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Holland & Barrett Herbal Rheumatic Pain Relief Tablets

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SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

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

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Each tablet contains:

50 mg Guaiacum Resin ( Guaiacum officinale L.)

24 mg of extract Dandelion root (Taraxacum officinale Weber ex Wigg)

7.5    mg of extract (as dry extract) from Celery fruit (Apium graveolens L.) (46:1)

Extraction solvent: Ethanol 50% v/v

7.5    mg of extract (as dry extract) from Buckbean herb (Menyanthes trifoliata L.) (5-7:1)

Extraction solvent: Ethanol 50% v/v For full list of excipients, see section 6.1

3 PHARMACEUTICAL FORM

Tablet

Brown round 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: One or two tablets to be taken after each meal.

If symptoms worsen or persist after 4 weeks, a doctor or a qualified healthcare practitioner should be consulted.

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

4.3 Contraindications

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

Obstructions of bile ducts, cholangitis, liver diseases, gallstones active peptic ulcer and any other biliary diseases

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 not sufficient and medical advice should be sought.

If symptoms persist or worsen 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.

The use in patients with renal failure and/or diabetes, and/or heart failure should be avoided because of possible risks due to hyperkalemia.

4.5 Interaction with other medicinal products and other forms of interaction

None known.

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.

Studies on the effects 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

Epigastric pain, hyperacidity and allergic reactions may occur with Dandelion root. The frequency is not known.

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

4.9 Overdose

No case of overdose has been reported for this product.

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

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

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Extract excipients:

Maltodextrin

Colloidal anhydrous silica

Tablet core

Calcium Sulphate Dihydrate Sago Flour

Calcium Phosphate Dibasic Magnesium Trisilicate

Stearic Acid Capsaicin

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. Store in the original package.

6.5 Nature and contents of container

Polystyrene tampertainer.

Pack size: 100 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 14010/0041

9    DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 19/04/2013

10


DATE OF REVISION OF THE TEXT

19/04/2013