Brivudine Aristo 125 mg tablets EFG
Spain
Table of Contents
Patient Information Leaflet
Introduction
Patient Information Leaflet
Brivudina Aristo 125 mg tablets EFG
brivudine
DO NOT TAKE Brivudina Aristo (BRIVUDINE) IF you have recently received, are currently receiving, or are scheduled to receive (within 4 weeks) chemotherapy or antineoplastic treatment for cancer. DO NOT TAKE Brivudina Aristo IF you have a fungal infection and have recently received or are currently receiving antifungal treatment with flucytosine (see section 2, including the red box warning). THE INTERACTION between Brivudina Aristo (brivudine) and certain cancer treatments or flucytosine is POTENTIALLY FATAL.
Read this entire leaflet carefully before you start taking this medicine, as it contains important information for you.
- Keep this leaflet, 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 only and must not be given to other people, 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 effects not listed in this leaflet. See section 4.
Leaflet Contents
- What Brivudina Aristo is and what it is used for
- What you need to know before taking Brivudina Aristo
- How to take Brivudina Aristo
- Possible adverse effects
- How to store Brivudina Aristo
- Package contents and additional information
1. What Brivudina Aristo is and what it is used for
Brivudina Aristo contains the active substance brivudine. Brivudina Aristo has an antiviral effect and stops the multiplication of the herpes virus (the varicella-zoster virus).
Brivudina Aristo is used for the early treatment of herpes infection (herpes zoster) in adults with normal immune systems (normal body defenses).
2. What you need to know before starting Brivudina Aristo
DO NOT take Brivudina Aristo
? if you have recently received, are currently receiving, or are scheduled to receive (within 4 weeks) antineoplastic chemotherapy (e.g., capecitabine, 5-fluorouracil (5-FU), tegafur, etc.) (see the red box and section “Other medicines and Brivudina Aristo”)
? if you have a fungal infection and have recently received or are currently receiving antifungal treatment with flucytosine (see the red box and section “Other medicines and Brivudina Aristo”)
? if you are allergic (hypersensitive) to the active substance brivudine
? 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 of age
DO NOT take Brivudine Aristo: ?if you have recently received, are currently receiving, or are scheduled to receive (within 4 weeks) antineoplastic chemotherapy (especially capecitabine, 5-fluorouracil (5-FU), or other fluoropyrimidines taken orally, by injection, or applied locally as creams, ointments, eye drops, or any other type of externally applied medication) ? if you have a fungal infection and have recently received or are currently receiving antifungal treatment with flucytosine ? if you have recently used, are currently using, or are scheduled to use (within 4 weeks) a medication for warts or a treatment for actinic keratosis or Bowen's disease containing fluoropyrimidines (5-fluorouracil or others) ? if your immune system (i.e., your body's defenses against infections) is severely impaired; for example, if you have recently received or are currently receiving:
? Specifically:
|
Warnings and precautions
Do not take Brivudina Aristo and consult your doctor or pharmacist:
Do not take Brivudina Aristo if your skin rash is already at an advanced stage (crusting has begun). If in doubt, consult your doctor.
Consult your doctor before taking Brivudina Aristo if you have any chronic liver disease (e.g., chronic hepatitis).
You must not take Brivudina Aristo for longer than 7 days, as extending treatment beyond the recommended duration of 7 days increases the risk of developing hepatitis (see also section 4).
Children and adolescents
Do not administer brivudine to children and adolescents between 0 and 18 years of age, as safety and efficacy have not been studied in this age group.
Other medicines and Brivudina Aristo
Before starting treatment with Brivudina Aristo, inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including those obtained without a prescription. This is extremely important because Brivudina Aristo can enhance the toxic effects of other medicines.
WARNING:
Special warning for patients receiving antineoplastic chemotherapy or antifungal treatment (see also the red box above):
Brivudina Aristo must not be used in patients who have recently received, are currently receiving, or are scheduled to receive (within 4 weeks) certain anticancer or antineoplastic chemotherapy. The harmful effects of these medicines (fluoropyrimidines) could increase significantly, possibly resulting in death.
? 5-fluorouracil (5-FU), including topical formulations
? capecitabine
? tegafur
? other 5-fluoropyrimidines
? combinations of some of the above substances with other active ingredients
Brivudina Aristo must not be used simultaneously with medicines containing the active substance flucytosine, 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 medicines listed above
? if you have recently received or are currently receiving antifungal treatment with flucytosine
If you have accidentally taken Brivudina Aristo together with any of the medicines listed above:
? discontinue taking both medicines immediately
? consult a doctor immediately
? go to a hospital for immediate treatment (to protect you from systemic infections and dehydration).
Symptoms and signs of 5-fluorouracil (and other fluoropyrimidine) toxicity due to the interactions described above include:
? dizziness; diarrhoea; inflammation of the mouth and/or oral mucosa; fatigue, increased susceptibility to infections, tiredness (decreased white blood cell count and impaired bone marrow function); reddish rash over the entire body, with skin sensitive to touch, progressing to large blisters that develop into extensive areas of skin peeling (toxic epidermal necrolysis) (see also section 4).
Post-marketing experience indicates a possible interaction between brivudine and dopaminergic medicines used to treat Parkinson's disease, which may lead to the development of chorea (abnormal, involuntary dance-like movements, especially of the arms, legs, and face).
Taking Brivudina Aristo with food and drink
You may take Brivudina Aristo with or without food.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor before taking this medicine.
You must not take brivudine during pregnancy.
You must not take brivudine while breastfeeding. The active ingredient in brivudine may pass to the baby through breast milk.
Driving and using machines
Although infrequently, some patients taking brivudine have experienced dizziness and drowsiness. If you experience these side effects, refrain from driving, operating machinery, or performing tasks where safety is compromised. Seek advice from your doctor.
This medicine contains lactose
If your doctor has informed you that you have an intolerance to certain sugars, consult him before taking this medicine.
3. How to take Brivudina Aristo
Follow exactly the instructions for use of this medicine as given by your doctor or pharmacist.
The recommended dose is:
1 Brivudina Aristo 125 mg tablet once daily for 7 days.
Take the brivudine tablet at approximately the same time each day. Brivudine may be taken with or without food.
Swallow the tablet whole with sufficient liquid, for example, a glass of water.
Treatment should be started as soon as possible. This means that, if possible, you should start taking brivudine:
- within 3 days of the first skin manifestations of herpes (skin rash), or
- within 2 days of the appearance of the first blisters.
Complete the full 7-day treatment course, even if you feel better before then.
If your symptoms persist or worsen during the week of treatment, you should consult your doctor.
Taking the normal dose of brivudine reduces the risk of developing postherpetic neuralgia in patients over 50 years of age. Postherpetic neuralgia is persistent pain that occurs in the area affected by herpes after the skin rash has improved.
Duration of treatment
This medicine is intended for short-term use only. It should be administered for only 7 days. Do not take a second course of treatment.
Use in children and adolescents
Do not take brivudine if you are under 18 years of age.
If you take more brivudine than you should
Inform a doctor if you take more tablets than you should. The doctor will decide whether additional measures are necessary.
In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately, or call the Toxicology Information Service at telephone number: 91 562 04 20, stating the medicine and the amount ingested.
If you forget to take brivudine
If you forget to take a dose, take it as soon as you remember. On the following day, take the next tablet at approximately the same time as the previous day. Maintain this new dosing schedule until completion of the 7-day treatment course.
Do not take a double dose to make up for a missed dose.
Inform your doctor if you repeatedly forget to take the daily dose of the medicine.
If you stop taking brivudine
Do not stop treatment with brivudine without first consulting your doctor. To achieve the maximum benefit from this treatment, it must be taken for 7 days.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Stop taking brivudine and inform your doctor immediately if you have an allergic reaction with signs and symptoms including itching or redness of the skin (rash), increased sweating, swelling (of hands, feet, tongue, lips, eyelids or larynx), or difficulty breathing. These symptoms could be serious and require urgent medical attention.
The following adverse effects were observed frequently (may affect up to 1 in 10 people):
- nausea (feeling sick)
The following adverse 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 certain types of white blood cells (eosinophils, lymphocytes, monocytes)
-
a decrease in the number of red blood cells (anaemia)
-
allergic reactions including:
-
skin itching (pruritus)
-
redness of the skin (erythematous rash)
-
increased sweating
-
swelling of hands, feet, face, tongue, lips, eyelids, larynx (laryngeal oedema)
-
cough, difficulty breathing and/or shortness of breath
-
loss of appetite
-
anxiety
-
insomnia, drowsiness
-
headache
-
dizziness
-
vertigo (spinning sensation)
-
abnormal sensations, e.g. burning, prickling, tingling, pins and needles sensation under the skin, mainly in arms and legs (paraesthesia)
-
high blood pressure
-
indigestion (dyspepsia), vomiting, stomach pain
-
diarrhoea
-
excess gas in the stomach or intestines (flatulence)
-
constipation
-
chronic liver disease with fat accumulation (fatty liver)
-
increase in blood levels of certain substances produced by the liver (increased liver enzymes)
-
weakness, tiredness (fatigue)
-
flu-like symptoms (malaise, fever, generalised pain and chills)
The following adverse 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
- altered sense of taste
- ear pain
- inflammation of the liver (hepatitis), increased bilirubin in blood
- bone pain
The following adverse effects have also been reported, although their frequency is unknown (frequency cannot be estimated from the available data):
- disturbance of balance
- inflammation of blood vessels (vasculitis)
- sudden onset liver failure
- localised skin inflammation that reappears in the same place after some time (fixed eruption), skin inflammation with peeling (exfoliative dermatitis), severe widespread skin rash 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 adverse effects
If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Brivudine Aristo
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after EXP. The expiry 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 via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE Point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.
6. Contents of the pack and other information
- The active substance is brivudine. Each tablet contains 125 mg of brivudine.
- The other components are: microcrystalline cellulose, lactose monohydrate, crospovidone (type B), povidone K 30, magnesium stearate.
Appearance of the product and contents of the pack
White to off-white, round, flat-faced tablets with bevelled edges.
The tablets are presented in blisters within packs 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
For further information about this medicinal product, 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 medicinal product is authorized in the Member States of the European Economic Area under 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
Date of the most recent review of this leaflet: April 2023
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS): http://www.aemps.gob.es/