When a pharmaceutical company changes an SPC or PIL, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.
Prolonged use of an anti-infective may result in the development of superinfection due to organisms resistant to the anti-infective.
Use with caution in patients with allergic tendencies and bronchospasm (see section 4.8)
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. 4.5 Interactions with other medicinal products and other forms of interaction
4.5 Interactions with other medicinal products and other forms of interaction
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.
In the absence of data on the excretion of fusafungine into the milk, the treatment is not recommended in breast-feeding women.
4.6. Fertility, pregnancy and lactation
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.
4.7. Effects on ability to drive and use machines
There is no evidence of any adverse effect on mental alertness.
Fusafungine has no or negligible influence on the ability to drive or use machines.
4.8. Undesirable effects 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), including isolated reports. 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. Administration site reactions (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. Allergic conditions (very rare): - immune system disorders: anaphylactic shock; - respiratory disorders: asthma, bronchospasm, dyspnoea, laryngeal spasm or oedema; - skin and subcutaneous disorders: 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.
4.8. Undesirable effects
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), including isolated reports.
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.
Administration site reactions (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.
Allergic conditions (very rare):
- immune system disorders: anaphylactic shock;
- respiratory disorders: asthma, bronchospasm, dyspnoea, laryngeal spasm or oedema;
- skin and subcutaneous disorders: 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.
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).
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.
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.
6.1. List of excipients
Flavour composition 14869 (contains propylene glycol [E1520])
Ethanol
Saccharin
Isopropyl myristate
Ethanol, anhydrous
10. Date of Revision of the Text
March 2009 July 2011
July 2011
Section 4.3 – Contraindications
Addition of “Children under 30 months (risk of laryngospasm).
Section 4.6 - Pregnancy and Lactation.
Addition of "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. In the absence of data on the excretion of fusafungine into the milk, the treatment is not recommended in breast-feeding women."
Section 4.8 - Undesirable Effects
Addition of "The following adverse effects have been observed during treatment with Locabiotal and ranked under the following frequency :
Please consult local treatment guidelines/protocols for anaphylaxis treatment.”
Change to date of renewal