ASCABIOL Facial treatment for scabies 125ml

ASCABIOL Facial treatment for scabies 125ml View larger

3400930020012

Meda Meda

ASCABIOL Insecticidal lotion for scabies 125ml without prescription is an emulsion for skin application, for the treatment of scabies and autumnal trombidiosis. For adults and children from 1 month.

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Used for : human disease, autumn trombidiosis

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ASCABIOL Facial treatment for scabies 125ml

For warnings, precautions for use and contraindications, please refer to the instructions for use of Ascabiol over-the-counter insecticide for scabies .

What are the different forms of human scabies?

Depending on the age, sex and health of the patient, scabies may have different characteristics. Thus, there are several forms of scabies:
Common scab (the most frequent form) characterized by a dozen sarcoptes of the scabies only, furrows between the fingers, itching on the hands, feet, body and scalp.
The scabies profuse with a few tens to a hundred sarcoptes of scabies, the scalp, the trunk and the torso are affected with lesions. It is a form of mange mostly contracted by people of advanced age to fragile health and that can follow up treatment of eczema.
Norwegian mange or hyperkeratotic scabies, a form of scabies found in people of advanced age, immunocompromised or in a state of great emaciation, with sometimes several thousand scabies. It is a chronic infection that does not itch or causes only mild itching, with scales that appear on the buttocks, hands and feet, trunk, face, scalp. this type of scabies resembles an eczema due to the presence of red patches and the patient presents thick and yellow nails.
Infant scabies with vesicles on the scalp, feet and hands, nodules in the genitals or armpits, and the possibility of superinfection of the skin.

Description of Ascabiol lotion 125ml insecticide lotion

Ascabiol 1% belongs to a family of drugs called antiscabieux which act by destroying certain parasites including the one responsible for scabies and the Augustats.

This medication is used to treat:

  • the scabies,
  • autumnal trombidiosis (an infection usually occurring in late August or autumn, caused by mites called red mullets or august).

What is Scabies, this contagious parasite?

Human scab is a contagious disease that is transmitted through direct human contact. Contrary to popular belief, it affects all age groups, populations and socio-economic backgrounds. It is estimated that about 300 million people are affected worldwide.

Human scabies or sarcoptic mange is due to the contamination of the skin by a mite, that is to say a small parasite called Sarcoptes scabiei hominis . Human scab is a contagious disease that is usually transmitted through direct, intimate and prolonged human contact as it exists within a couple or family. It is caused by a parasite that penetrates the surface layer of the skin.

Tips and advice on Ascabiol lotion 125ml insecticide lotion

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 without prescription consists of 2 applications at 8 days interval between D0 and D8 .

Composition of ASCABIOL Insecticide lotion for scabies

The active substance is : benzyl benzoate

100 ml of emulsion for dermal application contains 10 g of benzyl benzoate

The other ingredients are : 96 percent ethanol, polysorbate 80, disodium phosphate dodecahydrate, monopotassium phosphate, sodium chloride, purified water.

Presentation of Ascabiol insecticide lotion

125 ml bottle

Drug warnings

Attention, the medicine Ascabiol without prescription Insecticide lotion for scabies   is not a product like the others. Read the package leaflet carefully before ordering. Do not take Ascabiol without a prescription   within the reach of children. If symptoms persist, seek the advice of your doctor or pharmacist. Beware of incompatibilities on your current products.

Please inform your on-line pharmacist of ongoing treatments to identify possible incompatibilities. The order validation form contains a customized message field provided for this purpose.

Click here to read the package leaflet for Ascabiol without prescription Insecticide lotion for scabies on the website of the National Agency for the Safety of Medicines and Health Products.

VIDAL OF THE FAMILY

Ascabiol

External antiparasitic

benzoate

. Presentations . Composition . Indications . Warning . Pregnancy and breastfeeding . Directions for use and dosage . Advice . Undesirable effects . Lexicon

PRESENTATIONS (summary)

ASCABIOL 10%: emulsion for dermal application; 125 ml bottle.
Refunded at 65%. - price: 14,62 euro (s).

Laboratory Zambon France

COMPOSITION (summary)
p 100 ml
Benzyl benzoate 10 g
Alcohol 10 g

INDICATIONS (summary)
This emulsion contains an active substance on certain parasites of the skin (mites, scabies and scabs).
It is used in the treatment of scabies and chickens.
WARNING (Contents)
If scabies are infected, consult your doctor before any treatment.
This medicine may be irritating: rinse thoroughly in case of contact with the mucous membranes .
This emulsion contains benzoic acid and benzyl benzoate which can be absorbed by the skin of newborns. These substances may cause mild irritation of the skin, eyes and mucous membranes or allergic reactions. The use of this medication is advised against in newborns, except in cases of absolute necessity.
It is recommended that young children be given gloves after application to avoid possible ingestion of the product. The nails must be clean and cut short.
PREGNANCY AND BREAST-FEEDING (summary)
Pregnancy :
This medication may be used in pregnant women, but only one layer of emulsion should be applied to each application.

Breastfeeding:
Breastfeeding should be discontinued in case of scabies to avoid contamination of the infant.
DIRECTIONS FOR USE AND DOSAGE (summary)
Shake well before use.
In the treatment of scabies, a bottle allows the application of the 2 successive layers for an adult of average size and corpulence. It takes two vials for a complete treatment.

Usual dosage:

Treatment of Augats: Apply 1 or 2 times the emulsion to the lesions using a cotton swab.
Treatment of scabies:
  • Adult and child over 2 years: 2 applications at 8 days interval. Take a bath or shower in the evening before treatment and dry thoroughly, using clean clothes (clothes, bath towel) to avoid further contamination. Using a compress, apply the emulsion in 2 successive layers spaced 10 to 15 minutes (time to let the emulsion dry) all over the body, except on the face, insisting on the hands and the folds of the skin and under the nails. Leave on for 24 hours, then wash and rinse thoroughly to remove the product. It is again necessary to take a bath towel and clean clothes. The sheets must also be changed twice: just before application and just after rinsing. A second application must be made according to the same methods 8 days later.
  • Pregnant woman: same pattern as adult, but applying only one layer.
  • Children from 1 month to 2 years: the same pattern as that of adults, but with the application of a single layer and a contact time of only 12 hours or even 6 hours in very young children.
TIPS (summary)
Persistent irritation or eczema may occur after treatment and warrant specific care.
After treatment, the itching regresses most often in two to three days. However, they may persist for up to four weeks after the end of treatment. This does not mean that the treatment has failed.
To avoid reinfestation, it is necessary that the entourage (family, sexual partner) follow the same treatment.
Recently worn clothing, slippers and hats must be disinfected. Body linen and bed linen must be washed at 60 ° C. The bedding (blanket, duvet, pillows) must also be disinfected with an ascaricide. There is also a simple way to get rid of the parasite: leave the contaminated clothing in a closed plastic bag in a cool place (temperature below 20 ° C) for 8 days.
When used, the emulsion must not be brought into contact with plastic materials (bathtub, container, etc.), as it could alter them.
This medication is only reimbursed in the treatment of scabies.
The bottle should be stored for a maximum of 10 days after opening.
POSSIBLE ADVERSE EFFECTS (summary)
Sensation of cooking, frequent local irritation, eczema , especially in case of repeated applications.
Risk of convulsions in case of accidental ingestion; call the Poison Control Center.


GLOSSARY (summary)


convulsions
Involuntary contractions limited to a few muscles or generalized to the whole body. They are due to excessive pain or stimulation of the brain: fever, poisoning, lack of oxygen, brain damage. Convulsions may be due to an epileptic seizure or high fever in young children.


eczema
Skin disease manifested by pimples and itching. Eczema may be due to contact with an allergic substance (contact eczema) or be linked to a genetic predisposition (atopic eczema).


scabies
Parasitic skin disease, highly contagious.


mucous
Tissue (membrane) that lines the cavities and ducts of the body communicating with the outside (digestive tract, respiratory tract, urinary tract, etc.).

Cliquez ici pour retrouver la notice de ce médicament sur le site de l'Agence Nationale de Sécurité du Médicament et des produits de santé.

Pharmacovigilance : Déclarer un ou des effet(s) indésirable(s) lié(s) à l'utilisation d'un médicament

NOTICE

ANSM - Updated on: 03/07/2015

Name of the medicinal product

ASCABIOL 10%, emulsion for skin application

Benzyl benzoate

framed

Please read this leaflet carefully before you start using this medicine because it contains important information for you.

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.

Review summary

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?

Pharmacotherapeutic group

This drug belongs to a family of medicines called antiscabieux which act by destroying certain parasites including that responsible for mange and the Augustats.

Therapeutic indications

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

Not applicable.

Cons-indications

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

See Warnings

Interaction with other medicines

Other drugs and Ascabiol

Inform your doctor or pharmacist if you are taking, have recently taken or may be taking any other medicines.

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

· 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

Sport

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 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, Mode and / or route (s) of administration, Frequency of administration and Duration of treatment

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.

Risk of withdrawal syndrome

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.

5. HOW TO STORE Ascabiol 10%?

Keep this medicine out of the reach and sight of children.

Expiration date

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.

Storage conditions

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.

6. ADDITIONAL INFORMATION

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.

Name and address of the marketing authorization holder and the holder of the manufacturing authorization responsible for the release of the lots, if different

Marketing Authorization Holder and Manufacturer

Holder

ZAMBON FRANCE SA .

13 RUE RENE JACQUES

92138 ISSY-LES-MOULINEAUX CEDEX

exploiting

ZAMBON FRANCE SA

13 RUE RENE JACQUES

92138 ISSY-LES-MOULINEAUX CEDEX

Maker

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.

Internet Information

Detailed information on this medicine is available on the ANSM website (France).

Information for health professionals only

Not applicable.

Other

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.

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