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Valaciclovir Apotex
01/31/2021 | Medications
NOTICE: This Consumer Medicine Information (CMI) is intended for persons living in Australia.
VALACICLOVIR APOTEX
Valaciclovir Tablets
Consumer Medicine Information
What is in this leaflet
This leaflet answers some common questions about valaciclovir. It does not contain all 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 this medicine against the benefits they expect it will 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 this medicine is used for
Valaciclovir belong to a group of medicines called antivirals.
Valaciclovir is used for the following conditions in adults:
Treatment of herpes zoster (shingles):
It can reduce the duration of pain, length and severity of a shingles outbreak. Start the treatment within the first three days of the shingles attack.
Treatment of ophthalmic zoster
(shingles affecting the eye region)
Treatment of genital herpes:
Valaciclovir can reduce the length and severity of a herpes outbreak, and reduce the duration of pain and time to healing of herpes blisters and crusts. It does not eliminate the herpes simplex virus (HSV) from the body. If you start taking it as soon as you feel an outbreak starting, you may prevent blisters from developing.
Prevention of genital herpes in immunocompromised patients with moderate to normal kidney function:
Valaciclovircan be taken by immunocompromised patients with adequate kidney function to help prevent the HSV infection coming back.
Reduction of transmission of genital herpes:
Valaciclovir can reduce the risk of transmitting the HSV virus in patients who are taking it continuously. It does not cure genital herpes or eliminate the risk of transmission. Therefore, in addition to valaciclovir, it is recommended to avoid intercourse during a herpes outbreak and always use condoms to minimise the risk of spreading herpes to your partner.
Prevention of cytomegalovirus infection (CMV) and disease:
Valaciclovir is used to prevent cytomegalovirus (CMV) infection and disease following solid organ transplantation. CMV is a type of herpes virus. It can cause symptoms similar to glandular fever (high temperature, sore throat and swollen glands).
How it works
Valaciclovir works by stopping the multiplication of the virus which causes shingles and herpes.
Ask your doctor if you have any questions about why valaciclovir has been prescribed for you.
Your doctor may have prescribed it for another reason.
This medicine is not addictive.
This medicine is available only with a doctor’s prescription.
There is not enough information to recommend the use of valaciclovir in children.
Before you take this medicine
When you must not take it
Do not take this medicine if you have an allergy to:
valaciclovir
acyclovir
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 after the expiry date printed on the pack or if the packaging is torn or shows signs of tampering.
If has expired or is damaged, return it to your pharmacist for disposal.
If you are not sure whether you should be taking this medicine, 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 kidney or liver problems.
Tell your doctor if you are pregnant, intend to become pregnant or are breastfeeding.
Your doctor can discuss with you the risks and benefits involved.
If you have not told your doctor about any of the above, tell them before you start taking this medicine.
Taking other medicines
Tell your doctor and pharmacist 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 interfere with valaciclovir. These include:
cimetidine, used for indigestion
probenecid, used to treat joint disorders
mycophenolate, cyclosporin and tacrolimus, used after organ transplantation
These medicines may be affected by this medicine or may affect how well it works. You may need to use different amounts of your medicine or you may need to take different medicines.
Your doctor and pharmacist have more information on medicines to be careful with or avoid while taking valaciclovir.
How to take this medicine
Follow all directions given to you by your doctor or 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
Your doctor will decide what dose you should take and how often you should take valaciclovir. The dosage may vary depending on your medical history.
Treatment of herpes zoster:
The usual dose is two tablets taken three times a day.
Treatment of genital herpes (first case):
The usual dose is one tablet taken two times a day.
Treatment of genital herpes (recurrent cases):
The usual dose is one tablet taken two times a day. You should start to take this medicine as early as possible if you think you are about to have an attack of genital herpes. Dosing should ideally start just before, or straight after the first signs of genital herpes infection appear.
Prevention of genital herpes in immunocompromised patients with moderate to normal kidney function:
The usual dose is one tablet taken twice a day.
Reduction of transmission of genital herpes:
In adults with normal immune function with less than 10 recurrences of genital herpes infection per year, the usual dose for the infected partner is one tablet taken once daily.
Prevention of cytomegalovirus infection (CMV) and disease:
The usual dose is 4 tablets taken four times a day for 90 days.
How to take it
Swallow the tablets whole with a full glass of water. You should drink plenty of fluids while taking valaciclovir, especially if elderly.
When to take it
Take your medicine at about the same time each day.
Taking your tablets at the same time each day will have the best effect. It will also help you to remember when to take the tablets.
How long to take it
Treatment of herpes zoster:
The usual course of treatment is 7 days.
Treatment of genital herpes infections:
The usual course of treatment is 5 days. However, in some instances your doctor may want you to take your tablets for 10 days.
Prevention of genital herpes infections in immunocompromised patients with moderate to normal kidney function and reduction of transmission of the genital herpes infection:
You should continue to take this medicine as long as prescribed by your doctor.
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 are not sure what to do, ask your doctor or pharmacist.
If you have trouble remembering when to take your medicine, ask your pharmacist for some hints.
If you take too much (overdose)
Immediately telephone your doctor or the Poisons Information Centre (telephone 13 11 26) or go to Accident and Emergency at your nearest hospital if you think that you or anyone else has taken too much valaciclovir. Do this even if there are no signs of discomfort or poisoning.
You may need urgent medical attention.
While you are using this medicine
Things you must do
If you are about to be started on any new medicine, tell your doctor and pharmacist that you are taking this medicine.
Tell any doctors, dentists or pharmacists that treat you that you are taking this medicine.
If you become pregnant while taking valaciclovir, tell your doctor immediately.
Drink plenty of fluids while you are taking valaciclovir.
Keep all of your doctor’s appointments so that your progress can be checked.
Your doctor may do some tests from time to time to make sure the medicine is working and to prevent unwanted side effects.
Things you must not do
Do not take valaciclovir to treat any other complaints unless your doctor says to.
Do not give this medicineto anyone else, even if they have the same condition as you.
Do not stop taking valaciclovir, or change the dose, without first checking with your doctor.
If you stop too soon, the infection may start again.
Things to be careful of
Be careful driving or operating machinery until you know how valaciclovir affects you.
Side effects
Tell your doctor and pharmacist as soon as possible if you not feel well while you are taking valaciclovir.
This medicine helps most people, but it may cause unwanted some 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 this list of possible side-effects. You may not experience any of them.
Ask your doctor or pharmacist any questions you may have.
Tell your doctor if you notice any of the following and they worry you:
dry mouth
fever, chills
difficulty sleeping
back pain, headache
nervousness
skin rash which may be itchy
dizziness, drowsiness, weakness
sensitivity to UV light, such as developing a rash-like sunburn even after short exposure to UV light
stomach discomfort, such as vomiting,nausea, diarrhoea, constipation, pain, indigestion, flatulence
The above list includes the more common side effects of your medicine.
If any of the following happen, tell your doctor immediately or go to Accident and Emergency at your nearest hospital:
wheezing, or difficulty in breathing; swelling of the lips/mouth; hay fever; rash, hives, fainting (signs of an allergic reaction)
hallucinations, confusion
kidney damage
unusual bruising or bleeding (signs of low platelet count)
liver damage
The above list includes very serious side effects. You may need urgent medical attention or hospitalisation.
Tell your doctor or pharmacist if you notice anything that is making you feel unwell.
Other side effects not listed above may also occur in some people.
Storage and Disposal
Storage
Keep your tablets in the 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 this 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 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.
Disposal
If your doctor tells you to stop taking this medicine or the expiry date has passed, ask your pharmacist what to do with any tablets that are left over.
Product description
What it looks like
Blue coloured, capsule- shaped, biconvex, film-coated tablets, debossed with ‘V’ and ‘5’ on either side of the breakline on one side, notched on either side along with the breakline and plain on the other side. AUST R 177375.
Available in blister packs containing 10, 30, 42 or 100 tablets.
*Not all pack sizes may be available.
Ingredients
This medicine contains 500 mg of valaciclovir hydrochloride as theactive ingredient.
It also contains the following:
microcrystalline cellulose
magnesium stearate
crospovidone
povidone (K 30)
povidone (K 90D)
indigo carmine aluminium lake
Opadry 02C50740 Blue
Opadry 02C50740 Blue consists of:
hypromellose
titanium dioxide
macrogol 400
macrogol 6000
polysorbate 80
indigo carmine aluminium lake
This medicine does not contain sucrose, gluten, tartrazine or any other azo dyes.
Sponsor
Apotex Pty Ltd
16 Giffnock Avenue
Macquarie Park NSW 2113
This leaflet was prepared in November 2018.
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