BRIVUDINA 125 мг Коированная таблетка

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1. Brivudina Aristo 125 mg tablets
   1. What is Brivudina Aristo and what is it used for?
   2. What you need to know before you take 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

Brivudina Aristo 125 mg tablets

brivudina

Generic medicine

DO NOT TAKE Brivudina Aristo (BRIVUDINA) IFyou have recently undergone, are currently
undergoing or are about to undergo (within 4 weeks) a certain type of antitumor chemotherapy. DO NOT TAKE Brivudina Aristo IF YOU HAVE AN ONGOING 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 INTERACTIONbetween
Brivudina Aristo (brivudina) and certain antitumor medicines or flucytosine is

POTENTIALLY FATAL.

Read this leaflet carefully before taking this medicine as 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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If any side effects occur, 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 you take 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 is Brivudina Aristo and what is it used for?

Brivudina Aristo contains the active ingredient brivudine. Brivudina Aristo has an antiviral effect and
blocks the multiplication of the virus that causes shingles (the varicella zoster virus).
Brivudina Aristo is used in adults who do not present any abnormalities at the level of the immune
system (the body's defenses) for the early treatment of shingles (herpes
zoster).

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

DO NOT take Brivudina Aristo (brivudine):

• if you have recently undergone, are currently undergoing or are awaiting to undergo (within 4 weeks) a certain type of anticancer chemotherapy (e.g. capecitabine, 5-fluorouracil (5-FU), tegafur, etc.) (see red box and paragraph “Other medicines and Brivudina Aristo”)
• if you have an ongoing fungal infection and have recently taken or are currently taking antifungal therapy with flucytosine (see red box and paragraph “Other medicines and Brivudina Aristo”)
• if you are allergic (hypersensitive) to the active ingredient brivudine
• if you are allergic (hypersensitive) to any of the excipients of Brivudina Aristo (see paragraph 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 anticancer medicines (chemotherapy), in particular capecitabine, 5-fluorouracil (5-
FU) or other fluoropyrimidines for oral use, by injection, for local use as creams, ointments, eye
drops or any other form of medicine for external use.
ifyou have an ongoing fungal infection and have recently taken or are currently taking a
antifungal therapy with flucytosine
if you have recently used, are currently taking or are about to take (within 4 weeks) a
medicine against warts or a medicine against 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
compromised, e.g. if you have recently taken or are currently taking:

• Anticancer medicines (chemotherapy) or
• Immunosuppressant medicines (medicines that suppress or decrease the function of theimmune system)

In particular:

• DO NOT take Brivudina Aristo together with medicines containing fluoropyrimidines (forexample capecitabine, 5-FU, tegafur, flucytosine) (even during periods of rest betweentreatments, when you are not taking any capecitabine tablets or undergoinginfusions of 5-FU or other fluoropyrimidine formulations or when you have recentlytaken such medicines).
• If you have taken Brivudina Aristo, you must wait at least 4 weeks after the end oftreatment with Brivudina Aristo before taking capecitabine, 5-FU or otherfluoropyrimidines. See also the paragraph “Do not take Brivudina Aristo (brivudine)”.

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

• if you have recently taken or are currently taking or if you are about to take (within 4 weeks) chemotherapeutic medicines (for oral use, by injection or for local use as creams, ointments, eye drops or any other form of medicine for external use)
• If you have an ongoing fungal infection and have recently taken or are currently taking antifungal therapy with flucytosine (see the paragraph “Do not take Brivudina Aristo”, the red box and the paragraph “Other medicines and Brivudina Aristo”).

Do not take Brivudina Aristo if the skin rashhas 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 chronicliver diseases(e.g. chronic hepatitis).
Do not take Brivudina Aristo for more than 7 days, as prolonging the duration of treatment
beyond the recommended time of 7 days increases the risk of developing hepatitis (see also paragraph 4
“Possible side effects”).

Children and adolescents
Do not give Brivudina Aristo 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, tell your doctor or pharmacist if you
are taking, have recently taken or might take any other medicines, including those
available without a prescription. This is extremely important as Brivudina Aristo can enhance
the toxic effect of other medicines.

NOTE:
Special warnings for patients undergoing anticancer chemotherapy or with fungal infections
(see also the red box above):
Brivudina Aristo must notbe used in patientswho have recently taken, are
currently taking and are about to take (within 4 weeks) certain chemotherapeutic medicines. The harmful effects of these medicines (fluoropyrimidines) can increase
considerably and 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 ingredient 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) therapy based on any of the aforementioned medicines
• you have recently undergone or are currently undergoing antifungal therapy with flucytosine

If you have accidentally taken Brivudina Aristo in conjunction with one of the medicines listed
above:

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

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

• Feeling unwell, diarrhea, inflammation of the mouth and/or the inside of the mouth; feeling tired, increased susceptibility to infections, fatigue (decreased number of white blood cells and bone marrow depression); skin rash and redness all over the body with painful skin to the touch, followed by large blisters leading to extensive areas of skin exfoliation (toxic epidermal necrolysis) (see also paragraph 4 “Possible side effects”). Post-marketing experience indicates a possible interaction of brivudine with dopaminergic drugs for Parkinson's disease, which may promote the onset of chorea (abnormal, involuntary movements, similar to those of dance, especially of the arms, legs and face).

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

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant, are planning a pregnancy or are breastfeeding,
ask your doctor or pharmacist for advice before taking this medicine.
Do not take Brivudina Aristo during pregnancy.
Do not take Brivudina Aristo if you are breastfeeding. The active ingredient of Brivudina Aristo can
pass to your baby through breast milk.

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 work without
a firm support. Consult your doctor.

Brivudina Aristo contains lactose
This medicine contains milk sugar (lactose). If you have been told by your doctor that you
are intolerant to some sugars, contact your doctor before taking this medicine.

3. How to take Brivudina Aristo

Take this medicine following exactly the instructions of your doctor. If you have doubts, consult your
doctor or pharmacist.
The recommended dose is:

1 tablet of Brivudina Aristo 125 mg once a day for 7 days.
Take your Brivudina Aristo tablet every day at approximately the same time.
You can take Brivudina Aristo with or without food.
Swallow the tablet whole with sufficient liquid, for example with a glass of water.
You must start treatment as soon as possible.This means that if possible you should start
taking Brivudina Aristo:

• Within 3 days of the appearance of the first skin signs of shingles 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, consult your doctor.
Taking the usual dose of Brivudina Aristo reduces the risk of developing postherpetic neuralgia in patients over 50 years of age. Postherpetic neuralgia is a persistent pain that
develops in the area previously affected by herpes zoster after improvement of the skin rash

Duration of treatment
This medicine is intended for short-term use. It must be taken only for 7 days.
Do not take this medicine for a second cycle of treatment

Use in children and adolescents
Do not take Brivudina Aristo if you are under 18 years of age.

If you take more Brivudina Aristo than you should
If you take more tablets than you should, please consult a doctor. He will decide if further
measures are necessary.

If you forget to take Brivudina Aristo
If you forget to take the 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 the previous day. Continue with the
new time of administration until the completion of the 7-day treatment cycle.
Do not take a double dose to compensate for the forgotten tablet.
If you repeatedly forget to take the daily dose, inform your doctor.

If you stop taking Brivudina Aristo
Do not stop taking Brivudina Aristo without first consulting your doctor. In order for
the treatment to be completely effective, you must take the medicine for 7 days.
If you have any doubts 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 Brivudina Aristo and tell your doctor immediately if you experience an
allergic reaction with signs and symptomsincluding 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 observed commonly (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 (anemia)
• allergic reactions including:
• skin itching (pruritus)
• skin redness (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
• difficulty sleeping (insomnia), drowsiness
• headache
• dizziness
• vertigo (sensation of spinning)
• abnormal sensations such as burning, numbness, tingling, more frequently in arms and legs (paresthesia)
• increased blood pressure
• indigestion (dyspepsia), vomiting, stomach pain
• diarrhea
• excessive gas in the stomach or intestines (flatulence)
• constipation
• chronic liver disease with fat accumulation (fatty liver)
• increased levels in the blood of certain substances produced by the liver (increased liver enzymes)
• weakness, 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
• decreased number of platelets in the blood
• hallucinations, delusions
• confusion
• tremor
• altered sense of taste
• ear pain
• liver inflammation (hepatitis), increased bilirubin in the blood
• bone pain

The following side effects have been reported, although their frequency is not known
(frequency cannot be estimated based on available data):

• loss of balance
• inflammation of blood vessels (vasculitis)
• rapidly developing liver failure
• localized skin inflammation that recurs in the same place for a certain period of time (fixed eruption), skin inflammation with peeling (exfoliative dermatitis), severe rash on the entire surface of the body and inside the mouth due to an allergic reaction (erythema multiforme), ulceration of skin, mouth, eyes and genital areas (Stevens Johnson syndrome).

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through 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 which is stated on the package and on the blister after
“Exp.”. The expiry date refers to the last day of that month.
Keep the blister inside the outer packaging to protect the medicine from light.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

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

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

Description of the appearance of Brivudina Aristo and contents of the pack
Brivudina Aristo tablets contain white, round tablets with beveled edges and
flat on both sides.
The tablets are supplied in blisters packaged 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 Member States of the European Economic Area with the
following denominations
Austria Brivudin Aristo 125 mg Tabletten
Germany Brivudin Aristo 125 mg Tabletten
Italy Brivudina Aristo
Spain Brivudina Aristo 125 mg comprimidos