Aciclovir Mylan Pharma 5 Percent Cream Tube 2g is a medicine indicated for the treatment of outbreaks of localized labial herpes also called "cold sores" in adults and children over 6 years old.
For warnings, precautions for use and contraindications, please consult the instructions for use of ACICLOVIR MYLAN PHARMA 5% Cr T/2g.
Aciclovir Mylan Pharma 5 Percent Cream Tube 2g is a medicine indicated for the treatment of outbreaks of localized herpes labialis also called " cold sores " in adults and children over 6 years old.
Cold sores usually appear on an outer edge of a lip as a "clump" of blisters over an area of redness, forming a "cold sore". The blisters contain a clear fluid rich in virus. They sometimes come together forming a bubble, then break. They then give way to a crust that covers the lesion and falls off in a few days.
A mild fever may accompany this rash.
Warning signs appear before the eruption:
It is necessary to know how to recognize these symptoms because the local treatment must be started as soon as they appear.
Do not use this cream in children under 6 years old.
Apply the cream to the lesions (exclusively on the lips) and around the lesions, 5 times a day.
Dermal.
For EXTERNAL USE only.
The applications are to be spread over the day with an interval of approximately 4 hours between 2 applications. The duration of treatment is limited to 10 days.
The active substance is :
Aciclovir........................................... 50 mg
For 1 g of cream
The other components are :
Propylene glycol, white petrolatum, liquid paraffin, ARLATONE 983 S (glycerol monostearate, polyoxyethylene 30 stearate), cetyl alcohol, dimethicone, purified water).
List of excipients with known effect :
Propylene glycol
2g tube
Attention, the drug ACICLOVIR MYLAN PHARMA 5% Cr T/2g is not a product like the others. Read the medication leaflet carefully before ordering it. Do not leave medicines within the reach of children. If symptoms persist, seek the advice of your doctor or pharmacist. Beware of incompatibilities on your current products.
Please inform your online pharmacist of the treatments in progress in order to identify any incompatibilities. The order validation form contains a personalized message field provided for this purpose.
Pharmacovigilance Report an adverse drug reaction(s)
ANSM - Updated on: 03/07/2017
ACICLOVIR MYLAN PHARMA 5%, cream
acyclovir
Please read this leaflet carefully before you start using this medicine because it contains important information for you .
You should always use this medication exactly as prescribed in this leaflet or by your doctor, pharmacist or nurse.
· Keep this leaflet. You might need to read it again.
· Ask your pharmacist for advice or information.
· If you experience any side effects, talk to your doctor, pharmacist or nurse. 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.
1. What is ACICLOVIR MYLAN PHARMA 5%, cream and in which cases is it used?
2. What should I know before using ACICLOVIR MYLAN PHARMA 5%, cream?
3. How to use ACICLOVIR MYLAN PHARMA 5%, cream?
4. What are the possible side effects?
5. How to store ACICLOVIR MYLAN PHARMA 5%, cream?
6. Package contents and other information.
1. WHAT IS ACICLOVIR MYLAN PHARMA 5%, cream AND WHAT CASES IS IT USED FOR?
Pharmacotherapeutic group : antiviral for topical use - ATC code: D06BB03
This medication is indicated in the treatment of localized cold sores of herpes called also "cold sores" in adults and children over 6 years.
2. BEFORE YOU USE ACICLOVIR MYLAN PHARMA 5%, cream?
Do not use ACICLOVIR MYLAN PHARMA 5%, cream:
· In children under 6 years.
· If you are allergic to acyclovir, propylene glycol or any of the other ingredients of this medication mentioned in section 6 or valaciclovir.
Warnings and Precautions
Talk to your doctor, pharmacist or nurse before using ACICLOVIR MYLAN PHARMA 5%, cream.
Take the advice of your pharmacist or doctor if you have any doubts about the nature of your lesion.
To avoid local irritations, avoid applying cream to the mucous membranes (buccal, ocular and vaginal). Avoid accidental contact with the eyes.
If you are severely immunosuppressed (eg, AIDS, transplant), see your doctor for treatment of any infection .
This medicine contains propylene glycol as an excipient, which may cause skin irritation.
This medicinal product contains cetyl alcohol as an excipient which may cause local skin reactions (eg contact dermatitis).
In the absence of healing after 5 days of treatment or worsening of your cold sore: stop treatment and consult your doctor immediately.
In the event of a herpes outbreak, some hygiene precautions are necessary to protect your environment from the risk of transmission of the virus:
· Avoid close contact, a kiss for example, with your entourage.
· NEVER ENROLL A CHILD IN LOWER AGE.
· 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 medicines and ACICLOVIR MYLAN PHARMA 5%, cream
It is not recommended to use ACICLOVIR MYLAN PHARMA 5%, cream, with other creams.
Inform your doctor or pharmacist if you are using, have recently used or could use any other medicines, even those not prescribed.
ACICLOVIR MYLAN PHARMA 5%, cream with food, drinks and alcohol
Not applicable.
Pregnancy and breast feeding
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.
Driving and using machines
There are no data on effects on the ability to drive and use machines.
ACICLOVIR MYLAN PHARMA 5%, cream contains propylene glycol and cetyl alcohol.
Propylene glycol may cause skin irritation.
Cetyl alcohol can cause local skin reactions (eg, contact dermatitis).
3. HOW TO USE ACICLOVIR MYLAN PHARMA 5%, cream?
Instructions for proper use
Do not use this cream in children under 6 years of age.
Dosage
Apply the cream to the lesions (exclusively at the level of the lips) and around the lesions, 5 times a day, each application being spaced at least 3 to 4 hours apart and without night application.
Administration mode
Dermal.
Reserved for EXTERNAL USE.
· Begin applications on the first itching or burns before the vesicles appear, the treatment being more effective if it is started at the first symptoms of a cold sores (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.
· Tightly close the dispensing tube or pump 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 2 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.
If you used more ACICLOVIR MYLAN PHARMA 5%, cream you should not have
Consult your doctor or pharmacist.
If you forget to use ACICLOVIR MYLAN PHARMA 5%, cream
Do not use a double dose to make up for a missed dose.
If you stop using ACICLOVIR MYLAN PHARMA 5%, cream
Not applicable.
If you have any further questions on the use of this medication, ask your doctor, pharmacist or nurse for more information.
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 less than 1 in 100 patients):
· Sensations of tingling or transient burns following the application of the cream, slight drying or desquamation (elimination of dead skin) of the skin, itching.
Rare side effects (affecting less than 1 in 1,000 patients):
· Erythema (redness), contact dermatitis (allergic skin reaction) to application. In the sensitivity tests carried out, the excipients present in the cream gave rise to a higher reactivity than aciclovir.
Very rare side effects (affecting less than 1 in 10,000 patients):
· Immediate hypersensitivity (allergic) reaction including angioedema (swelling in the face and neck) and urticaria.
In this case, discontinue treatment and seek the advice of your pharmacist or doctor.
Declaration of side effects
If you experience any side effects, talk to your doctor, pharmacist or nurse. 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 ACICLOVIR MYLAN PHARMA 5%, cream?
Keep this medicine out of the reach and sight of children.
Do not use this medication after the expiry date which is stated on the tube or on the dosing pump bottle. The expiry date refers to the last day of that month.
Store at a temperature not exceeding 25 ° C.
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 ACICLOVIR MYLAN PHARMA 5% contains, cream
· The active substance is:
Aciclovir ................................................. .................................................. ............................ 50 mg
For 1 g of cream.
· The other components are:
Propylene glycol, white petroleum jelly, liquid paraffin, ARLATONE 983S (glycerol monostearate, polyoxyethylene 30 stearate), cetyl alcohol, dimethicone, purified water.
What is ACICLOVIR MYLAN PHARMA 5%, cream and contents of the pack
This medication is in the form of a cream.
Tube of 2 g.
2 gm dosing pump bottle.
Marketing Authorization Holder
MYLAN SAS
117, ALLEE DES PARCS
69800 SAINT-PRIEST
Marketing Authorization Operator
117, ALLEE DES PARCS 69800
SAINT-PRIEST
MICROWEG 22
6545 CM NIJMEGEN
NETHERLANDS
or
LABORATORIES LEURQUIN-MEDIOLANUM
68-84, RUE AMPERE
ZI DES CHANOUX
93330 NEUILLY SUR MARNE
or
MYLAN SAS
117 ALLEE DES PARCS
69800 SAINT-PRIEST
or
CHEFARO INTERNATIONAL BV
KEILEWEG 8 - 3029 BS ROTTERDAM
NETHERLANDS
or
CHEMINEAU LABORATORIES
93, ROAD OF CURRENCY
37210 VOUVRAY
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]
<{MM / YYYY}> <{YYYY month}.>
Detailed information on this medicine is available on the ANSM website (France).
ADVICE / HEALTH EDUCATION
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 (blisters) in bouquets around the lips, called fever. 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
. Presentations . Composition . Indications . Contraindications . Warning . Pregnancy and breastfeeding . Directions for use and dosage . Advice . Undesirable effects . Lexicon
ACICLOVIR MYLAN PHARMA 5%: cream; 2 g tube.
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ACICLOVIR MYLAN PHARMA 5%: cream; 2 g pump bottle.
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Mylan Laboratory
| p 100 g | |
| acyclovir | 5 g |
| Propylene glycol | + |
Usual dosage:
The figures are astonishing: 9 million French people develop cold sores each year! Depending on the country, 50 to 90% of the population is infected with this virus! By the age of 4, 75% of children have already been in contact with this highly contagious virus. What is herpes? Herpes labialis or cold sore is a benign condition for the majority of people that we would…
Read the article on the blogFever is characterized by a marked increase in body temperature. It manifests itself in all warm-blooded living beings and in humans, this rise can go beyond 40 ° C. As the normal temperature of the human body oscillates between 36.5 ° C and 37.5 ° C, it is considered to be in the presence of a fever from 38 °…
Read the article on the blog
