Leaflet: information for the user

Valaciclovir Aurovitas 1.000 mg film-coated tablets EFG

valaciclovir hydrochloride

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 or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1.What is Valaciclovir Aurovitas and what it is used for

2.What you need to know before you start taking Valaciclovir Aurovitas

3.How to take Valaciclovir Aurovitas

4.Possible side effects

5.Storage of Valaciclovir Aurovitas

6.Contents of the pack and additional information

Valaciclovir Aurovitas 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).,varicella zoster (VZV) and cytomegalovirus (CMV).

Valaciclovir can be used for:

?to treat shingles (in adults).

?to treat skin infections and genital herpes (in adults and adolescents over 12 years old). It is also used to prevent these infections from recurring.

?to treat fevers (in adults and adolescents over 12 years old).

?to prevent CMV infection after organ transplants (in adults and adolescents over 12 years old).

?to treat and prevent recurring eye infections caused by HSV (in adults and adolescents over 12 years old).

Do not take Valaciclovir Aurovitas

?If you are allergic to valaciclovir or aciclovir or any of the other components of this medication (listed in section 6).

?Do not take valaciclovir if the above point affects you. If you are unsure, speak with your doctor or pharmacist before taking valaciclovir.

?If you have ever developed a generalized rash associated with fever, lymph node inflammation, elevated liver enzyme levels, and/or eosinophilia (drug reaction with eosinophilia and systemic symptoms) after taking valaciclovir.

Warnings and precautions

Consult your doctor or pharmacist before taking Valaciclovir Aurovitas 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 presents with flu-like symptoms and a rash on the face, followed by a generalized rash with increased body temperature, elevated liver enzyme levels in blood tests, an increase in a type of white blood cell (eosinophilia), and lymph node inflammation.

If you develop a rash associated with fever and lymph node inflammation, 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 valaciclovir.

Prevention of genital herpes transmission to others

If you are taking valaciclovir 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 prevent transmitting the infection to others. Do not have sex if you have genital ulcers or blisters.

Other medications andValaciclovir Aurovitas

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

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 for the treatment of shingles or after an organ transplant.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

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

Driving and operating machinery

Valaciclovir 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.

Follow exactly and carefully 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 valaciclovir for you. Your doctor will tell you the appropriate dosage.

Herpes zoster treatment

?The recommended dose is 1,000 mg (one 1,000 mg tablet or two 500 mg tablets) three times a day.

?You should take valaciclovir for seven days.

CMV fever treatment

?The recommended dose is 2,000 mg (two 1,000 mg tablets or four 500 mg tablets) two times a day.

?The second dose should be taken 12 hours after the first dose (not before 6 hours).

?You should only take valaciclovir for one day (two doses).

Herpes simplex skin and genital infections treatment

?The recommended dose is 500 mg (one 500 mg tablet) two times a day.

?For the first infection, you should take valaciclovir for five days or up to ten days if your doctor tells you to. For recurrent infections, the treatment duration is usually 3-5 days.

Prevention of recurrent VHS infections once you have had them

?The recommended dose is one 500 mg tablet once a day.

?Some people with frequent recurrences may benefit from taking 250 mg two times a day.

?You should take valaciclovir until your doctor tells you to stop.

To prevent CMV (citomegalovirus) infection

?The recommended 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 valaciclovir as soon as possible after surgery.

?You should take valaciclovir for about 90 days after surgery, until your doctor tells you to stop.

Your doctor may adjust the valaciclovir dose if:

?You are over 65 years old.

?You have a weakened immune system.

?You have kidney problems.

?Speak with your doctor before taking valaciclovir if any of the above points affect you.

Use in children under 12 years

Valaciclovir should not be used in children under 12 years.

Taking this medication

?Take this medication orally.

?Swallow the tablets whole with a glass of water.

?Take valaciclovir at the same time every day.

?Take valaciclovir according to the instructions of your doctor or pharmacist.

Use in elderly people (over 65 years old) or with kidney problems

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

If you take more Valaciclovir Aurovitas than you should

Valaciclovir is usually not harmful, unless you take too much over several days. If you take too many tablets, you may experience nausea, vomiting, kidney problems, feel confused, agitated, feel less attentive, see things that are not really there, or become unconscious.

Speak with your doctor or pharmacist if you take too much valaciclovir. Bring the packaging with you.In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take Valaciclovir Aurovitas

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

If you have any other questions about taking this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects,although not everyone will experience them.This medicine can cause the following side effects:

Symptoms to be aware of

Stop taking valaciclovir and seek medical attention immediately if you notice any of the following symptoms:

?severe allergic reactions (anaphylaxis).These are rare in people taking valaciclovir. 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.

Skin rashes or redness.The skin reaction can appear as rashes with or without blisters. It can cause skin irritation, edema (DRESS syndrome), fever, and symptoms similar to the flu.

The following side effects can also occur with this medicine:

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.

?itching (pruritus).

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

?feeling confused.

?seeing or hearing things that do not exist (hallucinations).

?feeling very drowsy.

?tremors.

?feeling agitated.

These neurological side effects usually occur in patients with kidney problems, elderly patients, or transplant patients taking high doses of8 gramsor more of valaciclovir per day. They usually improve when valaciclovir is stopped or the dose is reduced.

Other uncommon side effects:

?difficulty breathing (dyspnea).

?stomach pain.

?rash, sometimes with itching, hives (urticaria).

?lower back pain (renal pain).

?blood in the urine (hematuria).

May appear in blood tests:

?reduction in the number of white blood cells (leucopenia).

?reduction in the number of platelets, which help blood to clot (thrombocytopenia).

?increase in substances produced by the liver.

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

?unsteadiness and lack of coordination (ataxia).

?slow and slurred speech (dysarthria).

?seizures (convulsions).

?altered brain function (encephalopathy).

?loss of consciousness (coma).

?confused or disordered thoughts (delirium).

These neurological side effects usually occur in people with kidney problems, elderly patients, or transplant patients taking high doses of8 gramsor more of valaciclovir per day. They usually improve when valaciclovir is stopped or the dose is reduced.

Other rare side effects:

?kidney problems that cause little or no urination.

Unknown frequency(cannot be estimated with available data):

?drug reaction with eosinophilia and systemic symptoms (DRESS or drug hypersensitivity syndrome), characterized by generalized rash, high body temperature, elevated liver enzymes, blood abnormalities (eosinophilia), lymph node inflammation, and possible involvement of other body organs. See section 2.

?inflammation of the kidneys (tubulointerstitial nephritis).

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 Medicinal Products for Human Use: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.

Do not use this medication after the expiration date that appears on theblister, the boxor the bottle, after “CAD”. The expiration date is the last day of the month indicated.

This medicationdoes not require special storage conditions.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of packaging and medications you no longer need. This will help protect the environment.

Composition of Valaciclovir Aurovitas

-The active ingredient is valaciclovir. Each tablet contains valaciclovir hydrochloride (hydrate) equivalent to 1,000 mg of valaciclovir.

-The other components are:

Core:microcrystalline cellulose (E460), crospovidone (type A), povidone K90, magnesium stearate.

Covering:hypromellose, indigotin aluminum lake (E132), titanium dioxide (E171), macrogol 400, polysorbate 80.

Appearance of the product and contents of the package

Coated tablets with a blue filmcoating, in capsule shape,with a partial notch on both sides, with the marks “F” on one side and “8” and “3”on the other.

The tablet can be divided into equal doses.

Valaciclovir Aurovitas is available in PVC/PVdC-Aluminum blister packs or in high-density polypropylene (PEAD) bottles.

Packaging sizes:

Blister:7, 10, 21, 30, 42, 50, 90, and 112 coated tablets.

Bottle:30 and 500 coated tablets.

Only some packaging sizes may be commercially available.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Responsible manufacturer

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

This medicine is authorized in the member states of theEuropean Economic Areawith the following names:

Spain:Valaciclovir Aurovitas 1,000 mg coated tablets EFG

Italy:Valaciclovir Aurobindo 1000 mg coated tablets with film

Portugal:Valaciclovir Aurobindo

Date of the last review of this leaflet:May 2023

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