Apaisyl Gel 0.75% After Insect Stings Gel 30 Gr

Description:

FOR FULL DETAILED DESCRIPTION AND WARNINGS PLEASE SEE BELOW.

Apaisyl Insect Bite Gel: Itch Relief, Insect Bites - Suitable from 30 months onwards. This product is recommended for teenagers, adults, and children. For pregnant women and breastfeeding mothers, use only upon medical advice. This gel is a medication containing an antihistamine for local use. It is specially formulated to alleviate itchiness, particularly in cases of insect bites. Apaisyl Insect Bite Gel comes in a 30g tube.

The active ingredient of the Apaisyl Gel is Chlorhydrate d'isothipendyl (0.750g per 100g of gel). Other ingredients include edetic acid, sodium carboxymethylcellulose, sorbic acid, non-crystallizable 70% sorbitol, sodium hydroxide, and purified water.

Use Apaisyl Gel with caution. Due to the risk of the active ingredient entering the bloodstream, the gel should not be applied on mucous membranes, on a large surface, under an occlusive dressing, on damaged skin, or on premature infants or infants. It contains sorbic acid, which can cause local skin reactions such as eczema. In case of persistent or worsening discomfort, medical advice may be required as the itching may have other origins.

Apaisyl Gel should not be used during pregnancy and breastfeeding without consulting a doctor or pharmacist. If you are allergic to any antihistamine medication, do not use Apaisyl Gel. This product is not intended for use on infected, irritated, and oozing wounds.

Apaisyl Insect Bite Gel is intended for adults and children over 30 months old. It is to be applied on the skin 2-3 times a day for 3-5 days. If symptoms persist after 5 days, seek medical advice.

Indications:

Insect stings.

Composition:

Aqua, Alcohol Denat, ALoe Barbasensis Leaf Juice, Menthol, Menthyl Lactate, Bisabolol, Glycyrrhetinic Acid, Algae Extract, Carbomer, Lecithin, Propylene Glycol, DIsodium EDTA, Sodium Sufate, Magnesium Chloride, Aminomethyl Propanol, Magnsium Nitrate, Citric Acid, Ascorbic Acid, Phenoxyethanol, Chlorphenesin, Sodium Benzoate, Potassium Sorbate, Sodium Dehydroacetate, .

Directions:

It is to be applied on the skin 2-3 times a day for 3-5 days. If symptoms persist after 5 days, seek medical advice.

Details:

EAN/UPC: 3400931717881

Contents: 30 Grams

Presentation: Tube - Gel

FULL PRODUCT DISCLOSURE:

1. NAME OF THE MEDICATION

APAISYLGEL 0.75%, gel for topical application

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Isothipendyl Hydrochloride .................................................................................................. 0.750 g

For 100 g of gel for topical application.

Noteworthy excipient: Sorbic Acid (E200).

For the complete list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Gel for topical application.

4. CLINICAL DATA

4.1. Therapeutic Indications

Local symptomatic treatment of itching, particularly insect bites.

4.2. Dosage and Method of Administration

Dosage

Reserved for adults and children over 2 years old.

1 application 2 to 3 times a day.

Do not exceed 5 days of treatment without medical advice.

Pediatric Population

The safety and effectiveness of APAISYLGEL 0.75%, gel for topical application in children under 2 years old have not been established.

No data is available.

Method of Administration

Cutaneous route

Apply only to the insect bite without spreading on healthy skin.

Wash hands after use.

4.3. Contraindications

· Hypersensitivity to the active substance or to any of the excipients listed in section 6.1

· History of allergy to antihistamines,

· Infected or irritated dermatoses

· Oozing lesions

· Eczema

4.4. Special Warnings and Precautions for Use

Special Warnings

· Itching is only a symptom. In all cases, it requires the search for and treatment of its etiology.

· Persistence or worsening of itching may be related to an allergy to one of the components of the preparation.

· Given the presence of isothipendyl hydrochloride, there is a risk of cutaneous sensitization and photosensitization. In case of proven cutaneous sensitization to isothipendyl hydrochloride contained in the gel, cross-sensitizations could occur after administration of phenothiazines systemically.

· Therefore, persistence or worsening of itching may be related to an allergy to isothipendyl hydrochloride or to one of the components of this medication.

· The appearance of an allergy to isothipendyl hydrochloride may contraindicate in the future certain medications used systemically (certain local anesthetics, certain antihistamines).

· Do not apply over a large area, under occlusive dressing or on injured skin due to the risk of passage of the active principle into the blood.

· Do not apply to mucous membranes.

· In the absence of data on cutaneous resorption, the risk of systemic effects cannot be excluded. It is all the more to be feared that the topical is used over a large area, under occlusive dressing, on injured skin (especially burned), a mucous membrane.

· This medication contains sorbic acid (E200) and can cause local skin reactions (for example: contact dermatitis).

Precautions for Use

Given the photosensitizing effect of phenothiazines, it is preferable not to expose oneself to the sun or U.V.A during the treatment.

It is recommended to protect the areas treated by wearing a garment for the entire duration of the treatment to avoid any risk of photosensitization.

This medication is not a sunscreen.

Do not apply to large areas of the body.

This medication should not be used as a care cream on healthy skin.

4.5. Interactions with other medications and other forms of interaction

At recommended doses, isothipendyl hydrochloride for topical use is not likely to cause 

significant drug interactions from a medical standpoint.

4.6. Fertility, Pregnancy and Lactation

To be used with caution in pregnant or breastfeeding women due to the anticholinergic properties of isothipendyl hydrochloride. Do not apply to the breasts during breastfeeding.

4.7. Effects on the ability to drive vehicles and use machines

Not applicable.

4.8. Adverse Effects

Risk of sensitization to isothipendyl or another component. The reactions are usually cutaneous and localized at the site of application.

Very rare cases of photosensitization have been reported.

Very rare cases of generalized hypersensitivity reactions have been reported.

Declaration of Suspected Adverse Effects

The declaration of suspected adverse effects after authorization of the medication is important. It allows continuous monitoring of the benefit/risk ratio of the medication. Healthcare professionals report any suspected adverse effect via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and network of Regional Pharmacovigilance Centers - Website: www.signalement-sante.gouv.fr.

4.9. Overdose

Signs of an overdose in phenothiazines: seizures (especially in infants and children), consciousness disorders, coma. Symptomatic treatment will be instituted in a specialized environment.

5. PHARMACOLOGICAL PROPERTIES

5.1. Pharmacodynamic Properties

Pharmacotherapeutic class: ANTIPRURITICS, INCLUDING ANTIHISTAMINES, ANESTHETICS, Topical Antihistamine.

ATC code: D04AA22.

Isothipendyl hydrochloride from the class of aliphatic side chain phenothiazines, is a H1 antihistamine neuroleptic, anticholinergic, adrenolytic, antidopaminergic.

Antihistamines share the property of opposing, by more or less reversible competitive antagonism, the effects of histamine notably on the skin, vessels and conjunctival, nasal, bronchial and intestinal mucous membranes.

5.2. Pharmacokinetic Properties

There are no pharmacokinetic data on the use of isothipendyl hydrochloride topically.

Isothipendyl hydrochloride belongs to the class of phenothiazines, whose maximum plasma concentration after oral absorption is reached in approximately 1 hour. After a significant first-pass hepatic effect, excretion is primarily urinary.

By analogy with nearby structure phenothiazines and similar pharmacological behavior, a systemic absorption of isothipendyl hydrochloride can occur from its topical application on the treated area.

5.3. Preclinical Safety Data

No specific preclinical study exists for this route of administration.

6. PHARMACEUTICAL DATA

6.1. List of Excipients

Edetic Acid, Sorbic Acid, non-crystallizable 70% Sorbitol, Sodium Carboxymethylcellulose, Sodium Hydroxide, purified water.

6.2. Incompatibilities

Not applicable.

6.3. Shelf Life

3 years.

6.4. Special Precautions for Storage

Store at a temperature not exceeding 25°C.

6.5. Nature and Content of the Outer Packaging

Aluminum tube sealed with 30 g, internally coated with an epoxyphenolic varnish. Tube of 20, 30 or 40 g.

6.6. Special Precautions for Disposal and Other Handling

No special requirements. Any unused medication or waste should be disposed of in accordance with current regulations.

7. HOLDER OF THE MARKETING AUTHORIZATION

P&G HEALTH France

163/165, quai aulagnier

92600 asnieres-sur-seine

8. NUMBER(S) OF THE MARKETING AUTHORIZATION

· 34009 317 177 1 3 : 20 g in tube (varnished aluminum).

· 34009 317 178 8 1 : 30 g in tube (varnished aluminum).

· 34009 327 790 8 6 : 40 g in tube (varnished aluminum).

9. DATE OF FIRST AUTHORIZATION / RENEWAL OF THE AUTHORIZATION

[to be completed later by the holder]

10. DATE OF UPDATE OF THE TEXT

[to be completed later by the holder]

11. DOSIMETRY

Not applicable.

12. INSTRUCTIONS FOR THE PREPARATION OF RADIOPHARMACEUTICALS

Not applicable.