Zovirax 400 mg/5 ml oral suspension

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Zovirax 400 mg/5 ml oral suspension

aciclovir

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 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. This belongs to a group of medicines known as 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 is weakened, 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. Also, you should drink enough fluids during treatment to maintain adequate hydration.

• If you have genital herpes infection, it is recommended to take precautions during sexual intercourse even if antiviral treatment has been initiated.

Taking Zovirax with other medicines

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

Tell 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 might 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 use of 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 400 mg/5 ml oral suspension contains sorbitol, benzyl alcohol, methyl parahydroxybenzoate, propyl parahydroxybenzoate and sodium.

This medicine contains 1.575 g of sorbitol in each 5 ml of oral suspension.

Sorbitol is a source of fructose. If your doctor has informed you that you (or your child) have an intolerance to certain sugars, or have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which patients cannot metabolize fructose, consult your doctor before you (or your child) take this medicine.

Sorbitol may cause gastrointestinal discomfort and a mild laxative effect.

This medicine contains less than 1 mg of benzyl alcohol in each 5 ml of oral suspension.

Benzyl alcohol may cause allergic reactions.

Consult your doctor or pharmacist if you are pregnant or breastfeeding. This is because large amounts of benzyl alcohol may accumulate in your body and cause adverse effects (metabolic acidosis).

Consult your doctor or pharmacist if you have liver or kidney disease. This is because large amounts of benzyl alcohol may accumulate in the body and cause adverse effects (metabolic acidosis).

Benzyl alcohol has been associated with the risk of serious adverse effects, including respiratory problems ("gasping syndrome") in children.

Do not administer this medicine to your newborn (up to 4 weeks of age) unless recommended by your doctor.

This medicine should not be used for longer than one week in children under 3 years of age unless directed by your doctor or pharmacist.

This medicine may cause allergic reactions (possibly delayed) because it contains methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216).

This medicine contains less than 23 mg of sodium (1 mmol) per 5 ml of oral suspension; i.e., essentially "sodium-free".

3. How to take Zovirax

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

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

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

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

Use in adults

The recommended dose is 200 mg (2.5 ml of suspension) five times a day, during the part of the day when you are awake (omitting the dose during sleep 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 (1.25 ml), five times a day, every four hours during the part of the day when you are awake (omitting the dose during sleep at night).

Children over 2 years: 200 mg (2.5 ml), five times a day, every four hours during the part of the day when you are awake (omitting the dose during sleep at night).

Do not dilute the oral suspension. To administer the prescribed dose, use the dosing device provided in the package or a dosing device recommended by your doctor or pharmacist.

Prevention of recurrent herpes simplex infections (preventing these problems from recurring after having had them):

Use in adults

The recommended dose is 200 mg (2.5 ml), 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 (preventing these problems in people whose immune system functions poorly, meaning their bodies are less able to fight infections):

Use in adults

The recommended dose is 200 mg (2.5 ml), 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 (1.25 ml), four times a day, every six hours.

Children over 2 years: 200 mg (2.5 ml), four times a day, every six hours.

Do not dilute the oral suspension. To administer the prescribed dose, use the dosing device provided in the package or a dosing device recommended by your doctor or pharmacist.

Treatment of chickenpox and herpes zoster (shingles):

Use in adults

The recommended dose is 800 mg (10 ml), five times a day, during the waking hours (omitting the dose during nighttime sleep), 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 (2.5 ml), four times a day.

Children between 2 and 6 years: 400 mg (5 ml), four times a day.

Children over 6 years: 800 mg (10 ml), four times a day.

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

Do not dilute the oral suspension. To administer the prescribed dose, use the dosing device provided in the package or a dosing device recommended by your doctor or pharmacist.

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: 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Zovirax

Do not take a double dose to make up for missed doses; simply wait for the next scheduled dose.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone gets them.

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

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

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

• Hair loss.
• Urticaria.

Rare adverse 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 adverse effects (may affect up to 1 in 10,000 people)

• Anaemia (reduction in red blood cells) or leucopenia (reduction in white blood cells), bruising (due to reduced platelet count).

• Agitation, confusion, tremors, difficulty with movements, difficulty speaking, confusion or imagining things (hallucinations), changes in personality and behaviour, seizures, drowsiness, encephalopathy (brain dysfunction), coma. These effects are usually reversible and generally 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 tightness in the chest, collapse, swelling of the 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 of the suspension unless your doctor tells you to.

Reporting of adverse effects

If you get any adverse effects, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Zovirax 400 mg/5 ml oral suspension

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

Do not store above 30°C.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

100 ml bottle: once opened, the shelf life is 15 days. Store below 25°C.

200 ml bottle: once opened, the shelf life is 27 days. Store below 25°C.

Medicines must not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE point in your pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medicines no longer needed. This will help protect the environment.

6. Contents of the pack and other information

Composition of Zovirax 400 mg/5 ml oral suspension

• The active substance is aciclovir. Each 5 ml of oral suspension contains 400 mg of aciclovir.

• The other components (excipients) are non-crystallizable sorbitol solution (70%) (E420), glycerol (E422), microcrystalline cellulose (E460) and sodium carboxymethylcellulose (Avicel RC 591F), methyl 4-hydroxybenzoate (E218), propyl 4-hydroxybenzoate (E216), orange flavouring (contains benzyl alcohol), and purified water.

Appearance of the medicine and contents of the container

Amber-coloured glass bottle, type III, with a screw metal cap with a child-resistant closure or plastic closure. Pack containing a 100 ml or 200 ml bottle, accompanied by a dual measuring spoon for 2.5 ml and 5 ml.

Only certain pack sizes may be marketed.

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

Aspen Bad Oldesloe GmbH
Industriestrasse 32-36
D-23843 Bad Oldesloe (Germany)

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