FAMVIR 250MG TABLETS

Active substance: FAMCICLOVIR

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PACKAGE LEAFLET:
INFORMATION FOR THE USER

Famvir® 125, 250 and
500 mg film-coated tablets
famciclovir

Read all of this leaflet carefully before you start
taking this medicine.
• 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. Do not pass
it on to others. It may harm them, even if their
symptoms are the same as yours.
• If any of the side effects gets serious, or if you
notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.
In this leaflet:
1. What Famvir is and what it is used for
2. Before you take Famvir
3. How to take Famvir
4. Possible side effects
5. How to store Famvir
6. Further information

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

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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. BEFORE YOU TAKE FAMVIR
Do not take Famvir
- If you are allergic (hypersensitive) to famciclovir,
to any of the other ingredients of Famvir 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.
Take special care with 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

Production Site:
CTM:

Printing Colours:
Comp. Description:
LEAFLET FAMVIR FCT. 125/250/500 MG. GB. (MOCK UP)
Comp. No. New:
870562_GB_LFT
Comp. No. Old:
N/A
Format/Dimension: 148x297mm
Tech. Drawing No.: n.a.
Technical Colours:
Min. Font Size Text: 8 pt
Proof No.: 2
21.08.2013
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you passing the infection on to others. You should
not have sex if you have genital sores or blisters.
Taking other medicines
Please tell your doctor or pharmacist if you are
taking or have recently taken 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.
Taking Famvir with food and drink
You can take Famvir with or without food.
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before
taking any medicine.
If you are pregnant or think you may be, tell your
doctor. 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.
If you are breast-feeding, tell your doctor. 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.
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.
Important information about some of the
ingredients of Famvir
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 contain lactose.

3. HOW TO TAKE FAMVIR
Always take Famvir exactly as your doctor has
told you. You should 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.
Dose for shingles
If you have a normal immune system, the
recommended dose is
- one tablet of 500 mg, three times a day, for seven
days
If you have a reduced immune system, the
recommended dose is
- one tablet of 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:
- one tablet of 250 mg three times a day, for five
days.
To treat further outbreaks, the recommended dose is:
- one tablet of 125 mg twice a day, for five days.
To prevent future outbreaks, the recommended dose
is:
- one tablet of 250 mg twice a day.
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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:
- one tablet of 500 mg twice a day, for seven days.
To prevent future outbreaks, the dose is
- one tablet of 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
product, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS
Like all medicines, Famvir can cause side effects,
although not everybody gets them. The side effects
caused by Famvir are usually mild to moderate in
intensity.
The frequency of possible side effects listed below
is defined using the following convention:
- very common (affects more than 1 user in 10)
- common (affects 1 to 10 users in 100)

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- uncommon (affects 1 to 10 users in 1,000)
- rare (affects 1 to 10 users in 10,000)
- very rare (affects less than 1 user in 10,000)
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).
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
- Headache
Common side effects
- Feeling sick (nausea)
- Vomiting
- Dizziness
- Rash
- Itching
- Liver function test giving abnormal results
Uncommon side effects
- Confusion
- Drowsiness (usually in older people)
- Itchy rash (urticaria)
Rare side effects
- Hallucinations (seeing or hearing things that are
not really there)
If any of the side effects gets serious, or if you
notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.

Production Site:
CTM:

Printing Colours:
Comp. Description:
LEAFLET FAMVIR FCT. 125/250/500 MG. GB. (MOCK UP)
Comp. No. New:
870562_GB_LFT
Comp. No. Old:
N/A
Format/Dimension: 148x297mm
Tech. Drawing No.: n.a.
Technical Colours:
Min. Font Size Text: 8 pt
Proof No.: 2
21.08.2013
Braille:

! PLEASE

Barbera
Gonzalez Conde Rebeca
Black

Cutting

Sabatino

TURN

OVERPRINTING

ON !

5. HOW TO STORE FAMVIR
• Keep out of the reach and sight of children.
• Do not use Famvir after the expiry date which is
stated on the label after the expiry date. The
expiry date refers to the last day of that month.
• Store in the original package in order to protect
from moisture. Do not store above 25ºC.
• Do not use Famvir if you notice the pack is
damaged or shows signs of tampering.
• Medicines should not be disposed of via wastewater
or household waste. Ask your pharmacist how to
dispose of medicines no longer required. These
measures will help to protect the environment.

Famvir tablets are made by Novartis Farmaceutica
S.A., Rhonda Santa Maria, 158 08210 Barbera Del
Valles, Barcelona, Spain and Novartis Pharmaceuticals
UK Limited, Frimley Business Park, Frimley,
Camberley, Surrey, GU16 7SR, England
If you would like any more information, or would
like this leaflet in a different format, please contact
Medical Information at Novartis Pharmaceuticals
UK Ltd, telephone number 01276 698370.
This medicinal product is authorised in the
Member States of the EEA under the following
names:
125 mg film coated tablets

6. FURTHER INFORMATION

Member State EU / EEA

What Famvir contains
The active substance is famciclovir.
One film-coated tablet contains 125 mg, 250 mg or
500 mg famciclovir.
The other ingredients are hydroxypropylcellulose,
lactose (125 mg and 250 mg tablets only), sodium
starch glycollate and magnesium stearate. The tablet
coating contains hydroxypropylmethylcellulose,
titanium dioxide (E171) and polyethylene glycol.

Famvir
Austria, Cyprus, Denmark,
Finland, Germany, Greece,
Hungary, Iceland, Ireland, Italy,
Luxembourg, Malta,
Netherlands, Spain, Sweden,
United Kingdom

What Famvir looks like and contents of the pack
Famvir 125 mg film-coated tablets are round, white
tablets marked FAMVIR or FV on one side, and 125 on
the other. They come in blister packs of 10 tablets.
Famvir 250 mg film-coated tablets are round, white
tablets marked FAMVIR or FV on one side, and
250 on the other. They come in blister packs of
3, 15, 21 or 56 tablets.
Famvir 500 mg film-coated tablets are oval, white
tablets marked FAMVIR 500 or ORAVIR 500 or FV
500 on one side. They come in blister packs of
14, 21, 30 and 56 tablets.
Marketing Authorisation Holder and Manufacturer
The product licence holder is Novartis
Pharmaceuticals UK Limited, Frimley Business Park,
Frimley, Camberley, Surrey, GU16 7SR, England.

France

(Invented) Name

Oravir

250 mg film coated tablets
Member State EU / EEA

(Invented) Name

Austria, Cyprus, Finland,
Germany, Greece, Hungary,
Ireland, Italy, Luxembourg,
Malta, Netherlands, Spain,
Sweden, United Kingdom

Famvir

500 mg film coated tablets
Member State EU / EEA
(Invented) Name
Famvir
Austria, Denmark, Finland,
Greece, Iceland, Italy,
Netherlands, Spain, Sweden,
United Kingdom
France
Oravir
This leaflet was last revised in August 2013.
870562_GB_LFT
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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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