Thompson And Capper Devils Claw Tablets
Out of date information, search anotherSUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Thompson and Capper Devil’s Claw tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 600mg of extract (as dry extract) from Devil’s Claw root (Harpagophytumprocumbens D.C. and /or H. zeyheri L. Decne, radix) (Equivalent to 2100mg-3000mg of Devil’s Claw root).
Extraction solvent: Ethanol 60% v/v For full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film Coated Tablets
Green Oval Shaped Film Coated Tablet
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 administration.
For adults and the elderly, take one tablet twice a day (in the morning and in the evening) Tablets should be swallowed with some water or other liquid.
The use in children or 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 qualified healthcare practitioner should be consulted.
4.3 Contraindications
Hypersensitivity to the active substance or any of the excipients.
4.4 Special warnings and precautions for use
Do not exceed the stated dose.
If the condition worsens during the use of the product or symptoms persist for more than 4 weeks consult a doctor or qualified healthcare practitioner.
The use of this product in children or adolescents under 18 years of age is not recommended because data are not sufficient and medical advice should be sought.
If articular pain accompanied by swelling of joint, redness or fever are present a doctor should be consulted.
Caution should be taken when Devil’s claw is administered to patients with cardiac disorders.
As a general precaution, patients with gastric or duodenal ulcer should not use Devil’s claw preparations
4.5 Interaction with other medicinal products and other forms of interaction
None Known
4.6 Fertility, Pregnancy and lactation
The safety of the prouct during pregnancy and lactation has not been established. In the absence of sufficient data the use in pregnancy and lactation is not recommended.
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. In rare cases some patients have experienced dizziness and somnolence while taking Devil’s claw.
4.8 Undesirable effects
Gastrointestinal disorders: diarrhoea, nausea, vomiting, abdominal pain. Central Nervous system disorders: headache, dizziness. Skin disorders: allergic skin reactions (rash and itching) 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
There are no data on human overdose with Devil’s claw. Symptomatic and supportive measures should be taken as appropriate.
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 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Extract
Maltodextrin
Silica colloidal anhydrous
Tablet Core Maltodextrin Microcrystalline cellulose Croscarmellose Sodium Stearic Acid Magnesium Stearate Silica Collodical Anhydrous
Tablet coating Hypromellose Copper Chlorophyllin Titanium Dioxide (E171)
Glycerol
6.2 Incompatibilities
None known.
6.3 Shelf life
30 months
6.4 Special precautions for storage
Do not store above 25 °C. Store in the original packaging.
6.5 Nature and contents of container
Tablets are packed into PVC/PVDC blister strips of 15 tablets in the following pack sizes; 30, 60, 90 Tablets and packed into a Carton
Not all pack sizes may be marketed.
6.6 Special precautions for disposal
No special requirements.
7 MARKETING AUTHORISATION HOLDER
THOMPSON & CAPPER (UK) LTD
HARDWICK ROAD
ASTMMOOR
RUNCORN
CHESHIRE
WA7 1PH
8 MARKETING AUTHORISATION NUMBER(S)
THR 01359/0007
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
16/06/2011
10 DATE OF REVISION OF THE TEXT
16/06/2011