Famciclovir Pensa 250 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Famciclovir Pensa 250 mg film-coated tablets EFG

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 pass it on to others. It may harm them even if they have the same symptoms as you.
• If you get any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the 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 stops the replication of the infecting virus. Since the virus replicates in a very early stage of infection, you will benefit most from treatment if you start taking Famciclovir Pensa as soon as the first symptoms appear.

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 spread of the virus in the body, leading to faster healing.
• Famciclovir Pensa is also used in the treatment of herpes zoster affecting the area around the eye or even 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 recurrences.

2. What you need to know before starting to take Famciclovir Pensa

Do not take Famciclovir Pensa

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

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

Take special care with Famciclovir Pensa

• If you have kidney disease (or have had it previously). Your doctor may decide to give you a lower dose of Famciclovir Pensa.
• If you have problems with your immune system.
• If you have liver problems.

If any of these 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.

Preventing the spread of genital herpes to other people

If you are taking Famciclovir Pensa to treat or suppress genital herpes, or if you have had genital herpes in the past, you should practice safe sex by using condoms. This is important to help prevent spreading the infection to others. You should not have sex if you have pain or blisters in the genital area.

Taking Famciclovir Pensa with other medicines

Inform your doctor or pharmacist if you are taking or have recently taken any other medicines, including those obtained without a prescription.

It is especially 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 levels of uric acid associated with gout and to increase blood levels of penicillin-type antibiotics) or other medicines that may affect your kidneys.

Taking Famciclovir Pensa with food and drink

You may take Famciclovir Pensa with or without food.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

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

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

Driving and using machines

Famciclovir Pensa may cause dizziness, drowsiness, or confusion. If you experience any of these symptoms while being treated with Famciclovir Pensa, do not drive or operate machinery.

3. How to take Famciclovir Pensa

Follow exactly the instructions given by your doctor for taking this medicine. If you are unsure, consult your doctor or pharmacist again.

• 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 the first signs and symptoms appear.
• Do not have sexual intercourse with anyone if you have symptoms of genital herpes – even if you have started treatment with Famciclovir Pensa. This is because you may transmit the herpes 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.

Dosage for herpes zoster

If you have a normal immune system, the recommended dose is:

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

If you have a weakened immune system, the recommended dose is:

• one 500 mg tablet three times a day for ten days.

Dosage for genital herpes:

The dose depends on the status of your immune system and the stage of your infection.

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

For the first episode, the recommended dose is:

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

For treating new episodes, the recommended dose is:

• one 125 mg tablet twice a day for five days.

For preventing new episodes, the recommended dose is:

• one 250 mg tablet twice a day.

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

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

For treating the current episode, the recommended dose is:

• one 500 mg tablet twice a day for seven days.

For preventing new episodes, the dose is:

• one 500 mg tablet twice a day.

Your doctor will inform you 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 someone else has accidentally taken your medicine, go immediately to your doctor or hospital. Show them your tablet pack. You may also call the Toxicology Information Service at 91 562 04 20, stating the medicine and the amount taken.

Taking too much Famciclovir Pensa may damage your kidneys. People with kidney problems may rarely develop kidney failure if their dose is not appropriately reduced.

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 scheduled time. However, do not take two doses within less than 1 hour; in that case, skip the missed dose. Also, do not take a double dose to make up for a missed dose.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, Famciclovir Pensa may cause adverse effects, although not everyone experiences them. The adverse effects caused by Famciclovir Pensa are usually mild to moderate in intensity.

Serious adverse effects of Famciclovir Pensa:

Most of these adverse effects are rare or uncommon (affect between 1 and 100 out of every 10,000 patients):

• Severe blisters on the skin and/or mucous membranes of the lips, eyes, mouth, nostrils, or genitals (these could be signs of serious allergic skin reactions; see frequency details below).
• Unexplained appearance of bruises, redness, or purple-colored areas on the skin, or nosebleeds (these may be signs of a decreased platelet count in the blood; see frequency details below).
• Swelling beneath the skin surface (for example, facial swelling around the eyes, eyelid swelling, throat inflammation).
• Yellowing of the skin and/or eyes (signs of jaundice).

If you notice any of these adverse effects, contact a doctor immediately or go to the nearest emergency department.

Very common adverse effects (may affect more than 1 in 10 patients):

• Headache

Common adverse effects (may affect between 1 and 10 in every 100 patients):

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

Uncommon adverse effects (may affect between 1 and 10 in every 1,000 patients):

• Confusion
• Severe skin reactions

Rare adverse effects (may affect between 1 and 10 in every 10,000 patients):

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

If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effect not mentioned in this leaflet, inform your doctor or pharmacist.

Reporting of adverse effects:

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Famciclovir Pensa

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.
• Do not store above 30°C. Store in the original container to protect from moisture.
• Do not use this medicine if you notice that the packaging is damaged or shows signs of deterioration.
• Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE point in your pharmacy. If in doubt, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

The active substance is famciclovir. Each tablet contains 250 mg of famciclovir.

The other components are: Core: pregelatinized corn starch, 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 contents of the pack

Famciclovir Pensa 250 mg is presented as white, round, biconvex, film-coated tablets, scored on one side, with a diameter of approximately 10.6 mm. Each pack contains 21 tablets.

The tablet may be divided into two equal parts. Use tablets with the lowest available dose strength whenever possible.

Marketing Authorization Holder

Towa Pharmaceutical, S.A.

C/ de Sant Martí, 75-97

08107 Martorelles (Barcelona)

Spain

Manufacturer

PharmaPath S.A.

28is Oktovriou 1, Agia Varvara,

123 51, Greece

This patient information leaflet was approved in December 2013

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/