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Famciclovir 250mg Film-Coated Tablets

Document: leaflet MAH GENERIC_PL 00289-0976 change

tevauk Ref 231-30-86390-X LEA FAMCICLOVIR A/S TAB TUK FrCAN

Version: 4

4 June 2015


FAMCICLOVIR 125 mg, 250 mg AND 500 mg FILM-COATED TABLETS


PACKAGE LEAFLET: INFORMATION FORTHE USER


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.

•    This medicine 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 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.


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.


IN THIS LEAFLET:


Pregnancy and breast-feeding

Ask your doctor or pharmacist for advice before taking any medicine.


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


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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.


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

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


^ HOW TO TAKE FAMCICLOVIR

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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:

• Raloxifene (used to prevent and treat osteoporosis)


Always take Famciclovir exactly as your doctor or pharmacist 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.


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teva uk Ref 231-30-86390-X LEA FAMCICLOVIR A/S TAB TUK FrCAN

Version: 4

4 June 2015


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.

ra 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).

Serious side effects of Famciclovir are:

   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, for frequency see below)

   Unexplained bruising, reddish or purplish patches on the skin or nosebleeds (these could be signs of a decrease in the number of blood platelets, for frequency see below).

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

•    Drowsiness

•    Rash


•    Pruritus

•    Liver function test giving abnormal results.

Uncommon side effects

•    Confusion

•    Severe skin reactions.

Rare side effects

•    Hallucinations (seeing or hearing things that are not really there)

•    Yellowing of the skin and/or eyes

•    Low platelet count.

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 at: www.mhra.gov.uk/yellowcard

By reporting side effects you can help provide more information on the safety of this medicine.

^ HOW TO STORE FAMCICLOVIR

Keep out of the reach and sight of children.

Do not use Famciclovir after the expiry date which is stated on the packaging after "exp" on the box or the blister pack.The expiry date refers to the last day of that month.

Keep the blister in the outer carton in order to protect from light.

Do not use Famciclovir if you notice the pack is damaged or shows signs of tampering.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

^ FURTHER INFORMATION

What Famciclovir Film-coated tablets contain

The active substance is famciclovir. One tablet contains 125 mg, 250 mg or 500 mg of famciclovir.

The other ingredients are microcrystalline cellulose E460, sodium starch glycolate (Type A), colloidal anhydrous silica E551, low substituted hydroxypropylcellulose, croscarmellose sodium, sodium stearyl fumarate, titanium dioxide E 171, polydextrose, hypromellose, triacetin and macrogol.

What Famciclovir Film-coated tablets look like and contents of the pack

Famciclovir comes in 3 different strengths of tablets which can be identified by their inscription:

125 mg: White to off-white, round, film-coated tablets, engraved 8117 on one side and 93 on the other side.

250 mg: White to off-white, round, film-coated tablets, engraved 8118 on one side and 93 on the other side.

500 mg: White capsule shaped film-coated tablets, engraved 93 on one side and 8119 on the other side

The 125 mg tablets come in packs of: 1, 10, 21 & 30 film-coated tablets. Hospital packs of 50 (50 x 1) film-coated tablets.

The 250 mg tablets come in packs of: 1, 12, 14, 15, 20, 21, 30, 56 & 60 film-coated tablets. Hospital packs of 50 (50 x 1) film-coated tablets.

The 500 mg tablets come in packs of: 1, 10, 14, 15, 20, 21, 30, 56 & 60 film-coated tablets. Hospital packs of 50 (50 x 1) film-coated tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

TEVA UK Limited, Eastbourne, BN22 9AG.

Company responsible for manufacture

TEVA UK Limited, Eastbourne, BN22 9AG.

This leaflet was last revised:

June 2015

PL 00289/0975-7



TEVA UK LIMITED    86390-X

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