FlexiHerb – SPC Summary of Product Characteristics 1 Name of the medicinal product Flexiherb Muscle & Joint Pain Relief tablets Jointlieve Devil’s Claw film-coated tablets Higher Nature Devil’s Claw Muscle & Joint Pain Relief film-coated tablets Zipvit Devil’s Claw Joint Relief tablets Simply Supplements Devil’s Claw Muscle and Joint Pain Relief tablets 2 Qualitative and quantitative composition Each film-coated tablet contains 600 mg of extract (as dry extract) from Devil’s Claw root (Harpagophytum procumbens) (equivalent to 900-1500 mg of Devil’s Claw root). Extraction solvent: water Also contains 170mg of lactose monohydrate and 20 mg of sucrose (See Section 4.4 ‘Special warnings and precautions for use.’) For full list of excipients, see section 6.1 3 Pharmaceutical form Film-coated tablet. White, oblong, smooth surface film coating without ruptures. 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 only. For adults and the elderly, take 1 tablet twice daily. Take one dose in the morning and one in the evening. The dose can be increased to 2 tablets twice daily if the patient does not obtain relief after 3-5 days. Tablets should be swallowed whole with a little liquid. The tablets should not be chewed. 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 the symptoms worsen, or do not improve after four weeks, a doctor or a qualified healthcare practitioner should be consulted. 4.3 Contraindications Do not use in cases of known hypersensitivity to the active substance or one 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 the symptoms worsen, or do not improve after four weeks a doctor or qualified healthcare practitioner should be consulted. The use in children or adolescents less than 18 years old is not recommended due to lack of adequate data If articular pain accompanied by swelling of joint, redness or fever are present, a doctor should be consulted. This product contains sucrose. 1 film-coated tablet contains max. 20mg of sucrose or 0,031 carbohydrate units. This product contains lactose. 1 film-coated tablet contains max. 170 mg lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine. Patients with gallstones should consult a doctor prior to taking Devils 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 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, abdomina 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 a 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 continual monitoring of the benefit/risk 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 No case of overdose has been reported. 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 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 Cellulose, powdered Lactose monohydrate Sodium Starch Glycolate (Type A) Silica, colloidal anhydrous Magnesium stearate Sucrose Titanium dioxide E 171 Hypromellose Cellulose, microcrystalline Stearic acid. 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 Original packages containing 40 film-coated tablets (Jointlieve Devil’s Claw film-coated tablets, Higher Nature Devil’s Claw Muscle & Joint Pain Relief film-coated tablets, ZipVit Devil’s Claw Joint Relief tablets). The tablets are packed in PVC/ PVDC aluminium blisters and inserted into a carton together with the package leaflet. Not all pack sizes may be marketed. 6.6 Special precautions for disposal No special requirements 7 Marketing authorisation holder Schwabe Pharma (UK) Ltd Alexander House Mere Park Dedmere Road Marlow Buckinghamshire SL7 1FX 8 Marketing authorisation number THR 23056/0001 9 Date of first authorisation/renewal of the authorisation 02/06/2017 10 Date of revision for the text 02/06/2017
