APAISYL Insect sting gel 30 g

ANSM - Updated on : 07/19/2010

1. DRUG NAME

APAISYLGEL 0.75%, gel for topical application

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Isothipendyl hydrochloride ................................................................................................................ 0.750 g

Per 100 g of gel for topical application.

Excipient: sorbic acid.

For full 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 pruritus, particularly insect bites.

4.2. Dosage and administration

For adults and children over 30 months.

Apply to the skin.

1 application 2 to 3 times a day.

Do not exceed 5 days' treatment.

4.3. Contraindications

- A history of allergy to antihistamines,

- Infected or irritated skin,

- Oozing lesions.

4.4 Special warnings and precautions for use

Special warnings

- Pruritus is only a symptom. In all cases, its etiology must be sought out and treated.

- The persistence or aggravation of pruritus may be linked to an allergy to one of the ingredients of the preparation.

- This product contains sorbic acid and may cause local skin reactions (e.g. eczema).

- In the absence of data on skin resorption, the risk of systemic effects cannot be ruled out. It is all the more likely to occur when the topical is used over a large surface area, under an occlusive dressing, on injured skin (particularly burns), mucous membranes, or on the skin of premature babies or infants (due to the surface/weight ratio and the occlusive effect of diapers in the breech area).

Precautions for use

This product is not a sunscreen.

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

4.5. Interactions with other medicinal products and other forms of interaction

Not applicable.

4.6. Pregnancy and breast-feeding

Use with caution in pregnant or breast-feeding women, in the absence of usable clinical data.

4.7. Effects on ability to drive and use machines

Not applicable.

4.8. Undesirable effects

Risk of sensitization to isothipendyl.

Very rare cases of photosensitization have been reported.

4.9. Overdosage

Not applicable.

5. PHARMACOLOGICAL PROPERTIES

5.1. Pharmacodynamic properties

Pharmacotherapeutic class: ANTIHISTAMINIC FOR LOCAL USE.

ANTIPRURIGINAL, ATC Code: D04AA22.

(D: Dermatology).

5.2. Pharmacokinetic properties

No information available.

5.3. Preclinical safety data

Not available.

6. PHARMACEUTICAL DATA

6.1. List of excipients

Edetic acid, sorbic acid, 70 % non-crystallizable sorbitol, sodium carboxymethylcellulose, sodium hydroxide, purified water.

6.2 Incompatibilities

Not applicable.

6.3. Shelf life

3 years.

6.4. Special storage precautions

Store at temperatures below 25°C.

6.5. Nature and contents of packaging

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

6.6. Special precautions for disposal and handling

No special requirements.

7. MARKETING AUTHORIZATION HOLDER

MERCK MEDICATION FAMILIALE SAS

37 RUE SAINT-ROMAIN

69379 LYON CEDEX 08

8. MARKETING AUTHORIZATION NUMBER(S)

- 317 177-1: 20 g in tube (coated aluminum).

- 317 178-8: 30 g in tube (coated aluminum).

- 327 790-8: 40 g in tube (aluminum painted).

9. DATE OF FIRST AUTHORIZATION/AUTHORIZATION RENEWAL

[to be completed by holder]

10. DATE OF TEXT UPDATE

[to be completed by holder]

11. DOSIMETRY

Not applicable.

12. INSTRUCTIONS FOR THE PREPARATION OF RADIOPHARMACEUTICALS

Not applicable.

Not subject to medical prescription.