NOTICE
ANSM - Updated: 04/10/2016
Name of the drug
TRANSVERCID 3.62 mg / 6 mm, device for cutaneous application
Salicylic acid
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 the symptoms get worse or persist, consult a 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 IS TRANSVERCID 3.62 mg / 6 mm, Device for Cutaneous Application AND WHAT IT IS USED FOR?
2. BEFORE YOU USE TRANSVERCID 3.62 mg / 6 mm, device for cutaneous application?
3. HOW TO USE TRANSVERCID 3.62 mg / 6 mm, Device for Cutaneous Application?
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
5. HOW TO STORE TRANSVERCID 3.62 mg / 6 mm, device for cutaneous application?
6. ADDITIONAL INFORMATION
1. WHAT IS TRANSVERCID 3.62 mg / 6 mm, Device for Cutaneous Application AND WHAT IT IS USED FOR?
Pharmacotherapeutic class
keratolytic
(D: dermatology)
Therapeutic indications
This medicine is indicated for the local treatment of common warts in children.
2. BEFORE YOU USE TRANSVERCID 3.62 mg / 6 mm, device for cutaneous application?
List of information needed before taking the medication
Not applicable.
Cons-indications
Never use TRANSVERCID 3.62 mg / 6 mm, device for skin application in the following cases:
· In case of allergy to one of the components.
Precautions for use; special warnings
Take special care with TRANSVERCID 3.62 mg / 6 mm, device for cutaneous application:
Special warnings
DO NOT LEAVE THIS MEDICINE WITHIN THE REACH OF CHILDREN.
A MEDICAL NOTICE IS NECESSARY in case of arteritis, diabetes or neuropathy.
Precautions for use
The treatment of a wart in children under 6 requires medical advice.
In case of failure after one month of treatment or in case of recurrence : IT IS IMPERATIVE TO CONSULT A DOCTOR.
Avoid contact of the device with healthy skin and / or mucous membranes.
In case of pain, irritation, ulceration, bleeding, treatment should be discontinued.
Do not use the product on moles, wine stains, anogenital warts.
Interactions with other drugs
Taking 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
This medicine has no indication in pregnant women. It should not be given during pregnancy.
In general, consult your doctor or pharmacist before taking any medicine.
Sport
Not applicable.
Effects on ability to drive or use machines
Not applicable.
List of excipients with known effect
Not applicable.
3. HOW TO USE TRANSVERCID 3.62 mg / 6 mm, Device for Cutaneous Application?
Instructions for a good use
Not applicable.
Dosage, Mode and / or Route (s) of Administration, Frequency of Administration and Duration of Treatment
Dosage
In the evening before bedtime, after soaking in warm water, lightly rub the wart with a soft lime and clean with warm water and soap.
Open the bag on one side, and across the width. Spread the edges, gently pull the tab to the first device, peel it off and apply it to the wart. The part in contact with the support tongue is applied to the skin, and the blue protective film appears on the upper part of the device.
Hold the device in place using one of the adhesive strips attached to the packaging; finally let the device work all night (at least 8 hours), and remove it in the morning.
Repeat the operation each evening, using a new device until the wart disappears.
The duration of treatment is limited to 1 month.
Method and route of administration
DERMAL
Frequency of administration
Once a day in the evening at bedtime.
Duration of treatment
Do not exceed one month of treatment. If the wart persists, consult your doctor.
Symptoms and instructions in case of overdose
If you have used more TRANSVERCID 3.62 mg / 6 mm, device for skin application than you should:
Risk of burns in case of overdose
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, this medicine can cause side effects, although not everybody gets them:
· Local irritation of the skin around the treated wart,
· ulceration,
· bleeding.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This also applies to any undesirable effect that is not mentioned in this leaflet. You can also report side effects directly via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and the network of Regional Pharmacovigilance Centers - Website: www.ansm.sante.fr
By reporting side effects, you can help provide more information about the safety of the medicine .
5. HOW TO STORE TRANSVERCID 3.62 mg / 6 mm, device for cutaneous application?
Keep this medicine out of the sight and reach of children.
Expiration date
Do not use TRANSVERCID 3.62 mg / 6 mm, device for skin application after the expiry date which is stated on the outer carton.
Storage conditions
Store at a temperature not exceeding 25 ° C.
If necessary, warn against some visible signs of deterioration
Medications should not be thrown away at the sewer or with household waste. 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 does TRANSVERCID 3.62 mg / 6 mm contain, device for cutaneous application?
The active substance is:
Salicylic acid ................................................ .................................................. ........................... 3.62 mg
For a device of 6 mm.
The other components are:
Gum of sterculia, propylene glycol, macrogol 300, N- (3-chloroallyl) hexaminium chloride (QUATERNIUM 15).
Non-removable protective film in high density polyethylene, colored blue.
Removable protective polyester support (MYLAR).
Plaster in acrylic adhesive low density polyethylene.
Pharmaceutical form and content
What is TRANSVERCID 3.62 mg / 6 mm, device for skin application and contents of the pack?
This medicine is in the form of a device for cutaneous application. Box of 10.
Name and address of the marketing authorization holder and the production authorization holder responsible for batch release, if different
Holder
DUCRAY DERMATOLOGICAL LABORATORIES
45 place Abel Gance
92100 Boulogne
exploiting
Laboratoires PIERRE FABRE MEDICAMENT
45 place Abel Gance
92100 BOULOGNE
Maker
SIMAPHAC
Industrial Zone of Châteaurenard
45220 CHATEAURENARD
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 ANSM website (France).
Information reserved for health professionals
Not applicable.
Other
Not applicable.