ZECOVIR 125 mg Coated Tablet

Зміст інструкції

1. What is Zecovir and what is it used for
2. What you need to know before you take Zecovir
3. How to take Zecovir
4. Possible side effects
5. How to store Zecovir
6. Contents of the pack and other information

Zecovir125 mg tablets
Brivudina

DO NOT TAKE ZECOVIR (BRIVUDINA) IFyou have recently undergone, are currently undergoing
or are awaiting (within 4 weeks) a certain type of anticancer chemotherapy. DO NOT
TAKE ZECOVIR IF YOU HAVE A FUNGAL INFECTION and have recently taken or are
currently taking medicines containing flucytosine for the treatment of a fungal infection (see
paragraph 2, including the red box). THE INTERACTIONbetween Zecovir (brivudina) and certain anticancer
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. Never give it to others, even if they have the same symptoms as you, as it could be harmful.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See paragraph 4.

Contents of this leaflet:

• 1. What Zecovir is and what it is used for
• 2. What you need to know before you take Zecovir
• 3. How to take Zecovir
• 4. Possible side effects
• 5. How to store Zecovir
• 6. Contents of the pack and other information

1. What is Zecovir and what is it used for

Zecovir contains the active ingredient brivudine. Zecovir has an antiviral effect and prevents the virus that causes shingles (varicella-zoster virus) from multiplying.
Zecovir is used in adult subjects who do not have abnormalities 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 Zecovir

DO NOT take Zecovir:
if you have recently undergone, are currently undergoing or are scheduled 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 Zecovir”)
if you currently have a fungal infection and have recently taken or are currently taking antifungal therapy with flucytosine (see red box and paragraph “Other medicines and Zecovir”)
if you are allergic (hypersensitive) to the active ingredient brivudine
if you are allergic (hypersensitive) to any of the excipients of Zecovir (see paragraph 6)
if you are pregnant or breastfeeding
if you are under 18 years of age.

DO NOT take Zecovir:
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 or for local use such as creams, ointments, eye drops or any other form of medicine for external use
if you currently have a fungal infection and have recently taken or are currently taking antifungal therapy with flucytosine
if you have recently taken, 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 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 the immune system)

In particular:

• DO NOT take Zecovir together with medicines containing fluoropyrimidines (e.g. capecitabine, 5-FU, tegafur, flucytosine) (even during rest periods between treatments, when you are not taking any capecitabine tablets or are not undergoing infusions of 5-FU or other fluoropyrimidine formulations, or when you have recently taken such medicines)
• if you have taken Zecovir, you must wait at least 4 weeks after the end of treatment with Zecovir before taking capecitabine, 5-FU or other fluoropyrimidines. See also the paragraph “Do not take Zecovir (brivudine)”.

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

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

Do not take Zecovir if the skin rashhas already fully developed (start of crust formation).
If in doubt, consult your doctor.
Ask your doctor for advice before taking Zecovir if you suffer from chronic liver disease(e.g. chronic hepatitis).
Do not take Zecovir 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).

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

NOTE:
Special warning for patients undergoing anticancer chemotherapy or with fungal infections
(see also the red box above:

Zecovir must not be used in patientswho 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 be fatal:
5-fluorouracil (5-FU), including topical forms
capecitabine
tegafur
other 5-fluoropyrimidines
combinations of any of the above substances with other active ingredients.
Zecovir must not be taken with medicines containing the active ingredient flucytosine used to treat fungal infections.
Do not take Zecovir 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 Zecovir in combination 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 fluoropyrimidine) 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); rash and redness all over the body, with skin painful to the touch, followed by large blisters leading to widespread skin exfoliation (toxic epidermal necrolysis) (see also paragraph 4).
Post-marketing experience indicates a possible interaction of brivudine with dopaminergic drugs for Parkinson's disease, which may favor the onset of chorea (abnormal, involuntary movements, similar to those of dance, particularly of the arms, legs and face).

Zecovir with food and drink
You can take Zecovir with or without food.

Pregnancy and breastfeeding
Ask your doctor or pharmacist for advice before using any medicine.
Do not use Zecovir during pregnancy.
Do not use Zecovir if you are breastfeeding. The active ingredient of Zecovir can pass into your baby through breast milk.

Driving and using machines
Dizziness and drowsiness have been observed in some patients taking Zecovir, although not common. If you experience these side effects, do not drive vehicles, use machines and do not perform any work without a secure support. Ask your doctor for advice.

Zecovir contains lactose
This medicine contains lactose. If your doctor has diagnosed you with intolerance to certain sugars, contact him before taking this medicine.

3. How to take Zecovir

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

1 Zecovir 125 mg tablet once a day for 7 days.
Take the Zecovir tablet at approximately the same time each day.
Zecovir can be taken with or without food.
Swallow the tablet whole with a sufficient amount of liquid, e.g. a glass of water.
You must start treatment as soon as possible, which means that, if possible, you should start taking
Zecovir:
within 3 days of the appearance of the first skin signs of shingles (rash) or
within 2 days of the appearance of the first blisters.
Complete the 7-day treatment course even if you feel better before.
If symptoms persist or worsen during the week of treatment, consult your doctor.
Taking the usual dose of Zecovir 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 rash.

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

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

If you take more Zecovir than you should
If you take more tablets than you should, consult your doctor. He will decide if further
measures are necessary.

If you forget to take Zecovir
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 end of the 7-day treatment cycle.
Do not take a double dose to make up for the missed tablet.
If you repeatedly forget to take the daily dose, inform your doctor.

If you stop taking Zecovir
Do not stop taking Zecovir without first consulting your doctor. For the treatment to be
completely effective, the medicine must be taken 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 Zecovirand tell your doctor immediately if you experience an allergic
reactionwith signs and symptoms including itching or skin redness (rash), increased
sweating, swelling (of hands, feet, face, tongue, lips, eyelids or larynx), difficulty breathing (see
also section 4). These symptoms may be severe 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):
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 (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 insomnia, drowsiness headache dizziness vertigo 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) increase in blood levels of certain substances produced by the liver (increased liver enzymes) weakness, fatigue (fatigue) flu-like symptoms (feeling unwell, fever, aches and chills) The following side effects have been observed rarely (may affect up to 1 in 1000 people):► low blood pressure ► decreased number of platelets in the blood ► hallucinations, delirium ► confused 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 based on available data):► loss of balance ► inflammation of blood vessels (vasculitis) ► rapidly developing liver failure ► localized skin inflammation that occurs in the same place for a certain period of time (fixed eruption), skin inflammation with peeling (exfoliative dermatitis), severe rash on the entire body surface and inside the mouth due to an allergic reaction (erythema multiforme), ulceration of skin, mouth, eyes and genital areas (Stevens Johnson syndrome). ► restlessness ► mood change ► depressed mood ► feeling of aggression, agitation, anxiety ► fainting
• Reporting of side effectsIf 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 Zecovir

Keep out of the reach and sight of children.
Do not use this medicine after the expiry date which is stated on the carton and blister. The expiry date refers to the last day of that month.
Store the blister in the outer packaging to protect the medicine from light.
Do not dispose of any medicine in waste water 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 Zecovir contains
The active ingredient is brivudine.
1 Zecovir tablet contains 125 mg of brivudine.
The other ingredients are:
microcrystalline cellulose
lactose monohydrate
povidone K 24-27
magnesium stearate

Description of Zecovir and contents of the pack
Zecovir 125 mg tablets are round, flat, white or almost white with bevelled edges.
The tablets are contained in blisters inside a carton.
Zecovir is available in packs containing 1 and 7 tablets and in multiple packs including 5 cartons,
each containing 7 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Laboratori Guidotti S.p.A. – Via Livornese, 897 – Pisa – La Vettola
Manufacturer:
Berlin-Chemie AG , Glienicker Weg 125 – 12489 Berlin (Germany)

This medicinal product is authorised in the Member States of the EEA under the
following denominations:
Germany Zostex
Belgium Zonavir
Greece Zostevir
Italy Zecovir
Luxembourg Zonavir