SOMATOLINE*EMULS 30BS 0.1+0.3%

States of localized adiposity accompanied by cellulite. SOMATOLINE is indicated in adults

Therapeutic indications

States of localized adiposity accompanied by cellulite. SOMATOLINE is indicated in adults.

Dosage and method of use

Posology and Method of administration Sachets : apply locally 20 g of product per day (equal to 2 sachets) for the first two consecutive days, then 10 g of product (equal to 1 sachet) per day or every other day. If the product is to be used on the thighs, apply 1 sachet (10 g) to each thigh for the first two days. The following days, half a sachet (5 g) per thigh.

If the skin is oily or thickened, it is advisable to first wash the area to be treated, dry well and then practice a simple massage until a slight redness is produced; then proceed with the application of the treatment as illustrated above; the clinical results begin to become evident, generally, towards the end of the second week of treatment. Pediatric population Safety and efficacy in children and adolescents have not yet been demonstrated. There is no data available.

Contraindications

Hypersensitivity to the active substances or to any of the excipients listed in section 6.1. Iodine intolerance. Generally contraindicated during pregnancy and lactation (see par. 4.6).

Side effects

Cases with symptoms attributable to impaired thyroid function have been reported very rarely. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorization of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the website: http://agenziafarmaco.gov.it/it/responsabili

Special warnings

The use, especially if repeated or prolonged, of products for topical use can give rise to sensitization phenomena. If this occurs, interrupt the treatment and evaluate the need to institute a suitable therapy. Do not use near mucous membranes. SOMATOLINE contains para-hydroxybenzoates which may cause allergic reactions (possibly delayed).

Pregnancy and breastfeeding

There are no known experimental or clinical data against the use of the product during pregnancy. However, prudence advises against applying the product during pregnancy or while breastfeeding.

Expiration and conservation

This medicine does not require any special storage conditions.

Interactions with other drugs

There are no phenomena of intolerance or incompatibility with other drugs.

Overdose

No phenomena of overdose have been highlighted.

Active principles

100 g of emulsion contain: active ingredients: levothyroxine 100 mg escin 300 mg Excipients with known effects: methyl p-hydroxybenzoate, propyl p-hydroxybenzoate. For the full list of excipients, see section 6.1.

Excipients

Glycerylmonostearate AE, xanthan gum, liquid paraffin, decyloleate, non-crystallizable sorbitol 70%, polyacrylamide isoparaffin laureth-7, imidazolidinylurea, methyl para-hydroxybenzoate, propyl para-hydroxybenzoate , citric acid monohydrate, rose perfume, purified water.