FAMCICLOVIR NORMON 250 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Famciclovir Normon 250 mg Film-Coated Tablets EFG

Famciclovir

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 further 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 their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

1. What is Famciclovir Normon and what is it used for

Famciclovir Normon film-coated tablets contain the active ingredient famciclovir. Famciclovir is an antiviral medicine. It stops the multiplication of the infecting virus. Since the virus reproduces in a very early stage of infection, you will benefit more from treatment if you start taking famciclovir after the first symptoms appear.

Famciclovir is used to treat two types of viral infections in adults:

• Herpes zoster, which is a viral infection caused by a virus called varicella-zoster (the same virus that causes chickenpox). Famciclovir stops the spread of the virus in the body, so healing occurs more quickly.
• Famciclovir is also used to treat herpes zoster in the area around the eye or even in the eye itself (herpes zoster ophthalmicus).

Genital herpes. Genital herpes is a viral infection caused by the herpes simplex virus type 1 or 2. It is usually spread by sexual contact. It causes blisters and a burning or itching sensation around the genitals, which can be painful. Famciclovir is used to treat genital herpes infections in adults. People who have frequent episodes of genital herpes can also take famciclovir to help prevent its recurrence.

2. What you need to know before you take Famciclovir Normon

• Do not take Famciclovir Normon

• if you are allergic to famciclovir, or 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).

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

Warnings and precautions

Consult your doctor before starting to take Famciclovir Normon.

• Be especially careful with Famciclovir Normon:

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

Children and adolescents (under 18 years)

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

Prevention of spreading genital herpes to others

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

• Taking Famciclovir Normon with other medicines

Tell your doctor or pharmacist if you are taking or have recently taken or might take any other medicines.

It is especially important that you tell 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 Normon with food and drink

You can take Famciclovir Normon with or without food.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before taking this medicine. Famciclovir Normon should not be used during pregnancy unless clearly necessary. Your doctor will discuss with you the potential risks of taking Famciclovir Normon during pregnancy.

Famciclovir Normon should not be used during breastfeeding unless clearly necessary. Your doctor will discuss with you the potential risks of taking Famciclovir Normon during breastfeeding.

• Driving and using machines

Famciclovir Normon may cause dizziness, drowsiness, or confusion. If you experience any of these symptoms during treatment with Famciclovir Normon, do not drive or use machines.

Famciclovir Normon contains less than 23 mg of sodium (1mmol) per tablet; this is, essentially “sodium-free”

3. How to take Famciclovir Normon

• Follow exactly the administration instructions of this medicine given by your doctor. 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 get 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 Normon. This is because you can spread 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 Normon.

Recommended dose for herpes zoster

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

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

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

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

• 500 mg, three times a day, for ten days

Recommended dose for herpes zoster ophthalmicus:

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

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

The recommended dose for genital herpes is:

The dose depends on the state 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:

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

For treating new episodesthe recommended dose is:

• 125 mg twice a day, for five days.

For preventing new episodesthe recommended dose is:

• 250 mg twice a day

Your doctor will tell 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:

• 500 mg twice a day, for seven days.

For preventing new episodesthe dose is:

• 500 mg twice a day

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

• If you take more Famciclovir Normon than you should

If you have taken more tablets than you should, or if someone else has taken your medicine by mistake, contact your doctor or hospital immediately. Show them your tablet pack.

You can also contact the Toxicology Information Service, telephone 91 562 04 20, stating the medicine and the amount taken.

Taking too much Famciclovir Normon can harm your kidneys. People with kidney problems may rarely experience kidney failure if their dose is not lowered correctly.

If you forget to take Famciclovir Normon

Do not take a double dose to make up for forgotten doses. If you forget to take a dose of Famciclovir Normon, take it as soon as you remember. Then take the next dose at the usual time. However, do not take two doses in a period of less than 1 hour, in this case skip the forgotten dose. Also, do not take an extra dose to make up for the forgotten dose.

If you have any further 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 everybody gets them.

Serious side effects:

Many of these effects are uncommon (may affect up to 1 in 100 people) or rare (may affect up to 1 in 1,000 people)

• Severe blisterson the skin and/or mucous membranes of the lips, eyes, mouth, nasal passages, or genitals (these could be signs of severe allergic skin reactions).
• Unexplained bruising, redness, or purple areas on the skin or nosebleeds(these may be signs of a decrease in the number of platelets in the blood).
• Swellingunder the skin surface (e.g., swelling in the face, around the eye, on the eyelids, and in the throat)
• Yellowing of the skin and/or eyes(signs of jaundice).

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

• Purple spots on the skin, itching, burning (signs of inflamed blood vessels).
• Seizures or epileptic fits.
• Difficulty breathing or swallowing. Rash, itching, hives, wheezing or cough, feeling faint, dizziness, changes in levels of consciousness. Low blood pressure, with or without general itching, flushing of the skin, swelling of the face/throat, blue discoloration of the lips, tongue, or skin (signs of a severe allergic reaction).

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

Very common side effects (these side effects may affect more than 1 in 10 people)

• Headache

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

• Nausea
• Vomiting
• Abdominal pain
• Diarrhea
• Dizziness
• Rash
• Itching
• Abnormal liver function test results

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

• Confusion
• Somnolence (usually in elderly people)
• Itchy rash (hives)

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

• Hallucinations (seeing or hearing things that are not real)
• Palpitations (signs of abnormal heartbeats)

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Medicines Surveillance System for Human Use www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Famciclovir Normon

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date is the last day of the month shown.
• Do not store above 30°C. Store in the original package to protect from moisture.
• Do not use this medicine if you notice that the packaging is damaged or shows signs of deterioration.
• Medicines should not be disposed of via wastewater or household waste. Return the containers and any unused medicine to a pharmacy for disposal. This will help protect the environment.

6. Contents of the pack and other information

Composition of Famciclovir Normon

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

The other ingredients are:

Core:Pregelatinized corn starch,sodium lauryl sulfate,microcrystalline cellulose (E-460),sodium croscarmellose,anhydrous colloidal silica,stearic acid.

Coating:Hypromellose (E464), titanium dioxide (E171), macrogol 4000, macrogol 6000.

Appearance of the product and contents of the pack

Famciclovir Normon 250 mg is presented in the form of white, round, biconvex film-coated tablets, scored on one side, with a diameter of approximately 10.6 mm. The tablet can be divided into two equal halves. Use the lower dose tablets when available. Each pack contains 21 tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder:

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (Spain)

Manufacturer

PharmaPath S.A.

1,28 Octovriou str., Ag. Varvara, 12351 Athens (Greece)

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6-28760 Tres Cantos- Madrid (Spain)

OTHER PRESENTATIONS

Famciclovir Normon 125 mg film-coated tablets EFG

This leaflet was approved in September 2021

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