Brivudine Aristo

Package leaflet: Information for the user

Brivudina Aristo 125 mg tablets

brivudine
Equivalent medicine
DO NOT TAKE Brivudina Aristo (BRIVUDINE) IF you have recently undergone, are currently undergoing, or are scheduled to undergo (within 4 weeks) a specific antitumour chemotherapy. DO NOT TAKE Brivudina Aristo IF YOU CURRENTLY HAVE A FUNGAL INFECTION and have recently taken or are currently taking medicines containing flucytosine for the treatment of a fungal infection (see section 2, including the red box). THE INTERACTION between Brivudina Aristo (brivudine) and certain antitumour medicines or flucytosine is POTENTIALLY FATAL.
Read this leaflet carefully before taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, because it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

1. What Brivudina Aristo is and what it is used for
2. What you need to know before taking Brivudina Aristo
3. How to take Brivudina Aristo
4. Possible side effects
5. How to store Brivudina Aristo
6. Contents of the pack and other 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
inhibits the replication of the virus that causes shingles (the varicella zoster virus).
Brivudina Aristo is used in adults who do not have any abnormalities of the immune system (the body's
defences) for the early treatment of shingles (herpes zoster).

2. What you need to know before taking Brivudina Aristo

DO NOT take Brivudina Aristo (brivudine):

• if you have recently undergone, are currently undergoing, or are scheduled to undergo (within 4 weeks) a specific antitumor chemotherapy (e.g. capecitabine, 5-fluorouracil (5-FU), tegafur, etc.) (see red box and section “Other medicines and Brivudina Aristo”)
• if you currently have a fungal infection and have recently taken or are currently taking antifungal therapy with flucytosine (see 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 excipients of Brivudina Aristo (see section 6)
• if you are pregnant or breastfeeding
• if you are under 18 years of age.

DO NOT take Brivudina Aristo:
if you have recently taken, are currently taking, or are about to take (within 4 weeks)
certain antitumor medicines (chemotherapy), particularly capecitabine, 5-fluorouracil (5-FU)
or other fluoropyrimidines administered orally, by injection, topically as creams, ointments,
eye drops, or any other form of externally applied medicine.
if you currently have a fungal infection and have recently taken or are currently taking
antifungal therapy with flucytosine
if you have recently used, are currently taking, or are about to take (within 4 weeks) a
medicine for warts or a medicine for actinic keratosis or Bowen’s disease containing
fluoropyrimidines (5-fluorouracil or others)
if your immune system (i.e. your body’s defences against infections) is severely
compromised, for example if you have recently taken or are currently taking:

• Anticancer medicines (chemotherapy) or
• Immunosuppressive medicines (medicines that suppress or reduce immune system function)

In particular:

• You must NOT take Brivudina Aristo together with medicines containing fluoropyrimidines (e.g. capecitabine, 5-FU, tegafur, flucytosine) (even during treatment-free intervals when you are not taking capecitabine tablets or receiving 5-FU infusions or other fluoropyrimidine formulations, or if you have recently taken such medicines).
• If you have taken Brivudina Aristo, you must wait at least 4 weeks after completing treatment with Brivudina Aristo before taking capecitabine, 5-FU or other fluoropyrimidines. See also section “Do not take Brivudina Aristo (brivudine)”.

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

• if you have recently taken, are currently taking, or are about to take (within 4 weeks) chemotherapeutic medicines (administered orally, by injection, or topically as creams, ointments, eye drops, or any other form of externally applied medicine)
• if you currently have a fungal infection and have recently taken or are currently taking antifungal therapy with flucytosine (see section “Do not take Brivudina Aristo”, the red box, and section “Other medicines and Brivudina Aristo”).

Do not take Brivudina Aristo if the skin rash has already fully developed (onset of crusting). If in doubt, consult your doctor.
Ask your doctor for advice before taking Brivudina Aristo if you suffer from chronic liver disease (e.g. chronic hepatitis).
You must not take Brivudina Aristo for longer than 7 days, as extending the treatment beyond the recommended 7-day period increases the risk of developing hepatitis (see also section 4 “Possible side effects”).

Children and adolescents
Do not give Brivudina Aristo to children and adolescents aged between 0 and 18 years, 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 take any other medicines, including those not requiring a prescription. This is extremely important because Brivudina Aristo can enhance the toxic effects of other medicines.

IMPORTANT:
Special warnings for patients undergoing antitumor chemotherapy or with fungal infections (see also the red box above):
Brivudina Aristo must NOT be used in patients who have recently taken, are currently taking, or are about to take (within 4 weeks) certain chemotherapeutic medicines. The harmful effects of these medicines (fluoropyrimidines) can increase significantly and may be fatal:

• 5-fluorouracil (5-FU), including topical formulations
• capecitabine
• tegafur
• other 5-fluoropyrimidines
• combinations of any of the above substances with other active ingredients.

Brivudina Aristo must not be taken with medicines containing the active substance flucytosine used to treat fungal infections.

Do not take Brivudina Aristo and contact your doctor immediately if:

• you have recently undergone, are currently undergoing, or will undergo (within 4 weeks) treatment with any of the above-mentioned medicines
• you have recently undergone or are currently undergoing antifungal treatment with flucytosine

If you have accidentally taken Brivudina Aristo together with any of the medicines listed above:

• Stop taking both medicines immediately
• Consult a doctor immediately
• Go to hospital for immediate treatment (to protect against systemic infections and dehydration).

Symptoms and signs of 5-fluorouracil (and other fluoropyrimidines) toxicity due to the above interactions include:

• Malaise, diarrhoea, inflammation of the mouth and/or oral mucosa; fatigue, increased susceptibility to infections, tiredness (decreased white blood cell count and bone marrow suppression); skin rash and redness over the entire body with painful skin, followed by large blisters leading to extensive skin peeling (toxic epidermal necrolysis) (see also section 4 “Possible side effects”). Post-marketing experience indicates a possible interaction between brivudine and dopaminergic medicines used for Parkinson’s disease, which may trigger episodes of chorea (abnormal, involuntary dance-like movements, particularly affecting arms, legs and face).

Brivudina Aristo with food and drink
You may take Brivudina Aristo with or without food.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Do not take Brivudina Aristo during pregnancy.
Do not take Brivudina Aristo if you are breastfeeding. The active substance in Brivudina Aristo may pass into your breast milk and harm your baby.

Driving and using machines
Although uncommon, some patients treated with Brivudina Aristo have experienced dizziness and drowsiness. If you experience these side effects, do not drive, operate machinery, or perform work without secure support. Consult your doctor.

Brivudina Aristo contains lactose
This medicine contains milk sugar (lactose). If your doctor has informed you that you have an intolerance to certain sugars, contact your doctor before taking this medicine.

3. How to take Brivudine Aristo

Take this medicine exactly as instructed by your doctor. If you have any doubts, consult your
doctor or pharmacist.
The recommended dose is:
1 Brivudine Aristo 125 mg tablet once daily for 7 days.
Take your Brivudine Aristo tablet every day at approximately the same time.
You may take Brivudine Aristo with or without food.
Swallow the tablet whole with sufficient liquid, for example, a glass of water.
You must start treatment as soon as possible. This means you should start taking Brivudine Aristo:

• Within 3 days of the appearance of the first skin symptoms of shingles, or
• Within 2 days of the appearance of the first blisters.

Complete the full 7-day course of treatment, even if you feel better before it ends.
If during the treatment week your symptoms persist or worsen, contact your doctor.
Taking the usual dose of Brivudine Aristo reduces the risk of developing postherpetic neuralgia in
patients over 50 years of age. Postherpetic neuralgia is persistent pain that develops in the area
previously affected by herpes zoster after the skin rash has improved.
Duration of treatment
This medicine is intended for short-term use only. It should be taken only for 7 days.
Do not take this medicine for a second course of treatment.
Use in children and adolescents
Do not take Brivudine Aristo if you are under 18 years of age.
If you take more Brivudine Aristo than you should
If you take more tablets than prescribed, contact a doctor immediately. The doctor will decide whether
further measures are necessary.
If you forget to take Brivudine Aristo
If you forget to take your tablet at the usual time, take it as soon as you remember. Take the next
tablet the following day at approximately the same time as on the previous day. Continue with this
new dosing time until completion of the 7-day treatment course.
Do not take a double dose to make up for the forgotten tablet.
If you repeatedly forget to take your daily dose, inform your doctor.
If you stop taking Brivudine Aristo
Do not stop taking Brivudine Aristo without first consulting your doctor. For the treatment to be
fully effective, you must take the medicine for 7 days.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking Brivudine Aristo and inform your doctor immediately if you experience an allergic
reaction with signs and symptoms including itching or skin redness (rash), increased sweating,
swelling (of hands, feet, face, tongue, lips, eyelids or larynx), difficulty breathing. These symptoms
can be serious and require urgent medical attention.

The following side effect has been commonly observed (may affect up to 1 in 10 people):

• nausea (feeling unwell)

The following side effects have been observed uncommonly (may affect up to 1 in 100 people):

• reduction 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)
• reduction in the number of red blood cells (anaemia)
• allergic reactions including:
• skin itching (pruritus)
• skin redness (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
• sleeplessness (insomnia), drowsiness
• headache
• dizziness
• vertigo (sensation of spinning)
• abnormal sensations such as burning, numbness, tingling, more frequently in arms and legs (paraesthesia)
• increased blood pressure
• indigestion (dyspepsia), vomiting, stomach ache
• diarrhoea
• excessive gas in the stomach or intestines (flatulence)
• constipation
• chronic liver disease with fat accumulation (fatty liver)
• increased blood levels of certain substances produced by the liver (increased liver enzymes)
• weakness, tiredness (fatigue)
• flu-like symptoms (feeling unwell, fever, aches and chills)

The following side effects have been 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
• confusional state
• tremor
• altered sense of taste
• ear pain
• inflammation of the liver (hepatitis), increased bilirubin in the blood
• bone pain

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

• loss of balance
• inflammation of blood vessels (vasculitis)
• rapidly developing liver failure
• localized recurring skin inflammation at the same site over a certain period of time (fixed eruption), skin inflammation with peeling (exfoliative dermatitis), severe rash over the entire body 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 side effects, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Brivudina 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 the blister after "Exp.". The expiry date refers to the last day of that month.
Keep the blister inside the outer carton to protect the medicine from light.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Brivudina Aristo contains
The active substance is brivudine.
1 Brivudina Aristo tablet contains 125 mg of brivudine.
The other ingredients are:

• Microcrystalline cellulose
• Lactose monohydrate
• Crospovidone (type B)
• Povidone K 30
• Magnesium stearate

Description of the appearance of Brivudina Aristo and the contents of the pack
Brivudina Aristo tablets are white, round, bevelled-edged tablets, flat on both sides.
The tablets are supplied in blisters packed in cardboard boxes.
Brivudina Aristo is available in packs containing 7 tablets.
Marketing Authorisation Holder and Manufacturer
Aristo Pharma GmbH
Wallenroder Straße 8-10
13435 Berlin
Germany
This medicinal product is authorised in the European Economic Area Member States under the
following names
Austria Brivudin Aristo 125 mg Tabletten
Germany Brivudin Aristo 125 mg Tabletten
Italy Brivudina Aristo
Spain Brivudina Aristo 125 mg comprimidos