- 1. Name of the medicinal product
- 2. Qualitative and quantitative composition
- 3. Pharmaceutical form
- 4. Clinical particulars
- 4.1 Therapeutic indications
- 4.2 Posology and method of administration
- 4.3 Contraindications
- 4.4 Special warnings and precautions for use
- 4.5 Interaction with other medicinal products and other forms of interaction
- 4.6 Fertility, pregnancy and lactation
- 4.7 Effects on ability to drive and use machines
- 4.8 Undesirable effects
- 4.9 Overdose
- 5. Pharmacological properties
- 5.1 Pharmacodynamic properties
- 5.2 Pharmacokinetic properties
- 5.3 Preclinical safety data
- 6. Pharmaceutical particulars
- 6.1 List of excipients
- 6.2 Incompatibilities
- 6.3 Shelf life
- 6.4 Special precautions for storage
- 6.5 Nature and contents of container
- 6.6 Special precautions for disposal and other handling
- 7. Marketing authorisation holder
- 8. Marketing authorisation number(s)
- 9. Date of first authorisation/renewal of the authorisation
- 10. Date of revision of the text
1. Name of the medicinal product
Benylin Tickly Coughs & Sore Throat Non-Drowsy Syrup
2. Qualitative and quantitative composition
per 5 ml
3. Pharmaceutical form
4. 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 mlChildren 1 5 years: 5 mlThe 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.
Hypersensitivity to the active substance(s) or to any of the excipients listed in section 6.1.
4.4 Special warnings and precautions for use
Diabetics should take note of the carbohydrate content of this product.Do not give to children under one year.Keep all medicines out of the sight and reach of children.Information relating specifically to excipients in the formulation.This medicine contains small amounts of ethanol (alcohol), less than 100mg per 5ml dose.This medicine contains sucrose and glucose. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrose-isomaltase insufficiency should not take this medicine.
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
4.8 Undesirable effects
No adverse effects would be anticipated.
Reporting of suspected adverse reactionsReporting 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.
Management:Overdosage would not be expected to cause any problems and treatment would be merely symptomatic and supportive.
5. Pharmacological properties
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: Cough suppressants and mucolytics, ATC code: R05FB01 Glycerol and sucrose have demulcent properties and will soothe irritated sore throats and possibly block sensory cough receptors within the respiratory tract.
5.2 Pharmacokinetic properties
Glycerol is readily absorbed from the gastrointestinal tract and undergoes extensive metabolism principally in the liver. It may be used in the synthesis of lipids, and is metabolised to glucose or glycogen or oxidised to carbon dioxide and water. It may also be excreted in the urine unchanged.Sucrose is hydrolysed in the small intestine by the enzyme sucrase to glucose and fructose which are then absorbed.
5.3 Preclinical safety data
There are no preclinical data of relevance to the prescriber which are additional to that already included.
6. Pharmaceutical particulars
6.1 List of excipients
Citric acid monohydrateSodium benzoate (E211)Cough syrup 513277 flavour (containing anise oil, liquorice, propylene glycol, ethanol (alcohol)Black treacleLiquid glucosePurified water
6.3 Shelf life
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.
7. Marketing authorisation holder
McNeil Products LimitedFoundation ParkRoxborough WayMaidenheadBerkshire SL6 3UGUnited Kingdom
8. Marketing authorisation number(s)
9. Date of first authorisation/renewal of the authorisation
11th January 2005
10. Date of revision of the text
McNeil Products Ltd
Foundation Park, Roxborough Way, Maidenhead, Berks, SL6 3UG
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