Package Leaflet: Information for the User

TRIDIAVIR 1.000 mg Film-Coated Tablets

Valaciclovir

Read this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, talk to your doctor, pharmacist or nurse. See section 4.

1. What Tridiavir is and what it is used for

2. What you need to know before you start taking Tridiavir

3. How to take Tridiavir

4. Possible side effects

5. Storage of Tridiavir

6. Contents of the pack and additional information

Tridiavir belongs to a group of medications called antivirals. It works by stopping or slowing the growth of viruses called herpes simplex (HSV), varicella zoster (VZV), and cytomegalovirus (CMV).,

Tridiavir can be used for:

• Treating shingles (in adults).
• Treating infections caused by HSV and genital herpes (in adults and adolescents over 12 years old). It is also used to prevent these infections from recurring.
• Treating fevers (in adults and adolescents over 12 years old).
• Preventing CMV infection after organ transplants (in adults and adolescents over 12 years old).
• Treating and preventing eye infections caused by HSV.

Do not take Tridiavir

• If you are allergic (hypersensitive) to valaciclovir or aciclovir or to any of the other components of this medication (including those listed in section 6).
• Do not take Tridiavir if the above point affects you. If you are unsure, speak with your doctor or pharmacist before taking Tridiavir.
• If you have ever developed a prolonged skin rash associated with fever, lymph node enlargement, elevated liver enzyme levels, and/or eosinophilia (drug reaction with eosinophilia and systemic symptoms) after taking valaciclovir.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to take Tridiavir if:

• You have kidney problems or are elderly, your doctor may use a lower dose. Additionally, you must drink enough liquid during treatment to maintain adequate hydration.
• You have liver problems
• You are over 65 years old
• Your immune system is weakened
• You do not expose yourself unnecessarily to strong sunlight and do not use sunlamps or solarium while taking valaciclovir, as you may be more sensitive to the sun while taking valaciclovir tablets (sunburn-type reactions)

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 rash on the face, followed by a prolonged rash with high body temperature, elevated liver enzyme levels observed in blood tests, and an increase in a type of white blood cell (eosinophilia) and enlarged lymph nodes.

If you develop a rash associated with fever and enlarged lymph nodes, stop taking valaciclovir and contact your doctor or seek immediate medical attention.

If you are unsure whether any of the above points affect you, consult your doctor or pharmacist before taking Tridiavir.

Prevention of genital herpes transmission to others

If you are taking Tridiavir to treat or prevent genital herpes, or have had genital herpes in the past, you must practice safe sex, including the use of condoms. This is important to avoid transmitting the infection to others. Do not have sex if you have genital ulcers or blisters.

Use of Tridiavir with other medications

Inform your doctor or pharmacist if you are using or have recently used other medications, including those obtained without a prescription or herbal medications.

Inform your doctor or pharmacist if you are taking any medication that affects the kidneys. These include: aminoglycosides, organoplatinum compounds, iodinated contrast media, methotrexate, pentamidine, foscarnet, cyclosporine, tacrolimus, cimetidine, and probenecid.

Pregnancy, breastfeeding, and fertility

Tridiavir is usually not recommended for use during pregnancy. If you are pregnant, think you may be pregnant, or are planning to become pregnant, do not take Tridiavir without consulting your doctor. Your doctor will weigh the benefits for you against the risk to the baby if you take Tridiavir while pregnant or breastfeeding.

Driving and operating machinery

Tridiavir may cause adverse effects that affect your ability to drive.

→Do not drive or operate machinery unless you are sure it does not affect you.

Tridiavir contains lactose and ethanol

This medication contains lactose. If your doctor has told you that you have a certain sugar intolerance, consult with them before taking this medication.

This medication contains 0.5% ethanol (alcohol), which corresponds to 7.57 mg/tablet.

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The dose you should take will depend on why your doctor prescribed Tridiavir for you. Your doctor will indicate the appropriate dosage.

Herpes zoster treatment

• The usual dose is 1,000 mg (one 1,000 mg tablet or two 500 mg tablets) three times a day.
• You should take Tridiavir for seven days.

Febrile treatment

• The usual dose is 2,000 mg (two 1,000 mg tablets or four 500 mg tablets) twice a day.
• The second dose should be taken 12 hours after the first dose (not before 6 hours).
• You should only take Tridiavir for one day (two doses).

Epidermal and genital herpes virus infections treatment

• The usual dose is 500 mg twice a day.
• For the first infection, you should take Tridiavir for five days or up to ten days if your doctor indicates. For recurrent infections, the treatment duration is usually 3-5 days.

Prevention of recurrent infections by VHS once you have had them

• The usual dose is one 500 mg tablet once a day.
• Some people with frequent recurrences may benefit from taking two 250 mg tablets a day.
• You should take Tridiavir until your doctor tells you to stop.

To avoid infection with CMV (citomegalovirus)

• The usual dose is 2,000 mg (two 1,000 mg tablets or four 500 mg tablets) four times a day..
• You should space the doses 6 hours apart.
• You should start taking Tridiavir as soon as possible after surgery.
• You should take Tridiavir for about 90 days after surgery, until your doctor tells you to stop.

Your doctor may adjust the Tridiavir dose if

• You are over 65 years old.
• You have a weakened immune system.
• You have kidney problems.

Consult your doctor before taking Tridiavir if any of the above points affect you.

If you have any other doubts about the use of this product, ask your doctor or pharmacist.

Medication intake

• Take this medication orally.
• Swallow the tablets whole with a glass of water.
• Take Tridiavir at the same time every day.
• Take Tridiavir according to your doctor's or pharmacist's instructions.

People over 65 years old or with kidney problems

It is very important that while taking Tridiavir, you drink water regularly throughout the day.This will help you reduce the adverse effects that can affect the kidneys or the nervous system. Your doctor will monitor you to detect any signs of this. Nervous system adverse effects may include feeling confused or agitated, or feeling abnormally sleepy or drowsy.

If you take more Tridiavir than you should

Tridiavir is usually not harmful, unless you take too much over several days. If you take too many tablets, you may experience nausea, vomiting, or feel confused, agitated, or abnormally drowsy. If you take more Tridiavir than you should, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, or go to the nearest hospital emergency department immediately. If possible, bring your tablets or the packaging with you so the doctor knows what you have taken.

If you forgot to take Tridiavir

• If you forget to take Tridiavir, take it as soon as you remember. However, if it is almost time for your next dose, omit the missed dose.
• Do not take a double dose to compensate for the missed doses.

Like all medicines, Tridiavir can cause side effects, although not everyone will experience them.

The following side effects may occur with this medicine:

Symptoms to be aware of

• severe allergic reactions(anaphylaxis). These are rare in people taking Tridiavir. Rapid development of symptoms including:

• skin rash with redness, itching
• swelling of the lips, face, neck, and throat, which causes difficulty breathing (angioedema)
• drop in blood pressure leading to collapse

→If you have an allergic reaction, stop taking Tridiavir and see your doctor immediately.

Very common(may affect more than 1 in 10 people):

• headache

Common(may affect up to 1 in 10 people):

• nausea
• dizziness
• vomiting
• diarrhea
• skin reaction after exposure to sunlight (photosensitivity)
• rash

Uncommon(may affect up to 1 in 100 people):

• difficulty breathing (shortness of breath)
• stomach pain
• rash, sometimes with itching, hives (urticaria)
• lower back pain (renal pain)

Side effects that may appear in your blood tests:

• reduction in the number of white blood cells (leucopenia)
• reduction in the number of platelets, which are cells that help blood to clot (trombocytopenia)
• increase in substances produced by the liver.

Very rare(may affect up to 1 in 1,000 people):

• agitation
• confusion
• tremor
• difficulty moving
• difficulty speaking
• confusion or imagination of things (hallucinations)
• seizures
• drowsiness
• encephalopathy (alteration in the brain)
• coma

These neurological side effects usually occur in people with kidney problems, elderly patients, or patients who have undergone transplantation and are taking high doses of 8 grams or more of Tridiavir per day. They usually improve when Tridiavir is stopped or the dose is reduced.

Other rare side effects:

• kidney problems that cause little or no urine to be produced

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

• Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), also known as hypersensitivity reaction or syndrome, which is characterized by a generalized rash, high body temperature, elevated liver enzymes, blood abnormalities (eosinophilia), enlarged lymph nodes, and possible involvement of other organs in the body. See section 2.
• Tubulointerstitial nephritis (inflammation of the kidneys)

If you consider that any of the side effects you experience are severe or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Vigilance of Medicines for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Store at a temperature below 30 °C.

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE drop-off point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Tridiavir

• The active ingredient is valaciclovir.

Each film-coated tablet contains 1,000 mg of valaciclovir as valaciclovir hydrochloride.

• The other components (excipients) are:

Tablet core:pregelatinized cornstarch, lactose monohydrate, povidone, sodium croscarmellose, titanium dioxide (E-171), magnesium stearate, and ethanol.

Coating:hypromellose, titanium dioxide (E-171), macrogol 400, and polysorbate 80 (E-433).

Appearance of the product and contents of the packaging

Tridiavir 1,000 mg tablets are presented in blister packs of 21 film-coated tablets. They are cream-colored, oblong in shape, scored, and can be divided into two equal halves.

Other presentations of Tridiavir:

Tridiavir 500 mg film-coated tablets EFG, 10 or 42 tablets.

Only some package sizes may be commercially available.

Marketing authorization holder and manufacturer responsible

Laboratorios SERRA PAMIES, S.A.

Ctra. Castellvell, 24

43206 REUS (Spain)

Last review date of this leaflet: January 2024

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/