- 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 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
Glycerin and Blackcurrant Linctus or Benylin Dry Coughs Blackcurrant or CalCough Children's Soothing Syrup or Benylin Children's Blackcurrant Flavour Cough Syrup or Benylin Children's Cough & Sore Throat Syrup
2. Qualitative and quantitative composition
Quantity per 5ml
Glycerin Ph. Eur.
(Equivalent to sucrose B.P.
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
Adults, 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.For oral administration.
Hypersensitivity or intolerance to any of the ingredients.
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 reach of children.
4.5 Interaction with other medicinal products and other forms of interaction
No clinically significant interactions known.
4.6 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 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.
Overdosage would not be expected to cause any problems and treatment would be merely symptomatic and supportive.
5. Pharmacological properties
5.1 Pharmacodynamic properties
Glycerin 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
Glycerin 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 gran Sodium benzoateAnthocyaninBlackcurrant Flavour 1740.7107 IFF Blackcurrant Juice 1740.1436 IFFLiquid Glucose BPC 1963 Purified Water
6.3 Shelf life
6.4 Special precautions for storage
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.
6.6 Special precautions for disposal and other handling
7. Marketing authorisation holder
The Boots Company PLC 1 Thane Road West Nottingham NG2 3AA Trading as: BCM
8. Marketing authorisation number(s)
9. Date of first authorisation/renewal of the authorisation
|Date of First Authorisation:||14 March 1984|
|Date of Last Renewal:||25 July 2000|
10. Date of revision of the text
McNeil Products Ltd
Foundation Park, Roxborough Way, Maidenhead, Berks, SL6 3UG
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