ZOVIRAX 400 mg/5 ml ORAL SUSPENSION

Introduction

Package Leaflet: Information for the User

Zovirax 400 mg/5 ml Oral Suspension

Aciclovir

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

1. What Zovirax is and what it is used for

Zovirax belongs to a group of medicines called antivirals.

It is used in infants, children, adolescents, and adults to treat and prevent infections caused by the herpes simplex virus, genital herpes, herpes zoster, and varicella virus.

2. What you need to know before you 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

Talk to your doctor or pharmacist before taking Zovirax:

• If you have kidney disease or are elderly. Your doctor may need to reduce your dose. Also, you should drink plenty of fluid during treatment to maintain adequate hydration.

- If you have genital herpes, it is recommended to take precautions during sexual intercourse even if you have started antiviral treatment.

Taking Zovirax with other medicines

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

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

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.

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

Driving and using machines

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

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 told you that you (or your child) have an intolerance to some sugars, or have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder, in which the patient cannot break down fructose, talk to your doctor before you (or your child) take this medicine.

Sorbitol may cause gastrointestinal upset 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.

Talk to your doctor or pharmacist if you are pregnant or breastfeeding. This is because large amounts of benzyl alcohol can build up in your body and cause side effects (metabolic acidosis).

Talk to your doctor or pharmacist if you have liver or kidney disease. This is because large amounts of benzyl alcohol can build up in your body and cause side effects (metabolic acidosis).

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

Do not give this medicine to your newborn (up to 4 weeks of age) unless your doctor has recommended it.

This medicine should not be used for more than one week in children under 3 years of age unless your doctor or pharmacist has told you to.

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; it is essentially "sodium-free".

3. How to take Zovirax

Take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, talk to your doctor or pharmacist again.

Your doctor will decide the correct dose, frequency, and duration of treatment.

Remember to take your medicine.

Your doctor will tell you how long to take Zovirax. Do not stop treatment before.

The usual doses for adults are:

• for the treatment of herpes simplex infections: 2.5 ml of suspension five times a day, every four hours, omitting the night dose
• for the suppression of herpes simplex virus recurrences: 2.5 ml of suspension four times a day, every six hours, or 5 ml twice a day, every twelve hours
• for the prevention of herpes simplex infections in immunocompromised patients: 2.5 ml of suspension four times a day, every six hours
• for the treatment of varicella and herpes zoster infections: 10 ml of suspension five times a day, every four hours, omitting the night dose.

The usual doses for children are:

• for the treatment of herpes simplex infections and prevention of herpes simplex infections in immunocompromised children:
• children and adolescents (2 to 18 years): the dose is the same as for adults
• infants (28 days to 23 months): will be treated with half the adult dose.
• for the treatment of varicella:
• children (over 6 years) and adolescents: 10 ml of suspension four times a day
• children between 2 and 6 years: 5 ml of suspension four times a day
• children under 2 years: 2.5 ml of suspension four times a day.

The suspension will be administered using the double spoon that allows dosing of 2.5 ml and 5 ml.

Do not dilute the oral suspension. It is recommended to drink plenty of fluid while taking this treatment.

If you feel that the effect of ZOVIRAX 400 mg/5 ml oral suspension is too strong or too weak, talk to your doctor or pharmacist.

If you take more Zovirax 400 mg/5 ml oral suspension than you should

In case of overdose or accidental ingestion, talk to your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Zovirax 400 mg/5 ml oral suspension

Do not take a double dose to make up for forgotten doses, simply wait for the next dose.

4. Possible side effects

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

Side effectscommon (may affect up to 1 in 10 people)

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

Side effectsuncommon (may affect up to 1 in 100 people)

• Hair loss.
• Hives.

Side effectsrare (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).
• Breathing difficulties.
• Angioedema (swelling of the lips, eyes, and tongue).
• Sudden and severe allergic reaction (anaphylactic reaction).

Side effectsvery rare (may affect up to 1 in 10,000 people)

• Anemia (decrease in red blood cells) or leukopenia (decrease in white blood cells), bruising (due to a decrease in platelets).

• Agitation, confusion, tremors, difficulty moving, difficulty speaking, confusion or imagining things (hallucinations), changes in personality and behavior, seizures, drowsiness, encephalopathy (brain disorder), coma. These effects are usually reversible and normally occurred in patients with kidney disorders or predisposing factors.
• Hepatitis (inflammation of the liver), jaundice (yellow color of the skin and eyes), acute kidney failure, kidney pain (may be associated with kidney failure).

Tell your doctor immediatelyif you experience any of the following symptoms of allergy: sudden breathing difficulties, palpitations or chest tightness, 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 takemore suspension unless your doctor tells you to.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaRAM.es. By reporting side 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 which is stated on the carton after EXP. The expiry date is the last day of the month shown.

Bottle of 100 ml: once opened, the validity period is 15 days. Store below 25°C

Bottle of 200 ml: once opened, the validity period is 27 days. Store below 25°C

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 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 ingredients (excipients) are sorbitol liquid non-crystallizable (70%) (E420), glycerol (E422), microcrystalline cellulose (E460) and sodium carboxymethylcellulose (Avicel RC 591F), methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), orange flavoring (contains benzyl alcohol) and purified water.

Appearance and packaging

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

Not all 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 last revision of this leaflet:June 2022.

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