PACKAGE LEAFLET: INFORMATION FOR THE USER

Your medicine is available using the name Famvir 250mg Tablets, but will be referred to as Famvir Tablets throughout this leaflet. Other strengths are available.

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 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. See section 4.

What is in this leaflet:

1.    What Famvir Tablets are and what they are used for

2.    What you need to know before you take Famvir Tablets

3.    How to take Famvir Tablets

4.    Possible side effects

5.    How to store Famvir Tablets

6.    Contents of the pack and other information

1. What Famvir Tablets are and what they are used for

Famvir Tablets 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 Tablets as soon as the first symptoms appear.

Famvir Tablets 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 Tablets stops the virus from spreading in the body so that healing can occur faster.

■    Famvir Tablets 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 Tablets is used to treat genital herpes infections in adults. People who have frequent episodes of genital herpes can also take Famvir Tablets to help to prevent the attacks.

2. What you need to know before you take Famvir Tablets

Do not take Famvir Tablets

■    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 Tablets

■    If you have kidney problems (or have had them before). Your doctor may decide to give you a lower dose of Famvir Tablets.

■    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 Tablets.

Children and adolescents (below the age of 18 years) Famvir Tablets is not recommended for use in children and adolescents.

Prevent passing genital herpes to others

If you are taking Famvir Tablets 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 Tablets

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 Tablets with food and drink

You can take Famvir Tablets 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 Tablets are not to be used during pregnancy unless clearly necessary. Your doctor will discuss with you the potential risks of taking Famvir Tablets during pregnancy.

Famvir Tablets is not to be used during breast-feeding unless clearly necessary. Your doctor will discuss with you the possible risks of taking Famvir Tablets during breast-feeding.

Driving and using machines

Famvir Tablets can cause dizziness, drowsiness or confusion.

Do not drive or use machines if you have any of these symptoms while taking Famvir Tablets.

Famvir Tablets 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 Tablets 125mg and 250mg tablets only).

3. How to take Famvir Tablets

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.

■    Do not have sexual contact with anyone if you have symptoms of genital herpes - even if you have started treatment with Famvir Tablets. 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 Tablets.

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 Tablets 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 Tablets 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 Tablets

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 Tablets 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 abonormal    heart beat)

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. 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 Tablets

■    Store in their original package.

■    Do not store above 30°C.

■    Keep out of the sight and reach of children.

■    Do not take the tablets after their expiry date which is printed on the outside of the pack.

■    If your tablets appear to be discoloured or show any other signs of deterioration, please return to your pharmacist who will advise you further.

■    If your doctor tells you to stop taking the tablets, please take them back to the pharmacist for safe disposal. Do not throw them away with your normal household water or waste. This will help to protect the environment. Only keep the tablets if your doctor tells you to.

6.    Contents of the pack and other information

What Famvir Tablets contains

■    The active ingredient in Famvir Tablets is famciclovir. Each film-coated tablet contains 250mg of famciclovir.

■    The other ingredients are hyprolose, lactose, sodium starch glycollate and magnesium stearate. The film coat contains hypromellose, titanium dioxide (E171), macrogol 4000 and macrogol 6000.

What Famvir Tablets looks like and contents of the pack

Famvir Tablets are white, round, bi-convex, film-coated tablets, embossed 'FV' on one face and 250 around the edge on the other face.

Famvir Tablets are available in blister packs of 21 tablets.

Manufacturer

Famvir Tablets are manufactured by: Novartis Farmaceutica S.A., Barbera del Valles, Barcelona, Spain.

Procured from with in the EU and repackaged by: Doncaster Pharmaceuticals Group Ltd., Kirk Sandall, Doncaster, DN3 1QR.

Product Licence holder: Landmark Pharma Ltd., 7 Regents Drive, Prudhoe, Northumberland, NE42 6PX.

PL No: 21828/0360

Leaflet revision date: 23.02.15

Famvir® is a registered trademark of Novartis International Pharmaceutical Ltd

PACKAGE LEAFLET: INFORMATION FOR THE USER

Your medicine is available using the name Famciclovir 250mg Tablets, but will be referred to as Famciclovir Tablets throughout this leaflet.

Other strengths are available.

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 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. See section 4.

What is in this leaflet:

1.    What Famciclovir Tablets are and what they are used for

2.    What you need to know before you take Famciclovir Tablets

3.    How to take Famciclovir Tablets

4.    Possible side effects

5.    How to store Famciclovir Tablets

6.    Contents of the pack and other information

1. What Famciclovir Tablets are and what they are used for

Famciclovir Tablets 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 Tablets as soon as the first symptoms appear.

Famciclovir Tablets 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 Tablets stops the virus from spreading in the body so that healing can occur faster.

■    Famciclovir Tablets 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 Tablets is used to treat genital herpes infections in adults. People who have frequent episodes of genital herpes can also take Famciclovir Tablets to help to prevent the attacks.

2. What you need to know before you take Famciclovir Tablets

Do not take Famciclovir Tablets

■    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 Famciclovir Tablets

■    If you have kidney problems (or have had them before). Your doctor may decide to give you a lower dose of Famciclovir Tablets.

■    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 Tablets.

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

Prevent passing genital herpes to others

If you are taking Famciclovir Tablets to treat or to suppress genital herpes, or you have had genital herpes in the past, you should still practice 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 Famciclovir Tablets

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.

Famciclovir Tablets with food and drink

You can take Famciclovir Tablets 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. Famciclovir Tablets are not to be used during pregnancy unless clearly necessary. Your doctor will discuss with you the potential risks of taking Famciclovir Tablets during pregnancy.

Famciclovir Tablets is not to be used during breast-feeding unless clearly necessary. Your doctor will discuss with you the possible risks of taking Famciclovir Tablets during breast-feeding.

Driving and using machines

Famciclovir Tablets can cause dizziness, drowsiness or confusion. Do not drive or use machines if you have any of these symptoms while taking Famciclovir Tablets.

Famciclovir Tablets 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 (Famciclovir Tablets 125mg and 250mg tablets only).

3. How to take Famciclovir Tablets

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.

■    Do not have sexual contact with anyone if you have symptoms of genital herpes - even if you have started treatment with Famciclovir Tablets. 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 Tablets.

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 Famciclovir Tablets 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 Tablets 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 FamciclovirTablets

If you forget to take a dose of Famciclovir Tablets, 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 Famciclovir Tablets 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 Card Scheme: 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 Famciclovir Tablets

■    Store in their original package.

■    Do not store above 30°C.

■    Keep out of the sight and reach of children.

■    Do not take the tablets after their expiry date which is printed on the outside of the pack.

■    If your tablets appear to be discoloured or show any other signs of deterioration, please return to your pharmacist who will advise you further.

■    If your doctor tells you to stop taking the tablets, please take them back to the pharmacist for safe disposal. Do not throw them away with your normal household water or waste. This will help to protect the environment. Only keep the tablets if your doctor tells you to.

6.    Contents of the pack and other information

What Famciclovir Tablets contains

■    The active ingredient in Famciclovir Tablets is famciclovir. Each film-coated tablet contains 250mg of famciclovir.

■    The other ingredients are hyprolose, lactose, sodium starch glycollate and magnesium stearate. The film coat contains hypromellose, titanium dioxide (E171), macrogol 4000 and macrogol 6000.

What Famciclovir Tablets looks like and contents of the pack

Famciclovir Tablets are white, round, bi-convex, film-coated tablets, embossed 'FV' on one face and 250 around the edge on the other face.

Famciclovir Tablets are available in blister packs of 21 tablets.

Manufacturer

Famciclovir Tablets are manufactured by:

Novartis Farmaceutica S.A., Barbera del Valles, Barcelona, Spain.

Procured from within the EU and repackaged by: Doncaster Pharmaceuticals Group Ltd, Kirk Sandall, Doncaster, DN3 1QR.

Product Licence holder: Landmark Pharma Ltd, 7 Regents Drive, Prudhoe, Northumberland, NE42 6PX.

PL No: 21828/0360 POM

Leaflet revision date: 23.02.15

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