Publications
Partners
(for genital herpes)
Contains the active ingredient, famciclovir (fam-SYE-klo-veer)
Consumer Medicine Information
For a copy of a large print leaflet, Ph: 1800 195 055
Disclaimer
Read this information carefully before taking your medicine. Ask your doctor or pharmacist if you do not understand anything or are worried about taking your medicine.
This information answers some common questions about famciclovir.
It does not contain all the available information.
It does not take the place of talking to your doctor or pharmacist.
The information was last updated on the date listed at the end of this information piece. Some more recent information on your medicine may be available. Speak to your pharmacist or doctor to obtain the most up-to-date information.
All medicines have risks and benefits. Your doctor has weighed the risks of you using this medicine against the benefits they expect it will have for you.
What famciclovir is used for
The name of your medicine is APO-Famciclovir. It contains the active ingredient, famciclovir.
Famciclovir is an antiviral medicine for adults and adolescents. It is used to treat outbreaks of genital herpes and also to suppress (prevent) recurrent outbreaks of the condition.
How it works
Genital herpes is a viral infection caused by herpes simplex 1 or herpes simplex 2. It is usually transmitted
through sexual contact.
Symptoms include tingling, burning or itching of the genitals, followed by blisters that may be painful.
People who have frequent episodes of genital herpes can also take famciclovir to help prevent the attacks.
Although famciclovir does not cure the viral infection, it helps to relieve the symptoms and shorten their duration.
The best results are obtained if the medicine is started as soon as possible after the first symptoms begin to appear.
Taking famciclovir does not prevent you from spreading the herpes virus to another person.
Ask your doctor if you have any questions about why this medicine has been prescribed for you.
Your doctor may have prescribed famciclovir for another reason.
This medicine is available only with a doctor's prescription.
There is no evidence that this medicine is addictive.
Use in children
Famciclovir is not recommended for use in children under 12 years of age.
Before you take famciclovir
When you must not take it
Do not take this medicine if you have had an allergic reaction to famciclovir, penciclovir (a related
antiviral medicine) or any of the ingredients listed at the end of this information piece.
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
Tell your doctor if:
1. You have allergies to:
• Any other medicines
• Any other substances, such as foods, preservatives or dyes.
Your doctor will want to know if you are prone to allergies.
If you experience an allergic reaction, stop using the medicine and inform your doctor or pharmacist
immediately.
2. You have or have had any medical conditions, especially the following:
• problems with your body's immune system, which helps to fight off infections
• your kidneys
• your liver.
Your doctor may want to take extra precautions in that case.
3. You plan to become pregnant or breast-feed.
It is not known whether taking this medicine during pregnancy could affect your baby or whether famciclovir passes into the breastmilk. Your doctor can discuss with you the benefits and risks 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 or pharmacist if you are taking any other medicines, including any that you buy without a
prescription from your pharmacy, supermarket or health food shop.
Some medicines and famciclovir may interfere with each other. These include:
• probenecid, a prescription medicine used to treat gout (a disease with painful, swollen joints caused by uric acid crystals)
• medicines that can affect your kidneys.
These medicines may be affected by famciclovir or may affect how well it works. You may need different amounts of your medicines, or you may need to take different medicines.
Your doctor and pharmacist can tell you if you are taking any of these medicines. They may also have more
information on medicines to be careful with or avoid while taking famciclovir.
Other interactions not listed above may also occur.
How to take this medicine
Follow all directions given to you by your doctor or pharmacist carefully.
They may be different to the information in this piece.
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.
These instructions may differ from the information contained here.
Do not change the dose yourself, without your doctor's advice, regardless of how well you may feel.
Ask your doctor or pharmacist if you are unsure of the correct dose for you.
They will tell you exactly how much to take.
For people whose immune system does not work as well as it should, the dose and duration of treatment
may need to be increased.
For people who have reduced kidney function, the dose may need to be reduced.
How to take it
Swallow the tablets whole with a full glass of water.
The tablets may be taken with or without food.
If you do not understand the instructions on the label, ask your doctor or pharmacist for help.
When to take it
There are different ways to take famciclovir depending on your condition.
1. To treat an outbreak of genital herpes
To treat an outbreak, take the tablets as soon as possible after the first symptoms of genital herpes
appear.
The tablets are best taken within 6 hours of the first symptoms of genital herpes appearing.
There are two ways to take famciclovir to treat an outbreak of genital herpes and your doctor will tell you which regimen is best for you:
• Two 250 mg famciclovir tablets to start with, followed by one 250mg tablet every 12 hours for the next 3 doses or
• One 125 mg famciclovir tablet every 12 hours for 5 days.
Both of these outbreak treatment doses deliver the same total quantity of famciclovir (1250 mg) during the treatment course.
Take the second and subsequent doses 12 hours after the first dose, or as close as possible to 12 hours during waking hours.
If you take the first dose in the late morning or early afternoon, you can take the next dose before going to bed, but do not take any doses less than 6 hours apart.
During normal waking hours, take any remaining doses at 12 hourly intervals.
Your doctor may have prescribed a different dose.
2. To suppress (prevent) outbreaks of recurrent genital herpes
Start suppressive treatment to prevent outbreaks of recurrent genital herpes as soon as possible after you have your prescription filled.
Take one 250 mg famciclovir tablet twice each day.
Continue to take one 250 mg Famciclovir tablet twice each day for as long as your doctor tells you to. Do this even if you do not have an outbreak.
This medicine helps to control your condition but does not cure it. Your doctor will tell you when you can stop.
Fill your next repeat prescription before using all of the tablets in your current carton.
This will ensure that your treatment can be continued and give you the best results.
Try to take the tablets at about the same times each day, as directed by your doctor or pharmacist.
Taking your tablet at the same times each day will have the best effect. It will also help you remember when to take the tablets.
How long to take it
Continue taking famciclovir every day for as long as your doctor tells you.
To help clear up your infection, you must keep taking this medicine, even if your symptoms begin to clear up after a few days.
To prevent recurrent episodes of genital herpes, you must take the tablets each day, even if you have no symptoms.
It is important to keep taking your medicine even if you feel well.
If you forget to take it
Take a dose as soon as you remember. Take your next tablet at the usual time, and then go back to taking it as you would normally.
Do not take a double dose to make up for the one that you missed.
This may increase the chance of you getting an unwanted side effect.
If 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 the Poisons Information Centre (Tel: 13 11 26 for Australia) for advice, or go to the Accident and Emergency Department at the nearest hospital, if you think that you or anyone else may have taken too much famciclovir.
Do this even if there are no signs of discomfort or poisoning.
You may need urgent medical attention.
While you are taking famciclovir
Things you must do
If you become pregnant while taking famciclovir, tell your doctor.
Your doctor can discuss with you the risks of taking it while you are pregnant.
Tell any other doctors, dentists, and pharmacists who are treating you that you are taking famciclovir.
Things you must not do
Do not give this medicine to anyone else, even if their symptoms seem similar to yours.
Do not use it to treat any other complaints unless your doctor tells you to.
Do not stop taking your tablets or change the dosage without checking with your doctor first.
If you stop your tablets suddenly, your condition may worsen or you may have unwanted side effects.
Things to be careful of
Be careful driving, operating machinery or doing jobs that require you to be alert until you know how famciclovir affects you.
This medicine can cause dizziness, sleepiness or confusion in some people
Things that may help your condition
Take the following precautions to help manage your condition:
• Use condoms between episodes to reduce the risk of infecting your partner
• Keep the areas affected by the virus as clean and dry as possible
• Wear loose-fitting clothing to avoid irritating the blisters
• Avoid touching or scratching the sore area as you may spread the virus on your fingers.
Side effects of famciclovir
Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking famciclovir.
All medicines can have side effects. 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 these lists 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:
• headache
• dizziness
• nausea (feeling sick) or vomiting
• diarrhoea.
The above side effects are usually mild.
Tell your doctor as soon as possible if you notice any of the following:
• a rash on other parts of your body
• extreme sleepiness or confusion, usually in older people
• hallucinations (seeing or hearing things that are not really there)
• painful or swollen joints
• aching muscles or muscle tenderness or weakness that is not caused by exercise.
The above side effects may need medical attention.
Tell your doctor immediately or go to Accident and Emergency at your nearest hospital if any of the
following side effects happen:
• bruising or bleeding more easily than usual as it may indicate that the number of platelets (a type of blood cell responsible for blood clotting) in your blood is reduced
• signs of a serious skin or mouth reaction, which may include widespread red, raised areas, blisters or sores
• signs of a possible liver problem such as persistent pain in the upper right abdomen, yellowing of the skin and/or eyes, dark urine or pale bowel motions.
The above side effects are very rare.
Tell your doctor if you notice anything else that is making you feel unwell.
Other side effects not listed here or not yet known may happen in some people.
After taking this medicine
Storage
Keep your medicine in its original packaging until it is time to take them.
If you take the tablets out of their original packaging they 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 it 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 tells you to stop taking this medicine or the expiry date has passed, ask your pharmacist what to do with anymedicine you have left over.
Where to go for further information
Pharmaceutical companies are not in a position to give people an individual diagnosis or medical advice.
Your doctor or pharmacist is the best person to give you advice on the treatment of your condition.
Product description
What APO-Famciclovir looks like
125 mg tablets
White, round, biconvex, film-coated and engraved "FAM" over "125" on one side and "APO" on the other
side.
# Blister pack sizes: 10, 28, 40 or 56 tablets.
# Bottle pack sizes: 28, 40 or 56 tablets.
250 mg tablets
White, round, biconvex, film-coated and engraved "FAM" over "250" on one side and "APO" on the other
side.
# Blister pack sizes: 5, 14, 20, 21, 28, 30 or 56 tablets.
# Bottle pack sizes: 14, 20, 21, 28, 40 or 56 tablets.
# Not all strengths, pack types and/or pack sizes may be available
Ingredients
Each tablet contains 125 mg or 250 mg of famciclovir as the activeingredient.
It also contains the following inactive ingredients:
• poloxamer
• stearic acid
• hypromellose
• titanium dioxide
• macrogol 8000.
This medicine is gluten-free, lactose-free, sucrose-free, tartrazine-free and free of other azo dyes.
Australian Registration Numbers
APO-Famciclovir 125 mg tablets (blister pack): AUST R 160559.
APO-Famciclovir 250 mg tablets (blister pack): AUST R 160556.
APO-Famciclovir 125 mg tablets (bottle): AUST R 160558.
APO-Famciclovir 250 mg tablets (bottle): AUST R 160560.
Sponsor
Apotex Pty Ltd
66 Waterloo Road
North Ryde NSW 2113
Australia
Apotex Pty Ltd is the licensee of the registered trade marks AX logo, APO and APOTEX from the registered
proprietor, Apotex Inc.
This information was prepared in May 2010.
Contains the active ingredient, famciclovir (fam-SYE-klo-veer)
Consumer Medicine Information
For a copy of a large print leaflet, Ph: 1800 195 055
Disclaimer
Read this information carefully before taking your medicine. Ask your doctor or pharmacist if you do not understand anything or are worried about taking your medicine.
This information answers some common questions about famciclovir.
It does not contain all the available information.
It does not take the place of talking to your doctor or pharmacist.
The information was last updated on the date listed at the end of this information piece. Some more recent information on your medicine may be available. Speak to your pharmacist or doctor to obtain the most up-to-date information.
All medicines have risks and benefits. Your doctor has weighed the risks of you using this medicine against the benefits they expect it will have for you.
What famciclovir is used for
The name of your medicine is APO-Famciclovir. It contains the active ingredient, famciclovir.
Famciclovir is an antiviral medicine for adults and adolescents. It is used to treat outbreaks of genital herpes and also to suppress (prevent) recurrent outbreaks of the condition.
How it works
Genital herpes is a viral infection caused by herpes simplex 1 or herpes simplex 2. It is usually transmitted
through sexual contact.
Symptoms include tingling, burning or itching of the genitals, followed by blisters that may be painful.
People who have frequent episodes of genital herpes can also take famciclovir to help prevent the attacks.
Although famciclovir does not cure the viral infection, it helps to relieve the symptoms and shorten their duration.
The best results are obtained if the medicine is started as soon as possible after the first symptoms begin to appear.
Taking famciclovir does not prevent you from spreading the herpes virus to another person.
Ask your doctor if you have any questions about why this medicine has been prescribed for you.
Your doctor may have prescribed famciclovir for another reason.
This medicine is available only with a doctor's prescription.
There is no evidence that this medicine is addictive.
Use in children
Famciclovir is not recommended for use in children under 12 years of age.
Before you take famciclovir
When you must not take it
Do not take this medicine if you have had an allergic reaction to famciclovir, penciclovir (a related
antiviral medicine) or any of the ingredients listed at the end of this information piece.
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
Tell your doctor if:
1. You have allergies to:
• Any other medicines
• Any other substances, such as foods, preservatives or dyes.
Your doctor will want to know if you are prone to allergies.
If you experience an allergic reaction, stop using the medicine and inform your doctor or pharmacist
immediately.
2. You have or have had any medical conditions, especially the following:
• problems with your body's immune system, which helps to fight off infections
• your kidneys
• your liver.
Your doctor may want to take extra precautions in that case.
3. You plan to become pregnant or breast-feed.
It is not known whether taking this medicine during pregnancy could affect your baby or whether famciclovir passes into the breastmilk. Your doctor can discuss with you the benefits and risks 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 or pharmacist if you are taking any other medicines, including any that you buy without a
prescription from your pharmacy, supermarket or health food shop.
Some medicines and famciclovir may interfere with each other. These include:
• probenecid, a prescription medicine used to treat gout (a disease with painful, swollen joints caused by uric acid crystals)
• medicines that can affect your kidneys.
These medicines may be affected by famciclovir or may affect how well it works. You may need different amounts of your medicines, or you may need to take different medicines.
Your doctor and pharmacist can tell you if you are taking any of these medicines. They may also have more
information on medicines to be careful with or avoid while taking famciclovir.
Other interactions not listed above may also occur.
How to take this medicine
Follow all directions given to you by your doctor or pharmacist carefully.
They may be different to the information in this piece.
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.
These instructions may differ from the information contained here.
Do not change the dose yourself, without your doctor's advice, regardless of how well you may feel.
Ask your doctor or pharmacist if you are unsure of the correct dose for you.
They will tell you exactly how much to take.
For people whose immune system does not work as well as it should, the dose and duration of treatment
may need to be increased.
For people who have reduced kidney function, the dose may need to be reduced.
How to take it
Swallow the tablets whole with a full glass of water.
The tablets may be taken with or without food.
If you do not understand the instructions on the label, ask your doctor or pharmacist for help.
When to take it
There are different ways to take famciclovir depending on your condition.
1. To treat an outbreak of genital herpes
To treat an outbreak, take the tablets as soon as possible after the first symptoms of genital herpes
appear.
The tablets are best taken within 6 hours of the first symptoms of genital herpes appearing.
There are two ways to take famciclovir to treat an outbreak of genital herpes and your doctor will tell you which regimen is best for you:
• Two 250 mg famciclovir tablets to start with, followed by one 250mg tablet every 12 hours for the next 3 doses or
• One 125 mg famciclovir tablet every 12 hours for 5 days.
Both of these outbreak treatment doses deliver the same total quantity of famciclovir (1250 mg) during the treatment course.
Take the second and subsequent doses 12 hours after the first dose, or as close as possible to 12 hours during waking hours.
If you take the first dose in the late morning or early afternoon, you can take the next dose before going to bed, but do not take any doses less than 6 hours apart.
During normal waking hours, take any remaining doses at 12 hourly intervals.
Your doctor may have prescribed a different dose.
2. To suppress (prevent) outbreaks of recurrent genital herpes
Start suppressive treatment to prevent outbreaks of recurrent genital herpes as soon as possible after you have your prescription filled.
Take one 250 mg famciclovir tablet twice each day.
Continue to take one 250 mg Famciclovir tablet twice each day for as long as your doctor tells you to. Do this even if you do not have an outbreak.
This medicine helps to control your condition but does not cure it. Your doctor will tell you when you can stop.
Fill your next repeat prescription before using all of the tablets in your current carton.
This will ensure that your treatment can be continued and give you the best results.
Try to take the tablets at about the same times each day, as directed by your doctor or pharmacist.
Taking your tablet at the same times each day will have the best effect. It will also help you remember when to take the tablets.
How long to take it
Continue taking famciclovir every day for as long as your doctor tells you.
To help clear up your infection, you must keep taking this medicine, even if your symptoms begin to clear up after a few days.
To prevent recurrent episodes of genital herpes, you must take the tablets each day, even if you have no symptoms.
It is important to keep taking your medicine even if you feel well.
If you forget to take it
Take a dose as soon as you remember. Take your next tablet at the usual time, and then go back to taking it as you would normally.
Do not take a double dose to make up for the one that you missed.
This may increase the chance of you getting an unwanted side effect.
If 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 the Poisons Information Centre (Tel: 13 11 26 for Australia) for advice, or go to the Accident and Emergency Department at the nearest hospital, if you think that you or anyone else may have taken too much famciclovir.
Do this even if there are no signs of discomfort or poisoning.
You may need urgent medical attention.
While you are taking famciclovir
Things you must do
If you become pregnant while taking famciclovir, tell your doctor.
Your doctor can discuss with you the risks of taking it while you are pregnant.
Tell any other doctors, dentists, and pharmacists who are treating you that you are taking famciclovir.
Things you must not do
Do not give this medicine to anyone else, even if their symptoms seem similar to yours.
Do not use it to treat any other complaints unless your doctor tells you to.
Do not stop taking your tablets or change the dosage without checking with your doctor first.
If you stop your tablets suddenly, your condition may worsen or you may have unwanted side effects.
Things to be careful of
Be careful driving, operating machinery or doing jobs that require you to be alert until you know how famciclovir affects you.
This medicine can cause dizziness, sleepiness or confusion in some people
Things that may help your condition
Take the following precautions to help manage your condition:
• Use condoms between episodes to reduce the risk of infecting your partner
• Keep the areas affected by the virus as clean and dry as possible
• Wear loose-fitting clothing to avoid irritating the blisters
• Avoid touching or scratching the sore area as you may spread the virus on your fingers.
Side effects of famciclovir
Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking famciclovir.
All medicines can have side effects. 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 these lists 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:
• headache
• dizziness
• nausea (feeling sick) or vomiting
• diarrhoea.
The above side effects are usually mild.
Tell your doctor as soon as possible if you notice any of the following:
• a rash on other parts of your body
• extreme sleepiness or confusion, usually in older people
• hallucinations (seeing or hearing things that are not really there)
• painful or swollen joints
• aching muscles or muscle tenderness or weakness that is not caused by exercise.
The above side effects may need medical attention.
Tell your doctor immediately or go to Accident and Emergency at your nearest hospital if any of the
following side effects happen:
• bruising or bleeding more easily than usual as it may indicate that the number of platelets (a type of blood cell responsible for blood clotting) in your blood is reduced
• signs of a serious skin or mouth reaction, which may include widespread red, raised areas, blisters or sores
• signs of a possible liver problem such as persistent pain in the upper right abdomen, yellowing of the skin and/or eyes, dark urine or pale bowel motions.
The above side effects are very rare.
Tell your doctor if you notice anything else that is making you feel unwell.
Other side effects not listed here or not yet known may happen in some people.
After taking this medicine
Storage
Keep your medicine in its original packaging until it is time to take them.
If you take the tablets out of their original packaging they 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 it 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 tells you to stop taking this medicine or the expiry date has passed, ask your pharmacist what to do with anymedicine you have left over.
Where to go for further information
Pharmaceutical companies are not in a position to give people an individual diagnosis or medical advice.
Your doctor or pharmacist is the best person to give you advice on the treatment of your condition.
Product description
What APO-Famciclovir looks like
125 mg tablets
White, round, biconvex, film-coated and engraved "FAM" over "125" on one side and "APO" on the other
side.
# Blister pack sizes: 10, 28, 40 or 56 tablets.
# Bottle pack sizes: 28, 40 or 56 tablets.
250 mg tablets
White, round, biconvex, film-coated and engraved "FAM" over "250" on one side and "APO" on the other
side.
# Blister pack sizes: 5, 14, 20, 21, 28, 30 or 56 tablets.
# Bottle pack sizes: 14, 20, 21, 28, 40 or 56 tablets.
# Not all strengths, pack types and/or pack sizes may be available
Ingredients
Each tablet contains 125 mg or 250 mg of famciclovir as the activeingredient.
It also contains the following inactive ingredients:
• poloxamer
• stearic acid
• hypromellose
• titanium dioxide
• macrogol 8000.
This medicine is gluten-free, lactose-free, sucrose-free, tartrazine-free and free of other azo dyes.
Australian Registration Numbers
APO-Famciclovir 125 mg tablets (blister pack): AUST R 160559.
APO-Famciclovir 250 mg tablets (blister pack): AUST R 160556.
APO-Famciclovir 125 mg tablets (bottle): AUST R 160558.
APO-Famciclovir 250 mg tablets (bottle): AUST R 160560.
Sponsor
Apotex Pty Ltd
66 Waterloo Road
North Ryde NSW 2113
Australia
Apotex Pty Ltd is the licensee of the registered trade marks AX logo, APO and APOTEX from the registered
proprietor, Apotex Inc.
This information was prepared in May 2010.
