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Drug information

Boots Easy Breathing pastilles

OTC
Read time: 1 mins
Last updated: 07 Dec 2011
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Summary of product characteristics


1. Name of the medicinal product

Boots Easy Breathing Pastilles


2. Qualitative and quantitative composition

Sylvestris Pine Oil

0.3% V/W

Abietis Oil BPC 1949

0.3% V/W

Menthol BP

0.6% W/W

For full list of excipients, see section 6.1


3. Pharmaceutical form

Pastille


4.1. Therapeutic indications

For the relief of catarrhal symptoms and coughs


4.2. Posology and method of administration

One pastille to be dissolved slowly in the mouth as required.ADULTS, THE ELDERLY AND CHILDREN OF 12 YEARS AND OVER: Do not take more than 18 pastilles in 24 hours.CHILDREN 6 – 12 YEARS:Do not take more than 12 pastilles in 24 hours.Not recommended for children under 6 years old.


4.3. Contraindications

Hypersensitivity to any of the ingredients


4.4. Special warnings and precautions for use

Keep out of reach and sight of children. If symptoms persist consult your doctor.Contains a total of 1.3g of sucrose and glucose per pastille. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.


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

None reported


4.6. Fertility, pregnancy and lactation

The use of Catarrh Pastilles during pregnancy and lactation is not restricted.


4.7. Effects on ability to drive and use machines

None


4.8. Undesirable effects

Isolated cases of hypersensitivity reactions including anaphylaxis, angioedema, bronchospasm, rash, urticaria and flushing have been reported with menthol-containing preparations.


4.9. Overdose

No example of overdose has been reported.


5.1. Pharmacodynamic properties

All the actives have decongestant properties.


5.2. Pharmacokinetic properties

Not applicable


5.3. Preclinical safety data

There is no preclinical data available specific to the product.


6.1. List of excipients

Granulated sugarModified starchLiquid Glucose BPCPeppermint oilEucalyptus oilWater


6.2. Incompatibilities

None known


6.3. Shelf life

60 months for the unopened pack.3 months after opening the 45g pack.6 months after opening the 500g pack.


6.4. Special precautions for storage

None


6.5. Nature and contents of container

Tied polythene bag, 500 gSecuritainer, 500 gHeat-sealed laminated sachet integral with carton, 45 g


6.6. Special precautions for disposal and other handling

None specific to the packs.


7. Marketing authorisation holder

Ernest Jackson & Co LtdHigh StreetCreditonDevon, EX17 3AP, UK


8. Marketing authorisation number(s)

PL 0094/5014R


9. Date of first authorisation/renewal of the authorisation

First granted 23 April 1987 / Renewed June 2004


10. Date of revision of the text

July 2011

4.1 Therapeutic indications

For the relief of catarrhal symptoms and coughs

4.2 Posology and method of administration

One pastille to be dissolved slowly in the mouth as required.ADULTS, THE ELDERLY AND CHILDREN OF 12 YEARS AND OVER: Do not take more than 18 pastilles in 24 hours.CHILDREN 6 – 12 YEARS:Do not take more than 12 pastilles in 24 hours.Not recommended for children under 6 years old.

4.3 Contraindications

Hypersensitivity to any of the ingredients

4.4 Special warnings and precautions for use

Keep out of reach and sight of children. If symptoms persist consult your doctor.Contains a total of 1.3g of sucrose and glucose per pastille. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.

4.5 Interaction with other medicinal products and other forms of interaction

None reported

4.6 Fertility, pregnancy and lactation

The use of Catarrh Pastilles during pregnancy and lactation is not restricted.

4.7 Effects on ability to drive and use machines

None

4.8 Undesirable effects

Isolated cases of hypersensitivity reactions including anaphylaxis, angioedema, bronchospasm, rash, urticaria and flushing have been reported with menthol-containing preparations.

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Drugs appearing in this section are approved by UK Medicines & Healthcare Products Regulatory Agency (MHRA), & the European Medicines Agency (EMA).