Efriviral labiale

Package leaflet: Information for the patient

Efrivirallabiale 50 mg/g cream

Aciclovir
Generic medicine
Please read all of this leaflet carefully before you start 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 advice or information, consult your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• Consult your doctor if you do not notice improvement or if your symptoms worsen after 10 days.

Contents of this leaflet:

1. What EFRIVIRALLABIALE is and what it is used for
2. What you need to know before using EFRIVIRALLABIALE
3. How to use EFRIVIRALLABIALE
4. Possible side effects
5. How to store EFRIVIRALLABIALE
6. Contents of the pack and other information

1. What EFRIVIRALLABIALE is and what it is used for

EFRIVIRALLABIALE contains the active substance aciclovir, which is used for the treatment of infections caused by
herpesviruses ( herpes ), including the herpes simplex virus.
EFRIVIRALLABIALE is indicated for the treatment of herpes simplex virus infections of the lips (common
herpes labialis ) in adults and adolescents over 12 years of age.
Consult your doctor if you do not feel better or feel worse after 10 days.

2. What you need to know before using EFRIVIRALLABIALE

Do not use EFRIVIRALLABIALE

• 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 (see "Children" in section 3).

Warnings and precautions
Talk to your doctor or pharmacist before using EFRIVIRALLABIALE

• If you are unsure whether you have herpes labialis.
• If you have a particularly severe form of herpes labialis.
• If your immune system is weakened (for example, if you have undergone a bone marrow transplant or if you have AIDS). In such cases, consult your doctor for the treatment of any infection.

Take care with EFRIVIRALLABIALE
EFRIVIRALLABIALE is for external use only and should only be used to treat lesions on the lips caused by herpes simplex. Application on mucous membranes, such as those in the mouth (e.g. in case of mouth ulcers), nose, and eyes, is not recommended, and it must not be used for the treatment of 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.
Special care should be taken to avoid accidental contact with the eyes. If the cream accidentally gets into the eyes, rinse them thoroughly with lukewarm water.
If you have any doubts, consult your doctor.
Prolonged use of the product may lead to sensitization (allergic reactions). If this occurs, discontinue treatment and consult your doctor.
Patients with particularly severe forms of herpes labialis should consult their doctor. Be cautious and consult your doctor if you are uncertain whether you have cold sores.
Other medicines and EFRIVIRALLABIALE
Inform your doctor or pharmacist if you are currently using, have recently used, or might use any other medicines, including over-the-counter medicines. It is unlikely that EFRIVIRALLABIALE will interact significantly with other medicines.
Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking any medicine.
During pregnancy and/or breastfeeding, EFRIVIRALLABIALE should only be used after consulting your doctor, who will assess 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.
Important information about some excipients in EFRIVIRALLABIALE
EFRIVIRALLABIALE contains propylene glycol. It may cause skin irritation.
EFRIVIRALLABIALE contains cetyl stearyl alcohol. It may cause local skin reactions (e.g. contact dermatitis).

3. How to use EFRIVIRALLABIALE

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.
EFRIVIRALLABIALE is for external use only.
It is important to start treatment as soon as the first symptoms of infection appear (e.g. itching and/or burning and/or pain).
If treatment was not started at the onset of the first symptoms, it may still be initiated when blisters appear. EFRIVIRALLABIALE remains effective whether used in the early phase of infection (itching and/or burning and/or pain) or during the blister phase.
Wash your hands before and after applying the cream, and avoid rubbing the lesions unnecessarily or touching them with a towel, in order to prevent worsening or spreading of the infection.

Dosage
Caution: Do not exceed the recommended dose.
Adults and adolescents over 12 years of age
Apply enough cream to cover the entire affected area, including the outer edges of any blisters, 5 times daily at approximately 4-hour intervals, omitting the nighttime application.
Children under 12 years of age
EFRIVIRALLABIALE must not be used in children under 12 years of age (see section DO NOT USE EFRIVIRALLABIALE).

Duration of treatment
Treatment should continue for at least 4 days. If healing has not occurred, treatment may continue for up to a maximum of 10 days. If lesions are still present after 10 days, consult your doctor. Do not exceed the recommended dose.
It is important to start treatment as soon as the first symptoms of infection appear (itching, and/or burning, and/or pain) or at the first sign of lesions (blisters).
Consult your doctor if the condition recurs frequently or if you have noticed any recent changes in its characteristics.

How to apply
Take a small amount of cream and apply it to the affected area to cover the lesion completely.
Always wash your hands before and after applying the cream.
Avoid rubbing the lesions unnecessarily or touching them with a towel, in order to prevent worsening or spreading of the infection.

If you use more EFRIVIRALLABIALE than you should
If you have used more than the recommended dose, speak to your doctor or pharmacist immediately, taking the package with you to show them.
EFRIVIRALLABIALE is a topical preparation.
Even if the cream is accidentally applied in excessive amounts or ingested, adverse effects are not expected. However, in case of accidental ingestion of EFRIVIRALLABIALE, contact your doctor immediately or go to the nearest hospital, taking the package with you to show them.

If you forget to use EFRIVIRALLABIALE
If you forget to apply the cream, do not worry. Apply it as soon as you remember, and continue treatment as before. Do not apply a double amount of cream to make up for missed doses.

If you have any doubts about how to use EFRIVIRALLABIALE, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, EFRIVIRALLABIALE may cause side effects, although not everyone experiences them.
The side effects reported for aciclovir cream are:
Uncommon side effects (may affect up to 1 in 100 people):

• transient burning or pain after application
• mild dryness or peeling of the skin
• itching

Rare side effects (may affect up to 1 in 1,000 people):

• erythema (redness of the skin)
• contact dermatitis following application. Where sensitivity tests have been conducted, it has been shown that the substances causing reactions were components of the cream base rather than aciclovir itself.

Very rare side effects (may affect up to 1 in 10,000 people):

• immediate allergic reactions (hypersensitivity) including angioedema (swelling of the lips, face, neck and throat) and urticaria (skin reaction).

If you experience an allergic reaction with symptoms such as facial swelling, stop using the product immediately and contact your doctor without delay.
These side effects are generally transient.
Following the instructions provided 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, speak to your doctor or pharmacist. You can also report side effects directly via the national reporting system at the following website: http://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 EFRIVIRALLABIALE

Keep this medicine out of the sight and reach of children.
The seal covering the tube opening must be intact.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month indicated.
The expiry date applies to the product in its original, undamaged packaging, correctly stored.
Store below 25°C. Do not refrigerate.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.
It is important to always keep the medicine information available; therefore, retain both the outer box and the package leaflet.

6. Package contents and other information

EFRIVIRALLABIALE contains aciclovir, an antiviral agent active against the oral herpes virus.
One gram of cream contains:
Active substance: Aciclovir 50 mg
Excipients: Cetostearyl alcohol, Liquid paraffin, Poloxamer 407, Sodium lauryl sulfate, Purified water,
White soft paraffin, Arlacel 165, Dimethicone 20, Propylene glycol.
Description of the appearance of EFRIVIRALLABIALE and the contents of the pack
EFRIVIRALLABIALE is a cream for cutaneous use supplied in an aluminium tube of 3 g.
The tube contains 150 mg of aciclovir (5%).
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
AESCULAPIUS FARMACEUTICI S.r.l.
Via Cefalonia, 70 - 25124 BRESCIA
Manufacturer
Special Product’s Line S.p.A.
Via Fratta Rotonda Vado Largo, 1 – 03012 Anagni (FR)

Patient Information Leaflet

EFRIVIRALLABIALE 50 mg/g cutaneous pencil

Aciclovir
Equivalent medicine
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

1. What EFRIVIRALLABIALE is and what it is used for
2. What you need to know before using EFRIVIRALLABIALE
3. How to use EFRIVIRALLABIALE
4. Possible side effects
5. How to store EFRIVIRALLABIALE
6. Package contents and other information

1. What EFRIVIRALLABIALE is and what it is used for

EFRIVIRALLABIALE contains the active substance aciclovir, which is used to treat infections caused by viruses known as herpesviruses (herpes), including the herpes simplex virus.
EFRIVIRALLABIALE is indicated for the treatment of herpes simplex virus infections of the lips (common cold sores) in adults and adolescents over 12 years of age.
Consult your doctor if you do not feel better or feel worse after 10 days.

2. What you need to know before using EFRIVIRALLABIALE

DO NOT use EFRIVIRALLABIALE

• 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 (see "Children" in section 3).

Warnings and precautions
Talk to your doctor before using EFRIVIRALLABIALE

• If you are unsure whether you have cold sores (herpes labialis).
• 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 if you have AIDS). In such cases, consult your doctor for the treatment of any infection.

Take care with EFRIVIRALLABIALE
EFRIVIRALLABIALE is for external use only and should only be used to treat lesions on the lips caused by herpes simplex. Application on mucous membranes, such as those in the mouth (e.g. in case of mouth ulcers), nose, eyes, is not recommended, and it must not be used for the treatment of 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 pencil, or after touching the lesions. In particular, avoid touching your eyes after touching the lesions or applying the pencil.
Take special care to avoid accidental application into the eyes. If the content of the pencil comes into contact with the eyes, rinse them thoroughly with lukewarm water.
If you have any doubts, consult your doctor.
Prolonged use of the product may lead to sensitization (allergic reactions). If this occurs, stop treatment and consult your doctor.
Patients with particularly severe recurrent forms of cold sores should consult their doctor.
Be cautious and consult your doctor if you are uncertain whether you have cold sores.
People affected by cold sores are advised to avoid transmitting the virus, especially when active lesions are present.

Other medicines and EFRIVIRALLABIALE
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those not requiring a prescription. It is unlikely that EFRIVIRALLABIALE will interact significantly with other medicines.

Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before using this medicine.
During pregnancy and/or breastfeeding, EFRIVIRALLABIALE should only be used after consulting a doctor, who will evaluate the potential risks and benefits for both mother and child.

Driving and using machines
No adverse effects on the ability to drive or use machinery are known.

Important information about some of the excipients in EFRIVIRALLABIALE
EFRIVIRALLABIALE contains butylated hydroxytoluene. It may cause localized skin reactions (e.g. contact dermatitis) or irritation to the eyes and mucous membranes.

3. How to use EFRIVIRALLABIALE

Use this medicine exactly as stated in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
EFRIVIRALLABIALE is for external use only.
It is important to start treatment as soon as the first symptoms of infection appear (for example, itching and/or burning and/or pain).
If treatment has not been started at the onset of the first symptoms, it may still be initiated when blisters appear. EFRIVIRALLABIALE remains effective whether used in the early phase of infection (itching and/or burning and/or pain) or during the blister phase.
Wash your hands before and after applying the pencil, and avoid unnecessarily rubbing the lesions or touching them with a towel in order to prevent worsening or spreading of the infection.

Dosage
Caution: Do not exceed the recommended dose.

Adults and adolescents over 12 years of age
Directly from the container, apply enough medicine to cover the entire infected area, including the outer edges of any blisters, 5 times daily at intervals of approximately 4 hours throughout the day, omitting the nighttime application.

Children under 12 years of age
EFRIVIRALLABIALE must not be used in children under 12 years of age (see section DO NOT use EFRIVIRALLABIALE).

Duration of treatment
Treatment should continue for at least 4 days. If healing has not occurred, treatment may continue up to a maximum of 10 days. If lesions are still present after 10 days, consult your doctor. Do not exceed the recommended dose.
Maximum effectiveness of EFRIVIRALLABIALE is achieved when it is used promptly at the onset of a herpes lesion. For optimal results, apply the medicine at the first signs of herpes (tingling, redness, swelling, or itching) or at the first appearance of lesions (blisters).
Consult your doctor if the condition recurs frequently or if you have noticed any recent changes in its characteristics.

How to apply
The medicine should be applied directly to the lesions without touching them with the hands; patients should, however, wash their hands after application. Avoid unnecessarily rubbing the lesions or touching them with a towel to prevent worsening or spreading of the infection.

The medicine is intended for personal use only; once opened, it must be used exclusively by the same patient for the entire duration of the medicine's shelf life and must not be shared with other individuals.

If you use more EFRIVIRALLABIALE than you should
If you have used more than the recommended dose, speak to your doctor or pharmacist immediately, taking the package with you to show them.
EFRIVIRALLABIALE is a topical preparation.
Even if the content of the pencil is accidentally applied in excessive amounts or ingested, adverse effects are not expected. In case of accidental ingestion/ingestion of EFRIVIRALLABIALE, contact your doctor immediately or go to the nearest hospital, taking the package with you to show them.

If you forget to use EFRIVIRALLABIALE
If you forget to use the medicine, do not worry. Apply the pencil as soon as you remember and continue treatment as before. Do not apply a double amount to make up for missed doses.

If you have any doubts about how to use EFRIVIRALLABIALE, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, EFRIVIRALLABIALE can cause side effects, although not everyone experiences them.
The side effects reported for topical aciclovir are:

Uncommon side effects (may affect up to 1 in 100 people):

• transient burning or pain after application of EFRIVIRALLABIALE
• mild dryness and peeling of the skin
• itching

Rare side effects (may affect up to 1 in 1,000 people):

• erythema (redness of the skin)
• contact dermatitis after application. Where sensitivity tests have been conducted, the substances causing reactivity have been shown to be the cream's excipients rather than aciclovir itself.

Very rare side effects (may affect up to 1 in 10,000 people):

• immediate allergic reactions (hypersensitivity) including angioedema (swelling of the lips, face, neck, and throat) and urticaria (skin reaction).

If you experience an allergic reaction with symptoms such as facial swelling, stop using the product and contact your doctor immediately.
These side effects are generally transient.
Following the instructions provided 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, speak to your doctor or pharmacist. You can also report side effects directly via the national reporting system at: http://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 EFRIVIRALLABIALE

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
The expiry date applies to the product in its original, unopened packaging, correctly stored.
Store at a temperature not exceeding 25°C, in the original packaging, to protect the medicine from light.
Do not refrigerate.
After first opening the container, the medicine should be used before the expiry date indicated on the packaging; after this period, any remaining medicine must be discarded.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.
It is important to always keep the information about the medicine available; therefore, retain both the outer box and the package leaflet.

6. Package contents and other information

EFRIVIRALLABIALE contains aciclovir, an antiviral agent active against the herpes labialis virus.
One gram contains
Active substance: Aciclovir 50 mg
Excipients: castor oil, semisynthetic glycerides, carnauba wax, white paraffin, beeswax, octyldodecanol,
butylated hydroxytoluene, vanilla flavour
Description of the appearance of EFRIVIRALLABIALE
EFRIVIRALLABIALE is presented in the form of a skin pencil (stick) contained in a cylindrical dispenser/applicator, which releases the medicine by rotating the top. The package contains 1 applicator with 3 g of skin pencil (stick).
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
AESCULAPIUS FARMACEUTICI S.r.l.
Via Cefalonia, 70 - 25124 BRESCIA
Manufacturer
Laboratorio Chimico Farmaceutico A. Sella srl - Via Vicenza, 67 - Schio (VI)