed by this list of possible side effects. You may not experience any of them.

After taking Valaciclovir GA tablets

Storage

Keep this medicine where young 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 Valaciclovir GA 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 GA tablets, or the tablets have passed their expiry date, ask your pharmacist what to do with any tablets left over.

Product description

What Valaciclovir GA tablets look like

Valaciclovir GA 500 mg tablets are creamy oblong, film coated tablets.

Ingredients

Valaciclovir GA tablets contain the active ingredient valaciclovir. The tablets also contain

  • starch – maize,
  • lactose,
  • povidone,
  • croscamellose sodium,
  • titanium dioxide,
  • magnesium stearate,
  • hypromellose,
  • macrogol 400,
  • polysorbate 80.

Supplier

Valaciclovir GA is distributed in Australia by:
Ascent Pharma Pty Ltd
151-153 Clarendon Street
South Melbourne
Vic 3205

For further information, call 1800 554 414

Registration Numbers

  • Valaciclovir GA 500 mg
    AUST R 162728
  • Valaciclovir GA 1000 mg
    AUST R 162729

Sponsor

Southern Cross Pharma Pty Ltd
56 Illabunda Drive
Malua Bay NSW 2536
ABN 47 094 447 677

Date of Information: November 2010

Published by MIMS April 2015