Label: information for the user

Valaciclovir TecniGen 1000 mg film-coated tablets

Read the entire label carefully before starting to take the medication:

• Keep this label, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed for you and should not be given to others, even if they have the same symptoms, as it may harm them.
• If you consider any of the adverse effects you are experiencing to be severe or if you notice any adverse effect not mentioned in this label, inform your doctor or pharmacist.

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 for:

• Treating shingles (in adults).
• Treating skin infections 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).
• Eye infections

Do not take Valaciclovir

Be especially careful with Valaciclovir

Consult 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

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

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

Prevention of genital herpes transmission 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 transmitting the infection to others. Do not have sex if you have genital ulcers or blisters

Use of 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. Always inform your doctor or pharmacist about other medications you are taking if you are taking Valaciclovir TecniGen for the treatment of herpes zoster or after an organ transplant.

Valaciclovir with food and beverages

Valaciclovir TecniGen can be taken with or without food.

Pregnancy and breastfeeding

Valaciclovir TecniGen 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 Valaciclovir TecniGen without consulting your doctor. Your doctor will weigh the benefits for you against the risk to the baby if you take Valaciclovir TecniGen while pregnant or breastfeeding.

Consult your doctor or pharmacist before taking any medication.

Driving and operating machinery

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

Always take Valaciclovir TecniGen exactly as your doctor has instructed. Consult your doctor or pharmacist if you have any doubts.

The dose you should take will depend on why your doctor prescribed Valaciclovir TecniGen for you. Your doctor will inform you of 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 Valaciclovir PharOS 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) after the first dose.

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

Epidermal VHS and genital herpes treatment

• 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 PharOS for 5 days or up to 10 days, if your doctor instructs you. For recurrent infections, the treatment duration is usually 3-5 days.

Prevention of recurrent VHS infections 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 twice a day.
• You should take Valaciclovir TecniGen until your doctor tells you to stop.

To prevent CMV (cytomegalovirus) 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 dose every 6 hours.
• You will usually 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

Speak with your doctor before taking Valaciclovir TecniGen if any of the above points affect you.

Dosage form and/or route of administration

• Take this medication orally.
• Swallow the tablets whole with a glass of water.
• Take Valaciclovir TecniGen at the same time every day.
• Take Valaciclovir TecniGen according to the instructions of 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 regularly throughout the day. This will help reduce the adverse effects that may affect the kidneys or 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 too much Valaciclovir

Valaciclovir TecniGen 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. Speak with your doctor or pharmacist if you take too much Valaciclovir TecniGen. Bring the packaging with you.

In case of overdose or accidental ingestion, consult your doctor, pharmacist, or call the Toxicological Information Service at telephone 91 562 04 20, indicating the medication 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, omit the missed dose.
• Do not take a double dose to compensate for the missed dose.

Like all medicines, valaciclovir may cause side effects, although not everyone will experience them.

Symptoms to be aware of

• Severe adverse reactions (anaphylaxis). These are rare in people taking Valaciclovir TecniGen 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 Valaciclovir TecniGen and see your doctor immediately.

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

• Headache

Common(may affect between 1 and 10 in 100 people)

• Nausea
• Dizziness
• Vomiting
• Diarrhea
• Skin reactions after exposure to sunlight (photosensitivity)
• Rash

Uncommon(may affect between 1 and 10 in 1,000 people):

• Difficulty breathing (dyspnea)
• Abdominal pain
• Rash, sometimes with itching, hives (urticaria)
• Back pain in the lower back (kidney pain)

Abnormalities in your blood tests may also occur:

• Reduction in the number of white blood cells (leucopenia)
• Reduction in the number of platelets, which help blood to clot (thrombocytopenia)
• Increased levels of substances produced by the liver

Rare(may affect between 1 and 10 in 10,000 people):

• Seizures
• Confused or disorganized thoughts

These neurological 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 urination.

Very Rare(may affect fewer than 1 in 10,000 people):

• Agitation
• Confusion
• Tremor
• Difficulty moving
• Difficulty speaking
• Confusion or imagination of things (hallucinations)
• Seizures
• Drowsiness
• Encephalopathy (brain alteration)
• Coma

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

• Drug reaction with eosinophilia and systemic symptoms, also known as drug reaction with eosinophilia and systemic symptoms (DRESS), characterized by a generalized rash, high body temperature, elevated liver enzymes, blood abnormalities (eosinophilia), enlarged lymph nodes, and possible involvement of other body organs. See section 2.
• Tubulointerstitial nephritis (inflammation of the kidneys)

These effects are generally reversible and usually occurred in patients with renal impairment or predisposing factors.

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 Pharmacovigilance 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.

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

Keep out of the reach and sight of children.

Do not use Valaciclovir TecniGen after the expiration date that appears on the packaging. The expiration date (CAD) is the last day of the month indicated.

Do not use this medication if you observe visible signs of deterioration

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and medicines that you do not need at the SIGRE collection pointof the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines that you do not need. In this way, you will help protect the environment.

Composition of Valaciclovir TecniGen

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

The other components areTablet core:Povidone K90, Maize pregelatinised starch, Crospovidone, Anhydrous colloidal silica, Magnesium stearate,Covering:Titanium dioxide (E171), Hypromellose 6cP, Hypromellose 3cP, Polyethylene glycol 400 and Polysorbate 80.

Appearance of the product and contents of the package

Oval-shaped tablets, white in color.

Valaciclovir TecniGen 1000 mg coated tablets with EFG film coating are presented in packages with blisters containing 21 tablets.

Other presentations:

Valaciclovir TecniGen 250 mg coated tablets with EFG film coating: packages of 10 or 42 tablets.

Valaciclovir TecniGen 500 mg coated tablets with EFG film coating: packages of 10 or 42 tablets.

Holder of the marketing authorization and Responsible for manufacturing:

Holder:

Tecnimede España Industria Farmacéutica, S.A.

Avda. de Bruselas, 13, 3rd floor. Edificio América. Arroyo de la Vega Industrial Estate,

28108 Alcobendas (Madrid) SPAIN

Responsible for manufacturing:

ATLANTIC PHARMA - PRODUÇOES FARMACEUTICAS, S.A.

Rua da Tapada Grande, No 2

2710-089 Abrunheira, Sintra, Portugal

This leaflet was revised in October 2022

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