Prospect: Information for the Patient

Famciclovir Normon 250 mg Film-Coated Tablets

Famciclovir

Read this prospect carefully before starting to take this medicine because it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.

• This medicine has been prescribed only for you and should not be given to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist even if they are not listed in this prospect..See section 4.

1. What is Famciclovir Normon and how is it used

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

3. How to take Famciclovir Normon

4. Possible adverse effects

5. Storage of Famciclovir Normon

6. Contents of the pack and additional information

Famciclovir Normon film-coated tablets contain the active ingredient famciclovir. Famciclovir 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 treatment if you start taking famciclovir after the appearance of the first symptoms.

Famciclovir 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 stops the virus from spreading in the body, resulting in faster recovery.
• Famciclovir is also used in the treatment of herpes zoster in the area around the eye or even in the eye itself (ocular 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 is used to treat genital herpes infections in adults.People who have frequent episodes of genital herpes may also take famciclovir to help prevent its recurrence.

• Do not take Famciclovir Normon

-if you are allergic to famciclovir, to any of the other components of this medicine (listed in section 6), or to penciclovir (active metabolite of famciclovir and ingredient of some other medicine).

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 any 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 body's immune system.
• If you have liver problems.

If any of these affect 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 genital herpes transmission 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, using condoms. This is important to avoid infecting others. Do not have sex if you have pain or blisters in your genitals.

• Taking Famciclovir Normon with other medicines

Inform your doctor or pharmacist if you are taking or have recently taken or may need to take any other medicine.

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

• 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).

Taking Famciclovir Normon with food and drinks

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 plan to become pregnant, consult your doctor before taking this medicine. Famciclovir Normon should not be used during pregnancy unless clearly necessary. Your doctor will discuss the potential risks of taking Famciclovir Normon during pregnancy with you.

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

• Driving and operating machines

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

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

• Follow exactly the administration instructions for 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..

-For 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 Normon. This is because you may infect your partner with genital herpes.

- If you have or have had kidney problems, your doctor may decide to give you a lower dose of Famciclovir Normon.

Recommended dose for shingles

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

If you have anormal immune system, the recommended dose is

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

If you have aweakened immune system, the recommended dose is

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

Recommended dose for ocular shingles:

If you have anormal 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 your immune system status and the phase of your infection.

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

For thefirst episode,the recommended dose is:

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

Fortreatment of new episodesthe recommended dose is:

- 125 mg two times a day, for five days.

Forprevention of new episodesthe recommended dose is:

• 250mg 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:

- 500 mg two times a day, for seven days.

Forprevention of new episodesthe dose is:

• 500mg two times a day

Your doctor will inform you for 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 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 Normon 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 Normon

Do not take a double dose to make up for the missed doses. If you forgot to take the dose of Famciclovir Normon, you should 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 make up for the missed dose.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

Severe side effects:

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

• Severe blisterson the skin and/or mucous membranes of the lips, eyes, mouth, nostrils, or genitals (these may be signs of severe allergic skin reactions).
• Unexplained appearance of bruises, redness, or purple areas on the skin or hemorrhages in the nose(these may be signs of a decrease in platelet count in the blood).
• Swellingunder the skin's surface (for example, swelling in the face, around the eye, on the eyelids, and in the throat)
• Yellowish discoloration of the skin and/or eyes(signs of jaundice).

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

-Blue or purple spots on the skin, itching, burning (signs of inflamed blood vessels).

-Convulsions or epileptic seizures.

-Difficulty breathing or swallowing. Rash, itching, urticaria, wheezing, or cough, feeling of fainting, dizziness, changes in levels of consciousness. Hypotension, with or without generalized itching, facial flushing/throat swelling, blue discoloration of the lips, tongue, or skin (signs of severe allergic reaction).

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

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

- Headache

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

- 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 patients)

- ConfusionSomnolence (usually in older people)

- Rash with itching (urticaria)

Rare side effects(these side 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 side effects

If you experience any type of side effect, consult yourdoctor, even if it is apossible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System of Pharmacovigilance of Medicines for Human Usewww.notificaRAM.es.By reporting side effects, you cancontribute toproviding moreinformation 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 humidity.
• 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 trash. Dispose of 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 unused packaging and medications. By doing so, you will help protect the environment.

Composition of Famciclovir Normon

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

The other components are:

Core:Pre-gelatinized cornstarch,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 packaging

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

Holder of the marketing authorization and responsible manufacturer

Holder of the marketing authorization:

LABORATORIOS NORMON, S.A.

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

Responsible 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

This prospectus was approved in September2021

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