FAMCICLOVIR 125MG FILM COATED TABLETS

Active substance: FAMCICLOVIR

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Ref:

231-30-86390-V LEA FAMCICLOVIR A/S TAB TUK
Version:

3

27 January 2011

PL Number(s),
PL 00289/0975-77. TEVA UK Limited Licence (Responsible Regulatory Officer = Sarah Bell),
MA Holder & Packer: Packed at Novopharma, Torronto, Canada.
Reason for revision:

Artwork Originator;
Sign & Date:

Elle
Brown

Versions 1: Renewal. V2: Addition of 3rd party supplier artwork code. Requested by Greg Belshaw 22/12/10 at
5:35pm. V3: Change of 3rd party supplier artwork code from “REV01” to “REV02”. Requested by Greg Belshaw
27/01/11 at 2:32pm.

Digitally signed by Elle
Brown
DN: cn=Elle Brown,
o=TEVA UK Ltd.,
ou=Artwork
Origination, email=elle.
brown@teva.com, c=GB
Date: 2011.01.27
15:26:18 Z

Artwork Checker;
Sign & Date:

Digitally signed by Liz
Morgan
DN: cn=Liz Morgan,
o=TEVA UK Limited,
ou=Artwork Origination,
email=elizabeth.
morgan@tevauk.com,
c=GB
Date: 2011.01.27 15:33:10
Z

Approved for Regulatory submission into MHRA/IMB;
Sign & Date:

Sarah Bell
2011.01.2
7 16:39:38
Z

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

Final approval by MA Holder confirming receipt of MHRA/IMB
approval; Sign & Date:

Sarah Bell
2011.02.1
5 16:56:30
Z

Packing Site Approval (where not TEVA UK Limited)
Sign & Date:

Clyde
Gray

Digitally signed by Clyde Gray
DN: cn=Clyde Gray, o=Teva
Canada, ou=Graphics
Department, email=Clyde.
Gray@tevacanada.com, c=CA
Date: 2011.01.27 11:12:43 -05'00'

Taking other medicines

Read all of this leaflet carefully before you
start taking this medicine.

Taking Famciclovir with food and drink
Pregnancy and breast-feeding
1. What Famciclovir is and what it is used for
2. Before you take Famciclovir
3. How to take Famciclovir
4. Possible side effects
5. How to store Famciclovir
6. Further information

1

WHAT FAMCICLOVIR IS AND WHAT IT
IS USED FOR

Driving and using machines
Do not
drive or use machines

3

2

HOW TO TAKE FAMCICLOVIR

BEFORE YOU TAKE FAMCICLOVIR

Do not take Famciclovir
Dose for shingles

Ask your doctor for advice
Take special care with Famciclovir

Dose for genital herpes

Children and adolescents (below the
age of 18 years)

first outbreak

Prevent passing genital herpes to others

treat further outbreaks

prevent future outbreaks

Teva Pharmaceuticals Europe B.V
Effective Date: 16-Apr-2012

REG0066484

Version 1.0

Valid For 7 Days from 04-Mar-2013

Effective
Page 1 of 3

Dimensions:

L:
W:

330 mm
153 mm

Fonts: Variants of Univers

Colours:

Pharma Code (top to bottom
on the front face when reading
the text design right way up):
361-33-731417500 REV02

(PANTONE® is a registered
trademark of Pantone, Inc.)

BLACK

Please refer to the
latest version of the
full base material
specification: 92655

Base Font Size: 8.5 Pt
IMPORTANT: Artwork, text and content must not be reset, remade, amended or
altered. The only exceptions to this are: bleeds, chokes, spreads or other print
related adjustments required for reproduction by the supplier. We must receive a
copy of any 3rd Party Supplier’s Proof before approval to print will be granted.

5

PANTONE® GREEN C

HOW TO STORE FAMCICLOVIR

Keep out of the reach and sight of children.
treat the current outbreak

prevent future outbreaks

If you take more Famciclovir than you should

6

FURTHER INFORMATION

What Famciclovir Film-coated tablets contain

If you forget to take Famciclovir

What Famciclovir Film-coated tablets look
like and contents of the pack

4

POSSIBLE SIDE EFFECTS

Severe blistering

Unexplained bruising
nosebleeds
Marketing Authorisation Holder and
Manufacturer
Contact a doctor or go to the emergency
department at your nearest hospital straight
away

Company responsible for manufacture

Very common side effects

This leaflet was last revised:

Common side effects

Uncommon side effects

Rare side effects

Teva Pharmaceuticals Europe B.V
Effective Date: 16-Apr-2012

REG0066484

Version 1.0

Valid For 7 Days from 04-Mar-2013

Effective
Page 2 of 3

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
m
g-film-coated-tablets

APPROVALS
Signed by
Michelle Blake

Meaning of Signature
Regulatory Affairs Approval

Teva Pharmaceuticals Europe B.V
Effective Date: 16-Apr-2012

Server Date

REG0066484

16-Apr-2012 02:42:22 PM

Version 1.0

Valid For 7 Days from 04-Mar-2013

Effective
Page 3 of 3

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

IN THIS LEAFLET:
1. What Famciclovir is and what it is used for
2. Before you take Famciclovir
3. How to take Famciclovir
4. Possible side effects
5. How to store Famciclovir
6. Further 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.
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.

Ref:

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

Version:

4

19 December 2012

PL Number(s),
PL 00289/0975-77. TEVA UK Limited Licence,
MA Holder & Packer: Packed at Novopharma, Torronto, Canada.
Reason for revision: Version 1: Change of packaging line, at Novopharma - resulting in new leaflet dimensions. V2: Updated Cutter/Template received from TEVA Canada 07/09/2012.
V3: Updated Cutter/Template received from TEVA Canada 10/09/2012 with outlined OCRA font.
V4: Request to remove ‘Text Area’ boxes. 11/12/12 14:12. TEVA Canada. Trackwise: 175303.

Dimensions:

L:
W:

345 mm
280 mm

Fonts: Variants of Univers

Base Font Size: 11.75 Pt

Pharma Code: 132 (0000101) Colours:
(PANTONE® is a registered
3rd Party Code:
trademark of Pantone, Inc.)
361-33-731417500 Rev 03

IMPORTANT: Artwork, text and content must not be reset, remade, amended or
altered. The only exceptions to this are: bleeds, chokes, spreads or other print
related adjustments required for reproduction by the supplier. We must receive a
copy of any 3rd Party Supplier’s Proof before approval to print will be granted.

Please refer to the
latest version of the
full base material
specification: 92655

PANTONE® GREEN
BLACK

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)
• 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.
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.

3 HOW TO TAKE 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.
• 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.
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.
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 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).
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
• Pruritus
• Liver function test giving abnormal results.

Rare side effects
• 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 FAMCICLOVIR
Keep out of the reach and sight of children.
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 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.
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.

6 FURTHER INFORMATION
What Famciclovir Film-coated tablets contain
The active substance is famciclovir. One tablet contains 125 mg,
250 mg or 500 mg of famciclovir.
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 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 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.
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.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
TEVA UK Limited,
Eastbourne, BN22 9AG.
Company responsible for manufacture
TEVA UK Limited,
Eastbourne, BN22 9AG.
This leaflet was last revised:
October 2010
PL 00289/0975-7

Uncommon side effects
• Confusion
• Severe skin reactions.

86390-W

Ref:

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

Version:

4

19 December 2012

PL Number(s),
PL 00289/0975-77. TEVA UK Limited Licence,
MA Holder & Packer: Packed at Novopharma, Torronto, Canada.
Reason for revision: Version 1: Change of packaging line, at Novopharma - resulting in new leaflet dimensions. V2: Updated Cutter/Template received from TEVA Canada 07/09/2012.
V3: Updated Cutter/Template received from TEVA Canada 10/09/2012 with outlined OCRA font.
V4: Request to remove ‘Text Area’ boxes. 11/12/12 14:12. TEVA Canada. Trackwise: 175303.

Dimensions:

L:
W:

345 mm
280 mm

Fonts: Variants of Univers

Base Font Size: 11.75 Pt

Pharma Code: 132 (0000101) Colours:
(PANTONE® is a registered
3rd Party Code:
trademark of Pantone, Inc.)
361-33-731417500 Rev 03

IMPORTANT: Artwork, text and content must not be reset, remade, amended or
altered. The only exceptions to this are: bleeds, chokes, spreads or other print
related adjustments required for reproduction by the supplier. We must receive a
copy of any 3rd Party Supplier’s Proof before approval to print will be granted.

Please refer to the
latest version of the
full base material
specification: 92655

PANTONE® GREEN
BLACK

Ref:

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

Version:

4

19 December 2012

PL Number(s),
PL 00289/0975-77. TEVA UK Limited Licence,
MA Holder & Packer: Packed at Novopharma, Torronto, Canada.
Reason for revision: Version 1: Change of packaging line, at Novopharma - resulting in new leaflet dimensions. V2: Updated Cutter/Template received from TEVA Canada 07/09/2012.
V3: Updated Cutter/Template received from TEVA Canada 10/09/2012 with outlined OCRA font.
V4: Request to remove ‘Text Area’ boxes. 11/12/12 14:12. TEVA Canada. Trackwise: 175303.

Artwork Originator;
Sign & Date:

Dimensions:

Artwork Checker;
Sign & Date:

L:
W:

345 mm
280 mm

Fonts: Variants of Univers

Base Font Size: 11.75 Pt

Approved for Regulatory submission into MHRA/IMB;
Sign & Date:

Pharma Code: 132 (0000101) Colours:
(PANTONE® is a registered
3rd Party Code:
trademark of Pantone, Inc.)
361-33-731417500 Rev 03

IMPORTANT: Artwork, text and content must not be reset, remade, amended or
altered. The only exceptions to this are: bleeds, chokes, spreads or other print
related adjustments required for reproduction by the supplier. We must receive a
copy of any 3rd Party Supplier’s Proof before approval to print will be granted.

Please refer to the
latest version of the
full base material
specification: 92655

Final approval by MA Holder confirming receipt of MHRA/IMB
approval; Sign & Date:

PANTONE® GREEN
BLACK

Packing Site Approval (where not TEVA UK Limited)
Sign & Date:

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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