Activir 5% isindicated for the treatment oflocalized cold sores(also known as “fever blisters”) in adults and children over 6 years of age.
Cold sores, or fever blisters, are a cluster of blisters on the lips caused by a virus. They are caused by the herpes simplex virus type 1 (HSV-1), which remains in the body following an initial infection. A common condition, it recurs during episodes of infection, exposure to the sun, etc.
Activir 5%is indicated for the treatment oflocalized cold sores(also called “fever blisters”) in adults and children over 6 years of age.
Cold sorescannot be permanently cured, but there are treatments available to speed up healing. Symptoms disappear on their own within seven to ten days.
Treatment forcold sores(or fever blisters) is based on:
Rapid Relief from Cold Sore Outbreaks with Activir 5%
An Advanced Solution for Cold Sores
Activir 5% is specifically formulated to treat localized cold sores—commonly known as “fever blisters”—in adults and children over 6 years of age. Its powerful formula acts directly on the virus responsible for herpes, providing fast and effective relief from the unpleasant symptoms associated with this skin condition.
Targeted Action for Faster Healing
Thanks to its high concentration of antiviral active ingredients, Activir 5% acts quickly to reduce the duration and intensity of cold sores. Its advanced formula penetrates the skin quickly to directly target the virus, thereby accelerating the healing process and promoting the disappearance of skin lesions in record time.
Convenient and Easy to Use
Activir 5% is available as a cream to be applied topically to cold sore lesions. Its convenient format and light texture make it easy to apply, ensuring hygienic and precise use. Thanks to Activir 5%, say goodbye to cold sores and restore healthy, soothed skin in no time.
Method of Administration
Topical use.
Dosage
Apply the cream to the herpes lesions and the surrounding area 5 times a day, with at least 3 to 4 hours between applications and no application at night.
Frequency of Application
Spread applications throughout the day, with at least a 3- to 4-hour interval between applications.
For example, apply the cream in the morning after breakfast, at noon after lunch, after an afternoon snack, in the evening after dinner, and at bedtime.
Duration of Treatment
Treatment should not exceed 5 days without medical advice.
Natural Remedies for Cold Sores
There are some natural remedies that can help a cold sore heal. Be careful, though—these methods are not recommended for pregnant women or children.
The active ingredient is (per 100 g of cream):
Acyclovir: 5.00 g
The other ingredients are:
Propylene glycol, poloxamer 407, sodium lauryl sulfate, cetostearyl alcohol, petrolatum, dimethicone 20, liquid paraffin, purified water, glycerol monostearate, macrogol stearate 100.
This medication contains propylene glycol and may cause skin irritation.
If the cold sore has not healed after 5 days of treatment or if it worsens: Stop treatment and consult your doctor immediately.
If you have a cold sore outbreak, certain hygiene precautions are necessary to protect those around you from the risk of virus transmission.
In addition to your treatment, to prevent transmission of the virus, you must follow these hygiene guidelines:
FAQs about Activir 5%:
Q: How often should I apply Activir 5%?
A: It is recommended to apply Activir 5% up to five times a day, spacing applications at least four hours apart. Always follow the instructions on the package insert or those given by your doctor.
Q: Can Activir 5% be used on children?
A: Yes, Activir 5% can be used in children over 6 years of age under adult supervision. However, be sure to follow the dosage recommendations specific to this age group.
Q: Are there any side effects associated with using Activir 5%?
A: In most cases, Activir 5% is well tolerated and does not cause any significant side effects. However, mild skin reactions, such as tingling or redness, may occasionally occur. If you experience an allergic reaction or serious side effects, stop using the product immediately and consult a healthcare professional.
This medication is available as a cream. 2 g tube.
Pharmacovigilance Report an adverse drug reaction(s)
ANSM - Last updated: 08/06/2017
acyclovir
You should always use this medication exactly as prescribed in this leaflet or by your doctor or pharmacist.
· Keep this leaflet. You might need to read it again.
· Ask your pharmacist for advice or information.
· If you experience any of the side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this leaflet. See section 4.
· You should contact your doctor if you experience no improvement or feel less well after 5 days.
Do not use this medication for children.
1. What is ACTIVIR 5 PERCENT, cream and in what cases is it used?
2. What should I know before using ACTIVIR 5 PER CENT, cream?
3. How to use ACTIVIR 5 PERCENT, cream?
4. What are the possible side effects?
5. How to keep ACTIVIR 5 PER CENT, cream?
6. Package contents and other information.
1. WHAT TO ACTIVATE 5 PER CENT, cream AND WHAT USE IS IT USED FOR?
Pharmacotherapeutic group: ANTIVIRALS - ATC code: D06BB03
2. BEFORE YOU USE ACTIVITY 5%, cream?
Never use ACTIVIR 5 PERCENT, cream:
· in children under 6 years of age,
· if history of hypersensitivity to aciclovir, valaciclovir, propylene glycol or any of the other ingredients of this medicinal product mentioned in section 6.
If in doubt, you should seek the advice of your doctor or pharmacist.
Warnings and Precautions
Special warnings
DO NOT LEAVE THIS MEDICINE FOR CHILDREN.
Precautions for use
Precautions should be taken to avoid the accidental introduction of the cream into the eye.
To avoid local irritation, avoid applying cream to the mucous membranes (buccal and vaginal).
If you are severely immunosuppressed (eg, AIDS, transplant), see your doctor for treatment of any infection.
The propylene glycol excipient may cause skin irritation and cetostearyl alcohol may induce local skin reactions (eg contact dermatitis).
In case of absence of healing after 5 days of treatment or aggravation of your cold sore:
STOP TREATMENT AND SEEK YOUR DOCTOR IMMEDIATELY.
· In case of an outbreak of labial herpes, some hygiene precautions are necessary, to protect your entourage from the risk of transmission of the virus.
In addition to your treatment, to avoid transmission of the virus, you must respect the following hygiene rules:
· Avoid close contact, a kiss for example, with your entourage,
· NEVER ENGAGE A CHILD IN LOWER AGE,
· Take the advice of your pharmacist or doctor if you have any doubts about the nature of your lesion,
· Wash your hands thoroughly in case of contact with the lesion,
· During treatment, do not rub your eyes or eyelids with your hands and if you wear contact lenses, do not moisten them with your saliva,
· Avoid touching or scratching the lesions.
· In case of another localization of your herpes crisis, never use this cream, TAKE THE OPINION OF YOUR DOCTOR.
Children and Youth
Not applicable.
Other drugs and ACTIVIR 5 PER CENT, cream
Inform your doctor or pharmacist if you are taking, have recently taken or may take any other medicines.
ACTIVATE 5 PERCENT, cream with food, drinks and alcohol
Not applicable.
Pregnancy
The use of aciclovir by the dermal route is possible in the pregnant woman in compliance with the indications.
If you discover that you are pregnant during treatment, tell your doctor as he alone can judge the need to continue.
feeding
If maternal pathology permits, breast-feeding is possible with this medication.
Generally, during pregnancy and breast-feeding, you should always seek advice from your doctor or pharmacist before taking any medication.
Sport
Not applicable.
Driving and using machines
There are no data on effects on the ability to drive and use machines.
ACTIVIR 5 PERCENT, cream contains: Cetostearyl alcohol, propylene glycol.
3. HOW TO USE ACTIVATE 5 PER CENT, cream?
Apply the cream to the herpetic lesions and around the lesions, 5 times a day, each application being spaced at least 3 to 4 hours apart and without application at night.
Method and route of administration
Dermal.
Begin the first itching or burns before the vesicles appear, the treatment being more effective if it is started from the first symptoms announcing a herpes outbreak or cold sore.
Wash your hands thoroughly before and after each application of the cream on your cold sore to avoid transmitting the infection.
Apply the cream with your finger, overlapping largely around the lesion.
Close the tube or dispensing pump correctly after use.
How to use the pump:
It is recommended to perform at least 3 to 4 slow and complete pressures, so that the pumping device is fully primed as soon as it is first used and thus ensure optimal delivery of the product.
Frequency of Administration
The applications are to be distributed during the day, with an interval of at least 3 to 4 hours between two applications.
For example, apply the cream in the morning after breakfast, at lunchtime after lunch, after tasting, in the evening after dinner, in the evening before bedtime.
Duration of treatment
The duration of treatment should not exceed 5 days, without medical advice.
Use in children and adolescents
Do not use this cream in children under 6 years of age.
If you used more ACTIVIR 5 PERCENT, cream than you should:
Immediately consult your doctor or pharmacist.
If you forget to use ACTIVIR 5 PER CENT, cream:
If you stop using ACTIVIR 5 PER CENT, cream:
Not applicable.
4. WHAT ARE POSSIBLE SIDE EFFECTS?
Like all medicines, this medicine may cause side effects, although not everybody gets them.
Due to the nature of the adverse events observed, it is not possible to determine which effects are related to the administration of the drug and which are related to the disease.
Uncommon side effects (affecting 1 to 10 users in 1,000): Tingling sensations or transient burns, dry skin, flaking of the skin, pruritus.
Uncommon side effects (affecting 1 to 10 users out of 10,000): Erythema, contact dermatitis.
Very rare side effects (affecting less than 1 user in 10 000): Cases of urticaria and angioedema (abrupt swelling of the face and neck of allergic origin) have been reported.
If you notice any side effects not listed in this leaflet, or if any of the side effects gets serious, contact your doctor or pharmacist.
Declaration of side effects
If you experience any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this leaflet. You can also report adverse reactions directly via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and network of Regional Centers of Pharmacovigilance - Website: www.ansm.sante.fr
By reporting adverse reactions, you are helping to provide more information about the safety of the drug.
5. HOW TO STORE ACTIVATE 5 PER CENT, cream?
Keep this medicine out of the reach and sight of children.
Do not use this medicine after the expiry date which is stated on the package. The expiry date refers to the last day of that month.
Store at a temperature below 25 ° C. Do not refrigerate.
Do not throw any medicines into drains or rubbish. Ask your pharmacist to remove any medications you are no longer using. These measures will help protect the environment.
6. PACKAGE CONTENTS AND OTHER INFORMATION
What ACTIVIR 5 PERCENT, cream contains
· The active substance is:
aciclovir ................................................. .................................................. ............................. 5.00 g
· The other components are:
Propylene glycol, poloxamer 407, sodium lauryl sulfate, cetostearyl alcohol, petroleum jelly, dimethicone 20, liquid paraffin, purified water, glycerol monostearate, macrogol stearate 100.
What is ACTIVIR 5 PER CENT, cream and contents of the pack
This medication is in the form of a cream. Tube of 2 g.
Marketing Authorization Holder
GLAXOSMITHKLINE HEALTH GRAND PUBLIC
100, ROUTE DE VERSAILLES
CS 80001
78164 MARLY LE ROI CEDEX
Marketing Authorization Operator
GLAXOSMITHKLINE HEALTH GRAND PUBLIC
100, ROUTE DE VERSAILLES
CS 80001
78164 MARLY LE ROI CEDEX
HAMIRE ROAD
BARNARD CASTLE
COUNTY DURHAM DL 12 8 DT
UK
Names of the medicinal product in the Member States of the European Economic Area
Not applicable.
The last date on which this leaflet was revised is:
[to be completed later by the holder]
Detailed information on this medicine is available on the ANSM website (France).
Health Education Council
Cold sores or cold sores are due to an infection caused by a virus called Herpes Simplex. After a primary infection, the virus persists in the body without causing symptoms.
During an event such as fatigue, menstruation, fever, emotion or sun exposure, the virus can sometimes be "reactivated" and cause the appearance of vesicles (blistering) in a bouquet around the lips, called "cold sores". These vesicles are contagious until the appearance of scabs, sign of scarring.
There are signs before riders located at the usual location of the lesion, which usually result in a burning sensation and / or tingling.
These signs are important to know:
· it is as soon as they appear that the treatment must be started which prevents viral multiplication and makes it possible to prevent or limit the development of the cold sore,
· it is also as soon as they appear that you must respect the hygiene rules given to you in the precautions of use, in order to reduce the risk of transmission of the virus.
On the other hand, aciclovir can not act on viruses that persist latently in the body and aciclovir does not prevent the occurrence of recurrences after the interruption of treatment.
Local antiherpetics
acyclovir
. Presentations . Composition . Indications . Contraindications . Warning . Pregnancy and breastfeeding . Directions for use and dosage . Advice . Undesirable effects . Lexicon
ACTIVITY 5%: cream; 2 g tube with metering pump.
-
ACTIVITY 5%: cream; 2 g tube.
-
Laboratory GlaxoSmithKline Consumer Healthcare
| p 100 g | |
| acyclovir | 5 g |
| Propylene glycol | + |
Usual dosage:
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