Benzydamine Hydrochloride 0.15% w/v Oromucosal Spray

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

BENZYDAMINE HYDROCHLORIDE

Available from:

ABDI FARMA Unipessoal Lda.

ATC code:

R02AX; R02AX03

INN (International Name):

BENZYDAMINE HYDROCHLORIDE

Dosage:

0.15 percent weight/volume

Pharmaceutical form:

Oromucosal spray, solution

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Other throat preparations; Benzydamine

Authorization status:

Not marketed

Authorization date:

2018-02-09

Patient Information leaflet

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PACKAGE LEAFLET: INFORMATION FOR THE USER
BENZYDAMINE HYDROCHLORIDE 0.15 % W/V OROMUCOSAL SPRAY
Benzydamine hydrochloride
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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 with 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 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 Benzydamine Hydrochloride 0.15% w/v Oromucosal Spray is and what
it is used for
2.
What you need to know before you use Benzydamine Hydrochloride 0.15%
w/v Oromucosal
Spray
3.
How to use Benzydamine Hydrochloride 0.15% w/v Oromucosal Spray
4.
Possible side effects
5.
How to store Benzydamine Hydrochloride 0.15% w/v Oromucosal Spray
6.
Contents of the pack and other information
1.
WHAT BENZYDAMINE HYDROCHLORIDE 0.15% W/V OROMUCOSAL SPRAY IS AND WHAT
IT IS USED FOR
Benzydamine Hydrochloride 0.15% w/v Oromucosal Spray contains the
active substance benzydamine
hydrochloride, which belongs to a group of medicines called
non-steroidal anti-inflammatory drugs or
NSAIDS.
Benzydamine Hydrochloride 0.15% w/v Oromucosal Spray 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
-
Sore tongue or gums
-
Discomfort associated with dentures or dental work.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE BENZYDAMINE HYDROCHLORIDE 0.15%
W/V
OROMUCOSAL SPRAY
DO NOT USE BENZYDAMINE HYDROCHLORIDE 0.15% W/V OROMUCOSAL SPRAY IF:
-
You are allergic to benzydamine hydrochloride
-
You are all

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Benzydamine Hydrochloride 0.15% w/v Oromucosal Spray
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each metered dose pump spray delivers Benzydamine hydrochloride 0.15 %
w/v,
approximately 180 microlitres per
puff.
Excipient(s) with known effect: methyl parahydroxybenzoate, 1.000
mg/ml and ethanol, 81.0008 mg/ml. Each puff
(0.18 ml) of the spray delivers 0.18 milligrams of methyl
parahydroxybenzoate and 14.58 milligrams of ethanol 96%.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Oromucosal spray, solution
Colorless and clear solution with mint odor.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Benzydamine Hydrochloride 0.15 % w/v Oromucosal
Spray is
a locally acting analgesic and anti-inflammatory
treatment for the throat and mouth.
It
is used to treat
various painful
oropharyngeal
conditions such as mouth ulcers,
sore throat,
sore mouth or gums,
dental pain.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Adults adolescents and elderly : 4 - 8 puffs every 1.5 – 3 hourly.
Children (6 - 12): 4 puffs every 1.5 – 3 hourly.
Children under 6: One puff to be administered per 4 kg of body weight,
up to a maximum of 4 puffs, 1.5 – 3 hourly.
Elderly: Because of the small amount of drug applied, elderly patients
can receive the same dose as adults.
Method of administration
Prior to use, the pump should be actuated a maximum of 5 times to
release an even spray mist. After not having used
the spray for a longer time,
the pump should be actuated once before applying the product again.
For application the
spray bottle should be used in an upright position with the nozzle
targeted at the affected area whilst pushing down the
pump head completely.
Uninterrupted treatment should not exceed seven days, except under
medical supervision.
4.3 CONTRAINDICATIONS
Benzydamine Hydrochloride 0.15 % w/v Oromucosal Spray is
contra-indicated in patients with known hypersensitivity
to the active substance benzydamine hydrochloride or to a