APHTHEAL 5% w/w Oromucosal Paste

Riik: Iirimaa

keel: inglise

Allikas: HPRA (Health Products Regulatory Authority)

Toimeaine:

Amlexanox

Saadav alates:

Mylan IRE Healthcare Limited

ATC kood:

A01AD; A01AD07

INN (Rahvusvaheline Nimetus):

Amlexanox

Annus:

5 percent weight/weight

Ravimvorm:

Oromucosal paste

Retsepti tüüp:

Product subject to prescription which may not be renewed (A)

Terapeutiline ala:

Other agents for local oral treatment; amlexanox

Volitamisolek:

Not marketed

Loa andmise kuupäev:

2009-06-12

Infovoldik

1
PACKAGE LEAFLET
2
PACKAGE LEAFLET: INFORMATION FOR THE USER
_ _
APHTHEAL 5% W/W OROMUCOSAL PASTE
AMLEXANOX
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or dentist.
-
This medicine has been prescribed for you. Do not pass it on to
others. It may harm them, even
if their symptoms are the same as yours.
-
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 dentist.
-
Aphtheal 5% Oromucosal Paste will be known as Aphtheal throughout this
leaflet.
IN THIS LEAFLET:
1. What Aphtheal is and what it is used for
2. Before you use Aphtheal
3. How to use Aphtheal
4. Possible side effects
5. How to store Aphtheal
6. Further information
1.
WHAT APHTHEAL IS AND WHAT IT IS USED FOR
Aphtheal contains the active ingredient amlexanox, which belongs to a
group of medicines called anti-
allergic and anti-inflammatory agents.
Aphtheal is used for the treatment of minor mouth ulcers (minor
aphthous ulcers) in adults. It works
by speeding up the healing and relieving the pain of minor mouth
ulcers.
2.
BEFORE YOU USE APHTHEAL
DO NOT USE APHTHEAL IF:

You are allergic (hypersensitive) to amlexanox or any of the other
ingredients of Aphtheal. A
full list of ingredients is provided in Section 6 “Further
Information”

You are under 18 years of age

You are over 65 years of age.
TAKE SPECIAL CARE WITH APHTHEAL
Talk to your doctor or dentist before using Aphtheal if:

You are being treated for kidney (renal) conditions

You are being treated for liver (hepatic) conditions.
TAKING OR USING OTHER MEDICINES
Please tell your doctor or dentist if you are taking or have recently
taken any other medicines,
including medicines obtained without a prescription.
PREGNANCY AND BREAST-FEEDING
Aphtheal should not be used if you are pregnant or breast-feeding.
Ask your doctor or dentist for advice before taking any medicine.
3
DRI

Toote omadused

Health Products Regulatory Authority
08 February 2019
CRN008QPQ
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
APHTHEAL 5% w/w Oromucosal Paste
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1g oromucosal paste contains 50 mg amlexanox.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Oromucosal Paste.
The product is a granular beige-coloured paste.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Aphtheal 5% oromucosal paste, is indicated for the treatment of minor
aphthous
ulcers in adults.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
ADULTS
The paste should be applied as soon as possible and within 48 hours of
the start of
symptoms once the patient is aware of the symptoms of minor aphthous
ulcers. The
paste should be applied four times daily, after meals and oral
hygiene.
Approximately 0.5cm of paste, equivalent to 3mg amlexanox, should be
squeezed
onto a finger tip and then the paste should be gently applied onto the
ulcer. Repeat
this procedure with a further 0.5 cm of paste for each ulcer in the
mouth. In the
clinical studies up to three ulcers were treated, equating to a
maximum daily dose of
36 mg. Use of the medicinal product should be continued up to a
maximum of
seven days treatment.
CHILDREN AND ADOLESCENTS (<18 YEARS) AND THE ELDERLY
Aphtheal 5% oromucosal is not recommended for use in children below 18
years or
in the elderly due to a lack of data on safety and efficacy (see
sections 5.1 and 5.2).
i.e. no specific studies have been conducted in these patient groups.
Health Products Regulatory Authority
08 February 2019
CRN008QPQ
Page 2 of 7
4.3 CONTRAINDICATIONS
Hypersensitivity to the active substances (amlexanox), or to any of
the excipients.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Caution should be taken when using Aphtheal 5% oromucosal paste in
patients with
renal or hepatic impairment as no specific studies have been conducted
in these
patient groups.
The hands should be washed immediately after applying the paste. In
case of
contact with t