Vaclovir Tablets

Vaclovir Tablets is a brand of medicine containing the active ingredient valaciclovir.

Find out more about active ingredients.

Consumer medicine information (CMI) leaflet

Developed by the pharmaceutical company responsible for this medicine in Australia, according to TGA regulations.

Vaclovir

contains the active ingredient valaciclovir (as hydrochloride)


Consumer Medicine Information

What is in this leaflet

This leaflet answers some common questions about Vaclovir.

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 benefits and risks. Your doctor has weighed the risks of you taking Vaclovir against the benefits they expect it will have for you.

If you have any concerns about taking this medicine, talk to your doctor or pharmacist. Keep this leaflet with your medicine.

You may need to read it again.

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What Vaclovir is used for

Vaclovir belongs to a group of medicines called antivirals.

Vaclovir is used for the treatment of shingles (herpes zoster) and ophthalmic zoster (shingles affecting the eye region).

Vaclovir is also used to prevent cytomegalovirus (CMV) infection and disease, following solid organ transplantation. CMV is another type of herpes virus. It can cause symptoms similar to glandular fever (high temperature, sore throat and swollen glands). Vaclovir can help prevent CMV infection and herpes simplex infections.

Vaclovir is also used for the treatment of Genital Herpes Infection. Vaclovir works 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.

Vaclovir 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.

Vaclovir can also be taken long term to help prevent the HSV infection coming back.

Vaclovir works by stopping the multiplication of the virus which causes shingles. They can reduce the length and severity of an outbreak of shingles and the duration of pain associated with shingles. It is important the treatment is started within the first three days of the shingles attack.

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

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

Vaclovir (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 Vaclovir has been prescribed for you.

Vaclovir is not addictive.

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Before you take Vaclovir

When you must not take it

  • Do not take Vaclovir if you have ever had an allergic reaction to valaciclovir, aciclovir or any of the ingredients listed at the end this leaflet.
    Refer to "Side Effects" section for some common symptoms of an allergic reaction.
    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 Vaclovir 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 Vaclovir tablets when pregnant and during breastfeeding.
  • Do not take Vaclovir after the expiry date (EXP) printed on the pack.
    If you take them after the expiry date has passed, they may not work as well.
  • Do not take Vaclovir if the packaging is torn or shows signs of tampering.

If you are not sure whether you should be taking Vaclovir, talk to your doctor.

Before you start to take it

You must tell your doctor if:

  • you are allergic to foods, dyes, preservatives or any other medicines.
  • you are anaemic (reduced red blood cells or iron stores).
  • you have a kidney or liver condition.
  • you are pregnant or plan to become pregnant. Your doctor will discuss the risk and benefit of taking Vaclovir when pregnant.

If you have not told your doctor about any of the above, please do so before you take Vaclovir.

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. Mycophenolate mofetil, cyclosporin and tacrolimus are medicines commonly taken by transplant patients and require close attention. These medicines may be affected by Vaclovir or Vaclovir may be affected by these medicines. Your doctor or pharmacist will be able to tell you what to do when taking Vaclovir with other medicines.

Use in children

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

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How to take Vaclovir

Take Vaclovir 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

Shingles

If you have been prescribed Vaclovir 500 mg tablets, the normal dose to take is two tablets with water three times a day.

If you have been prescribed Vaclovir 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.

CMV

If you have been prescribed Vaclovir tablets to prevent CMV infection and disease, the usual dose for adults and children over 12 years of age is four 500mg tablets four times a day for 90 days.

Your doctor will decide what dose to take, how often you should take it and what strength of Vaclovir you should use. The dosage may vary depending on your medical history.

If you have a kidney disease your doctor may reduce your dose.

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

Genital herpes

Acute (short term) treatment of genital herpes:
If you have had a herpes infection before, you should start to take Vaclovir 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 Vaclovir 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 Vaclovir 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 than 10 recurrences (attacks) in one year, your doctor may recommend that you take 1000 mg of Vaclovir 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 with a glass of water.

You should drink plenty of fluids while taking Vaclovir, especially if you are elderly.

When to take them

Shingles

For the treatment of shingles the usual times to take the tablets are in the morning, afternoon and evening.

CMV

To prevent CMV infection and disease, the tablets should be taken four times a day (i.e. morning, noon, afternoon and evening).

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

Genital herpes

The usual times to take the tablets for the treatment of genital herpes are in the morning and evening.

How long to take them for

Shingles

For shingles the usual course of treatment is seven days.

Do not stop taking Vaclovir before the course of treatment is finished just because you feel better. The shingles may not be completely over.

CMV

For the prevention of CMV infection and disease, the usual course of treatment is 90 days.

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 Vaclovir before the course of treatment is finished just because you feel better. The herpes outbreak may not be completely over.

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.

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

If you miss more than one dose, or you are not sure what to do ask your doctor or pharmacist.

If you have trouble remembering to take your medicine ask your pharmacist for some hints.

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 Vaclovir, 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.

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While you are taking Vaclovir

Things you must do

Tell your doctor or pharmacist that you are taking Vaclovir 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 Vaclovir.

Drink plenty of fluids while you are taking Vaclovir.

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 Vaclovir affect you.

Things you must not do

Do not stop taking Vaclovir or change 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 Vaclovir to treat any other conditions unless advised by your doctor.

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Side effects

Check with your doctor as soon as possible if you have any health problems while taking Vaclovir, even if you do not think the problems are connected with the medicine or are not listed in this leaflet. Like all medicines, Vaclovir 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 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")
  • fainting.

If you think you are having an allergic reaction to Vaclovir, 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 Vaclovir include:

  • sensitivity to UV light, such as development of a rash like sunburn even after short exposure to UV light. Talk to your doctor or pharmacist if you experience this.
  • damage to the kidney, which gets better when Vaclovir 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 Vaclovir 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 Vaclovir:

  • confusion or imagining sight or sounds (hallucinations)
  • dizziness
  • 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.

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After taking Vaclovir

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 Vaclovir 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 Vaclovir, or the tablets have passed their expiry date, ask your pharmacist what to do with any tablets left over.

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Product description

What it looks like

Vaclovir Valaciclovir (as hydrochloride) 500 mg tablets: White coloured, oval shaped, biconvex film coated tablet with break line on one side and plain on the other side. Blister packs of 8, 10, 30 and 42 tablets.

Bottles of 30 and 42 tablets.

Ingredients

The active ingredient in Vaclovir tablets is valaciclovir.

The tablets also contain:

  • microcrystalline cellulose
  • magnesium stearate
  • Opadry complete film coating system White OY-58900 (Proprietary Ingredient number 3446)

The tablets are gluten free.

Supplier

Vaclovir is supplied by:
Alphapharm Pty Limited
(ABN 93 002 359 739)
Level 1, 30 The Bond
30-34 Hickson Road
Millers Point NSW 2000
Phone: (02) 9298 3999
www.alphapharm.com.au

Australian registration numbers:
Vaclovir 500 Valaciclovir (as hydrochloride) 500mg tablet
Blister pack AUST R 153822
Bottles AUST R 153823

This leaflet was prepared on
13 November 2013.

Vaclovir_cmi\Nov13/00

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CMI provided by MIMS Australia, January 2014  

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