Active ingredients: Aciclovir
CYCLOVIRAN LABIAL 5% Cream
Why is Cycloviran Labiale used? What is it for?
CYCLOVIRAN LABIAL contains the active substance aciclovir, it is indicated for the treatment of infections caused by Herpes simplex, such as recurrent herpes labialis (which keeps coming back) in adults and adolescents over 12 years.
Contact your doctor if the lesions on the lips are still present after 10 days.
Contraindications When Cycloviran Labiale should not be used
DO NOT use LABIAL CYCLOVIRAN
- If you are allergic to aciclovir, valaciclovir, or any of the other ingredients of this medicine.
- If you are under the age of 12.
Precautions for use What you need to know before taking Cycloviran Labiale
Talk to your doctor before using CYCLOVIRAN LABIAL
- 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.
Take special care with LABIAL CYCLOVIRAN
- CYCLOVIRAN LABIALE is for external use only and should only be used to treat lesions on the lips caused by herpes simplex. Therefore, do not apply LABIAL CYCLOVIRAN to the mucous membranes of the mouth, nose, eyes or vagina, and do not use it to treat genital herpes.
- Do not rub the lesions unnecessarily or touch them with the towel to avoid worsening or transmitting the infection. Always wash your hands before and after applying the cream.
- Do not touch your eyes after touching the lesions or applying the cream.
- If you use CYCLOVIRAN LABIALE for a long time, sensitization phenomena (allergic reactions) may occur. In this case, stop the treatment and contact your doctor.
Interactions Which drugs or foods can modify the effect of Cycloviran Labiale
Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.
Do not apply other skin products, eg. make-up, sunscreen, cocoa butter, or other medicines used to treat herpes during treatment with CYCLOVIRAN LABIAL.
Warnings It is important to know that:
Pregnancy and breastfeeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.
During pregnancy and lactation, CYCLOVIRAN LABIALE should only be used after consultation with the doctor, who will evaluate the possible risks and benefits for the mother and the baby.
Driving and using machines
There are no known adverse effects on the ability to drive and use machines.
CYCLOVIRAN LABIAL contains propylene glycol
It can cause skin irritation.
CYCLOVIRAN LABIAL contains cetostearyl alcohol
It can cause local skin reactions (e.g. contact dermatitis).
Dose, Method and Time of Administration How to use Cycloviran Labiale: Posology
Always use this medicine exactly as described in this leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
CYCLOVIRAN LABIALE is for external use only.
Start treatment as soon as the first symptoms of infection appear (eg itching and / or burning and / or pain and / or swelling).
If you have not started treatment as soon as you have the first symptoms of infection, it can also start when blisters appear. phase of the vesicles.
Wash your hands before and after applying the cream and avoid unnecessarily rubbing the lesions or touching them with a towel to prevent infection from worsening or passing on.
Warning: do not exceed the recommended dose.
Adults and adolescents over 12 years of age
The recommended dose is one application 5 times a day at intervals of about 4 hours, skipping the night application.
Children under the age of 12
CYCLOVIRAN LABIALE should not be used in children below 12 years of age (see section "DO NOT use CYCLOVIRAN LABIALE").
Continue the treatment for at least 4 days. If after 4 days it has not healed, you can continue the treatment for up to 10 days.
If the lesions are still present after 10 days, please contact your doctor.
Also contact your doctor if the disorder occurs repeatedly or if you notice any recent changes in its characteristics.
If you forget to use CYCLOVIRAN LABIAL
If you have forgotten to apply the cream, apply it as soon as you remember and then continue the treatment as before. Do not use a double dose to make up for a forgotten dose.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Overdose What to do if you have taken too much Cycloviran Labiale
If you have used more than the recommended dose or if you have accidentally swallowed CYCLOVIRAN LABIAL, notify your doctor immediately or go to the nearest hospital.
Side Effects What are the side effects of Cycloviran Labiale
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The undesirable effects reported for CYCLOVIRAN LABIAL are:
Uncommon side effects (may affect up to 1 in 100 people):
- transient burning or pain after application
- moderate dryness or peeling of the skin
- itch.
Rare side effects (may affect up to 1 in 1,000 people):
- redness of the skin (erythema)
- inflammation of the skin following application due to contact with the cream (contact dermatitis).
Very rare side effects (may affect up to 1 in 10,000 people):
- immediate allergic (hypersensitivity) reactions including swelling of the lips, face, neck and throat (angioedema) and skin reaction (hives).
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system at www.agenziafarmaco.it/it/responsabili. By reporting side effects you can help provide more information on the safety of this medicine.
Expiry and Retention
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 which is stated on the package after EXP. The expiry date refers to the last day of that month.
Do not throw any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. This will help protect the environment.
It is important to always have the information about the medicine available, so keep both the box and the package leaflet.
Other information
What CYCLOVIRAN LABIAL contains
- The active ingredient is aciclovir. One gram of cream contains 50 mg of aciclovir.
- The other ingredients are: propylene glycol, white petroleum jelly, cetostearyl alcohol, liquid paraffin, arlacel 165, poloxamer 407, dimethicone 20, sodium lauryl sulfate, purified water.
Description of what CYCLOVIRAN LABIAL looks like and contents of the pack
CYCLOVIRAN LABIALE is a white and homogeneous cream, contained in a 2 g aluminum tube.
Each pack contains 1 tube of 2 g.
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.
01.0 NAME OF THE MEDICINAL PRODUCT
LIP CYCLOVIRAN 5% CREAM
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
One gram of cream contains:
Active principle
Aciclovir 50 mg
Excipients with known effects:
Propylene glycol 400 mg
Cetostearyl alcohol 67.5 mg
For the full list of excipients, see section 6.1
03.0 PHARMACEUTICAL FORM
Cream.
04.0 CLINICAL INFORMATION
04.1 Therapeutic indications
CYCLOVIRAN LABIALE is indicated for the treatment of virus infections herpes simplex lip (herpes labialis recurrent) in adults and adolescents over 12 years.
04.2 Posology and method of administration
Adults and adolescents over 12 years of age
CYCLOVIRAN LABIALE must be applied 5 times a day at intervals of approximately 4 hours, omitting the nocturnal application.
CYCLOVIRAN LABIAL should be applied to lesions or areas where they are developing as early as possible after the onset of infection.
It is particularly important to start treatment for recurrent episodes during the prodrome phase or at the first appearance of lesions.
Treatment can also be started during the later stages (papules or vesicles).
Treatment should continue for at least 4 days and up to a maximum of 10 if there is no healing. 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 CYCLOVIRAN LABIALE have not been studied in patients less than 12 years of age.
04.3 Contraindications
Hypersensitivity to the active substance, to valaciclovir, or to any of the excipients listed in section 6.1.
Children under the age of 12.
04.4 Special warnings and appropriate precautions for use
CYCLOVIRAN LABIALE should only be used for cold sores present on the lips. The product is not for ophthalmic use, nor is it recommended for application on the mucous membranes of the mouth, nose or vagina as it could be irritating.
The product should not be used in the treatment of genital herpes.
Particular care should be taken to avoid accidental application into the eye.
The use of the product, especially if prolonged, can give rise to sensitization phenomena, where this happens it is necessary to interrupt the treatment.
There are no reports of addiction or dependence on the drug.
In severely immunocompromised patients (AIDS patients or bone marrow transplant patients) administration of aciclovir in oral formulations should be considered. Such patients should be recommended to consult their physician regarding the treatment of any infection.
Important information about some of the ingredients of CYCLOVIRAN LABIALE:
CYCLOVIRAN LABIAL contains propylene glycol. It can cause skin irritation.
CYCLOVIRAN LABIAL contains cetostearyl alcohol. It can cause skin reactions (e.g. contact dermatitis).
04.5 Interactions with other medicinal products and other forms of interaction
Other types of dermatological products (such as cosmetics, sunscreen creams, cocoa butter) or drugs that treat herpes should not be applied at the same time as CYCLOVIRAN LABIALE.
04.6 Pregnancy and breastfeeding
Fertility
There are no data on fertility in women. Acyclovir cream has not been shown to have an effect on sperm count, morphology and motility in humans (see section 5.3).
Pregnancy
The use of CYCLOVIRAN LABIAL should only be considered if the potential benefits outweigh the possibility of unknown risks however, the exposure to aciclovir following topical application of aciclovir cream is very low.
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 particularities or common characteristics that would suggest a single cause.
Feeding time
Limited data indicate that the drug is found in breast milk following systemic administration. However, the dose received by an infant following the use of CYCLOVIRAN LABIAL in the mother should be insignificant.
04.7 Effects on ability to drive and use machines
None known.
04.8 Undesirable effects
The following convention has been used for the classification of undesirable effects in terms of frequency: Very common (≥ 1/10), Common (≥1 / 100,
Skin and subcutaneous tissue disorders
Uncommon
• transient burning or pain after applying CYCLOVIRAN LABIALE
• moderate dryness and peeling of the skin
• itch
Rare
• erythema
• contact dermatitis after application. Where sensitivity tests were conducted, it was shown that the substances that produced reactive phenomena were the components of the base cream rather than acyclovir.
Disorders of the immune system
Very rare
• immediate hypersensitivity reactions including angioedema and urticaria.
Reporting of suspected adverse reactions
Reporting of suspected adverse reactions occurring after authorization of the medicinal product is important as it allows continuous monitoring of the benefit / risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system. "address www.agenziafarmaco.gov.it/it/responsabili.
04.9 Overdose
No overdose effects are known.
05.0 PHARMACOLOGICAL PROPERTIES
05.1 Pharmacodynamic properties
Pharmacotherapeutic group: antivirals for topical use, ATC code: D06BB03.
Acyclovir is a highly active antiviral, in vitro, against viruses herpes simplex type 1 and 2 and varicella zoster. Host cell toxicity is low. Once it enters the herpes-infected cell, acyclovir is transformed into the active compound: acyclovir triphosphate. The first stage of the phosphorylation process is dependent on the thymidine kinase encoded by the virus.
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.
05.2 Pharmacokinetic properties
Pharmacology studies revealed only minimal systemic absorption of aciclovir following repeated topical administration of aciclovir.
05.3 Preclinical safety data
The results of a large number of mutagenicity tests in vitro and in vivo indicate that acyclovir poses no genetic risk for humans.
Acyclovir 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.
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 on the mother. The clinical relevance of these findings is still uncertain.
06.0 PHARMACEUTICAL INFORMATION
06.1 Excipients
Propylene Glycol, White Vaseline, Cetostearyl Alcohol, Liquid Paraffin, Arlacel 165, Poloxamer 407, Dimethicone 20, Sodium Lauryl Sulphate, Purified Water.
06.2 Incompatibility
Incompatibilities with other medicines are unknown.
06.3 Period of validity
3 years.
06.4 Special precautions for storage
Do not store above 25 ° C, do not refrigerate.
06.5 Nature of the immediate packaging and contents of the package
2 g aluminum tube.
06.6 Instructions for use and handling
No particular instructions for disposal.
Unused medicine and wastes derived from this medicine must be disposed of in accordance with local regulations.
07.0 MARKETING AUTHORIZATION HOLDER
Sigma-Tau Industrie Farmaceutiche Riunite S.p.A.
Viale Shakespeare, 47 - 00144 Rome
08.0 MARKETING AUTHORIZATION NUMBER
CYCLOVIRAN LABIALE AIC n. 038902019
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION
Date of first authorization: 30 April 2009
Latest renewal date: July 2013
10.0 DATE OF REVISION OF THE TEXT
October 2016
