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Famciclovir 500 Mg Film-Coated Tablets.

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Document: leaflet MAH BRAND_PL 00101-0623 change

& NOVARTIS

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.

-    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.    878042_gb_lft


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 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 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

•    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), and 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), and 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.

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, Germany, Greece, Hungary, Iceland, Ireland, Italy, Luxembourg, Malta, Netherlands, Spain, Sweden, United Kingdom

Famvir

France

Oravir

250 mg film coated tablets


Member State EU / EEA

(Invented) Name

Austria, Cyprus, Finland, Germany, Greece, Hungary, Ireland, Italy, Luxembourg, Malta, Netherlands, Spain, Sweden, United Kingdom

Famvir

500 mg film coated tablets


Member State EU / EEA

(Invented) Name

Austria, Denmark, Finland, Greece, Iceland, Italy, Netherlands, Spain, Sweden, United Kingdom

Famvir

France

Oravir

This leaflet was last revised in September 2014.

878042_GB_LFT


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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 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 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

6.    Contents of the pack and other 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. WHAT YOU NEED TO KNOW BEFORE YOU TAKE FAMCICLOVIR

Do not take Famciclovir

•    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

•    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 vearst 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 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

Tell your doctor or pharmacist if you are taking, have recently

DODD

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 with food and drink

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

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.

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 (Famciclovir 125 mg and 250 mg tablets only).

3. HOW TO TAKE FAMCICLOVIR

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.

DODD

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

•    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.

0000000-SDZ 00A/B-GB

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 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 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

•    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 25 °C.

•    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 away any medicines via waste water or household waste. Ask your pharmacist how to throw away medicines you no longer require.

These measures will help to protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Famciclovir contains

Famciclovir 125 mg film-coated tablets

•    The active substance is famciclovir.

•    The other ingredients are lactose, anhydrous, sodium starch glycolate (Type A), and hydroxypropyl cellulose and magnesium stearate. The tablet coating is composed of hypromellose, titanium dioxide (E171), Macrogol 4000 and Macrogol 6000.

Famciclovir 250 mg film-coated tablets

•    The active substance is famciclovir.

•    The other ingredients are lactose, anhydrous, sodium starch glycolate (Type A), and hydroxypropyl cellulose and magnesium stearate. The tablet coating is composed of hypromellose, titanium dioxide (E171), Macrogol 4000 and Macrogol 6000.

Famciclovir 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 Famciclovir looks like and contents of the pack

Famciclovir is supplied as film-coated tablets.

Famciclovir 125 mg film-coated tablets

White, round, film-coated tablets, biconvex, bevelled edges,

debossed with “FV” on one side and 125 on the reverse side.

Famciclovir 250 mg film-coated tablets

White, round, film-coated tablets, biconvex, bevelled edges,

debossed with “FV” on one side and 250 on the reverse side.

Famciclovir 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.

Famciclovir tablets are made by Novartis Farmaceutica S.A., Rhonda Santa Maria, 158 08210 Barbera Del Valles, Barcelona, Spain and Novartis Pharmaceuticals UK Ltd, Frimley Business Park, Frimley Camberley Surrey, GU16 7SR, England.

Famciclovir tablets are distributed by Sandoz Ltd, Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, UK.

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 leaflet was last revised September 2014.

SZ00000LT000 0000000-SDZ 00A/B-GB

0000