EFRIVIRALLABIALE 5% Ołówek skórny

Treść ulotki

1. Efrivirallabiale 50 mg/g cream
   1. What is EFRIVIRALLABIALE and what is it 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
2. EFRIVIRALLABIALE 50 mg/g cutaneous pencil
   1. How to store EFRIVIRALLABIALE

Efrivirallabiale 50 mg/g cream

Aciclovir
Generic medicine

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 to.
• 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 EFRIVIRALLABIALE is and what it is used for
• 2. What you need to know before you use 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 is EFRIVIRALLABIALE and what is it used for

EFRIVIRALLABIALE contains the active ingredient aciclovir which is used for the treatment of infections
caused by viruses called herpes (herpes) including the herpes simplexvirus.
EFRIVIRALLABIALE is indicated in the treatment of herpes simplexvirus infections of the lips (herpes

labialisfrequent) in adults and adolescents over the age of 12 years.
See a doctor if you do not feel better or if you 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 the age of 12 years (see “Children” in section 3).

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

• If you are not sure you have oral herpes.
• If you have a particularly severe form of oral herpes.
• If your immune system is compromised (for example if you have undergone a bone marrow transplant or if you have AIDS). In this case, consult your doctor for the treatment of any infection.

Be careful with EFRIVIRALLABIALE
EFRIVIRALLABIALE is for external use only and should only be used to treat lesions on the lips caused
by herpes simplex. Application to mucous membranes, such as those of the mouth (for
example in the case of mouth ulcers), nose and eyes is not recommended and it should not be used for the treatment
of genital herpes.
Do not unnecessarily rub the lesions and do not touch them with a towel to avoid worsening or transmitting
the infection. Always wash your hands before and after applying the cream or after touching the lesions. Do not
touch your eyes in particular after touching the lesions or applying the cream.
Particular care should be taken to avoid accidental application to the eyes. If the cream accidentally gets 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 phenomena (allergic reactions). If this
happens, stop treatment and consult your treating doctor.
People with particularly severe forms of herpes labialisare recommended to consult their doctor. Be
careful and consult your doctor if you are not sure you have oral herpes.

Other medicines and EFRIVIRALLABIALE
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines, including those available without a prescription. It is unlikely that EFRIVIRALLABIALE will interact
significantly with other medicines.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect or are planning a pregnancy, or if you are breastfeeding, ask your doctor or
pharmacist for advice before taking any medicine.
During pregnancy and/or breastfeeding, EFRIVIRALLABIALE should only be used after consulting
your doctor who will assess the possible risks and benefits for the mother and the child.

Driving and operating machinery
No adverse effects on the ability to drive and operate machinery are known.

Important information about some of the excipients of EFRIVIRALLABIALE
EFRIVIRALLABIALE contains propylene glycol. It may cause skin irritation.
EFRIVIRALLABIALE contains cetostearyl alcohol. It may cause local skin reactions (e.g.
contact dermatitis).

3. How to use EFRIVIRALLABIALE

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.
EFRIVIRALLABIALE is for external use only.
It is important to start treatment as soon as the first symptoms of the infection appear (for example,
itching and/or burning and/or pain).
If you have not started treatment when the first symptoms of the infection appear, it is
also possible to start it when blisters appear. EFRIVIRALLABIALE is still effective both
used in the early stage of the infection (itching and/or burning and/or pain) and in the blister stage.
Wash your hands before and after applying the cream and avoid rubbing the lesions unnecessarily or touching them
with a towel in order to avoid worsening or transmission of the infection.

How much
Caution: do not exceed the recommended dose.

Adults and adolescents over 12 years of age
Apply the amount of cream necessary to cover the entire infected area, including the outer edges of any
blisters, 5 times a day at intervals of approximately 4 hours, omitting the nighttime application.

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

For how long
Treatment should continue for at least 4 days. If there is no improvement, treatment may
continue for up to a maximum of 10 days. If the 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 the infection appear (itching, and/or
burning and/or pain) or at the first appearance of the lesions (blisters).
Consult your doctor if the disorder occurs repeatedly or if you have noticed any recent change
in its characteristics.

How
Take a small amount of cream and apply it to the infected area 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
transmission of the infection.

If you use more EFRIVIRALLABIALE than you should
If you have used a higher dose than recommended, talk to your doctor or pharmacist immediately,
bringing the packaging with you to show them.
EFRIVIRALLABIALE is a preparation for topical use.
Even if the cream is accidentally applied in excessive quantities or ingested, no
adverse effects are expected. In case of accidental ingestion of EFRIVIRALLABIALE, immediately notify
your doctor or go to the nearest hospital, bringing the packaging with you to show them.

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

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

4. Possible side effects

Like all medicines, EFRIVIRALLABIALE can cause side effects, although not everybody gets 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
• moderate dryness or scaling 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, the substances that gave reactivity phenomena have been shown to be the components of the cream base rather than aciclovir.

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).

In case of an allergic reaction with symptoms such as facial swelling, stop using the product and consult your
doctor immediately.
These side effects are generally transient.

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.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 sealing membrane of the tube opening must be intact.
Do not use the medicine after the expiry date stated on the packaging. The expiry date refers to
the last day of the month.
The expiry date refers to the product in intact packaging, correctly stored.
Store at a temperature not exceeding 25°C. Do not
refrigerate.
Medicines should not be disposed of via drains or household waste. Ask your pharmacist
how to dispose of medicines you no longer use. This will help protect the environment.

It is important to always have the information about the medicine available, therefore keep both the

6. Contents of the pack and other information

EFRIVIRALLABIALE contains aciclovir, an antiviral agent active against the herpeslabialis virus.
One gram of cream contains:

Active substance: Aciclovir 50mg

Excipients: Cetostearyl alcohol, Liquid paraffin, Poloxamer 407, Sodium lauryl sulfate, Purified water,
White petrolatum, Arlacel 165, Dimethicone 20, Propylene glycol.

Description of the appearance of EFRIVIRALLABIALE and contents of the pack
EFRIVIRALLABIALE is presented as a cream for topical use available in aluminum tubes of
2 g.
The tube contains 100 mg of aciclovir (5%).

Marketing authorization holder and manufacturer
Marketing authorization holder
AESCULAPIUS FARMACEUTICI S.r.l.
Via Cefalonia, 70 - 25124 BRESCIA
Manufacturer
Glaxo Operations UK Ltd – Harmire Road
Barnard Castle – Great Britain

EFRIVIRALLABIALE 50 mg/g cutaneous pencil

Aciclovir
Generic medicine

Read this leaflet carefully before using this medicine as it contains important information for you

• Use this medicine always as exactly 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 you get any side effects, see section 4, talk to your doctor or pharmacist.
• If your symptoms do not improve or get worse after 10 days, talk to your doctor.

Contents of this leaflet

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

EFRIVIRALLABIALE contains the active ingredient aciclovir, which is used for the treatment of infections
caused by viruses called herpes viruses (herpes) including the herpes simplexvirus.
EFRIVIRALLABIALE is indicated for the treatment of herpes simplexvirus infections of the lips (frequent herpes

labialis) in adults and adolescents over the age of 12 years.
See your doctor if you do not feel better or if you feel worse after 10 days.
.

Warnings and precautions
Talk to your doctor before using EFRIVIRALLABIALE

• If you are not sure you have lip herpes.
• If you have a particularly severe form of lip herpes.
• If your immune system is compromised (for example if you have had a bone marrow transplant or if you have AIDS). In this case, see your doctor for treatment of any infection.

I

Be careful with EFRIVIRALLABIALE
EFRIVIRALLABIALE is for external use only and should only be used to treat lesions on the lips
caused by herpes simplex. Application to mucous membranes, such as those of the
mouth (for example in case of mouth ulcers), nose, eyes is not recommended and it should not be used for the
treatment of genital herpes.
Do not rub the lesions unnecessarily and do not touch them with a towel to avoid worsening or transmitting
the infection. Always wash your hands before and after applying the pencil or after touching the lesions. Do not
touch your eyes in particular after touching the lesions or applying the pencil.
Particular care should be taken to avoid accidental application to the eyes. If the contents of the
pencil accidentally come into contact with the eyes, wash them thoroughly with lukewarm water.
If you have any doubts, consult your doctor.
Prolonged use of the product may lead to sensitization reactions (allergic reactions). If this
happens, stop treatment and consult your doctor.
It is recommended that people with particularly severe recurrent lip herpesconsult
the doctor.
Be careful and consult your doctor if you are not sure you have lip herpes.
It is recommended that those who suffer from lip herpesavoid transmitting the virus, especially
when active lesions are present.

Other medicines and EFRIVIRALLABIALE
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines, including over-the-counter medicines. It is unlikely that EFRIVIRALLABIALE will interact
significantly with other medicines.
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.
During pregnancy and/or breastfeeding, EFRIVIRALLABIALE should only be used after consulting
the doctor who will assess the possible risks and benefits for the mother and the baby.

Driving and operating machinery
No adverse effects on the ability to drive and operate machinery are known.
Important information about some of the excipients of EFRIVIRALLABIALE
EFRIVIRALLABIALE contains butylhydroxytoluene. It may cause localized skin reactions (e.g.
contact dermatitis) or irritation to the eyes and mucous membranes.
Always use this medicine exactly as described in this leaflet or as instructed by
your doctor or pharmacist. If you have 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 the infection appear (e.g.
itching and/or burning and/or pain).
If you have not started treatment at the onset of the first symptoms of the infection, you can start it even when the vesicles appear. EFRIVIRALLABIALE is still effective both
used in the early stage of the infection (itching and/or burning and/or pain), and in the stage of the vesicles.
Wash your hands before and after applying the pencil and avoid rubbing the lesions unnecessarily or touching them
with a towel in order to avoid worsening or transmission of the infection.

How much
Caution: do not exceed the recommended dose.

Adults and adolescents over 12 years of age
Apply directly from the container the amount of medicine needed to cover the entire infected area,
including the outer edges of any blisters, 5 times a day at intervals of about 4 hours during the
day, omitting the night application

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

For how long
Treatment should continue for at least 4 days. If no improvement has occurred, treatment may
continue for up to 10 days. If the lesions are still present after 10 days, consult your
doctor. Do not exceed the recommended dose.
The maximum effectiveness of EFRIVIRALLABIALE is achieved when it is used promptly,
at the beginning of a herpetic lesion. For optimal results, it is advisable to apply the medicine at the first signs
of herpes(tingling, redness, swelling or itching) or at the first appearance of lesions (vesicles).
Consult your doctor if the disorder recurs or if you have noticed any recent changes
in its characteristics.

How
The medicine should be applied directly to the lesions without using contact with the hands; patients must, however, wash their hands after application; it is necessary to avoid rubbing
the lesions unnecessarily or touching them with a towel in order to avoid worsening or transmission
of the infection.

The medicine is for exclusive personal use; therefore, once opened it must be
used by the same patient for the entire life of the medicine and must not be shared
with different subjects.
If you use more EFRIVIRALLABIALE than you should
If you have used a higher dose than recommended, talk to your doctor or pharmacist immediately,
bringing the packaging with you to show.
EFRIVIRALLABIALE is a preparation for topical use.
Even if the contents of the pencil are accidentally applied in excessive quantity or are
ingested, no adverse effects are expected. In case of accidental ingestion/intake of
EFRIVIRALLABIALE, immediately inform your doctor or go to the nearest hospital, bringing
the packaging with you to show.

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

If you have any questions about using EFRIVIRALLABIALE, ask your doctor or pharmacist.
Like all medicines, EFRIVIRALLABIALE can cause side effects, although not everybody
gets them.
The side effects reported for aciclovir for topical use are:

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

• transient burning or pain after application of EFRIVIRALLABIALE
• moderate dryness and flaking 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 performed, it has been shown that the substances that gave reactivity phenomena were the base components of the cream rather than aciclovir.

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).

In case of an allergic reaction with symptoms such as swelling of the face, stop using the product and see
your doctor immediately.
These side effects are generally transient.

Reporting of side effects
If you get any side effects, see your doctor or pharmacist. You can also report side effects directly through the national reporting system at the address: 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 sight and reach of children.
Do not use the medicine after the expiry date stated on the packaging. The expiry date refers
to the last day of the month.
The expiry date refers to the product in intact 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 the first opening of the container, the medicine must be used within the expiry date indicated
on the packaging; after this period, any remaining medicine must be disposed of.
Medicines should not be disposed of via drains or household waste. Ask your pharmacist
how to dispose of medicines you no longer use. This will help protect the environment.

It is important to always have the information about the medicine available, therefore keep both the
EFRIVIRALLABIALE contains aciclovir, an antiviral agent active against the herpeslabialis virus.
One gram contains
Active ingredient: Aciclovir 50 mg
Excipients: castor oil, semi-synthetic glycerides, carnauba wax, white paraffin, beeswax, octyldodecanol,

butylated hydroxytoluene, vanilla flavour
EFRIVIRALLABIALE is presented in the form of a cutaneous pencil (stick) contained in a
cylindrical container/applicator which dispenses the medicine by rotating the top. The package contents are
1 applicator of 3 g of cutaneous 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)