Vilacir

PACKAGE LEAFLET: INFORMATION FOR THE USER

Vilacir 500 mg film-coated tablets

Famciclovir
Generic medicine
Please read this leaflet carefully before 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, because it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Vilacir is and what it is used for

Vilacir is an antiviral medicine. It prevents the infecting virus from reproducing. Since the virus begins to replicate immediately at the onset of infection, you will achieve better treatment outcomes if you take Vilacir as soon as the first symptoms appear.
Vilacir 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). Vilacir prevents the virus from spreading in the body, allowing faster healing.
• Vilacir is also used to treat infections 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 usually transmitted sexually. It causes blisters and burning or itching in the genital area, which may be painful. Vilacir is used for the treatment of genital herpes infections in adults. Individuals who experience frequent episodes of genital herpes may also take Vilacir to try to prevent new episodes.

2. What you need to know before taking Vilacir

Do not take Vilacir

• 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 Vilacir

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

Children and adolescents (under 18 years of age)
The use of Vilacir is not recommended in children and adolescents.
Prevention of transmission of genital herpes to other individuals
If you are taking Vilacir for the treatment or suppression of genital herpes, or if you have previously had genital herpes, you should continue to practice protected sex by using a condom.
This is important to prevent transmission of the infection to others. You must not have sexual intercourse if you have genital blisters or sores.
Other medicines and Vilacir
Tell 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.

Vilacir with food and drink
Vilacir can be taken with or without food.
Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, ask your doctor for advice before taking this medicine. Vilacir must not be used during pregnancy unless strictly necessary. Your doctor will discuss with you the potential risks of taking Vilacir during pregnancy.
Vilacir must not be used during breastfeeding unless strictly necessary. Your doctor will discuss with you the possible risks of taking Vilacir while breastfeeding.
Driving and using machines
Vilacir may cause dizziness, drowsiness or confusion. Do not drive or operate machinery if you experience any of these symptoms while taking Vilacir.

3. How to take Vilacir

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

• The daily dose and duration of treatment 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 have symptoms of genital herpes – even if you have already started treatment with Vilacir. 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 Vilacir.

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 weakened, 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 first outbreak, the recommended dose is:

• 250 mg three times a day, for five days.

For the treatment of further outbreaks, the recommended dose is:

• 125 mg twice a day, for five days.

For the prevention of future outbreaks, 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 weakened, the doses are as follows:
For the treatment of the current outbreak, the recommended dose is:

• 500 mg twice a day, for seven days.

For the prevention of future outbreaks, 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 Vilacir 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 Vilacir can impair kidney function. In patients who already have kidney problems, failure to appropriately reduce the dose may rarely lead to kidney failure.
If you forget to take Vilacir
If you forget to take a dose of Vilacir, take it as soon as you remember. Then take the next dose at the usual time. However, do not take two doses within less than 1 hour of each other: in this case, you should skip the missed dose. Also, do not take a double dose to make up for a forgotten dose.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
Serious side effects of Vilacir include:
Most of these side effects are rare or uncommon (occurring in 1–100 patients per 10,000)

• Severe blistering rash on the skin or mucous membranes of the lips, eyes, mouth, nasal cavity, or genitals (these could be signs of a severe skin allergic reaction).
• Unexplained bruising, reddish or purplish spots on the skin, or nosebleeds (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 (cannot be estimated from available data):

• Purple skin spots, itching, burning sensation (signs of blood vessel inflammation).
• Seizures or epileptic fits.
• Difficulty breathing or swallowing. Skin rash, itching, hives, breathing difficulties or cough, sensation of emptiness in the head, dizziness, altered 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 really 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 https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Vilacir

• 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 use this medicine if you notice that the packaging is damaged or shows signs of tampering.
• Store this medicine at a temperature not exceeding 30°C.
• Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Other information

What Vilacir contains
The active substance is Famciclovir.
Each tablet contains 500 mg of famciclovir.
The other components are: Hydroxypropyl cellulose, Sodium starch glycollate, Magnesium stearate, Microcrystalline cellulose 101, Microcrystalline cellulose 102 (coating: Hypromellose, Titanium dioxide BP, Polyethylene glycol 400).

Description of the appearance of Vilacir and contents of the pack
Film-coated tablets.
Vilacir tablets are film-coated, round, biconvex, white in colour.
Vilacir is available in packs containing 21 tablets.

Marketing Authorization Holder
Genetic S.p.A., Via Della Monica n. 26, 84083 Castel San Giorgio (SA)

Manufacturer:
Genetic S.p.A. – Contrada Canfora – 84084 Fisciano (SA)

This patient information leaflet was last approved on