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FAMCICLOVIR 125MG FILM COATED TABLETS

Active substance(s): FAMCICLOVIR

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TEVA UK Ref:

231-30-86390-X LEA FAMCICLOVIR A/S TAB TUK FrCAN

FAMCICLOVIR 125 mg, 250 mg AND 500 mg
FILM-COATED TABLETS
PACKAGE LEAFLET: INFORMATION
FOR THE USER

What Famciclovir is and what it is used for
Before you take Famciclovir
How to take Famciclovir
Possible side effects
How to store Famciclovir
Further information

IN THIS LEAFLET:

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 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.

1.
2.
3.
4.
5.
6.

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.
Famciclovir 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).
Famciclovir stops the virus from spreading in 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.

2 BEFORE YOU TAKE FAMCICLOVIR
Do not take Famciclovir
• if you are allergic (hypersensitive) to famciclovir, to any of the other
ingredients of Famciclovir 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
• 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 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.
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:
• Raloxifene (used to prevent and treat osteoporosis)



Version:

4
4 June 2015

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

3 HOW TO TAKE FAMCICLOVIR

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






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 shingles
If you have a normal immune system, the recommended dose is:
• one tablet of 500 mg, three times a day, for seven days.

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.
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.

Always take Famciclovir exactly as your doctor or pharmacist has told
you. You should check with your doctor or pharmacist if you are not
sure.

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To prevent future outbreaks, the recommended dose is:
• one tablet of 250 mg twice a day.

To treat further outbreaks, the recommended dose is:
• one tablet of 125 mg twice a day, for five days.

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.

Dose for genital herpes
The dose depends on the state of your immune system, and the stage
of your infection.

Version 2.4

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TEVA UK Ref:

Version:

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Pruritus
Liver function test giving abnormal results.

4 June 2015

What Famciclovir Film-coated tablets look like and contents of the pack
Famciclovir comes in 3 different strengths of tablets which can be
identified by their inscription:
125 mg: White to off-white, round, film-coated tablets, engraved 8117 on
one side and 93 on the other side.
250 mg: White to off-white, round, film-coated tablets, engraved 8118 on
one side and 93 on the other side.
500 mg: White capsule shaped film-coated tablets, engraved 93 on one
side and 8119 on the other side

The other ingredients are microcrystalline cellulose E460, sodium starch
glycolate (Type A), colloidal anhydrous silica E551, low substituted
hydroxypropylcellulose, croscarmellose sodium, sodium stearyl
fumarate, titanium dioxide E 171, polydextrose, hypromellose, triacetin
and macrogol.

What Famciclovir Film-coated tablets contain
The active substance is famciclovir. One tablet contains 125 mg, 250 mg
or 500 mg of famciclovir.

6 FURTHER INFORMATION

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.

Keep the blister in the outer carton in order to protect from light.
Do not use Famciclovir if you notice the pack is damaged or shows
signs of tampering.

Do not use Famciclovir after the expiry date which is stated on the
packaging after "exp" on the box or the blister pack. The expiry date
refers to the last day of that month.

Keep out of the reach and sight of children.

5 HOW TO STORE FAMCICLOVIR

By reporting side effects you can help provide more information on the
safety of this medicine.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects not listed in this leaflet. You can also
report side effects directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard

Rare side effects
• Hallucinations (seeing or hearing things that are not really there)
• Yellowing of the skin and/or eyes
• Low platelet count.

Uncommon side effects
• Confusion
• Severe skin reactions.




231-30-86390-X LEA FAMCICLOVIR A/S TAB TUK FrCAN

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 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
If you forget to take a dose of
Famciclovir, 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 can cause side effects, although not
everybody gets them. The side effects caused by Famciclovir are usually
mild to moderate in intensity.

The 125 mg tablets come in packs of: 1, 10, 21 & 30 film-coated tablets.
Hospital packs of 50 (50 x 1) film-coated tablets.
The 250 mg tablets come in packs of: 1, 12, 14, 15, 20, 21, 30, 56 & 60
film-coated tablets. Hospital packs of 50 (50 x 1) film-coated tablets.

Company responsible for manufacture
TEVA UK Limited, Eastbourne, BN22 9AG.

Marketing Authorisation Holder and Manufacturer
TEVA UK Limited, Eastbourne, BN22 9AG.

86390-X

The 500 mg tablets come in packs of: 1, 10, 14, 15, 20, 21, 30, 56 & 60
film-coated tablets. Hospital packs of 50 (50 x 1) film-coated tablets.

This leaflet was last revised:
June 2015

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)
• 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 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).

PL 00289/0975-7

Not all pack sizes may be marketed.

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
• Drowsiness
• Rash

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Version 2.4
REG0066484

THIS IS A REPRESENTATION OF AN ELECTRONIC RECORD THAT WAS SIGNED ELECTRONICALLY AND THIS
PAGE IS THE MANIFESTATION OF THE ELECTRONIC SIGNATURE

Teva Pharmaceuticals Europe B.V
1.3.2
mockup-pil-uk-pl-00289-0975-0976-0977-famciclovir-125mg-250mg-500mg-fi
lm-coated-tablets

APPROVALS
Signed by
Arun Ramachandran

REG0066484

Meaning of Signature
Regulatory Affairs Approval

Version 2.4

Approved

Server Date
17-Jun-2015 09:37:52 AM

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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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