Zecovir

Package leaflet: Information for the user

Zecovir 125 mg tablets

Brivudine
DO NOT TAKE ZECOVIR (BRIVUDINE) if you have recently undergone, are currently undergoing,
or are scheduled (within 4 weeks) to undergo a specific antitumour chemotherapy treatment. DO NOT
TAKE ZECOVIR IF YOU HAVE AN ACTIVE 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 Zecovir (brivudine) and certain anticancer medicines or flucytosine is POTENTIALLY FATAL.
Please 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 other people, even if their symptoms are the same as yours, because it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Zecovir is and what it is used for
2. What you need to know before taking 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 Zecovir is and what it is used for

Zecovir contains the active substance brivudine. Zecovir has an antiviral effect and prevents the virus causing shingles (the varicella-zoster virus) from multiplying.
Zecovir is used in adults who do not have impairments of the immune system (the body's defences) for the early treatment of shingles (herpes zoster).

2. What you need to know before taking Zecovir

DO NOT take Zecovir:
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 Zecovir”)
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 Zecovir”)
if you are allergic (hypersensitive) to the active substance brivudine
if you are allergic (hypersensitive) to any of the excipients of Zecovir (see section 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 antitumor medicines (chemotherapy), particularly capecitabine,
5-fluorouracil (5-FU), or other oral, injectable, or topical fluoropyrimidines such as
creams, ointments, eye drops, or any other form of topical medicine
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 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:

• antitumor medicines (chemotherapy) or

• immunosuppressive medicines (medicines that suppress or reduce immune system function)

In particular:

• You must NOT take Zecovir 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 Zecovir, you must wait at least 4 weeks after completing Zecovir treatment before taking capecitabine, 5-FU, or other fluoropyrimidines. See also section “Do not take Zecovir (brivudine)”.

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

• if you have recently taken, are currently taking, or are about to take (within 4 weeks) chemotherapeutic medicines (oral, injectable, or topical such as creams, ointments, eye drops, or any other form of topical 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 Zecovir”, the red box, and section “Other medicines and Zecovir”).

Do not take Zecovir if the skin rash has already fully developed (at the onset 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).
You must not take Zecovir for more than 7 days, as prolonging treatment beyond the recommended duration of 7 days increases the risk of developing hepatitis (see also section 4).
Children and adolescents
Do not give Zecovir to children and adolescents aged 0 to 18 years, as safety and efficacy have not been studied in this age group.
Other medicines and Zecovir
Before starting treatment with Zecovir, inform 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 because Zecovir can enhance the toxic effects of other medicines.
IMPORTANT NOTE:
Special warning for patients undergoing antitumor chemotherapy or with fungal infections
(see also the red box above):
Zecovir 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.
Zecovir must not be taken together with medicines containing the active substance 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) 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 Zecovir 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 fluoropyrimidine) 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).
Post-marketing experience indicates a possible interaction between brivudine and dopaminergic medicines used for Parkinson’s disease, which may trigger an attack of chorea (abnormal, involuntary dance-like movements, particularly of the arms, legs, and face).
Zecovir with food and drink
You may take Zecovir with or without food.
Pregnancy and breastfeeding
Ask your doctor or pharmacist for advice before taking any medicine.
Do not use Zecovir during pregnancy.
Do not use Zecovir if you are breastfeeding. The active substance of Zecovir may pass into your baby through breast milk.
Driving and using machines
Dizziness and drowsiness have been observed in some patients taking Zecovir, although these are not common. If you experience these side effects, do not drive, operate machinery, or perform any work without secure support. Consult your doctor.
Zecovir contains lactose
This medicine contains lactose. If your doctor has diagnosed you with an intolerance to certain sugars, contact him or her before taking this medicine.

3. How to take Zecovir

Take this medicine exactly as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.

Recommended dose:
1 tablet of Zecovir 125 mg once daily for 7 days.
Take the Zecovir tablet at approximately the same time each day.
Zecovir may be taken with or without food.
Swallow the tablet whole with a sufficient amount of liquid, for example a glass of water.

You must start treatment as soon as possible, meaning that, if possible, you should start taking Zecovir:

• within 3 days of the appearance of the first skin symptoms of shingles (skin rash), 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 recommended dose of Zecovir 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 for only 7 days. Do not take this medicine for a second course of treatment.

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 prescribed, contact your doctor. The doctor will decide whether further action is needed.

If you forget to take Zecovir
If you forget to take your tablet at your usual time, take it as soon as you remember. Then take the next tablet the following day at approximately the same time as the previous day. Continue with this new time of administration until the end of the 7-day treatment course.
Do not take a double dose to make up for the missed tablet.
If you repeatedly forget to take your 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 fully effective, the medicine must be taken for 7 days.

If you have any questions about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
Stop taking Zecovir and contact your doctor immediately if you experience an allergic reaction
with signs and symptoms such as itching or skin redness (rash), increased sweating,
swelling (of hands, feet, face, tongue, lips, eyelids or larynx), or 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 (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
• insomnia, drowsiness
• headache
• dizziness
• vertigo
• abnormal sensations such as burning, numbness, tingling, most commonly in arms and legs (paraesthesia)
• increased blood pressure
• indigestion (dyspepsia), vomiting, stomach discomfort
• diarrhoea
• excess 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 (malaise, 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, delirium
► confusion
► 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 skin inflammation occurring repeatedly at the same site over time (fixed eruption), exfoliative skin inflammation (exfoliative dermatitis), severe rash affecting the entire body surface and inside the mouth due to allergic reaction (erythema multiforme), ulceration of the skin, mouth, eyes and genital areas (Stevens-Johnson syndrome)
► restlessness
► mood changes
► depressed mood
► feelings of aggression, agitation, anxiety
► fainting

• Reporting of side effects
  If you experience any side effect, including those not listed in this leaflet, please inform 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 Zecovir

Keep this medicine out of the reach and sight of children.
Do not use this medicine after the expiry date 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 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 Zecovir contains
The active substance is brivudine.
1 tablet of Zecovir contains 125 mg of brivudine.
The other components are:
microcrystalline cellulose
lactose monohydrate
povidone K 24-27
magnesium stearate

Description of the appearance 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 a blister within a box.
Zecovir is available in packs containing 1 and 7 tablets, and in multiple packs comprising 5 cartons, each containing 7 tablets.
It is possible that not all pack sizes are marketed.

Marketing Authorization Holder and Manufacturer
Marketing Authorization 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 EEA Member States under the
following names:
Germany Zostex
Belgium Zonavir
Greece Zostevir
Italy Zecovir
Luxembourg Zonavir