SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

Potter’s Backache Relief

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Each film-coated tablet contains: -

60 mg Shepherd’s Purse herb (Capsella bursa-pastoris L.)

60 mg Wild Carrot root (Daucus carota L.)

60 mg of extract (as dry extract) from Uva Ursi leaf (Arctostaphylos uva-ursi (L.) Spreng) (5:2) (equivalent to 150 mg Uva Ursi leaf)

Extraction Solvent: Water

35 mg of extract (as dry extract) from Clivers herb (Galium aparine L.) (100:28) (equivalent to 125 mg Clivers herb)

Extraction solvent: Water

For full list of excipients see Section 6.1

3 PHARMACEUTICAL FORM

Tablet.

A pale olive green, round biconvex film-coated tablet

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

A traditional herbal medicinal product used for the symptomatic relief of lower backache including lumbago and sciatica, based on traditional use only.

4.2 Posology and method of administration

For oral use only.

Adults and the elderly: Two tablets three times a day.

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 healthcare practitioner should be consulted.

4.3 Contraindications

Hypersensitivity to the active ingredients or any of the excipients. Kidney disorders.

4.4 Special warnings and precautions for use

Do not exceed the stated dose.

A doctor or qualified healthcare practitioner should be consulted if pain is accompanied by swelling of the joints or redness or if fever is experienced.

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

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

4.5 Interaction with other medicinal products and other forms of interaction

None known.

4.6 Fertility, Pregnancy and lactation

The safety of this product during pregnancy and lactation has not been established. Therefore in the absence of sufficient data, the use of this product during pregnancy and lactation is not recommended.

Studies on fertility have not been performed.

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

Nausea, vomiting, stomach ache have been reported with the use of Uva ursi leaf. The frequency is not known.

If any adverse reactions 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

No cases of overdose have been reported.

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 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 foetal 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 hydrquinone during the short-term treatment with Uva ursi leaf preparations are considered minimal.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Maltodextrin

Microcrystalline Cellulose Calcium Hydrogen Phosphate Colloidal Anhydrous Silica Croscarmellose Sodium Magnesium Stearate Hydroxypropyl Cellulose

Sodium Copper Chlorophyllin (E141) Titanium Dioxide (E171)

Black Iron Oxide (E172)

Yellow Iron Oxide (E172)

Ethyl Cellulose Juniper Berry Oil

6.2 Incompatibilities

None known.

6.3 Shelf life

Three years.

6.4 Special precautions for storage

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

6.5 Nature and contents of container

Tamper evident polyethylene/polypropylene pot packed in a cardboard box: 50, 60, 84 and 100 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

MARKETING AUTHORISATION NUMBER(S)

THR 44893/0011

DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

25/02/2013

DATE OF REVISION OF THE TEXT

28/09/2015