MEROCAINE
Active substance: CETYLPYRIDINIUM CHLORIDE
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SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Merocaine
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Cetylpyridinium chloride Benzocaine 1.4mg/lozenge. 10.0mg/lozenge.
Also contains sucrose, glucose liquid and sunset yellow. For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM Lozenge
4 4.1
CLINICAL PARTICULARS Therapeutic Indications Merocaine Lozenges provide rapid and profound local anaesthetic action and topical antibacterial effects for the temporary relief of pain and discomfort in sore throat and superficial mouth infections. Indicated for relief of minor throat irritations and adjunctively, for symptomatic relief of pain and discomfort in more serious throat infections, such as tonsillitis and pharyngitis.
4.2
Posology and method of administration Route of administration: Oral Adults and Children 12 years and over:
Allow to dissolve slowly in mouth. One lozenge every 2 hours as needed but not more than 8 lozenges in 24 hours.
4.3
Contra-indications
Hypersensitivity to the active substance or to any of the excipients
4.4
Special warnings and precautions for use
Label: If sore throat persists for more than three days consult your doctor.
Patients with rare hereditary problems of fructose intolerance, glucosegalactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine. Keep out of the reach and sight of children.
4.5 Interactions with other Medicinal Products and other Forms of Interaction None known.
4.6
Fertility, pregnancy and lactation
There is no or inadequate evidence of safety of cetylpyridinium chloride in human pregnancy but it has been in wide use for many years without apparent illconsequences. No data are available on the use of Merocaine lozenges in pregnancy. However, as with all medicines, caution should be exercised during pregnancy and lactation
4.7
Effects on Ability to Drive and Use Machines Not applicable.
4.8
Undesirable Effects Allergic reactions and methaemoglobinaemia hae been reported with Benzocaine. "If symptoms persist, or are severe, or are accompanied by fever, headache, nausea and vomiting, consult your doctor". - appears on label.
4.9
Overdose No experience of overdosage. Treatment
No experience of overdosage but normal procedures of gastric lavage and maintenance of respiration and circulation (using vaspressor drugs if necessary) should apply.
5
PHARMACOLOGICAL PROPERTIES
5.1
Pharmacodynamic Properties Cetylpyridinium Chloride - topical anticaterial agent. Benzocaine - local anaesthetic.
5.2
Pharmacokinetic Properties Not applicable.
5.3
Preclinical Safety Data Not applicable.
6. 6.1
PHARMACEUTICAL PARTICULARS List of Excipients Lime Oil Lemon Oil Sucrose granular. Glucose Liquid 80% Quinoline Yellow E104 FD&C Blue No. 2 Isopropyl Alcohol Ethyl Alcohol Purified Water
6.2
Incompatibilities None known.
6.3
Shelf Life 36 months unopened
6.4
Special Precautions for Storage Do not store above 25C.
6.5
Nature and Contents of Container 1. 24 Lozenges: PVC/PVdC/alumlnium foil laminate blister in cardboard cartons. 2. 3. 8 Lozenge Sample pack as above. 4 Lozenge Sample pack - Blister as above in cardboard wallet.
6.6
Instruction for Use/Handling None stated.
7.
Marketing Authorisation Holder SSL International PLC Venus, 1 Old Park Lane, Trafford Park, Manchester M41 7HA UK
8.
Marketing Authorisation Numbers PL 17905/00
9.
Date of First Authorisation/Renewal of Authorisation 31/01/2006
10
DATE OF REVISION OF THE TEXT
06/06/2012
1
NAME OF THE MEDICINAL PRODUCT
Merocaine
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Cetylpyridinium chloride Benzocaine 1.4mg/lozenge. 10.0mg/lozenge.
Also contains sucrose, glucose liquid and sunset yellow. For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM Lozenge
4 4.1
CLINICAL PARTICULARS Therapeutic Indications Merocaine Lozenges provide rapid and profound local anaesthetic action and topical antibacterial effects for the temporary relief of pain and discomfort in sore throat and superficial mouth infections. Indicated for relief of minor throat irritations and adjunctively, for symptomatic relief of pain and discomfort in more serious throat infections, such as tonsillitis and pharyngitis.
4.2
Posology and method of administration Route of administration: Oral Adults and Children 12 years and over:
Allow to dissolve slowly in mouth. One lozenge every 2 hours as needed but not more than 8 lozenges in 24 hours.
4.3
Contra-indications
Hypersensitivity to the active substance or to any of the excipients
4.4
Special warnings and precautions for use
Label: If sore throat persists for more than three days consult your doctor.
Patients with rare hereditary problems of fructose intolerance, glucosegalactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine. Keep out of the reach and sight of children.
4.5 Interactions with other Medicinal Products and other Forms of Interaction None known.
4.6
Fertility, pregnancy and lactation
There is no or inadequate evidence of safety of cetylpyridinium chloride in human pregnancy but it has been in wide use for many years without apparent illconsequences. No data are available on the use of Merocaine lozenges in pregnancy. However, as with all medicines, caution should be exercised during pregnancy and lactation
4.7
Effects on Ability to Drive and Use Machines Not applicable.
4.8
Undesirable Effects Allergic reactions and methaemoglobinaemia hae been reported with Benzocaine. "If symptoms persist, or are severe, or are accompanied by fever, headache, nausea and vomiting, consult your doctor". - appears on label.
4.9
Overdose No experience of overdosage. Treatment
No experience of overdosage but normal procedures of gastric lavage and maintenance of respiration and circulation (using vaspressor drugs if necessary) should apply.
5
PHARMACOLOGICAL PROPERTIES
5.1
Pharmacodynamic Properties Cetylpyridinium Chloride - topical anticaterial agent. Benzocaine - local anaesthetic.
5.2
Pharmacokinetic Properties Not applicable.
5.3
Preclinical Safety Data Not applicable.
6. 6.1
PHARMACEUTICAL PARTICULARS List of Excipients Lime Oil Lemon Oil Sucrose granular. Glucose Liquid 80% Quinoline Yellow E104 FD&C Blue No. 2 Isopropyl Alcohol Ethyl Alcohol Purified Water
6.2
Incompatibilities None known.
6.3
Shelf Life 36 months unopened
6.4
Special Precautions for Storage Do not store above 25C.
6.5
Nature and Contents of Container 1. 24 Lozenges: PVC/PVdC/alumlnium foil laminate blister in cardboard cartons. 2. 3. 8 Lozenge Sample pack as above. 4 Lozenge Sample pack - Blister as above in cardboard wallet.
6.6
Instruction for Use/Handling None stated.
7.
Marketing Authorisation Holder SSL International PLC Venus, 1 Old Park Lane, Trafford Park, Manchester M41 7HA UK
8.
Marketing Authorisation Numbers PL 17905/00
9.
Date of First Authorisation/Renewal of Authorisation 31/01/2006
10
DATE OF REVISION OF THE TEXT
06/06/2012
Source: Medicines and Healthcare Products Regulatory Agency
Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
