Zovicrem Labial 50 mg/g cream
Spain
Table of Contents
Patient Information Leaflet
Introduction
Package Leaflet: Information for the patient
Zovicrem Labial 50 mg/g cream
aciclovir
Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.
Follow exactly the instructions for use provided in this leaflet or those given by your doctor or pharmacist.
- Keep this leaflet, as you may need to read it again.
- If you need advice or further information, consult your pharmacist.
- If you experience any side effects, consult your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.
- You should consult a doctor if your condition worsens or does not improve after 10 days.
Leaflet Contents
- What Zovicrem Labial is and what it is used for
- What you need to know before using Zovicrem Labial
- How to use Zovicrem Labial
- Possible side effects
- How to store Zovicrem Labial
- Contents of the pack and other information
1. What Zovicrem labial is and what it is used for
It is a cream containing the active substance aciclovir. Aciclovir belongs to a group of medicines called antivirals, active against the herpes simplex virus.
It is indicated for the local relief of symptoms caused by cold sores (fever blisters), such as itching, burning, or tingling.
Zovicrem labial 50 mg/g cream can be used by adults and adolescents aged 12 years and older.
You should consult a doctor if your condition worsens or does not improve after 10 days.
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 ingredients 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.
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This medicine should only be used for cold sores of the lips.
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Do not apply the product inside the mouth, nose, or vagina, as this may cause local irritation.
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Do not use for the treatment of genital herpes.
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Avoid contact of the cream with the eyes; if contact occurs, rinse thoroughly with water and consult your doctor.
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Before starting treatment with this medicine, immunocompromised patients (e.g. patients with AIDS, transplant recipients, or those undergoing radiotherapy or chemotherapy) should consult their doctor.
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To prevent transmission:
Wash your hands after applying the product.
Do not allow contact between the lip lesion and other areas of the body or the skin of other people, especially infants and children. While the lesion persists, avoid rubbing bed linens against your lips if sleeping with another person, do not share towels, and use paper tissues and napkins to avoid self-reinfection.
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If the lesion worsens or has not healed within 10 days, stop treatment and consult your doctor.
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This medicine does not prevent future outbreaks or recurrence of symptoms.
Additional recommendations for patients with cold sores
Cold sores or labial herpes are caused by infection with a virus called Herpes simplex. Typically, a first infection occurs inside the mouth (often in childhood), which may go unnoticed, but in children should be diagnosed by a doctor to avoid confusion with teething disorders or other oral conditions. After this initial infection, the herpes simplex virus remains in the body without causing symptoms. The infection frequently recurs later in life, often triggered by sunburn, colds, fever, emotional stress, anxiety, mouth injuries, menstruation, dental or surgical procedures, or drug allergies.
These outbreaks consist of a tingling or itching sensation on the lips, followed one or two days later by the appearance of several small blisters, which then develop into an open sore on the lips and eventually form 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 itching, tingling, or burning sensation appears, before the blisters appear, the virus is actively multiplying and treatment is most effective. If you apply the product at this stage, you can prevent viral replication and achieve faster symptom relief.
To avoid the risk of virus transmission, follow the instructions given in the section To prevent transmission.
Use of Zovicrem labial with other medicines
Inform your doctor or pharmacist if you are using, have recently used, or might need to use any other medicines.
Although no interactions have been reported with this medicine via topical use, other preparations should not be applied simultaneously to the area of the cold sore during treatment without consulting your 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 use of machines
No effects on the ability to drive or operate machinery have been reported.
Zovicrem labial contains propylene glycol, cetostearyl alcohol, and sodium lauryl sulfate
This medicine contains 400 mg of propylene glycol per gram of cream.
Propylene glycol may cause skin irritation. Do not use this medicine in infants under 4 weeks of age with open wounds or large areas of damaged skin (such as burns) without first consulting your doctor or pharmacist.
This medicine may cause local skin reactions (such as contact dermatitis) because it contains cetostearyl alcohol.
This medicine contains 7.5 mg of sodium lauryl sulfate per 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. Patients with impaired skin barrier function, such as those with atopic dermatitis, are more sensitive to the irritating properties of sodium lauryl sulfate.
3. How to use Zovicrem labial
Follow exactly the instructions for use provided in this leaflet or those indicated by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.
This medicine is for topical use only on the lip.
Recommended dose:
Adults and adolescents aged 12 years and older
- It is advisable to wash your hands before and after treating cold sores, and to avoid unnecessary touching of the lesions with your hands.
- Treatment should begin as soon as symptoms appear. The onset of a cold sore 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 sleeping hours), up to a maximum of 5 times daily. If you forget a dose, apply it as soon as you remember.
- Treatment should continue for at least 4 days. If the cold sore has not healed, treatment may continue for up to a maximum of 10 days.
- Do not use for more than 10 days without consulting your doctor.
If you think that the effect of Zovicrem Labial is too strong or too weak, inform your doctor or pharmacist.
Use in children
Do not give 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 at telephone number: 91 562 04 20, indicating the medicine and the amount ingested.
If you forget to use Zovicrem labial
If you forget to apply a dose, do so as soon as you remember, and continue treatment as prescribed.
Do not use a double dose to make up for forgotten doses.
If you stop using Zovicrem labial
If you have any further questions about using this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine may cause adverse effects, although not everyone will experience them.
Uncommon (in at least 1 out of 1,000 patients):
- Transient burning or itching after application of Zovicrem.
- Dryness or peeling of the skin or lips
- Itching sensation.
Rare (in at least 1 out of 10,000 patients):
- Redness of the skin
- Contact dermatitis (a type of local allergy) after application. Most often, the substances causing it are components of the cream other than aciclovir, which is the active substance.
Very rare (in less than 1 out of 10,000 patients):
- Immediate allergic reactions, including angioedema, manifested as swelling of the throat or difficulty swallowing or breathing. If this effect is severe, you must seek medical attention immediately, as urgent measures are required.
If you consider any of the adverse effects you experience to be serious, or if you notice any adverse effects not listed in this leaflet, inform your doctor or pharmacist.
Reporting of adverse effects:
If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not mentioned in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaRam.es. By reporting adverse 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 refers to the last day of the month indicated.
Medicines must not be disposed of via wastewater drains or in household waste. Return unused containers and medicines to the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of Zovicrem cream
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The active substance is aciclovir. Each gram of cream contains 50 mg of aciclovir.
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The other components (excipients) are: poloxamer 407, cetylstearyl alcohol, sodium lauryl sulfate, soft white paraffin, dimethicone, arlacel 165 (macrogol 100 stearate and glycerol monostearate), liquid paraffin, propylene glycol and purified water.
Appearance of the product and contents of the pack
Zovicrem is a white cream. It is available in two presentations:
- aluminium tube containing 2 g of cream
- polypropylene container with a 2 g dosing pump.
Marketing Authorization Holder and Manufacturer
Marketing Authorization 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 most recent revision of this leaflet:
March 2022