- Do not use Chloralieve Blackcurrant 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.
- Do not use if you have hypersensitivity to the active substances or to any of the excipients, or a history of allergy to local anaesthetics of the amide type.
- Do not use in patients who have a history of or are suspected to have methaemoglobinaemia.
- 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 (e.g., 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.
- Chloralieve Blackcurrant Flavour lozenges contains 1.016 g of glucose per lozenge and 1.495 g of sucrose per lozenge. This should be considered when treating patients with glucose-galactose malabsorption and patients with diabetes mellitus. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.
- Chloralieve Blackcurrant Flavour lozenges may cause numbness of the tongue and may increase the danger of biting trauma. Therefore care should be taken in eating and drinking hot foods. The patient should be aware that the production of topical anaesthesia may impair swallowing and thus enhance the danger of aspiration. For this reason, food should not be ingested directly following use of local anaesthetic preparations in the mouth or throat area.
- Cochineal Red Colourant and Black PN Colourant may cause allergic reactions.
Interaction with other medicinal products and other forms of interaction
While a number of interactions are theoretically possible with lidocaine, these drug interactions are unlikely to be clinically relevant to the safety of the patient as the product is administered topically. However, potential interactions include:
- Increased toxicity of orally administered lidocaine with concomitant administration of erythromycin, itraconazole, cimetidine, fluvoxamine, beta-blockers, and other antiarrhythmics (e.g., mexiletine).
- Beta-adrenergic blocking agents can reduce hepatic blood flow, slowing lidocaine metabolism and increasing toxicity risk.
- Cimetidine can inhibit the hepatic metabolism of lidocaine, increasing toxicity risk.
- Cross-sensitivity to other local anaesthetics of the amide type may occur.
- The isoenzymes CYP1A2 and CYP3A4 of the cytochrome P450 are involved in lidocaine metabolism; therefore, other medications such as fluvoxamine, erythromycin, and itraconazole may increase plasma concentrations of lidocaine.
- The simultaneous or successive use of other antiseptics is not advised due to possible interference (antagonism, deactivation).
Fertility, pregnancy and lactation
- Pregnancy: The safety of Chloralieve Blackcurrant Flavour lozenges in pregnancy has not been established. In the absence of documented experience, the use of Chloralieve Blackcurrant Flavour lozenges is not recommended during pregnancy.
- Breast-feeding: The safety of Chloralieve Blackcurrant Flavour lozenges during lactation has not been established. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Chloralieve Blackcurrant Flavour lozenges therapy, taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman.
- Fertility: There are no data on the effect of use of lidocaine, amylmetacresol and 2,4-Dichlorobenzyl Alcohol on male and female fertility.
Effects on ability to drive and use machines
This medicinal product has no or negligible influence on the ability to drive and use machines.
Undesirable effects (Adverse events)
During the period of use, the following adverse reactions have been reported:
- Rare: Hypersensitivity reactions (burning, itching), angioedema, urticaria, bronchospasm, hypotension, stinging of the throat and unpleasant taste.
- Not known frequency: Pharyngeal edema, nausea, oral discomfort, swelling of the mouth, dysgeusia, rash.
Report suspected adverse reactions after authorisation of the medicinal product via the Yellow Card Scheme, Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
Overdose
Given the low level of the active ingredients, overdose is unlikely. In case of abnormal use (much higher dosage, lesions of the mucous membranes), overdose may occur, manifesting initially as excessive anaesthesia of the upper respiratory and digestive tract. Systemic reactions due to lidocaine absorption can occur, with the most serious effects including central nervous system intoxication (insomnia, restlessness, excitement and respiratory depression) and cardiovascular system effects; methaemoglobinaemia may also occur. In the event of an overdose, induction of vomiting and/or gastric lavage (within one hour) may be considered for potentially serious intoxication. Additional measures are supportive and symptomatic.
