Famvir

Package leaflet: Information for the user

Famvir 125 mg film-coated tablets, 250 mg film-coated tablets, 500 mg film-coated tablets

Famciclovir
Please 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including any not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Famvir is and what it is used for

Famvir is an antiviral medicine. It prevents the infecting virus from reproducing. Since the virus begins to reproduce immediately at the onset of infection, you will achieve better treatment results if you take Famvir as soon as the first symptoms appear.
Famvir is used in adults to treat two types of viral infections:

• Herpes zoster, which is a viral infection caused by a virus called varicella zoster (the same virus that causes chickenpox). Famvir prevents the virus from spreading in the body, allowing faster healing.
• Famvir is also used to treat infections around or within the eye (ophthalmic zoster).
• Genital herpes. Genital herpes is a viral infection caused by herpes simplex virus type 1 or 2. It is usually transmitted sexually. It causes blisters and burning or itching in the genital area, which can be painful. Famvir is used for the treatment of genital herpes infections in adults. Individuals who experience frequent episodes of genital herpes may also take Famvir to try to prevent new episodes.

2. What you need to know before taking Famvir

Do not take Famvir

• If you are allergic to famciclovir, to 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). Consult your doctor if you think you may be allergic.

Warnings and precautions
Talk to your doctor before taking Famvir

• If you have kidney problems (or have had them in the past). Your doctor may decide to prescribe a lower dose of Famvir.
• If you have any disorders of the immune system.
• If you have liver problems. If any of these conditions apply to you, consult your doctor before taking Famvir.

Children and adolescents (under 18 years of age)
The use of Famvir is not recommended in children and adolescents.
Prevention of transmission of genital herpes to other individuals
If you are taking Famvir for the treatment or suppression of genital herpes, or if you have previously had genital herpes, you should continue to use barrier protection such as condoms during sexual intercourse.
This is important to prevent transmission of the infection to others. You should not have sexual intercourse if you have genital blisters.

Other medicines and Famvir
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those not requiring a prescription.
It is particularly important that you inform 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 antibiotics such as penicillin), or any other medicine that may damage the kidneys.

Famvir with food and drink
Famvir can be taken with or without food.
Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, planning a pregnancy, or are breastfeeding, consult your doctor before taking this medicine. Famvir must not be used during pregnancy unless clearly necessary. Your doctor will discuss with you the potential risks of taking Famvir during pregnancy.
Famvir must not be used during breastfeeding unless clearly necessary. Your doctor will discuss with you the possible risks of taking Famvir while breastfeeding.
Driving and using machines
Famvir may cause dizziness, drowsiness, or confusion. Do not drive or operate machinery if you experience any of these symptoms while taking Famvir.
Famvir 125 mg film-coated tablets contain lactose
If your doctor has informed you that you have an intolerance to certain sugars, such as lactose, consult your doctor before taking this medicine.
Famvir 250 mg film-coated tablets contain lactose
If your doctor has informed you that you have an intolerance to certain sugars, such as lactose, consult your doctor before taking this medicine.

3. How to take Famvir

Take this medicine exactly as instructed by your doctor. If you have any doubts, consult your doctor or pharmacist.

• 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 achieve the best results, start taking the medicine as soon as possible after the first signs and symptoms appear.
• Avoid sexual contact if you are experiencing symptoms of genital herpes – even if you have already started treatment with Famvir. This is because you could transmit the infection to your partner.
• 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 your immune defenses are reduced, the recommended dose is 500 mg three times a day for ten days.

Dose for genital herpes
The dose depends on the condition of your immune system and the stage of the infection.
If you have a normal immune system, the doses are as follows:
For the initial episode, the recommended dose is 250 mg three times a day for five days.
For the treatment of subsequent episodes, the recommended dose is 125 mg twice a day for five days.
For the prevention of future episodes, the recommended dose is 250 mg twice a day.
Your doctor will tell you how long you should continue taking the tablets.

If your immune defenses are reduced, the doses are as follows:
For the treatment of the current episode, the recommended dose is 500 mg twice a day for seven days.
For the prevention of future episodes, the dose is 500 mg twice a day.
Your doctor will tell you how long you should continue taking the tablets.

If you take more Famvir than you should
If you have taken more tablets than you were told to take, or if someone else has accidentally taken your medicine, contact your doctor or go to a hospital immediately. Show them your tablet pack.
Taking too much Famvir can affect the kidneys. In patients who already have kidney problems, failure to appropriately reduce the dose may rarely lead to kidney failure.

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 scheduled time. However, do not take two doses within less than 1 hour of each other: in this case, you should skip the dose you missed. Also, do not take a double dose to make up for a forgotten dose.

If you have any 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 everyone experiences them.
Serious side effects of Famvir include:
Most of these side effects are rare or uncommon (occurring in 1 to 100 patients out of 10,000).

• Severe blistering rash on the skin or mucous membranes of the lips, eyes, mouth, nasal passages, or genitals (these could be signs of a severe skin allergic reaction).
• Unexplained bruising, reddish or purplish spots on the skin, or bleeding from the nose (these could be signs of a reduced platelet count).
• Swelling beneath the skin surface (e.g. facial swelling, swelling around the eye, eyelid swelling, throat swelling).
• Yellowing of the skin and/or eyes (signs of jaundice).

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

• Purple skin spots, itching, burning (signs of inflammation of blood vessels).
• Seizures or epileptic fits.
• Difficulty breathing or swallowing. Skin rash, itching, hives, breathing difficulties or cough, feeling of emptiness in the head, dizziness, altered state of consciousness. Hypotension, with or without generalized itching, skin redness, facial and throat swelling, bluish discoloration of the lips, tongue, or skin (signs of a severe allergic reaction).

Contact a doctor or go to the nearest hospital emergency department if you experience any of
these side effects.
Very common side effects (these side effects affect more than 1 in 10 people)

• Headache

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

• Feeling unwell (nausea)
• Vomiting
• Abdominal pain
• Diarrhea
• Dizziness
• Skin rash
• Itching
• Abnormal liver function test results

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

• Confusion
• Drowsiness (usually in elderly patients)
• Itchy skin rash (urticaria)

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

• Hallucinations (seeing or hearing things that are not actually present)
• Palpitations (signs of abnormal heartbeat)

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Famvir

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date stated on the label after "Exp.". The expiry date refers to the last day of that month.
• Do not store above 25°C.
• Store in the original packaging to protect the medicine from moisture.
• Do not use this medicine if you notice that the packaging is damaged or shows signs of tampering.
• Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. OTHER INFORMATION

What Famvir contains
Famvir 125 mg film-coated tablets

• The active substance is famciclovir.
• The other components are anhydrous lactose, sodium starch glycolate (type A), hydroxypropylcellulose and magnesium stearate. The tablet coating consists of hypromellose, titanium dioxide (E171), Macrogol 4000 and Macrogol 6000.

Famvir 250 mg film-coated tablets

• The active substance is famciclovir.
• The other components are anhydrous lactose, sodium starch glycolate (type A), hydroxypropylcellulose and magnesium stearate. The tablet coating consists of hypromellose, titanium dioxide (E171), Macrogol 4000 and Macrogol 6000.

Famvir 500 mg film-coated tablets

• The active substance is famciclovir.
• The other components are sodium starch glycolate (type A), hydroxypropylcellulose and magnesium stearate. The tablet coating consists of hypromellose, titanium dioxide (E171), Macrogol 4000 and Macrogol 6000.

Description of the appearance of Famvir and contents of the pack
Famvir is available as film-coated tablets.
Famvir 125 mg film-coated tablets
White, round, biconvex, film-coated tablet with bevelled edges, marked with
“FV” on one side and “125” on the other side.
Famvir 250 mg film-coated tablets
White, round, biconvex, film-coated tablet with bevelled edges, marked with
“FV” on one side and “250” on the other side.
Famvir 500 mg film-coated tablets
White, oval, biconvex, film-coated tablet with bevelled edges, marked with “FV 500” on one side only.

Marketing Authorisation Holder
Phoenix Labs
Suite 12, Bunkilla Plaza
Bracetown Business Park
Clonee, Co. Meath
Ireland

Manufacturer
Novartis Farma S.p.A.
Via Provinciale Schito 131
80058 Torre Annunziata (NA)
Italy
Novartis Farma S.p.A.
Largo Umberto Boccioni 1
21040 Origgio VA
Italy
Laboratori Fundació DAU
Pol. Ind. Consorci Zona Franca. c/ C, 12-14
08040 Barcelona
Spain

This medicinal product is authorised in the European Economic Area countries with the following names:
Austria Famvir
Cyprus Famvir
Denmark Famvir
Finland Famvir
France Oravir
Germany Famvir / Famvir Zoster / Famciclovir Sandoz / Famciclovir SB
Greece Famvir
Iceland Famvir
Ireland Famvir
Italy Famvir / Famciclovir Sandoz
Luxembourg Famvir / Famvir Zoster
Malta Famvir
Netherlands Famvir
United Kingdom Famvir
Spain Famvir
Sweden Famvir
Hungary Famvir

This summary of product characteristics was last approved on