Famciclovir Normon 125 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Famciclovir Normon 125 mg film-coated tablets EFG

Famciclovir

Read the entire leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, as you may need to read it again. If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you personally and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if such effects are not listed in this leaflet. See section 4.

Contents of the leaflet

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

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

Famciclovir Normon film-coated tablets contain the active substance famciclovir. Famciclovir is an antiviral medicine. It stops the replication of the infecting virus. Since the virus replicates at a very early stage of infection, you will benefit most from treatment if you start taking famciclovir as soon as the first symptoms appear.

Famciclovir is used to treat 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 stops the spread of the virus in the body, leading to faster healing.
• Famciclovir is also used to treat 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 may be painful. Famciclovir is used to treat genital herpes infections in adults. Individuals who experience frequent episodes of genital herpes may also take famciclovir to help prevent recurrences.

2. What you need to know before taking Famciclovir Normon

Do not take Famciclovir Normon

• if you are allergic to famciclovir, or to any of the other components 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:

• If you have any kidney disease (or have had it previously). Your doctor may decide to give you a lower dose of famciclovir.
• If you have problems with your body's 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 of age)

The use of Famciclovir Normon is not recommended in children and adolescents.

Preventing transmission of 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 should practice safe sex by using condoms. This is important to help prevent spreading the infection to others. You should avoid sexual activity if you have pain or blisters in the genital area.

Taking Famciclovir Normon with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

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 Normon with food and drinks

You may take Famciclovir Normon with or without food.

Pregnancy, breast-feeding, and fertility

Pregnancy

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to become pregnant, consult your doctor before using 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 breast-feeding unless clearly necessary. Your doctor will discuss with you the potential risks of taking Famciclovir Normon while breast-feeding.

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 operate machinery.

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

3. How to take Famciclovir Normon

• Follow exactly the instructions given by your doctor for taking this medicine. If in doubt, 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 Normon. 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 Normon.

Recommended dose for herpes zoster

The dose depends on the status 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 ophthalmic zoster:

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

• 500 mg three times a day for seven days

Recommended dose 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 250 mg three times a day for five days.

• To treat new episodes, the recommended dose is 125 mg twice a day for five days.

• To prevent new episodes, the recommended dose is 250 mg 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:

• To treat the current episode, the recommended dose is 500 mg twice a day for seven days.

• To prevent new episodes, the dose is 500 mg twice a day.

Your doctor will inform 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 anyone 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 telephone number 91 562 04 20, indicating the medicine and the amount taken.

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

• 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 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, this medicine can cause adverse effects, although not everyone will experience them.

Serious adverse effects:

Many of these effects are uncommon (may affect up to 1 in 100 patients) or rare (may affect up to 1 in 1,000 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).
• Unexplained bruising, redness, or purple-coloured areas on the skin or nosebleeds (these may be signs of a decrease in the number of platelets in the blood).
• Swelling beneath the skin surface (e.g., swelling of the face, around the eyes, eyelids, or throat).
• Yellowing of the skin and/or eyes (signs of jaundice).

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

• Purple spots on the skin, itching, burning sensation (signs of inflamed blood vessels).
• Seizures or epileptic fits.
• Difficulty breathing or swallowing. Rash, itching, hives, wheezing or coughing, feeling faint, dizziness, changes in consciousness level. Hypotension, with or without generalized itching, skin redness, facial or throat swelling, bluish discoloration of the lips, tongue, or skin (signs of a severe allergic reaction).

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 up to 1 in 10 patients):

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

Uncommon adverse effects (may affect up to 1 in 100 patients):

• Confusion
• Drowsiness (usually in elderly people)
• Itchy rash (urticaria)

Rare adverse effects (may affect up to 1 in 1,000 patients):

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

Reporting of adverse effects

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

5. Storage of Famciclovir Normon

• Keep this medicine out of 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. Keep in the original packaging 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 a SIGRE point at your pharmacy. If in doubt, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Famciclovir Normon

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

The other components are:

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

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

Appearance of the product and contents of the pack

Famciclovir Normon 125 mg is presented as white, round, biconvex film-coated tablets with a diameter of approximately 7.6 mm. Each pack contains 10 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 250 mg film-coated tablets EFG

This leaflet was approved in September 2021

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