ACICLINLABIALE 50 mg /G Krem

Treść ulotki

1. Aciclinlabiale 50 mg/g cream
   1. What Aciclinlabiale is and what it is used for
   2. What you need to know before using Aciclinlabiale
   3. How to use Aciclinlabiale
   4. Possible side effects
   5. How to store Aciclinlabiale
   6. Contents of the pack and other information
2. Aciclinlabiale 50 mg/g cutaneous pencil
   1. What Aciclinlabiale is and what it is used for
   2. What you need to know before using Aciclinlabiale
   3. How to use Aciclinlabiale
   4. Possible side effects
   5. How to store Aciclinlabiale
   6. Contents of the pack and other information

Aciclinlabiale 50 mg/g cream

Aciclovir

Read this leaflet carefully before using this medicine as it contains important
information for you.
Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.

• Keep this leaflet. You may need to read it again.
• If you would like more information or advice, ask your pharmacist.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• See a doctor if you do not feel better or if your symptoms worsen after 10 days.

Contents of this leaflet:

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

1. What Aciclinlabiale is and what it is used for

What is Aciclinlabiale?
Aciclinlabiale contains the active ingredient aciclovir; it is a specific and selective antiviral medicine that acts
against herpes viruses, including the herpes simplex virus.

What is Aciclinlabiale used for?
Aciclinlabiale is used for the treatment of herpes simplex virus infections of the lips (recurrent herpes labialis
) in adults and adolescents over the age of 12 years.

What is lip herpes?
The term herpes identifies a category of infections caused by viruses of the Herpesviridaegenus. Herpes
Simplex 1 (HSV1) is the virus responsible for lip herpes, which manifests with the appearance of lesions and
roundish, painful blisters and redness predominantly located on the lips.
Below are some sanitary hygiene indications to be adopted in case of lip herpes infection:
Lip herpes is a contagious virus, for this reason do not allow other people to touch the lesions or
use personal objects that could transmit the infection (for example, the towel).
Always wash your hands, before and after touching the lesions.
After applying the cream, do not touch other parts of your body with your fingers, especially your eyes, before
washing your hands. Herpetic eye infection can lead to corneal ulcers.
Avoid kissing, especially children, when lesions are present on the lips.
Avoid breaking blisters and scratching scabs; this is not only because it could infect the lesions with
other viruses, but also because it could infect your fingers with the lip herpes virus.
Do not share glasses, cutlery and other personal objects with other people.

2. What you need to know before using Aciclinlabiale

Do not use Aciclinlabiale:

• if you are allergic to the active ingredient aciclovir, to valaciclovir or to any of the other ingredients of this medicine (listed in section 6);
• if you are under 12 years of age.

Warnings and precautions
Consult your doctor or pharmacist before using Aciclinlabiale.
Apply the cream exclusively to the lesions present on the lips; do not apply the cream to the soft tissues
(mucous membranes) of the mouth, eyes, nose and vagina as this may cause irritation.
Do not use Aciclinlabiale for the treatment of genital herpes.
Take particular care when using the cream, in order to avoid accidental application into the eyes.
The use, especially if prolonged, of this medicine may lead to allergic reactions (sensitization phenomena). If this happens, stop treatment and consult your doctor.
It is not known whether Aciclinlabiale may lead to tolerance or dependence.
It is important to avoid transmission of the virus, especially when active lesions are present.
Inform your doctor before using this medicine:

• in the event that you suffer from a particularly severe and/or recurrent form of labial herpes;
• if you have a severely compromised immune system (immunocompromised), e.g. if you suffer from acquired immunodeficiency (AIDS) or if you have undergone a bone marrow transplant. In this case, your doctor may prescribe aciclovir in oral form.

Children and adolescents
Aciclinlabiale is not recommended for children under 12 years of age.

Other medicines and Aciclinlabiale
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.
Do not apply other types of dermatological products for skin and body care (such as cosmetics, sunscreens, cocoa butter) or other medicines for the treatment of herpes, while you are using
Aciclinlabiale.
However, no clinically significant interactions have been reported.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant, are planning to become pregnant, or are breastfeeding with breast
milk, ask your doctor or pharmacist for advice before using this medicine.

Pregnancy
Following marketing authorisation, it has been possible to monitor pregnancy outcomes in women who
have taken aciclovir in various formulations during pregnancy.
Analysis of these data has not shown an increase in the number of birth defects in children born to
women exposed to aciclovir, compared to the general population and all birth defects found have not shown particularities or common characteristics, suggesting a single cause.
The doctor will assess whether the possible benefits of treatment outweigh the possibility that unknown risks may occur.

Breastfeeding
Limited data indicate that Aciclinlabiale may pass into breast milk following systemic administration.
However, the dose received by an infant following the use of Aciclinlabiale in the mother should be negligible.

Fertility
Aciclovir cream has not shown effects on the number, morphology and motility of spermatozoa
in men. No data are available regarding the effects of aciclovir cream on fertility in women.

Driving and using machines
There are no known effects of Aciclinlabiale on the ability to drive vehicles or operate machines.

Aciclinlabiale contains methyl parahydroxybenzoate and propylene glycol

• Methyl parahydroxybenzoate may cause allergic reactions (including delayed reactions).
• Propylene glycol may cause skin irritation.

3. How to use Aciclinlabiale

Use this medicine following exactly as described in this leaflet, or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Apply Aciclinlabiale 5 times a day, every 4 hours throughout the day, for at least 5 consecutive days, avoiding nighttime application.
Take a small amount of cream and apply it to the affected area so as to cover the lesion. Always wash your hands before and after applying the cream.
Avoid rubbing the lesions unnecessarily or touching them with a towel in order to avoid worsening or transmitting the infection.
If healing does not occur within the first 5 days of treatment, the application of the cream may be extended for another 5 days (up to a maximum of 10 days). Do not exceed the indicated doses.
The maximum effectiveness of Aciclinlabiale is achieved when the cream is used promptly, at the first signs of a lesion. For optimal results, it is advisable to apply the cream at the first signs of herpes (tingling, redness, swelling or itching). Consult your doctor if the condition recurs or if you have noticed any recent change in its characteristics.
Consult your doctor if symptoms persist after 10 days of treatment or if they worsen at any time.

Use in children and adolescents
Aciclinlabiale is not recommended for children under 12 years of age (see section “Children and adolescents”).

If you use more Aciclinlabiale than you should
In case of ingestion/accidental intake of an excessive dose of Aciclinlabiale, immediately notify your doctor or go to the nearest hospital.

If you forget to use Aciclinlabiale
If you forgot to apply the cream, do so as soon as you remember. Then continue application according to the recommended dosage schedule.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop treatment with Aciclinlabiale and contact your doctor immediately if you experience any of the
following serious side effects:

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

• allergic reactions immediately after application (immediate hypersensitivity) including swelling of the skin (angioedema) and skin rashes (urticaria).

Uncommon (may affect up to 1 in 100 people)

• transient burning or pain after application of Aciclinlabiale;
• moderate dryness or loss of the upper layer of the skin (skin peeling);
• itching.

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

• skin irritation (erythema);
• inflammatory skin reaction after application (contact dermatitis). Sensitivity tests have shown that the substances responsible for reactivity phenomena are the components of the cream, rather than aciclovir.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the national reporting system at: http://www.agenziafarmaco.it/it/responsabili
By reporting side effects you can help provide more information on the safety of
this medicine.

5. How to store Aciclinlabiale

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the label. The expiry date refers to the last day of that month.
Do not store at a temperature above 25°C. Do not refrigerate.
After first opening the tube, use Aciclinlabiale within 3 months; after this period, the remaining cream
must be discarded.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Aciclinlabiale contains

• The active ingredient is aciclovir 50 mg
• The other ingredients are: Tefose 1500, glycerin, stearic acid, liquid paraffin, methyl parahydroxybenzoate, Purified water.

Description of the appearance of Aciclinlabiale and contents of the pack
Aciclinlabiale is presented in the form of a white and homogeneous cream.
The pack contains 1 aluminum tube of 2 g of cream.

Marketing authorization holder and manufacturer

Marketing authorization holder
Fidia Farmaceutici S.p.A.
Via Ponte della Fabbrica, 3/A
35031 Abano Terme (PD)

Manufacturer
Fidia Farmaceutici S.p.A.
Via Ponte della Fabbrica, 3/A
35031 Abano Terme (PD)

Aciclinlabiale 50 mg/g cutaneous pencil

Aciclovir

Read this leaflet carefully before using this medicine as it contains important information for you.
Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.

• Keep this leaflet. You may need to read it again.
• If you want more information or advice, ask your pharmacist.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• See a doctor if you do not feel better or if your symptoms worsen after 10 days.

Contents of this leaflet:

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

1. What Aciclinlabiale is and what it is used for

What is Aciclinlabiale?
Aciclinlabiale contains the active ingredient aciclovir; it is a specific and selective antiviral medicine that
acts against herpes viruses, including the herpes simplex virus.

What is Aciclinlabiale used for?
Aciclinlabiale is used for the treatment of herpes simplex virus infections of the lips (recurrent herpes labialis)
in adults and adolescents over the age of 12 years.

What is lip herpes?
The term herpes identifies a category of infections caused by viruses of the Herpesviridaegenus. Herpes
Simplex 1 (HSV1) is the virus responsible for lip herpes, which manifests with the appearance of lesions and
round, painful blisters and redness predominantly located on the lips.
Below are some health hygiene indications to be adopted in case of lip herpes infection:
Lip herpes is a contagious virus, therefore do not allow other people to touch the
lesions or use personal objects that could transmit the infection (e.g. the towel).
Always wash your hands before and after touching the lesions.
After applying the cutaneous pencil, do not touch other parts of the body with your fingers, especially the eyes, before
washing your hands. Herpetic eye infection can lead to corneal ulcers.
Avoid kissing, especially children, when lesions are present on the lips.
Avoid breaking blisters and scratching scabs; this is not only because it could infect the lesions with
other viruses, but also because it could infect your fingers with the lip herpes virus.
Do not share glasses, cutlery and other personal items with other people.

2. What you need to know before using Aciclinlabiale

Do not use Aciclinlabiale:

• if you are allergic to the active ingredient aciclovir, to valaciclovir or to any of the other ingredients of this medicine (listed in section 6);
• children under 12 years of age.

Warnings and precautions
Consult your doctor or pharmacist before using Aciclinlabiale.
Apply the pencil exclusively to lesions present on the lips; do not apply the pencil to the soft tissues
(mucous membranes) of the mouth, eyes, nose and vagina as this may cause irritation.
Do not use Aciclinlabiale for the treatment of genital herpes.
Take particular care when using the cutaneous pencil, in order to avoid accidental application
to the eyes.
The use, especially if prolonged, of this medicine may lead to allergic reactions (sensitization phenomena). If this happens, stop treatment and consult your doctor.
It is not known whether Aciclinlabiale can lead to tolerance or dependence.
It is important to avoid the transmission of the virus, especially when active lesions are present.
Inform your doctor before using this medicine:

• in the event that you suffer from a particularly severe and/or recurrent form of lip herpes;
• if you have a severely compromised immune system (immunocompromised), e.g. if you have acquired immunodeficiency syndrome (AIDS) or if you have undergone bone marrow transplantation. In this case, your doctor may prescribe aciclovir in oral form.

Children and adolescents
Aciclinlabiale is not recommended for children under 12 years of age.

Other medicines and Aciclinlabiale
Inform your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.
Do not apply other types of dermatological products for skin and body care (such as cosmetics, sun creams, cocoa butter) or other medicines for the treatment of herpes while using
Aciclinlabiale.
However, no clinically significant interactions have been reported.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding with breast
milk, ask your doctor or pharmacist for advice before using this medicine.

Pregnancy
Following marketing authorization, it has been possible to monitor pregnancy outcomes in women who
have taken aciclovir in various formulations during the period of gestation.
Analysis of these data has not shown an increase in the number of birth defects in children born to
women exposed to aciclovir, compared to the general population and all birth defects found have not shown particularities or common characteristics, suggesting a single cause.
The doctor will assess whether the possible benefits of treatment outweigh the possibility of unknown risks
occurring.

Breastfeeding
Limited data indicate that Aciclinlabiale may pass into breast milk following systemic administration.
However, the dose received by an infant following the use of Aciclinlabiale in the mother,
should be negligible.

Driving and using machines
There are no known effects of Aciclinlabiale on the ability to drive vehicles or operate
machinery.

Aciclinlabiale contains propyl-parahydroxybenzoate and butyl-hydroxytoluene

• Propyl-parahydroxybenzoate may cause allergic reactions (including delayed reactions).
• butyl-hydroxytoluene may cause local skin reactions (e.g. contact dermatitis) or irritation of the eyes and mucous membranes.

3. How to use Aciclinlabiale

Use this medicine following exactly as stated in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.

This medicine is for personal use only; therefore, once opened, use it only yourself and do not share it with other people.
Apply Aciclinlabiale 5 times a day, every 4 hours throughout the day, for at least 5 consecutive days, avoiding nighttime application.
Apply a small amount of the stick directly from the container to the affected area, without using hand contact. Always wash your hands after applying Aciclinlabiale.
Avoid rubbing the lesions unnecessarily or touching them with a towel in order to avoid worsening or transmission of the infection.
If healing does not occur within the first 5 days of treatment, the application may be prolonged for an additional 5 days (up to a maximum of 10 days). Do not exceed the indicated doses.
The maximum effectiveness of Aciclinlabiale is achieved when the stick is used promptly, at the first signs of a lesion. For optimal results, it is advisable to apply Aciclinlabiale at the first signs of herpes (tingling, redness, swelling or itching). Consult your doctor if the condition occurs repeatedly or if you have noticed any recent change in its characteristics.
Consult your doctor if the symptoms persist after 10 days of treatment or if they worsen at any time.

Use in children and adolescents
Aciclinlabiale is not recommended for children under 12 years of age (see section “Children and adolescents”).

If you use more Aciclinlabiale than you should
In case of ingestion/accidental intake of an excessive dose of Aciclinlabiale, immediately notify your doctor or go to the nearest hospital.

If you forget to use Aciclinlabiale
If you forgot to apply the stick, do so as soon as you remember. Then continue application according to the recommended dosage schedule.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop treatment with Aciclinlabiale and contact your doctor immediately if you experience any of the
following serious side effects:

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

• allergic reactions immediately after application (immediate hypersensitivity) including swelling of the skin (angioedema) and skin rashes (urticaria).

Uncommon (may affect up to 1 in 100 people)

• transient burning or pain after applying Aciclinlabiale;
• moderate dryness or loss of the upper layer of the skin (skin peeling);
• itching.

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

• skin irritation (erythema);
• inflammatory skin reaction after application (contact dermatitis). Sensitivity tests have shown that the substances responsible for reactivity are the components of the stick, rather than aciclovir.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the national reporting system at: http://www.agenziafarmaco.it/it/responsabili
By reporting side effects you can help provide more information on the safety of
this medicine.

5. How to store Aciclinlabiale

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the label. The expiry date refers to the last day of the month.
Do not store at a temperature above 25°C. Do not refrigerate.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Aciclinlabiale contains

• The active ingredient is aciclovir 50 mg.
• The other ingredients are: liquid paraffin, soft white paraffin, solid paraffin, beeswax, white ceresin, Arlacel 582, sodium hyaluronate, allantoin, d, l-alpha-tocopheryl acetate, propyl-parahydroxybenzoate, butylhydroxytoluene, purified water, disodium edetate, vanilla flavour, sweet flavour.

Description of the appearance of Aciclinlabiale and contents of the pack
Aciclinlabiale is presented in the form of a cutaneous pencil (stick) with a cylindrical white plastic applicator and
a screw cap closure that dispenses the medicine by rotating the base.
The pack contains 1 applicator of 2.5 g.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder
Fidia Farmaceutici S.p.A.
Via Ponte della Fabbrica, 3/A
35031 Abano Terme (PD)

Manufacturer
Laboratorio Chimico Farmaceutico A. Sella S.r.l.
Via Vicenza, 67
Schio (VI)