Package Insert: Information for the User

Famvir 500 mg Film-Coated Tablets

Famciclovir

Read this package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, and you should not give it to others who may have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

Famvir is an antiviral medication. It stops the multiplication of the infecting virus. Since the virus reproduces at an early stage of the infection, you may benefit more from the 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, resulting in faster recovery.
• Famvir is also used to treat herpes zoster in the area around the eye or even in the eye itself (ophthalmic zoster).
• Genital herpes. Genital herpes is a viral infection caused by herpes simplex virus type 1 or 2. It is usually transmitted through 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 may also take Famvir to help prevent its recurrence.

Do not take Famvir

• if you are allergic to famciclovir or any of the other ingredients in this medicine (listed in section 6), or to penciclovir (an 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 starting to take 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 body's immune system.
• If you have liver problems.

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

Children and adolescents (under 18 years)

Famvir is not recommended for use in children and adolescents.

Preventing the spread of 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 using condoms. This is important to avoid passing the infection to others. Do not have sex if you have pain or blisters on your genitals.

Taking Famvir with other medicines

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medicine.

It is especially important to inform your doctor or pharmacist if you are taking any of the following medicines:

• Raloxifeno (used to prevent and treat osteoporosis).
• Probenecid (used to treat high levels of uric acid associated with gout and to increase levels of penicillin-type antibiotics in the blood) 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 plan to become pregnant, consult your doctor before using this medicine. Famvir should not be used during pregnancy unless it is clearly necessary. Your doctor will discuss the potential risks of taking Famvir during pregnancy with you.

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

Driving and operating machines

Famvir may cause dizziness, drowsiness, or confusion. If you experience any of these symptoms during treatment with Famvirdo not drive or operate machines.

Follow exactly the administration instructions of this medication as indicated by your doctor.

In case of doubt, consult your doctor or pharmacist again.

• The daily dose and treatment duration will depend on the type of viral infection you are suffering from – see below. Your doctor will prescribe the correct dose for you.
• To achieve the best results, start taking the medication 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 may infect your partner with genital herpes.
• 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 anormal immune system, the recommended dose is 500 mg three times a day, for seven days.

If you have aweakened 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 phase of your infection.

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

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

Totreat new episodesthe recommended dose is 125 mg two times a day, for five days.

Toprevent new episodesthe recommended dose is 250 mg two times a day.

Your doctor will inform you for how long you need to continue taking your tablets.

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

Totreat the current episode,the recommended dose is 500 mg two times a day, for seven days.

Toprevent new episodesthe dose is 500 mg two times a day.

Your doctor will inform you for how long you need to continue taking your tablets.

If you take more Famvir than you should

If you have taken more tablets than you should, or if anyone else has taken your medication accidentally, go immediately to your doctor or hospital. Show them your tablet packaging. You can also call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount taken.

Taking too much Famvir can damage your kidneys. People with kidney problems may, rarely, suffer from kidney failure if their dose is not lowered correctly.

If you forgot to take Famvir

If you forgot to take the dose of Famvir, take it as soon as you remember. Then take the next dose at the scheduled time. However, do not take two doses in a period of less than 1 hour, in that case, skip the missed dose. Also, do not take a double dose to compensate for the missed dose.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

Severe side effects:

Many of these side effects are rare (may affect up to 1 in 100 patients) or very rare (may affect up to 1 in 1,000 patients).

• Severe blisterson the skin and/or mucous membranes of the lips, eyes, mouth, nostrils, or genitals (these could be signs of severe allergic skin reactions).
• Unexplained appearance of bruises, redness, or purple areas on the skin ornosebleeds(these may be signs of a decrease in platelet count in the blood).
• Swellingunder the skin's surface (for example, swelling in the face, around the eye, on the eyelids, and in the throat).
• Yellowish coloron the skin and/or eyes (signs of jaundice).

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

• Blue spots on the skin, itching, burning (signs of inflamed blood vessels).
• Convulsions or epileptic seizures.
• Difficulty breathing or swallowing. Rash, itching, urticaria, wheezing, or cough, feeling of fainting, dizziness, changes in levels of consciousness. Hypotension, with or without generalized itching, skin redness, facial swelling/throat swelling, blue discoloration of the lips, tongue, or skin (signs of severe allergic reaction).

If you notice any of these side effectscontact a doctor immediately or go to the nearest emergency service.

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

• Headache

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

• 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 patients)

• Confusion
• Drowsiness (usually in older people)
• Rash with itching (urticaria)

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

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

Reporting side effects

If you experience any type of side effect, consult your doctor, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use (www.notificaRAM.es). By reporting side effects, you can contribute to providing more information on the safety of this medicine.

• Keep this medication out of the sight and reach of children.
• Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.
• Do not store above 25°C.
• Store in the original packaging to protect it from moisture.
• Do not use this medication if you observe that the packaging is damaged or shows signs of deterioration.
• Medications should not be disposed of through drains or trash. Deposit the containers and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. In this way, you will help protect the environment.

Famvir Composition

• The active ingredient is famciclovir.
• The other components are sodium starch glycolate (Type A), hydroxypropyl cellulose, and magnesium stearate. The coating of the tablet consists of hypromellose, titanium dioxide (E 171), Macrogol 4000, and Macrogol 6000.

Appearance of the product and contents of the package

Famvir is presented in the form of film-coated tablets.

White, oval, biconvex, beveled-edge tablet, marked with “FV 500” on one side and nothing on the other.

Each package contains 21 tablets.

Marketing Authorization Holder

Phoenix Labs

Suite 12, Bunkilla Plaza

Bracetown Business Park

Clonee, County Meath, Ireland

[email protected]

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

Responsible for manufacturing

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 authorized in the member states of the European Economic Area with the following trade names:

Last review date of this leaflet: June 2017

The detailed information of this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/