Leaflet: information for the patient

Zovicrem Labial 50 mg/g cream

aciclovir

Read this leaflet carefully before you start using this medicine, because it contains important information for you.

Follow exactly the administration instructions of the medicine contained in this leaflet or those indicated by your doctor or pharmacist.

-Keep this leaflet, as you may need to read it again.

-If you need advice or more information, consult your pharmacist.

• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.
• You should consult a doctor if you get worse or do not improve after 10 days.

1. What Zovicrem labial is and what it is used for

2. What you need to know before using Zovicrem labial.

3. How to use Zovicrem labial

4. Possible side effects

5. Storage of Zovicrem labial

6. Contents of the pack and additional information.

It is a cream that contains the active ingredientaciclovir.Aciclovirbelongs to a group of medicines called antivirals, active against the herpes simplex virus.

It is indicated for the relief of local symptoms caused by herpes labialis (fever blisters), such as: itching, burning or tingling.

Zovicrem labial50 mg/g creammay be used by adults and adolescents aged 12 years and older.

You should consult a doctor if it worsens or does not improve after 10 days.

No use Zovicrem labial

If you are allergic to aciclovir, valaciclovir, or any of the other components of this medication (listed in section 6).

Children under 12 years of age.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to use Zovicrem labial.

- This medication should only be used for lip fever.

- Do not apply the product inside the mouth, nose, or vagina, as it may cause local irritation.

- Do not use for genital herpes treatment.

- Avoid contact of the cream with the eyes, and in case of contact, wash abundantly with water and consult a doctor.

- Before starting treatment with this medication, immunocompromised patients (e.g. patients with AIDS, transplant recipients, or those undergoing radiation or chemotherapy), should consult a doctor.

- To avoid contagion:

Wash your hands after applying the product.

Do not put the lip lesion in contact with other body areas or with the skin of other people, especially infants and children. While the lesion persists, try not to rub the bedclothes with your lips if you sleep with someone else, do not share towels, and use paper napkins and tissues to avoid re-infecting yourself.

- If the lesion worsens or has not healed in 10 days, discontinue treatment and consult a doctor.

- This medication does not prevent subsequent outbreaks or reappearance of symptoms.

Additional recommendations for patients with herpes labial

Fevers or herpes labial appear due to an infection caused by a virus called Herpes simple. Normally, the first infection occurs within the mouth (usually in childhood) and may go unnoticed, but in the case of children, it should be diagnosed by a doctor to avoid confusing it with dental disorders or other oral processes. After this first infection, the Herpes simple virus remains in the body without symptoms. The infection often presents with new outbreaks, at other times in life, which usually appear as a result of sunburn, colds, fever, emotions, anxiety, mouth injuries, menstruation, dental or surgical interventions, or allergies to some medications.

These outbreaks consist of a tingling or itching sensation in the lips followed by the appearance, within one or two days, of several small blisters that then evolve into open sores on the lips, which finally transform into a scab.

Until the scab appears, indicating that the lesion has healed, the blisters or sores are contagious.

It should be noted that: At the moment when the itching, tingling, or stinging sensation appears, before the appearance of the blisters, it is when the virus is multiplying, and when treatment is most effective. If you apply the product at this stage, you will be able to prevent the virus from multiplying and obtain faster relief from symptoms.

To avoid the risk of virus transmission, respect the indications given in the sectionFor avoiding contagion.

Use of Zovicrem labial with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

Although no interactions of this medication have been described by this route, do not apply other preparations simultaneously in the area of the fever while this treatment lasts without consulting a doctor or pharmacist.

Pregnancy, lactation, and fertility

If you are pregnant, or in a lactation period, or think you may be pregnant, or intend to become pregnant, consult your doctor or pharmacist before using this medication.

Pregnant women or those in a lactation period should not use this medication without consulting a doctor.

Driving and operating machinery

No effects on the ability to drive or operate machinery have been described.

Zovicrem labial contains propylenglycol, cetoestearic alcohol, and sodium lauryl sulfate

This medication contains 400 mg of propylenglycol in each gram of cream.

Propylenglycol may cause skin irritation.Do not use this medication in infants under 4 weeks with open wounds or large areas of damaged skin (such as burns) without consulting a doctor or pharmacist first.

This medication may cause local skin reactions (such as contact dermatitis) because it contains cetoestearic alcohol.

This medication contains 7.5 mg of sodium lauryl sulfate in each gram of cream.

Sodium lauryl sulfate may cause local skin reactions (such as itching or burning sensation) or increase skin reactions caused by other medications when applied to the same area.Patients with decreased skin barrier function, such as atopic dermatitis, are more sensitive to the irritating properties of sodium lauryl sulfate.

Follow exactly the administration instructions of the medication contained in this leaflet or those indicated by your doctor or pharmacist.In case of doubt, ask your doctor or pharmacist.

This medication is for exclusive use on the skin of the lip.

The recommended dose is:

Adults andadolescents 12 years of age and older.

• It is advisable to wash your hands before and after treating the fever, and avoid unnecessary rubbing of the lesions with your hands.
• You should start treatment as soon as the symptoms of the process begin. The onset of fever can be easily recognized by itching and burning.
• Apply with your finger a sufficient amount of product to cover the affected area of the lip with a thin layer, approximately every 4 hours (excluding sleep hours), up to a maximum of 5 times a day. If you forget an application, do it as soon as you remember.

• Continue treatment for at least 4 days. If the fever has not healed, treatment can be continued up to a maximum of 10 days.
• Do not use more than 10 days without consulting a doctor.

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

Use in children

Do not administer this medication to children under 12 years of age (see section “Do not use Zovicrem labial”).

Using more Zovicrem labial 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.

Forgetting to use Zovicrem labial

In case of forgetting an application, do it as soon as possible and continue treatment as prescribed.

Do not take a double dose to compensate for the missed doses.

Interrupting treatment withZovicrem labial

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

Like all medications, this medication may produce adverse effects, although not all people will experience them.

Infrequent (in at least 1 in 1,000 patients):

• Mild burning or itching sensations after applying Zovicrem.
• Dryness or flaking of the skin or lips.
• Itching sensation.

Rare (in at least 1 in 10,000 patients)

• Redness of the skin.
• Contact dermatitis (a type of local allergy) after application. Most of the time, the substances that cause it are components of the cream other than aciclovir, which is the active ingredient.

Very Rare (in fewer than 1 in 10,000 patients):

• Immediate allergic reactions, including angioedema, which manifests as throat inflammation or difficulty swallowing or breathing. If this effect is very intense, seek medical attention as it requires emergency measures.

If you consider any of the adverse effects you experience to be severe or if you notice any adverse effect not mentioned in this prospectus, inform your doctor or pharmacist..

Reporting Adverse Effects:

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: https://www.notificaRam.es. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

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

Do not store at a temperature above 25°C. Do not refrigerate.

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 packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Zovicrem labial

• The active ingredient is aciclovir. Each gram of cream contains 50 mg of aciclovir.

• The other components (excipients) are: poloxamer 407, cetostearic alcohol, sodium lauryl sulfate, soft white paraffin, dimethicone, arlacel 165 (macrogol 100 stearate and mono-glycerol stearate), liquid paraffin, propylene glycol, and purified water

Appearance of the product and contents of the packaging

Zovicrem is a white cream. It has two presentations:

• aluminum tube with 2g of cream
• polypropylene container with a 2g dosing pump

Holder of the marketing authorization and responsible for manufacturing

Holder:

Haleon Spain, S.A.

P.T.M.-C/Severo Ochoa, nº 2

28760 Tres Cantos (Madrid) Spain

Responsible for manufacturing:

Haleon Germany GmbH

Barthstrasse 4

80339 Munich

Germany

Last review date of this leaflet:

March 2022