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FAMCICLOVIR 750MG FILM COATED TABLETS

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(famciclovir)

Read all of this leaflet carefully
before you start using this
medicine.
• 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. 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 Famciclovir is and what it is used
for
2. Before you use Famciclovir
3. How to use Famciclovir
4. Possible side effects
5. How to store Famciclovir
6. Further information.
1. WHAT FAMCICLOVIR IS AND
WHAT IT IS USED FOR
Famciclovir belongs to a group of medicines
called antiviral agents. These are medicines
used in the treatment of infections caused by
viruses.
Famciclovir is used in patients with a normal
immune system to treat attacks of genital
herpes. Genital herpes is a viral infection
which is normally spread by sexual contact.
It causes blisters and burning around your
genitals, which may be painful.
Famciclovir is used in the treatment of
shingles in both patients with a normal
immune system and in patients with a
weakened immune system. Shingles is
caused by a virus called herpes zoster or
varicella zoster.
It is used in the treatment of herpes zoster
infections of the eye in patients with a
normal immune system.
Famciclovir is used in patients with a
weakened immune system for the treatment
of infections caused by herpes simplex virus,
such as genital herpes or fever blisters
(herpes labialis).
2. BEFORE YOU USE FAMCICLOVIR
Do not use Famciclovir:
• if you are allergic (hypersensitive) to
famciclovir, penciclovir or any of the
other ingredients of Famciclovir.
Take special care with Famciclovir:
• if you have kidney problems.You should
talk with your doctor before you begin
treatment with Famciclovir, as it may be
necessary to adjust your dosage.
As genital herpes is a sexually transmitted
disease, you should avoid sexual activity if
you have any symptoms of
herpes, even if you have
started treatment, to reduce
the risk of spreading the
disease to your partner.
You should also take
appropriate steps for
protected intercourse if you
are on long-term treatment with famciclovir
for the same reason. Patients should
therefore take appropriate steps for
protected intercourse (i.e. use condoms).

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Consult your doctor if one of the
above-mentioned warnings applies to you,
or has applied to you in the past.
Using 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.
If you are taking other medicines at the same
time as famciclovir, these medicines may
interfere with each other. This might be
harmful. The effects of the medicines could
be increased or diminished and side effects
could occur more easily.

In particular this applies to:
• probenecid, a medicine against viruses
and gout
• some painkillers such as acetylsalicylic
acid and ibuprofen.
Using Famciclovir with food and
drink - Famciclovir can be taken with or
without food. Swallow the tablets with
water.
Pregnancy and breast-feeding:
Pregnancy - It is not known if it is safe to
use Famciclovir during pregnancy.
Famciclovir must not be used during
pregnancy, unless it is absolutely necessary
and only in accordance with your doctor's
instructions.
Breast-feeding - There is limited
experience with Famciclovir in breastfeeding women. Therefore, it should not
be used during breast-feeding unless you
are directly instructed to do so by your
doctor.
Ask your doctor or pharmacist for advice
before taking any medicine.
Driving and using machines - In rare
instances, use of Famciclovir may have side
effects, such as dizziness, drowsiness and
confusion. If you experience any such side
effects then do not drive or operate
machinery.
3. HOW TO USE FAMCICLOVIR
Always use Famciclovir exactly as your
doctor has told you. You should check with
your doctor or pharmacist if you are not
sure.
Treatment with Famciclovir should start as
soon as possible after the symptoms of
eruption/rash appear.
You should keep taking the medicine even if
there is no improvement, as it may take
several days for the medicine to work.
Keep taking the tablets until you have used
the whole pack, unless your doctor has
given you other instructions. Use lower
dosage strength tablets, where these are
available.
Adults:
Recurrent genital herpes infection in
patients with a normal immune
system - 250 mg twice daily. In the
treatment of genital herpes, you should start
taking Famciclovir as soon as possible after
the occurrence of the first symptoms (pain,
burning sensation, blisters).
First outbreak of genital herpes in
patients with a normal immune
system - 250 mg three times daily. In the
treatment of genital herpes, you should start
taking Famciclovir as soon as possible after
the occurrence of the first symptoms (pain,
burning sensation, blisters).
Genital herpes infection in patients
with a weakened immune system 500 mg twice daily. In the treatment of
genital herpes, you should start taking
Famciclovir as soon as possible after the
occurrence of the first symptoms (pain,
burning sensation, blisters).

three times daily. In the treatment of shingles
(herpes zoster), you should start taking
Famciclovir as soon as possible (within 48
hours) after the occurrence of the first
symptoms of the infection (rash).
Patients with kidney problems Depending on how severely the function of
your kidneys is affected, your doctor may
reduce the dose of famciclovir you must take.

Children - Famciclovir is not
recommended for use in children below
18 years of age due to lack of data on
safety and efficacy.
*Only relevant for the 750 mg strength.

6. FURTHER INFORMATION

Duration of treatment:
Treatment of genital herpes in
patients with a normal immune
system - 5 days
Treatment of genital herpes in
patients with a weakened immune
system - 7 days
Shingles in patients with a normal
immune system - 7 days
Shingles in patients with a
weakened immune system - 10 days
Fever blisters in patients with a
weakened immune system - 7 days.

What Famciclovir contains - The active
substance is famciclovir.

Elderly patients - Your doctor may adjust
your dosage of famciclovir according to
your kidney function.

If you use more Famciclovir than you
should - Contact your doctor or pharmacist
if you have taken more Famciclovir than
stated in this leaflet, or more than the doctor
has prescribed.
Rarely, acute kidney failure has occurred in
patients with existing kidney disease when
the dose of famciclovir was not adjusted
accordingly.
If you forget to use Famciclovir - If
you forget to take the medicine, take it as
soon as you remember, or skip the forgotten
tablet if it is time for your next dose. Then
continue taking the tablets as normal. Do
not take a double dose to make up for a
forgotten dose. If you have forgotten several
doses, you should contact your doctor.
If you stop using Famciclovir - Do not
stop taking Famciclovir without consulting
your doctor first.
If you have any further questions on the use
of this product, ask your doctor or
pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Famciclovir can cause
side effects, although not everybody gets
them.
The following side effects may occur:
Common side effects (occur in 1 to 10
users in 100): • headache • nausea,
diarrhoea, vomiting, abdominal pain,
constipation • increased sweating • itching.
Rare side effects (occur in 1 to 10 users in
10,000): • confusion (mainly in elderly
patients).

Herpes zoster infection of the eye in
patients with a normal immune
system - 500 mg three times daily or
750 mg twice daily* for 7 days.
Shingles in patients with a
weakened immune system - 500 mg

Not known (cannot be estimated from the
available data): • fever.

Shingles in patients with a normal
immune system - 500 mg three times
daily. In the treatment of shingles (herpes
zoster), you should start taking Famciclovir
as soon as possible (within 48 hours) after
the occurrence of the first symptoms of the
infection (rash).

5. HOW TO STORE FAMCICLOVIR
Keep out of the reach and sight of children.
Do not store above 30°C. Store in the
original package to protect from moisture.
Do not use Famciclovir after the expiry date
which is stated on the carton after 'EXP'. The
expiry date refers to the last day of that
month. 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.

Very rare effects (occur in less than 1 user
in 10,000): • blood disorders (shortage of
blood cells, called blood platelets that help
blood to clot) accompanied by bruises and
proneness to bleeding (so-called
thrombocytopenia) • hallucinations (seeing
and hearing things that are not really there)
• dizziness, fatigue (tiredness), drowsiness
(primarily in elderly patients) • yellowing of
the skin and eyes (jaundice) • abnormal
liver function tests • severe skin reactions,
such as serious allergic reactions
(hypersensitivity) with (high) temperature,
dark red patches on the skin, joint pains
and/or eye infections (so-called StevensJohnson syndrome), acute severe
(hypersensitivity) reactions associated with
fever and blisters on the skin, shedding of
skin (so-called toxic epidermal necrolysis) or
rash with reddish (weeping) irregular
patches (so-called erythema multiforme);
rash, nettle rash.

Fever blister in patients with a
weakened immune system - 500 mg
twice daily. In the treatment of a fever blister
(herpes labialis), you should start taking
Famciclovir as soon as possible after the
occurrence of the first symptoms of the
infection (pain, burning sensation, blisters).

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.

125 mg tablet - each tablet contains 125 mg
of famciclovir.
250 mg tablet - each tablet contains 250 mg
of famciclovir.
500 mg tablet - each tablet contains 500 mg
of famciclovir.
750 mg tablet - each tablet contains 750 mg
of famciclovir.
The other ingredients are:
Tablet core: Starch Pregelatinised, Sodium
Laurilsulfate, Cellulose, Microcrystalline,
Croscarmellose Sodium, Silica Colloidal
Anhydrous, Stearic acid.
Film-coating: Hypromellose (E464), Titanium
Dioxide (E171), Macrogol 4000, Macrogol
6000.
What Famciclovir looks like and
contents of the pack - 125 mg
film-coated tablets: white, round, biconvex,
film-coated tablets with diameter of 7.6 mm
approximately.
250 mg film-coated tablets: white, round,
biconvex, film-coated tablets, scored on one
side with diameter of 10.6 mm
approximately.
500 mg film-coated tablets: white, oval,
film-coated tablets, scored on both sides with
dimensions of 18.2 x 8.6 mm
approximately.
750 mg film-coated tablets: white, oval,
film-coated tablets with dimensions of
20.5 x 9.8 mm approximately.
250 mg and 500 mg film-coated tablets:
The tablet can be divided into equal halves.
Use lower strength tablets where these are
available.
Famciclovir is available in blister packs of:
125 mg: 10 tablets
250 mg: 10, 15, 21, 56 tablets
500 mg: 14, 30, 56 tablets
750 mg: 7 tablets
Not all pack sizes may be marketed.
Marketing Authorisation Holder:
Generics [UK] Limited, Potters Bar,
Hertfordshire, EN6 1TL.
Manufacturer: McDermott Laboratories
Ltd. T/A Gerard Laboratories, 35/36
Baldoyle Industrial
Estate, Grange Road,
Dublin 13, Ireland.
This medicinal
product is
authorised in the
Member States of the EEA under the
following names:
Austria - Famciclovir Arcana Filmtabletten
Denmark - Famciclovir Generics
Ireland - Myclovear
Italy - Famciclovir Mylan Generics
compresse rivestite con film
Greece - Famciclovir Generics Film coated
tablets
Spain - Famciclovir Mylan comprimidos
recubiertos con película EFG
UK - Famciclovir film-coated tablets.

This leaflet was last approved in: 09/2009

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5571

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FAMCICLOVIR 125 mg,
250 mg, 500 mg, 750 mg
FILM-COATED TABLETS

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PACKAGE LEAFLET: INFORMATION FOR THE USER

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Further information

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