Difflam Spray, 0.15% w/v, Oromucosal Spray

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

BENZYDAMINE HYDROCHLORIDE

Available from:

Mylan IRE Healthcare Limited

ATC code:

A01AD; A01AD02

INN (International Name):

BENZYDAMINE HYDROCHLORIDE

Dosage:

0.15 percent weight/volume

Pharmaceutical form:

Oromucosal spray

Prescription type:

Product not subject to medical prescription

Therapeutic area:

Other agents for local oral treatment; benzydamine

Authorization status:

Marketed

Authorization date:

2008-06-20

Patient Information leaflet

PACKAGE LEAFLET
PACKAGE LEAFLET: INFORMATION FOR THE USER
DIFFLAM
SPRAY 0.15% W/V,
OROMUCOSAL SPRAY
benzydamine hydrochloride
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 or pharmacist has told
you.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm
them, even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet.
-
You must talk to a doctor if you do not feel better or if you feel
worse.
The name of your medicine is Difflam spray 0.15% w/v, oromucosal
spray, which will be called
Difflam spray throughout this leaflet.
WHAT IS IN THIS LEAFLET:
1.
What Difflam spray is and what it is used for
2.
What you need to know before you use Difflam spray
3.
How to use Difflam spray
4.
Possible side effects
5.
How to store Difflam spray
6.
Contents of the pack and other information
1.
WHAT DIFFLAM SPRAY IS AND WHAT IT IS USED FOR
Difflam spray contains the active ingredient benzydamine, which
belongs to a group of medicines
called local analgesics and anti-inflammatories. Difflam spray is used
along with other treatments to
relieve painful inflammatory conditions of the mouth and throat.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE DIFFLAM SPRAY
DO NOT USE DIFFLAM SPRAY:
-
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 OR PRECAUTIONS
Talk to your doctor or pharmacist before using Difflam spray. Try not
to get Difflam spray in your
eyes. If you do, wash them thoroughly with clean water. Stop using if
the cond

Summary of Product characteristics

Health Products Regulatory Authority
19 March 2021
CRN009Z15
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Difflam Spray, 0.15% w/v, Oromucosal Spray
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each puff (175 microlitres) contains 262. 5 micrograms of benzydamine
hydrochloride (0.15% w/v).
Excipients: Each puff contains 0.17 mg of Methyl parahydroxybenzoate
(E218), 14 mg of Ethanol and mint flavour (see section
4.4 for details).
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Oromucosal spray.
Difflam Spray is a metered dose pump oromucosal spray solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
As an adjunct in the symptomatic relief of painful inflammatory
conditions of the throat and mouth.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
FOR OROMUCOSAL ADMINISTRATION.
ADULTS AND ELDERLY: 4 to 8 puffs, 1½-3 hourly.
CHILDREN (6-12):4 puffs, 1½-3 hourly.
CHILDREN UNDER 6: One puff to be administered per 4 kg body weight, up
to a maximum of 4 puffs, 1½-3 hourly.
Because of the small amount of drug applied, elderly patients can
receive the same dose as adults.
The spray should be directed onto the affected area. Uninterrupted
treatment should not exceed seven days, except under
medical supervision.
4.3 CONTRAINDICATIONS
Use in patient with a known hypersensitivity (eg bronchospasm,
rhinitis, urticaria) to this product.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Avoid contact with the eyes.
If the condition is aggravated or not improved use should cease.
This medicinal product contains:

14 mg of alcohol (ethanol) in each puff. The small amount of alcohol
in this medicine will not have any noticeable
effects.
Health Products Regulatory Authority
19 March 2021
CRN009Z15
Page 2 of 4

less than 1 mmol sodium (23 mg) per dose of 8 puffs, that is to say
essentially 'sodium-free'.

methyl parahydroxybenzoate (E218) which may cause allergic reactions
(possibly delayed)

mint flavour with benzyl alcohol, cinnamyl alcohol, citral,
citronellol, eugeno