Difflam Oral Rinse 0.15% w/v, gargle

Država: Malta

Jezik: angleščina

Source: Medicines Authority

Aktivna sestavina:

BENZYDAMINE HYDROCHLORIDE

Dostopno od:

Mylan IRE Healthcare Limited Unit 35/36, Grange Parade, Baldoyle Industrial Estate, Dublin 13, Ireland

Koda artikla:

M01AX07

INN (mednarodno ime):

BENZYDAMINE HYDROCHLORIDE 0.15 % (W/V)

Farmacevtska oblika:

GARGLE MOUTH WASH

Sestava:

BENZYDAMINE HYDROCHLORIDE 0.15 % (W/V)

Tip zastaranja:

OTC

Terapevtsko območje:

ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS

Status dovoljenje:

Authorised

Datum dovoljenje:

2006-03-29

Navodilo za uporabo

PACKAGE LEAFLET
PACKAGE LEAFLET: INFORMATION FOR THE USER
DIFFLAM ORAL RINSE 0.15% W/V, GARGLE
benzydamine hydrochloride
Read all of this leaflet carefully before you start taking this
medicine because it contains important
information for you.
Always take this medicine exactly as described in this leaflet or as
your doctor or pharmacist has told
you.
-
Keep this leaflet. You may need to read it again.
-
Ask your pharmacist if you need more information or advice.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
-
You must talk to a doctor if you do not feel better or if you feel
worse.
The name of your medicine is Difflam Oral Rinse 0.15% w/v gargle,
which will be called Difflam
rinse throughout this leaflet.
WHAT IS IN THIS LEAFLET:
1.
What Difflam rinse is and what it is used for
2.
What you need to know before you use Difflam rinse
3.
How to use Difflam rinse
4.
Possible side effects
5.
How to store Difflam rinse
6.
Contents of the pack and other information
1.
WHAT DIFFLAM RINSE IS AND WHAT IT IS USED FOR
Difflam rinse contains the active ingredient benzydamine, which
belongs to a group of medicines
called local analgesics and anti-inflammatories. Difflam rinse is used
to relieve painful inflammatory
conditions of the mouth and throat including:
-
Pharyngitis (sore throat) caused by removal of the tonsils or use of
naso-gastric tube (feeding
tube).
-
Pharyngitis, and mouth ulcers caused by radiation therapy
-
After dental operations.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE DIFFLAM RINSE
DO NOT USE DIFFLAM RINSE:
-
If you are allergic to benzydamine or any of the other ingredients of
this medicine (listed in
section 6). An allergic reaction may include rash, itching, difficulty
breathing or swelling of
the face, lips, throat or tongue.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before using Difflam rinse. Try not
to get Difflam rinse in your
eyes. If you do, rinse thoroughly with clean water.
Tak

Lastnosti izdelka

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Difflam Oral Rinse 0.15% w/v, gargle
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 15ml contains 22.5mg
_ _
benzydamine hydrochloride equivalent to 0.15% w/v
Excipients: Each 15ml dose contains 15mg of methyl parahydroxybenzoate
(E218), 1126 mg of
ethanol, mint flavour (contains allergens including 2 mg benzyl
alcohol) and <1mmol of sodium.
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Gargle.
Clear, green solution with pleasant taste.
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.
Benzydamine exerts an anti-inflammatory and analgesic action by
stabilising the cellular membrane
and inhibiting prostaglandin synthesis.
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
Rinse or gargle with 15 ml (approximately 1 tablespoonful) every 1.5
to 3 hours as required for pain
relief.
Not suitable for children aged 12 years or under.
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.
ELDERLY: No special dosage recommendations are made for elderly
patients.
4.3.
CONTRAINDICATIONS
Use in patients with a known hypersensitivity to the active
ingredient, benzydamine hydrochloride, or
to any of the other ingredients.
4.4.
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Avoid contact with eyes.
Difflam Oral rinse is for oromucosal use only and should not be
swallowed.
This product contains 1126 mg of alcohol (ethanol) in each 15 ml dose.
The