Skip to Content

POTTERS SUGAR FREE COUGH PASTILLES

View full screen / Print PDF » Download PDF ⇩

PDF Transcript

SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Potter's Sugar Free Cough Pastilles

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Liquorice Extract
Benzoin Tincture
Levomenthol
Star Anise Oil
Peppermint Oil

3

1.73% w/w
0.5% v/w
0.5% w/w
0.3% v/w
0.025% v/w

PHARMACEUTICAL FORM
Pastille

4

CLINICAL PARTICULARS

4.1

Therapeutic indications
For the symptomatic relief of bronchial catarrh, coughs and colds.

4.2

Posology and method of administration
The recommended dose for all ages is one pastille dissolved slowly in the mouth as
required.

4.3.

Contraindications
Hypersensitivity to menthol, liquorice, peppermint, benzoin, star anise oil, capsicin or
any of the other ingredients

4.4

Special warnings and precautions for use
Keep out of reach and sight of children. If symptoms persist, consult your doctor.
Contains sorbitol. Patients with rare hereditary problems of fructose intolerance
should not take this medicine.

4.5

Interaction with other medicinal products and other forms of interaction
None known

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
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

5.1.

Pharmacodynamic Properties
Liquorice extract and star anise oil have expectorant properties. Menthol and benzoin
in combination relieve the symptoms of bronchitis, sinusitis and similar conditions.
Peppermint is a source of menthol. Clove oil acts as a local analgesic. Capsicum is
counter irritant.

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
Gum Acacia
Sorbitol liquid, non-crystallising
Chloroform
Simethicone Antifoam (water, polydimethyl siloxane and silica mix, polyoxyethylene 20
sorbitan monostearate, glyceryl monostearate, sodium carboxymethyl cellulose, methyl-4hydroxybenzoate, propyl-4-hydroxybenzoate, hydrogen chloride)
Brilliant Black E151
Clove Leaf Oil
Capsicum Tincture
Vegetable oil
Beeswax
Water

6.2

Incompatibilities
None

6.3

Shelf life
Packs of 500 g, 60 months in the unopened pack and 6 months after opening.
45 g packs, 36 months in the unopened pack and 6 months after opening.

6.4

Special precautions for storage
None

6.5

Nature and contents of container
Tied polythene bag and Securitainer of 500 g.
Heat sealed triple laminate bag integral with carton of 45 g.
Heat sealed laminate bag of polypropylene and polyethylene in carton of 45 g

6.6

Special precautions for disposal
None

7

MARKETING AUTHORISATION HOLDER
Ernest Jackson & Company Limited
High Street
Crediton
Devon EX17 3AP
UK

8

MARKETING AUTHORISATION NUMBER(S)
PL 00094/5009R

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
01/10/1987 / 27/03/2003

10

DATE OF REVISION OF THE TEXT
31/12/2012

Expand Transcript

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.

Hide