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POTTERS DECONGESTANT PASTILLES

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Potter's Decongestant Pastilles

2.

QUALITATIVE AND QUANTITATIVE COMPOSITION
Menthol BP
Eucalyptus Oil BP

3.

0.8% w/w
0.6% v/w

PHARMACEUTICAL FORM
Pastille

4.

CLINICAL PARTICULARS

4.1.

Therapeutic indications
For the relief of coughs and catarrhal colds.

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. Dosage restricted by age in any 24 hour period.
Contains a total of 1.0g 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.

Interactions with other medicaments and other forms of interaction
No such interactions have been reported.

4.6.

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
The pastilles do not affect the ability to drive or use machines.

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 overdose has been reported.

5.

PHARMACOLOGICAL PROPERTIES

5.1.

Pharmacodynamic properties
Menthol and eucalyptus, in combination relieve the symptoms of catarrh and
coughs.

5.2.

Pharmacokinetic properties
Not applicable.

5.3.

Preclinical safety data
No preclinical safety data is available for the product.

6.

PHARMACEUTICAL PARTICULARS

6.1.

List of excipients
Granulated sugar
Modified starch
Liquid glucose
Acetic acid
Water

6.2.

Incompatibilities
None known.

6.3.

Shelf life
60 months for the unopened pack.
6 months after the pack has been opened.

6.4.

Special precautions for storage

None.

6.5.

Nature and contents of container
Heat sealed lined carton 45g or 50g
Tied polythene bag 500g
Securitainer 500g

6.6.

Instructions for use/handling
None.

ADMINISTRATION DETAILS

7.

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

8.

MARKETING AUTHORISATION NUMBER(S)
PL 0094/5017R

9.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
First grant 23 April 1987 / Renewed 22 September 1998 and 07 January 2004

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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