Difflam Spray, 0.15% w/v, Oromucosal Spray

Страна: Ирландия

Език: английски

Източник: HPRA (Health Products Regulatory Authority)

Активна съставка:

BENZYDAMINE HYDROCHLORIDE

Предлага се от:

PCO Manufacturing Ltd.

АТС код:

A01AD; A01AD02

INN (Международно Name):

BENZYDAMINE HYDROCHLORIDE

дозиране:

0.15 percent weight/volume

Лекарствена форма:

Oromucosal spray

Вид предписание :

Product not subject to medical prescription

Терапевтична област:

Other agents for local oral treatment; benzydamine

Статус Оторизация:

Authorised

Дата Оторизация:

2017-03-01

Листовка

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
conditio

Данни за продукта

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 0.17mg of Methyl parahydroxybenzoate (E218) and 14mg of
Ethanol. For a full list of excipients, see
section 6.1.
3 PHARMACEUTICAL FORM
Oromucosal spray.
_Product imported from the UK:_
Difflam Spray is a metered dose pump oromucosal spray solution.
4 CLINICAL PARTICULARS
As per PA1332/017/003
5 PHARMACOLOGICAL PROPERTIES
As per PA1332/017/003
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Glycerol
Saccharin
Sodium bicarbonate
Ethanol
Methyl parahydroxybenzoate (E218)
Mouthwash flavour
Polysorbate 20
Purified Water
6.2 INCOMPATIBILITIES
Not applicable.
6.3 SHELF LIFE
The shelf-life expiry date of this product is the date shown on the
container and outer package of the product on the
market in the country of origin.
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Do not store above 30°C. Do not refrigerate or freeze. Store in the
original package.
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6.5 NATURE AND CONTENTS OF CONTAINER
Difflam spray is presented in a box containing a 30 ml plastic bottle
with a metering valve spray pump.
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL AND OTHE