SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

Potter’s Catarrh Mixture

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Each 5 ml contains: -0.6 ml of extract (as liquid extract) from Boneset herb (Eupatorium perfoliatum L.) (1:1) (equivalent to 0.6 gm Boneset herb)

Extraction Solvent: Water 0.35 ml of extract (as liquid extract) from Hyssop herb (Hyssopus officinalis L.) (1:1) (equivalent to 0.35 gm Hyssop herb)

Extraction Solvent: Water 0.25 ml of extract (as liquid extract) from Burdock Root (Arctium lappa L.) (1:1) (equivalent to 0.25 gm Burdock Root)

Extraction Solvent: Water

Excipients:

5 ml of oral liquid contains approximately 0.6 ml of ethanol. (See Section 4.4 “Special warnings and precautions for use”.)

For a full list of excipients, see section 6.1

3 PHARMACEUTICAL FORM

Oral liquid.

A brown liquid.

CLINICAL PARTICULARS

4.1 Therapeutic indications

A traditional herbal medicinal product used to relieve the symptoms of nasal catarrh and catarrh of the throat, based on traditional use only.

4.2 Posology and method of administration

For oral use.

Adults and the elderly: One 5 ml teaspoonful three times a day.

Children and adolescents over 12 years: One 5 ml teaspoonful morning and evening.

Not recommended for children under 12 years of age. (See section 4.4 ‘Special warnings and precautions for use’.)

Duration of use:

Do not use this product for more than 7 days.

If the symptoms do not improve within 7 days, or in cases of fever lasting several days or in cases of shortness of breath or blood in the saliva, a doctor should be consulted.

4.3 Contraindications

Hypersensitivity to the active ingredients, other plants of the Asteraceae (Compositae) family or any of the excipients.

4.4 Special warnings and precautions for use

Do not exceed the stated dose.

If the symptoms do not improve within 7 days, or in cases of fever lasting several days or in cases of shortness of breath or blood in the saliva, a doctor should be consulted.

Not recommended for children under 12 years of age because data are not sufficient and medical advice should be sought.

This medicinal product contains 11.7% v/v ethanol (alcohol). Each 5 ml corresponds to 468 mg alcohol equivalent to 11.7 ml beer, 4.9 ml wine.

Harmful for those suffering from alcoholism. To be taken into account in pregnant or breast-feeding women, children and high-risk groups such as patients with liver disease or epilepsy.

4.5 Interaction with other medicinal products and other forms of interaction

Contains alcohol and should be avoided in patients taking other medicines known to interact with alcohol (e.g. metronidazole).

4.6    Fertility, Pregnancy and lactation

Safety during pregnancy and lactation has not been established.

In the absence of sufficient data, the use during pregnancy and lactation is not recommended.

Tests on the effects on fertility have not been performed.

4.7    Effects on ability to drive and use machines

This product contains alcohol and therefore may impair ability to drive or operate machines. If affected do not drive or operate machines (See Section

4.4 ‘Special warnings and precautions for use’.)

4.8 Undesirable effects

Anaphylactic shock has been reported with the use of Burdock root. The frequency is not known.

If other adverse reactions not mentioned above occur, a doctor or a qualified health care practitioner should be consulted.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard

Overdose

No cases have been reported.

Overdose of this product may result in alcohol intoxication: the amount of alcohol in a full bottle (9.36 gm in 100 ml; 18.72 gm in 200 ml: equivalent to 0.4 and 0.8 large glasses of wine, respectively) may result in intoxication and should be treated accordingly.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Not required as per Article 16c(1)(a)(iii) of Directive 2001/83/EC as amended.

5.2 Pharmacokinetic properties

Not required as per Article 16c(1)(a)(iii) of Directive 2001/83/EC as amended.

5.3 Preclinical safety data

Tests on reproductive toxicity, genotoxicity and carcinogenicity have not been performed.

6    PHARMACEUTICAL PARTICULARS

6.1    List of excipients

Rectified Spirit (90% ethanol)

Capsicum Tincture(capsicum oleoresin, 90% ethanol)

Colour Solution (caramel, glycerin, 90% ethanol, water)

Cherry Flavouring (non-natural with propylene glycol, water, ethanol) Water

6.2 Incompatibilities

None known.

6.3 Shelf life

Three years.

6.4 Special precautions for storage

Do not store above 25°C. Keep in the original container.

6.5 Nature and contents of container

Glass bottle with child-resistant safety cap contained in cardboard carton: 75 ml, 100 ml, 135 ml, 150 ml, 200 ml or 250 ml.

Not all pack sizes may be marketed.

6.6 Special precautions for disposal

There are no special precautions for disposal.

7 MARKETING AUTHORISATION HOLDER

Soho Flordis UK Limited 1 Botanic Court,

Martland Park,

Wigan,

WN5 0JZ,

UK.

Trading as: Potters, Wigan WN5 0JZ

8    MARKETING AUTHORISATION NUMBER(S)

THR 44893/0004

DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

17/04/2012

DATE OF REVISION OF THE TEXT

28/09/2015