Servier Laboratories Ireland Ltd

Locabiotal 500 micrograms per metered dose, Nasal/Oromucosal spray solution

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.

Nasal/Oromucosal spray solution.

The solution is oily, colourless to pale yellow, clear, with a characteristic odour.

In the treatment of local infections of the nasal passages and oropharynx due to micro-organisms sensitive to this anti-infective.

Adults: 1 actuation by mouth and (or) 1 actuation in each nostril every 4 hours.

Children over 30 months: 1 actuation by mouth and (or) 1 actuation in each nostril every 6 hours.

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 at length on the adapter while inhaling as for normal breathing.

Use the same procedure for nasal administration, after fitting the nasal adapter (yellow) on the bottle.

Known hypersensitivity to fusafungine or its excipients.

Children under 30 months (risk of laryngospasm).

Use with caution in patients with allergic tendencies and bronchospasm (see section 4.8)

Prolonged use of an anti-infective may result in the development of superinfection due to organisms resistant to the anti-infective.

If symptoms and signs do not improve in one week, alternative therapy should be considered.

This medicinal product contains small amounts of ethanol (alcohol), less than 100 mg per dose.

There have been no documented reports of any interactions with fusafungine used topically.

No interaction studies have been performed.

For Locabiotal, no clinical data on exposed pregnancies are available. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development (see section 5.3). Caution should be exercised when prescribing to pregnant women.

It is unknown whether Fusafungine is excreted in human breast milk. The excretion of Fusafungine in milk has not been studied in animals. A decision on whether to continue/discontinue breast-feeding or to continue/discontinue therapy should be made taking into account the benefit of breast-feeding to the child and the benefit of therapy to the woman.

In the absence of data on the excretion of fusafungine into the milk the treatment is not recommended in breast-feeding women.

Fusafungine has no or negligible influence on the ability to drive or use machines.

The following adverse effects have been observed during treatment with Locabiotal and ranked under the following frequency :

Very common (1/10); common (1/100, <1/10) ; uncommon (1/1000, <1/100); rare (1/10000, <1/1000); very rare (<1/10000); not known (cannot be estimated form the available data).

Allergic reactions are very rare but may occur, particularly in patients with allergic tendencies.

The most commonly reported undesirable effects are local reactions at the site of application.

General disorders and administration site condition:

Common or very common: dryness of the nose or throat, pricking, sneezing, coughing, nausea, unpleasant taste in the mouth, eyes congestion.

These do not usually necessitate discontinuation of treatment.

Immune system disorders:

Very rare: anaphylactic shock.

Respiratory, thoracic and mediastinal disorders:

Very rare: asthma, bronchospasm, dyspnoea, laryngeal spasm or oedema.

Skin and subcutaneous tissue disorders:

Very rare: rash, pruritus, urticaria, Quincke's oedema.

In case of allergic reaction, fusafungine should not be readministered.

Due to the risk of anaphylactic shock, in case of respiratory, laryngeal or cutaneous (pruritus, generalised erythema) signs, an intramuscular injection of adrenaline (epinephrine) may be necessary urgently.

The adrenaline usual dose is 0.01 mg/kg by intramuscular route. The dose may be repeated after 15 to 20 minutes if needed.

Please consult local treatment guidelines/protocols for anaphylaxis treatment.

There are no reports of any overdosage and the management should be symptomatic and supportive.

Fusafungine is a topical antibiotic produced by Fusanium Luteritium strain 347, with anti-inflammatory properties. It is bacteriostatic.

Topical use. No systemic absorption of fusafungine has been shown.

Not applicable

Flavour composition 14869 (contains propylene glycol [E1520])

Ethanol, anhydrous

Saccharin

Isopropyl myristate

Not applicable.

2 years.

Do not store above 25°C.

15 ml type III glass bottle (plasticised with PVC) sealed with a plastic metered dose pump, containing 2.5 ml solution corresponding to approximately 50 metered doses.

No special requirements.

Servier Laboratories Ireland Ltd.

First Floor, Block Two,

West Pier Business Campus,

Old Dunleary Rd.,

Dun Laoghaire,

County Dublin.

PA 68/4/1

Date of first authorisation: 01 April 1977

Date of last renewal: 01 April 2007

July 2011