Amylmetacresol

Relief of symptoms of sore throat in adults and adolescents over 12 years of age.

Posology Adults and children over 12 years of age: 1 lozenge every 2-3 hours, and when necessary, up to a maximum of 8 lozenges in a 24-hour period (maximum of 4 lozenges for children).

Paediatric population:

The medicine is not to be used in children under 12 years of age. Method of administration For oromucosal use. Slowly dissolve the lozenge in the mouth, do not dissolve in the sac of the cheek. Do not take this medicine before meals or drinking.

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Elderly:

Adjustment of the dose is not required.

Patients with impaired renal and/or liver function:

There are no data available for use of Chloralieve Honey & Lemon Flavour lozenges in patients with hepatic or renal impairment.

During the period of use, the following adverse reactions have been reported for the combination of active substances in this medicinal product. During treatment of chronic conditions and with long-term use additional side effects may occur.

The adverse reactions associated with the combination of active substances in this medicinal product are described below by system organ class and ranked according to frequency: very common (≥ 1/10), common (≥ 1/100, < 1/10), uncommon (≥ 1/1,000, < 1/100), rare (≥1/10,000, < 1/1,000), very rare (< 1/10,000), not known (cannot be estimated from the available data) System Organ Class Frequency Adverse events Immune system disorders Rare Hypersensitivity reactions1 (burning, itching), angioedema, urticaria, bronchospasm, hypotension, stinging of the throat and unpleasant taste Respiratory, thoracic and mediastinal disorders Not known Pharyngeal edema Gastrointestinal disorders Not known Nausea, oral discomfort, swelling of the mouth, dysgeusia.

Skin and subcutaneous tissue disorders Not known Rash Description of Selected Adverse Reactions 1 Hypersensitivity reactions to lidocaine may present in the form of angioedema, urticaria, bronchospasms and hypotension with syncope.

Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

− Do not use Chloralieve Honey & Lemon Flavour Lozenges in children under 12 years of age due to the risk of rapid absorption of the anaesthetic and the risk of reflex laryngospasm. 1 − A history of allergy to local anaesthetics of the amide type.

− In patients who have a history of or are suspected to have methaemoglobinaemia.