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 125, 250 and
500 mg film-coated tablets
famciclovir
Read all of this leaflet carefully before you start
taking this medicinebecause 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.
• This medicine 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
• efects not listed in this leaflet. See section 4.
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

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.
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.
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.
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).

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.
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.
878042_GB_LFT

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 abonormal 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 this medicine out of the sight and reach of
children.
• Do not use this medicine 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.
• Do not store above 25oC.
• Store in the original package in order to protect
from moisture.
• Do not use this medicine if you notice the pack is
damaged or shows signs of tampering.

• Do not throw any medicines via wastewater
or household waste. Ask your pharmacist
how to throw away medicines you no longer
required. These measures will help to protect the
environment.

6. Contents of the pack and other information

What Famvir contains
Famvir 125 mg film-coated tablets
• The active substance is famciclovir.
• The other ingredients are lactose, anhydrous,
sodium starch glycolate (Type A), and
hydroxypropyl cellulose and magnesium stearate.
The tablet coating is composed of hypromellose,
titanium dioxide (, E171), Macrogol 4000 and
Macrogol 6000.
Famvir 250 mg film-coated tablets
• The active substance is famciclovir.
• The other ingredients are lactose, anhydrous,
sodium starch glycolate (Type A), and
hydroxypropyl cellulose and magnesium stearate.
The tablet coating is composed of hypromellose,
titanium dioxide (, E171), Macrogol 4000 and
Macrogol 6000.
Famvir 500 mg film-coated tablets
• The active substance is famciclovir.
• The other ingredients are sodium starch
glycolate, hydroxypropyl cellulose and
magnesium stearate. The tablet coating is
composed of hypromellose, titanium dioxide
(, E171), Macrogol 4000 and Macrogol 6000.
What Famvir looks like and contents of the pack
Famvir is supplied as film-coated tablets.
Famvir 125 mg film-coated tablets
White, round, film-coated tablet, biconvex, bevelled
edges, debossed with “FV” on one side and 125 on
the reverse side.
Famvir 250 mg film-coated tablets
White, round, film-coated tablet, biconvex, bevelled
edges, debossed with “FV” on one side and 250 on
the reverse side.
Famvir 500 mg film-coated tablets.
White, oval film-coated tablet, biconvex, bevelled
edges, debossed with “FV 500” on one side and
plain on the reverse side.

Marketing Authorisation Holder and Manufacturer
The product licence holder is Novartis
Pharmaceuticals UK Limited, Frimley Business Park,
Frimley, Camberley, Surrey, GU16 7SR, England.
Famvir tablets are made by Novartis Farmaceutica
S.A., Rhonda Santa Maria, 158 08210 Barbera Del
Valles, Barcelona, Spain.
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
Member State EU / EEA
Austria, Cyprus, Denmark,
Finland, Germany, Greece,
Hungary, Iceland, Ireland,
Italy, Luxembourg, Malta,
Netherlands, Spain, Sweden,
United Kingdom
France
250 mg film coated tablets

(Invented) Name
Famvir

Member State EU / EEA
Austria, Cyprus, Finland,
Germany, Greece, Hungary,
Ireland, Italy, Luxembourg,
Malta, Netherlands, Spain,
Sweden, United Kingdom
500 mg film coated tablets

(Invented) Name
Famvir

Oravir

Member State EU / EEA
(Invented) Name
Austria, Denmark, Finland,
Famvir
Greece, Iceland, Italy,
Netherlands, Spain, Sweden,
United Kingdom
France
Oravir
This leaflet was last revised in September 2014.
878042_GB_LFT

PACKAGE LEAFLET:
INFORMATION FOR THE USER

SZ00000LT000

Famciclovir 125 mg, 250 mg
and 500 mg Film-coated Tablets
(famciclovir)

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

1. WHAT FAMCICLOVIR IS AND WHAT IT IS USED
FOR
Famciclovir 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
Famciclovir as soon as the first symptoms appear.

the body so that healing can occur faster.
• Famciclovir 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. Famciclovir is
used to treat genital herpes infections in adults. People who
have frequent episodes of genital herpes can also take
Famciclovir to help to prevent the attacks.

taken or might take any other medicines, including medicines
obtained without a prescription.

Do not take Famciclovir
• 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.

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.
Famciclovir is not to be used during pregnancy unless clearly
necessary. Your doctor will discuss with you the potential risks
of taking Famciclovir during pregnancy.

2. WHAT YOU NEED TO KNOW BEFORE YOU
TAKE FAMCICLOVIR

Warnings and precautions
Talk to your doctor before taking Famciclovir
• If you have kidney problems (or have had them before). Your
doctor may decide to give you a lower dose of Famciclovir.
• 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
Famciclovir.
Children and adolescents (below the age of 18 years)
Famciclovir is not recommended for use in children and
adolescents.

Prevent passing genital herpes to others
If you are taking Famciclovir to treat or to suppress genital
herpes, or you have had genital herpes in the past, you should
still practice safe sex, including the use of condoms. This is
important to prevent you passing the infection on to others. You
Famciclovir is used to treat two types of viral infections in adults: should not have sex if you have genital sores or blisters.
• Shingles (herpes zoster), which is a viral infection caused by
a virus called varicella zoster (the same virus that causes
Other medicines and Famciclovir
chickenpox). Famciclovir stops the virus from spreading in
Tell your doctor or pharmacist if you are taking, have recently

draft: 44019390, 44019391, 44019392,
44019393, 44019394
laetus code: 0000
mat.no.: 0000000-SDZ 00A/B-GB

0000

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.
Famciclovir with food and drink
You can take Famciclovir with or without food.

Famciclovir is not to be used during breast-feeding unless
clearly necessary. Your doctor will discuss with you the possible
risks of taking Famciclovir during breast-feeding.
Driving and using machines
Famciclovir can cause dizziness, drowsiness or confusion. Do
not drive or use machines if you have any of these symptoms
while taking Famciclovir.
Famciclovir 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 (Famciclovir 125 mg and 250 mg
tablets only).

3. HOW TO TAKE FAMCICLOVIR

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.
0000

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 Famciclovir. 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 Famciclovir.

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.

0000000-SDZ 00A/B-GB

Your doctor will tell you how long you need to continue taking
your tablets.

If you take more Famciclovir 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.

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)
Taking too much Famciclovir may affect the kidneys. In people
who already have kidney problems it may, rarely, lead to kidney • Vomiting
• Abdominal pain
failure if their dose is not correctly lowered.
• Diarrhoea
• Dizziness
If you forget to take Famciclovir
If you forget to take a dose of Famciclovir, you should take it as • Rash
soon as you remember. Then take your next dose as scheduled. • Itching
• Liver function test giving abnormal results.
However, do not take two doses within a time interval of less
than 1 hour, in that case you should skip the missed dose.
Uncommon side effects (these side effects affect up to 1 in 100
Furthermore, do not take a double dose to make up for a
people)
forgotten dose.
• Confusion
If you have any further questions on the use of this medicine,
• Drowsiness (usually in older people)
ask your doctor or pharmacist.
• Itchy rash (urticaria).

4. POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects,
although not everybody gets them.
Serious side effects of Famciclovir 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

draft: 44019390, 44019391, 44019392,
44019393, 44019394
laetus code: 0000
mat.no.: 0000000-SDZ 00A/B-GB

the last day of that month.
• Do not store above 25 °C.
• Store in the original package in order to protect from
moisture. Do not use this medicine if you notice the pack is
damaged or shows signs of tampering.
• Do not throw away any medicines via waste water or
household waste. Ask your pharmacist how to throw away
medicines you no longer require.
These measures will help to protect the environment.

6. CONTENTS OF THE PACK AND OTHER
INFORMATION

What Famciclovir contains
Famciclovir 125 mg film-coated tablets
• The active substance is famciclovir.
• The other ingredients are lactose, anhydrous, sodium starch
glycolate (Type A), and hydroxypropyl cellulose and
magnesium stearate. The tablet coating is composed of
hypromellose, titanium dioxide (E171), Macrogol 4000 and
Macrogol 6000.

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).

Famciclovir 250 mg film-coated tablets
• The active substance is famciclovir.
• The other ingredients are lactose, anhydrous, sodium starch
glycolate (Type A), and hydroxypropyl cellulose and
magnesium stearate. The tablet coating is composed of
hypromellose, titanium dioxide (E171), Macrogol 4000 and
Macrogol 6000.

5. HOW TO STORE FAMCICLOVIR

0000

Famciclovir 250 mg film-coated tablets
White, round, film-coated tablets, biconvex, bevelled edges,
debossed with “FV” on one side and 250 on the reverse side.
Famciclovir 500 mg film-coated tablets.
White, oval film-coated tablet, biconvex, bevelled edges,
debossed with “FV 500” on one side and plain on the reverse
side.
Marketing Authorisation Holder and Manufacturer
The product licence holder is Novartis Pharmaceuticals UK
Limited, Frimley Business Park, Frimley, Camberley, Surrey,
GU16 7SR, England.

Famciclovir tablets are made by Novartis Farmaceutica S.A.,
Rhonda Santa Maria, 158 08210 Barbera Del Valles, Barcelona,
Spain and Novartis Pharmaceuticals UK Ltd, Frimley Business
Park, Frimley, Camberley, Surrey, GU16 7SR, England.
Famciclovir tablets are distributed by Sandoz Ltd, Frimley
Business Park, Frimley, Camberley, Surrey, GU16 7SR, UK.

What Famciclovir looks like and contents of the pack
Famciclovir is supplied as film-coated tablets.

Reporting of side effects
Famciclovir 500 mg film-coated tablets
If you get any side effects, talk to your doctor or pharmacist.
• The active substance is famciclovir.
This includes any possible side effects not listed in this leaflet.
• The other ingredients are sodium starch glycolate,
You can also report side effects directly via the Yellow Card
hydroxypropyl cellulose and magnesium stearate. The tablet
Scheme: www.mhra.gov.uk/yellowcard By reporting side effects
coating is composed of hypromellose, titanium dioxide
you can help provide more information on the safety of this
(E171), Macrogol 4000 and Macrogol 6000.
medicine.
• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date which is stated
on the label after the expiry date. The expiry date refers to

Famciclovir 125 mg film-coated tablets
White, round, film-coated tablets, biconvex, bevelled edges,
debossed with “FV” on one side and 125 on the reverse side.

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 leaflet was last revised September 2014.

0000

SZ00000LT000
0000000-SDZ 00A/B-GB

Expand view ⇕

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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