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Filme
Otolaryngology
Filme Os

Oral Oil Gel - 100% Tocopherol Acetate

Nickel (<1ppm) and Gluten (<10ppm) tested
Contains no preservatives and alcohol


1 tube 8 ml with applicator
EUROPEAN PATENT


Type of product: CE Class IIa Medical Device

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FILME OS is a medical device made from Tocopherol Acetate (Vitamin E), it forms a protective film and insolates mouth lesions, reduces the pain of the inflamed mucosa and injury, to prevents the risks of further irritation.

FILME OS is a medical device made from Tocopherol Acetate (Vitamin E), it forms a protective film to isolates mouth lesions, reduces pain of inflamed mucosa and injury, to prevents the risks of further irritation. The protective film formed by the Vitamin E promotes the physiological healing processes. FILME OS can be applied to ulcers, stomatitis of various origins, small lesions caused by braces, fixed and removable dentures. FILME OS does not burn on contact and contains no preservatives or colourants. Indicated for the treatment of mouth ulcers in adults and children. FILME OS contributes in the reduction of biofilm, keeping the physiological microbiota of the skin and oral mucosa in good condition.


MEDICAL DEVICE
After use, dispose of in accordance with your national legislation.
Do not disperse in the environment.

KEEP OUT OF REACH OF CHILDREN


MANUFACTURER:
PANIN S.R.L. a socio unico
Viale della Scienza 24 - 45100 Rovigo (Italy)


EXCLUSIVE SALES LICENSEE FOR ITALY:
HULKA S.R.L. a socio unico
Viale della Scienza, 26 - 45100 Rovigo (Italy)

Tocopherol Acetate

Hypersensitive towards the components.

Do not inject nor ingest. Avoid contact with eyes. Not harmful if ingested.

No known interactions with other medicines or oral products. In the case of the use of oral hygiene wash, wait at least 5 minutes before applying FILME OS.

To prevent aphthous ulcers from developing, start by applying FILME OS at the first onset of the characteristics of symptoms (burning or stinging) 3 times a day for at least 4-5 days. The preservation of the product in the refrigerator allows increased viscosity of the gel, which help to obtain a greater relief of the symptoms.
Apply one or two drops of FILME OS on the lesion until it is fully covered, if needed spread with your finger.
Do not massage and avoid touching even with the tongue for at least 1-2 minutes to encourage the formation of the protective film. It is recommended to apply the product at least an hour before eating


• Unscrew the cap of the tube
• Attach applicator supplied to the head of the product tube
• Before use, remove the protective cap from the applicator
• Apply FILME OS on the treatment area covering the whole lesion
• Avoid rubbing treatment area with tongue for at least 1-2 minutes after application
• After use, close applicator with protective cap
• It is not necessary to detach applicator from tube

For topic use. Wash hands thoroughly when fingers are used to apply product.

Product application can be repeated 3-4 times during the day or as needed, preferably between meals. If discomfort persists, seek medical advice.

Although FILME OS is extremely tolerable, in some rare cases it may cause a stinging effect, irritation and allergic reaction. If this occurs discontinue use and consult a doctor. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Store at room temperature. DO NOT USE AFTER THE INDICATED EXPIRY DATE ON THE INNER PACKAGING OR ON THE OUTER PACKAGING.

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