Holland & Barrett Herbal Rheumatic Pain Relief Tablets
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