Package Insert: Information for the Patient

Nervinex 125 mg Tablets

Brivudina

DO NOT TAKE Nervinex (BRIVUDINA)IF you have recently received, are currently receiving, or are scheduled to receive (within 4 weeks) chemotherapy for cancer or an antineoplastic treatment. DO NOT TAKE Nervinex IF you have a fungal infection and have recently received or are currently receiving an antifungal treatment with flucitosina (see section 2, including the red box). TheINTERACTIONbetween Nervinex (brivudina) and some cancer treatments or flucitosina isPOTENTIALLY FATAL.

Package Insert Contents:

1.What Nervinex is and for what it is used

2.What you need to know before starting to take Nervinex

3.How to take Nervinex

4.Possible adverse effects

5.Storage of Nervinex

6.Contents of the package and additional information

Nervinex contains the active substance brivudine. Nervinex has an antiviral effect and inhibits the multiplication of the virus that causes herpes (varicella-zoster virus).

Nervinex is used in the early treatment of herpes infection (herpes zoster) in adults withoutimmune system alterations(the body's defenses).

Do not take Nervinex:

• if you have recently received, are currently receiving, or are scheduled to receive (within 4 weeks) chemotherapy (e.g., capecitabina, 5-fluorouracil (5-FU), tegafur, etc.) (see red box and section «Other medications and Nervinex»)
• if you have a fungal infection and have recently received or are currently receiving antifungal treatment with flucitosina (see red box and section «Other medications and Nervinex»)
• if you are allergic (hypersensitive) to the active substance brivudine
• if you are allergic (hypersensitive) to any of the other components of Nervinex (see section 6)
• if you are pregnant or breastfeeding
• if you are under 18 years old

Warnings and precautions

Do not take Nervinex andconsult your doctor or pharmacist:

• if you have recently received, are currently receiving, or are scheduled to receive (within 4 weeks) chemotherapy (by mouth or through injection or locally in the form of creams, ointments, eye drops or any other type of medication that is applied externally)
• if you have a fungal infection and have recently received or are currently receiving antifungal treatment with flucitosina(see sections«NoDEBE tomarNervinex»in red box,and«Use of Nervinex with other medications»).

Do not take Nervinex if yourskin rashis very advanced (onset of crusting). In case of doubt, consult your doctor.

Consult your doctor before taking Nervinex if you have anychronic liver disease(such as chronic hepatitis).

Do not take Nervinex for more than 7 days, as extending the treatment beyond the recommended 7-day duration increases the risk of developing hepatitis (see also section 4).

Children and adolescents

Do not administer Nervinex to children and adolescents between 0 and 18 years old, as the safety and efficacy have not been studied in this age group.

Use of Nervinex with other medications

Before starting treatment with Nervinex,inform your doctor or pharmacist if you are using, have recently used, or may need to use any other medication, even those purchased without a prescription.This is extremely important as Nervinex may enhance the toxic effects of other medications.

ATTENTION:

Special warning for patients withchemotherapy or fungal infections(see also the red box above):

Nervinexshould not be used in patientswho have recently received, are currently receiving, or are scheduled to receive (within 4 weeks) certainchemotherapy for cancer or antineoplásica. The harmful effectsof these medications (fluoropirimidinas)may be greatly increasedand potentially fatal.

• 5‑fluorouracil (5-FU),including topical use
• capecitabina
• tegafur
• other 5-fluoropirimidinas
• combinations of some of the active substances mentioned with other active principles

Nervinex should not be used simultaneously with medications that contain the active substance flucitosina used to treat fungal infections.

Do not take Nervinex and consult your doctor immediately:

• if you have recently received,are currently receiving, or are scheduled to receive (within 4 weeks)any of the medications mentioned above
• if you have recently received or are currently receiving antifungal treatment with flucitosina

If you have accidentally taken Nervinex and one of the medications mentioned above:

• stop taking both medications
• consult your doctor immediately
• go to a hospital for immediate treatment(to protect you from systemic infections and dehydration).

The symptoms and signs of 5-fluorouracil(and other fluoropirimidinas)toxicity, due to the interactions mentioned above, include:

• dizziness; diarrhea; inflammation of the mouth and/or mucous membranes of the mouth;fatigue, increased sensitivity to infections, tiredness (decreased white blood cell count and decreased bone marrow function); red rash all over the body, with the skin sensitive to touch, which evolves into large blisters that progress to extensive areas of skin peeling (necrolysis epidermal toxica) (see also section 4).

Post-marketing experience indicates a possible interaction of brivudine with dopamine medications for Parkinson's disease treatment, which may facilitate the onset of chorea (abnormal and involuntary movements, similar to a dance, especially of arms, legs, and face).

Administration of Nervinex with food and drinks

You can take Nervinex with or without food.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medication.

Do not take Nervinex during pregnancy.

Do not take Nervinex if you are breastfeeding. The active ingredient of Nervinex may pass through breast milk.

Driving and operating machines

Although infrequently, some patients who have taken Nervinex have experienced dizziness and drowsiness. If you notice these side effects, refrain from driving, using machines, or working in an unsafe position. Consult your doctor.

Nervinex contains lactose

This medication contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with him before taking this medication.

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

The recommended dose is:

1 tablet of 125 mg of Nervinex once a day for 7 days.

Take the Nervinex tablet every day approximately at the same hour.

You can take Nervinex with or without food.

Swallow the tablet whole with sufficient liquid, for example, a glass of water.

You must start treatmentas soon as possible.This means that, if possible, you should start taking Nervinex:

• within 3 days of the appearance of the first skin manifestations (cutaneous eruption) of herpes or
• within 2 days of the appearance of the first vesicles.

Complete the 7-day treatment cycle even if you feel better before finishing it.

If your symptoms persisted or worsened during the week of treatment, you should consult your doctor.

Taking the normal dose of Nervinex reduces the risk of developing postherpetic neuralgia in patients over 50 years old. Postherpetic neuralgia is a persistent pain that appears in the affected area by herpes, after the improvement of the eruption.

Treatment duration

This medication is for short-term use. It should only be administered for 7 days. Do not take a second treatment cycle.

Use in children and adolescents

Do not take Nervinex if you are under 18 years old.

If you take more Nervinex tablets than you should

Inform your doctor if you take more tablets than you should. He will decide if additional measures are necessary.

If you forget to take Nervinex

If you forget to take a tablet at the usual time, take it as soon as you remember. The next day, take the corresponding tablet approximately at the same hour as the previous day. Maintain this new dosage rhythm until completing the 7-day treatment cycle.

Do not take a double dose to compensate for the missed doses.

Inform your doctor if you have repeatedly forgotten to take the daily dose of the medication.

If you interrupt the Nervinex treatment

Do not interrupt the Nervinex treatment without consulting your doctor first. To achieve the maximum benefit of this treatment, you must take it for 7 days.

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.

Stop taking Nervinex and inform your doctor immediately if you have an allergic reaction with signs and symptomsthat include itching or redness of the skin (rash), increased sweating, swelling (of hands, feet, tongue, lips, eyelids, or larynx), difficulty breathing (see also section 4). These symptoms could be severe and require urgent medical attention.

The following side effects were observed frequently (may affect up to 1 in 10 people):

• nausea (urge to vomit)

The following side effects were observed withlow frequency(may affect up to 1 in 100 people):

• a decrease in the number of a type of white blood cell (granulocytes)
• an increase in the number of a certain type of white blood cell (eosinophils, lymphocytes, monocytes)
• a decrease in the number of red blood cells (anemia)
• allergic reactions that include:

• itching of the skin (pruritus)
• redness of the skin (erythematous rash)
• increased sweating
• swelling of hands, feet, face, tongue, lips, eyelids, larynx (laryngeal edema)
• cough, difficulty breathing, and/or shortness of breath

• loss of appetite
• anxiety
• insomnia, drowsiness
• headache
• dizziness
• vertigo (sensation of spinning)
• abnormal sensations, e.g. burning, prickling, tingling, feeling of having pins and needles under the skin, mainly in arms and legs (paresthesia)
• high blood pressure
• indigestion (dyspepsia), vomiting, stomach pain
• diarrhea
• excess gas in the stomach or intestines (flatulence)
• constipation
• chronic liver disease with fatty accumulation (fatty liver)
• an increase in blood levels of certain substances produced by the liver (elevated liver enzymes)
• weakness, fatigue (fatigue)
• symptoms similar to the flu (discomfort, fever, generalized pain, and chills)

The following side effects were observed rarely (may affect up to 1 in 1,000 people):

• low blood pressure
• decrease in the number of platelets in the blood
• hallucinations, delirium
• confusion
• shaking
• alteration of taste
• ear pain
• inflammation of the liver (hepatitis), increase in bilirubin in the blood
• bone pain

The following side effects have also been reported, although the frequency is unknown (the frequency cannot be estimated with the available information):

• alteration of balance
• inflammation of blood vessels (vasculitis)
• acute liver failure
• localized inflammation of the skin that reappears in the same place over time (fixed rash), inflammation of the skin with peeling (exfoliative dermatitis), generalized rash on the skin and inside the mouth, due to an allergic reaction (erythema multiforme), ulceration of the skin, mouth, eyes, and genital areas (Stevens-Johnson syndrome).
• restlessness
• change in mood
• depressive mood
• sensation of aggression, agitation, anxiety
• syncope

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist even if it is a possible side effect that does not appear in this leaflet. You can also report them through the Spanish System for the Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es. By reporting side effects, you can contribute to providing more information 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 box and on the blister pack. The expiration date is the last day of the month indicated.

Store the blister pack in the outer packaging to protect it from light.

Medications should not be disposed of through drains or in the trash. Dispose of 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 Nervinex

The active principle is brivudina.

Each Nervinex tablet contains 125 mg of brivudina.

The other components are:

Microcrystalline cellulose, lactose monohydrate, povidone K 24-27, magnesium stearate.

Appearance of the product and contents of the packaging

Nervinex 125 mg tablets are round, flat, white or almost white, and have beveled edges (at an angle).

They are presented in a blister pack within a box.

Nervinex is available in boxes containing 1 to 7 tablets and in packs containing 5 boxes, each containing 7 tablets.

Not all packaging sizes are marketed.

Holder of the marketing authorization

Guidotti, S.p.A. Via Livornese 897, Loc. “La Vettola” (San Piero a Grado, PISA) Italy.

Local representative

GUIDOTTI FARMA, S.L.

Alfons XII, 587 – 08918 Badalona (Barcelona) Spain

Responsible for manufacturing

BERLIN-CHEMIE AG, Glienicker Weg 125, D-12489 Berlin, Germany

This medicine has been authorized in the member states of the European Economic Area with the following names:

Last review date of this leaflet:February 2021

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