Package Insert: Information for the User

Zovirax 200 mg Dispersible Tablets

aciclovir

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

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to others even if they 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 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 in 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 lower your dose. You should also drink enough liquid during treatment to keep yourself well hydrated.

-If you have genital herpes, it is recommended to take precautions during sex 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, cimetidine or mycophenolate mofetil (a 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 200 mg dispersible tablets contain sodium

This medicine contains less than 23 mg of sodium (1 mmol) per tablet; 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 indicate 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: one 200 mg tablet five times a day every four hours, omitting the nighttime dose
• for the suppression of recurrences caused by herpes simplex virus: one 200 mg tablet four times a day every six hours, or two 200 mg tablets twice a day every twelve hours
• for the prevention of infections caused by herpes simplex in immunocompromised patients: one 200 mg tablet four times a day every six hours
• for the treatment of chickenpox and herpes zoster infections: four 200 mg tablets five times a day every four hours, omitting the nighttime 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.

Other presentations are available that are more suitable for children under 6 years.

• for the treatment of chickenpox:
• children (over 6 years) and adolescents: four 200 mg tablets four times a day
• children between 2 and 6 years: two 200 mg tablets four times a day.

Other presentations are available that are more suitable for children under 6 years.

Dissolve the tablet in a minimum of 50 ml of water and shake before taking.

It is recommended that you drink plenty of liquid while on this treatment.

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

If you take more Zovirax 200 mg tablets 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 200 mg tablets

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

Like all medicines, this medicine can 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 effectsless frequent (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).

Very rare side effects (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, somnolence, encephalopathy (brain alteration), coma.These effects are generally reversible and normally appeared in patients with kidney disorders or predisposing factors.
• Hepatitis (liver inflammation), jaundice (yellowing of the 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 shortness of breath, palpitations or chest tightness, 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 tablets 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 the 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 above30°C. Store in the original packaging to protect it from moisture.

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.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition ofZovirax 200 mg dispersible tablets

-The active ingredient is aciclovir. Each tablet contains 200 mg of aciclovir.

-The other components (excipients) are: core: microcrystalline cellulose (E460), aluminium and magnesium silicate, sodium carboxymethyl starch (type A) (from potato), povidone K30, magnesium stearate (E572). Coating:, titanium dioxide (E171), hypromellose, macrogol 400, macrogol 8000.

Appearance of the product and contents of the packaging

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

Package containing 25 dispersible tablets.

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

[email protected]

Responsible for manufacturing

Glaxo Wellcome, S.A.

Avda.DeExtremadura, 3

09400 Aranda de Duero (Burgos)

Date of the last review of this leaflet:

June 2022

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