Summary of Product Characteristics (SmPC) - Lamberts Devils Claw tablets,Natures Best Devils Claw tablets
1 NAME OF THE MEDICINAL PRODUCT
Lamberts Devils Claw Tablets
Nature’s Best Devils Claw Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 450mg of extract (as dry extract) from Devil’s Claw root (Harpagophytum procumbens D.C. and/or H. zeyheri L. Decne, radix) (Equivalent to 1575mg to 2250mg 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).
Not recommended for use in children and adolescents under the age of 18 years (see section 4.4 ‘Special warnings and precautions for use’).
Tablets should be swallowed whole with some water or other liquid.
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 to any of the excipients.
Patients with active gastric or duodenal ulcer
4.4 Special warnings and precautions for use
Do not exceed the stated dose.
If symptoms worsen or do not improve after 4 weeks, a doctor or qualified healthcare practitioner.
The use in children or adolescents under 18 years of age is not recommended because of the lack of available data and medical advice should be sought.
If articular pain accompanied by swelling of joint, redness or fever are present a doctor should be consulted.
Patients with gallstones should consult a doctor prior to taking Devil’s Claw
4.5 Interaction with other medicinal products and other forms of interaction
None known
4.6 Fertility, pregnancy and lactation
The safety of the product during pregnancy and lactation has not been established. In the absence of sufficient data the use in pregnancy and lactation is not recommended.
No studies on the effects on fertility have 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. 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. Hypersensitivity reactions: rash, hives, facial oedema. The frequency is not known.
If other adverse reactions not mentioned above occur, a doctor or qualified healthcare practitioner should be consulted.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme website www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
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
Reverse mutation assays (Ames test) on bacteria indicated that the extract in product was not mutagenic in Salmonella typhimurium (strains TA 98, TA 100, TA 102, TA 1535 and TA 1537) mutation assays with or without metabolic activation.
Tests on reproductive toxicity and carcinogenicity have not been performed.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Extract
Maltodextrin
Silica colloidal anhydrous
Tablet Core
Maltodextrin
Microcrystalline cellulose
Sodium croscarmellose
Stearic Acid
Magnesium Stearate
Silica colloidal anhydrous
Tablet coating
Hypromellose
Titanium Dioxide
Copper Chlorophyllin (E141)
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 or 90 film coated 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
LAMBERTS HEALTHCARE LIMITED
1 LAMBERTS ROAD
TUNBRIDGE WELLS
KENT
TN2 3EH
8 MARKETING AUTHORISATION NUMBER(S)
THR 34425/0003
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
27/07/2016
10 DATE OF REVISION OF THE TEXT
16/01/2018