- 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 Dry Coughs Non-Drowsy Blackcurrant Flavour SyrupBenylin Children's Dry Cough & Sore Throat SyrupCalCough Children's Syrup
2. Qualitative and quantitative composition
|Active Ingredient||Quantity per 5ml|
|Excipient with known effect:|
3. Pharmaceutical form
Syrup A dark red, blackcurrant flavoured syrup.
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
PosologyAdults, elderly and children over 5 years: 10mlChildren 1 - 5 years: 5mlThe dose may be repeated three or four times a day.Children under one year: Not to be given to children under 1 year.
Method of AdministrationFor oral administration.
Hypersensitivity to the active substances 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. Patients with rare hereditary problems of fructose intolerance, glucose galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.Do not give to children under one year.Keep out of the sight and reach of children.
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 medicine 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
Immune system disorder: hypersensitivity reactions, including anaphylaxis.
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: R05FB01Glycerol 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 monohydrate Sodium benzoate E211AnthocyaninBlackcurrant Flavour 1740.7107 IFF Blackcurrant Juice 1740.1436 IFFLiquid Glucose Purified 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
125ml, 150ml or 200ml white flint glass, or amber glass bottle with an aluminium roll-on pilfer-proof cap with a flowed in liner, or a triseal (LDPE/EPE/LDPE) liner. Alternative caps: A wadless polypropylene tamper evident cap, or a child resistant polypropylene cap with a EPE liner. A double ended measuring spoon of 2.5ml and 5.0ml capacity may optionally be provided with the product. 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
24 November 2014
10. Date of revision of the text
McNeil Products Ltd
Foundation Park, Roxborough Way, Maidenhead, Berks, SL6 3UG
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