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FAMCICLOVIR 500MG TABLETS

Active substance(s): FAMCICLOVIR

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Famvir® 500 mg Tablets

2438
01.05.15[3]

(famciclovir)
PATIENT INFORMATION LEAFLET
Your medicine is available using the above name but will be referred to as
Famvir throughout this leaflet.
Famvir is also available in 125 mg and 250 mg strength.

Pregnancy, breast-feeding and fertility
If you are pregnant or breast feeding, think you may be pregnant or are
planning to have a baby, ask your doctor for advice before taking this
medicine. Famvir is not to be used during pregnancy unless clearly
necessary. Your doctor will discuss with you the potential risks of taking
Famvir during pregnancy.
Famvir is not to be used during breast-feeding unless clearly necessary.
Your doctor will discuss with you the possible risks of taking Famvir during
breast-feeding.

Read all of this leaflet carefully before you start taking this medicine
because it contains important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or pharmacist.
- Famvir has been prescribed for you only. Do not pass it on to others. It
may harm them, even if their signs of illness are the same as yours.
- If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects not listed in this leaflet. See section 4.

Driving and using machines
Famvir can cause dizziness, drowsiness or confusion. Do not drive or use
machines if you have any of these symptoms while taking Famvir.

What is in this leaflet:
1. What Famvir is and what it is used for
2. What you need to know before you take Famvir
3. How to take Famvir
4. Possible side effects
5. How to store Famvir
6. Contents of the pack and other information

3. HOW TO TAKE FAMVIR
Always take this medicine exactly as your doctor has told you. Check with
your doctor or pharmacist if you are not sure.
- The daily dose and length of treatment will depend on the type of viral
infection you have – see below. Your doctor will prescribe the correct
dose for you.
- For the best results start the medicine as soon as possible after the first
signs and symptoms appear.
- Do not have sexual contact with anyone if you have symptoms of genital
herpes – even if you have started treatment with Famvir. This is
because you could pass the herpes infection to your partner.
- If you have or have had kidney problems, your doctor may decide to
give you a lower dose of Famvir.

1. WHAT FAMVIR IS AND WHAT IT IS USED FOR
Famvir is an antiviral medicine. It stops the infecting virus from reproducing.
Since the virus reproduces very early in the infection, you will benefit most
from treatment if you take Famvir as soon as the first symptoms appear.
Famvir is used to treat two types of viral infections in adults:
- Shingles (herpes zoster), which is a viral infection caused by a virus
called varicella zoster (the same virus that causes chickenpox). Famvir
stops the virus from spreading in the body so that healing can occur
faster.
- Famvir is also used for the treatment of shingles in the area around the
eye or of the eye itself (ophthalmic zoster).
- Genital herpes. Genital herpes is a viral infection caused by herpes
simplex virus type 1 or 2. It is normally spread by sexual contact. It
causes blisters and burning or itching around the genitals, which may be
painful. Famvir is used to treat genital herpes infections in adults.
People who have frequent episodes of genital herpes can also take
Famvir to help to prevent the attacks.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE FAMVIR
Do not take Famvir
- If you are allergic to famciclovir, to any of the other ingredients of this
medicine (listed in section 6), or to penciclovir (the active metabolite of
famciclovir and an ingredient of some other medicines).
Ask your doctor for advice, if you think you may be allergic.
Warnings and precautions
Talk to your doctor before taking Famvir
- If you have kidney problems (or have had them before). Your doctor
may decide to give you a lower dose of Famvir.
- If you have problems with your body’s immune system.
- If you have liver problems.
If any of these applies to you, tell your doctor before you take Famvir.
Children and adolescents (below the age of 18 years)
Famvir is not recommended for use in children and adolescents.
Prevent passing genital herpes to others
If you are taking Famvir to treat or to suppress genital herpes, or you have
had genital herpes in the past, you should still practise safe sex, including
the use of condoms. This is important to prevent you passing the infection
on to others. You should not have sex if you have genital sores or blisters.
Other medicines and Famvir
Tell your doctor or pharmacist if you are taking, have recently taken or
might take any other medicines, including medicines obtained without a
prescription.
It is especially important that you tell your doctor or pharmacist if you are
taking any of the following medicines:
- Raloxifen (used to prevent and treat osteoporosis).
- Probenecid (used to treat high blood levels of uric acid associated with
gout and to increase blood levels of penicillin-type antibiotics), or any
other medicine that can affect your kidneys.
Famvir with food and drink
You can take Famvir with or without food.

Famvir contains lactose
If you have been told by your doctor that you have an intolerance to some
sugars, e.g. lactose, contact your doctor before taking this medicine
(Famvir 125 mg and 250 mg tablets only).

Dose for shingles
If you have a normal immune system, the recommended dose is
- 500 mg, three times a day, for seven days
If you have a reduced immune system, the recommended dose is
- 500 mg three times a day, for ten days.
Dose for genital herpes
The dose depends on the state of your immune system, and the stage of
your infection.
If you have a normal immune system, the doses are as follows:
For the first outbreak, the recommended dose is:
- 250 mg three times a day, for five days.
To treat further outbreaks, the recommended dose is:
- 125 mg twice a day, for five days.
To prevent future outbreaks, the recommended dose is:
- 250 mg twice a day.
Your doctor will tell you how long you need to continue taking your tablets.
If you have a reduced immune system, the doses are as follows:
To treat the current outbreak, the recommended dose is:
- 500 mg twice a day, for seven days.
To prevent future outbreaks, the dose is
- 500 mg twice a day.
Your doctor will tell you how long you need to continue taking your tablets.
If you take more Famvir than you should
If you have taken more tablets than you have been told to take, or if
someone else accidentally takes your medicine, go to your doctor or
hospital for advice immediately. Show them your pack of tablets.
Taking too much Famvir 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.
If you forget to take Famvir
If you forget to take a dose of Famvir, you should take it as soon as you
remember. Then take your next dose as scheduled. However, do not take
two doses within a time interval of less than 1 hour, in that case you should
skip the missed dose. Furthermore, do not take a double dose to make up
for a forgotten dose.
If you have any further questions on the use of this medicine, ask your
doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although not
everybody gets them.
Serious side effects of Famvir are:
Most of these side effects are rare or uncommon (they affect between 1 to
100 in every 10,000 patients)
- Severe blistering of the skin or mucous membranes of the lips, eyes,
mouth, nasal passages or genitals (these could be signs of a serious
allergic skin reaction).
- Unexplained bruising, reddish or purplish patches on the skin or
nosebleeds (these could be signs of a decrease in the number of blood
platelets).
- Swelling below the surface of the skin (e.g. facial swelling, swelling
around eye, eyelid swelling, throat swelling).
- Yellowing of the skin and/or eyes (signs of jaundice).
- Purple skin patches, itching, burning (signs of inflamed blood
vessels).
Contact a doctor or go to the emergency department at your nearest
hospital straight away if you get any of these effects.
Very common side effects (these side effects affect more than 1 in 10
people)
- Headache
Common side effects (these side effects affect up to 1 in 10 people)
- Feeling sick (nausea)
- Vomiting
- Abdominal pain
- Diarrhoea
- Dizziness
- Rash
- Itching
- Liver function test giving abnormal results
Uncommon side effects (these side effects affect up to 1 in 100 people)
- Confusion
- Drowsiness (usually in older people)
- Itchy rash (urticaria)
Rare side effects (these side effects affect up to 1 in 1,000 people)
- Hallucinations (seeing or hearing things that are not really there)
- Palpitations (signs of abnormal heart beat)
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This
includes any possible side effects not listed in this leaflet. You can also
report side effects directly via the Yellow Scheme at:
www.mhra.gov.uk/yellowcard. By reporting side effects you can help
provide more information on the safety of this medicine.
5. HOW TO STORE FAMVIR
Keep all medicines out of the sight and reach of children.
Do not store above 30ºC. Store in the original package.
Do not take the tablets after their expiry date which is printed on the outside
of the pack.
If the medicines become discoloured or show any other signs of
deterioration, consult your pharmacist who will tell you what to do.
Medicines should not be disposed of via wastewater or household waste.
Ask you pharmacist how to dispose of medicine no longer required. These
measures will help to protect the environment.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Famvir contains
The active ingredient in your tablets is called famciclovir.
Each film-coated tablet contains 500mg famciclovir.
The tablets also contain hydroxypropyl cellulose, sodium starch glycollate,
magnesium stearate, hypromellose, macrogol 4000, macrogol 6000 and
titanium dioxide (E171).
What Famvir looks like and contents of the pack
Famvir tablets are white, oval, biconvex film-coated tablets, marked ‘FV500’
on one side and plain on other side.
Available in packs of 14, 21, 28 and 56 tablets.

MANUFACTURER AND PRODUCT LICENCE HOLDER
Manufactured by
Novartis Farmaceutica S.A., Ronda Santa Maria, 158- Barbera Del VallesBarcelona, Spain.
Novartis Farma S.p.A., Via Provinciale Schito, 131-80058 Torre Annunziata
(NA), Italy.
Procured from within the EU by Product Licence holder
Star Pharmaceuticals Ltd, 5 Sandridge Close, Harrow, Middlesex HA1 1XD.
Repackaged by Servipharm Ltd.
POM

PL 20636/2438

Leaflet revision issue date (Ref) 01.05.15[3]
Famvir is trademark of Novartis AG.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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