CHLORALIEVE MINT FLAVOUR

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 Mint 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.

If symptoms do not improve or become worse after 2 days, contact a doctor or pharmacist. Follow the indicated dosage: when taken in large amounts or repeatedly, this medicine may impact the nervous system as it passes through the bloodstream, possibly causing convulsions or affecting the heart.

The prolonged use of this medicine for more than 5 days is not recommended, as it may alter the natural microbial balance of the throat. If symptoms persist for longer than 2 days, get worsen or if other symptoms appear, such as high fever, headache, nausea or vomiting, and skin rash, the clinical condition should be evaluated for bacterial infections (angina, tonsillitis).

It should be administered with caution in acutely ill or frail elderly patients, as they are more sensitive to adverse reactions to this medicinal product. In susceptible patients, due to the local anaesthetic effect, the risk of choking may increase, or the sensitivity of the mouth or throat may temporarily be modified.

This medicine should not be used in the area of mouth and throat if greater acute wounds exist. The anaesthesia of the throat caused by this medicinal product may lead to pulmonary aspiration (coughing while eating, giving the impression that the person is choking).

It is therefore imperative not to take this medicine before meals or drinking. 016 g of glucose per lozenge, which should be considered when treating patients with glucose-galactose malabsorption and patients with diabetes mellitus.

Chloralieve Mint Flavour lozenges contains sucrose. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase- isomaltase insufficiency should not take this medicine. 495 g of sucrose per lozenge, which should be considered when treating patients with glucose-galactose malabsorption and patients with diabetes mellitus.

Chloralieve Mint Flavour lozenges contains terpenes found in levomenthol. Excessive doses of terpenes have been associated with neurological complications such as convulsions in children. Chloralieve Mint Flavour lozenges may cause numbness of the tongue and may increase the danger of biting trauma.

− Do not use Chloralieve Mint 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.