英文药名：Aftach Adhesive Tablet(Triamcinolone Acetonide)
Aftach Adhesive Tablet 25μg
Each adhesive of topical application in the mouth contains 0.025 mg of Triamcinolone Acetonide.
Packages with 20 or 60 tablets.
VII -1 – (Medicines for topical application in the mouth)
MARKETING AUTHORIZATION HOLDER
ANGELINI FARMACÊUTICA, LDA Rua João Chagas, nº 53 – 3º Piso
Under license of:
WHAT AFTACH IS AND WHAT IT IS USED FOR?
AFTACH is a new kind of preparation intended for the treatment of aphthous stomatitis containing a steroidal anti-inflammatory, Triamcinolone Acetonide, vehiculated in a new adhesive formulation easily applied to the mucosa of the mouth.
AFTACH tablets are presented under the form of a thin disk constituted by a double layer: a white adhesive layer containing the active substance and another one, coloured, for support purposes.
Given its fixation capacity to the affected area, AFTACH has demonstrated, when compared to conventional preparations, a high power of adhesion and great therapeutic effectiveness.
IN WHICH SITUATIONS IS AFTACH INDICATED?
AFTACH is indicated in the treatment of aphthous stomatitis.
WHEN SHOULD IT NOT BE USED AND WHAT ARE THE SIDE EFFECTS THAT MAY OCCUR?
AFTACH is contraindicated in individuals with hypersensitivity to this medicine and it should not be used in cases of infection of the oral cavity; in these situations a previous medication with a bactericide or fungicide agent must be performed.
No significant side effects were reported, except for the sporadic development of candidiasis In this case, treatment should be interrupted and you should apply an adequate fungicide until complete regression of the symptoms.
DRUG INTERACTIONS AND OTHER FORMS OF INTERACTION
SPECIAL PRECAUTIONS FOR USE
Do not swallow the tablets because this is a topical adhesive preparation to be applied on the mucosa of the mouth cavity.
The incorrect application may cause the non-adhesion of the tablet to the affected area. You should apply the tablets correctly on the area to treat, according to the described further on.
EFFECTS ON PREGNANT AND BREAST-FEEDING WOMEN, CHILDREN, ELDERLY PATIENTS AND PATIENTS WITH SPECIAL PATHOLOGIES
Although no adverse effects caused by this product have been described in these subjects, its use should always depend on the doctor’s opinion.
EFFECTS ON THE ABILITY TO DRIVE OR TO USE MACHINES
By its characteristics, this medicine does not interfere with the ability to drive or use machines.
WHEN AND HOW SHOULD IT BE USED?
Apply one tablet by each affected area, one or two times a day, making the white layer of the tablet adhere on the surface to treat:
(1) Moisture the tip of the finger and pressure the coloured layer of the tablet.
Holding the tablet like this (2), place the white layer directly in contact with the mucosa to treat, gently pressuring for 2 or 3 seconds (3).
Do not moisture the white layer before the application because it will hardly adhere to the mucosa.
On the other hand, the mucosa of the affected area should not have excess of saliva, in order to make the adhesion of the tablet easier.
WHAT TO DO IF YOU FORGET OR CANNOT TAKE ONE OR MORE DOSES?
Since the posology is adjustable according to the severity of the lesion, it is not applied a rigorous posological scheme for the use of this medicine; tablets may be applied whenever necessary.
WHAT TO DO IN CASE OF OVERDOSAGE AND / OR INTOXICATION?
As with any other medicine, the previously recommended doses should not be exceeded. However, if by chance this situation occurs, contact your doctor or go to the nearest Hospital.
Any side effect not included in this patient leaflet should be reported to your doctor or pharmacist.
Do not use after the expiry term stated on the package.
Store protected from heat and humidity.
DATE OF THE REVISION OF THE LEAFLET : JAN. 03.