SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

Nutrition Warehouse Herbal Joint Pain Relief Tablets Holland & Barrett Herbal Joint Pain Relief Tablets

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Each tablet contains:

250 mg of extract (as dry extract) from Willow bark (Salix alba L.) (6-8:1) Extraction solvent: Ethanol 50% v/v

10 mg of extract (as dry extract) from Passion Flower herb (Passiflora incarnata L.) (4-6:1)

Extraction solvent: Ethanol 70% v/v

15 mg of extract (as dry extract) from Valerian root (Valeriana officinalis L.) (5-6:1)

Extraction solvent: Ethanol 70% v/v For full list of excipients, see section 6.1

3    PHARMACEUTICAL FORM

Tablet

Brown round biconvex tablet.

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

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

4.2 Posology and method of administration

For oral use only.

Adults and the elderly: 1- 2 tablets up to four 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.’)

Duration of use

If symptoms worsen or do not improve after 4 weeks, a doctor or qualified healthcare practitioner should be consulted.

4.3 Contraindications

Hypersensitivity to the active ingredients or to any of the excipients. Hypersensitivity to salicylates or to other NSAIDs (e.g. history of angioedema, bronchial spasm, or chronic urticaria in response to salicylates or to other NSAIDs).

Asthma.

Active peptic ulcer disease.

Severe liver or renal dysfunction, coagulation disorders, gastric/duodenal ulcer and glucose-6- phosphate dehydrogenase deficiency.

4.4 Special warnings and precautions for use

Do not exceed the stated dose.

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

If symptoms worsen or do not improve after 4 weeks, a doctor or qualified healthcare practitioner should be consulted.

If articular pain is accompanied by swelling of the joint, redness of if fever occurs, a doctor should be consulted.

Concomitant use with salicylates and other NSAIDs is not recommended without medical advice.

4.5 Interaction with other medicinal products and other forms of interaction

Willow bark may increase the effects of anticoagulants such as coumarin derivatives.

Only limited data on pharmacological interactions with other medicinal products are available. Clinically relevant interactions with drugs metabolised by the CYP 2D6, CYP 3A4/5, CYP1A2 or CYP 2E1 pathway has not been observed.

Additive effects with hypnotics and other sedative drugs cannot be excluded and therefore co-medication is not recommended as a general precaution.

The effect of Valerian may be potentiated by alcohol. Excessive concomitant consumption of alcohol should therefore be avoided.

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. Salicylates cross the placenta and appear in breast milk.

Studies on the effects on fertility have not been performed.

4.7    Effects on ability to drive and use machines

May impair the ability to drive and use machines. If affected, patients should not drive or operate machinery.

4.8 Undesirable effects

Allergic reactions such as rash, pruritis, urticaria, asthma, exanthema and gastrointestinal symptoms such as, nausea, vomiting, abdominal pain, dyspepsia, heartburn, diarrhoea may occur with Willow bark. The frequency is not known.

One case of hypersensitivity (vasculitis) and one case of nausea and tachycardia have been reported with Passion flower. The frequency is not known. Gastrointestinal symptoms, such as nausea, abdominal cramps, may occur with Valerian 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.

4.9 Overdose

No cases of overdose have not been reported.

Valerian root at a dose of approximately 20g caused benign symptoms (fatigue, abdominal cramp, chest tightness, light- headedness, hand tremor and mydriasis), which disappeared within 24 hours. If symptoms arise, treatment should be supportive.

After intake of very high doses of Valerian root over several years (daily consumption corresponding to approximately 30g of the drug) withdrawal symptoms (delirium) have been reported.

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

Extract excipients Maltodextrin

Silica, colloidal anhydrous Tablet core

Tribasic Calcium Phosphate Calcium Sulphate Dihydrate Potato Starch Stearic Acid

Dibasic Calcium Phosphate Ethylcellulose N100

6.2    Incompatibilities

None known

6.3    Shelf life

3 years

6.4    Special precautions for storage

Do not store above 25°C.

6.5 Nature and contents of container

PET (Polyethylene terephthalate) bottles. Pack size: 60 tablets.

6.6 Special precautions for disposal

There are no special precautions for disposal.

7 MARKETING AUTHORISATION HOLDER

Nutrition Warehouse Limited

Samuel Ryder House

Barling Way

Eliot Park

Nuneaton

Warwickshire

CV10 7RH

United Kingdom

8    MARKETING AUTHORISATION NUMBER(S)

THR 14010/0038

9    DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

19/04/2013

10    DATE OF REVISION OF THE TEXT

19/04/2013