Boxs Herbals Rheumatox Tablets
Out of date information, search anotherSUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Napiers Joint Ability Herbal Tablets Box's Herbals Rheumatox Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains:-
30mg of Capsicum fruit (Capsicum frutescens L.)
50mg of Guaiacum resin (Guaiacum officinale L)
52mg of soft extract of Blue Flag rhizome (Iris versicolor L.) (100:52)
Extraction Solvent: Water
28mg of dry extract of Uva ursi leaf (Arctostaphylos uva-ursi L.) (5:2)
Extraction solvent: Water.
Each tablet contains 23 mg of sucrose (See section 4.4. Special warnings and precautions for use)
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablets, pink biconvex
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: Take two tablets three times a day.
The use in children and adolescents under the age of 18 is not recommended (see section 4.4 ‘Special warnings and precautions for 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 to any of the excipients.
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.
This product contains sucrose. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.
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.
Uva ursi leaf may cause a greenish-brown colouration of the urine.
4.5 Interaction with other medicinal products and other forms of interaction
No studies have been carried out to determine if drug interactions occur with this product.
4.6 Fertility, pregnancy and lactation
The safety of this product during pregnancy and lactation has not been established. In the absence of sufficient data the use of this product during pregnancy and lactation is not recommended.
Studies on the effect of this product on fertility have not been performed.
4.7 Effects on ability to drive and use machines
No studies on the effects on the ability to drive or operate machines have been performed.
4.8 Undesirable effects
Nausea , vomiting, stomach-ache have been reported with Uva ursi laef preparations. The frequency is not known.
If other adverse reaction occurs, a doctor or qualified health care practitioner should be consulted.
4.9 Overdose
No cases have been reported with 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
Tests on reproductive toxicity, genotoxicity and carcinogenicity have not been performed.
Available tests on genotoxicity of water and ethanolic extracts of Uvae ursi folium are inadequate. Reproductive toxicity has not been studied. Available carcinogenicity studies have been negative.
Arbutin, the principal component of Uvae ursi folium, 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 Uvae ursi folium preparations are considered minimal.
PHARMACEUTICAL PARTICULARS
6
6.1 List of excipients
Dicalcium phosphate, anhydrous Sucrose
Sodium starch glycolate
Magnesium stearate
Talc
Shellac
Kaolin light
Syrup (sucrose)
Beetroot powder Water
6.2 Incompatibilities
Not applicable.
6.3 Shelf life
3 years
6.4 Special precautions for storage
Do not store above 25oC. Store in the original container.
6.5 Nature and contents of container
Glass bottle with Bakelite type screw-cap, packed in a cardboard carton: 50 tablets 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
Rickard Lane’s and W. H. Box Ltd 24 Tennant Street
Edinburgh EH6 5ND
8 MARKETING AUTHORISATION NUMBER(S)
THR 15670/0042
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
04/04/2013
10 DATE OF REVISION OF THE TEXT
04/04/2013