Active ingredients: Triamcinolone acetonide
AFTAB 25 micrograms - mucoadhesive buccal tablets
Why is Aftab used? What is it for?
AFTAB is a dental preparation (affecting the mouth) that contains the active ingredient triamcinolone acetonide (a corticosteroid) used in local oral treatment. AFTAB is used for aphthous ulcers of the oral cavity.
Contraindications When Aftab should not be used
Do not use AFTAB
- if you are allergic to triamcinolone acetonide or any of the other ingredients of this medicine (listed in section 6)
Precautions for use What you need to know before taking Aftab
Talk to your doctor or pharmacist before using AFTAB.
If you have active oral infections you should not use AFTAB. If absolutely necessary, you can use it after taking a suitable antibacterial preparation or an antifungal.
Children
The use of Aftab is not recommended in children.
Interactions Which drugs or foods can modify the effect of Aftab
Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.
Warnings It is important to know that:
Pregnancy and breastfeeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.
You must not use AFTAB if you are pregnant or think you are pregnant or if you are breast-feeding. You must not use AFTAB even if you are planning to become pregnant.
Driving and using machines
There are no known effects on the ability to drive or use machines.
AFTAB contains lactose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Dose, Method and Time of Administration How to use Aftab: Posology
Always use this medicine exactly as described in this leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
AFTAB should not be swallowed or chewed. AFTAB is an adhesive preparation for topical use that you must apply in the oral cavity.
How many
Apply one tablet to each affected area once or twice a day.
Do not exceed the maximum daily dose of 4 tablets.
Warning: do not exceed the indicated doses without the advice of your doctor.
When and for how long
AFTAB tablets can be applied at any time of the day.
Do not use this medicine for more than 7 days.
Consult your doctor if the disorder occurs repeatedly or if you have noticed any recent changes in its characteristics.
Like
Wash your hands thoroughly before proceeding with the application.
- Take a tablet from the blister and place it, with the orange layer facing up, on a paper towel.
- Before application, gently swab the injured surface of the mucosa with a tissue to dry the saliva.
- Slightly moisten the tip of the index finger with saliva: press the tip of the moistened finger lightly against the orange layer of the tablet to be able to lift it.
- Apply the white adhesive layer of the tablet to the mucosa making sure to cover the injured surface as much as possible.
- Press gently for 2-3 seconds with your fingertip and finally release. Be careful not to touch the tablet for a few minutes with your tongue, as it may move or come off.
- If the affected part is the tongue, wipe off the saliva 2 or 3 times, apply the tablet and wait about 2-3 minutes until the orange part has become gelatinous.
If you forget to use AFTAB
Do not use a double dose to make up for a forgotten dose.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Overdose What to do if you have taken too much Aftab
In case of accidental ingestion / intake of an overdose of AFTAB, notify your doctor immediately or go to the nearest hospital.
Side Effects What are the side effects of Aftab
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Candidiasis (infection caused by a fungus of the genus Candida) can occur. If symptoms associated with candidiasis occur, administration of AFTAB should be suspended until symptoms disappear by using an appropriate fungicide.
These side effects are usually transient. However, when they occur, it is advisable to consult your doctor or pharmacist. Compliance with the instructions contained in the package leaflet reduces the risk of undesirable effects.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system at: www.agenziafarmaco.gov.it/it/responsabili. By reporting side effects you can help provide more information on the safety of this medicine.
Expiry and Retention
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the package after "Expires on". The expiry date indicated refers to the last day of that month.
It is important to always have the information about the medicine available, so keep both the box and the package leaflet.
Do not throw any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. This will help protect the environment.
Other information
What AFTAB contains
The active ingredient is triamcinolone acetonide.
Each tablet consists of a white adhesive layer containing the active ingredient and a colored backing layer.
The WHITE ADHESIVE LAYER of one tablet contains 0.025 mg of triamcinolone acetonide.
The other ingredients are hydroxypropylcellulose, carboxyvinyl polymer, magnesium stearate, talc, aluminum magnesium metasilicate.
The COLORED BACKING LAYER of one tablet contains Lactose, Hydroxypropylcellulose, Calcium carboxymethylcellulose, Magnesium stearate, Color E110 (sunset yellow).
Description of what AFTAB looks like and contents of the pack
AFTAB comes in the form of a muco-adhesive buccal tablet, it is a thin tablet consisting of a white adhesive layer containing the active ingredient and an orange support layer.
The package consists of a box containing a blister of 10 tablets.
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
AFTAB 25 MCG MUCO-ADHESIVE BUCCAL TABLETS
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each muco-adhesive buccal tablet contains
active principle:
Triamcinolone acetonide 25 mcg.
Excipients:
lactose 36.12 mg.
For the full list of excipients, see section 6.1.
03.0 PHARMACEUTICAL FORM
Muco-adhesive buccal tablet.
The preparation is a thin discoid tablet, consisting of a white adhesive layer containing triamcinolone acetonide and an orange support layer which dissolves readily in the oral cavity after application.
04.0 CLINICAL INFORMATION
04.1 Therapeutic indications
Aphthous ulcers of the oral cavity.
04.2 Posology and method of administration
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 must 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 should 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 proceeding with application.
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 upwards, on a paper towel.
2) Before application, gently dab 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
04.3 Contraindications
Hypersensitivity to the active substance or to any of the excipients.
Pregnancy and breastfeeding.
04.4 Special warnings and appropriate precautions for use
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.
04.5 Interactions with other medicinal products and other forms of interaction
There are no known interactions.
04.6 Pregnancy and breastfeeding
The safety of the preparation in the period of pregnancy and lactation has not been established. Therefore, the preparation should not be used during pregnancy and breastfeeding.
04.7 Effects on ability to drive and use machines
There are no known effects in this regard.
04.8 Undesirable 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 medicinal product is important, as it allows continuous monitoring of the benefit / risk ratio of the medicinal product.
Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at: www.agenziafarmaco.gov.it/it/responsabili.
04.9 Overdose
No cases of overdose have been reported.
05.0 PHARMACOLOGICAL PROPERTIES
05.1 Pharmacodynamic properties
Pharmacotherapeutic group: corticosteroids for local oral treatment
ATC: A01AC
Triamcinolone acetonide is a derivative of triamcinolone and has anti-inflammatory, anti-allergic and anti-itch activity.
The adhesive layer of AFTAB consists of a set of polymers, mainly hydroxypropylcellulose and a carboxyvinyl polymer; the layer has the property of adhering strongly to the mucous membrane of the mouth and swelling in contact with saliva to form a thin elastic film that covers and protects the injured surface. The adhesive layer cannot be detached even by rubbing and the active principle is released gradually by slow dissolution determined by the adhesion and permanence of the tablet on the lesion for a long period of time.
05.2 Pharmacokinetic properties
Preclinical and clinical studies, including double-blind ones, confirm the efficacy of triamcinolone acetonide which, by remaining at the application site, gradually penetrates the wound tissues and is present there in high concentration for a long period of time.
05.3 Preclinical safety data
There is no information, deriving from preclinical data, of significant importance to the physician that has not already been reported in the other sections of the Summary of Product Characteristics.
06.0 PHARMACEUTICAL INFORMATION
06.1 Excipients
WHITE ADHESIVE LAYER: hydroxypropylcellulose, carboxyvinyl polymer, magnesium stearate, talc, aluminum magnesium metasilicate.
COLORED BACKING LAYER: lactose, hydroxypropylcellulose, calcium, carboxymethylcellulose, magnesium stearate, color E110 (sunset yellow).
06.2 Incompatibility
Not relevant.
06.3 Period of validity
4 years.
06.4 Special precautions for storage
Store in a dry place away from heat sources.
06.5 Nature of the immediate packaging and contents of the package
Box containing 10 tablets
Box containing 6 tablets
06.6 Instructions for use and handling
No special instructions.
07.0 MARKETING AUTHORIZATION HOLDER
ROTTAPHARM S.p.A. - Galleria Unione, 5 - 20122 Milan
08.0 MARKETING AUTHORIZATION NUMBER
10 tablets: code A.I.C. 028478016
6 tablets: code A.I.C. 028478030
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION
October 28, 1994
