Patient leaflet - Chloralieve Blackcurrant Flavour 2 mg / 0.6 mg / 1.2 mg lozenges
1. What Chloralieve™ is and what it is used for
Chloralieve Blackcurrant Flavour lozenges (referred to as Chloralieve in this leaflet) contains amylmetacresol and 2,4-dichlorobenzyl alcohol - both antiseptics, and lidocaine hydrochloride - a local anaesthetic for the throat. Chloralieve is indicated for the local relief of symptoms of sore throat in adults and adolescents over 12 years of age.
You must talk to a doctor if you do not feel better or if you feel worse after 2 days.
2. What you need to know before you take Chloralieve™.
Do not take Chloralieve:
if you are allergic to lidocaine hydrochloride or other amide-type local anaesthetic drugs, amylmetacresol, 2,4-dichlorobenzyl alcohol or any of the other ingredients of this medicine (listed in section 6).
- Children under 12 years old should not take this medicine.
- If you have a history of allergy to local anaesthetics such as lidocaine, bupivacaine, and ropivacaine.
- If you have a history of or are suspected to have a blood condition called methaemoglobinaemia.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking Chloralieve. You should inform your doctor if:
- You suffer from asthma or narrowing of the airways (bronchospasm).
- Your symptoms do not improve after two days or if you have a fever, headaches, nausea, vomiting or skin rash.
This product may be harmful for the teeth.
- The anesthetic contained in this medicine may cause aspiration (coughing during meals or a choking sensation) while eating. Do not take food directly following the use of this medicine.
- This medicine 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.
- Prolonged use of this medicine (more than 5 days) is not recommended, as it may alter the natural microbial balance of the throat.
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recommended dose, this medicine should not affect your reactions or cause drowsiness. However, if you observe either of these effects, avoid driving or operating heavy machinery.
Chloralieve contains glucose, sucrose, cochineal red and black PN.
Chloralieve contains sucrose and glucose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Chloralieve contains 1.016 g of glucose per lozenge. This should be taken into account in patients with diabetes mellitus.
Chloralieve contains 1.495 g of sucrose per lozenge. This should be taken into account in patients with diabetes mellitus.
Cochineal red Colourant and black PN colourant may cause allergic reactions.
3. How to take Chloralieve™
Follow the instructions contained in this leaflet. Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
The lowest efficient dose should be used over the shortest duration to achieve a resolution of symptoms. The recommended doses are the following: Adults and adolescents over 12 years: dissolve one lozenge slowly in the mouth every 2 to 3 hours, up to a maximum of 8 lozenges over 24 hours (maximum of 4 lozenges for children). Do not dissolve in the sac of the cheek. Not recommended for children under 12 years. No adjustment of dosage is necessary in elderly patients. Use in children and adolescents
The medicine is not to be used in children under 12 years of age.
If you take more Chloralieve than you should
Events that may occur in the event of misuse or overdose: excessive anesthesia of the upper digestive and respiratory tract, insomnia, restlessness, excitement, respiratory depression. Shortness of breath, headache, fatigue, excercise intolerance, dizziness and loss of consciousness may also occur due to a disorder called Methemoglobinemia. Other serious side effects of lidocaine overdose include: low blood pressure, low heart rate or heart stopping, breathing stopping and starting or stopping completely, seizures, coma, cardiac arrest and deathSeek medical help immediately, or call the Toxicology Information Service specifying the medicine and the amount taken.
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse. Treatment:
Treatment should be symptomatic and supportive; medical supervision is advisable.
Methemoglobinemia (presence of methemoglobin in the blood) may be treated by immediate intravenous injection of methylene blue (1-4 mg/kg).
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. During the period of use, the following adverse reactions have been reported for the combination of active substances in this medicinal product:
You should stop taking Chloralieve and see your doctor immediately if you experience symptoms of angioedema, such as
- Hypersensitivity: Hypersensitivity to lidocaine may manifest itself as accumulation of fluid in the skin and/or mucous membranes accompanied by itching, itchy skin rash, bronchospasms, hypotension with syncope.
- swelling of the mouth and throat
- abdominal pain, nausea, oral discomfort, burning sensation of tingling in the mouth of the throat, disruption of the taste.
- skin rash
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet.
You can also report side effects directly via the national reporting system: Yellow Card Scheme, website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Chloralieve™
Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the carton after 'EXP'. The expiry date refers to the last day of that month.
Do not store above 30°C.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What Chloralieve contains
The active substances are:
Lidocaine hydrochloride 2.00 mg
Amylmetacresol 0.60 mg
2,4-dichlorobenzyl alcohol 1.20 mg
The other ingredients are:
Levomenthol, Sodium saccharin (E-954),
Sucrose, Liquid glucose, Black PN (E-151),
Cochineal red (E-124), Citric acid monohydrate (E-330), Blackcurrant flavour
What Chloralieve looks like and contents of the pack
Chloralieve Blackcurrant Flavour lozenges are purple biconvex, cylindrical, 19 mm diameter, blackcurrant flavoured lozenges.
PVC-PVDC/Aluminium blisters. 12 or 24 lozenges. Marketing Authorisation Holder:
Prestige Brands (UK) Ltd., 5-7 London Road, St. Albans, AL1 1LA UK.
Manufacturer:
Lozy's Pharmaceuticals S.L.,
31795 Lekaroz (Navarra), Spain.
This leaflet was last revised in March 2023
© Prestige Brands (UK) Limited 2022.
PL18259/0011
CDALBV1231122
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