Treat Scabies
Name of the drug
ASCABIOL 10%, emulsion for skin application
Benzyl benzoate
framed
Please read this leaflet carefully before using this medicine as it contains important information for you.
You should always use this medicine by carefully following the information provided in this leaflet or by your doctor, pharmacist or nurse.
- Keep this leaflet. You might need to read it again.
- Contact your pharmacist for any advice or information.
If you get any side effects, talk to your doctor, pharmacist or nurse. This also applies to any undesirable effect not mentioned in this leaflet. See section 4.
You should talk to your doctor if you do not feel any improvement or look worse after 8 days.
Summary notice
What does this booklet contain :
- 1. What is ASCABIOL 10% and what is it used for?
- 2. What information should I know before using ASCABIOL 10%?
- 3. How to use ASCABIOL 10%?
- 4. What are the possible side effects?
- 5. Preservative comment ASCABIOL 10%?
- 6. Additional Information.
WHAT ASCABIOL 10% IS AND WHAT IT IS USED FOR?
Pharmacotherapeutic class
This medicine belongs to a family of medicines called antiscabieux which caused by destroying certain parasites which are responsible for scabies and chiggers.
Therapeutic indications
This medicine is used to treat:
scabies
· autumnal trombidiosis (an infection which normally occurs at the end of August or in autumn and which is caused by mites called red mullets or chiggers).
BEFORE USING ASCABIOL 10%?
List of information needed before taking the drug
Not applicable.
Contraindications
Never use ASCABIOL 10%:
if you are allergic (hypersensitive) to the active substance or to any of the other ingredients of this medication mentioned in section 6 or to benzyl alcohol or benzoic acid (which appears from the active substance).
Precautions for use; special warnings
Ascabiol may contain benzyl alcohol (maximum amount 12.5 mg per vial) and benzoic acid (maximum amount 12.5 mg per vial) which both contain the active substance benzyl benzoate :
o Due to the extensive dermal absorption of benzyl alcohol, Ascabiol may cause reduced skin, eye and mucous membrane irritation and allergic reactions. In addition, due to the serious side effects seen in newborns ("choking syndrome"), Ascabiol should not be used in newborns less than one month old (full term or premature), except in case of absolute necessity.
o Due to the immaturity of the skin of neonates, dermal absorption of benzoic acid and benzyl benzoate is extensive. Ascabiol may cause mild skin, eye and mucous membrane irritation and allergic reactions. In addition, benzoic acid can aggravate jaundice (yellowing of the skin and eyes) in newborns (full term or premature) who already have jaundice.
Due to the presence of 96 percent ethanol (100 mg per ml) as an excipient, Ascabiol may cause skin irritation. In addition, in newborns (full term or premature) and infants (under 2 years of age), the skin and general effects of alcohol are increased due to greater absorption through their immature skin. Therefore, talk with your doctor or pharmacist before using ascabiol on your baby.
· Do not apply this medicine to the mucous membranes (in the nose, ears or vagina), face and eyes.
· Do not swallow this medicine.
· Seek the advice of your doctor if there are visible lesions on the skin.
· Talk to your doctor or pharmacist or nurse before using Ascabiol.
· You must have short, clean fingernails.
· After each application of Ascabiol (D1 and D9), you must change your clothes, sheets and towels and wash them at at least 60°C, which makes it possible to effectively decontaminate the laundry.
· Disinfect at the same time the clothes and bed linen of all people living under the same roof, used for less than 72 hours in case of common scabies.
· In the event that the linen cannot be machine washed at this temperature, the use of an acaricide makes it possible to carry out a proposal for the linen in a relatively short time. Linen can also be left in a bag for at least 72 hours at indoor temperature (> 20°) (see section 3. Dosage).
· You should store items that cannot be washed at at least 60°C (e.g.clothes, blood pressure cuff, shoes, soft toys) in a closed plastic bag (see section 3. Dosage).
· Carpets and cushions should be vacuumed vigorously.
Children
See Warnings
Interactions with other drugs
Other medicines and Ascabiol
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Interactions with food and drink
Not applicable.
Interactions with phytotherapy products or alternative therapies
Not applicable.
Use during pregnancy and lactation
Pregnancy and breast feeding
If you are pregnant or breast-feeding, think you may be pregnant or plan to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.
Breast-feeding must be interrupted during treatment with Ascabiol in order to avoid contamination of the child.
Athletes
Not applicable.
Effects on ability to drive or use machines
Driving and using machines
The effects on the ability to drive or use machines have not been studied. Under normal conditions of use, it is unlikely that Ascabiol may affect the ability to drive or use machines.
List of excipients with known effect
ASCABIOL 10%, emulsion for skin application contains 96 percent ethanol.
3. HOW TO USE ASCABIOL 10%?
Instructions for proper use
· SHAKE THE BOTTLE WELL BEFORE USE.
· Do not put ASCABIOL in contact with plastic materials when using it (bathtub, containers, gloves and applicator, etc.):
o Indeed, this medicine can damage certain plastic materials.
o If necessary, it is therefore recommended to use a glass container to handle this medicine.
Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if in doubt.
Dosage, Mode and/or route(s) of administration, Frequency of administration and Duration of treatment
Dosage
Always use this medicine exactly as instructed in this leaflet or as instructed by your doctor, or pharmacist or nurse. Check with your doctor or pharmacist or nurse if you are not sure.
