FAMCICLOVIR 125MG TABLETS

Active substance: FAMCICLOVIR

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Famciclovir 125mg, 250mg
and 500mg tablets
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.
• 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 tablets are and
what they are used for
2 Before you take
3 How to take
4 Possible side effects
5 How to store
6 Further information
1 What Famciclovir tablets are and

what they are 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 tablets as
soon as the first symptoms appear.
Famcilovir tablets are 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). Famciclovir tablets stop the
virus from spreading in the body so that
healing can occur faster.
• Famciclovir tablets are 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 tablets are used to
treat genital herpes infections in adults.
People who have frequent episodes of
genital herpes can also take Famciclovir
tablets to help to prevent the attacks.

2 Before you take
Do not take Famciclovir tablets if you
• are allergic (hypersensitive) to famciclovir,
to any of the other ingredients of
Famciclovir tablets 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 Famciclovir
tablets if you

• have kidney problems (or have had them
before). Your doctor may decide to give
you a lower dose of Famciclovir tablets.
• have problems with your body’s immune
system.
• have liver problems.
If any of these applies to you, tell your doctor
before you take Famciclovir tablets.

Children and adolescents (below the
age of 18 years)
Famciclovir tablets are not recommended for
use in children and adolescents.

Prevent passing genital herpes to
others
If you are taking Famciclovir tablets 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.
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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 Famciclovir tablets with food
and drink
You can take Famciclovir tablets 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. Famciclovir tablets are not to
be used during pregnancy unless clearly
necessary. Your doctor will discuss with you
the potential risks of taking Famciclovir
tablets during pregnancy.
If you are breast-feeding, tell your doctor.
Famciclovir tablets are not to be used during
breast-feeding unless clearly necessary. Your
doctor will discuss with you the possible
risks of taking Famciclovir tablets during
breast-feeding.

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

3 How to take

Always take Famciclovir tablets 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
Famciclovir tablets. 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 tablets.
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
Continued over page
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: 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 Famciclovir tablets
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 famciclovir 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 Famciclovir
tablets
If you forget to take a dose of Famciclovir
tablets, 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, Famciclovir tablets can
cause side effects, although not everybody
gets them. The side effects caused by
Famciclovir tablets are usually mild to
moderate in intensity.
Serious side effects of Famciclovir are:
• 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, for
frequency see below).
• Unexplained bruising, reddish or purplish
patches on the skin or nosebleeds (these
could be signs of a decrease in the number
of blood platelets, for frequency see
below).

Contact a doctor or go to the emergency
department at your nearest hospital
straight away if you get any of these effects.
Tell your doctor if you notice any of the
following side effects:
Very common (affects more than 1 user in
10): headache
Common (affects 1 to 10 users in 100):
feeling sick (nausea), vomiting, dizziness,
drowsiness, rash, pruritus, itching, liver
function test giving abnormal results
Uncommon (affects 1 to 10 users in 1,000):
confusion, severe skin reactions, hives (skin
rash with red, raised, itchy bumps), severe
swelling of the skin or mucous membranes
(angio-oedema), e.g. of the face, eyelids or
throat

Ask your pharmacist how to dispose of
medicines no longer required. These
measures will help to protect the
environment.

6 Further information
What Famciclovir tablets contain
The active substance is famciclovir. Each
tablet contains either 125mg, 250mg or
500mg 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 tablets look like
and contents of the pack
125mg film-coated tablets: white, round,
biconvex, film-coated tablets with diameter
of 7.6mm approximately.
250mg film-coated tablets: white, round,
biconvex, film-coated tablets, scored
on one side with diameter of 10.6mm
approximately.
500mg film-coated tablets: white, oval, film
coated tablets, scored on both sides with
dimensions of 18.2 x 8.6mm approximately.
250mg and 500mg film-coated tablets:
The tablet can be divided into equal halves.
Use lower strength tablets where these are
available.
Famciclovir tablets are available in blister
packs of:
125mg: 10 tablets
250mg: 21 tablets
500mg: 14 tablets
Marketing Authorisation Holder
Actavis Group PTC ehf,
Reykjavikurvegur 76-78,
220 Hafnarfjordur,
Iceland
Manufacturer
Specifar S.A.
1, 28 Octovriou str., Ag. Varvara,
12351 Athens
Greece
MPF B.V.
Site 1: Appelhof 13, 8465RX – Oudehaske,
NL (P.O. Box 570, 8440 AN Heerenveen,
The Netherlands)
&
Site 2: Neptunus 12,
8448CN – Heerenveen,
NL (P.O.Box 713, 8440 AS Heerenveen,
The Netherlands)
This leaflet was last revised in January 2012.

If you would like a
leaflet with larger
text, please contact
01271 311257.

Rare (affects 1 to 10 users in 10,000):
hallucinations (seeing or hearing things that
are not really there), yellowing of the skin
and/or eyes, low platelet count.
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.

5 How to store

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 tablets 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.

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Actavis, Barnstaple, EX32 8NS, UK

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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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