Prospect: information for the user

Brivudina Aristo 125 mg tablets EFG

brivudina

DO NOT TAKE Brivudina Aristo (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 Brivudina Aristo IF you have a fungal infection and have recently received or are currently receiving an antifungal treatment with flucitosina (see section 2, including red box). TheINTERACTIONbetween Brivudina Aristo (brivudina) and some cancer treatments or flucitosina isPOTENTIALLY FATAL.

Read this prospect carefully before starting to take this medication, as 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 medication 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 Brivudina Aristo and for what it is used

2. What you need to know before starting to take Brivudina Aristo

3. How to take Brivudina Aristo

4. Possible adverse effects

5. Storage of Brivudina Aristo

6. Contents of the package and additional information

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

Brivudina Aristo is used in the early treatment of herpes infection (herpes zoster) in adults without immune system alterations (the body's defenses).

Do not take Brivudina Aristo

? if you have recently received, are currently receiving, or are scheduled to receive (within 4 weeks) chemotherapy (e.g., capecitabina, 5-fluorouracilo (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 currently receiving antifungal treatment with flucitosina (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 components 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 yourskin eruptionis very advanced (crust formation). In case of doubt, consult your doctor.

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

Do not take Brivudina Aristo 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 brivudina to children and adolescents between 0 and 18 years old, as the 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 used recently, or may need to use any other medication, even those purchased without a prescription. This is extremely important as Brivudina Aristo may enhance the toxic effects of other medications.

ATTENTION:

Special warning for patients with chemotherapy or fungal infections(see also the previous red box):

Brivudina Aristoshould not be used in patientswho have recently received, are currently receiving, or are scheduled to receive (within 4 weeks) certain chemotherapy for cancer or antineoplastic treatment. The harmful effects of these medications (fluoropirimidinas) may be greatly increasedand potentially fatal.

?5-fluorouracilo(5-FU),including forms of uselocal

?capecitabina

?tegafur

?other 5-fluoropirimidinas

?combinations of some of the substances mentioned with other active principles

Brivudina Aristo should not be used simultaneously with medications that contain the active ingredient flucitosina used to treat fungal infections.

Do not take Brivudina Aristo 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

?ifyou have recently received or are currently receiving antifungal treatment with flucitosina

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

?interrupt the intake of 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-fluorouracilo(and other fluoropirimidinas),due to the interactions mentioned above, include:

?dizziness; diarrhea; inflammation of the mouth and/or the mucous membrane 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, that evolves into large blisters that progress to extensive areas of skin peeling (necrolytic acral erythema) (see also section 4).

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

Brivudina Aristo with food and beverages

You can take Brivudina Aristo with or without food.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, consult your doctor before taking this medication.

Do not take brivudina during pregnancy.

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

Driving and operating machines

Although rarely, some patients who have taken brivudina have experienced dizziness and drowsiness. If you notice these side effects, refrain from driving, using machines, or working in a safe position. Consult your doctor.

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 or pharmacist.

The recommended dose is:

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

Take the Brivudina tablet every day approximately at the same hour. You can take Brivudina 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 Brivudina:

• 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 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 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 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. He will decide if additional measures are necessary.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological 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 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 treatment with Brivudina

Do not interrupt the treatment with Brivudina 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 brivudine 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 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 with low 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 decreasein the amount 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 accumulation of fat (fatty liver)
• 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
• 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 the frequency is unknown (the frequency cannot be estimated with the available data):

• 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 eruption), inflammation of the skin with peeling (exfoliative dermatitis), severe 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).

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 prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use: https://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 after CAD. The expiration date is the last day of the month indicated.

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

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and unused medications atthe SIGRE Collection Pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and unused medications. By doing so, you will help protect the environment.

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

Appearance of the product and contents of the packaging

White-colored, round, flat-faced, beveled-edge tablets

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

Marketing Authorization Holder

Aristo Pharma GmbH

Wallenroder Straße 8-10

13435 Berlin

Germany

Responsible for manufacturing

Aristo Pharma GmbH

Wallenroder Straße 8-10

13435 Berlin

Germany

or

MEDIS INTERNATIONAL A.S.

Prumyslova 961/16 - Bolatice - 74723 - Czech Republic

For further information about this medicine, please contact the local representative of the marketing authorization holder:

Aristo Pharma Iberia, S.L.

C/ Solana, 26

28850, Torrejón de Ardoz

Madrid. Spain

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

Austria Brivudin Aristo 125 mg Tabletten

Germany Brivudin Aristo 125 mg Tabletten

Italy Brivudina Aristo 125 mg compresse

Spain Brivudina Aristo 125 mg comprimidos EFG

Last review date of this leaflet: April 2023

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