NOTICE
ANSM - Updated: 13/01/1999
Name of the drug
KENDIX 5 PERCENT, cream
acyclovir
framed
Read this leaflet carefully before using this medicine. It contains important information for your treatment.
If you have further questions, if you are not sure, ask your doctor or pharmacist for more information.
· Keep this leaflet, you may need to read it again.
· If you need more information and advice, talk to your pharmacist.
· If symptoms worsen or persist for 10 days, consult your doctor.
· If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Summary notice
In this notice :
1. WHAT KENDIX 5 PERCENT, CREAM AND WHAT IT IS USED FOR
2. WHAT YOU NEED TO KNOW BEFORE USING KENDIX 5 PERCENT, cream?
3. HOW TO USE KENDIX 5 PERCENT, cream?
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
5. HOW TO STORE KENDIX 5 PERCENT, cream?
6. ADDITIONAL INFORMATION
1. WHAT KENDIX 5 PERCENT, CREAM AND WHAT IT IS USED FOR
Pharmacotherapeutic class
ATC Class: D06BB03
ANTIVIRAL FOR TOPICAL USE
Therapeutic indications
This medicine is indicated for the treatment of outbreaks of localized cold sores (also known as cold sores).
2. WHAT YOU NEED TO KNOW BEFORE USING KENDIX 5 PERCENT, cream?
List of information needed before taking the medication
Not applicable.
Cons-indications
Never use KENDIX 5 PERCENT, cream
YOU SHOULD NOT TAKE this medicine if you are allergic to any of the ingredients in the cream.
IN CASE OF DOUBT, IT IS ESSENTIAL TO ASK THE ADVICE OF YOUR DOCTOR OR PHARMACIST.
Precautions for use; special warnings
Be careful with KENDIX 5 PERCENT, cream:
Special warnings
DO NOT LEAVE THIS MEDICINE WITHIN THE REACH OF CHILDREN.
Do not apply the cream on the mucous membranes (oral, vaginal and ocular).
Avoid accidental contact with the eyes.
In patients with impaired immune function: it is imperative to consult their physician before using this medication.
Precautions for use
Only use this medicine with caution
· If there is no healing after 10 days of treatment or worsening of your cold sore : STOP THE TREATMENT AND CONSULT YOUR DOCTOR IMMEDIATELY.
· In case of outbreak of cold sores, some hygiene precautions are needed to protect your family 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 :
o avoid close contact, a kiss for example, with your entourage,
o NEVER BRISTLE A CHILD IN THE AGE,
o take the advice of your pharmacist or doctor if you are not sure about the nature of your injury,
o wash your hands thoroughly in case of contact with the lesion,
o during treatment, so as not to spread the lesions, do not rub your eyes or eyelids with your hands and if you wear contact lenses, never moisten them with your saliva,
o avoid touching or scratching lesions.
· In case of another location of your herpes crisis, never use this cream, TAKE THE OPINION OF YOUR DOCTOR.
Interactions with other drugs
Taking or using other medicines
If you are taking or have recently taken any other medicines, including medicines obtained without a prescription, tell your doctor or pharmacist.
Interactions with food and drinks
Not applicable.
Interactions with herbal products or alternative therapies
Not applicable.
Use during pregnancy and lactation
Pregnancy and breast feeding
Ask your doctor or pharmacist for advice before taking any medicine. |
Sport
Not applicable.
Effects on ability to drive or use machines
Not applicable.
List of excipients with known effect
List of excipients with known effect: Propylene Glycol.
3. HOW TO USE KENDIX 5 PERCENT, cream?
Instructions for a good use
Not applicable.
Dosage, Mode and / or Route (s) of Administration, Frequency of Administration and Duration of Treatment
Do not use this cream in children under 6 years |
Dosage
Apply the cream on the lesions and around the lesions, 5 times a day.
Administration mode
Dermal.
Reserved for EXTERNAL USE.
Begin applications with the first itching or burning before the vesicles appear, the treatment being more effective if it is started at the first symptoms announcing an outbreak of cold sores (cold sores).
Wash your hands thoroughly before and after applying the cream on your cold sore to avoid transmitting the infection.
Apply the cream with your finger, overflowing widely around the lesion.
Space apps at least 3 to 4 hours,
· Divide the 5 applications on the day; for example.:
o In the morning after breakfast.
o At lunchtime after lunch.
o Around 16 - 17 h.
o In the evening after dinner.
o The evening before bedtime.
Do not apply overnight.
Duration of the treatment
The duration of use is limited to 10 days |
Symptoms and instructions in case of overdose
Not applicable.
Instructions for omitting one or more doses
Not applicable.
Risk of withdrawal syndrome
Not applicable.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Description of adverse effects
Like all medicines, KENDIX 5 PERCENT, cream can cause side effects, although not everybody gets them:
Sensations of tingling or passing burns may occur after application of the cream.
In some patients, the cream may induce erythema (redness), pruritus (itching), dryness of the skin or eczema.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
5. HOW TO STORE KENDIX 5 PERCENT, cream?
Keep out of the reach and sight of children.
Expiration date
Do not use KENDIX 5 PERCENT, cream after the expiry date which is stated on the carton.
Storage conditions
No special storage conditions.
If necessary, warn against some visible signs of deterioration
Medicines should not be thrown away with sewage or garbage. Ask your pharmacist what to do with unused medications. These measures will help protect the environment.
6. ADDITIONAL INFORMATION
Complete list of active substances and excipients
What KENDIX contains 5 PERCENT, cream?
The active substance is:
Aciclovir ................................................. .................................................. .............................................. 5 g
For 100 g of cream.
The other components are:
Macrogol stearate, dimethicone, cetyl alcohol, liquid paraffin, petrolatum, propylene glycol, purified water.
Pharmaceutical form and content
What KENDIX 5 PERCENT, cream and contents of the pack?
This medicine comes in the form of cream. Box of 1 tube.
Name and address of the marketing authorization holder and the production authorization holder responsible for batch release, if different
Holder
EG LABO - EuroGenerics Laboratories
"The Quintet" - Building A
12, Danjou Street
92517 Boulogne Billancourt Cedex
exploiting
EG LABO EuroGenerics Laboratories
"The Quintet" - Bât A
12, Danjou Street
92517 BOULOGNE BILLANCOURT Cedex
Maker
STADA ARZNEIMITTEL AG
Stadastrasse 2-18
D-61118 BAD VILBEL
GERMANY
Names of the drug in the member states of the European Economic Area
Not applicable.
Date of approval of the notice
The last date this notice was approved is {date}.
AMM under exceptional circumstances
Not applicable.
Internet information
Detailed information on this medicine is available on the Afssaps (France) website.
Information reserved for health professionals
Not applicable.
Other
ADVICE / HEALTH EDUCATION
Cold sores or herpes labialis 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.
On the occasion of 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 a bouquet around the lips, called pimples. fever. These vesicles are contagious until the appearance of crusts, sign of healing.
There are early warning signs located in the usual place of the lesion, which usually result in a burning sensation and / or tingling sensation.
These signs are important to know:
· it is from their appearance that we must start the treatment that prevents viral multiplication and can prevent or limit the development of cold sores,
· it is also from their appearance that the hygiene rules given in the precautions for use must be respected, in order to reduce the risk of transmission of the virus.
On the other hand, aciclovir can not act on viruses that persist in the latent state in the body and aciclovir does not prevent the occurrence of recurrence after the interruption of treatment.