SUMMARY OF PRODUCT CHARACTERISTICS

1    NAME OF THE MEDICINAL PRODUCT

Potter’s Joint Pain Relief

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Each film coated tablet contains: -

75 mg Yarrow Herb (Achillea millefolium L.)

60 mg Elder Flower (Sambucus nigra L.)

60 mg Prickly Ash, Southern Bark (Zanthoxylum clavaherculis L.)

24 mg of extract (as dry extract) from Uva Ursi Leaf (Arctostaphylos uva-ursi (L.) Spreng) (5:2) (equivalent to 60 mg Uva Ursi leaf)

Extraction Solvent: Water

22 mg of extract (as dry extract) from Burdock Root (Arctium lappa L.) (100:37) (equivalent to 60 mg Burdock root)

Extraction Solvent: Water

17 mg of extract (as dry extract) from Clivers Herb (Galium aparine L.) (100:28)

(equivalent to 61 mg Clivers herb)

Extraction solvent: Water

6 mg of extract (as dry extract) from Poplar Bark (Populus tremuloides Michx.) (10:1) (equivalent to 60 mg Poplar bark)

Extraction solvent: Water

For full list of excipients see Section 6.1.

3 PHARMACEUTICAL FORM

Tablet.

A brown mottled, round biconvex film-coated tablet.

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

A traditional herbal remedy used for the symptomatic relief of rheumatic pain and general aches and pains in the muscles and joints, based on traditional use only.

For oral use only.

Adults and the elderly: Take two tablets three times a day with food.

The use in children and adolescents under 18 years of age is not recommended (see section 4.4 ‘Special warnings and precautions for use’).

If symptoms worsen or persist for more than 4 weeks, a doctor or a qualified health care practitioner should be consulted.

4.3 Contraindications

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

Kidney disorders

Hypersenstivity to salicylates or to other NSAIDs (e.g history of angiodema, bronchial spasm or chronic urticaria in response to salicylates or other NSAIDs)

Gastric/duodenal ulcers

4.4 Special warnings and precautions for use

Do not exceed the stated dose.

The use of this product is not recommended in children and adolescents under 18 years of age because data are not sufficient and medical advice should be sought.

If symptoms worsen or persist for more than 4 weeks, a doctor or a qualified health care practitioner should be consulted.

If articular pain accompanied by swelling of the joint or redness or fever is experienced, a doctor or qualified healthcare practitioner should be consulted. Concomitant use with salicylates or to other NSAIDs is not recommended without medical advice.

Uva ursi leaf may cause a greenish-brown coloration of the urine.

4.5 Interaction with other medicinal products and other forms of interaction

Interaction between the product and anticoagulant/antiplatelet drugs may occur.

4.6 Fertility, Pregnancy and lactation

The safety of this product during pregnancy and lactation has not been established, therefore the use of this product during pregnancy and lactation is not recommended.

Studies on fertility have not been carried out.

4.7 Effects on ability to drive and use machines

No studies on the effect on the ability to drive and use machines have been performed.

4.8 Undesirable effects

Possible side effects are nausea, vomiting, stomach cramps have been reported with Uva ursi and gastrointestinal symptoms e.g. diarrhoea.

Hypersensitivity reactions of the skin have been reported with Yarrow herb and anaphylactic shock has been reported with Burdock root. The frequency is not known.

If any other adverse effects not mentioned above occur, a doctor or a qualified healthcare 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

4.9 Overdose

Nausea, vomiting and diarrhoea may occur.

Treatment should be symptomatic and supportive in nature.

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.

Available tests on genotoxicity of water and ethanolic extracts of Uva ursi leaf are inadequate. Reproductive toxicity has not been studied. Available carcinogenicity studies have been negative.

Arbutin, the principal component of Uva ursi leaf, displayed some maternal and fetal toxicity in rats after subcutaneous administration of 400 mg/kg/day. No effect on reproduction has been observed at doses of 100 mg/kg/day.

Toxicity tests with hydroquinone, a hydrolysis product of arbutin, have demonstrated some evidence of genotoxicity and carcinogenicity. Risks posed by the exposure of hydroquinone during the short-term treatment with Uva ursi leaf preparations are considered minima

6    PHARMACEUTICAL PARTICULARS

6.1    List of excipients

Calcium Hydrogen Phosphate

Maltodextrin

Acacia Gum

Talc

Magnesium Stearate Croscarmellose Sodium Ethyl Cellulose

6.2 Incompatibilities

None known.

6.3 Shelf life

3 years.

6.4 Special precautions for storage

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

Tamper evident polyethylene/polypropylene pot packed in a cardboard box: 60, 84, 100, 126, 168 and 200 tablets.

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/ 0027

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

12/04/2013

10 DATE OF REVISION OF THE TEXT

28/09/2015