FAMVIR 500MG TABLETS

Active substance: FAMCICLOVIR

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Famvir® 500 mg Tablets

2438
18.04.13[2]

(famciclovir)
PATIENT INFORMATION LEAFLET
Your medicine is available using the above name but will be referred to as
Famvir throughout this leaflet.
Famvir is also available in 125 mg and 250 mg strength.
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.
- Famvir 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 Famvir is and what it is used for
2. Before you take Famvir
3. How to take Famvir
4. Possible side effects
5. How to store Famvir
6. Further 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. BEFORE YOU TAKE FAMVIR
Do not take Famvir
- If you are allergic (hypersensitive) to famciclovir, to any of the other
ingredients of Famvir 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 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.
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 Famvir with food and drink
You can take Famvir 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. 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.
If you are breast-feeding, tell your doctor. 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 breastfeeding.
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.
Important information about some of the ingredients of Famvir
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 contain lactose. Famvir 500 mg Tablets
does not contain lactose.

3. HOW TO TAKE FAMVIR
Always take Famvir 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 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
- 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 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.
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 product, ask your doctor
or pharmacist.

4. POSSIBLE SIDE EFFECTS
Like all medicines, Famvir can cause side effects, although not everybody
gets them. The side effects caused by Famvir 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)

MANUFACTURER AND PRODUCT LICENCE HOLDER
Manufactured by
Novartis Farmaceutica S.A., Ronda Santa Maria, 158- Barbera Del VallesBarcelona, Spain.
Novartis Farma S.p.A., Via Provinciale Schito, 131-80058 Torre Annunziata
(NA), Italy.
Procured from within the EU by Product Licence holder
Star Pharmaceuticals Ltd, 5 Sandridge Close, Harrow, Middlesex HA1 1XD.
Repackaged by Servipharm Ltd.
POM

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).

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
- Rash
- Itching
- Liver function test giving abnormal results
Uncommon side effects
- Confusion
- Drowsiness (usually in older people)
- Itchy rash (urticaria)
Rare side effects
- Hallucinations (seeing or hearing things that are not really there)
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 FAMVIR
Keep all medicines out of the sight and reach of children.
Do not store above 30ºC. Store in the original package.
Do not take the tablets after their expiry date which is printed on the outside
of the pack.
If the medicines become discoloured or show any other signs of
deterioration, consult your pharmacist who will tell you what to do.
Medicines should not be disposed of via wastewater or household waste.
Ask you pharmacist how to dispose of medicine no longer required. These
measures will help to protect the environment.
6. FURTHER INFORMATION
What Famvir contains
The active ingredient in your tablets is called famciclovir.
Each film-coated tablet contains 500mg famciclovir.
The tablets also contain hydroxypropyl cellulose, sodium starch glycollate,
magnesium stearate, hypromellose, macrogol 4000, macrogol 6000 and
titanium dioxide (E171).
What Famvir looks like and contents of the pack
Famvir tablets are white, oval, biconvex film-coated tablets, marked ‘FV500’
on one side and plain on other side.
Available in packs of 14, 21, 28 and 56 tablets.

PL 20636/2438

Leaflet revision issue date (Ref) 18.04.13[2]
Famvir is trademark of Novartis AG.

Famciclovir 500 mg Tablets

2438
18.04.13[2]

PATIENT INFORMATION LEAFLET
Your medicine is available using the above name but will be referred to as
Famciclovir throughout this leaflet.
Famciclovir is also available in 125 mg and 250 mg strength.
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.
- Famciclovir 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 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.
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 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 breastfeeding.
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.
Important information about some of the ingredients of Famciclovir
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.
Famciclovir 125 mg and 250 mg tablets contain lactose.
Famciclovir 500 mg Tablets does not contain lactose.

3. HOW TO TAKE FAMCICLOVIR
Always take Famciclovir 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. 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)

MANUFACTURER AND PRODUCT LICENCE HOLDER
Manufactured by
Novartis Farmaceutica S.A., Ronda Santa Maria, 158- Barbera Del VallesBarcelona, Spain.
Novartis Farma S.p.A., Via Provinciale Schito, 131-80058 Torre Annunziata
(NA), Italy.
Procured from within the EU by Product Licence holder
Star Pharmaceuticals Ltd, 5 Sandridge Close, Harrow, Middlesex HA1 1XD.
Repackaged by Servipharm Ltd.
POM

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.
Very common side effects
- Headache
Common side effects
- Feeling sick (nausea)
- Vomiting
- Dizziness
- Rash
- Itching
- Liver function test giving abnormal results
Uncommon side effects
- Confusion
- Drowsiness (usually in older people)
- Itchy rash (urticaria)
Rare side effects
- Hallucinations (seeing or hearing things that are not really there)
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 all medicines out of the sight and reach of children.
Do not store above 30ºC. Store in the original package.
Do not take the tablets after their expiry date which is printed on the outside
of the pack.
If the medicines become discoloured or show any other signs of
deterioration, consult your pharmacist who will tell you what to do.
Medicines should not be disposed of via wastewater or household waste.
Ask you pharmacist how to dispose of medicine no longer required. These
measures will help to protect the environment.
6. FURTHER INFORMATION
What Famciclovir contains
The active ingredient in your tablets is called famciclovir.
Each film-coated tablet contains 500mg famciclovir.
The tablets also contain hydroxypropyl cellulose, sodium starch glycollate,
magnesium stearate, hypromellose, macrogol 4000, macrogol 6000 and
titanium dioxide (E171).
What Famciclovir looks like and contents of the pack
Famciclovir tablets are white, oval, biconvex film-coated tablets, marked
‘FV500’ on one side and plain on other side.
Available in packs of 14, 21, 28 and 56 tablets.

PL 20636/2438

Leaflet revision issue date (Ref.) 18.04.13[2]

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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