Package Insert: Information for the Patient

Famciclovir Normon 125 mg Film-Coated Tablets EFG

Famciclovir

Read this package insert carefully before starting to take 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 personally 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 side effects, consult your doctor or pharmacist, even if they are not listed in this package insert. 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 side effects

5. Storage of Famciclovir Normon

6. Contents of the package and additional informationl

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 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 virus from spreading in the body, resulting in faster recovery.
• Famciclovir is also used to treat 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 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, or to any of the other ingredients 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:

• 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, have taken recently, or may have 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

Pregnancy

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

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

Driving and operating machinery

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

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

• 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 symptoms and signs 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 can 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 Normon.

Dose recommended 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

Dose recommended for ocular shingles:

If you have anormal immune system, the recommended dose is

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

Dose recommended for genital herpes

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.

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

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

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

• To prevent new episodes the dose is 500mg twice 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 ornosebleeds(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).
• Yellow color on the skin and/or eyes(signs of jaundice).

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

• Blue 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, skin redness, facial swelling/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)

- Confusion

- Drowsiness (usually in older people

- Itchy rash (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 ispossible side effects that do not appear in this prospectus. You can alsoreport them directly through theSpanish System for Pharmacovigilance of Medicines for Human Use(www.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 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. 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 125 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 content of the packaging

Famciclovir Normon 125 mg is presented in the form of coated tablets with a white film, round, biconvex, with a diameter of approximately 7.6 mm. Each package contains 10 tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

LABORATORIOS NORMON, S.A.

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

Responsible for manufacturing

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 coated tablets

This prospectus was approved in September 2021

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