FAMCICLOVIR SANDOZ for cold sores is an antiviral medicine used to treat recurrent outbreaks 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:
Although FAMCICLOVIR SANDOZ 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 pharmacist or doctor if you have any questions about why this medicine has been recommended for you.
FAMCICLOVIR SANDOZ for cold sores is only available from a pharmacy. The cold sores pack may be purchased without 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.
Do not take FAMCICLOVIR SANDOZ® for cold sores if you have an allergy to:
Some of the symptoms of an allergic reaction may include:
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.
Tell your pharmacist or doctor if you are over 65 years of age, or if you have:
Your pharmacist may want to take extra precautions or refer you to a doctor to determine if this medicine is suitable for you.
Tell your pharmacist or doctor if you are pregnant, intend to become pregnant or if you are breast-feeding.
FAMCICLOVIR SANDOZ should not be used during pregnancy unless necessary. Your pharmacist or doctor will discuss with you the potential risks of taking FAMCICLOVIR SANDOZ during pregnancy, and will also advise you if you should take FAMCICLOVIR SANDOZ 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, inform your pharmacist or doctor immediately.
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 SANDOZ for cold sores may interfere with each other. These include:
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.
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.
The usual dose is three 500 mg tablets taken together as a single dose. However if your pharmacist has referred you to your doctor to see if this medicine is suitable for you, your doctor may have recommended 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.
Take FAMCICLOVIR SANDOZ for cold sores 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.
Swallow the tablets whole with a full glass of water.
They may be taken with or without food. It is not necessary to chew or crush the tablet.
A single dose of FAMCICLOVIR SANDOZ 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 SANDOZ for cold sores contains enough medicine for one dose.
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 SANDOZ for cold sores. Show them your pack of tablets. Do this even if there are no signs of discomfort or poisoning. Keep the telephone numbers for these places handy.
Taking too much FAMCICLOVIR SANDOZ 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.
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 while taking FAMCICLOVIR SANDOZ, tell your pharmacist or doctor.
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.
Do not take less than the recommended dose of 3 tablets, unless advised by your pharmacist or 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.
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 SANDOZ for cold sores affects you.
This medicine can cause dizziness, sleepiness or confusion.
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:
Tell your pharmacist or doctor as soon as possible if you do not feel well while you are taking FAMCICLOVIR SANDOZ 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:
The above side effects are usually mild.
Tell your pharmacist or doctor as soon as possible if you notice any of the following:
The above side effects may need medical attention.
Tell your pharmacist or doctor immediately or go to Accident and Emergency at your nearest hospital if any of the following side effects happen:
The above side effects are very rare.
Tell your pharmacist or 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.
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 SANDOZ 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 your pharmacist or doctor recommended that you take less than the full dose in this pack, ask your pharmacist what to do with any tablets that you may have left over.
FAMCICLOVIR SANDOZ 500 mg tablets are white, oval, film-coated tablets with "FV 500" on one side. Each carton contains 3 tablets.
FAMCICLOVIR SANDOZ 500 mg tablets contain 500 mg famciclovir per tablet as the active ingredient. Each tablet also contains the following inactive ingredients:
The tablets do not contain lactose, sucrose, gluten, tartrazine or any other azo dyes.