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FAMCICLOVIR 125 MG FILM-COATED TABLETS

Active substance(s): FAMCICLOVIR

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1098

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.
1098

Comp. Description:

Both Production Site:
CTM:
LFT_FAMVIR_ALL DOSAGES_FCT_GB Printing Colours:

Barbera
Jimenez Lopez, Eva
Black

Comp. No. New:
Comp. No. Old:
Format/Dimension:
Tech. Drawing No.:

1109837-A14-GB
1109837-ST 13 B/B-GB
148 x 297 mm
N/A

Cutting

Min. Font Size Text:
Font Type:
Version No.: 1

8 pt
News Gothic
Date: 15 Oct 2014

 Yes /
1306923

Live Text:
WO:

Braille:

N/A



No /



J.N.: 238429

Technical Colours:

- 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.
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.
1109837-A14-GB

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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 abnormal heart beat)
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 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), 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), 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 and Novartis Pharmaceuticals UK
Limited, Frimley Business Park, Frimley, Camberley,
Surrey, GU16 7SR, England.
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
(Invented) Name
Austria, Cyprus, Denmark, Finland, Famvir
Germany, Greece, Hungary,
Iceland, Ireland, Italy, Luxembourg,
Malta, Netherlands, Spain, Sweden,
United Kingdom
France
Oravir
250 mg film coated tablets
Member State EU / EEA
Austria, Cyprus, Finland, Germany,
Greece, Hungary, Ireland, Italy,
Luxembourg, Malta, Netherlands,
Spain, Sweden, United Kingdom
500 mg film coated tablets
Member State EU / EEA
Austria, Denmark, Finland, Greece,
Iceland, Italy, Netherlands, Spain,
Sweden, United Kingdom
France

Comp. Description:

Both Production Site:
CTM:
LFT_FAMVIR_ALL DOSAGES_FCT_GB Printing Colours:

Barbera
Jimenez Lopez, Eva
Black

Comp. No. New:
Comp. No. Old:
Format/Dimension:
Tech. Drawing No.:

1109837-A14-GB
1109837-ST 13 B/B-GB
148 x 297 mm
N/A

Cutting

Min. Font Size Text:
Font Type:
Version No.: 1

8 pt
News Gothic
Date: 15 Oct 2014

 Yes /
1306923

Braille:

N/A



No /



J.N.: 238429

Technical Colours:

(Invented) Name
Famvir
Oravir

This leaflet was last revised in September 2014.

1109837-A14-GB
1098

Live Text:
WO:

(Invented) Name
Famvir

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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