BRIVUDINA ARISTO 125 mg TABLETS

2. What you need to know before taking Brivudina Aristo

DO NOT TAKE Brivudina Aristo

? if you have recently received, are receiving or are scheduled to receive (within 4 weeks) antineoplastic cancer chemotherapy (e.g., capecitabine, 5-fluorouracil (5-FU), tegafur, etc.) (see red box and section "Other Medications and Brivudina Aristo")

? if you have a fungal infection and have recently received or are receiving antifungal treatment with flucytosine (see red box and section "Other Medications and Brivudina Aristo")

? if you are allergic (hypersensitive) to the active ingredient brivudina

? if you are allergic (hypersensitive) to any of the other ingredients of Brivudina Aristo (see section 6),

? if you are pregnant or breastfeeding

? if you are under 18 years old

Warnings and Precautions

Do not take Brivudina Aristo and consult your doctor or pharmacist:

Do not take Brivudina Aristo if your skin rashis very advanced (start of crusting). If in doubt, consult your doctor.

Consult your doctor before taking Brivudina Aristo if you have any chronic liver disease(e.g., chronic hepatitis).

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

Children and Adolescents

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

Other Medications and Brivudina Aristo

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

WARNING:

Special Warning for Patients with Cancer Chemotherapy or Fungal Infections(see also the previous red box):

Brivudina Aristo should not be used in patientswho have recently received, are receiving or are scheduled to receive (within 4 weeks) certain cancer chemotherapy or antineoplastic therapy. The harmful effects of these medications (fluoropyrimidines) could increase greatly and be life-threatening.

? 5-fluorouracil (5-FU), including local forms

? capecitabine

? tegafur

? other 5-fluoropyrimidines

? combinations of some of the aforementioned substances with other active ingredients

Brivudina Aristo should not be used simultaneously with medications containing the active ingredient flucytosine used to treat fungal infections.

Do not take Brivudina Aristo and consult your doctor immediately:

? if you have recently received, are receiving or are scheduled to receive (within 4 weeks) any of the aforementioned medications

? if you have recently received or are receiving antifungal treatment with flucytosine

If you have accidentally received Brivudina Aristo and one of the aforementioned medications:

? stop taking both medications

? consult your doctor immediately

? go to the hospital for immediate treatment(to protect you from systemic infections and dehydration).

The symptoms and signs of toxicity due to 5-fluorouracil (and other fluoropyrimidines), due to the aforementioned interactions, include:

? nausea; diarrhea; inflammation of the mouth and/or oral mucosa; fatigue, increased sensitivity to infections, tiredness (decrease in white blood cell count and decrease in bone marrow function); red rash all over the body, with sensitive skin to the touch, which evolves into large blisters that progress to extensive areas of peeled skin (toxic epidermal necrolysis) (see also section 4).

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

Taking Brivudina Aristo with Food and Drinks

You can take Brivudina Aristo with or without food.

Pregnancy and Breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or plan to become pregnant, consult your doctor before taking this medication.

Do not take brivudina during pregnancy.

Do not take brivudina if you are breastfeeding. The active ingredient brivudina may pass into the baby through breast milk.

Driving and Using Machines

Although rare, some patients who have taken brivudina have experienced dizziness and drowsiness. If you notice these side effects, avoid driving, using machines, or working without being in a safe position. Ask your doctor for advice.

This Medication Contains Lactose

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

3. How to Take Brivudina Aristo

Follow the exact instructions for administering this medication as indicated by your doctor or pharmacist.

The recommended dose is:

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

Take the brivudina tablet each day at approximately the same time. You can take brivudina with or without food.

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

You should start treatment as soon as possible. This means that, if possible, you should start taking brivudina:

• within 3 days of the appearance of the first symptoms of herpes on the skin (skin rash) or
• within 2 days of the appearance of the first blisters.

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

If your symptoms persist or worsen during the week of treatment, you should consult your doctor.

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

Duration of Treatment

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

Use in Children and Adolescents

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

If You Take More Brivudina Than You Should

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

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If You Forget to Take Brivudina

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

Do not take a double dose to make up for forgotten doses.

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

If You Stop Treatment with Brivudina

Do not stop treatment with brivudina without consulting your doctor first. To achieve the maximum benefit from this treatment, you should take it for 7 days.

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

4. Possible Side Effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

Stop taking brivudina 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. These symptoms could be serious and require urgent medical attention.

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

• nausea (vomiting)

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

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

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

• loss of appetite
• anxiety
• insomnia, drowsiness
• headache
• dizziness
• vertigo (feeling of spinning)
• abnormal sensations, e.g., burning, pinching, tingling, feeling of having pins and needles under the skin, mostly in arms and legs (paresthesia)
• high blood pressure
• indigestion (dyspepsia), vomiting, stomach pain
• diarrhea
• excess gas in the stomach or intestine (flatulence)
• constipation
• chronic liver disease with fat accumulation (fatty liver)
• an increase in blood levels of certain substances produced by the liver (increase in liver enzymes)
• weakness, tiredness (fatigue)
• flu-like symptoms (malaise, 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
• tremor
• 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 their frequency is not known (the frequency cannot be estimated from the available data):

• balance disorder
• inflammation of blood vessels (vasculitis)
• sudden onset liver failure
• localized skin inflammation that reappears in the same place after a while (fixed eruption), skin inflammation with peeling (exfoliative dermatitis), severe generalized skin rash and inside the mouth due to an allergic reaction (erythema multiforme), skin ulcers, mouth, eyes, and genital areas (Stevens-Johnson syndrome).

Reporting Side Effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Brivudina Aristo

Keep this medication out of sight and reach of children.

Do not use this medication after the expiration date that appears on the box and on the blister after CAD. The expiration date is the last day of the month indicated.

Keep the blister in the outer packaging to protect it from light.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need in the SIGRE Collection Pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

• The active ingredient is brivudina. Each tablet contains 125 mg of brivudina.
• The other ingredients are: microcrystalline cellulose, lactose monohydrate, crospovidone (type B), povidone K 30, magnesium stearate.

Appearance of the Product and Package Contents

White or almost white, round, flat-faced tablets with beveled edges.

The tablets are presented in blisters in packages containing 7 tablets.

Marketing Authorization Holder

Aristo Pharma GmbH

Wallenroder Straße 8-10

13435 Berlin

Germany

Manufacturer

Aristo Pharma GmbH

Wallenroder Straße 8-10

13435 Berlin

Germany

or

MEDIS INTERNATIONAL A.S.

Prumyslova 961/16 - Bolatice - 74723 - Czech Republic

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

Aristo Pharma Iberia, S.L.

C/ Solana, 26

28850, Torrejón de Ardoz

Madrid, Spain

This medication is authorized in the Member States of the European Economic Area under the following names:

Austria Brivudin Aristo 125 mg Tablets

Germany Brivudin Aristo 125 mg Tablets

Italy Brivudina Aristo 125 mg tablets

Spain Brivudina Aristo 125 mg tablets EFG

Date of the Last Revision of this Package Leaflet:April 2023

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