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Mylan Viatris Conseil Aciclovir 5% Cold Sore Tube 2g
Over-the-counter medication

Mylan Viatris Conseil Aciclovir 5% Cold Sore Tube 2g

Brand : Mylan Viatris Mylan Viatris
€2.27 EXCL. VAT €2.49 INCL. VAT
This product is an over-the-counter medication. Please consult the package insert before ordering online.
In stock
Reference : 3400935400567
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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.

ACICLOVIR MYLAN PHARMA 5 PERCENT CREAM TUBE 2G

For warnings, precautions for use and contraindications, please consult the instructions for use of ACICLOVIR MYLAN PHARMA 5% Cr T/2g.

Description of Aciclovir Mylan Pharma 5 Percent Cream T ube 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:

  • local heat;
  • tingling;
  • itches.

It is necessary to know how to recognize these symptoms because the local treatment must be started as soon as they appear.

Indication of Aciclovir Mylan Pharma 5 Percent Cream T ube 2g

Directions:

  • Herpes labialis (INDICATION)
  • Herpes labialis (INDICATION_GROUP)
  • Viral infection (INDICATION_GROUP)
  • Viruses of the herpes group (INDICATION_GROUP)

Directions for use Aciclovir Mylan Pharma 5 Percent Cream T ube 2g

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.

  • Start the applications from the first itching or burning even before the blisters appear, the treatment being more effective if it is started at the first symptoms announcing a push of herpes labialis (cold sores).
  • Wash your hands thoroughly before and after applying the cream to your cold sore to avoid spreading the infection.
  • Apply the cream with the finger, overflowing widely around the lesion.
  • Close the tube after use.

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.

Composition of Aciclovir Mylan Pharma 5 Percent Cream T ube 2g

  • ACICLOVIR MYLAN 5% cream
  • liquid paraffin
  • aciclovir
  • petroleum jelly
  • dimeticone
  • purified water
  • propylene glycol
  • cetyl alcohol

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

Introducing Aciclovir Mylan Pharma 5 Percent Cream T ube 2g

2g tube

Drug Warnings

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)

Download PDF leaflet

NOTICE

ANSM - Updated on: 03/07/2017

Name of the medicinal product

ACICLOVIR MYLAN PHARMA 5%, cream

acyclovir

framed

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.

What is in this leaflet?

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

MYLAN SAS

117, ALLEE DES PARCS 69800

SAINT-PRIEST

Maker

SYNTHON BV

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}.>

Other

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.

VIDAL OF THE FAMILY

ACICLOVIR MYLAN PHARMA cream

Local antiherpetics

. Presentations . Composition . Indications . Contraindications . Warning . Pregnancy and breastfeeding . Directions for use and dosage . Advice . Undesirable effects . Lexicon

PRESENTATIONS (summary)

ACICLOVIR MYLAN PHARMA 5%: cream; 2 g tube.
-

ACICLOVIR MYLAN PHARMA 5%: cream; 2 g pump bottle.
-

Mylan Laboratory

COMPOSITION (summary)
p 100 g
acyclovir 5 g
Propylene glycol +

INDICATIONS (summary)
This drug is a potent antiviral . It blocks the multiplication of the herpes virus within the infected cells.
It is used in the treatment of cold sores (also called " cold sores").
CONTRAINDICATIONS (summary)
This medication should not be used in children younger than 6 years of age.
WARNING (Contents)
This cream available without a prescription is intended to be used on the advice of your pharmacist; report any history of an allergic reaction to a drug containing acyclovir or valaciclovir. Do not use it for herpes lesions other than on the lips.
Aciclovir treats herpes outbreaks but does not eliminate the virus from the body. It does not prevent the occurrence of other crises.
Ultraviolet stimulates herpes outbreaks. Avoid exposure to strong sunlight or UV light, or apply a full screen in sufficient quantity and renewed.
PREGNANCY AND BREAST-FEEDING (summary)
This cream can be used during pregnancy or lactation.
DIRECTIONS FOR USE AND DOSAGE (summary)
Treatment should begin as early as the first symptoms of a cold outbreak of cold sores.
Pump bottle: it is recommended to carry out at least 3 or 4 slow and complete pressures in order to prime the pumping device during the first use.

Usual dosage:

  • Adult and child over 6 years: 5 applications per day. The duration of treatment should not exceed 10 days.
TIPS (summary)
Herpes is a contagious disease. Wash your hands thoroughly after application of the cream or in case of contact with the lesions; especially, avoid touching your eyes with contaminated fingers. The risk of contagion is maximal at the moment when the vesicles appear (small blisters under the skin).
This medicinal product may be freely available in certain pharmacies; nevertheless, do not hesitate to ask your pharmacist for advice.
POSSIBLE ADVERSE EFFECTS (summary)
Tingling, local burning sensation, redness, dryness of the skin.
Contact eczema (presence of propylene glycol).


GLOSSARY (summary)


antiviral
Medication capable of fighting viruses.


Eczema
Skin disease manifested by pimples and itching. Eczema may be due to contact with an allergic substance (contact eczema) or be linked to a genetic predisposition (atopic eczema).


herpes
  • Viral disease due mainly to Herpes simplex 1 and 2 viruses. It manifests itself during outbreaks by a painful rash of fine vesicles. Between the flares, the virus remains present in the nervous ganglia. Type 1 virus is more likely to give lesions around the mouth, whereas type 2 virus preferably affects the genitals.
  • A family of viruses (herpesvirus) which includes Herpes simplex virus (HSV 1 and 2), varicella zoster virus (VZV), cytomegalovirus (CMV) and Epstein-Barr virus (EBV) of infectious mononucleosis .


allergic reaction
Reaction due to hypersensitivity of the organism to a drug. Allergic reactions can take a wide variety of aspects: urticaria, angioedema, eczema, eruption of pimples resembling measles, etc. Anaphylactic shock is a generalized allergic reaction that causes discomfort due to a sudden drop in blood pressure.


symptoms
Trouble felt by a person with an illness. The same symptom can translate different diseases and the same disease does not necessarily give the same symptoms in all the patients.


virus
A microscopic organism that penetrates the cells of the host, where it reproduces. Much smaller than bacteria, viruses are insensitive to antibiotics. They can sometimes be destroyed by antiviral substances.

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