Package Insert: Information for the User

Zovirax 400 mg/5 ml Oral Suspension

aciclovir

Read this entire package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, and you should not give it to others who may have the same symptoms as you, as it may harm them.

-If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

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, shingles, and the varicella virus.

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 any kidney disease or are elderly. Your doctor may need to reduce your dose. Also, you should drink enough liquid during treatment to keep yourself well hydrated.

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

Taking Zovirax with other medicines

Inform your doctor or pharmacist if you are using, have used recently or might have to use any other medicine.

Inform your doctor if you have recently taken probenecid, cimetidina or micofenolato de mofetilo (medicine used in transplant patients).

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you might be 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 side 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 affected.

Zovirax 400 mg/5 ml oral suspension contains sorbitol, benzyl alcohol, methyl parahydroxybenzoate, propyl parahydroxybenzoate and sodium.

This medicinecontains 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 certain sugars, or have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which the patient cannot break down 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 your body and cause adverse effects (metabolic acidosis).

Benzyl alcohol has been associated with the risk of severe adverse effects that include respiratory problems ("breathing difficulty") in children.

Do not administer this medicine to your newborn (up to 4 weeks old) unless your doctor recommends it.

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

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 (1mmol) per 5 ml of oral suspension; this is essentially “sodium-free”.

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

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

Remember to take your medication.

Your doctor will inform you of the duration of your treatment with Zovirax. Do not discontinue treatment before.

Usual doses for adults are:

• for the treatment of infections caused by herpes simplex: 2.5 ml of suspension five times a day every four hours, omitting the nocturnal dose
• for the suppression of recurrences caused by herpes simplex virus: 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 infections caused by herpes simplex in immunocompromised patients: 2.5 ml of suspension four times a day every six hours
• for the treatment of chickenpox and herpes zoster infections: 10 ml of suspension five times a day every four hours, omitting the nocturnal dose.

Usual doses for children are:

• for the treatment of infections caused by herpes simplex and prevention of infections caused by herpes simplex 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 chickenpox:
• 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 2.5 ml and 5 ml.

Do not dilute the oral suspension. It is recommended that you drink plenty of liquid while on this treatment.

If you estimate that the action of ZOVIRAX 400 mg/5 ml oral suspension is too strong or too weak, inform 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, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

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

Do not take a double dose to compensate for the missed doses, simply wait for the next dose.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

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

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

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

• Hair loss.
• Urticaria.

Side effectsrare (may affect up to 1 in 1,000 people)

• Abnormal blood test results (reversible increases in bilirubin and liver enzymes, increases in blood urea and creatinine).
• Difficulty breathing.
• Angioedema (swelling of the lips, eyes, and tongue).
• Severe and sudden allergic reaction (anaphylactic reaction).

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

• Anemia (decrease in red blood cell count) or leucopenia (decrease in white blood cell count), thrombocytopenia (decrease in platelet count).

• Agitation, confusion, tremors, difficulty moving, difficulty speaking, confusion or imagination of things (hallucinations), changes in personality and behavior, convulsions, drowsiness, encephalopathy (brain alteration), coma.These effects are generally reversible and normally appeared in patients with kidney disorders or predisposing factors.
• Hepatitis (liver inflammation), jaundice (yellow skin and eyes), acute renal failure, renal pain (may be associated with renal failure).

Inform your doctor immediately if you experience any of the following allergy symptoms: sudden tightness in the chest, palpitations, or feeling of suffocation, collapse, swelling of eyelids, face, lips, or other parts of the body, skin rash or petechiae. These symptoms may indicate that you are allergic to Zovirax.Do not take more suspension unless your doctor tells you to.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: https://www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not store at a temperature above 30°C.

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

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

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

Medicines should not be disposed of through drains or in the trash. Dispose of the containers and medicines you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medicines you no longer need. In this way, you will help protect the environment.

Composition of ZOVIRAX 400 mg/5 ml oral suspension

• The active ingredient is aciclovir, each 5 ml of oral suspension contains 400 mg of aciclovir.

• The other components (excipients) are non-crystallizable liquid sorbitol (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 of the product and contents of the packaging

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

Only some sizes of packaging may be commercially available.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

GlaxoSmithKline, S.A.

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

28760 Tres Cantos (Madrid)

Tel: +34 900 202 700

es-ci@gsk.com

Responsible for manufacturing

Aspen Bad Oldesloe GmbH

Industriestrasse 32-36

D-23843 Bad Oldesloe (Germany)

Last review date of this leaflet:June 2022.

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