Boxs Herbals Jointease Tablets
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Napiers Golden Joint Tablets Box's Herbals Jointease Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each coated tablet contains: -
60 mg of Guaiacum resin (Guaiacum officinale L)
60 mg of Prickly Ash Northen bark (Zanthoxylum americanum Mill)
0.04 mg of Celery seed oil (Apium graveolens L oil)
Each tablet contains 197 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
Coated tablet, round
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
A traditional herbal medicinal product used for the relief of backache, rheumatic or muscular 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.
Adults and the elderly: Two tablets three times daily after meals.
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 do not improve after 4 weeks a doctor or a 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.
If symptoms worsen or do not improve after 4 weeks a doctor or a qualified healthcare practitioner should be consulted.
If articular pain accompanied by swelling of the joint, redness or fever are present, a doctor should be consulted.
This product contains sucrose. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.
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 have been carried out to determine if drug interactions occur with this product.
4.8 Undesirable effects
None known.
If adverse reactions occur, 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.
6.1 List of excipients
Capsicum Oleoresin Pre-gelatinised starch
Confectioner’s sugar (sucrose & maize starch)
Acacia
Colloidal silica anhydrous
Sodium starch glycolate
Stearic acid
Talc
Ethanol
Sucrose
Calcium carbonate Shellac
Beetroot powder Beeswax
Carnauba wax
6.2 Incompatibilities
Not applicable.
6.3 Shelf life
3 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
in a
Polyethylene pot with polyethylene tamper-proof closure, packed cardboard carton: 50, 100, and 200 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
Highland Herbs Limited 10 Payne Street Glasgow G4 0LF
8 MARKETING AUTHORISATION NUMBER(S)
THR 43751/0018
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
25/03/2013
10 DATE OF REVISION OF THE TEXT
19/01/2015