(for shingles)
Contains the active ingredient, famciclovir (fam-SYE-klo-veer)
Consumer Medicine Information
What is in this leaflet
Read this leaflet carefully before taking your medicine.
This leaflet 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 in this leaflet was last updated on the date listed on the last page. More recent information on this medicine may be available.
Ask your doctor or pharmacist:
if there is anything you do not understand in this leaflet,
if you are worried about taking your medicine, or
to obtain the most up-to-date information.
You can also download the most up to date leaflet from www.apotex.com.au.
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.
Pharmaceutical companies cannot give you medical advice or an individual diagnosis.
Keep this leaflet with your medicine.
You may want to read it again.
What this medicine is used for
The name of your medicine is APO-Famciclovir. It contains the active ingredient, famciclovir.
Famciclovir is an antiviral medicine used to treat shingles in adults and adolescents.
How it works
Shingles is a condition that is caused by a herpes virus called varicella zoster, the same virus that causes chicken pox. The virus can become active again in the body, even after many years, resulting in shingles. The main symptom is a rash that can cause pain, burning and blisters.
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.
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 this medicine
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 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
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.
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
problems with your kidneys
problems with 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 breast milk. 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)
raloxifene, a medicine used to treat osteoporosis (a disease which causes bones to become less dense, gradually making them weaker, more brittle and likely to break)
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 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.
These instructions may differ from the information contained in this leaflet.
Do not change the dose yourself, without your doctor's advice, regardless of how well you may feel.
Ask your doctor if you are unsure of the correct dose for you.
They will tell you exactly how much to take.
The usual dose is one 250 mg tablet three times each day for seven days, beginning no later than 72 hours after the rash appears.
Your doctor may have prescribed a different dose.
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
Unless your doctor tells you otherwise, take one tablet when you get up in the morning, one in the afternoon and one just before going to bed at night.
Try to take the tablets at about the same time each day.
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.
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 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.
Taking too much famciclovir may affect the kidneys. In people who already have kidney problems, it may, rarely, lead to kidney failure if their dose is not correctly lowered.
While you are taking this medicine
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, tiredness or confusion in some people
Things that may help your condition
Take the following precautions to avoid spreading the virus:
Keep the areas affected by the virus as clean and dry as possible.
Wear loose-fitting clothing to avoid irritating the rash.
Avoid touching or scratching the sore area as you may spread the virus on your fingers.
Possible side effects
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
itching or an itchy rash (urticaria)
abnormal liver function test results.
The above side effects are usually mild.
Tell your doctor as soon as possible if you notice any of the following:
a rash that is separate from the shingles rash
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:
swelling below the surface of the skin (e.g. swelling around the face, eye, eyelid or throat)
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.
Storage and disposal
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, your pharmacist can dispose of the remaining medicine safely.
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.
500 mg tablets
White, oval, biconvex, film-coated and engraved "FAM500" on one side and "APO" on the other side.
Blister pack sizes: 3, 12, 14, 16, 20, 28, 30, 56 tablets.
Bottle pack sizes: 12, 14, 16, 20, 28, 30, 56 tablets.
Not all strengths, pack types and/or pack sizes may be available
Ingredients
Each tablet contains 125 mg, 250 mg or 500 mg of famciclovir as the active ingredient.
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.
