ASCABIOL Scabies Insecticide Lotion 125ml without prescription is an emulsion for cutaneous application, for the treatment of scabies and autumnal trombidiosis. For adults and children aged 1 month and over.
For warnings, precautions and contraindications, please consult theAscabiol insecticide scabies lotion leaflet.
Ascabiol 1% scabies lotion is an emulsion to be applied all over the body to treat scabies and trombidiosis caused by augusts.
Ascabiol 1% belongs to a family of medicines known as antiscabies, which act by destroying certain parasites, including the one responsible for scabies and the parasite known as augustats.
This medicine is used to treat:
Ascabiol lotion can be used by the whole family: adults, pregnant women and children over one month of age.
Always use this product exactly as instructed in this leaflet, or as directed by your doctor, pharmacist or nurse. Check with your doctor, pharmacist or nurse if in doubt.
Treatment of autumn trombidiosis
Apply Ascabiol to lesions with a cotton bud 1 or 2 times.
Treatment of scabies
As an indication, for the treatment of scabies, 1 bottle is sufficient for the application of 2 coats for an adult of average height and build (e.g.: 175 cm - 77 kg), i.e. 2 bottles for a complete treatment (D0 and D8) for an adult.
Over-the-counter treatment with Ascabiol consists of 2 applications 8 days apart, on D0 and D8.
The active substance is: Benzyl Benzoate
100 ml of emulsion for cutaneous application contains 10 g of benzyl benzoate.
Other ingredients are: 96% ethanol, polysorbate 80, disodium phosphate dodecahydrate, monopotassium phosphate, sodium chloride, purified water.
What are the side effects and contraindications?
Presentation-Packaging
Ascabiol 10% Emulsion comes in a 125 ml bottle.
Caution: Ascabiol Insecticide Lotion against scabies is not a product like any other. Read the package insert carefully before ordering. Do not leave Ascabiol without prescription within the reach of children. If symptoms persist, ask your doctor or pharmacist for advice. Beware of incompatibilities with your current products.
What is scabies, a contagious parasite?
Human scabies is a contagious disease transmitted by direct human contact. Contrary to popular belief, scabies affects all age groups, all populations and all socio-economic backgrounds. An estimated 300 million people worldwide are affected.
Human scabies, or sarcoptic mange, is caused by contamination of the skin by a small parasite called Sarcoptes scabiei hominis. Human scabies is a contagious disease that is generally transmitted through direct, intimate and prolonged human contact, such as that which occurs within a couple or a family. It is caused by a parasite that penetrates the superficial layer of the skin.
What are the different forms of human scabies?
Depending on the patient's age, sex and state of health, scabies can present different characteristics. There are several forms of scabies:
How is scabies treated with Ascabiol?
Scabies is treated with local antiparasitic agents (applied to the skin) or oral antiparasitic agents (applied by mouth). When a person is diagnosed with scabies, his or her family circle and anyone who has had close contact with him or her (sexual partners), even without clinical symptoms, must be treated.
Using a compress, applyAscabiol emulsion in 2 successive coats spaced 10 to 15 minutes apart (to allow the emulsion to dry) all over the body, except the face, paying particular attention to the hands, skin folds and under the nails. Leave on for 24 hours, then wash and rinse thoroughly to remove the product. Children aged 1 month to 2 years: same as for adults, but apply a single layer and leave on for only 12 hours, or even 6 hours for very young children.
Pharmacovigilance Report an adverse drug reaction(s)
ANSM - Updated on: 03/07/2015
ASCABIOL 10%, emulsion for skin application
Benzyl benzoate
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 of the 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 8 days.
What this leaflet contains:
1. What is ASCABIOL 10% and when is it used?
2. What should I know before using ASCABIOL 10%?
3. How to use ASCABIOL 10%?
4. What are the possible side effects?
5. How to keep ASCABIOL 10%?
6. Additional information.
1. WHAT ASCABIOL 10% AND IN WHAT CASES IS IT USED?
This medication is used to treat:
· scabies
· autumnal trombidiosis (an infection usually occurring in late August or autumn, caused by mites called red mullets or august).
2. BEFORE YOU USE ASCABIOL 10%?
List of information needed before taking the medication
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 come from the active substance).
Precautions for use; special warnings
· Ascabiol may contain benzyl alcohol (maximum 12.5 mg per vial) and benzoic acid (maximum 12.5 mg per vial), all of which are derived from the active ingredient benzyl benzoate:
o Due to the high dermal absorption of benzyl alcohol, Ascabiol may cause moderate skin, eye and mucous irritation and allergic reactions. In addition, because of the serious adverse effects observed in neonates ("choking syndrome"), Ascabiol should not be used in newborns less than one month of age (term or premature birth), 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 important. Ascabiol may cause mild irritation of the skin, eyes and mucous membranes and allergic reactions. In addition, benzoic acid may aggravate jaundice (yellowing of the skin and eyes) of newborns (term or premature babies) who already have jaundice.
Due to the presence of 96 percent ethanol (100 mg per ml) as excipient, Ascabiol may cause skin irritation. In addition, newborns (term or premature babies) and infants (under 2 years of age), the skin and general effects of alcohol are increased due to increased absorption by their immature skin. Therefore, discuss with your doctor or pharmacist before using Ascabiol on your baby.
· P e z has pliqu not what i med CAMENT on muqu e uses (not in the z, ear or the vagina), face and eyes.
· Do not swallow c e medication.
· Seek advice from your doctor if any major lesions appear on the skin.
· Talk to your doctor or pharmacist before using A scabiol .
· You must have short and very clean nails.
· After each application of Ascabiol (J1 and J9), you must change clothes, sheets and towels and wash at least 60 ° C, which allows you to effectively decontaminate the laundry.
· At the same time, disinfect the clothes and bed linen of all people living under the same roof, used for less than 72 hours in case of common scab.
· If the laundry can not be machine washed at this temperature, the use of an acaricide makes it possible to disinfect the laundry in a relatively short period of time. The laundry can also be left in a bag for at least 72 hours at room temperature (> 20 °) (see section 3. Dosage).
· Items that can not be washed at 60 ° C (eg, clothing, blood pressure cuff, shoes, fluff ) should be stored in a closed plastic bag (see section 3).
· You must vacuum the carpets and cushions energetically.
children
Interaction with other medicines
Other drugs and Ascabiol
Interactions with food and beverages
Not applicable.
Interactions with Herbal Medicines or Alternative Therapies
Not applicable.
Use during pregnancy and lactation
· If you are pregnant or breastfeeding, think you may be pregnant or plan a pregnancy, ask your doctor or pharmacist for advice before taking this medicine.
· Breast-feeding should be discontinued during treatment with Ascabiol in order to avoid contamination of the child.
Sport
Not applicable.
Effects on ability to drive or use machines
Driving and using machines
List of excipients with known effect
ASCABIOL 10%, emulsion for skin application contains 96 percent ethanol.
· SHAKE THE BOTTLE BEFORE USING.
· Do not put ASCABIOL in contact with plastic materials when using it (bathtub, containers, gloves and applicator, ...):
o This medication can damage certain plastics.
o If necessary, it is therefore recommended to use a glass container to handle this medicine.
Always use this medication exactly as prescribed by your doctor or pharmacist. Check with your doctor or pharmacist if in doubt.
Dosage
Always use this medication exactly as prescribed in this leaflet or as directed by your doctor, pharmacist or nurse. Check with your doctor or pharmacist or nurse if in doubt.
Treatment of autumnal trombidiosis
Apply Ascabiol to the lesions using a cotton swab 1 or 2 times.
Treatment of scabies
In the case of the treatment of scabies, 1 vial allows the application of 2 layers for an adult of average size and corpulence (example: 175 cm - 77 kg), or 2 bottles for a complete treatment (D0 and J8) for an adult.
Treatment with Ascabiol consists of 2 applications at 8 days interval between D0 and D8.
For adults
Day zero (D0): day of the 1st application of Ascabiol | - Take a bath or shower at night and dry. It is important to use clean linen (clothes, towel) after the shower and to change the bed linen to avoid further contamination. - Apply Ascabiol with a compress. Do not use cotton wool or impregnated wipes. Apply in 2 successive layers at 10-15 minutes intervals (corresponding to the drying time) over the entire body, insisting on the lesions, not to mention the skin folds, the spaces between the fingers and the toes, under the breasts, the navel, the external genitalia, under the nails, the scalp and avoiding the face and mucous membranes. - A 24-hour contact time must be respected. - For 24 hours, avoid washing (including hands). After 24 hours, wash and rinse thoroughly to remove the product. Use a bath towel and clean clothes. Change the bed sheets once again. |
Day One (J1): Bedding, linen and environmental treatment | - Treatment of the environment: in the morning following the application of Ascabiol, classically clean the premises and in case of severe (profuse or hyperkeratosis) mite disinfection with an acaricide of the bedding (mattress, box spring), carpeting and other furniture that may have been infested. - Treatment of clothing and linen: · Gather the linen used to this day (including towels, sheets, pillowcases ...) and wash it in the washing machine at 60 ° C. · If laundry can not be washed at this temperature, store it in a plastic bag closed at a temperature above 20 ° C for at least 3 days in case of common scab and 8 days in case of severe scab. · You can also disinfect it with an acaricide (storage in a plastic bag closed with an acaricide for at least three hours). - Do not forget to treat objects that may have been in contact with the body such as: blood pressure cuff, shoes, fluff ... - Vacuum thoroughly on carpets and cushions. |
Day eight (D8): day of the 2nd application of Ascabiol | Repeat the application of Ascabiol in the same manner as in D0. |
Day nine (J9): treatment of bedding, linen and the environment | See Day 1 for laundry and environmental decontamination measures. |
Treatment Scheme
Administration mode
Shake well before use .
If after application, hand washing is necessary, make a new application on the hands. This also applies to any other part of the body.
Use in pregnant women
Same pattern as adult with single layer application and 24 hour contact time on D0 and D8.
Use in children
If you are using Ascabiol in a child older than 2 years
Same pattern as adult.
If you are using Ascabiol in a child under 2 years of age
The application pattern is the same as that of the adult with the application of a single layer and a contact time of 12 hours or even 6 hours in very young children according to the extent of the lesions of the scabies and according to the tolerance of the child under the age of 2 years.
It is recommended to wrap the infant's hands in mittens to avoid ingesting Ascabiol and to limit the scratching lesions.
Ascabiol should not be used in newborns under one month of age (term or premature birth) unless absolutely necessary (see Warnings)
Duration of treatment
· The treatment of scabies consists of 2 applications of Ascabiol on day 0 and day 8 (day 1 and day 9 for the decontamination of linen, environment and bedding).
· You should contact your doctor if you experience no improvement after 8 days in case of scabies.
· After treatment of scabies, the itching disappears or decreases gradually most often in 2 to 3 days. However, they may persist for a few weeks without being a sign of treatment failure.
· In all cases, consult your doctor if symptoms worsen.
Symptoms and Instructions for Overdose
If you used more Ascabiol than you should have
· Reactions on the skin may occur. Therefore, you should follow the procedure to avoid overdosing.
· If you have used more Ascabiol than you should or have accidentally swallowed Ascabiol, contact your doctor or pharmacist immediately.
Instructions for omission of one or more doses
If you forget to use Ascabiol
· In the case of scabies, if the treatment on Day 8 is not carried out, the risk of recurrence of scabies is increased.
· However, do not reuse Ascabiol without consulting your pharmacist or doctor.
If you stop using Ascabiol
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?
Description of adverse reactions
Like all medicines, this medicine may cause side effects, although not everybody gets them.
The following effects may occur:
· A warm feeling appearing very quickly and located on z o u do u d r co ps.
· Red patches and Qu n g eaisons (e cz EMA) which inc e ntent lor s repeated applications.
· Redness generalized to the whole body with pustules, and accompanied by fever (general acute pustulosis).
· Allergic reactions (recognizable by swelling of the neck and face, pimples, redness, itching, difficulty breathing). If an allergic reaction occurs, contact an emergency doctor.
· Seizures if the drug is av al é or if the drug is applied sister a p e in with significant lesions or with a f ant under 2 years (because the drug then enters the bloodstream through the pea u ).
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.
Keep this medicine out of the reach and sight of children.
Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month.
Store at a temperature not exceeding 30 ° C
After first opening the vial: the medication should be stored for up to 10 days.
If necessary, warnings against visible signs of deterioration
Do not throw any medication into drains or household waste. Ask your pharmacist to remove any medications you are no longer using. These measures will help protect the environment.
Full list of active substances and excipients
What Ascabiol contains
· The active substance is benzyl benzoate.
100 ml of emulsion for dermal application contain 10 g of benzyl benzoate.
· The other components are: 96 percent ethanol, polysorbate 80, disodium phosphate dodecahydrate, monopotassium phosphate, sodium chloride, purified water.
Pharmaceutical form and content
Aspect of Ascabiol and contents of the pack
This medication is in the form of a milky white, dermal, emulsion with a characteristic aromatic odor.
This medicine is available as a 125 ml bottle.
Marketing Authorization Holder and Manufacturer
13 RUE RENE JACQUES
92138 ISSY-LES-MOULINEAUX CEDEX
13 RUE RENE JACQUES
92138 ISSY-LES-MOULINEAUX CEDEX
H2 PHARMA
21 RUE JACQUES TATI
ZAC LA CROIX BONNET
78390 BOIS D'ARCY
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 revised is {MM / YYYY}.
AMM under exceptional circumstances
Not applicable.
Detailed information on this medicine is available on the ANSM website (France).
Information for health professionals only
Not applicable.
Health Education Council:
Treatment of the environment
It is important to also treat the environment to avoid any further contamination. Parasites can be effectively removed by temperatures above 60 ° C or in the absence of air.
· Clothing, underwear, bed sheets and handkerchiefs must therefore be washed at a minimum of 60 ° C. This is also the case for objects that have been in contact with the body for a long time, such as cuffs, shoes, fluff. Unwashed items, or washable only at low temperatures, should be stored for 3-8 days in closed plastic bags.
· They can also be disinfected with an acaricide (storage in a plastic bag closed with an acaricide for at least three hours).
· Carpets, mattresses and upholstered furniture must be fully aspirated.
Risk of environmental contamination
Persons who have / have been in contact with the scabies patient should be examined. Due to the incubation period of a few weeks, small endemic diseases, initially unnoticed, in the family, in schools or nurseries, in nursing homes or in nursing homes, are not uncommon . People who have been in close or prolonged contact with the patient should be treated at the same time as they do if they have no skin lesions.
External antiparasitic
benzoate
. Presentations . Composition . Indications . Warning . Pregnancy and breastfeeding . Directions for use and dosage . Advice . Undesirable effects . Lexicon
ASCABIOL 10%: emulsion for dermal application; 125 ml bottle.
Refunded at 65%. - price: 14,62 euro (s).
Laboratory Zambon France
| p 100 ml | |
| Benzyl benzoate | 10 g |
| Alcohol | 10 g |
Usual dosage:
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