Labial Zovirax - Package Leaflet

Indications Contraindications Precautions for use Interactions Warnings Dosage and method of use Overdose Undesirable Effects Shelf Life and Storage

Active ingredients: Aciclovir

ZOVIRAXLABIALE 5% cream (aciclovir)

Why is Zovirax Labiale used? What is it for?

Aciclovir is a specific and selective antiviral with activity against herpes viruses including the herpes simplex virus.

ZOVIRAXLABIALE 5% cream is indicated in the treatment of herpes simplex virus infections of the lips (recurrent herpes labialis) in adults and adolescents (over 12 years of age).

Contraindications When Zovirax Labiale should not be used

Hypersensitivity to the active substance, to valaciclovir or to any of the excipients. Children under the age of 12.

Precautions for use What you need to know before taking Zovirax Labiale

ZOVIRAXLABIALE 5% cream is for external use only and should only be used for herpes simplex lesions on the lips.

It is not recommended for application on mucous membranes such as those of the mouth (for example in case of mouth ulcers), nose, eyes and should not be used in the treatment of genital herpes.

Particular care should be taken to avoid accidental application into the eyes. If the cream accidentally comes into contact with the eyes, wash them thoroughly with lukewarm water. If in any doubt, consult your doctor.

ZOVIRAXLABIALE 5% cream is not recommended in immunocompromised patients (e.g. bone marrow transplant patients or AIDS patients). It is recommended that such patients consult their physician regarding the treatment of any infections.

Prolonged use of the product can give rise to sensitization phenomena. If this happens, stop the treatment and consult the attending physician.

It is recommended that people with particularly severe forms of herpes labialis consult their doctor. Be careful and see your doctor if you are unsure if you have cold sores.

Interactions Which drugs or foods may change the effect of Zovirax Labiale

Tell your doctor or pharmacist if you have recently taken any other medicines, even those without a prescription.

ZOVIRAXLABIALE 5% cream is unlikely to interact significantly with other medicinal products.

Warnings It is important to know that:

Cold sores are contagious so do not allow other people to touch your lesions or use your personal items that can transmit the infection (eg a towel).

After applying the cream, do not touch other parts of the body, especially the eyes, with your fingers before washing your hands. Always wash your hands before and after touching injuries.

Avoid touching the eyes. Herpetic eye infection can lead to corneal ulcers. If the cream accidentally comes into contact with the eyes, wash them thoroughly with warm water.

Especially avoid kissing children when you have injuries.

Avoid breaking the blisters and scratching the scabs. Not only can the lesions be infected with other germs, but your fingers can also be infected with the virus.

Avoid sharing glasses, cutlery, etc. with other people.

WHEN IT CAN ONLY BE USED AFTER CONSULTING YOUR DOCTOR

It is also advisable to consult your doctor in cases where these disorders have occurred in the past.

WHAT TO DO DURING PREGNANCY AND BREASTFEEDING

Ask your doctor or pharmacist for advice before taking any medicine. In pregnancy and lactation ZOVIRAXLABIALE 5% cream should only be used after consulting your doctor and having evaluated with him the risk / benefit ratio in your case. Consult your doctor if you suspect a pregnancy or wish to plan a maternity leave.

EFFECTS ON THE ABILITY TO DRIVE VEHICLES AND ON THE USE OF MACHINERY

There are no known adverse effects on the ability to drive and use machines.

Important information about some of the excipients

ZOVIRAXLABIALE 5% cream contains propylene glycol. It can cause skin irritation. ZOVIRAXLABIALE 5% cream contains cetostearyl alcohol. It can cause local skin reactions (e.g. contact dermatitis).

Dose, Method and Time of Administration How to use Zovirax Labiale: Posology

For external use only.

It is important to start treatment as soon as the first symptoms of infection appear (eg itching and / or burning and / or pain).

In the event that treatment has not been started at the onset of the first symptoms of the infection, it can also be started when blisters appear. ZOVIRAXLABIALE 5% cream is however effective both used in the initial phase of the infection (itching and / or burning and / or pain), and in the blistering phase.

Wash your hands before and after applying the cream to avoid worsening or transmission of the infection.

HOW MUCH

Warning: do not exceed the indicated doses. 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 about 4 hours, omitting the night application.

WHEN AND FOR HOW LONG

Treatment should continue for at least 4 days. If there is no healing, treatment can continue for up to 10 days. If after 10 days the lesions are still present, consult your doctor. Do not exceed the recommended dose. Consult your doctor if the disorder occurs repeatedly or if you notice any recent change in its characteristics

Overdose What to do if you have taken too much Zovirax Labiale

If you have used more than the recommended dose, speak to your doctor or pharmacist immediately, taking the pack with you to show.

ZOVIRAXLABIALE 5% cream is a preparation for topical use.

Even if the cream is accidentally applied in excess or ingested, no side effects are expected.

In case of accidental ingestion / intake of an excessive dose of ZOVIRAXLABIALE 5% cream, notify your doctor immediately or go to the nearest hospital.

What to do if you have forgotten to take one or more doses

If you forgot to apply the cream, don't worry. Apply it as soon as you remember and then continue the treatment as before. Do not apply a double amount of cream to make up for forgotten doses.

If you have any questions about the use of ZOVIRAXLABIALE 5% cream, ask your doctor or pharmacist.

Side Effects What are the side effects of Zovirax Labiale

Like all medicines, ZOVIRAXLABIALE 5% cream can cause side effects, although not everybody gets them.

The undesirable effects reported for ZOVIRAXLABIALE 5% cream are listed according to the following frequency of occurrence convention: very common: ≥ 1/10, common: ≥ 1/100 and <1/10, uncommon: ≥ 1/1000 and < 1/100, rare: ≥ 1/10000 and <1/1000, very rare: <1/10000, not known (frequency cannot be estimated from the available data).

Skin and subcutaneous tissue disorders

Uncommon:

  • transient burning or pain after application of ZOVIRAXLABIALE 5% cream
  • moderate dryness or peeling of the skin
  • itch

Rare:

  • erythema (redness)
  • contact dermatitis following application. Where sensitivity tests were conducted, it was shown that the substances that gave phenomena of reactivity were the components of the base cream rather than acyclovir.

Disorders of the immune system

Very rare:

  • immediate hypersensitivity including angioedema and urticaria.

If you have an allergic reaction with symptoms such as swelling of the face, stop using the product and contact your doctor immediately.

These side effects are usually transient.

Compliance with the instructions contained in the package leaflet reduces the risk of undesirable effects. If any of the side effects get serious, or if you notice any

Expiry and Retention

Expiry: see the expiry date printed on the package.

The expiry date refers to the product in intact packaging, correctly stored. Warning: do not use the medicine after the expiry date shown on the package.

Store at a temperature not exceeding 25 ° C, do not refrigerate.

Medicines should not be disposed of via wastewater or household waste.

Ask your pharmacist how to throw away medicines you no longer use. This will help protect the environment.

Keep this medicine out of the sight and reach of children.

Pipe: the sealing membrane in the pipe opening must be intact.

Bottle: do not use the product if the adhesive seal is missing or not intact.

It is important to always have the information on the medicine available, so keep both the box and the package leaflet.

Composition

ZOVIRAXLABIALE 5% cream contains aciclovir, an antiviral agent active against the herpes labialis virus.

One gram of cream contains:

  • Active ingredient: aciclovir 50 mg.
  • Excipients: poloxamer 407, cetostearyl alcohol, sodium laurilsulfate, white petroleum jelly, liquid paraffin, arlacel 165, dimethicone 20, propylene glycol, purified water.

Source Package Leaflet: AIFA (Italian Medicines Agency). Content published in January 2016. The information present may not be up-to-date.
To have access to the most up-to-date version, it is advisable to access the AIFA (Italian Medicines Agency) website. Disclaimer and useful information.

Further information on Labial Zovirax can be found in the "Summary of Characteristics" tab. 01.0 NAME OF THE MEDICINAL PRODUCT 02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION 03.0 PHARMACEUTICAL FORM 04.0 CLINICAL PARTICULARS 04.1 Therapeutic indications 04.2 Posology and method of administration 04.3 Contraindications 04.4 Special warnings and appropriate precautions for use 04.5 Interactions with other medicinal products and other forms of interaction04.6 Pregnancy and lactation04.7 Effects on the ability to drive and use machines04.8 Undesirable effects04.9 Overdose05.0 PHARMACOLOGICAL PROPERTIES05.1 Pharmacodynamic properties05.2 Pharmacokinetic properties05.3 Preclinical data of 06.0 PHARMACEUTICAL PARTICULARS 06.1 Excipients 06.2 Incompatibilities 06.3 Shelf life 06.4 Special precautions for storage 06.5 Nature of the immediate packaging and contents of the package 06.6 Instructions for use and handling 07.0 HOLDER OF THE ALL AUTHORIZATION "PLACING ON MARKETING 08.0 MARKETING AUTHORIZATION NUMBER 09.0 DATE OF PR IMA AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION 10.0 DATE OF REVISION OF THE TEXT 11.0 FOR RADIOPharmaceuticals, COMPLETE DATA ON INTERNAL RADIATION DOSIMETRY 12.0 FOR RADIO DRUGS, FURTHER DETAILED INSTRUCTIONS ON PREPARATION AND QUALITY CONTROL

01.0 NAME OF THE MEDICINAL PRODUCT

ZOVIRAXLABIALE 5% CREAM


02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION

One gram of cream contains:

Active ingredient: aciclovir 50 mg.

For excipients see section 6.1


03.0 PHARMACEUTICAL FORM

Cream for skin use.


04.0 CLINICAL INFORMATION

04.1 Therapeutic indications

ZOVIRAXLABIALE 5% cream is indicated in the treatment of herpes simplex virus infections of the lips (herpes labialis recurrent) in adults and adolescents (over 12 years of age).


04.2 Posology and method of administration

Adults and adolescents over 12 years of age

ZOVIRAXLABIALE 5% cream should be applied 5 times a day at intervals of about 4 hours, omitting the night application.

ZOVIRAXLABIALE 5% cream should be applied as early as possible, preferably during the earliest stages (prodrome or erythema). However, treatment can also be started in the later stages (papules or vesicles).

Treatment should continue for at least 4 days. If there is no healing, treatment can continue for up to 10 days. If after 10 days the lesions are still present it is recommended that patients consult their doctor.

Patients should wash their hands before and after applying the cream and avoid unnecessarily rubbing the lesions or touching them with a towel in order to avoid worsening or transmission of the infection.

Children under the age of 12

The safety and efficacy of ZOVIRAXLABIALE have not been studied in patients less than 12 years of age.


04.3 Contraindications

Hypersensitivity to aciclovir, valaciclovir, propylene glycol or other components of ZOVIRAXLABIALE 5% cream.

Children under the age of 12.


04.4 Special warnings and appropriate precautions for use

ZOVIRAXLABIALE 5% cream should only be used for cold sores present on the mouth. It is not recommended for application on mucous membranes such as those of the mouth, eyes and should not be used in the treatment of genital herpes. Particular attention should be paid to avoid accidental application in the eyes.

It is recommended that people with particularly severe forms of recurrent cold sores consult their doctor.

The use of the product, especially if prolonged, can give rise to sensitization phenomena: if this happens it is necessary to interrupt the treatment and consult the attending physician.

It is recommended that those suffering from cold sores avoid transmission of the virus especially when active lesions are present.

The use of ZOVIRAXLABIALE 5% cream in immunocompromised patients is not recommended. It is recommended that such patients consult their physician regarding the treatment of any infections.

The excipient propylene glycol can cause skin irritation and the excipient cetostearyl alcohol can cause local skin reactions (eg contact dermatitis).


04.5 Interactions with other medicinal products and other forms of interaction

No clinically significant interactions have been identified.


04.6 Pregnancy and breastfeeding

A registry of post-marketing use of aciclovir in pregnancy provided data on pregnancy outcomes in women exposed to the various aciclovir formulations.

These observations did not show an increase in the number of birth defects among acyclovir exposed subjects compared to the general population, and all birth defects found did not show any common features or characteristics that would suggest a single cause.

The use of ZOVIRAXLABIALE 5% cream should only be considered if the potential benefits outweigh the possibility of unknown risks.

The systemic exposure of aciclovir following topical application of ZOVIRAXLABIALE 5% cream is very low.

Although some data indicate that aciclovir passes into breast milk following systemic administration, the dose taken by an infant following use of ZOVIRAXLABIALE 5% cream in the mother should be insignificant.

Fertility

See clinical studies.

Clinical Studies

There are no data on the effects of ZOVIRAXLABIALE 5% cream or aciclovir in oral or i.v. formulation. for infusion on female fertility.

In pregnancy and lactation ZOVIRAXLABIALE 5% cream should only be used after consulting your doctor and evaluating with him the risk / benefit ratio in the individual case.


04.7 Effects on ability to drive and use machines

None known.


04.8 Undesirable effects

The undesirable effects reported for ZOVIRAXLABIALE 5% cream are listed below by location and frequency of occurrence (very common: ≥ 1/10, common: ≥ 1/100 and

Skin and subcutaneous tissue disorders

Uncommon:

• transient burning or pain after application of ZOVIRAXLABIALE 5% cream

• moderate dryness or peeling of the skin

• itch

Rare:

• erythema

• contact dermatitis following application. Where sensitivity tests were conducted, it was shown that the substances that gave phenomena of reactivity were the components of the base cream rather than acyclovir.

Disorders of the immune system

Very rare:

• immediate hypersensitivity which includes angioedema and urticaria.


04.9 Overdose

ZOVIRAXLABIALE 5% cream is a preparation for topical use.

Even if the entire contents of a 2 g pack of ZOVIRAXLABIALE 5% cream are ingested, no undesirable effects should be expected.


05.0 PHARMACOLOGICAL PROPERTIES

05.1 Pharmacodynamic properties

Pharmacotherapeutic group: antivirals for topical use ATC code: D06BB03

Aciclovir is a highly active antiviral, in vitro, against herpes simplex viruses types 1 and 2 and Varicella Zoster. Toxicity to host cells is low.

Once it enters the cell infected with Herpes, acyclovir is transformed into the active compound: aciclovir triphosphate. The first stage of the phosphorylation process is dependent on the virus-encoded thymidine kinase. Acyclovir triphosphate acts both as a substrate and as an inhibitor of viral DNA-polymerase, blocking the continuation of viral-DNA synthesis without interfering with normal cellular processes.

Aciclovir cream significantly reduced the time to healing of the episodes (p

05.2 "Pharmacokinetic properties

Pharmacology studies revealed only minimal systemic absorption of aciclovir following repeated topical administration of ZOVIRAXLABIALE 5% cream.


05.3 Preclinical safety data

The results of a large number of in vitro and in vivo mutagenicity tests indicate that acyclovir poses no genetic risk for humans.

Aciclovir was not shown to be carcinogenic in long-term studies in rats and mice.

In rats and dogs, largely reversible toxic effects on spermatogenesis have been reported only at doses significantly higher than therapeutic ones. Two-generation studies in mice revealed no effects of aciclovir, administered orally, on fertility.

ZOVIRAXLABIALE 5% cream has not been shown to have an effect on the number, morphology and motility of spermatozoa in humans.

Systemic administration of aciclovir in internationally accepted standard tests did not produce embryonic toxicity or teratogenic effects in rabbits, rats or mice.

In an experimental test in rats, not included in the classic teratogenic tests, abnormalities of the fetus were observed after subcutaneous doses of aciclovir so high as to produce toxic effects in the mother. However, the clinical relevance of these findings is uncertain.


06.0 PHARMACEUTICAL INFORMATION

06.1 Excipients

Poloxamer 407, Cetostearyl alcohol, Sodium laurilsulfate, White Vaseline, Liquid paraffin, Arlacel 165, Dimethicone 20, Propylene glycol, Purified water.


06.2 Incompatibility

Incompatibilities with other medicines are unknown.


06.3 Period of validity

Tube: 3 years.

Dispenser bottle: 2 years.


06.4 Special precautions for storage

Store at a temperature not exceeding 25 ° C. Do not refrigerate.


06.5 Nature of the immediate packaging and contents of the package

2 g aluminum tube.

Polypropylene bottle with 2 g dispenser.


06.6 Instructions for use and handling

None.


07.0 MARKETING AUTHORIZATION HOLDER

GlaxoSmithKline S.p.A. - Via A. Fleming, 2 - 37100 Verona


08.0 MARKETING AUTHORIZATION NUMBER

2 g tube: AIC 037868015

2 g dispenser bottle: AIC 037868027


09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION

AIC Resolution no. 1615 of 17 July 2007 - Official Gazette no. 184 of 9 August 2007


10.0 DATE OF REVISION OF THE TEXT

January 2012


11.0 FOR RADIO DRUGS, COMPLETE DATA ON THE INTERNAL RADIATION DOSIMETRY

12.0 FOR RADIO DRUGS, FURTHER DETAILED INSTRUCTIONS ON EXEMPORARY PREPARATION AND QUALITY CONTROL

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