Orosoothe 0.15% w/v Oromucosal Spray

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

BENZYDAMINE HYDROCHLORIDE

Available from:

Phoenix Labs

ATC code:

A01AD02

INN (International Name):

BENZYDAMINE HYDROCHLORIDE

Dosage:

0.15 percent weight/volume

Pharmaceutical form:

Oromucosal spray

Therapeutic area:

benzydamine

Authorization date:

2019-03-22

Patient Information leaflet

Package leaflet: Information for the user
OROSOOTHE 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.
This medicine is available without prescription. However, you still
need to use it carefully to get the
best results from it. Always use this medicine exactly as described in
this leaflet or as your doctor or
pharmacist have told you.
•
Keep this leaflet. You may need to read it again.
•
Ask your pharmacist or doctor 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 or pharmacist if you do not feel better or
your symptoms worsen
after 7 days.
WHAT IS IN THIS LEAFLET:
1.
What Orosoothe Spray is and what it is used for
2.
What you need to know before you use Orosoothe Spray
3.
How to use Orosoothe Spray
4.
Possible side effects
5.
How to store Orosoothe Spray
6.
Contents of the pack and other information
1.
WHAT BENZYDAMINE IS AND WHAT IT IS USED FOR
Orosoothe Spray belongs to a group of medicines called non-steroidal
anti-inflammatory drugs or
NSAIDS.
Orosoothe Spray works by stopping pain and swelling (inflammation). It
is used to treat painful
conditions affecting the throat or mouth including:
•
Sore throat
•
Sore tongue or gums
•
Mouth ulcers
•
Discomfort caused by dentures or after dental work
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE OROSOOTHE SPRAY
DO NOT USE OROSOOTHE SPRAY
•
If you are allergic to benzydamine or any of the other ingredients of
this medicine (listed in
section 6).
TAKE SPECIAL CARE WITH OROSOOTHE SPRAY
Talk to your doctor or pharmacist before using Orosoothe Spray:
•
If you have a history of Asthma.
•
If you are allergic to acetylsalicylic acid or to other
anti-inflammatory painkillers called
NSAIDs.
IMPORTANT INFORMATION ABOUT SOME OF THE INGREDIENTS OF OROSOOTHE SPRAY
•
Orosoot

Summary of Product characteristics

Health Products Regulatory Authority
19 December 2023
CRN00DXTN
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Orosoothe 0.15% w/v Oromucosal Spray
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml of the solution contains 1.5mg of benzydamine hydrochloride. Each
puff (0.17 ml) contains 255 micrograms of
benzydamine hydrochloride (0.15% w/v).
Excipient(s) with known effect:
Contain methyl parahydroxybenzoate and ethanol. For a full list of
excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Oromucosal spray. A metered dose pump 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 7 days, except under medical
supervision.
4.3 CONTRAINDICATIONS
Hypersensitivity to benzydamine hydrochloride or any of the excipients
listed in section 6.1.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Avoid contact with the eyes.
Hypersensitivity reaction can occur with local use of medicinal
products, especially in prolonged exposure. If an allergic
reaction occurs, the drug should be discontinued and appropriate
therapy should be instituted.
Benzydamine use is not advisable in patients with hypersensitivity to
acetylsalicylic acid or other NSAIDs.
Bronchospasm may be precipitated in patients suffering from or with a
previous history of bronchial asthma. Caution should be
exercised in these patients.
Excipient Warnings:
Methyl parahydroxybenzoate may cause allergic reactions (possibly
delayed).
Health Products Regulatory Authority
19 Dece