Zovirax Labiale
Italy
Table of Contents
Package leaflet: Information for the patient
ZOVIRAXLABIALE 5% CREAM
aciclovir
Please read this leaflet carefully before using this medicine because it contains important information for you.
- Use this medicine exactly as described in this leaflet or as your doctor or pharmacist has instructed you.
- Keep this leaflet. You may need to read it again.
- If you need more information or advice, consult your pharmacist.
- If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
- Contact your doctor if you do not notice any improvement or if your symptoms worsen after 10 days.
Contents of this leaflet
- What ZOVIRAXLABIALE is and what it is used for
- What you need to know before using ZOVIRAXLABIALE
- How to use ZOVIRAXLABIALE
- Possible side effects
- How to store ZOVIRAXLABIALE
- Contents of the pack and other information
1. What ZOVIRAXLABIALE is and what it is used for
ZOVIRAXLABIALE contains the active substance aciclovir, which is used to treat infections caused by herpes viruses, including the herpes simplex virus.
ZOVIRAXLABIALE is used in adults and adolescents over the age of 12 for the treatment of lip infections (recurrent herpes labialis) caused by the herpes simplex virus.
If the lesions on your lips are still present after 10 days, consult your doctor.
2. What you need to know before using ZOVIRAXLABIALE
Do not use ZOVIRAXLABIALE
- 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
Talk to your doctor before using ZOVIRAXLABIALE
- If you are unsure whether you have cold sores.
- If you have a particularly severe form of cold sores.
- If your immune system is weakened (for example, if you have had a bone marrow transplant or have AIDS). In this case, consult your doctor for the treatment of any infection.
Be careful with ZOVIRAXLABIALE
- ZOVIRAXLABIALE is for external use only and should only be used to treat lesions on the lips caused by herpes simplex. Do not apply ZOVIRAXLABIALE to the mucous membranes of the mouth, nose, or eyes, and do not use it to treat genital herpes.
- Avoid unnecessary rubbing of the lesions and do not touch them with a towel to prevent worsening or spreading the infection. Always wash your hands before and after applying the cream or after touching the lesions.
In particular, avoid touching your eyes after touching the lesions or applying the cream. If the cream accidentally gets into the eyes, rinse them thoroughly with lukewarm water. If you use ZOVIRAXLABIALE for a prolonged period, sensitization reactions (allergic reactions) may occur. In this case, discontinue treatment and consult your doctor.
Other medicines and ZOVIRAXLABIALE
Inform your doctor or pharmacist if you are currently using, have recently used, or might use any other medicines.
It is unlikely that ZOVIRAXLABIALE will interact significantly with other medicines.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before using this medicine.
During pregnancy and breastfeeding, ZOVIRAXLABIALE should only be used after consulting your doctor, who will evaluate the potential risks and benefits for both mother and child.
Driving and using machines
No negative effects on the ability to drive or use machinery are known.
ZOVIRAXLABIALE contains cetostearyl alcohol, sodium lauryl sulfate, and propylene glycol
This medicine contains 200 mg of propylene glycol per dose equivalent to 400 mg/g.
This medicine contains cetostearyl alcohol. It may cause localized skin reactions (e.g., contact dermatitis).
This medicine contains 3.75 mg of sodium lauryl sulfate per dose equivalent to 7.5 mg/g. Sodium lauryl sulfate may cause skin irritation (stinging or burning sensation) or intensify skin reactions caused by other medicines when applied to the same area.
3. How to use ZOVIRAXLABIALE
Use this medicine exactly as stated in this leaflet or as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
ZOVIRAXLABIALE is for external use only.
Start treatment as soon as the first symptoms of infection appear (e.g. itching and/or burning and/or pain).
If you did not start treatment immediately upon experiencing the first symptoms of infection, you may begin treatment even when blisters appear. ZOVIRAXLABIALE can be used both during the early phase of infection (itching and/or burning and/or pain), and during the blister phase.
Wash your hands before and after applying the cream, and avoid unnecessarily rubbing the lesions or touching them with a towel, to prevent worsening or spreading of the infection.
Dosage
Caution: Do not exceed the recommended dose.
Adults and adolescents over 12 years of age
The recommended dose is one application 5 times daily at intervals of approximately 4 hours, omitting the nighttime application. Apply enough cream to cover the entire affected area, including the outer edges of any blisters.
Children under 12 years of age
ZOVIRAXLABIALE must not be used in children under 12 years of age (see section Do not use ZOVIRAXLABIALE).
Duration of treatment
Continue treatment for at least 4 days. If you have not healed after 4 days, you may continue treatment for up to a maximum of 10 days.
If lesions are still present after 10 days, consult your doctor.
Also consult your doctor if the condition recurs frequently or if you notice any recent changes in its characteristics.
If you use more ZOVIRAXLABIALE than you should
Even if the cream is applied in excessive amounts or accidentally ingested, adverse effects are not expected.
However, if you have used more than the recommended dose or have accidentally ingested ZOVIRAXLABIALE, contact your doctor immediately or go to the nearest hospital.
If you forget to use ZOVIRAXLABIALE
If you forget to apply the cream, do not worry. Apply it as soon as you remember, then continue treatment as before. Do not use a double dose to make up for the missed dose.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody will experience them.
The side effects reported for ZOVIRAXLABIALE are:
Uncommon side effects (may affect up to 1 in 100 people):
- temporary burning or pain after application of ZOVIRAXLABIALE
- moderate dryness or peeling of the skin
- itching.
Rare side effects (may affect up to 1 in 1,000 people):
- redness of the skin (erythema)
- skin inflammation at the application site due to contact with the cream (contact dermatitis).
Very rare side effects (may affect up to 1 in 10,000 people):
- immediate allergic reactions (hypersensitivity) including swelling of the lips, face, neck and throat (angioedema) and skin reaction (urticaria).
If you experience an allergic reaction with symptoms such as facial swelling, stop using the product and consult your doctor immediately.
These side effects are generally temporary. Following the instructions in this leaflet reduces the risk of side effects.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, consult your doctor or pharmacist. You may also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.
5. How to store ZOVIRAX 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 that month. The expiry date applies to the product stored in its original intact packaging and kept under the recommended storage conditions.
Do not use this medicine if you notice:
- the seal covering the tube opening is not intact
- the bottle's tamper-evident seal is missing or not intact.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to properly dispose of medicines you no longer use. This will help protect the environment.
It is important to always keep the medicine information available; therefore, retain both the carton and the package leaflet.
6. Package contents and other information
What ZOVIRAXLABIALE contains
- The active substance is aciclovir. One gram of cream contains 50 mg of aciclovir.
- The other ingredients are: poloxamer 407, cetyl stearyl alcohol, sodium lauryl sulfate, white soft paraffin, liquid paraffin, arlacel 165, dimethicone 20, propylene glycol, purified water.
Description of the appearance of ZOVIRAXLABIALE and contents of the pack
ZOVIRAXLABIALE is a cream contained in a 2 g aluminium tube or in a 2 g polypropylene bottle
with dispenser.
Marketing Authorization Holder
Haleon Italy S.r.l. - Via Monte Rosa 91 - 20149 Milano
Manufacturer
Haleon Germany GmbH - Barthstrasse 4 - 80339 München – Germany