Difflam Oral Rinse

Pays: Malte

Langue: anglais

Source: Medicines Authority

Ingrédients actifs:

BENZYDAMINE HYDROCHLORIDE

Disponible depuis:

Meda Pharmaceuticals Limited

Code ATC:

A01AD02

DCI (Dénomination commune internationale):

BENZYDAMINE HYDROCHLORIDE

forme pharmaceutique:

OROMUCOSAL SOLUTION

Composition:

BENZYDAMINE HYDROCHLORIDE 0.15 % (W/V)

Type d'ordonnance:

OTC

Domaine thérapeutique:

STOMATOLOGICAL PREPARATIONS

Statut de autorisation:

Authorised

Date de l'autorisation:

2006-03-29

Notice patient

Read all of this leaflet carefully before you
start taking this medicine because it contains
important information for you.
Always use this medicine exactly as
described in
this leaflet or as your doctor, pharmacist or nurse
have told you.
•
This medicine is available without
prescription. However, you still need to use
it carefully to get the best results.
•
Keep this leaflet. You may need to read it
again.
•
Ask your doctor, dentist or pharmacist if
you need more information or advice.
•
You must contact a doctor if your symptoms
worsen or do not improve.
•
If you get any side effects, talk to your doctor,
pharmacist or nurse. This includes any
possible side effects not listed in this leaflet.
See section 4.
What is in this leaflet:
1.
What Difflam Oral Rinse is and what it is
used for
2.
What you need to know before you use
Difflam Oral Rinse
3.
How to use Difflam Oral Rinse
4. Possible side effects
5.
How to store Difflam Oral Rinse
6. Contents of the pack and other information.
1. What Difflam Oral Rinse is and what
it is used for
Difflam Oral Rinse contains the active substance
benzydamine hydrochloride and belongs to
a group of medicines called non-steroidal
anti-inflammatory drugs or NSAIDS.
Difflam Oral Rinse works by stopping pain
and
swelling (inflammation). It is used to treat
many painful conditions of the mouth or throat
including:
•
Mouth ulcers
•
Sore throat
•
Discomfort associated with dentures or
dental work.
2. What you need to know before you use
Difflam Oral Rinse
Do not use Difflam Oral Rinse if
•
you are allergic to benzydamine hydro
chloride
•
you are allergic to any of the other ingredients
of Difflam Oral Rinse (see section 6).
Warnings and precautions
Talk to your doctor, pharmacist or nurse before
using Difflam Oral Rinse:
•
If you have a history of asthma
•
If you are allergic to acetylsalicylic acid or
other non-steroidal anti-inflammatory
(NSAID) drugs
If any of these apply to you, talk to your doctor,
dentist or pharmacist.
Other medicines and Difflam Oral R

Résumé des caractéristiques du produit

1
NAME OF THE MEDICINAL PRODUCT
Difflam 0.15%w/v Oral Rinse
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
A pleasant tasting, clear, green solution, containing benzydamine
hydrochloride 0.15% w/v.
Contains methyl parahydroxybenzoate and Ethanol
For a full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Liquid for use as mouthwash/gargle.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Difflam Oral Rinse is a locally acting analgesic and anti-inflammatory
treatment for the relief of
painful inflammatory conditions of the mouth and throat including:
Traumatic conditions: Pharyngitis following tonsillectomy or the use
of a naso-gastric tube.
Inflammatory conditions: Pharyngitis, aphthous ulcers and oral
ulceration due to radiation therapy.
Dentistry: For use after dental operations.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults:_
Rinse or gargle with 15 ml (approximately 1 tablespoonful) every 1
½
to 3 hours as
required for pain relief.
_Children:_
Not suitable for children aged 12 years or under.
_Elderly:_
No special dosage recommendations are made for elderly patients.
Method of administration
Rinse or gargle.
The solution should be expelled from the mouth after use.
Difflam Oral Rinse should generally be used undiluted, but if
‘stinging’ occurs the rinse may be
diluted with water.
Uninterrupted treatment should not exceed seven days, except under
medical supervision
4.3
CONTRAINDICATIONS
Difflam Oral Rinse is contra-indicated in patients with known
hypersensitivity to the active
substance benzydamine hydrocholoride or to any of the excipients
listed in section 6.1.
Page
1
of
5
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Benzydamine use is not advisible in patients with hypersensitivity to
acetylsalicylic acid or
other NSAIDs.
Difflam Oral Rinse should generally be used undiluted, but if
‘stinging’ occurs the rinse may be
diluted with water.
Avoid contact with eyes.
This medicinal product contains 10 vol % ethanol.
Methyl hydroxybenzoate may cause allergic reactions (possibly del