- Approval Id
- cc204a0d9e169618
- Drug Approval Emc Name
- Benylin Dry & Tickly Cough Syrup
- Drug Name
- Benylin Dry & Tickly Cough Syrup
- Company Name
- McNeil Products Ltd
- Company Address
- 50-100 Holmers Farm Way, High Wycombe, HP12 4EG, UK
- Company Medical Info Direct Line
- 0808 238 9999 (freephone)
- Company Medical Info Email
- consumer-gb@kenvue.com
- Atc Code
- R05FB01
- Legal Category
- General Sales List
- Authorisation Holder
- McNeil Products Limited
50 - 100 Holmers Farm Way
High Wycombe
Buckinghamshire
HP12 4EG
UK
- Authorisation Number
- PL 15513/0142
- Authorisation Date
- 11th January 2005
- Instruction Authorisation Holder
- McNeil Products Limited
50 - 100 Holmers Farm Way
High Wycombe
Buckinghamshire
HP12 4EG
UK
- Instruction Authorisation Number
- PL 15513/0142
- Instruction Authorisation Date
- 11th January 2005
- Instruction Composition
- | | |
| --- | --- |
| Active ingredient | per 5 ml |
| Glycerol | 0.75 ml |
| Sucrose | 1.71g |
| \*\*Excipients with known effect\*\*: | |
| Liquid Glucose | 2.342g |
| Propylene glycol (E1520) | 24mg |
| Sodium benzoate (E211) | 10mg |
| Ethanol | 5mg |
| Sodium | 1.62mg |
For the full list of excipients, see section 6.1.
- Instruction Dosage Form
- Syrup
- Instruction Clinical Particulars
- 4.1 Therapeutic indications
For the relief of irritating, tickling dry coughs and sore throats.4.2 Posology and method of administration
\*\*Posology\*\*:
Adults and children over 5 years: 10 ml
Children 1 – 5 years: 5 ml
The dose may be repeated three or four times a day.
Children under one year: Not to be given to children under 1 year.
\*Elderly\*:
There is no need for dosage reduction in the elderly.
\*\*Method of administration\*\*:
For oral use.4.3 Contraindications
Hypersensitivity to the active substance(s) or to any of the excipients listed in section 6.1.
Do not give to children under one year.4.4 Special warnings and precautions for use
Diabetics should take note that sucrose and glycerol may affect blood sugar levels.
\*\*Information relating specifically to excipients in the formulation.\*\*
This medicine contains sucrose and glucose. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.
This medicine contains 24 mg propylene glycol in each 5 ml which is equivalent to 4.8mg/ml.
This medicine contains 10 mg sodium benzoate (E211) in each 5ml
This medicine contains 5 mg of alcohol (ethanol) in each 5 ml dose. The amount in 5 ml of this medicine is equivalent to less than 1 ml beer or wine. The small amount of alcohol in this medicine will not have any noticeable effects.
This medicine contains less than 1 mmol sodium (23 mg) per 5 ml, that is to say essentially 'sodium-free'.
If symptoms persist for more than 3 days or get worse, patients should stop use and consult a doctor.4.5 Interaction with other medicinal products and other forms of interaction
No clinically significant interactions known.4.6 Fertility, pregnancy and lactation
The safety of this product during pregnancy and lactation has not been established, but is not considered to constitute a hazard during these periods.4.7 Effects on ability to drive and use machines
This medicine has no or negligible influence on the ability to drive and use machines.4.8 Undesirable effects
No known adverse effects.
\*\*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: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.4.9 Overdose
Management:
Treatment should be symptomatic and supportive.
- Instruction Pharmacology
- 5.1 Pharmacodynamic properties
Pharmacotherapeutic group: Cough suppressants and mucolytics, ATC code: R05FB01
Glycerol and sucrose have demulcent propertiese and will soothe irritated sore throats and possibly block sensory cough receptors within the respiratory tract.5.2 Pharmacokinetic properties
\*\*Absorption\*\*
Glycerol is readily absorbed from the gastrointestinal tract.
Sucrose is hydrolysed in the small intestine by the enzyme sucrase to glucose and fructose which are then absorbed.
\*\*Distribution\*\*
Glycerol combines with free fatty acids in the liver to form triglycerides which are distributed to adipose tissues.
There are limited data on the distribution of oral sucrose in man.
\*\*Metabolism\*\*
Glycerol undergoes extensive metabolism principally in the liver and to a lesser extent in the kidneys. Glycerol is metabolised to glucose or glycogen or oxidised to carbon dioxide and water. The hydrolysis products of sucrose are metaboliszed through different pathways in the body. Glucose elicits a glycaemic and insulinaemic response that stimulates its update into cells while fructose is mainly metaboliszed in the liver via an insulin-independent pathway not regulated by energy supply. Fructose may be converted into trioses that can be used for the de novo synthesis of triglycerides and cholesterol.
\*\*Elimination\*\*
It may also be excreted in the urine unchanged.5.3 Preclinical safety data
Non-clinical data reveal no special hazard for humans based on studies of repeated dose toxicity, genotoxicity, carcinogenic potential, toxicity to reproduction and development.
- Instruction Pharmaceutical Particulars
- 6.1 List of excipients
Citric acid monohydrate
Sodium benzoate (E211)
Cough syrup 513277 flavour (containing anise oil, liquorice, propylene glycol (E1520), ethanol (alcohol))
Black treacle
Liquid glucose
Purified water6.2 Incompatibilities
Not applicable.6.3 Shelf life
3 years.6.4 Special precautions for storage
This medicinal product does not require any special storage conditions.6.5 Nature and contents of container
A white flint glass bottle with an aluminium roll-on pilfer proof cap with a flowed in liner, or a triseal (LDPE/EPE/LDPE) liner.
Alternative cap: A wadless polypropylene tamper evident cap.
Pack size: 200 ml
Or
An amber glass bottle with an aluminium roll-on pilfer proof cap with a triseal (LDPE/EPE/LDPE) liner.
Pack size: 125ml or 150ml
Or
An amber PET bottle with a child resistant polypropylene cap fitted with an expanded polyethylene liner.
Alternative cap: An aluminium roll-on pilfer proof cap with a flowed in liner, or a triseal (LDPE/EPE/LDPE) liner.
Pack size: 150ml or 300ml.
Not all pack sizes may be marketed.6.6 Special precautions for disposal and other handling
No special requirements for disposal.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
- Instruction Content
- ## Composition
| | |
| --- | --- |
| Active ingredient | per 5 ml |
| Glycerol | 0.75 ml |
| Sucrose | 1.71g |
| \*\*Excipients with known effect\*\*: | |
| Liquid Glucose | 2.342g |
| Propylene glycol (E1520) | 24mg |
| Sodium benzoate (E211) | 10mg |
| Ethanol | 5mg |
| Sodium | 1.62mg |
For the full list of excipients, see section 6.1.
## Pharmaceutical Form
Syrup
## Clinical Particulars
4.1 Therapeutic indications
For the relief of irritating, tickling dry coughs and sore throats.4.2 Posology and method of administration
\*\*Posology\*\*:
Adults and children over 5 years: 10 ml
Children 1 – 5 years: 5 ml
The dose may be repeated three or four times a day.
Children under one year: Not to be given to children under 1 year.
\*Elderly\*:
There is no need for dosage reduction in the elderly.
\*\*Method of administration\*\*:
For oral use.4.3 Contraindications
Hypersensitivity to the active substance(s) or to any of the excipients listed in section 6.1.
Do not give to children under one year.4.4 Special warnings and precautions for use
Diabetics should take note that sucrose and glycerol may affect blood sugar levels.
\*\*Information relating specifically to excipients in the formulation.\*\*
This medicine contains sucrose and glucose. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.
This medicine contains 24 mg propylene glycol in each 5 ml which is equivalent to 4.8mg/ml.
This medicine contains 10 mg sodium benzoate (E211) in each 5ml
This medicine contains 5 mg of alcohol (ethanol) in each 5 ml dose. The amount in 5 ml of this medicine is equivalent to less than 1 ml beer or wine. The small amount of alcohol in this medicine will not have any noticeable effects.
This medicine contains less than 1 mmol sodium (23 mg) per 5 ml, that is to say essentially 'sodium-free'.
If symptoms persist for more than 3 days or get worse, patients should stop use and consult a doctor.4.5 Interaction with other medicinal products and other forms of interaction
No clinically significant interactions known.4.6 Fertility, pregnancy and lactation
The safety of this product during pregnancy and lactation has not been established, but is not considered to constitute a hazard during these periods.4.7 Effects on ability to drive and use machines
This medicine has no or negligible influence on the ability to drive and use machines.4.8 Undesirable effects
No known adverse effects.
\*\*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: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.4.9 Overdose
Management:
Treatment should be symptomatic and supportive.
## Pharmacological Properties
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: Cough suppressants and mucolytics, ATC code: R05FB01
Glycerol and sucrose have demulcent propertiese and will soothe irritated sore throats and possibly block sensory cough receptors within the respiratory tract.5.2 Pharmacokinetic properties
\*\*Absorption\*\*
Glycerol is readily absorbed from the gastrointestinal tract.
Sucrose is hydrolysed in the small intestine by the enzyme sucrase to glucose and fructose which are then absorbed.
\*\*Distribution\*\*
Glycerol combines with free fatty acids in the liver to form triglycerides which are distributed to adipose tissues.
There are limited data on the distribution of oral sucrose in man.
\*\*Metabolism\*\*
Glycerol undergoes extensive metabolism principally in the liver and to a lesser extent in the kidneys. Glycerol is metabolised to glucose or glycogen or oxidised to carbon dioxide and water. The hydrolysis products of sucrose are metaboliszed through different pathways in the body. Glucose elicits a glycaemic and insulinaemic response that stimulates its update into cells while fructose is mainly metaboliszed in the liver via an insulin-independent pathway not regulated by energy supply. Fructose may be converted into trioses that can be used for the de novo synthesis of triglycerides and cholesterol.
\*\*Elimination\*\*
It may also be excreted in the urine unchanged.5.3 Preclinical safety data
Non-clinical data reveal no special hazard for humans based on studies of repeated dose toxicity, genotoxicity, carcinogenic potential, toxicity to reproduction and development.
## Pharmaceutical Particulars
6.1 List of excipients
Citric acid monohydrate
Sodium benzoate (E211)
Cough syrup 513277 flavour (containing anise oil, liquorice, propylene glycol (E1520), ethanol (alcohol))
Black treacle
Liquid glucose
Purified water6.2 Incompatibilities
Not applicable.6.3 Shelf life
3 years.6.4 Special precautions for storage
This medicinal product does not require any special storage conditions.6.5 Nature and contents of container
A white flint glass bottle with an aluminium roll-on pilfer proof cap with a flowed in liner, or a triseal (LDPE/EPE/LDPE) liner.
Alternative cap: A wadless polypropylene tamper evident cap.
Pack size: 200 ml
Or
An amber glass bottle with an aluminium roll-on pilfer proof cap with a triseal (LDPE/EPE/LDPE) liner.
Pack size: 125ml or 150ml
Or
An amber PET bottle with a child resistant polypropylene cap fitted with an expanded polyethylene liner.
Alternative cap: An aluminium roll-on pilfer proof cap with a flowed in liner, or a triseal (LDPE/EPE/LDPE) liner.
Pack size: 150ml or 300ml.
Not all pack sizes may be marketed.6.6 Special precautions for disposal and other handling
No special requirements for disposal.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
