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THE BOOTS COMPANY PLC BOOTS EASY BREATHING PASTILLES

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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
Abietis Oil BPC 1949
Menthol BP

3

0.3% V/W
0.3% V/W
0.6% W/W

PHARMACEUTICAL FORM
Pastille

4

CLINICAL PARTICULARS

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

4.6.

Interaction with other medicinal products and other forms of interaction
None reported.

Fertility, Pregnancy and Lactation
Pregnancy
There is no or inadequate evidence of the safety of the active ingredients in this medicine in
human pregnancy. The potential risk for humans is unknown.
In the absence of sufficient data, the use during pregnancy is not recommended.
Lactation
It is not known whether the active ingredients of this product are excreted in human breast
milk.
In the absence of sufficient data, the use during lactation is not recommended.
Fertility
Studies on the effects on fertility have not been investigated.

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 mentholcontaining preparations.

4.9

Overdose
No example of overdose has been reported.

5

PHARMACOLOGICAL PROPERTIES

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

PHARMACEUTICAL PARTICULARS

6.1

List of excipients
Granulated sugar
Crystal Gum 85
Liquid Glucose BPC
Peppermint oil
Eucalyptus oil
Water

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 g

Securitainer, 500 g
Heat-sealed laminated sachet integral with carton, 45 g

6.6

Special precautions for disposal
None specific to the packs.

7

MARKETING AUTHORISATION HOLDER
Ernest Jackson & Co Ltd
High Street
Crediton
Devon
EX17 3AP
UK

8

MARKETING AUTHORISATION NUMBER(S)
PL 00094/5014R

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
First granted 23rd April 1987
Renewed 23rd April 1992

10

DATE OF REVISION OF THE TEXT
07/08/2012

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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