FAMCICLOVIR 250 MG FILM-COATED TABLETS

Active substance: FAMCICLOVIR

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Package leaflet: Information for the user

Famciclovir 125 mg, 250 mg and 500 mg
Film-coated Tablets
(Famciclovir)
Read all of this leaflet carefully before you start taking this
medicine because 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 your
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 effects not listed in this leaflet.

What is in this leaflet
1. What Famciclovir is and what it is used for
2. What you need to know before you take Famciclovir
3. How to take Famciclovir
4. Possible side effects
5. How to store Famciclovir

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.
Famciclovir with food
You can take Famciclovir with or without food.
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking this 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
Famciclovir can cause dizziness, drowsiness or confusion. Do not
drive or use machines if you have any of these symptoms while
taking Famciclovir.

6. Contents of the pack and other information

1. What Famciclovir is and what it is used for
The name of your medicine is Famciclovir film-coated tablets. In the
rest of this leaflet, your medicine is called Famciclovir. The tablets
are available in three strengths containing 125 mg, 250 mg or 500 mg
of famciclovir.
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, which is 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. What you need to know before you take Famciclovir
Do not take Famciclovir
• if you are allergic (hypersensitive) to famciclovir or 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 or pharmacist before taking 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.
Children and adolescents (below the age of 18 years)
Famciclovir is not recommended for use in children and adolescents.

PHARMACODE
AREA

Always take this medicine exactly as your doctor or pharmacist has
told you to. 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.

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FAMCICLOVIR
FILM-COATED TABLETS

XXXXX

3. How to take Famciclovir

PHARMACODE
AREA

FAMCICLOVIR
FILM-COATED TABLETS

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.

Famciclovir 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.

XXXXX



Other medicines and Famciclovir
Tell your doctor or pharmacist if you are taking, have recently taken
or might take any other medicines.

PACKAGING DEVELOPMENT
Product Name : Famciclovir 125 250 500 750mg Tab. (PIL) Item Code : XXXXX
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Cipla Inventory Code

Use in children and adolescents (below the age of 18 years)
Famciclovir is not recommended for use in children and adolescents.
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.

5. How to store Famciclovir







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 stop taking Famciclovir
It is important that you take all of the tablets prescribed by your
doctor. You should not stop taking your medicine without taking to
the doctor first, even if you feel well.
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. The side effects caused by Famciclovir are
usually mild to moderate in intensity.
Serious side effects of Famciclovir 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).
Contact a doctor or go to the emergency department at your
nearest hospital straight away if you get any of these effects.
The following side effects may also occur:
Very common side effects (may affect more than 1 in 10 people)
• Headache

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 carton after EXP. The expiry date refers to the last day of that
month.
Store in the original package.
Do not use this medicine if you notice the pack is damaged or
shows signs of tampering.
Do not throw away any medicines via wastewater or household
waste. Ask your pharmacist how to throw away medicines you no
longer use. These measures will help to protect the environment.

6. Contents of the pack and other information
What Famciclovir contains
• The active substance is famciclovir. Each tablet contains 125 mg,
250 mg or 500 mg famciclovir.
• The other ingredients are lactose monohydrate, croscarmellose
sodium, crospovidone and magnesium stearate. The film coat
contains hypromellose 15cP, titanium dioxide (E171) and macrogol.
What Famciclovir looks like and contents of the pack
Famciclovir 125 mg film-coated tablets are white to off white
coloured, circular, biconvex film-coated tablets, plain on both sides.
They are supplied in blister packs containing 10 tablets.
Famciclovir 250 mg film-coated tablets are white to off white
coloured, circular, biconvex film-coated tablets, plain on both sides.
They are supplied in blister packs containing 3, 15, 21 or 56 tablets.
Famciclovir 500 mg film-coated tablets are white to off white
coloured, capsule shaped, biconvex film-coated tablets, plain on both
sides. They are supplied in blister packs containing 14, 21, 30 and 56
tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Cipla (EU) Limited,
Hillbrow House,
Hillbrow Road, Esher,
Surrey, KT10 9NW.
Manufacturer
APC Pharmaceuticals & Chemicals (Europe) Limited,
9th Floor, CP House,
97-107 Uxbridge Road,
Ealing,
London W5 5TL

Common side effects (may affect up to 1 in 10 people)
• Feeling sick (nausea)
• Vomiting
• Dizziness
• Rash
• Itching
• Liver function test giving abnormal results

Distributed by
APC Pharmaceuticals & Chemicals (Europe) Limited,
9th Floor, CP House,
97-107 Uxbridge Road,
Ealing,
London W5 5TL

Uncommon side effects (may affect up to 1 in 100 people)
• Confusion
• Drowsiness (usually in older people)
• Itchy rash (urticaria)

This leaflet was last revised in October 2012.

Rare side effects (may affect up to 1 in 1,000 people)
• Hallucinations (seeing or hearing things that are not really there)

XXXXX

If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects not listed in this leaflet.

Cipla Inventory Code

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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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