Treatment of zoster and herpes labialis
contains the active ingredient valaciclovir (hydrochloride)
Consumer Medicine Information
What is in this leaflet
This leaflet answers some common questions about VALACICLOVIR ACTAVIS.
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 VALACICLOVIR ACTAVIS 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.
What VALACICLOVIR ACTAVIS is used for
VALACICLOVIR ACTAVIS is used to treat shingles (herpes zoster), ophthalmic zoster (shingles affecting the eye region) and cold sores (herpes labialis).
VALACICLOVIR ACTAVIS belongs to a group of medicines called antivirals.
It works by stopping the multiplication of the virus which causes the shingles and cold sores. VALACICLOVIR ACTAVIS reduces the length and severity of an outbreak and the duration of pain associated with the shingles and cold sores.
It is important to start treatment within three days of the shingles attack.
For treatment of cold sores the tablets should be taken at the earliest symptom of a cold sore (e.g. tingling, itching, or burning).
VALACICLOVIR ACTAVIS tablets are more effective in patients 50 years and over.
Your doctor may have prescribed VALACICLOVIR ACTAVIS for another reason. Ask your doctor if you have any questions about why VALACICLOVIR ACTAVIS has been prescribed for you.
VALACICLOVIR ACTAVIS is not recommended for use in children, as there have been no studies of its effects in children.
VALACICLOVIR ACTAVIS is available only with a doctor’s prescription.
There is no evidence that VALACICLOVIR ACTAVIS is addictive.
Before you take VALACICLOVIR ACTAVIS
When you must not take it
Do not take VALACICLOVIR ACTAVIS if you are allergic to medicines containing valaciclovir, aciclovir or any of the ingredients listed at the end of this leaflet. Some of the symptoms of an allergic reaction may include skin rash, itching or hives, swelling of the face, lips or tongue which may cause difficulty in swallowing or breathing, wheezing or shortness of breath or fainting.
Do not take VALACICLOVIR ACTAVIS if the expiry date (Exp.) printed on the pack has passed.
Do not take VALACICLOVIR ACTAVIS if the packaging is torn or shows signs of tampering.
Before you start to take it
Tell your doctor if you are allergic to any other medicines, foods, dyes or preservatives.
Tell your doctor if you are pregnant or plan to become pregnant. Your doctor will discuss the risks and benefits of taking VALACICLOVIR ACTAVIS during pregnancy.
Tell your doctor if you are breastfeeding or wish to breastfeed. Your doctor will discuss the risks and benefits of taking VALACICLOVIR ACTAVIS when breastfeeding.
Tell your doctor if you have, or have had, any medical conditions, especially the following:
- kidney or liver condition
If you have not told your doctor about any of the above, tell them before you start taking VALACICLOVIR ACTAVIS.
Taking other medicines
Tell your doctor if you are taking any other medicines, including any that you buy without a prescription from a pharmacy, supermarket or health food shop. Some medicines may be affected by VALACICLOVIR ACTAVIS, or may affect how well it works.
Tell your doctor if you are taking any of the following medicines:
- Mycophenolate mofetil
- Organoplatium compounds
- Iodinated contrast media
Your doctor or pharmacist will be able to tell you what to do when taking VALACICLOVIR ACTAVIS tablets with other medicines. Your doctor and pharmacist have more information on medicines to be careful with or avoid while taking VALACICLOVIR ACTAVIS.
How to take VALACICLOVIR ACTAVIS
How much to take for the treatment of shingles
If you have been prescribed VALACICLOVIR ACTAVIS 500 mg tablets, the normal dose to take is two tablets with water three times a day.
If you have been prescribed VALACICLOVIR ACTAVIS 1000 mg tablets, the normal dose to take is one tablet with water three times a day.
Follow all directions given to you by your doctor and pharmacist carefully.
How much to take for the treatment of cold sores
If you have been prescribed VALACICLOVIR ACTAVIS 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.
How to take VALACICLOVIR ACTAVIS
Swallow the tablets with a glass of water.
For the treatment of shingles the usual times to take the tablets are in the morning, afternoon and evening.
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.
If you forget to take VALACICLOVIR ACTAVIS
For treatment of shingles, 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 treatment of cold sores, take the second dose as soon as possible once 12 hours have passed.
Do not take a double dose to make up for the dose that you missed.
If you are not sure what to do, ask your doctor or pharmacist.
How long to take VALACICLOVIR ACTAVIS for
For shingles the usual course of treatment is seven days.
Do not stop taking VALACICLOVIR ACTAVIS tablets before the course of treatment is finished just because you feel better. The shingles may not be completely over.
For cold sores the course of the treatment should not exceed 1 day (2 doses) and the doses should be taken 12 hours apart.
If you take too much VALACICLOVIR ACTAVIS (overdose)
Immediately telephone your doctor, or the Poisons Information Centre (telephone 13 11 26), or go to Accident and Emergency at the nearest hospital, if you think you or anyone else may have taken too much VALACICLOVIR ACTAVIS. Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention.
While you are taking VALACICLOVIR ACTAVIS
Things you must do
Before starting any new medicine, tell your doctor or pharmacist that you are taking VALACICLOVIR ACTAVIS.
Tell all the doctors, dentists and pharmacists who are treating you that you are taking VALACICLOVIR ACTAVIS.
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.
Drink plenty of fluids while you are taking VALACICLOVIR ACTAVIS.
Things you must not do
Do not stop taking VALACICLOVIR ACTAVIS tablets, or alter the dose, without first checking with your doctor.
Do not use VALACICLOVIR ACTAVIS to treat any other conditions unless your doctor tells you to.
Do not give VALACICLOVIR ACTAVIS to anyone else, even if they have the same condition as you.
Things to be careful of
Be careful driving or operating machinery until you know how VALACICLOVIR ACTAVIS affects you. VALACICLOVIR ACTAVIS does not normally affect alertness; however make sure you know how VALACICLOVIR ACTAVIS affects you before driving, operating machinery or anything else that could be dangerous.
Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking VALACICLOVIR ACTAVIS. Like all other medicines, VALACICLOVIR ACTAVIS may have unwanted side effects in some people. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some of the side effects.
Do not be alarmed by this list of possible side effects. You may not experience any of them.
Ask your doctor or pharmacist to answer any questions you may have.
Tell your doctor if you notice any of the following and they worry you:
- gastrointestinal discomfort (vomiting, nausea, diarrhoea, constipation, abdominal pain and indigestion)
- dry mouth
- difficulty sleeping
- back pain
- skin rash which may be itchy
Some people are allergic to medicines. Symptoms of an allergic reaction may be mild or severe. They usually include some or all of the lips/mouth, difficulty in breathing, hay fever, lumpy rash (hives) or fainting.
If you think you are having a allergic reactions to VALACICLOVIR ACTAVIS tablets stop taking the tablets and tell your doctor immediately or go to Accident and Emergency at the nearest hospital. Symptoms usually include some or all of the following:
- swelling of the lips/mouth
- difficulty in breathing
- hay fever
- lumpy rash (hives)
Some rare side effects of VALACICLOVIR ACTAVIS are as follows:
- sensitivity to UV light, such as development of a rash like sunburn even after short exposure to UV light swelling of the lips or mouth
- damage to the kidney, which gets better when VALACICLOVIR ACTAVIS treatment is stopped
- unusual bruising or bleeding
- damage to the liver, which gets better when VALACICLOVIR ACTAVIS treatment is stopped.
- uncoordinated muscle movements and speech
- psychotic episodes
- brain injury
Tell your doctor immediately if you notice any bruising or bleeding, as this may indicate that your blood is not clotting properly.
Tell your doctor if you notice any of the following side effects which are more common in patients with kidney disease or those taking high doses of VALACICLOVIR ACTAVIS:
- decreased consciousness
Other side effects not listed above may also occur in some patients. Tell your doctor if you notice anything that is making you feel unwell.
After using VALACICLOVIR ACTAVIS
Keep VALACICLOVIR ACTAVIS 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.
Keep your tablets in their pack until it is time to take them. If you take the tablets out of the pack they may not keep well.
Keep your tablets in a cool dry place where the temperature stays below 25°C.
Do not store VALACICLOVIR ACTAVIS or any other medicine in the bathroom or near a sink.
Do not leave VALACICLOVIR ACTAVIS in the car or on window sills. Heat and dampness can destroy some medicines.
If your doctor tells you to stop taking VALACICLOVIR ACTAVIS, or your tablets have passed their expiry date, ask your pharmacist what to do with any that are left over.
What it looks like
- VALACICLOVIR ACTAVIS 500 is an oval white tablet marked with VC2 on one side.
Each pack contains 10, 30, 42 or 100 tablets.
- VALACICLOVIR ACTAVIS 1000 is an oval white tablet marked with VC3 on one side.
Each pack contains 4 or 21 tablets.
The active ingredient in VALACICLOVIR ACTAVIS is valaciclovir hydrochloride.
- each VALACICLOVIR ACTAVIS 500 tablet contains 500 mg of valaciclovir
- each VALACICLOVIR ACTAVIS 1000 tablet contains 1000 mg of valaciclovir
The tablets also contain:
- microcrystalline cellulose
- purified talc
- magnesium stearate
- Opadry II 85F18738 White (ARTG 12135)
The tablets do not contain gluten, lactose, sucrose, tartrazine or any other azo dyes.
Actavis Pty Ltd
Level 5, 117 Harrington Street
Australian Registration Numbers:
VALACICLOVIR ACTAVIS 500 – AUST R 170177
VALACICLOVIR ACTAVIS 1000 – AUST R 170193, AUST R 170196
Date of preparation: May 2014.
Published by MIMS November 2014