FAMCICLOVIR PENSA

PACKAGE LEAFLET: INFORMATION FOR THE USER

Famciclovir Pensa 250 mg film-coated tablets, 500 mg film-coated tablets

Equivalent medicine
Please read this leaflet carefully before using this medicine as 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 effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. WHAT FAMCICLOVIR PENSA IS AND WHAT IT IS USED FOR

Famciclovir Pensa is an antiviral medicine. It works by blocking the replication of viruses that cause infection.
Since viruses replicate very early in the course of an infection, you will obtain the greatest benefit by taking Famciclovir Pensa as soon as the first symptoms appear.
Famciclovir Pensa 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 Pensa prevents the virus from spreading in the body, allowing faster healing.
• Famciclovir Pensa is also used for the treatment of herpes zoster affecting the area around the eye or 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 around the genitals, which may be painful. Famciclovir Pensa is used to treat genital herpes infections in adults. Patients who experience frequent episodes of genital herpes may also take Famciclovir Pensa to help prevent recurrences.

2. WHAT YOU SHOULD KNOW BEFORE TAKING FAMCICLOVIR PENSA

Do not take Famciclovir Pensa

• If you are allergic (hypersensitive) to famciclovir, to any of the excipients in Famciclovir Pensa listed in section 6, or to penciclovir (the active metabolite of famciclovir and a component of some other medicines). Consult your doctor if you think you may be allergic.

Warnings and precautions
Talk to your doctor or pharmacist before taking Famciclovir Pensa:

• If you have kidney problems (or have had them in the past). Your doctor may decide to prescribe a lower dose of Famciclovir Pensa.
• 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 Famciclovir Pensa.

Children and adolescents (under 18 years of age)
The use of Famciclovir Pensa is not recommended in children and adolescents.
Prevention of transmission of genital herpes to other individuals
If you are taking Famciclovir Pensa for the treatment or suppression of genital herpes, or if you have previously suffered from genital herpes, you should continue to have protected sexual intercourse 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.

Other medicines and Famciclovir Pensa
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.

Famciclovir Pensa with food and drinks
Famciclovir Pensa 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 are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine. Famciclovir Pensa must not be used during pregnancy unless clearly necessary. Your doctor will discuss with you the potential risks associated with taking Famciclovir Pensa during pregnancy.
Famciclovir Pensa must not be used during breastfeeding unless clearly necessary. Your doctor will discuss with you the possible risks associated with taking Famciclovir Pensa during breastfeeding. Discontinuation of breastfeeding may need to be considered.
Driving and using machines
Famciclovir Pensa may cause dizziness, drowsiness, or confusion. Do not drive or operate machinery if you experience any of these symptoms while taking Famciclovir Pensa.
Famciclovir Pensa contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e., essentially ‘sodium-free’.

3. HOW TO TAKE FAMCICLOVIR PENSA

Take this medicine exactly as directed 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.
• For 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 Famciclovir Pensa. 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 Famciclovir Pensa.
• If you are undergoing hemodialysis, Famciclovir Pensa should be administered immediately after dialysis.

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 first outbreak, the recommended dose is:

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

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

• 125 mg (half a 250 mg tablet) 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 reduced, 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 Famciclovir Pensa than you should
If you have taken more tablets than prescribed, 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 Famciclovir Pensa can impair kidney function. In patients who already have kidney problems, failure to appropriately reduce the dose may rarely lead to renal failure.
If you forget to take Famciclovir Pensa
If you forget to take a dose of Famciclovir Pensa, 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, skip the missed dose. Also, do not take a double dose to make up for a missed dose.
If you stop taking Famciclovir Pensa
Do not stop taking Famciclovir Pensa without first consulting your doctor.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
Serious adverse reactions with Famciclovir Pensa are:
Most of these adverse reactions are rare or uncommon (may occur in 1 to 100 patients out of 10,000 patients).

• 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; see frequency below).
• Unexplained bruising, reddish or purplish spots on the skin, or nosebleeds (these could be signs of a reduced platelet count; see frequency below).
  • 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 adverse reactions is unknown (the 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, swelling of the face and throat, 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 adverse reactions.
Very common adverse reactions (these affect more than 1 in 10 people):

• Headache

Common adverse reactions (these affect up to 1 in 10 people):

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

Uncommon adverse reactions (these affect up to 1 in 100 people):

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

Rare adverse reactions (these affect up to 1 in 1,000 people):

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

If any of the adverse reactions worsen, or if you notice any adverse reaction not listed in this leaflet, inform your doctor or pharmacist.
Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, consult your doctor or pharmacist. You may also report adverse reactions directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. HOW TO STORE FAMCICLOVIR PENSA

Keep this medicine out of the sight and reach of children.
Do not store above 30°C.
Store in the original packaging to protect from moisture.
Do not use Famciclovir Pensa if you notice that the packaging is damaged or shows signs of tampering.
Do not use Famciclovir Pensa after the expiry date stated on the label after Exp.. The expiry date refers to the last day of the month. 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. PACK CONTENTS AND OTHER INFORMATION

What Famciclovir Pensa contains
The active substance is famciclovir.
250 mg tablets: each tablet contains 250 mg of famciclovir.
500 mg tablets: each tablet contains 500 mg of famciclovir.
The excipients are:
Tablet core: pregelatinized starch, sodium lauryl sulfate, microcrystalline cellulose,
sodium croscarmellose, anhydrous colloidal silica, stearic acid.
Coating: hypromellose (E464), titanium dioxide (E171), macrogol 4000, macrogol 6000.

Description of the appearance of Famciclovir Pensa and pack contents
250 mg film-coated tablets: white, round, biconvex, film-coated tablets with a breakline on one side, approximately 10.6 mm in diameter.
500 mg film-coated tablets: white, oval, film-coated tablets with a breakline on both sides, approximately 18.2 x 8.6 mm in size.
250 mg and 500 mg film-coated tablets: the tablet can be divided into two equal parts.
Use the tablet with the lower dose, if available.
250 mg: 21 tablets
500 mg: 21 tablets
Not all pack sizes may be marketed.

Marketing Authorization Holder
Pensa Pharma S.p.A.
Via Ippolito Rosellini, 12
20124 Milano, Italy

Responsible manufacturer for batch release
Specifar S.A.
1, 28 Octovriou str., Ag. Varvara, 12351
Athens, Greece

This medicinal product is authorized in the European Economic Area countries under the
following names:
IT: Famciclovir Pensa 250 mg & 500 mg film-coated tablets

This leaflet was last approved on