Summary of medicine characteristics - LIFEPLAN DEVILS CLAW JOINT RELIEF TABLETS
1 NAME OF THE MEDICINAL PRODUCT
Lifeplan Devil’s Claw Joint Relief Tablets.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 95.75mg of extract (as dry extract) from Devil’s Claw root (Harpagophytum procumbens DC. and / or H.zeyheri L. Decne.) root (equivalent to 335.13mg – 478.75mg). Extraction solvent: Ethanol 60% v/v.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Beige brown circular tablet.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
A traditional herbal medicinal product used for 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 only.
Adults and elderly: 2 tablets three times daily immediately after food.
This product is not recommended for use in children or adolescents less than 18 years old (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 Devils claw, or any of the other excipients
4.4 Special warnings and precautions for use
Do not exceed the stated dose.
If symptoms worsen or persist for more than 4 weeks, a doctor or a qualified healthcare practitioner should be consulted.
If articular pain accompanied by swelling of joint, redness or fever are present a doctor should be consulted.
The use of this product in children or adolescents under 18 years old is not recommended because data are not sufficient and medical advice should be sought.
Caution should be taken when Devil’s claw is administered to patients with cardiac disorders.
As a general precaution, patients with a 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
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. In rare cases some patients have experienced dizziness and somnolence while taking Devil’s claw. If affected, patients should not drive or use machinery.
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 effects not mentioned above occur, a doctor or qualified health care 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 at: www.mhra.gov.uk/yellowcard
4.9 Overdose
4.9 OverdoseThere 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 applicable -not required as per Article 16c (1) (a) (iii) of Directive 2001/83/EC as amended.
5.3 Preclinical safety data
5.3 Preclinical safety dataTests on reproductive toxicity, genotoxicity and carcinogenicity have not been performed.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Excipients in the extract
Maltodextrin
Silica colloidal anhydrous.
Excipients in the tablet
Dicalcium phosphate dihydrate
Microcrystalline cellulose
Magnesium stearate
Stearic acid
Croscarmellose sodium
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 packaging.
6.5 Nature and contents of container
Amber glass bottle with polypropylene cap and induction seal in cardboard carton. Pack size 60 tablets.
6.6 Special precautions for disposal
6.6 Special precautions for disposalNo special requirements.
7 MARKETING AUTHORISATION HOLDER
Lifeplan Products Ltd
Elizabethan Way, Lutterworth,
Leicestershire, United Kingdom
LE17 4ND
Telephone: +44 (0) 1455 556281
8 MARKETING AUTHORISATION NUMBER(S)
THR 20093/0003
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THEAUTHORISATION
11/02/2015