ULTRA CHLORASEPTIC ANAESTHETIC THROAT SPRAY 0.71% Oromucosal Spray Ref.[2548] Active ingredients: Benzocaine

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2010  Publisher: Prestige Brands (UK) Limited, Beechwood, 3 Scotlands Drive, Farnham Common, Slough, Berkshire, SL2 3ES, United Kingdom

Contraindications

  • Children under 6 years.
  • Epiglottitis
  • Known hypersensitivity to benzocaine or any of the other ingredients.
  • Methaemoglobinaemia.

Special warnings and precautions for use

Do not administer to children under 6 years.

Do not use for more than 3 consecutive days.

Do not spray into eyes.

If sore throat is severe or persistent, or accompanied by fever, headache or nausea consult your doctor.

You should experience temporary numbness in your throat after using the spray. This indicates that the product is working. Avoid eating or drinking as long as the numbness lasts.

Labelling will include the following information:

Do not use if you have any difficulty in breathing, noisy breathing or severe difficulty in swallowing.

Do not use if you have been told that you have a rare blood condition called methaemoglobinaemia.

Contains propylene glycol which may cause skin irritation.

Interaction with other medicinal products and other forms of interaction

None known.

Pregnancy and lactation

Animal studies are insufficient with respect to effects on pregnancy and lactation. The potential risk for humans is unknown. Therefore Ultra Chloraseptic spray is not recommended during pregnancy or breast-feeding.

Effects on ability to drive and use machines

None expected.

Undesirable effects

Allergic reactions have been reported very occasionally with benzocaine. There have been occasional reports of temporary breathing difficulty, face or mouth swelling.

Methaemoglobinaemia has been reported with benzocaine use.

Incompatibilities

None known.

No data held.

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