AFTAB * 10CPR ADHESIVE BUCC 0,025

AFTAB * 10CPR ADHESIVE BUCC 0,025

Therapeutic indications

Aphthous ulcers of the oral cavity.

Dosage and method of use

Adults: AFTAB should not be swallowed or chewed. Generally apply one tablet to each affected area once or twice a day, making the white layer adhere to the surface on which the lesion is present. It is recommended not to exceed the maximum daily dose of 4 tablets. The therapy should be of short duration and in any case not exceeding 7 days of treatment. AFTAB must be applied in the oral cavity and therefore cannot be administered for internal use (it must not be swallowed!). The preparation must not be chewed as it is an adhesive preparation for topical use that must be applied to the mucous membrane of the oral cavity. Patients should wash their hands thoroughly before applying. The preparation may not adhere adequately to the injured surface if it is not applied correctly; therefore follow the instructions below for the application. Correct application: 1) Take a tablet from the blister and place it, with the orange layer facing up, on a paper towel. 2) Before application, gently pat the injured surface of the mucosa with a tissue to dry the saliva. 3) Slightly moisten the tip of the index finger with saliva; lightly press the tip of the moistened finger against the orange layer of the tablet to be able to lift it. 4) Apply the white adhesive layer of the tablet on the mucosa making sure to cover the injured surface as much as possible. 5) Press gently for 2–3 seconds with your fingertip and finally release it. Be careful not to touch the tablet for a few minutes with your tongue, as it may move or come off. 6) If the affected part is the tongue, wipe off the saliva two or three times, apply the tablet and wait about 2–3 minutes until the orange part has become gelatinous. Warnings: If necessary, use a pair of tweezers to apply the compress. Be careful not to moisten the white layer before application as, in this case, it will hardly adhere to the mucosa. After application, the tablet must not be detached. When the mucous membrane of the injured area is strongly moistened by saliva, the tablet may not adhere to the surface. Children: Aftab is not recommended for use in children due to a lack of data on safety and / or efficacy

Contraindications

Hypersensitivity to the active substance or to any of the excipients. Pregnancy and breastfeeding.

Side effects

Candidiasis can occur. If symptoms associated with candidiasis occur, administration of the preparation should be suspended until the symptoms disappear by using an appropriate fungicide. Reporting of suspected adverse reactions. Reporting of suspected adverse reactions that occur after authorization of the medicine is important, as it allows continuous monitoring of the benefit / risk ratio of the medicine. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at: www.agenziafarmaco.gov.it/it/responsabili.

Special warnings

Patients with active oral infections should not be treated with this preparation. If absolutely necessary, such patients can be treated after taking a suitable antibacterial preparation or fungicide. Due to the lactose present in the formulation, subjects with rare hereditary forms with galactose intolerance, lactase deficiency, or glucose / galactose malabsorption should not take this medicine.

Pregnancy and breastfeeding

The safety of the preparation in the period of pregnancy and lactation has not been ascertained. Therefore the preparation should not be used during pregnancy and lactation.

Expiration and retention

Store in a dry place away from heat sources.

Interactions with other drugs

Concomitant treatment with CYP3A inhibitors, including cobicistat-containing medicines, is thought to increase the risk of systemic side effects. The combination should be avoided unless the benefit outweighs the increased risk of systemic side effects due to corticosteroids; in this case it is necessary to monitor the patients to verify the absence of systemic undesirable effects due to corticosteroids.

Overdose

No cases of overdose have been reported.

Active principles

Each muco-adhesive buccal tablet contains active ingredient: Triamcinolone acetonide 25 mcg Excipients: Lactose 36.12 mg For the full list of excipients, see section 6.1

Excipients

WHITE ADHESIVE LAYER: Hydroxypropylcellulose, Carboxyvinyl polymer, Magnesium stearate, Talc, Magnesium metasilicate of aluminum. COLORED BACKING LAYER: Lactose, Hydroxypropylcellulose, Calcium, Carboxymethylcellulose, Magnesium stearate, Color E110 (sunset yellow).