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Famciclovir 125mg Tablets

Informations for option: Famciclovir 125mg Tablets, show other option

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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 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:

^ What Famciclovir tablets are and what they are used for

^ Before you take

^ How to take

Possible side effects How to store

« Further information

^ What Famciclovir tablets are and what they are 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 tablets as soon as the first symptoms appear.

Famcilovir tablets are 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 stop the virus from spreading in the body so that healing can occur faster.

•    Famciclovir tablets are 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 are 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.

^ Before you take

Do not take Famciclovir tablets if you

•    are allergic (hypersensitive) to famciclovir, to any of the other ingredients of Famciclovir tablets 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 tablets if you

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

•    have problems with your body's immune system.

•    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 are 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 practise safe sex, including the use of condoms. This is important to prevent you passing the infection on to others.

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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 tablets with food and drink

You can take Famciclovir tablets 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 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.

If you are breast-feeding, tell your doctor. Famciclovir tablets are 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

In rare cases 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.

How to take

Always take Famciclovir tablets 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 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 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.    Continued overpage


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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 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 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 tablets

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 product, ask your doctor or pharmacist.

Possible side effects

Like all medicines, Famciclovir tablets can cause side effects, although not everybody gets them. The side effects caused by Famciclovir tablets are usually mild to moderate in intensity.

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.

Tell your doctor if you notice any of the following side effects:

Very common (affects more than 1 user in 10): headache

Common (affects 1 to 10 users in 100): feeling sick (nausea), vomiting, dizziness, drowsiness, rash, pruritus, itching, liver function test giving abnormal results

Uncommon (affects 1 to 10 users in 1,000): confusion, severe skin reactions, hives (skin rash with red, raised, itchy bumps), severe swelling of the skin or mucous membranes (angio-oedema), e.g. of the face, eyelids or throat

Rare (affects 1 to 10 users in 10,000): hallucinations (seeing or hearing things that are not really there), yellowing of the skin and/or eyes, low platelet count.

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.

How to store

Keep out of the reach and sight of children. Do not store above 30°C.

Store in the original package to protect from moisture.

Do not use Famciclovir tablets after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month.

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 tablets contain

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

The other ingredients are:

Tablet core: Starch Pregelatinised, Sodium Laurilsulfate, Cellulose, Microcrystalline, Croscarmellose Sodium, Silica Colloidal Anhydrous, Stearic Acid Film-coating: Hypromellose (E464), Titanium Dioxide (E171), Macrogol 4000, Macrogol 6000

What Famciclovir tablets look like and contents of the pack

125mg film-coated tablets: white, round, biconvex, film-coated tablets with diameter of 7.6mm approximately.

250mg film-coated tablets: white, round, biconvex, film-coated tablets, scored on one side with diameter of 10.6mm approximately.

500mg film-coated tablets: white, oval, film coated tablets, scored on both sides with dimensions of 18.2 x 8.6mm approximately.

250mg and 500mg film-coated tablets:

The tablet can be divided into equal halves. Use lower strength tablets where these are available.

Famciclovir tablets are available in blister packs of:

125mg: 10 tablets 250mg: 21 tablets 500mg: 14 tablets

Marketing Authorisation Holder

Actavis Group PTC ehf,

Reykjavikurvegur 76-78,

220 Hafnarfjordur,

Iceland

Manufacturer

Specifar S.A.

1, 28 Octovriou str., Ag. Varvara,

12351 Athens Greece

MPF B.V.

Site 1: Appelhof 13, 8465RX - Oudehaske,

NL (P.O. Box 570, 8440 AN Heerenveen,

The Netherlands)

&

Site 2: Neptunus 12,

8448CN - Heerenveen,

NL (P.O.Box 713, 8440 AS Heerenveen,

The Netherlands)

This leaflet was last revised in January 2012.

If you would like a leaflet with larger text, please contact

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^actavis


Actavis, Barnstaple, EX32 8NS, UK