Summary of Product Characteristics

Product Summary

Summary of Product Characteristics

Example SPC Document relating to PAGB Children’s Tickly Cough Syrup

Product Summary

1. NAME OF THE MEDICINAL PRODUCT

PAGB Infant Tickly Cough Syrup

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

PAGB Infant Tickly Cough contains:

Glycerol 0.75ml/5ml

For excipients see section 6.1

3. PHARMACEUTICAL FORM

Syrup

4. CLINICAL PARTICULARS

4.1. Therapeutic indications

PAGB Infant Tickly Cough Syrup is indicated for the relief of dry tickly coughs.

4.2. Posology and method of administration

For oral administration.
Do not give to infants under 3 months.
Infants 3 to 12 months – One 5ml spoonful three to four times a day
Children 1 to 5 years – Two 5ml spoonfuls three to four times a day

4.3. Contraindications

Contraindicated in patients with a known hypersensitivity to any of the ingredients.

4.4. Special warnings and precautions for use

If symptoms persist for more than 3 days consult a doctor.
Not recommended for children under 3 months.

The packs will carry the following statements:

Store below 30oC.
Keep out of reach and sight of children.

As with all medicines, if your child is currently taking any other medicine, consult your doctor or pharmacist before this product is taken.

4.5. Interactions with other medicinal products and other forms of interaction

No known drug interactions.

4.6. Pregnancy and lactation

The safety of this product during pregnancy and lactation has not been established but it is not though to constitute a hazard.

4.7. Effects on ability to drive and use machines

No known effects.

4.8. Undesirable effects

No known adverse effects.

4.9. Overdose

Overdosage with the product may cause diarrhoea. Treatment should be symptomatic.

5. PHARMACOLOGICAL PROPERTIES

5.1. Pharmacodynamic properties

Glycerin has a demulcent effect and may block sensory cough receptors in the respiratory tract.

5.2. Pharmacokinetic properties

Non-stated

5.3. Preclinical safety data

Not applicable.

6. PHARMACEUTICAL PARTICULARS

6.1. List of excipients

Maltitol solution
Glycerol
Sodium benzoate
Saccharin sodium
Flavour (blackcurrant)
Purified water

6.2. Incompatibilities

None known.

6.3. Shelf life

36 months.

6.4. Special precautions for storage

Store below 30oC.

6.5. Nature and contents of container

30 ml, 40 ml, 50 ml 100 ml and 125 ml amber glass bottles with polypropylene screw caps fitted with PVDC faced wads or a 3 piece plastic child resistant, tamper evident closure fitted with a polyvinylidene chloride (PVDC) faced wad or polyethylene/expanded polyethylene laminated wad

The nature of the bottle and wad will be identical to the 30 ml and 100 ml pack sizes.

A spoon with a 5 ml measures will be included in each pack.

6.6. Instruction for use and handling (, and disposal)

None applicable.

Administrative Data

7. MARKETING AUTHORISATION HOLDER

PAGB
Vernon House
Sicilian Avenue
London WC1A 2QS
United Kingdom

8. MARKETING AUTHORISATION NUMBER

PL xxxxxxxxxxx

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

April 2000

10. DATE OF REVISION OF THE TEXT

April 2010