Consumer Medicine Information
What is in this leaflet
This leaflet answers some common questions about FAMCICLOVIR GENERICHEALTH for cold sores.
It does not contain all the available information. It does not take the place of talking to your pharmacist or doctor.
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.
All medicines have risks and benefits. Your pharmacist or doctor has weighed the risks of you taking FAMCICLOVIR GENERICHEALTH against the benefits it can provide.
If you have any concerns about this medicine, ask your pharmacist or doctor.
Keep this leaflet with the medicine. You may need to read it again.
What FAMCICLOVIR GENERICHEALTH is used for
FAMCICLOVIR GENERICHEALTH is an antiviral medicine used to treat recurrent outbreaks of cold sores in adults who have a normal immune system (the body system which fights against harmful bacteria, viruses and fungi).
Cold sores are an infection caused by a virus called herpes simplex type 1 (HSV-1). The infection is most commonly acquired as a baby or child from contact with parents or relatives, often from kissing.
Cold sores usually begin on or around the lips, mouth, and nose as small red bumps that turn into fluid-filled blisters. Cold sores can be tender and painful. Many people who get cold sores know when one is coming by a tingling, burning, itchy or painful sensation or redness in the area. This can happen very rapidly.
After redness and swelling develop, blisters form. The blisters may weep or burst and this can be painful. Then a shallow ulcer and yellow crust form as the cold sore dries. The crust eventually falls off, exposing new pink-coloured skin. Generally the sores heal without scarring. After the initial infection has healed, the virus becomes dormant in nerve cells.
Cold sores can be unpredictable. The virus can become active again in the body, even after many years, resulting in recurrent outbreaks.
Even after many years, some people may experience recurring cold sores due to viral reactivation.
Some common triggers to a cold sore may include:
- sun exposure
- menstrual periods
- dry chapped lips
- skin trauma
- a cold.
Although FAMCICLOVIR GENERICHEALTH for cold sores does not cure the viral infection, it helps to relieve the symptoms and shorten the duration of an outbreak.
The best results are obtained if the medicine is started as soon as possible after the onset of symptoms of a cold sore, such as tingling, itching or burning, or the appearance of the first signs, such as redness or swelling. This is when the virus is reproducing rapidly.
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.
FAMCICLOVIR GENERICHEALTH is only available with a doctor's prescription. It is not addictive.
This medicine is not recommended for use in infants, children or adolescents under 18 years of age.
Before you take FAMCICLOVIR GENERICHEALTH
When not to take it
Do not take FAMCICLOVIR GENERICHEALTH for cold sores if you have an allergy to:
- famciclovir, the active ingredient
- penciclovir, a related antiviral medicine
- any of the other ingredients of FAMCICLOVIR GENERICHEALTH 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. 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
- you have a problem with your kidneys or 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. FAMCICLOVIR GENERICHEALTH should not be used during pregnancy unless necessary. Your doctor will discuss with you the potential risks of taking FAMCICLOVIR GENERICHEALTH during pregnancy, and will also advise you if you should take FAMCICLOVIR GENERICHEALTH while breast-feeding, based on the benefits and risks of your particular situation.
Tell your pharmacist or doctor if you are allergic to any other medicines, foods, dyes or preservatives. He/she 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 pharmacist or doctor 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 and FAMCICLOVIR GENERICHEALTH 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) and to increase blood levels of penicillin-type antibiotics
- 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.
You may need to take different amounts of these medicines or you may need to take different medicines. Your pharmacist and doctor have more information.
If you have not told your pharmacist or doctor about any of these things, tell him/her before you start taking this medicine.
How to take FAMCICLOVIR GENERICHEALTH
Follow all directions given to you by your pharmacist or doctor carefully. These instructions may differ from the information contained in this leaflet.
If you do not understand the instructions on the label, ask your pharmacist or doctor for help.
How much to take
The usual dose is three 500 mg tablets taken together as a single dose.
Your doctor may have prescribed a different dose.
Ask your pharmacist or doctor if you are unsure of the correct dose for you. He/she will tell you exactly how much to take.
When to take it
Take FAMCICLOVIR GENERICHEALTH for cold sores tablets as soon as possible after the first symptoms (e.g. tingling, itching or burning) or signs (e.g. redness or swelling) of a cold sore appear.
Do not take the tablets if a hard crust has already formed on the cold sore. Keep the tablets for the next episode.
How to take it
Swallow the tablets whole with a full glass of water.
They may be taken with or without food.
How long to take it for
A single dose of FAMCICLOVIR GENERICHEALTH for cold sores is all that is necessary for treating each episode of cold sores. The dose may be repeated if cold sores recur. Each pack of FAMCICLOVIR GENERICHEALTH for cold sores contains enough medicine for one dose.
If you take too much
Immediately telephone your doctor or the Poisons Information Centre (telephone number 13 11 26), or go to Accident and Emergency at your nearest hospital if you think that you or anyone else may have taken too much FAMCICLOVIR GENERICHEALTH for cold sores. Show them your pack of tablets. Do this even if the
re are no signs of discomfort or poisoning. Keep the telephone numbers for these places handy.
Taking too much FAMCICLOVIR GENERICHEALTH 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.
Things that may help your condition
Cold sores are contagious and the virus can be passed on from person to person through close physical contact or saliva, even when blisters are not present. The risk is much higher when the cold sore is visible, as the virus can be shed, making it easy to infect other people.
Take the following precautions to avoid spreading the virus:
- Keep the areas affected by the virus as clean and dry as possible
- Avoid touching or scratching the sore area as you may spread the virus on your fingers
- Do not share any objects that have been in contact with a cold sore (e.g. drinking glasses, eating utensils, or towels)
- Avoid direct skin-to-skin contact of the area with other people (e.g. kissing) until the cold sore has healed.
While you are taking FAMCICLOVIR GENERICHEALTH
Things you must do
Tell your pharmacist or doctor if your cold sore symptoms do not improve within a few days, or if they become worse.
If you become pregnant, tell your doctor before taking any further doses of this medicine to treat recurring episodes of cold sores. He/she 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 periodically take this medicine to treat recurring episodes of cold sores.
Tell any other doctor, dentist or pharmacist who treats you that you periodically take this medicine.
Things you must not do
Do not take less than the recommended dose of 3 tablets, unless advised by your doctor.
Do not give this medicine to anyone else even if their condition seems to be the same as yours.
Do not use it to treat any other complaints unless your doctor tells you to.
Things to be careful of
If you are pregnant or breast-feeding, ask your doctor or pharmacist for advice before taking any medicine.
Be careful driving, operating machinery or doing jobs that require you to be alert until you know how FAMCICLOVIR GENERICHEALTH for cold sores affects you. This medicine can cause dizziness, sleepiness or confusion..
Tell your pharmacist or doctor as soon as possible if you do not feel well while you are taking FAMCICLOVIR GENERICHEALTH for cold sores.
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 pharmacist or doctor to answer any questions you may have.
Tell your pharmacist or doctor if you notice any of the following and they worry you:
- nausea (feeling sick) or vomiting
- 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 elsewhere on the body, that is separate from the cold sore
- 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 (eg 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 are 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.
How to store FAMCICLOVIR GENERICHEALTH
Keep your medicine in the original container until it is time to take it.
Store your tablets in a dry place at room temperature.
Do not store your medicines 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. FAMCICLOVIR GENERICHEALTH 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 metres above the ground is a good place to store medicines.
If you stop taking this medicine or the expiry date has passed, ask your pharmacist what to do with any medicine you have left over.
What FAMCICLOVIR GENERICHEALTH tablets look like
FAMCICLOVIR GENERICHEALTH 250 mg tablets are white, round filmcoated tablets, marked with "FM" on one side and "250" on the other.
FAMCICLOVIR GENERICHEALTH 500 mg tablets are white, oval, filmcoated tablets with "FM" on one side and “500” on the reverse side.
FAMCICLOVIR GENERICHEALTH 250 contain 250 mg famciclovir per tablet.
FAMCICLOVIR GENERICHEALTH 500 contain 500 mg famciclovir per tablet.
Each tablet also contains the following inactive ingredients:
- Microcrystalline cellulose
- colloidal anhydrous silica
- sodium stearylfumarate
- Opadry White YS-22-18096.
Southern Cross Pharma Pty Ltd
Suite 5/118, Church St
Hawthorn, VIC, 3122
Distributed in Australia by
Generic Health Pty Ltd
Level 1, 1102 Toorak Road
Camberwell, VIC, 3124
Australian Registration Number
FAMCICLOVIR GENERICHEALTH 250 mg
Blister pack 177012
FAMCICLOVIR GENERICHEALTH 500 mg
Blister pack 177014
This leaflet was prepared in November 2017.
Published by MIMS February 2018