NOTICE
ANSM - Last updated: 19/07/2010
Name of the medicinal product
APAISYLGEL 0.75%, gel for local application
Isothipendyl hydrochloride
framed
Read this leaflet carefully before you start using this medicine. It contains important information for your treatment.
If you have any further questions, ask your doctor or pharmacist.
· Keep this leaflet, you may need to read it again.
· If you need more information and advice, ask your pharmacist.
· If symptoms worsen or persist, consult a physician.
· If you notice any side effects not listed in this leaflet, or if you experience any of the effects listed as serious, please tell your doctor or pharmacist.
Review summary
In this notice :
1. WHAT APAISYLGEL 0.75%, gel for local application AND WHAT IT IS USED FOR?
2. BEFORE YOU USE APAISYLGEL 0.75%, gel for local application?
3. HOW TO USE APAISYLGEL 0.75%, gel for local application?
4. WHAT ARE POSSIBLE SIDE EFFECTS?
5. HOW TO STORE APAISYLGEL 0.75%, gel for local application?
6. ADDITIONAL INFORMATION
1. WHAT APAISYLGEL 0.75%, gel for local application AND WHAT IT IS USED FOR?
Pharmacotherapeutic group
ANTIHISTAMINIC FOR LOCAL USE
Antipruritic.
(D: Dermatology).
This medication is an antihistamine for local use. It belongs to the class of dermatological drugs.
Therapeutic indications
It is recommended in case of itching, especially insect bites.
2. BEFORE YOU USE APAISYLGEL 0.75%, gel for local application?
List of information needed before taking the medication
Not applicable.
Cons-indications
Never use APAISYLGEL 0.75%, gel for local application in the following cases:
· History of allergy to antihistamines
· Infected or irritated skin lesions
· Oozing skin lesions.
IN CASE OF DOUBT, IT IS ESSENTIAL TO ASK FOR THE OPINION OF YOUR DOCTOR OR YOUR PHARMACIST.
Precautions for use; special warnings
Take special care with APAISYLGEL 0.75%, gel for local application:
Special warnings
Do not apply on a large area, under occlusive dressing, on injured skin or in premature infants or babies because of the risk of the active substance passing through the blood.
Do not apply to mucous membranes.
This medicine contains sorbic acid and may cause local skin reactions (eg, eczema).
Precautions for use
Itching is only a symptom that can have multiple causes requiring the advice of your doctor especially if persistence or aggravation of the disorders.
APAISYLGEL 0.75%, gel for local application, is not a solar protector.
APAISYLGEL 0.75%, gel for local application, should not be used as a care cream on healthy skin.
IN CASE OF DOUBT DO NOT HESITATE TO ASK FOR THE OPINION OF YOUR DOCTOR OR YOUR PHARMACIST
Interaction with other medicines
Taking or using other medicines
If you are taking or have recently taken any other medicines, including medicines obtained without a prescription, talk to your doctor or pharmacist.
Interactions with food and beverages
Not applicable.
Interactions with Herbal Medicines or Alternative Therapies
Not applicable.
Use during pregnancy and lactation
Pregnancy and breast feeding
This medication should be used with caution during pregnancy and lactation.
In general, you should seek advice from your doctor or pharmacist before taking any medication.
Sport
Not applicable.
Effects on ability to drive or use machines
Not applicable.
List of excipients with known effect
Important information about some of the ingredients of APAISYLGEL 0.75%, gel for local application:
List of excipients with known effect: Sorbic acid.
3. HOW TO USE APAISYLGEL 0.75%, gel for local application?
Instructions for proper use
Not applicable.
Dosage, Mode and / or route (s) of administration, Frequency of administration and Duration of treatment
Reserved for adults and children over 30 months.
Dosage
1 application 2 to 3 times a day.
Method and route of administration
Dermal.
Duration of treatment
If symptoms persist after 5 days of treatment, consult your doctor. |
Symptoms and Instructions for Overdose
Not applicable.
Instructions for omission of one or more doses
If you forget to take APAISYLGEL 0.75%, gel for local application:
Do not use a double dose to make up for the missed dose.
Risk of withdrawal syndrome
Not applicable.
4. WHAT ARE POSSIBLE SIDE EFFECTS?
Description of adverse reactions
Like all medicines, APAISYLGEL 0.75%, gel for local application is likely to have undesirable effects, although not everyone is subject to it:
· Risk of allergy to isothipendyl or to a component of the gel.
· Very rare cases of photosensitization (skin reaction when exposed to sun or UV).
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.
5. HOW TO STORE APAISYLGEL 0.75%, gel for local application?
Keep out of the reach and sight of children.
Expiration date
Do not use APAISYLGEL 0.75%, gel for local application after the expiry date stated on the outer packaging.
Storage conditions
Store at a temperature below 25 ° C.
If necessary, warnings against visible signs of deterioration
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist what to do with unused medications. These measures will help protect the environment.
6. ADDITIONAL INFORMATION
Full list of active substances and excipients
What does APAISYLGEL 0.75% contain, gel for local application?
The active substance is:
Isothipendyl hydrochloride .............................................. .................................................. 0.750 g
For 100 g of gel for local application.
The other components are:
Editic acid, sorbic acid, 70 percent non-crystallizable sorbitol, sodium carboxymethyl cellulose, sodium hydroxide, purified water.
Pharmaceutical form and content
What is APAISYLGEL 0.75%, local application gel and contents of the pack?
This medication is available as a gel for local application.
Tube of 20 g, 30 g or 40 g.
Name and address of the marketing authorization holder and the holder of the manufacturing authorization responsible for the release of the lots, if different
Holder
MERCK MEDICATION FAMILIALE SAS
37 RUE SAINT-ROMAIN
69379 LYON CEDEX 08
exploiting
MERCK MEDICATION FAMILIALE
18 C BOULEVARD WINSTON CHURCHILL
21000 DIJON
Maker
MERCK SANTE SAS
LACASSAGNE PRODUCTION CENTER
115 AVENUE LACASSAGNE
69003 LYON
or
FAMAR LYON
29 AVENUE CHARLES DE GAULLE
69230 SAINT GENIS LAVAL
or
PHARMACEUTICAL PRODUCTION AND HYGIENE (PHC)
7 IMPASSE OF BOUSSENOTS
21800 QUETIGNY-LES-DIJON
Names of the medicinal product in the Member States of the European Economic Area
Not applicable.
Date of approval of the notice
The last date on which this leaflet was approved is {date}.
AMM under exceptional circumstances
Not applicable.
Internet Information
Detailed information on this medicine is available on the Afssaps website (France).
Information for health professionals only
Not applicable.
Other
Not applicable.