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Chemmart Valaciclovir (herpes zoster)

for herpes zoster, ophthalmic zoster and herpes labialis

Contains the active ingredient valaciclovir hydrochloride monohydrate
Consumer Medicine Information
 

NOTICE: This Consumer Medicine Information (CMI) is intended for persons living in Australia. This page contains answers to some common questions about Chemmart Valaciclovir (herpes zoster). It does not contain all the information that is known about Chemmart Valaciclovir (herpes zoster). It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risk of you using this medicine against the benefits he/she expects it will have for you. If you have any concerns about using this medicine, ask your doctor or pharmacist. Bookmark or print this page, you may need to read it again.

What this medicine is used for

The name of your medicine is Chemmart Valaciclovir. It contains the active ingredient valaciclovir hydrochloride monohydrate. It is used to treat:
shingles (herpes zoster)
shingles affecting the eye region (ophthalmic zoster)
cold sores (herpes labialis)
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.
Shingles (herpes zoster), including shingles affecting the eye region (ophthalmic zosters):
Valaciclovir works by stopping the multiplication of the virus which causes shingles. It can reduce the length and severity of an outbreak of shingles and the duration of pain associated with shingles.
It is important that treatment for shingles is started within the first three days of the shingles attack.
Cold sores (herpes labialis):
Valaciclovir works by stopping the multiplication of the virus which causes cold sores. It can reduce the length and severity of an outbreak of cold sores and the duration of pain associated with cold sores.
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).
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 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. These include:
Mycophenolate mofetil, cylclosporin and tacrolimus, medicines commonly taken by transplant patients and require close attention.
Aminoglycoside antibiotics
Pentamidine, used to treat or prevent certain infections
Foscarnet, used against viruses
Methotrexate, used for conditions including rheumatoid arthritis and cancer
Organoplatinum compounds, used in cancer
Iodine based contrast media for scans.
If you are taking any of these you may need a different dose 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.
Shingles (herpes zoster), including shingles affecting the eye region (ophthalmic zosters):
The normal dose is either:
Two 500 mg tablets with water, three times a day.
or
One 1000 mg tablet with water, three times a day.
Cold sores (herpes labialis):
The normal dose for the one-day regimen is either:
Four 500 mg tablets with water twice a day, with the second dose taken about 12 hours after the first dose
or
Two 1000 mg tablets with water twice a day, with the second dose taken about 12 hours after the first dose.

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

Shingles (herpes zoster), including shingles affecting the eye region (ophthalmic zosters):
The usual times to take the tablets are in the morning, afternoon and evening.
Cold sores (herpes labialis):
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.

How long to take it for

Continue taking your medicine for as long as your doctor tells you.
Shingles (herpes zoster), including shingles affecting the eye region (ophthalmic zosters):
The usual course of treatment is seven days.
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.
Cold sores (herpes labialis):
The course of treatment should not exceed one day (2 doses) and the doses should be taken 12 hours apart.

If you forget to take it

Shingles (herpes zoster), including ophthalmic zosters (shingles affecting the eye region):
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.
Cold sores (herpes labialis):
Take the second dose as soon as possible once 12 hours have passed.
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, which may present as: decreased urine; fluid retention causing swollen legs, ankles or feet; nausea; drowsiness; fatigue; difficulties breathing.
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

Tell your doctor as soon as possible if you do not feel well while you are taking valaciclovir or if you have any questions or concerns.
Do not be alarmed by the following lists of side effects. You may not experience any of them. All medicines can have side effects. Sometimes they are serious but most of the time they are not.
Tell your doctor if you notice any of the following:
headache
gastrointestinal discomfort (vomiting, nausea, diarrhoea, constipation, flatulence, abdominal pain, indigestion)
dry mouth
infections or flu like symptoms
difficulty sleeping
chills
back pain
nervousness
skin rash
weakness
Below is a list of other possible side effects. These may be serious side effects and you may need medical attention.
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
decreased consciousness.
Other side effects not listed above may occur in some patients.

Allergic reactions

If you think you are having an allergic reaction to valaciclovir, do not take any more of this medicine and tell your doctor immediately or go to the Accident and Emergency department at your nearest hospital.
Symptoms of an allergic reaction may include some or all of the following:
cough, shortness of breath, wheezing or difficulty breathing
swelling of the face, lips, tongue, throat or other parts of the body
rash, itching or hives on the skin
fainting
hay fever-like symptoms.

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 Chemmart 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 tablets and bottles of 100 tablets.
1000 mg tablets
The 1000 mg tablets are white, oval shaped, biconvex film-coated tablet, partially scored and engraved "APO" on one side, "VAL 1000" on the other side.
Blisters of 3, 4, 21 tablets and bottles of 100 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

Chemmart Valaciclovir 500 mg tablets (blister pack):
AUST R 158913
Chemmart Valaciclovir 1000 mg tablets (blister pack):
AUST R 158908

Sponsor

Apotex Pty Ltd
16 Giffnock Avenue
Macquarie Park, NSW 2113
 
This leaflet prepared in September 2014.