- Approval Id
- 124aea13439e5df3
- Drug Approval Emc Name
- Lemsip Cough for Dry Cough & Sore Throat Oral Solution
- Drug Name
- Lemsip Cough for Dry Cough & Sore Throat Oral Solution
- Company Address
- RB Consumer Relations, PO Box 4644, SLOUGH, SL1 0NS, UK
- Company Website
- http://www.reckittbenckiser.com
- Company Telephone
- 0333 2005 345
- Company Medical Info Direct Line
- 0333 2005 345
- Company Customer Care Direct Line
- 0333 2005 345
- Atc Code
- R05X
- Legal Category
- General Sales List
- Authorisation Holder
- Reckitt Benckiser Healthcare (UK) Limited
Dansom Lane
Hull
HU8 7DS
- Authorisation Number
- PL 00063/0038
- Authorisation Date
- 24/04/1995
- Instruction Authorisation Holder
- Reckitt Benckiser Healthcare (UK) Limited
Dansom Lane
Hull
HU8 7DS
- Instruction Authorisation Number
- PL 00063/0038
- Instruction Authorisation Date
- 24/04/1995
- Instruction Composition
- | | | |
| --- | --- | --- |
| \*\*Active ingredients\*\* | \*\*Quantity/dose\*\* | \*\*Specification\*\* |
| Glycerol Honey Citric acid monohydrate Lemon oil terpeneless Syrup | 0.25 ml 500.00 mg 25.00 mg 0.0005 ml 3.75ml | EP HSE EP BP BP |
Excipient(s) with known effect:
- Sodium – 0.832 mg /5ml dose
- Ethanol – 37.865 mg (0.048 ml) /5ml dose
- Benzyl Alcohol\\* (\\*trace amounts present in Lemon Oil Terpeneless)
- Parahydroxybenzoates and their esters\\* (\\*nipasept sodium contains sodium ethyl p-hydroxybenzoate (E215), sodium propyl p-hydroxybenzoate and sodium methyl p-hydroxybenzoate (E219))
For the full list of excipients, see section 6.1.
- Instruction Dosage Form
- Oral syrup.
- Instruction Clinical Particulars
- 4.1 Therapeutic indications
For the symptomatic relief of dry tickly coughs and sore throats.4.2 Posology and method of administration
Route of administration - oral.
The lowest effective dose should be used for the shortest duration necessary to relieve symptoms and a healthcare professional should be consulted if symptoms persist or worsen.
No special dose is required for elderly patients.
Glass bottle
Adults and children 12 years and over: Two 5ml spoonfuls, three or four times daily.
Children 1-12 years: One 5ml spoonful, three or four times daily.
PETE plastic bottle
Adults and children 12 years and over: 10 ml dose (fill measure cup to 10 ml), three to four times daily.
Children aged 1-12 years: 5 ml dose (fill measure cup to 5 ml), three to four times daily.
Rinse the measure cup after use.4.3 Contraindications
Hypersensitivity to the active substance or any of the excipients listed in section 6.1.
Do not give to children under 1 year.4.4 Special warnings and precautions for use
Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.
This medicine contains less than 1 mmol sodium (23mg) per dose, that is to say essentially 'sodium-free'.
The product may contain sufficient amounts of sugar to affect the control of diabetes.
This medicine contains 0.04 mg alcohol (ethanol) in each 5ml dose. The amount in a 5 ml dose of this medicine is equivalent to less than 1 ml of beer or 1 ml of wine.
This medicine contains trace amounts of benzyl alcohol in each 5ml dose.Benzyl alcohol may cause allergic reactions.
Contains esters of parahydroxybenzoic acid which may cause allergic reactions (possibly delayed).
Citrates should not be taken together with aluminium hydroxide or aluminium-containing antacids in patients with-end stage renal disease unless consulted with health care professional (see section 4.5).
Duration of treatment should be limited to a maximum of 3 days for adults and children aged 1 year and over. The patient should consult a doctor if symptoms persist or worsen.4.5 Interaction with other medicinal products and other forms of interaction
Intestinal absorption of aluminium ions may be enhanced by oral doses of citrates, increasing the toxicity of aluminium.4.6 Fertility, pregnancy and lactation
\*\*Pregnancy\*\*
There are no or a limited amount of data from the use of glycerol, honey, citric acid monohydrate, lemon oil terpeneless and syrup in pregnant women. As a precautionary measure, it is preferable to avoid the use of the product during pregnancy unless clearly necessary. Consult a healthcare professional before use.
\*\*Breast-feeding\*\*
There is insufficient information on the excretion of glycerol, honey, citric acid monohydrate, lemon oil terpeneless and syrup or metabolites in human milk. A risk to newborns/infants cannot be excluded. Consult a healthcare professional before use.
\*\*Fertility\*\*
There is no information on the effects of glycerol, honey, citric acid monohydrate, lemon oil terpeneless and syrup on fertility.4.7 Effects on ability to drive and use machines
None known.4.8 Undesirable effects
Adverse events which have been associated with glycerol, honey, citric acid monohydrate, lemon oil terpeneless and syrup are given below, tabulated by system organ class and frequency.
Frequencies are defined as:
Very common (≥1/10);
Common (≥1/100 and <1/10);
Uncommon (≥1/1000 and <1/100);
Rare (≥1/10,000 and <1/1000);
Very rare (< 1/10,000);
Not known (cannot be estimated from the available data).
Within each frequency grouping, adverse events are presented in order of decreasing seriousness.
| | | |
| --- | --- | --- |
| \*\*System Organ Class\*\* | \*\*Frequency\*\* | \*\*Adverse Events\*\* |
| Immune system disorders | Not known | Hypersensitivity |
\*\*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. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: http:www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.4.9 Overdose
In the unlikely event of overdose, serious side effects are not expected.
If overdose does occur, consult a healthcare professional. Treatment consists of general supportive therapy and may include gastric lavage.
When taken orally large doses of glycerol may cause headache, nausea, and vomiting. Diarrhoea, thirst, dizziness, and mental confusion may occur less frequently. Cardiac arrhythmias have been reported.
Citric acid ingested frequently or in large quantities may cause erosion of the teeth and have a local irritant action or cause diarrhoea.
Overconsumption of sucrose is associated with the formation of dental caries.
- Instruction Pharmacology
- 5.1 Pharmacodynamic properties
Pharmacotherapeutic group: Respiratory System; Cough and Cold Preparations; Other Cold Preparations ATC Code: R05X
Glycerol, honey and syrup act as demulcents and provide a soothing medium for an irritated throat.
The citric acid monohydrate and the lemon oil terpeneless both add to the sharpness of the product and enhance the flavour.5.2 Pharmacokinetic properties
Glycerol is readily absorbed from the gastrointestinal tract and undergoes extensive metabolism, mainly in the liver; it may be used in the synthesis of lipids, metabolised to glucose or glycogen, or oxidised to carbon dioxide and water. It is also excreted in the urine unchanged.
Sucrose is hydrolysed in the small intestine by the enzyme sucrase to glucose and fructose, which are then absorbed.
No relevant pharmacokinetic data are available for citric acid monohydrate, honey or lemon oil terpeneless.5.3 Preclinical safety data
No preclinical findings of relevance have been reported.
- Instruction Pharmaceutical Particulars
- 6.1 List of excipients
Ethanol (96%),
Nipasept sodium,
Benzyl Alcohol\\* (\\*trace amounts present in Lemon Oil Terpeneless),
Parahydroxybenzoates and their esters\\* (\\*nipasept sodium contains sodium ethyl p-hydroxybenzoate (E215), sodium propyl p-hydroxybenzoate and sodium methyl p-hydroxybenzoate (E219)),
Water.6.2 Incompatibilities
None known.6.3 Shelf life
Glass bottle - Three years.
Transparent blue plastic PETE bottle - Two years.
Transparent green plastic PETE bottle - Two years.6.4 Special precautions for storage
Store below 25ºC.6.5 Nature and contents of container
Amber glass bottles with a polypropylene cap with a polyethylene tamper-evident band with expanded polyethylene wad (100ml and 200ml).
Transparent blue plastic PETE bottle (180ml).
Transparent green plastic PETE bottle (180ml).
Translucent yellow graduated polypropylene measuring cup.
Pack sizes: 100ml, 180ml and 200ml.
Not all pack sizes may be marketed.6.6 Special precautions for disposal and other handling
Oral administration.
- Instruction Content
- ## Composition
| | | |
| --- | --- | --- |
| \*\*Active ingredients\*\* | \*\*Quantity/dose\*\* | \*\*Specification\*\* |
| Glycerol Honey Citric acid monohydrate Lemon oil terpeneless Syrup | 0.25 ml 500.00 mg 25.00 mg 0.0005 ml 3.75ml | EP HSE EP BP BP |
Excipient(s) with known effect:
- Sodium – 0.832 mg /5ml dose
- Ethanol – 37.865 mg (0.048 ml) /5ml dose
- Benzyl Alcohol\\* (\\*trace amounts present in Lemon Oil Terpeneless)
- Parahydroxybenzoates and their esters\\* (\\*nipasept sodium contains sodium ethyl p-hydroxybenzoate (E215), sodium propyl p-hydroxybenzoate and sodium methyl p-hydroxybenzoate (E219))
For the full list of excipients, see section 6.1.
## Pharmaceutical Form
Oral syrup.
## Clinical Particulars
4.1 Therapeutic indications
For the symptomatic relief of dry tickly coughs and sore throats.4.2 Posology and method of administration
Route of administration - oral.
The lowest effective dose should be used for the shortest duration necessary to relieve symptoms and a healthcare professional should be consulted if symptoms persist or worsen.
No special dose is required for elderly patients.
Glass bottle
Adults and children 12 years and over: Two 5ml spoonfuls, three or four times daily.
Children 1-12 years: One 5ml spoonful, three or four times daily.
PETE plastic bottle
Adults and children 12 years and over: 10 ml dose (fill measure cup to 10 ml), three to four times daily.
Children aged 1-12 years: 5 ml dose (fill measure cup to 5 ml), three to four times daily.
Rinse the measure cup after use.4.3 Contraindications
Hypersensitivity to the active substance or any of the excipients listed in section 6.1.
Do not give to children under 1 year.4.4 Special warnings and precautions for use
Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.
This medicine contains less than 1 mmol sodium (23mg) per dose, that is to say essentially 'sodium-free'.
The product may contain sufficient amounts of sugar to affect the control of diabetes.
This medicine contains 0.04 mg alcohol (ethanol) in each 5ml dose. The amount in a 5 ml dose of this medicine is equivalent to less than 1 ml of beer or 1 ml of wine.
This medicine contains trace amounts of benzyl alcohol in each 5ml dose.Benzyl alcohol may cause allergic reactions.
Contains esters of parahydroxybenzoic acid which may cause allergic reactions (possibly delayed).
Citrates should not be taken together with aluminium hydroxide or aluminium-containing antacids in patients with-end stage renal disease unless consulted with health care professional (see section 4.5).
Duration of treatment should be limited to a maximum of 3 days for adults and children aged 1 year and over. The patient should consult a doctor if symptoms persist or worsen.4.5 Interaction with other medicinal products and other forms of interaction
Intestinal absorption of aluminium ions may be enhanced by oral doses of citrates, increasing the toxicity of aluminium.4.6 Fertility, pregnancy and lactation
\*\*Pregnancy\*\*
There are no or a limited amount of data from the use of glycerol, honey, citric acid monohydrate, lemon oil terpeneless and syrup in pregnant women. As a precautionary measure, it is preferable to avoid the use of the product during pregnancy unless clearly necessary. Consult a healthcare professional before use.
\*\*Breast-feeding\*\*
There is insufficient information on the excretion of glycerol, honey, citric acid monohydrate, lemon oil terpeneless and syrup or metabolites in human milk. A risk to newborns/infants cannot be excluded. Consult a healthcare professional before use.
\*\*Fertility\*\*
There is no information on the effects of glycerol, honey, citric acid monohydrate, lemon oil terpeneless and syrup on fertility.4.7 Effects on ability to drive and use machines
None known.4.8 Undesirable effects
Adverse events which have been associated with glycerol, honey, citric acid monohydrate, lemon oil terpeneless and syrup are given below, tabulated by system organ class and frequency.
Frequencies are defined as:
Very common (≥1/10);
Common (≥1/100 and <1/10);
Uncommon (≥1/1000 and <1/100);
Rare (≥1/10,000 and <1/1000);
Very rare (< 1/10,000);
Not known (cannot be estimated from the available data).
Within each frequency grouping, adverse events are presented in order of decreasing seriousness.
| | | |
| --- | --- | --- |
| \*\*System Organ Class\*\* | \*\*Frequency\*\* | \*\*Adverse Events\*\* |
| Immune system disorders | Not known | Hypersensitivity |
\*\*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. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: http:www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.4.9 Overdose
In the unlikely event of overdose, serious side effects are not expected.
If overdose does occur, consult a healthcare professional. Treatment consists of general supportive therapy and may include gastric lavage.
When taken orally large doses of glycerol may cause headache, nausea, and vomiting. Diarrhoea, thirst, dizziness, and mental confusion may occur less frequently. Cardiac arrhythmias have been reported.
Citric acid ingested frequently or in large quantities may cause erosion of the teeth and have a local irritant action or cause diarrhoea.
Overconsumption of sucrose is associated with the formation of dental caries.
## Pharmacological Properties
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: Respiratory System; Cough and Cold Preparations; Other Cold Preparations ATC Code: R05X
Glycerol, honey and syrup act as demulcents and provide a soothing medium for an irritated throat.
The citric acid monohydrate and the lemon oil terpeneless both add to the sharpness of the product and enhance the flavour.5.2 Pharmacokinetic properties
Glycerol is readily absorbed from the gastrointestinal tract and undergoes extensive metabolism, mainly in the liver; it may be used in the synthesis of lipids, metabolised to glucose or glycogen, or oxidised to carbon dioxide and water. It is also excreted in the urine unchanged.
Sucrose is hydrolysed in the small intestine by the enzyme sucrase to glucose and fructose, which are then absorbed.
No relevant pharmacokinetic data are available for citric acid monohydrate, honey or lemon oil terpeneless.5.3 Preclinical safety data
No preclinical findings of relevance have been reported.
## Pharmaceutical Particulars
6.1 List of excipients
Ethanol (96%),
Nipasept sodium,
Benzyl Alcohol\\* (\\*trace amounts present in Lemon Oil Terpeneless),
Parahydroxybenzoates and their esters\\* (\\*nipasept sodium contains sodium ethyl p-hydroxybenzoate (E215), sodium propyl p-hydroxybenzoate and sodium methyl p-hydroxybenzoate (E219)),
Water.6.2 Incompatibilities
None known.6.3 Shelf life
Glass bottle - Three years.
Transparent blue plastic PETE bottle - Two years.
Transparent green plastic PETE bottle - Two years.6.4 Special precautions for storage
Store below 25ºC.6.5 Nature and contents of container
Amber glass bottles with a polypropylene cap with a polyethylene tamper-evident band with expanded polyethylene wad (100ml and 200ml).
Transparent blue plastic PETE bottle (180ml).
Transparent green plastic PETE bottle (180ml).
Translucent yellow graduated polypropylene measuring cup.
Pack sizes: 100ml, 180ml and 200ml.
Not all pack sizes may be marketed.6.6 Special precautions for disposal and other handling
Oral administration.
- Company Detail Path
- /organization/reckitt-benckiser-healthcare-uk-ltd
