VALACICLOVIR TECNIGEN 1000 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Valaciclovir TecniGen 1000 mg film-coated tablets EFG

Read all of this leaflet carefully before you start taking this medicine:

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you, do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

Contents of the pack:

1. What is Valaciclovir TecniGen and what is it used for
2. What you need to know before you take Valaciclovir TecniGen
3. How to take Valaciclovir TecniGen
4. Possible side effects
5. Storing Valaciclovir TecniGen
6. Further information

1. What is VALACICLOVIR TECNIGEN and what is it used for

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

Valaciclovir can be used to:

• Treat shingles (in adults).
• Treat HSV skin infections, including genital herpes (in adults and adolescents over 12 years). It is also used to prevent these infections from coming back.
• Treat cold sores (in adults and adolescents over 12 years).
• Prevent CMV infection after organ transplants (in adults and adolescents over 12 years).
• Eye infections

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE VALACICLOVIR TECNIGEN

Do not take Valaciclovir

• If you are allergic (hypersensitive) to valaciclovir, aciclovir, or any of the other ingredients of this medicine (see section 6).
• Do not take Valaciclovir TecniGen if the above applies to you. If you are not sure, talk to your doctor or pharmacist before taking Valaciclovir TecniGen.
• If you have ever developed a prolonged rash associated with fever, swollen lymph nodes, increased liver enzymes, and/or eosinophilia (drug reaction with eosinophilia and systemic symptoms) after taking valaciclovir.

Be cautious with Valaciclovir

Talk to your doctor or pharmacist before taking Valaciclovir TecniGen if:

• You have kidney problems
• You have liver problems
• You are over 65 years old
• Your immune system is weakened

Drug reaction with eosinophilia and systemic symptoms (DRESS) has been reported with the use of valaciclovir. DRESS initially appears with symptoms similar to the flu and a rash on the face, followed by a prolonged rash with high body temperature, increased liver enzymes observed in blood tests, and an increase in a type of white blood cell (eosinophilia) and swollen lymph nodes.

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

If you have kidney disease or are elderly, your doctor may use a lower dose. You should also drink enough liquid during treatment to maintain adequate hydration.

If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before taking Valaciclovir TecniGen.

Preventing the spread of genital herpes to others

If you are taking Valaciclovir TecniGen to treat or prevent genital herpes, or have had genital herpes in the past, you should practice safe sex, including the use of condoms. This is important to prevent the spread of infection to others. You should not have sexual intercourse if you have genital ulcers or blisters.

Using other medicines

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

Tell your doctor or pharmacist if you are taking any medicine that affects the kidneys. These include aminoglycosides, platinum compounds, iodinated contrast media, methotrexate, pentamidine, foscarnet, cyclosporine, tacrolimus, cimetidine, and probenecid. Always tell your doctor or pharmacist about other medicines you are taking if you are taking Valaciclovir TecniGen for the treatment of shingles or after an organ transplant.

Taking Valaciclovir with food and drinks

Valaciclovir TecniGen can be taken with or without food.

Pregnancy and breastfeeding

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

Consult your doctor or pharmacist before taking any medicine.

Driving and using machines

Valaciclovir TecniGen may cause side effects that affect your ability to drive. Do not drive or use machines unless you are sure it does not affect you.

3. HOW TO TAKE VALACICLOVIR

Always take Valaciclovir TecniGen exactly as your doctor has told you. If you are not sure, talk to your doctor or pharmacist.

The dose you should take will depend on why your doctor has prescribed Valaciclovir TecniGen for you. Your doctor will tell you the right dose.

Treatment of shingles

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

Treatment of cold sores

• 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) after the first dose.

You should take Valaciclovir TecniGen only for one day (two doses).

Treatment of HSV skin infections and genital herpes

• The usual dose is 500 mg (one 500 mg tablet or two 250 mg tablets) twice a day.
• For the first infection, you should take Valaciclovir TecniGen for 5 days or up to 10 days if your doctor tells you to. For recurrent infections, the usual treatment duration is 3-5 days.

Prevention of recurrent HSV infections

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

For preventing CMV infection

• 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 every 6 hours.
• Usually, you will start taking Valaciclovir TecniGen as soon as possible after surgery.
• You should take Valaciclovir TecniGen for about 90 days after surgery, until your doctor tells you to stop.

Your doctor may adjust the dose of Valaciclovir TecniGen if:

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

Talk to your doctor before taking Valaciclovir TecniGen if any of the above applies to you.

Method of administration

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

People over 65 years old or with kidney problems

It is very important that while taking Valaciclovir TecniGen, you drink water regularlythroughout the day. This will help reduce the side effects that can affect the kidneys or nervous system. Your doctor will monitor you for signs of this. Nervous system side effects can include feeling confused or agitated, or feeling abnormally sleepy or drowsy.

If you take more Valaciclovir than you should

Valaciclovir TecniGen is not normally harmful, unless you take too much for several days. If you take too many tablets, you may feel sick, vomit, or feel confused, agitated, or abnormally drowsy. Talk to your doctor or pharmacist if you take too much Valaciclovir TecniGen. Take the pack with you.

In case of overdose or accidental ingestion, consult your doctor, pharmacist, or call the Toxicological Information Service telephone 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Valaciclovir

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

4. Possible side effects

Like all medicines, valaciclovir can cause side effects, although not everybody gets them.

Symptoms to look out for

• Severe allergic reactions (anaphylaxis). These are rare in people taking Valaciclovir TecniGen. Rapid development of symptoms, including:

• Rash with redness, itching
• Swelling of the lips, face, neck, and throat, causing difficulty breathing (angioedema)
• Drop in blood pressure leading to collapse
• If you have an allergic reaction, stop taking Valaciclovir TecniGen and go to the 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 reactions after sun exposure (photosensitivity)
• Rash

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

• Difficulty breathing (dyspnea)
• Stomach pain
• Rash, sometimes with itching, hives (urticaria)
• Back pain (kidney pain)

Uncommon side effects may appear in your blood tests:

• Decrease in the number of white blood cells (leukopenia)
• Decrease in the number of platelets that help blood clot (thrombocytopenia)
• Increased liver enzymes

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

• Seizures
• Confused or disordered thinking

These nervous system side effects usually occur in people with kidney problems, the elderly, or transplant patients taking high doses of 8 grams or more of Valaciclovir TecniGen per day. They usually improve when Valaciclovir TecniGen is stopped or the dose is reduced.

Other rare side effects:

• Kidney problems that cause little or no urine production.

Very rare(may affect less than 1 in 1,000 people):

• Agitation
• Confusion
• Tremors
• Difficulty moving
• Difficulty speaking
• Confusion or imagining things (hallucinations)
• Seizures
• Drowsiness
• Encephalopathy (brain disorder)
• Coma

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

• Drug reaction with eosinophilia and systemic symptoms, also known as hypersensitivity syndrome or DRESS, characterized by a widespread rash, high body temperature, elevated liver enzymes, blood abnormalities (eosinophilia), swollen lymph nodes, and possibly involvement of other organs. See also section 2.
• Kidney inflammation (tubulointerstitial nephritis)

These effects are usually reversible and normally occurred in patients with kidney problems or predisposing factors.

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

Reporting side effects

If you experience 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 Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing VALACICLOVIR TECNIGEN

Do not store above 30°C. Store in the original package

Keep out of the reach and sight of children.

Do not use Valaciclovir TecniGen after the expiry date stated on the package. The expiry date is the last day of the month shown.

Do not use this medicine if you notice visible signs of deterioration.

Medicines should not be disposed of via wastewater or household waste. Return the package and any unused medicine to the pharmacy. If you are unsure, ask your pharmacist how to dispose of the package and any unused medicine. This will help protect the environment.

6. FURTHER INFORMATION

Composition of Valaciclovir TecniGen

The active ingredient is valaciclovir. Each film-coated tablet contains 1112.40 mg of valaciclovir hydrochloride, equivalent to 1000 mg of valaciclovir.

The other ingredients are Core of the tablet:Povidone K90, pregelatinized corn starch, crospovidone, colloidal anhydrous silica, magnesium stearate, Coating:titanium dioxide (E171), hypromellose 6cP, hypromellose 3cP, polyethylene glycol 400, and polysorbate 80.

Appearance and packaging of the product

White, oblong tablets.

Valaciclovir TecniGen 1000 mg film-coated tablets EFG are available in blister packs containing 21 tablets.

Other presentations:

Valaciclovir TecniGen 250 mg film-coated tablets EFG: packs of 10 or 42 tablets.

Valaciclovir TecniGen 500 mg film-coated tablets EFG: packs of 10 or 42 tablets.

Marketing authorization holder and manufacturer:

Holder:

Tecnimede España Industria Farmacéutica, S.A.

Avenida de Bruselas, 13, 3º D. Edificio América. Polígono Arroyo de la Vega,

28108 Alcobendas (Madrid) SPAIN

Manufacturer:

ATLANTIC PHARMA - PRODUÇOES FARMACEUTICAS, S.A.

Rua da Tapada Grande, No 2

2710-089 Abrunheira, Sintra, Portugal

This leaflet was revised in October 2022

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.es/