Active ingredients: Levothyroxine, Escin
SOMATOLINE® 0.1% + 0.3% SKIN EMULSION
Why is Somatoline used? What is it for?
SOMATOLINE® is a dermatological preparation with anti-cellulite activity.
SOMATOLINE® is used for localized adiposity accompanied by cellulite.
Contraindications When Somatoline should not be used
Hypersensitivity to the active substance or to any of the excipients.
Iodine intolerance.
- When can it be used only after consulting your doctor
Pregnancy and breastfeeding (see WHAT TO DO DURING PREGNANCY AND BREASTFEEDING).
It is also advisable to consult your doctor in cases where problems have occurred in the past.
- What to do during pregnancy and breastfeeding
During pregnancy and breastfeeding SOMATOLINE® should only be used after consulting your doctor and evaluating with him the risk / benefit ratio in your case.
Consult your doctor if you suspect pregnancy or wish to plan a maternity leave.
Precautions for use What you need to know before taking Somatoline
There are no particular precautions to be taken before using SOMATOLINE®.
Interactions Which drugs or foods can modify the effect of Somatoline
At the moment there are no known medicines that can modify the effect of SOMATOLINE®.
If you are using other medicines ask your doctor or pharmacist for advice.
Warnings It is important to know that:
The use, especially if prolonged, of products for topical use can give rise to sensitization phenomena and produce undesirable effects. In this case it is necessary to stop the treatment and consult your doctor.
The product should not be used in the vicinity of the mucous membranes.
Dose, Method and Time of Administration How to use Somatoline: Posology
How many:
Sachets: apply locally 20 g of product per day (equal to 2 sachets) for the first two 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 for each thigh for the first two days, half a sachet per thigh for the following days.
Multidose bottle with dispenser (4 sprays 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 days alternate.
If the product is to be used on the thighs, apply 4 sprays per thigh for the first two days, 2 sprays per thigh for the following days.
To obtain 1 delivery, press the dosing pump all the way down.
WARNING: do not exceed the recommended doses without the advice of your doctor.
When and for how long:
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.
Consult your doctor if the disorder occurs repeatedly or if you have noticed any recent changes in its characteristics.
Like:
Apply the product on the area to be treated, massaging lightly until completely absorbed.
Overdose What to do if you have taken too much Somatoline
In case of accidental ingestion / intake of an excessive dose of SOMATOLINE®, notify your doctor immediately or go to the nearest hospital.
Side Effects What are the side effects of Somatoline
There are no known side effects attributable to the treatment.
Cases with symptoms attributable to impaired thyroid function have been reported very rarely. Compliance with the instructions contained in the package leaflet reduces the risk of undesirable effects.
These side effects are usually transient. However, when they occur, it is advisable to consult your doctor or pharmacist.
It is important to inform your doctor or pharmacist of any undesirable effects not described in the package leaflet. Request and fill in the Undesirable Effects report form available at the pharmacy (form B).
Expiry and Retention
See the expiration date indicated on the package. This date is intended for the product in intact packaging, properly stored.
No particular storage precautions are required.
WARNING: do not use the medicine after the expiry date indicated on the package. Bottle: after use, close the spout with the special cap applied to the dispenser.
It is important to always have the information about the medicine available, so keep both the box and the package leaflet.
Keep this medicine out of the reach of children.
Other_information "> Other information
Composition
100 g of emulsion contain: ACTIVE INGREDIENTS: 100 mg levothyroxine, 300 mg escin.
EXCIPIENTS: glyceryl monostearate A.E., liquid paraffin, decyloleate, non crystallizable sorbitol 70%, polyacrylamide isoparaffin laureth-7, imidazolidinylurea, methyl p-hydroxybenzoate, propyl p-hydroxybenzoate, citric acid monohydrate, rose perfume, purified water.
How it looks
SOMATOLINE® comes in the form of a skin emulsion and is available in:
- single-dose sachets of 10 g, in packs of 10, 15, 30, 45 and 60 sachets.
- multidose bottle with dispenser, 15 and 25 applications.
Source Package Leaflet: AIFA (Italian Medicines Agency). Content published in January 2016. The information present may not be up-to-date.
To have access to the most up-to-date version, it is advisable to access the AIFA (Italian Medicines Agency) website. Disclaimer and useful information.
01.0 NAME OF THE MEDICINAL PRODUCT -
SOMATOLINE 0.1% + 0.3% SKIN EMULSION
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION -
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.
03.0 PHARMACEUTICAL FORM -
Skin emulsion.
04.0 CLINICAL INFORMATION -
04.1 Therapeutic indications -
States of localized adiposity accompanied by cellulite.
SOMATOLINE is indicated in adults.
04.2 Posology and method of administration -
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.
Multidose bottle with dispenser : (4 sprays 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 sprays (10 g) for each thigh for the first two days. The following days 2 pumps (5 g) per thigh.
To obtain 1 delivery, press the dispenser all the way down.
Each treatment cycle can go from a minimum of 15 - 20 days to a maximum of 2 - 3 months and can be repeated at various time intervals. Massage the product in the area to be treated (the surface of which should not, as a rule, exceed 15 cm per side), until completely absorbed. Follow with a second deeper massage, lasting a few minutes (5 "-10"). 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 reddening is produced; then proceed with the application of the treatment as illustrated above; the clinical results generally begin to become evident towards the end of the second week of treatment.
Pediatric population
Safety and efficacy in children and adolescents have not yet been demonstrated.
No data are available.
04.3 Contraindications -
Hypersensitivity to the active substances or to any of the excipients listed in section 6.1.
Iodine intolerance.
Generally contraindicated in pregnancy and during lactation (see par. 4.6).
04.4 Special warnings and appropriate precautions for use -
The use, especially if repeated or protracted, of products for topical use can give rise to sensitization phenomena. If this occurs, stop the treatment and evaluate the need to institute a suitable therapy.
Do not use near the mucous membranes.
SOMATOLINE contains para-hydroxybenzoates which can cause allergic reactions (including delayed).
04.5 Interactions with other medicinal products and other forms of interaction -
There are no phenomena of intolerance or incompatibility with other drugs.
04.6 Pregnancy and breastfeeding -
There are no known experimental or clinical data to argue against the use of the product during pregnancy. However, prudence advises against applying the product during pregnancy or breastfeeding.
04.7 Effects on ability to drive and use machines -
Somatoline does not affect the ability to drive or use machines.
04.8 Undesirable effects -
Cases with symptoms attributable to impaired thyroid function have been reported very rarely.
Reporting of suspected adverse reactions
Reporting of suspected adverse reactions occurring after authorization of the medicine is important, as it allows continuous monitoring of the benefit / risk balance of the medicine. Healthcare professionals are asked to report any suspected adverse reactions via the website: http: //agenziafarmaco.gov.it/it/responsabili
04.9 Overdose -
No overdose phenomena were highlighted.
05.0 PHARMACOLOGICAL PROPERTIES -
05.1 "Pharmacodynamic properties -
Pharmacotherapeutic group: Other dermatological preparations - Various associations.
ATC code: D11AX99
The active ingredients of SOMATOLINE exert their activity essentially on adipose tissue, activating the process of hydrolysis and mobilization of triglycerides and fatty acids and carrying out an inhibiting action on the synthesis of lipids. They also act on the permeability of capillaries, exerting an anti-edema action and removal of stagnant liquids in the tissues, carrying out a mobilization effect at the tissue level of the saline water collections, frequently present in the tissues affected by cellulite.
05.2 "Pharmacokinetic properties -
Within the limits of the indicated posology, there is no systemic absorption of the active ingredients contained in SOMATOLINE.
05.3 Preclinical safety data -
Within the limits of the indicated posology, SOMATOLINE does not cause systemic side effects and does not interfere with the main parameters of thyroid function.
06.0 PHARMACEUTICAL INFORMATION -
06.1 Excipients -
Glyceryl monostearate A.E., xanthan gum, liquid paraffin, decyloleate, non crystallizable 70% sorbitol, polyacrylamide isoparaffin laureth-7, imidazolidinylurea, methyl para-hydroxybenzoate, propyl para-hydroxybenzoate, citric acid monohydrate, rose perfume, purified water.
06.2 Incompatibility "-
Not known.
06.3 Period of validity "-
4 years.
06.4 Special precautions for storage -
This medicine does not require any special storage conditions.
06.5 Nature of the immediate packaging and contents of the package -
• Paper-aluminum-polythene coupled sachet, containing 10 g of product.
• Polypropylene BOTTLE with a capacity of 100-150-250 ml (corresponding to 10, 15, 25 applications) containing a polyethylene bag and a polypropylene dispenser with butyl seals. The bottle is closed with a polypropylene cap. Polypropylene cap for the dispensing hole.
Not all pack sizes may be marketed.
06.6 Instructions for use and handling -
There are no particular instructions to follow for using the product.
To dispense the exact amount of product with the multidose bottle with dispenser, be careful to press the dispenser as far as it will go.
After use, close the spout with the special cap applied to the dispenser.
Unused medicine and wastes derived from this medicine must be disposed of in accordance with local regulations.
07.0 HOLDER OF THE "MARKETING AUTHORIZATION" -
Italo-British company L.MANETTI H.ROBERTS & C. for shares - Florence.
08.0 MARKETING AUTHORIZATION NUMBER -
SOMATOLINE 0.1% + 0.3% SKIN EMULSION - 10 sachets AIC n ° 022816019
SOMATOLINE 0.1% + 0.3% SKIN EMULSION - 15 sachets AIC n ° 022816072
SOMATOLINE 0.1% + 0.3% SKIN EMULSION - 30 sachets AIC n ° 022816021
SOMATOLINE 0.1% + 0.3% SKIN EMULSION - 35 sachets AIC n ° 022816108
SOMATOLINE 0.1% + 0.3% SKIN EMULSION - bottle with dispenser 10 applications AIC n ° 022816045
SOMATOLINE 0.1% + 0.3% SKIN EMULSION - bottle with dispenser 15 applications AIC n ° 022816058
SOMATOLINE 0.1% + 0.3% SKIN EMULSION - bottle with dispenser 25 applications AIC n ° 022816060
SOMATOLINE 0.1% + 0.3% SKIN EMULSION - 45 sachets AIC n ° 022816084
SOMATOLINE 0.1% + 0.3% SKIN EMULSION - 60 sachets AIC n ° 022816096
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION -
date of first authorization:
Box of 10 sachets: November 23, 1973
Box of 30 sachets: December 1, 1984
Bottles 100, 150, 250 ml: December 31, 2003
Box of 15 sachets: January 21, 2009
Boxes of 45 and 60 sachets: June 23, 2011
Box of 35 sachets: June 9, 2014
latest renewal date: June 1, 2010.
10.0 DATE OF REVISION OF THE TEXT -
19 September 2014
