Package Insert: Information for the User

Famciclovir 125 mg Film-Coated Tablets

Read this package insert carefully before taking this medicine, because

it contains important information for you.

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

Famciclovir Pensa 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 Famciclovir Pensa after the appearance of the first symptoms.

Famciclovir Pensa is used for the treatment of 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). Famciclovir Pensa stops the expansion of the virus in the body, so healing occurs more quickly.
• Famciclovir Pensa is also used in the treatment of 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. Famciclovir Pensa is used to treat genital herpes infections in adults. People who have frequent episodes of genital herpes may also take Famciclovir Pensa to help prevent its recurrence.

Do not take Famciclovir Pensa

• if you are allergic (hypersensitive) to famciclovir, to any of the other components of Famciclovir Pensa described in section 6, or to penciclovir (active metabolite of famciclovir and ingredient of some other medication).

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

Be especially careful with Famciclovir Pensa

• If you have any kidney disease (or have had it in the past). Your doctor may decide to give you a lower dose of Famciclovir Pensa.
• 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 Famciclovir Pensa.

Children and adolescents (under 18 years)

Famciclovir Pensa is not recommended for use in children and adolescents.

Preventing the spread of genital herpes to others

If you are taking Famciclovir Pensa 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 infecting others. Do not have sex if you have pain or blisters on your genitals.

Using Famciclovir Pensa with other medications

Inform your doctor or pharmacist if you are using or have recently used other medications, including those purchased without a prescription.

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

• 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 medications that may affect your kidneys.

Taking Famciclovir Pensa with food and drinks

You can take Famciclovir Pensa with or without food.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

If you are pregnant or think you may be, consult your doctor. Famciclovir Pensa should not be used during pregnancy unless clearly necessary. Your doctor will discuss the potential risks of taking Famciclovir Pensa during pregnancy with you.

Consult your doctor if you are breastfeeding. Famciclovir Pensa should not be used during breastfeeding unless clearly necessary. Your doctor will discuss the potential risks of taking Famciclovir Pensa during breastfeeding with you.

Driving and operating machinery

Famciclovir Pensa may cause dizziness, drowsiness, or confusion. If you experience any of these symptoms during treatment with Famciclovir Pensado not drive or operate machinery.

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 Famciclovir Pensa. This is because you may infect your partner with the herpes virus.
• If you have or have had kidney problems, your doctor may decide to give you a lower dose of Famciclovir Pensa.

Dose for shingles

If you have anormal immune system, the recommended dose is

• one 500 mg tablet, three times a day, for seven days

If you have aweakened immune system, the recommended dose is

• one 500 mg tablet, 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:

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

Fortreatment of new episodesthe recommended dose is:

• one 125 mg tablet, two times a day, for five days.

Forprevention of new episodesthe recommended dose is:

• one 250 mg tablet, 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:

Fortreatment of the current episode,the recommended dose is:

• one 500 mg tablet, two times a day, for seven days.

Forprevention of new episodesthe dose is:

• one 500 mg tablet, two times a day

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

If you take more Famciclovir Pensa than you should

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

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

If you forgot to take Famciclovir Pensa

If you forgot to take your Famciclovir Pensa dose, 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, Famciclovir Pensa can cause side effects, although not everyone will experience them. The side effects caused by Famciclovir Pensa are usually mild to moderate in intensity.

Severe side effects of Famciclovir Pensa:

Most of these side effects are rare or uncommon (affect between 1 and 100 of every 10,000 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, see frequency below).
• 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, see frequency below).
• Swelling under the skin's surface(for example, swelling around the eyes, swelling of the eyelids, inflammation of the throat).
• Yellow discoloration of the skin and/or eyes(signs of jaundice).

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

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

• Headache

Common side effects(can affect between 1 and 10 in every 100 patients)

• Nausea
• Vomiting
• Dizziness
• Drowsiness
• Rash
• Itching
• Abnormal liver function test results

Uncommon side effects(can affect between 1 and 10 in every 1,000 patients)

• Confusion
• Severe skin reactions

Rare side effects(can affect between 1 and 10 in every 10,000 patients)

• Hallucinations (seeing or hearing things that are not real)
• Yellow discoloration of the skin and/or eyes
• Low platelet count

If you consider that any of the side effects you are experiencing are severe or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist.

Reporting side effects:

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:https://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 at a temperature above 30°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 in the trash. Deposit the packaging 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 packaging and medications you no longer need. In this way, you will help protect the environment.

Composition of Famciclovir Pensa

The active ingredient is famciclovir. Each tablet contains 125 mg of famciclovir.

The other components are:Core:pregelatinized cornstarch, sodium lauryl sulfate, microcrystalline cellulose, sodium croscarmellose, anhydrous colloidal silica, stearic acid.Coating:hypromellose (E464), titanium dioxide (E171), macrogol 4000, macrogol 6000.

Appearance of Famciclovir Pensa and content of the packaging

Famciclovir Pensa 125 mg is presented in the form of film-coated tablets, white, round, biconvex, with a diameter approximately of 7.6 mm.

Each package contains 10 tablets.

Marketing Authorization Holder

Towa Pharmaceutical, S.A.

C/ de Sant Martí, 75-97

08107 Martorelles (Barcelona)

Spain

Responsible for Manufacturing

PharmaPath S.A.

28is Oktovriou 1, AgiaVarvara,

123 51,Greece

This leaflet was approved in December 2013

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