ZOVICREM LABIAL 50 mg/g CREAM

2. What you need to know before using Zovicrem Labial

Do not use Zovicrem Labial

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

In children under 12 years of age.

Warnings and precautions

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

• This medicine should only be used on cold sores on the lips.

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

• Do not use for the treatment of genital herpes.

• Avoid contact of the cream with the eyes, and if it occurs, wash abundantly with water and consult a doctor.

• Before starting treatment with this medicine, immunocompromised patients (e.g., patients with AIDS, those who have received transplants, or those undergoing radiotherapy or chemotherapy) should consult a doctor.

• To avoid contagion:

Wash your hands after applying the product.

Do not bring the lip lesion into contact with other areas of the body or with the skin of other people, especially infants and children. While the lesion lasts, try not to rub your lips against the bedding if you sleep with someone else, do not share towels, and use paper towels and tissues to avoid reinfecting yourself.

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

• This medicine does not prevent subsequent outbreaks or recurrences of symptoms.

Additional recommendations for patients with cold sores

Cold sores or fever blisters appear due to an infection with a virus called Herpes Simplex. Normally, there is a first infection inside the mouth (usually in childhood) that may go unnoticed, but in the case of children, it should be diagnosed by a doctor to avoid confusion with teething disorders or other oral conditions. After this first infection, the Herpes Simplex virus remains in the body without symptoms. The infection often presents with new outbreaks, at other times in life, which usually appear as a consequence of sunburn, colds, fever, emotions, anxiety, wounds in the mouth, menstruation, dental or surgical interventions, or allergies to some medication.

These outbreaks consist of a sensation of tingling or itching on the lips followed by the appearance, after one or two days, of several small blisters that later evolve into an open sore on the lips, which finally transforms into a crust.

Until the crust appears, a sign that the lesion has healed, the blisters or sores are contagious.

It should be taken into account that: At the moment when the sensation of itching, tingling, or burning 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 avoid the multiplication of the virus and obtain faster relief from symptoms.

To avoid the risk of transmission of the virus, follow the instructions given in the section To avoid contagion.

Using Zovicrem Labial with other medicines

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

Although no interactions of this medicine by this route have been described, other preparations should not be applied simultaneously in the area of the cold sore while this treatment lasts without consulting a doctor or pharmacist.

Pregnancy, breastfeeding, and fertility

If you are pregnant, breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnant or breastfeeding women should not use this medicine without consulting a doctor.

Driving and using machines

No effects on the ability to drive or use machines have been described.

Zovicrem Labial contains propylene glycol, cetyl alcohol, and sodium lauryl sulfate

This medicine contains 400 mg of propylene glycol in each gram of cream.

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

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

This medicine 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 medicines when applied to the same area. The population of patients with decreased skin barrier function, such as atopic dermatitis, is more sensitive to the irritating properties of sodium lauryl sulfate.

3. How to use Zovicrem Labial

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

This medicine is for external use only on the lip.

The recommended dose is:

Adults and adolescents aged 12 years and older.

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

• Treatment should be continued for at least 4 days. If the cold sore has not healed, treatment can be continued for up to 10 days.
• Do not use for more than 10 days without consulting a doctor.

If you think the effect of Zovicrem Labial is too strong or too weak, tell your doctor or pharmacist.

Use in children

Do not administer this medicine to children under 12 years of age (see section "Do not use Zovicrem Labial").

If you use more Zovicrem Labial than you should

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

If you forget to use Zovicrem Labial

If you forget an application, do it as soon as possible and continue treatment as prescribed.

Do not take a double dose to make up for forgotten doses.

If you stop using Zovicrem Labial

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

Uncommon (at least 1 in every 1,000 patients):

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

Rare (at least 1 in every 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 (less than 1 in 10,000 patients):

• Immediate allergic reactions, including angioedema, which manifests with throat inflammation or difficulty swallowing or breathing. If this effect is very intense, you should go to a medical center as it requires emergency measures.

If you think any of the side effects you are suffering from is serious, or if you notice any side effect not mentioned in this leaflet, tell your doctor or pharmacist.

Reporting side effects:

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report them 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 Zovicrem Labial

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

Do not store above 25°C. Do not refrigerate.

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

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicine in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Package contents and additional information

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, cetyl alcohol, sodium lauryl sulfate, soft white paraffin, dimeticone, arlacel 165 (macrogol 100 stearate and glycerol monostearate), liquid paraffin, propylene glycol, and purified water

Appearance of the product and package contents

Zovicrem is a white cream. It comes in two presentations:

• Aluminum tube with 2g of cream
• Polypropylene container with a dosing pump of 2g.

Marketing authorization holder and manufacturer

Holder:

Haleon Spain, S.A.

Paseo de la Castellana, 259D, 32nd floor,

28046 Madrid, Spain

Manufacturer:

Haleon Germany GmbH

Barthstrasse 4

80339 Munich

Germany

Date of the last revision of this leaflet:

March 2022