Ezovir Tablets for people with genital herpes
Ezovir Tablets for people with genital herpes is a brand of medicine containing the active ingredient famciclovir.
Find out more about active ingredients.
Consumer medicine information (CMI) leaflet
Developed by the pharmaceutical company responsible for this medicine in Australia, according to TGA regulations.
EZOVIR® for genital herpes
contains the active ingredient famciclovir
Consumer Medicine Information
What is in this leaflet
This leaflet answers some common questions about EZOVIR®.
It does not contain all the available information and 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 final page.
Some more recent information on the medicine may be available.
You should ensure that you speak to your pharmacist or doctor to obtain the most up to date information on the medicine.
Those updates may contain important information about the medicine and its use of which you should be aware.
All medicines have risks and benefits. Your doctor has weighed the risks of you taking EZOVIR® against the benefits it can provide.
If you have any concerns about taking this medicine, talk to your doctor or pharmacist.
Keep this leaflet with this medicine. You may need to read it again.
What EZOVIR® is used for
EZOVIR® 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.
Genital herpes is 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 e painful.
People who have frequent episodes of genital herpes can also take EZOVIR® to help prevent the attacks.
Although EZOVIR® 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 EZOVIR® does not prevent you form 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 it for another reason.
EZOVIR® is only available with a doctor's prescription. It is not addictive.
This medicine is not recommended for use in infants or children under 12 years of age.
Before taking EZOVIR®
When you must not take it
Do not take EZOVIR® if you have an allergy to:
- famciclovir, the active ingredient
- penciclovir, a related antiviral medicine
- any of the EZOVIR® ingredients listed at the end of this leaflet (see 'Product Description')
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 EZOVIR® after the expiry date printed on the pack.
Do not take EZOVIR® if the packaging is torn or shows signs of tampering.
In that case, return it to your pharmacist.
Before you start to take it
Tell your doctor if you have a problem 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.
Tell your doctor if you are pregnant, intend to become pregnant or if you are breast feeding.
It is not known whether taking this medicine during pregnancy could affect your baby or whether the active ingredient in EZOVIR® passes into the breast milk. Your doctor can discuss with you the benefits and risks involved.
Tell your doctor if you are lactose intolerant.
EZOVIR® tablets contain lactose.
Tell your doctor if you are allergic to any other medicines, foods, dyes or preservatives.
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.
Taking other medicines
Tell your doctor if you are taking any other medicines, including any that you get without a prescription from a pharmacy, supermarket or health food shop.
Some medicines and EZOVIR® 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
You may need to take different amounts of these medicines or may need to take different medicines. Your doctor and pharmacist have more information.
If you have not told your doctor about any of these things, tell him/her before your start taking this medicine.
How to take EZOVIR®
Swallow the tablets whole with a full glass of water.
They may be taken with or without food.
Follow all directions given to you by your doctor and pharmacist carefully.
These instructions may differ from the information contained in this leaflet.
If you do not understand the instructions on the label, ask your doctor or pharmacist for help.
How much to take
Follow your doctor's instructions on how many EZOVIR® tablets to take.
Ask your doctor or pharmacist if you are unsure of the correct dose for you.
They will tell you exactly how much to take.
Follow the instructions that they give you.
For people whose immune system does not work as well as it should, the dose and duration of treatment may be increased.
For people who have reduced kidney function, the dose may be reduced.
Do not change the dose yourself, without your doctor's advice, regardless of how well you may feel.
When to take it
There are different ways to take EZOVIR® depending on your condition.
- To treat and 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 to ways to take EZOVIR® to treat an outbreak of genital herpes and your doctor will tell you which regimen is best for you:
- Two 250 mg EZOVIR® tablets to start with, followed by one 250 mg tablet every 12 hours for the next 3 doses.
- One 125 mg tablet every 12 hours for 5 days.
Both of these outbreak treatment does 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 your 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.
- 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 EZOVIR® prescription filled.
Take one 250 mg EZOVIR® tablet twice each day.
Continue to take one 250 mg EZOVIR® tablet twice each day for as long as your doctor tells you to, even if you do not have an outbreak.
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 EZOVIR® every day for as long as your doctor tells you.
To help clear up your infection, your 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 change of you getting an unwanted side effect.
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 Australian Poisons Information Centre (telephone 13 11 26) for advice, or go to Accident and Emergency at your nearest hospital, if you think you or anyone else may have taken too much EZOVIR®. Do this even if there are no signs of discomfort or poisoning. Keep the telephone numbers for these places handy.
While you are taking EZOVIR®
Things you must do
If you become pregnant while taking EZOVIR®, tell your doctor.
Your doctor can discuss with you the risks of taking it while you are pregnant.
If you are about to be started on any new medicine, remind your doctor and pharmacist that you are taking EZOVIR®.
Tell any other doctor, dentist or pharmacist who treats you that you are taking EZOVIR®.
Things you must not do
Do not give this medicine to anyone else even if their condition seems to be the same as yours.
Do not use this medicine 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 EZOVIR® affects you.
This medicine can cause dizziness, sleepiness or confusion in some people.
Avoid sexual intercourse when symptoms are present, even if you have started taking EZOVIR®, because the risk of infecting your partner is increased.
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.
You may spread the virus on your fingers.
Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking EZOVIR®.
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 the below lists of possible side effects.
You may not experience any of them.
Tell your doctor if you notice any of the following and they worry you:
- nausea (feeling sick) or vomiting
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)
- 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 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 are reduced
- signs of a serious skin or mouth reaction, which may include widespread red, raised areas, blisters or sores
- painful or swollen joints
- aching muscles or muscle tenderness or weakness that is not caused by exercise
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.
Ask your doctor or pharmacist to answer any questions you may have.
After taking EZOVIR®
Keep your medicine in the original container until it is time to take it.
Store it in a dry place where the temperature stays below 25°C.
Do not store EZOVIR® or any other in the bathroom or near a sink.
Do not leave the tablets in the car or on window sills. Heat and dampness can destroy some medicines. EZOVIR® tablets will keep best if they are stored cool and dry.
Keep the medicine where children cannot reach it. A locked cupboard at least one-and-a-half meters above the ground is a good place to store medicines.
If your doctor tells you to stop taking this medicine or the expiry date has passed, ask your pharmacist what to do with any medicine you have left over.
What it looks like
EZOVIR® tablets are available in the following strengths for the treatment of genital herpes:
- 125mg - white, oval shape, biconvex, film coated, debossed with "FAM 125" on one side and "G" on other side in blister packs of 40.
- 250mg - white, oval shape, biconvex, film coated, debossed with "FAM 250" on one side and "G" on other side in blister packs of 20, 21 and 56.
The active ingredient in EZOVIR® is famciclovir.
Each EZOVIR® 125 tablet contains 125 mg of famciclovir
Each EZOVIR® 250 tablet contains 250 mg of famciclovir.
The tablets also contain the following inactive ingredients:
- sodium starch glycollate
- cellulose - microcrystalline
- silicon dioxide
- magnesium stearate
- Opadry II white OY-L-28900
EZOVIR® is supplied by:
Alphapharm Pty Limited
(ABN 93 002 359 739)
Chase Building 2
Wentworth Park Road
GLEBE NSW 2037
Phone: (02) 9298 3999
Phone: 1800 028 365
Australian registration numbers:
EZOVIR® 125 mg - AUST R 157789
EZOVIR® 250 mg - AUST R 157788
This leaflet was prepared on 18 March 2010.
CMI provided by MIMS Australia, June 2013