LOCABIOTAL 125 Microgram Nasal Spray Solution
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Patient Information leaflet
(PIL)
19-04-2024
Summary of Product characteristics
(SPC)
19-04-2024
Active ingredient:
FUSAFUNGINE
Available from:
Servier Laboratories (Ireland) Ltd
INN (International Name):
FUSAFUNGINE
Dosage:
125 Microgram
Pharmaceutical form:
Nasal Spray Solution
Prescription type:
Product subject to prescription which may not be renewed (A)
Authorization status:
Withdrawn
Authorization date:
2014-09-24
Patient Information leaflet
_LOCABIOTAL_
_®_
_ _
_ _
_PA 68/15/1 _
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
LOCABIOTAL
PRESSURISED 125 MICROGRAMS
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 before 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 your condition does
n
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Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Locabiotal Pressurised 125 micrograms, Nasal/Oromucosal spray solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each puff (delivered dose, ex actuator) contains 125micrograms of fusafungine.
The concentration of the solution is 500mg of fusafungine for 100ml.
For full list of excipients, see 6.1.
3 PHARMACEUTICAL FORM
Nasal/Oromucosal spray solution .
Yellow solution 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
4 puffs in the mouth and 2 puffs in each nostril 4 times daily.
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 : 2 puffs in the mouth and (or) 1 puff in each nostril 4 times daily.
Method of administration
Via the mouth and the nose using the appropriate attachment.
Before the very first use, press 4 times on the main actuator so as to prime the valve. The bottle must be held upright
between the thumb and index finger with the actuator uppermost. To administer the drug, place the mouth adaptor
(white) in the mouth, closing the lips around it. Then press firmly and at length on the adaptor while breathing
normally. Use the same procedure for nasal administration, after f
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