VALACICLOVIR AUROVITAS 1000 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Valaciclovir Aurovitas 1,000 mg Film-Coated Tablets EFG

valaciclovir hydrochloride

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

• 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 only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What Valaciclovir Aurovitas is and what it is used for
2. What you need to know before you take Valaciclovir Aurovitas
3. How to take Valaciclovir Aurovitas
4. Possible side effects
5. Storage of Valaciclovir Aurovitas
6. Contents of the pack and other information

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

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).

Valaciclovir can be used to:

? treat herpes zoster (in adults).

? treat HSV skin and genital herpes infections (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).

? treat and prevent HSV eye infections that keep coming back (in adults and adolescents over 12 years).

2. What you need to know before you take Valaciclovir Aurovitas

Do not take Valaciclovir Aurovitas

? if you are allergic to valaciclovir or aciclovir or any of the other ingredients of this medicine (listed in section 6).

? do not take valaciclovir if the above applies to you. If you are not sure, talk to your doctor or pharmacist before taking valaciclovir.

? if you have ever developed a widespread rash with fever, swollen lymph nodes, increased liver enzymes, and/or eosinophilia (drug reaction with eosinophilia and systemic symptoms) after taking valaciclovir.

Warnings and precautions

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

? you have kidney problems.

? you have liver problems.

? you are over 65 years of age.

? your immune system is weakened.

Drug reaction with eosinophilia and systemic symptoms (DRESS) has been reported with the use of valaciclovir. DRESS appears initially with flu-like symptoms and a rash on the face, then a widespread rash with increased body temperature, increased liver enzymes in blood tests, 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 are not sure if any of the above applies to you, talk to your doctor or pharmacist before taking valaciclovir.

Preventing the spread of genital herpes to others

If you are taking valaciclovir 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 infection from spreading to others. You should not have sexual intercourse if you have genital ulcers or blisters.

Other medicines and Valaciclovir Aurovitas

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

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, cyclosporin, tacrolimus, cimetidine, and probenecid.

Always tell your doctor or pharmacist about other medicines you are taking if you are taking valaciclovir for the treatment of herpes zoster or after an organ transplant.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

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

Driving and using machines

Valaciclovir may cause side effects that affect your ability to drive or use machines.

? do not drive or operate machinery unless you are sure that valaciclovir does not affect you.

3. How to take Valaciclovir Aurovitas

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

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

Treatment of herpes zoster

? 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.

Treatment of cold sores

? the recommended 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 take valaciclovir for only one day (two doses).

Treatment of HSV skin and genital herpes infections

? the recommended dose is 500 mg (one 500 mg tablet) twice 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 normally 3-5 days.

Prevention of recurrent HSV 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 twice a day.

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

To prevent CMV 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 will normally start taking valaciclovir as soon as possible after surgery.

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

Your doctor may adjust the dose of valaciclovir if:

? you are over 65 years of age.

? your immune system is weakened.

? you have kidney problems.

? talk to your doctor before taking valaciclovir if any of the above applies to you.

Use in children under 12 years

Valaciclovir should not be used in children under 12 years.

Taking this medicine

? take this medicine by mouth.

? swallow the tablets whole with a glass of water.

? take valaciclovir at the same time each day.

? take valaciclovir as instructed by your doctor or pharmacist.

Use in elderly patients (over 65 years of age) or with kidney problems

It is very important that while taking valaciclovir 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 Aurovitas than you should

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

Talk to your doctor or pharmacist if you take too much valaciclovir. Take the pack with you. In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, telephone 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Valaciclovir Aurovitas

• if you forget to take valaciclovir, 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 forgotten doses.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. The following side effects can occur with this medicine:

Symptoms to look out for

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, causing difficulty breathing (angioedema).
• drop in blood pressure that leads to collapse.

Skin rashes or redness.The adverse skin reaction can appear as rashes with or without blisters. They can cause skin irritation, edema (DRESS syndrome), and fever and flu-like symptoms.

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 sun exposure (photosensitivity).

? rash.

? itching (pruritus).

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

? feeling confused.

? seeing or hearing things that are not there (hallucinations).

? feeling very sleepy.

? tremors.

? feeling agitated.

These nervous system side effects usually occur in patients with kidney problems, elderly patients, or transplant patients taking high doses of 8 grams or 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).

? pain in the lower back (kidney pain).

? blood in the urine (hematuria).

Uncommon side effects may appear in your blood tests:

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

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

? increase in substances produced by the liver.

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

? lack of coordination and balance (ataxia).

? slow and slurred speech (dysarthria).

? seizures (convulsions).

? altered brain function (encephalopathy).

? unconsciousness (coma).

? confused or disturbed thoughts (delirium).

These nervous system side effects usually occur in patients with kidney problems, elderly patients, or transplant patients taking high doses of 8 grams or 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 urine production.

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

? drug reaction with eosinophilia and systemic symptoms (DRESS), also known as hypersensitivity syndrome, characterized by widespread rash, high body temperature, increased liver enzymes, blood abnormalities (eosinophilia), swollen lymph nodes, and possible involvement of other organs. See also section 2.

? kidney inflammation (tubulointerstitial nephritis).

Reporting of 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 via the Spanish Medicines Surveillance System for Human Use: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Valaciclovir Aurovitas

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

Do not use this medicine after the expiry date which is stated on the blister, carton, or bottle after “EXP”. The expiry date is the last day of the month shown.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

Composition of Valaciclovir Aurovitas

• The active substance is valaciclovir. Each tablet contains valaciclovir hydrochloride (hydrate) equivalent to 1,000 mg of valaciclovir.
• The other ingredients are:

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

Coating:hypromellose, aluminum lake of indigo carmine (E132), titanium dioxide (E171), macrogol 400, polysorbate 80.

Appearance of the product and pack contents

Blue, film-coated, capsule-shaped tablets with a partial score line 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 high-density polypropylene (HDPE) bottles.

Pack sizes:

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

Bottle:30 and 500 film-coated tablets.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Aurovitas Spain, S.A.U.

Avenida de Burgos, 16-D

28036 Madrid

Spain

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 the European Economic Area under the following names:

Spain: Valaciclovir Aurovitas 1,000 mg film-coated tablets EFG

Italy: Valaciclovir Aurobindo 1000 mg film-coated tablets

Portugal: Valaciclovir Aurobindo

Date of last revision of this leaflet:May 2023

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