NOTICE: This Consumer Medicine Information (CMI) is intended for persons living in Australia.
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.
What Vaclovir is used for
Vaclovir belongs to a group of medicines called antivirals.
Vaclovir is 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.
Ask your doctor if you have any questions about why Vaclovir has been prescribed for you.
Vaclovir is not addictive.
Before you take Vaclovir
When you must not take it
Do not take Vaclovir if you have an allergy to:
any medicine containing (valaciclovir, aciclovir)
any of the ingredients listed at the end of this leaflet
Some of the symptoms of an allergic reaction may include
shortness of breath
wheezing or difficulty breathing
swelling of the face, lips, tongue or other parts of the body
rash, itching or hives on the skin
Do not take this medicine if you are pregnant or are trying to become pregnant.
It may affect your developing baby if you take it during pregnancy.
Do not breast-feed if you are taking this medicine.
Your doctor will discuss the risks and benefits of using Vaclovir tablets when pregnant and during breastfeeding.
Do not give this medicine to children.
There is not enough information to recommend the use of Vaclovir in children.
Do not take this medicine after the expiry date printed on the pack or if the packaging is torn or shows signs of tampering.
If you take them after the expiry date has passed, they may not work as well.
If you are not sure whether you should be taking Vaclovir, talk to your doctor.
Before you start to take it
Tell your doctor if you have allergies to any other medicines, foods, preservatives or dyes.
Tell your doctor if you have or have had any of the following medical conditions:
you have a kidney or liver condition
are anaemic (reduced red blood cells or iron stores)
Care should be taken to ensure adequate fluid intake in patients who are at risk of dehydration, such as the elderly
previous skin reactions with Vaclovir which may include a rash, fever, facial swelling or blistering/peeling skin
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, ciclosporin 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 and pharmacist have more information on medicines to be careful with or avoid while taking this medicine.
How to take Vaclovir
Follow all directions given to you by your doctor and pharmacist carefully.
They may differ from the information contained in this leaflet.
If you do not understand the instructions on the box, ask your doctor or pharmacist for help.
How much to take
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.
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.
How to take it
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 it
To prevent CMV infection and disease, the tablets should be taken four times a day (i.e. morning, noon, afternoon and evening).
How long to take it
For the prevention of CMV infection and disease, the usual course of treatment is 90 days.
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 131126) 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.
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.
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.
Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking Vaclovir.
This medicine helps most people with cytomegalovirus (CMV) infection and disease but it may have unwanted side effects in some people.
All medicines can have side effects.Sometimes they are serious, most of the time they are not.You may need medical attention if you get some of the side effects.
Do not be alarmed by the following list of side effects.
You may not experience any of them.
Ask your doctor or pharmacist to answer any questions you may have.
The most commonly reported side effects are:
gastrointestinal discomfort (vomiting, nausea, diarrhoea, constipation, abdominal pain, indigestion)
These should be reported to the doctor or pharmacist if they are severe or become troublesome.
Tell your doctor or pharmacist if you notice any of the following and they worry you:
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 following:
swelling of the lips/mouth
difficulty in breathing
lumpy rash (“hives”)
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:
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.
skin reactions which may include a rash, fever, facial swelling or blistering or peeling skin
damage to the liver, which gets better when Vaclovir treatment is stopped.
agitation or tremor
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:
sensitivity to UV light, such as development of a rash like sunburn even after short exposure to UV or sunlight
confusion or imagining sight or sounds (hallucinations)
Tell your doctor if you notice anything else that is making you feel unwell, even if it is not on this list.
After taking Vaclovir
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.
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.
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.
The active ingredient in Vaclovir tablets is valaciclovir.
The tablets also contain:
Opadry complete film coating system White OY-58900 (Proprietary Ingredient number 3446)
The tablets are gluten free.
Vaclovir is supplied by:
Alphapharm Pty Ltd
Level 1, 30 The Bond
30-34 Hickson Road
Millers Point NSW 2000
Phone: (02) 9298 3999
Australian registration numbers:
Vaclovir 500 Valaciclovir (as hydrochloride) 500mg tablet
Blister pack AUST R 153822
Bottles AUST R 153823
This leaflet was prepared on
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