Somatoline Gel 0.1% + 0.3% 30 Sachets

SOMATOLINE 0.1% + 0.3% GEL

100 g of gel contains: ACTIVE INGREDIENTS: levothyroxine 100 mg; escin 300 mg Excipient with known effects This medicinal product contains 500 mg of alcohol (ethanol) in each sachet and 125 mg of alcohol (ethanol) in each actuation from the dispenser bottle, which is equivalent to 50 mg in each gram of gel. For the full list of excipients, see section 6.1.

Ethyl alcohol, sorbitol, phenoxyethanol, carbomer, triethanolamine, imidazolidinyl urea, xanthan gum, rose scent, purified water

SOMATOLINE 0.1% + 0.3% GEL is indicated for the treatment of localized adiposity accompanied by cellulite in adults.

Dosage Apply locally 20 g of product per day for the first two consecutive days, then 10 g of product daily or every other day. 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. Multi-dose bottle with dispenser : (4 pumps correspond to 10 g of product). Apply locally 20 g of product per day (equal to 8 sprays) for the first two days, then 10 g of product (equal to 4 sprays) per day or every other day. If the product is to be used on the thighs, apply a dose corresponding to 4 pumps (10 g) for each thigh for the first two days. The following days 2 sprays (5 g) per thigh. To obtain 1 delivery, press the dispenser all the way down. Each treatment cycle can range from a minimum of 15 - 20 days to a maximum of 2 - 3 months and can be repeated at various time intervals. For an adequate application it is recommended 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 product by vigorously massaging the area to be treated (the surface of which must, as a rule, not exceed 15 cm on each side), for a few minutes until completely absorbed; clinical results generally begin to become evident towards the end of the second week of treatment.

Do not store above 25°C. For storage conditions after first opening, see paragraph 6.3.

• The use, especially if repeated or prolonged, of products for topical use can give rise to sensitization phenomena. If this occurs, discontinue treatment and evaluate the need to institute suitable therapy. • Do not apply near mucous membranes or on damaged skin. • This medicine contains 500 mg of alcohol (ethanol) in each sachet and 125 mg of alcohol (ethanol) in each actuation from the dispenser bottle, which is equivalent to 50 mg in each gram of gel. SOMATOLINE 0.1% + 0.3% GEL contains alcohol (ethanol) which may cause burning sensation on damaged skin. • Particular caution is recommended when used by individuals with pre-existing thyroid problems, although no evidence of thyroid alterations was observed during clinical studies and no systemic absorption of thyroxine (T4) was detected, nor a significant increase in levels blood levels of FT4, FT3 and TSH after topical application. Pediatric population Safety and efficacy in children and adolescents have not yet been demonstrated and therefore the use of SOMATOLINE 0.1% + 0.3% GEL in the pediatric population is not recommended.

No interaction studies have been performed.

No clinical data are available regarding overdose with SOMATOLINE 0.1% + 0.3% GEL. Given the nature of the cutaneous application and the fact that no systemic absorption has been detected, the risk of overdose is still considered low. Preclinical studies have shown that application to large areas of skin does not cause significant increases in circulating levels of thyroxine (T4) and protein-bound iodine (PBI).

Pregnancy The product is intended for cutaneous application and no systemic absorption has been detected, furthermore there is no experimental or clinical evidence demonstrating harmful effects on pregnancy or the fetus. However, the use of the product is contraindicated during pregnancy. Breastfeeding The product is intended for cutaneous application and no systemic absorption has been detected, furthermore there is no experimental or clinical evidence demonstrating harmful effects on the newborn during breastfeeding. However, the use of the product is contraindicated during breastfeeding. Fertility No specific studies on the potential effect on human fertility have been conducted. Considering the cutaneous application and that no systemic absorption has been detected, the product is not expected to affect fertility. However, women of childbearing age who are planning to become pregnant should consult their doctor or pharmacist before using the product.