ADULT MELTUS CHESTY COUGHS SUGAR & COLOUR FREE
Active substance: GUAIPHENESIN
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SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Adult Meltus Chesty Coughs Sugar & Colour Free
Own label:
Lemsip Cough for Mucus Cough Sugar & Colour Free 100mg/2.5mg/5ml Oral Solution
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Adult Cough Linctus Sugar & Colour Free contains per 5 ml dose: Guaiphenesin BP 100 mg Cetylpyridinium chloride BP 2.5 mg Also contains Sorbitol solution (E420), Glycerol and Ethanol. For full list of excipients, see section 6.1
3
PHARMACEUTICAL FORM
Oral Solution
4
4.1
CLINICAL PARTICULARS
Therapeutic indications
For the symptomatic relief of acute chesty coughs and catarrh associated with influenza, colds and mild throat infections.
4.2
Posology and method of administration
Oral Adults and children 12 years of age and over One or two 5 ml spoonfuls to be taken and swallowed slowly every three or four hours. Not recommended for children under 12 years of age.
4.3
Contraindications
Hypersensitivity to the active substance or to any of the excipients
4.4
Special warnings and precautions for use
Ask your doctor before use if you suffer from a chronic cough, if you have asthma or are suffering from an acute asthma attack. Stop use and ask a healthcare professional if your cough lasts for more than 5 days, comes back, or is accompanied by a fever, rash, or persistent headache. Do not take with a cough suppressant. Not suitable for children under 12 years of age. This medicinal product contains 11.1% v/v of ethanol i.e. each 5ml dose contains up to 360 mg of alcohol, equivalent to 2.3ml of beer, or 5.4ml of wine. This can be harmful for those suffering from alcoholism. This should be taken into account in pregnant or breast-feeding women, children and high-risk groups such as patients with liver disease, or epilepsy.
4.5
Interaction with other medicinal products and other forms of interaction
Can cause transient abnormality in platelet aggregation patterns determined one hour after ingestion. If urine is collected within 24 hours of a dose of the medicinal product, a metabolite of guaifenesin may cause a colour interference with laboratory determinations of urinary 5-hydroxyindoleacetic acid (5-HIAA) and vanillylmandelic acid (VMA).
4.6
Fertility, pregnancy and lactation
No known contraindications. There is limited amount of data from the use of Guaifenesin in pregnant women. There is no information on use in lactation. Therefore, it should not be used during pregnancy or breastfeeding unless advised by a doctor or a pharmacist.
4.7
Effects on ability to drive and use machines
Not applicable.
4.8
Undesirable effects
The following side effects may be associated with the use of Guaifenesin: Gastro-intestinal disorders: Nausea and vomiting. Immune system disorders: Hypersensitivity reactions
4.9
Overdose
Very large doses may cause nausea and vomiting. It is however, rapidly metabolised and excreted in the urine. The patient should be kept under observation and treated symptomatically.
5
5.1
PHARMACOLOGICAL PROPERTIES
Pharmacodynamic properties
A cough linctus containing an expectorant and an oral antiseptic in a sugar and colour free base. The expectorant, guaiphenesin, is employed to produce a thinning of mucous secretions and thus provide relief to bronchial catarrh. The antiseptic, cetylpyridinium chloride, is used for the treatment of superficial mouth infections.
5.2
Pharmacokinetic properties
None stated.
5.3
Preclinical safety data
None stated.
6
6.1
PHARMACEUTICAL PARTICULARS
List of excipients
Glycerin BP Alcohol 96% BP Menthol BP Sorbitol Solution (E420) BP Saccharin Sodium BP Sodium Cyclamate BP Povidone (Kollidon 90) BP Custard Flavour 510514E Raspberry Flavour 500251E Blackberry Flavour 500225E Water
6.2
Incompatibilities
None stated.
6.3
Shelf life
Five years unopened.
6.4
Special precautions for storage
Store at or below 25C
6.5
Nature and contents of container
Amber glass sirop bottle fitted with tamper evident polypropylene cap with expanded polyethylene liner, packed in printed cartons containing 100ml of linctus. A measuring cup is also supplied with some own label brands.
6.6
Special precautions for disposal
None stated.
7
MARKETING AUTHORISATION HOLDER
Ultra Chemical Limited Venus 1 Old Park Lane Trafford Park Manchester M41 7HA
8
MARKETING AUTHORISATION NUMBER(S)
PL 14236/0007
9
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
24/08/2010
10
DATE OF REVISION OF THE TEXT
11/01/2013
1
NAME OF THE MEDICINAL PRODUCT
Adult Meltus Chesty Coughs Sugar & Colour Free
Own label:
Lemsip Cough for Mucus Cough Sugar & Colour Free 100mg/2.5mg/5ml Oral Solution
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Adult Cough Linctus Sugar & Colour Free contains per 5 ml dose: Guaiphenesin BP 100 mg Cetylpyridinium chloride BP 2.5 mg Also contains Sorbitol solution (E420), Glycerol and Ethanol. For full list of excipients, see section 6.1
3
PHARMACEUTICAL FORM
Oral Solution
4
4.1
CLINICAL PARTICULARS
Therapeutic indications
For the symptomatic relief of acute chesty coughs and catarrh associated with influenza, colds and mild throat infections.
4.2
Posology and method of administration
Oral Adults and children 12 years of age and over One or two 5 ml spoonfuls to be taken and swallowed slowly every three or four hours. Not recommended for children under 12 years of age.
4.3
Contraindications
Hypersensitivity to the active substance or to any of the excipients
4.4
Special warnings and precautions for use
Ask your doctor before use if you suffer from a chronic cough, if you have asthma or are suffering from an acute asthma attack. Stop use and ask a healthcare professional if your cough lasts for more than 5 days, comes back, or is accompanied by a fever, rash, or persistent headache. Do not take with a cough suppressant. Not suitable for children under 12 years of age. This medicinal product contains 11.1% v/v of ethanol i.e. each 5ml dose contains up to 360 mg of alcohol, equivalent to 2.3ml of beer, or 5.4ml of wine. This can be harmful for those suffering from alcoholism. This should be taken into account in pregnant or breast-feeding women, children and high-risk groups such as patients with liver disease, or epilepsy.
4.5
Interaction with other medicinal products and other forms of interaction
Can cause transient abnormality in platelet aggregation patterns determined one hour after ingestion. If urine is collected within 24 hours of a dose of the medicinal product, a metabolite of guaifenesin may cause a colour interference with laboratory determinations of urinary 5-hydroxyindoleacetic acid (5-HIAA) and vanillylmandelic acid (VMA).
4.6
Fertility, pregnancy and lactation
No known contraindications. There is limited amount of data from the use of Guaifenesin in pregnant women. There is no information on use in lactation. Therefore, it should not be used during pregnancy or breastfeeding unless advised by a doctor or a pharmacist.
4.7
Effects on ability to drive and use machines
Not applicable.
4.8
Undesirable effects
The following side effects may be associated with the use of Guaifenesin: Gastro-intestinal disorders: Nausea and vomiting. Immune system disorders: Hypersensitivity reactions
4.9
Overdose
Very large doses may cause nausea and vomiting. It is however, rapidly metabolised and excreted in the urine. The patient should be kept under observation and treated symptomatically.
5
5.1
PHARMACOLOGICAL PROPERTIES
Pharmacodynamic properties
A cough linctus containing an expectorant and an oral antiseptic in a sugar and colour free base. The expectorant, guaiphenesin, is employed to produce a thinning of mucous secretions and thus provide relief to bronchial catarrh. The antiseptic, cetylpyridinium chloride, is used for the treatment of superficial mouth infections.
5.2
Pharmacokinetic properties
None stated.
5.3
Preclinical safety data
None stated.
6
6.1
PHARMACEUTICAL PARTICULARS
List of excipients
Glycerin BP Alcohol 96% BP Menthol BP Sorbitol Solution (E420) BP Saccharin Sodium BP Sodium Cyclamate BP Povidone (Kollidon 90) BP Custard Flavour 510514E Raspberry Flavour 500251E Blackberry Flavour 500225E Water
6.2
Incompatibilities
None stated.
6.3
Shelf life
Five years unopened.
6.4
Special precautions for storage
Store at or below 25C
6.5
Nature and contents of container
Amber glass sirop bottle fitted with tamper evident polypropylene cap with expanded polyethylene liner, packed in printed cartons containing 100ml of linctus. A measuring cup is also supplied with some own label brands.
6.6
Special precautions for disposal
None stated.
7
MARKETING AUTHORISATION HOLDER
Ultra Chemical Limited Venus 1 Old Park Lane Trafford Park Manchester M41 7HA
8
MARKETING AUTHORISATION NUMBER(S)
PL 14236/0007
9
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
24/08/2010
10
DATE OF REVISION OF THE TEXT
11/01/2013
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.
