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FAMCICLOVIR PHARMATHEN 125 MG FILM-COATED TABLETS

Active substance(s): FAMCICLOVIR

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PACKAGE LEAFLET: INFORMATION FOR THE USER
Famciclovir Pharmathen 125 film-coated tablets
Famciclovir Pharmathen 250 film-coated tablets
Famciclovir Pharmathen 500 film-coated tablets
Famciclovir
Read all of this leaflet carefully before you start using this medicine.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor or your 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 get 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 Pharmathen is, and what it is used for
2.
Before you take Famciclovir Pharmathen
3.
How to take Famciclovir Pharmathen
4.
Possible side effects
5.
How to store Famciclovir Pharmathen
6.
Further information

1.

WHAT FAMCICLOVIR PHARMATHEN IS AND WHAT IT IS USED FOR

Famciclovir Pharmathen 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 Pharmathen as soon as the first symptoms appear.
Famciclovir Pharmathen 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 Pharmathen stops the virus from spreading in
the body so that healing can occur faster.
Famciclovir Pharmathen 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 Pharmathen is used to treat genital herpes infections
in adults.
People who have frequent episodes of genital herpes can also take Famciclovir Pharmathen to
help to prevent the attacks.
The tablets are available in four different strengths.

2.

BEFORE YOU TAKE FAMCICLOVIR PHARMATHEN

Do not take [Famciclovir]
If you are allergic (hypersensitive) to famciclovir, to any of the other ingredients of Famciclovir
Pharmathen 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 Pharmathen If you have kidney problems (or have had them before). Your doctor may decide to give you a
lower dose of Famciclovir Pharmathen
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 Pharmathen is not recommended for use in children and adolescents.
Prevent passing genital herpes to others
If you are taking Famciclovir Pharmathen 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 condom. 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).

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 Pharmathen with food and drink
You can take Famciclovir Pharmathen 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 Pharmathen is not to be used
during pregnancy unless clearly necessary. Your doctor will discuss with you the potential risks of
taking Famciclovir Pharmathen during pregnancy.
If you are breast-feeding, tell your doctor. Famciclovir Pharmathen is not to be used during breastfeeding unless clearly necessary. Your doctor will discuss with you the possible risks of taking
Famciclovir Pharmathen during breast-feeding.
Driving and using machines
Famciclovir Pharmathen can cause dizziness, drowsiness or confusion. Do not drive or use machines
if you have any of these symptoms while taking [Famciclovir].

3.

HOW TO TAKE FAMCICLOVIR PHARMATHEN

Always take Famciclovir Pharmathen 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 Pharmathen 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 Pharmathen 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 Pharmathen
If you forget to take a dose of Famciclovir Pharmathen, 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 Pharmathen can cause side effects although not everybody gets them.
The side effects caused by Famciclovir Pharmathen 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 Pharmathen are:



Severe blistering of the skin and/or mucous membranes of the lips, eyes, mouth, nasal passages
or genitals (these could be signs of 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
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 out of the reach and sight of children.
Do not store above 25ºC.
Store in the original package in order to protect from moisture.
Do not use Famciclovir Pharmathen if you notice the pack is damaged or shows signs of tampering.
Do not take the tablets after the expiry date which is stated on the label 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.

6.

FURTHER INFORMATION

What Famciclovir Pharmathen contains
The active substance is famciclovir.
125 mg film-coated tablets contain 125 mg famciclovir as active substance.
250 mg film-coated tablets contain 250 mg famciclovir as active substance.
500 mg film-coated tablets contain 500 mg famciclovir as active substance.
The other ingredients are:
Table core: Microcrystalline cellulose PH102, crospovidone (XL), silicon dioxide anhydrous,
copovidone, sodium stearyl fumarate.
Table coat: hypromellose, polydextrose, triethyl citrate, titanium dioxide (E171), macrogol 8000.
What Famciclovir Pharmathen looks like and contents of the pack
Famciclovir Pharmathen tablets are available in four strengths:




Famciclovir Pharmathen 125 mg is supplied as white, round coated tablet, debossed with a ‘‘P’’
logo on one side and ‘‘125’’ on the other.
Famciclovir Pharmathen 250 mg is supplied as white, round coated tablet, debossed with a ‘‘P’’
logo on one side and ‘‘250’’ on the other.
Famciclovir Pharmathen 500 mg is supplied as white, oval coated tablet, debossed with a ‘‘P’’
logo on one side and ‘‘500’’ on the other.

Famciclovir Pharmathen is available in packs of:
125 mg tablets: 10 tablets (blister packs)
250 mg tablets: 15, 21, 56 tablets (blister packs)
500 mg tablets: 14, 21, 30, 56 tablets (blister packs)

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer:
Pharmathen S.A.
6 Dervenakion str., Pallini Attiki, 153 51 Greece
Tel.: +30 210 666 5067
Fax: + 30 210 666 6749
E-mail: info@pharmathen.com

This medicinal product is authorised in the Member States of the EEA under the following
names:
UK: Famciclovir Pharmathen
AT: Famciclovir Pharmathen
CZ: Famciclovir Pharmathen
EE: Famciclovir Pharmathen
EL: Famciclovir Pharmathen
ES: Famciclovir Pharmathen
FR: Famciclovir Pharmathen
IT: Famciclovir Pharmathen
LT: Famciclovir Pharmathen
LV: Famciclovir Pharmathen
SK: Famciclovir Pharmathen
This leaflet was last approved in 06/2011

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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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