Valaciclovir Aurovitas 1000 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Valaciclovir Aurovitas 1,000 mg film-coated tablets EFG

valaciclovir hydrochloride

Read the entire 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, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Valaciclovir Aurovitas is and what it is used for
2. What you need to know before taking Valaciclovir Aurovitas
3. How to take Valaciclovir Aurovitas
4. Possible adverse effects
5. How to store 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 eliminating or stopping the growth of viruses known as herpes simplex virus (HSV), varicella zoster virus (VZV), and cytomegalovirus (CMV).

Valaciclovir can be used for:

• treating shingles (in adults).

• treating skin infections caused by HSV and genital herpes (in adults and adolescents over 12 years of age). It is also used to prevent these infections from recurring.

• treating cold sores (in adults and adolescents over 12 years of age).

• preventing CMV infection after organ transplantation (in adults and adolescents over 12 years of age).

• treating and preventing recurrent HSV eye infections (in adults and adolescents over 12 years of age).

2. What you need to know before taking Valaciclovir Aurovitas

Do not take Valaciclovir Aurovitas

? If you are allergic to valaciclovir, 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 unsure, speak with your doctor or pharmacist before taking valaciclovir.

? If you have ever developed a widespread rash associated with fever, swollen lymph nodes, increased liver enzyme levels, 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 initially presents with flu-like symptoms and a rash on the face, followed by a generalized rash, fever, elevated liver enzymes in blood tests, an increase in a type of white blood cells (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 immediate medical attention.

If you are unsure whether any of the above apply to you, consult your doctor or pharmacist before taking valaciclovir.

Preventing transmission 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 using condoms. This is important to avoid spreading the infection to others. You should not have sexual intercourse if you have genital ulcers or blisters.

Other medicines and Valaciclovir Aurovitas

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Tell your doctor or pharmacist if you are taking any medicine that affects the kidneys. These include: aminoglycosides, platinum-containing compounds, iodinated contrast media, methotrexate, pentamidine, foscarnet, ciclosporin, tacrolimus, cimetidine, and probenecid.

Always inform your doctor or pharmacist about any other medicines you are taking if you are using 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 plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Valaciclovir is generally 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 to you against the risks to the baby if you take valaciclovir during pregnancy or while breastfeeding.

Driving and using machines

Valaciclovir may cause side effects that could affect your ability to drive.

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

3. How to take Valaciclovir Aurovitas

Follow exactly the instructions for use of this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The dose you should take will depend on why your doctor has prescribed valaciclovir to you. Your doctor will tell you the appropriate dosage.

Treatment of herpes zoster

• The recommended dose is 1,000 mg (one 1,000 mg tablet or two 500 mg tablets) three times daily.

• 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 daily.

• The second dose should be taken 12 hours after the first dose (not earlier than 6 hours).

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

Treatment of skin HSV infections and genital herpes

• The recommended dose is 500 mg (one 500 mg tablet) twice daily.

• For the first infection, you should take valaciclovir for five days or up to ten days if your doctor instructs you to do so. For recurrent infections, the treatment duration is usually 3–5 days.

Prevention of recurrent HSV infections once they have occurred

• The recommended dose is one 500 mg tablet once daily.

• Some people with frequent recurrences may benefit from taking 250 mg twice daily.

• You should continue taking valaciclovir until your doctor tells you to stop treatment.

To prevent CMV (cytomegalovirus) infection

• The recommended dose is 2,000 mg (two 1,000 mg tablets or four 500 mg tablets) four times daily.

• Doses should be spaced 6 hours apart.

• You will usually 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 treatment.

Your doctor may adjust your valaciclovir dose if:

• you are over 65 years of age.

• you have a weakened immune system.

• you have kidney problems.

• Talk to your doctor before taking valaciclovir if any of the above apply to you.

Use in children under 12 years of age

Valaciclovir must not be used in children under 12 years of age.

How to take 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 according to the instructions given by your doctor or pharmacist.

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

It is very important that while taking valaciclovir you drink water regularly throughout the day. This will help reduce adverse effects that may affect the kidneys or nervous system. Your doctor will monitor you for signs of such effects. Nervous system side effects may include confusion, agitation, or feeling abnormally sleepy or drowsy.

If you take more Valaciclovir Aurovitas than you should

Valaciclovir is usually not harmful unless taken in excess over several days. If you take too many tablets, you may experience nausea, vomiting, kidney problems, confusion, agitation, reduced alertness, seeing things that are not really there (hallucinations), or loss of consciousness.

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

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 a missed dose.

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

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them. The following adverse effects may occur with this medicine:

Symptoms to watch for

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

? Severe allergic reactions (anaphylaxis). These are rare in people taking valaciclovir. Rapid onset of symptoms including:

• Skin rash with redness, itching.
• Swelling of the lips, face, neck, and throat, causing difficulty breathing (angioedema).
• Drop in blood pressure leading to collapse.

Skin rashes or redness. Skin adverse reactions may appear as rashes with or without blisters. Skin irritation, edema (DRESS syndrome), fever, and flu-like symptoms may also occur.

The following side effects may 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 drowsy.

? Tremors.

? Feeling restless.

These nervous system adverse 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 discontinued or the dose is reduced.

Other uncommon adverse 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 adverse effects may also appear in blood tests:

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

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

? Increase in substances produced by the liver.

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

? Unsteadiness when walking and lack of coordination (ataxia).

? Slurred or slow speech (dysarthria).

? Seizures (convulsions).

? Altered brain function (encephalopathy).

? Loss of consciousness (coma).

? Confused or disturbed thoughts (delirium).

These nervous system adverse effects usually occur in people 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 discontinued or the dose is reduced.

Other rare adverse effects:

? Kidney problems causing reduced or no urine output.

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

? Drug Reaction with Eosinophilia and Systemic Symptoms, also known as DRESS or drug hypersensitivity syndrome, characterized by widespread rash, high body temperature, elevated liver enzymes, blood abnormalities (eosinophilia), swollen lymph nodes, and possible involvement of other organs. See also section 2.

? Inflammation of the kidneys (tubulointerstitial nephritis).

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaram.es. By reporting adverse 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 stated on the blister pack, the carton or the bottle, following "EXP". The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Unused medicines and their containers should be handed over to the SIGRE Point at your pharmacy. Ask your pharmacist how to dispose of medicines and containers you no longer need. This 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 components are:

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

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

Appearance of the product and contents of the pack

Film-coated blue, capsule-shaped tablets, with a partial score line on both sides, marked “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 (HDPE) bottles.

Pack sizes:

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

Bottles: 30 and 500 film-coated tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Aurovitas Spain, S.A.U.

Avda. 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 medicinal product is authorized in the Member States of the European Economic Area (EEA) 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 the most recent revision of this leaflet: May 2023

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