Zovirax 200 mg dispersible tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Zovirax 200 mg dispersible tablets

aciclovir

Read the entire leaflet carefully before you start taking this medicine, as 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.

Leaflet contents

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

1. What Zovirax is and what it is used for

Zovirax contains the active substance aciclovir. It belongs to a group of medicines called antivirals. It works by stopping the growth of certain viruses.

Zovirax can be used to:

• treat skin and mucous membrane infections caused by the herpes simplex virus (cold sores, genital herpes, and other herpes simplex infections)
• prevent recurrences of recurrent herpes simplex infections (to prevent these problems from returning after they have occurred)
• prevent herpes simplex infections in immunocompromised patients (to avoid these problems in people whose immune system does not work properly, meaning their bodies are less able to fight infections)
• treat chickenpox and shingles (herpes zoster)

2. What you need to know before starting to take Zovirax

Do not take Zovirax:

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take Zovirax:

• If you have a kidney disease or are elderly. Your doctor may need to reduce your dose. You should also drink an adequate amount of fluid during treatment to maintain proper hydration.
• If you have genital herpes infection, it is recommended to take precautions during sexual intercourse even after antiviral treatment has been initiated.

Taking Zovirax with other medicines

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

Inform your doctor if you have recently taken probenecid, cimetidine, or mycophenolate mofetil (a medicine used in transplant patients).

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Aciclovir passes into breast milk. Contact your doctor or pharmacist if you are breastfeeding.

Driving and operating machinery

Some adverse effects such as drowsiness or sleepiness may affect your ability to concentrate and react. Do not drive or operate machinery if you feel your ability is impaired.

Zovirax 200 mg dispersible tablets contain sodium

This medicine contains less than 23 mg of sodium (1 mmol) per tablet; that is, essentially “sodium-free”.

3. How to take Zovirax

Your doctor will determine the correct dose, frequency, and duration of treatment depending on:

• age
• the type of infection you have
• whether the treatment is intended to treat the infection or to prevent it from recurring

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

Treatment of herpes simplex infections (treatment of cold sores, genital herpes, and other herpes simplex infections):

Use in adults

The recommended dose is 200 mg five times a day, during the waking hours (omitting doses while sleeping at night), approximately every four hours for five days.

Your doctor may adjust the dose as necessary (for example, if you have reduced immune resistance, are elderly, or have kidney problems). If you are elderly or have kidney problems, it is important to drink plenty of water during treatment.

Use in children

Children under 2 years: 100 mg five times a day, every four hours during waking hours (omitting doses while sleeping at night).

Children over 2 years: 200 mg five times a day, every four hours during waking hours (omitting doses while sleeping at night).

Other formulations of this medicine may be more suitable for children. Consult your doctor or pharmacist.

Prevention of recurrent herpes simplex infections (to prevent these problems from recurring after they have occurred):

Use in adults

The recommended dose is one 200 mg tablet four times a day, every six hours.

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

Your doctor may adjust the dose as necessary (for example, if you have reduced immune resistance, are elderly, or have kidney problems). If you are elderly or have kidney problems, it is important to drink plenty of water during treatment.

Prevention of herpes simplex infections in immunocompromised patients (to prevent these problems in people with weakened immune systems, meaning their bodies are less able to fight infections):

Use in adults

The recommended dose is 200 mg four times a day, every six hours.

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

Your doctor may adjust the dose as necessary (for example, if you have reduced immune resistance, are elderly, or have kidney problems). If you are elderly or have kidney problems, it is important to drink plenty of water during treatment.

Use in children

Children under 2 years: 100 mg four times a day, every six hours.

Children over 2 years: 200 mg four times a day, every six hours.

Other formulations of this medicine may be more suitable for children. Consult your doctor or pharmacist.

Treatment of chickenpox and shingles (herpes zoster):

Use in adults

The recommended dose is 800 mg five times a day, during waking hours (omitting doses while sleeping at night), approximately every four hours, for seven days.

Your doctor may adjust the dose as necessary (for example, if you have reduced immune resistance, are elderly, or have kidney problems). If you are elderly or have kidney problems, it is important to drink plenty of water during treatment.

Use in children

Children under 2 years: 200 mg four times a day.

Children between 2 and 6 years: 400 mg four times a day.

Children over 6 years: 800 mg four times a day.

Treatment should continue for five days. Your doctor may adjust the dose depending on body weight.

Other formulations of this medicine may be more suitable for children. Consult your doctor or pharmacist.

Dissolve the tablet in at least 50 ml of water and shake before taking.

If you think that the effect of Zovirax is too strong or too weak, inform your doctor or pharmacist.

If you take more Zovirax than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Zovirax

Do not take a double dose to make up for forgotten doses; simply wait and take the next dose at the scheduled time.

4. Possible side effects

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

Common side effects (may affect up to 1 in 10 people)

• Headache, dizziness, feeling tired, fever.
• Nausea, vomiting, diarrhoea, stomach pain.
• Itching, skin rash (sometimes caused by sensitivity to sunlight).

Uncommon side effects (may affect up to 1 in 100 people)

• Hair loss.
• Hives.

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

• Changes in blood tests (reversible increases in bilirubin and liver enzymes, increases in blood urea and creatinine).
• Difficulty breathing.
• Angioedema (swelling of the lips, eyes, and tongue).
• Sudden and severe allergic reaction (anaphylactic reaction).

Very rare side effects (may affect up to 1 in 10,000 people)

• Anaemia (reduced number of red blood cells) or leucopenia (reduced number of white blood cells), bruising (due to reduced number of platelets).
• Agitation, confusion, tremors, difficulty moving, difficulty speaking, confusion or hallucinations (seeing or imagining things), changes in personality and behaviour, seizures, drowsiness, encephalopathy (brain dysfunction), coma. These effects are usually reversible and typically occurred in patients with kidney disorders or predisposing factors.
• Hepatitis (inflammation of the liver), jaundice (yellowing of the skin and eyes), acute kidney failure, kidney pain (may be associated with kidney failure).

Tell your doctor immediately if you experience any of the following symptoms of allergy: sudden wheezing, palpitations or chest tightness, collapse, swelling of eyelids, face, lips or other parts of the body, skin rash or bruising. These symptoms may mean that you are allergic to Zovirax. Do not take any more tablets unless your doctor tells you to.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Zovirax

Keep this medicine out of sight and reach of children.

Do not store above 30°C. Keep in the original packaging to protect from moisture.

Do not use this medicine after the expiry date stated on the container after EXP. The expiry date is the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE point at your pharmacy. If you are in doubt, 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 Zovirax 200 mg dispersible tablets

• The active substance is aciclovir. Each tablet contains 200 mg of aciclovir.
• The other components (excipients) are: core: microcrystalline cellulose (E460), magnesium aluminium silicate, sodium carboxymethyl starch (potato type A), povidone K30, magnesium stearate (E572). Coating: titanium dioxide (E171), hypromellose, polyethylene glycol 400, polyethylene glycol 8000.

Appearance of the product and contents of the pack

PVC/PVDC/aluminium/paper child-resistant blister pack.

Pack containing 25 dispersible tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

GlaxoSmithKline, S.A.

P.T.M. C/ Severo Ochoa, 2

28760 Tres Cantos (Madrid)

Tel: +34 900 202 700

[email protected]

Manufacturer

Glaxo Wellcome, S.A.

Avda. de Extremadura, 3

09400 Aranda de Duero (Burgos)

Date of the most recent review of this leaflet: August 2025

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