FAMVIR 500 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Famvir 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.

Contents of the pack and other information

1. What is Famvir and what is it used for
2. What you need to know before you take Famvir
3. How to take Famvir
4. Possible side effects
5. Storing Famvir
6. Contents of the pack and other information

1. What is Famvir and what is it used for

Famvir is an antiviral medicine. It stops the infecting virus from multiplying. Since the virus reproduces in a very early stage of infection, you will benefit more from treatment if you start taking Famvir after the first symptoms appear.

Famvir is used to treat two types of viral infections in adults:

• Herpes zoster, 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 healing occurs more quickly.
• Famvir is also used to treat herpes zoster in the area around the eye or even in the eye itself (herpes zoster ophthalmicus).
• Genital herpes. Genital herpes is a viral infection caused by the herpes simplex virus type 1 or 2. It is usually spread by sexual contact. It causes blisters and a burning or itching sensation around the genitals, which can 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 prevent their recurrence.

2. What you need to know before you take Famvir

Do not take Famvir

• if you are allergic to famciclovir or any of the other ingredients of this medicine (listed in section 6), or to penciclovir (the active metabolite of famciclovir and an ingredient in some other medicines)

If you think you may be allergic, consult your doctor.

Warnings and precautions

Consult your doctor before taking Famvir

• If you have any kidney disease (or have had it in the past). Your doctor may decide to give you a lower dose of Famvir.
• If you have problems with your immune system.
• If you have liver problems.

If any of these apply to you, consult your doctor before taking Famvir.

Children and adolescents (under 18 years)

Famvir is not recommended for use in children and adolescents.

Prevention of transmitting genital herpes to others

If you are taking Famvir to treat or suppress genital herpes, or if you have had genital herpes in the past, you can practice safe sex by using condoms. This is important to prevent infecting others. You should not have sex if you have pain or blisters on your genitals.

Taking Famvir with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

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 levels of uric acid associated with gout and to increase blood levels of penicillin-type antibiotics) or other medicines that may affect your kidneys.

Taking Famvir with food and drinks

You can take Famvir with or without food.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before taking this medicine. Famvir should not be used during pregnancy unless clearly necessary. Your doctor will discuss with you the potential risks of taking Famvir during pregnancy.

Famvir should not be used during breastfeeding unless clearly necessary. Your doctor will discuss with you the potential risks of taking Famvir during breastfeeding.

Driving and using machines

Famvir may cause dizziness, drowsiness, or confusion. If you experience any of these symptoms while taking Famvir, do not drive or use machines.

3. How to take Famvir

Follow the instructions for administration of this medicine exactly as told by your doctor.

If you are unsure, consult your doctor or pharmacist again.

• The daily dose and duration of treatment will depend on the type of viral infection you have - see below. Your doctor will prescribe the correct dose for you.
• To get the best results, start taking the medicine as soon as the first signs and symptoms appear.
• Do not have sex with anyone if you have symptoms of genital herpes - even if you have started treatment with Famvir. This is because you can infect your partner with the herpes infection.
• If you have or have had kidney problems, your doctor may decide to give you a lower dose of Famvir.

Dose for herpes zoster

If you have a normal immune system, the recommended dose is 500 mg three times a day, for seven days.

If you have a weakened immune system, the recommended dose is 500 mg three times a day, for ten days.

Dose for genital herpes

The dose depends on your immune system status and the stage of your infection.

If you have a normal immune system, the dose is as follows:

For the first episode, the recommended dose is 250 mg three times a day, for five days.

For treating new episodes, the recommended dose is 125 mg twice a day, for five days.

For preventing new episodes, the recommended dose is 250 mg twice a day.

Your doctor will tell you how long you need to keep taking your tablets.

If you have a weakened immune system, the dose is as follows:

For treating the current episode, the recommended dose is 500 mg twice a day, for seven days.

For preventing new episodes, the dose is 500 mg twice a day.

Your doctor will tell you how long you need to keep taking your tablets.

If you take more Famvir than you should

If you have taken more tablets than you should, or if someone else has taken your medicine by mistake, go to your doctor or hospital immediately. Show them your tablet pack. You can also call the Toxicology Information Service, telephone 91 562 04 20, stating the medicine and the amount taken.

Taking too much Famvir can harm your kidneys. People with kidney problems may rarely have kidney failure if their dose is not lowered correctly.

If you forget to take Famvir

If you forget to take a dose of Famvir, take it as soon as you remember. Then take the next dose at the usual time. However, do not take two doses in a period of less than 1 hour; in this case, skip the missed dose. Also, do not take a double dose to make up for the missed dose.

If you have any other questions about 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:

Many of these effects are uncommon (may affect up to 1 in 100 people) or rare (may affect up to 1 in 1,000 people).

• Severe skin and/or mucous membrane blisters(these could be signs of severe allergic reactions).
• Unexplained bruising, redness, or purple areas on the skin or nosebleeds(these may be signs of a decrease in the number of platelets in the blood).
• Swellingunder the skin surface (e.g., swelling of the face, around the eye, eyelids, and throat).
• Yellowing of the skin and/or eyes(signs of jaundice).

The frequency of the following side effects is not known (cannot be estimated from the available data):

• Purple spots on the skin, itching, burning (signs of inflamed blood vessels).
• Seizures or epileptic fits.
• Difficulty breathing or swallowing. Rash, itching, hives, wheezing, cough, feeling of fainting, dizziness, changes in levels of consciousness. Low blood pressure, with or without general itching, flushing of the skin, swelling of the face/throat, blue discoloration of the lips, tongue, or skin (signs of severe allergic reaction).

If you notice any of these side effects, contact a doctor immediately or go to the nearest emergency department.

Very common side effects(these side effects may affect more than 1 in 10 people)

• Headache

Common side effects(these side effects may affect up to 1 in 10 people)

• Nausea
• Vomiting
• Abdominal pain
• Diarrhea
• Dizziness
• Rash
• Itching
• Abnormal liver function test results

Uncommon side effects(these side effects may affect up to 1 in 100 people)

• Confusion
• Drowsiness (usually in elderly people)
• Itchy rash (hives)

Rare side effects(these side effects may affect up to 1 in 1,000 people)

• Hallucinations (seeing or hearing things that are not real)
• Palpitations (signs of abnormal heartbeats)

Reporting of side effects

If you experience any side effects, talk to your doctor, even if it is possible that they are not listed in this leaflet. You can also report side effects directly to the Spanish Medicines and Healthcare Products Agency (AEMPS) through the website http://www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing 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 carton after EXP. The expiry date refers to the last day of the month shown.
• Do not store above 25°C.
• Store in the original package to protect from moisture.
• Do not use this medicine if you notice the pack is damaged or shows signs of deterioration.
• Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to your pharmacist. This will help to protect the environment.

6. Contents of the pack and other information

What Famvir contains

• The active substance is famciclovir.
• The other ingredients are potato starch glycolate (Type A), hydroxypropyl cellulose, and magnesium stearate. The tablet coating is composed of hypromellose, titanium dioxide (E 171), Macrogol 4000, and Macrogol 6000.

Appearance and packaging

Famvir is available as film-coated tablets.

White, oval, biconvex, film-coated tablet with beveled edges, marked with "FV 500" on one face and nothing on the other.

Each pack contains 21 tablets.

Marketing authorisation holder

Phoenix Labs

Suite 12, Bunkilla Plaza

Bracetown Business Park

Clonee, County Meath, Ireland

info@phoenixlabs.ie

Local representative

EUROMED PHARMA SPAIN S.L.

C/Eduard Maristany, 430-432

08918 Badalona

Barcelona - Spain

Tel: + 34 932 684 208

Fax: + 34 933 150 469

Manufacturer

LABORATORI FUNDACIÓ DAU

Pol. Ind. Consorci Zona Franca. c/ C, 12-14

08040 Barcelona

Spain

Cosmo S.p.A.

Via Cristoforo Colombo, 1

20020 Lainate (Milan)

Italy

This medicine is authorised in the Member States of the European Economic Area under the following names:

Date of last revision of this leaflet: June 2017

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Healthcare Products (AEMPS) http://www.aemps.gob.es/