Talavir

Patient Information Leaflet

Talavir 500 mg film-coated tablets, 1000 mg film-coated tablets

valaciclovir
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. Do not give it to others, even if they have the same symptoms as yours, as it may 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 Talavir is and what it is used for
2. What you need to know before taking Talavir
3. How to take Talavir
4. Possible side effects
5. How to store Talavir
6. Contents of the pack and other information

1. What Talavir is and what it is used for

Talavir contains the active substance valaciclovir, which belongs to a group of medicines called antivirals. Talavir works by killing or inhibiting the growth of viruses known as Herpes simplex (HSV), varicella zoster (VZV), and Cytomegalovirus (CMV).
Talavir is indicated for:

• treating herpes zoster (shingles) and ocular zoster in adults with normal immune system function.
• treating herpes zoster (shingles) in adults with mildly or moderately impaired immune system function.
• treating and suppressing herpes simplex infections of the skin and mucous membranes in adults and adolescents over 12 years of age, and in adults with compromised immune system function:
  o treatment of the first episode of genital herpes.
  o treatment and suppression of recurrent genital herpes infections.
• treating and preventing recurrence of herpes simplex eye infections in adults and adolescents over 12 years of age, and in adults with compromised immune system function.
• treatment of cold sores in adults and adolescents over 12 years of age.
• prevention of Cytomegalovirus (CMV) infections following organ transplantation in adults and adolescents over 12 years of age.

2. What you need to know before taking Talavir

Do not take Talavir

• if you are allergic to valaciclovir, aciclovir, or any of the other ingredients of this medicine (listed in section 6).
• if you have previously developed a widespread skin rash associated with fever, swollen lymph nodes, increased liver enzyme levels, and/or eosinophilia (drug reaction with eosinophilia and systemic symptoms) after taking valaciclovir.

Warnings and precautions
Talk to your doctor or pharmacist before taking Talavir if:

• you have kidney problems.
• you have liver problems.
• you are over 65 years old.
• your immune system is weakened.

If you are unsure whether any of the above applies to you, consult your doctor or pharmacist before taking Talavir.
Pay particular attention:

• If you are taking Talavir to treat or prevent genital herpes or if you have previously had genital herpes, you should practice protected sex, including using a condom. This is important to prevent transmission of the infection to others. While taking Talavir, it is very important that you drink water regularly throughout the day, especially if you are elderly or have kidney problems. This will help reduce unwanted effects that may affect the kidneys or the nervous system. Your doctor will monitor you closely for signs of these effects.
• Drug reaction with eosinophilia and systemic symptoms (DRESS) has been reported with the use of valaciclovir. DRESS initially presents with flu-like symptoms and a skin rash on the face, followed by a widespread rash, high body temperature, increased liver enzyme levels observed in blood tests, increased eosinophils (a type of white blood cell) (eosinophilia), and swollen lymph nodes. If you develop a skin rash associated with fever and swollen lymph nodes, stop taking valaciclovir and contact your doctor or seek immediate medical advice immediately.

Children
Talavir must not be used in children under 12 years of age.

Other medicines and Talavir
Inform your doctor or pharmacist if you are currently using, have recently used, or might use any other medicines.
Tell your doctor or pharmacist if you are taking any other medicines, including:

• aminoglycosides (antibiotics),
• platinum-containing compounds (anticancer agents),
• iodinated contrast media,
• methotrexate (anticancer agent),
• pentamidine (antibiotic),
• foscarnet (antiviral),
• ciclosporin (immunosuppressant),
• tacrolimus (immunosuppressant used to prevent transplant rejection),
• cimetidine (anti-acid),
• probenecid (used to promote uric acid excretion),
• tenofovir (antiviral).

Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, are planning to become pregnant, or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
In general, the use of Talavir is not recommended during pregnancy. If you are pregnant, think you might be, or are planning a pregnancy, do not take Talavir without first consulting your doctor.
Your doctor will assess the benefit to you and the risk to your baby of taking Talavir during pregnancy or while breastfeeding.

Driving and using machines
Talavir may cause side effects that affect your ability to drive or operate machinery.
Do not drive or use machinery unless you are certain you will not be affected.

3. How to take Talavir

Take this medicine exactly as directed by your doctor. If you have any doubts, consult your
doctor or pharmacist.
The dose you should take depends on the reason your doctor has prescribed Talavir for you. Your doctor
will tell you how much Talavir to take and for how long.

Treatment of Herpes zoster (shingles) and ocular zoster
Use in adults with normal immune system function

• The recommended dose is 1000 mg (1 tablet of 1000 mg or 2 tablets of 500 mg) three times a day for seven days.

Use in adults with impaired immune system function

• The recommended dose is 1000 mg (1 tablet of 1000 mg or 2 tablets of 500 mg) three times a day for at least seven days and for an additional 2 days after scab formation.

Treatment of Herpes simplex infections of the skin and mucous membranes
Use in adults and adolescents over 12 years of age with normal immune system function

• The recommended dose is 500 mg (1 tablet of 500 mg) twice a day.
• For the first infection, you may need to take Talavir for up to ten days if recommended by your doctor.
• For recurrent infections, the treatment duration is usually 3 to 4 days.

Treatment of cold sores (Herpes labialis)

• The recommended dose is 2000 mg (2 tablets of 1000 mg or 4 tablets of 500 mg) twice a day for one day only.
• The second dose should be taken 12 hours (but not earlier than 6 hours) after the first dose.

Use in adults with impaired immune system function

• The recommended dose is 1000 mg (1 tablet of 1000 mg or 2 tablets of 500 mg) twice a day for at least 5 days.
• For the first infection, you may need to take Talavir for up to ten days if recommended by your doctor.

Suppression of recurrent Herpes simplex infections
Use in adults and adolescents over 12 years of age with normal immune system function

• The recommended dose is 500 mg (1 tablet of 500 mg) once a day.
• You should continue taking Talavir until your doctor tells you to stop.

Use in adults with impaired immune system function

• The recommended dose is 500 mg (1 tablet of 500 mg) twice a day.
• You should continue taking Talavir until your doctor tells you to stop.

Prevention of Cytomegalovirus infection

• The recommended dose is 2000 mg (2 tablets of 1000 mg or 4 tablets of 500 mg) four times a day.
• You will usually start taking Talavir as soon as possible after transplantation.
• You will need to take Talavir for 90 days after transplantation or until your doctor tells you to stop.

How to take the medicine

• Take the tablets by mouth.
• Swallow the tablets whole with a glass of water.
• Take Talavir at the same time each day.
• Take Talavir as instructed by your doctor or pharmacist.

Use in elderly patients and patients with kidney problems
In elderly patients and patients with kidney problems, the dose may need to be adjusted. Your
doctor will tell you how much Talavir to take. It is very important while taking Talavir that
you drink water regularly throughout the day.

If you take more Talavir than you should
If you accidentally take too much Talavir, contact your doctor immediately or go to the nearest hospital.
Take the medicine pack with you.
Talavir is generally not harmful unless taken in excessive amounts over several days. If you take too many
tablets, you may experience nausea, vomiting, kidney problems, confusion, agitation, reduced awareness,
hallucinations (seeing things that are not there), or loss of consciousness.

If you forget to take Talavir

• If you forget to take Talavir, take it as soon as you remember. However, if it is almost time for your next dose according to your prescription, skip the missed dose.
• Do not take a double dose to make up for the missed dose.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Conditions to which you should pay attention

• Severe allergic reactions (anaphylaxis). These are rare in people taking Talavir. Rapid onset of symptoms including: flushing, itchy rash on the skin, or swelling of the lips, face, neck, and throat causing difficulty in breathing (angioedema), or sudden drop in blood pressure leading to collapse. If you have an allergic reaction, stop taking Talavir and contact your doctor immediately.

The following side effects may occur with this medicine:
Very common side effects (may affect more than 1 in 10 people)

• Headache.

Common side effects (may affect up to 1 in 10 people)

• Nausea
• Dizziness
• Vomiting
• Diarrhea
• Skin rashes, even after exposure to sunlight (photosensitivity)
• Itching

Uncommon side effects (may affect up to 1 in 100 people)

• Confusion
• Reduced level of consciousness
• Seeing or hearing things that are not there (hallucinations)
• Tremors
• Agitation
• Shortness of breath (dyspnea)
• Stomach discomfort
• Skin rash, sometimes with itching, hives
• Lower back pain (renal pain)
• Blood in the urine (haematuria)
• Decrease in the number of white blood cells (leucopenia)
• Decrease in the number of platelets in the blood (thrombocytopenia)
• Reversible changes in liver function tests

Rare side effects (may affect up to 1 in 1,000 people)

• Severe allergic reactions
• Unsteadiness while walking and lack of coordination (ataxia)
• Slurred or impaired speech (dysarthria)
• Seizures
• Altered brain function (encephalopathy)
• Loss of consciousness (coma)
• Mental problems
• Confused or disturbed thinking (delirium)
• Swelling due to fluid accumulation, especially of the face, mouth, and eyes (angioedema)
• Kidney problems, even severe (acute kidney impairment and failure)

Frequency not known (frequency cannot be estimated from the available data):

• Drug reaction with eosinophilia and systemic symptoms, also known as DRESS or drug hypersensitivity syndrome, characterized by widespread skin rash, high body temperature, increased liver enzymes, blood abnormalities (eosinophilia), swollen lymph nodes, and possibly involvement of other organs (see also section “Warnings and precautions”).
• Inflammation of the kidneys (tubulointerstitial nephritis).

Reporting of side effects
If you experience any side effect, 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 Talavir

Store below 30°C.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack after Exp.
The expiry date refers to the last day of that month.
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 Talavir contains

• The active substance is valaciclovir hydrochloride. Each tablet contains 250 mg, 500 mg or 1000 mg of valaciclovir (as valaciclovir hydrochloride).
• The other components are:
  Tablet core: microcrystalline cellulose, crospovidone, povidone K90, magnesium stearate, anhydrous colloidal silica.
  Coating: hypromellose, titanium dioxide, macrogol 400, polysorbate 80 (only for 500 mg and 1000 mg tablets), carnauba wax.

Description of the appearance of Talavir and the contents of the pack
Talavir tablets are contained in polyvinyl chloride/aluminum blisters.
Talavir 500 mg tablets are available in packs containing 10, 30, 42, 90 or 112 film-coated tablets.
Talavir 1000 mg tablets are available in packs containing 21 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Alfasigma S.p.A. - Via Ragazzi del '99, n. 5 - 40133 Bologna (BO)
Manufacturer
Alfasigma S.p.A. - Via Pontina km 30,400 - 00071 Pomezia (RM)