LOCABIOTAL 500 MICROGRAMS PER METERED DOSE, NASAL/ 500 Microgram Unknown
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Patient Information leaflet
(PIL)
24-04-2024
Summary of Product characteristics
(SPC)
24-04-2024
Active ingredient:
FUSAFUNGINE
Available from:
Servier Laboratories (Ireland) Ltd
INN (International Name):
FUSAFUNGINE
Dosage:
500 Microgram
Pharmaceutical form:
Unknown
Prescription type:
Product subject to prescription which may not be renewed (A)
Authorization status:
Authorised
Authorization date:
0000-00-00
Patient Information leaflet
_LOCABIOTAL_
_®_
_ _
_ _
_PA68/4/1 _
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
LOCABIOTAL 500 MICROGRAMS PER METERED DOSE
Nasal/Oromucosal spray solution
Fusafungine
READ ALL OF THIS LEAFLET CAREFULLY BEFORE
YOU START TAKING THIS MEDICINE
BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again
-
If you have further questions,
please ask your doctor, or pharmacist or nurse
-
This medicine has been prescribed for you. 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 or nurse. This includes any
possible side effects not listed in this leaflet. See
section 4.
_ _
WHAT IS IN THIS LEAFLET
1. What LOCABIOTAL
is and what it is used for
2.
What you need to know b
efore you take LOCABIOTAL
3. How to use LOCABIOTAL
4. Possible side effects
5. How to store LOCABIOTAL
6.
Contents of the pack and
further information
1. WHAT LOCABIOTAL IS AND WHAT IT IS USED FOR
LOCABIOTAL
is a local
antibiotic with anti-inflammatory properties for treatment of local infections and
inflammatory conditions of the nose and throat.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE LOCABIOTAL
DO NOT USE LOCABIOTAL:
-
If you are allergic (sensitive) to the active
substance fusafungine or any of the other ingredients of
LOCABIOTAL
(listed in section 6)
.
-
the treatment is not recommended in children under 30
months (risk of laryngospasm).
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist or nurse before using LOCABIOTAL.
This medicine should be used with caution:
-
If you use LOCABIOTAL for a long period of time,
it may cause superinfection. If
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Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Locabiotal 500 micrograms per metered dose, Nasal/Oromucosal spray solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Fusafungine 1% w/v
Each metered dose delivers approximately 500 micrograms of fusafungine.
Excipients: trace amounts of ethanol (alcohol) and propylene glycol (E1520).
For full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Nasal/Oromucosal spray solution.
The solution is oily, colourless to pale yellow, clear, with a characteristic odour.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
In the treatment of local infections of the nasal passages and oropharynx due to micro-organisms sensitive to this anti-
infective.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Adults: 1 spray actuation by mouth and (or) 1 spray actuation in each nostril every 4 hours.
Special populations
_Elderly population_
There is no dose adjustment necessary for
elderly patients
_Renal impairment_
There is no dose adjustment necessary for patients suffering from renal impairment
_Hepatic impairment_
There is no dose adjustment necessary for patients suffering from hepatic impairment
Paediatric population
LOCABIOTAL should not be used in children aged 0 to 30 months because of safety concerns (see section 4.3).
Children over 30 months: 1 spray actuation by mouth and (or) 1 spray actuation in each nostril every 6 hours.
Method of administration
Via the mouth and the nose using the appropriate attachment.
Before the very first use, press 5 times on the main adapter so as to prime the pump. The bottle must be held upright
between the thumb and index finger with the adapter uppermost.
To administer the drug, place the mouth adapter (white) in the mouth, closing the lips around it. Then press firmly and
IRISH M
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