This information is intended for use by health professionals

1. Name of the medicinal product

Benylin Children's Apple Flavour Cough Syrup or CalCough Infant Syrup or Benylin Infant's Cough Syrup

2. Qualitative and quantitative composition

Active ingredient

% v/v

Quantity per 5 ml

Glycerol

15.0

0.75ml

Excipient with known effect:

Maltitol liquid (E965)

1.5ml

Sodium

6.95mg

Sodium benzoate (E211)

10mg

Propylene glycol (E1520)

18.24mg

For the full list of excipients, see section 6.1

3. Pharmaceutical form

Syrup

A clear colourless syrup with an apple flavour.

4. Clinical particulars
4.1 Therapeutic indications

For the relief of dry tickly coughs.

4.2 Posology and method of administration

Posology

Children 3 months - 1 year: one 5ml spoonful three to four times a day.

Children 1 to 5 years: two 5ml spoonfuls three to four times a day.

Children under 3 months: not recommended.

Method of administration

For oral use.

4.3 Contraindications

Hypersensitivity to the active substance or to any of the ingredients listed in section 6.1.

Not recommended for children under 3 months.

Patients with rare hereditary problems of fructose intolerance should not take this medicine.

4.4 Special warnings and precautions for use

Diabetics should take note that glycerol may affect blood sugar levels.

If symptoms persist for more than 3 days or get worse, patients should stop use and consult a doctor.

This medicine contains less than 1 mmol sodium (23 mg) per 5ml, that is to say essentially 'sodium-free'.

This medicine contains 10 mg sodium benzoate (E211) in each 5ml which is equivalent to 2mg/ml.

This medicine contains 18.24 mg propylene glycol (E1520) in each 5ml which is equivalent to 3.65 mg/5ml.

4.5 Interaction with other medicinal products and other forms of interaction

No clinically significant drug interactions.

4.6 Fertility, pregnancy and lactation

Not applicable.

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

Maltitol may have a mild laxative effect.

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

Symptoms

Overdose with this product may possibly cause diarrhoea.

Treatment

Treatment should be symptomatic and supportive.

5. Pharmacological properties
5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Cough suppressants and mucolytics, ATC code: R05FB01.

Glycerol has demulcent properties and may possibly block sensory cough receptors in the respiratory tract.

5.2 Pharmacokinetic properties

Absorption

Glycerol is readily absorbed from the gastrointestinal tract.

Distribution

Glycerol combines with free fatty acids in the liver to form triglycerides which are distributed to the adipose tissues.

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 oxidized to carbon dioxide and water.

Elimination

Glycerol may 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.

6. Pharmaceutical particulars
6.1 List of excipients

Maltitol liquid (E965)

Hydroxyethylcellulose

Sodium benzoate

Citric acid monohydrate

Sodium citrate

Apple flavouring 5112OIE (containing propylene glycol)

Purified water

6.2 Incompatibilities

None stated

6.3 Shelf life

3 years

6.4 Special precautions for storage

Keep the bottle tightly closed.

Do not store above 25°C.

6.5 Nature and contents of container

1) Bottle amber PET with polypropylene child resistant closure fitted with expanded polythene liner.

A spoon with a 5 ml and 2.5 ml measure is supplied with this pack.

Pack size: 100 ml and 150 ml.

Contained in a box board carton.

2) Bottle amber glass with polypropylene child resistant closure fitted with an expanded polyethylene liner.

A spoon with a 5 ml and 2.5 ml measure is supplied with this pack.

Pack size 100, 125ml or 150ml.

Contained in a box board carton.

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 Limited

50 - 100 Holmers Farm Way

High Wycombe

Buckinghamshire

HP12 4EG

UK

8. Marketing authorisation number(s)

PL 15513/0168

9. Date of first authorisation/renewal of the authorisation

19 March 2009

10. Date of revision of the text

10 March 2021