More Information about FlexiHerb
Summary of Product Characteristics (SPC)
1 Name of the medicinal product
Flexiherb film-coated tablets
2 Qualitative and quantitative composition
1 film-coated tablet contains 600 mg of extract (as dry extract aqueous) from Devil’s Claw root (Harpagophytum procumbens) (equivalent to 900-1500 mg of Devil’s Claw root).
Excipients: 1 film-coated tablet contains 170mg of lactose monohydrate and 20 mg of sucrose. 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 short term use only. The patient should consult a doctor if symptoms worsen or do not improve after 8 weeks. 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. This product is not indicated for use in patients less than 18 years old.
Do not use in cases of known hypersensitivity to the active substance or one of the excipients. Patients under 18 years of age.
4.4 Special warnings and precautions for use
Do not exceed the stated dose.
If the condition worsens, or if symptoms persist for more than eight weeks, or if adverse effects not mentioned in the package leaflet occur, consult a healthcare practitioner.
The dosing and safety of Devil's claw have not been studied thoroughly in children, and safety is not established.
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.
As a general precausion, 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
There is no evidence, from limited interaction studies, that Devil's clae root extracts will interact with other medicinal products. 4.6 Pregnancy and lactation The safety of the product during pregnancy and lactation has not been established. Therefore it should be avoided during pregnancy or lactation.
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.
4.8 Undesirable effects
Gastrointestinal disorders: diarrhoea, nausea, vomiting, abdomina pain. Central
Nervous system disorders: Headache, dizziness Skin disorders: allergic skin reactions (rash and itching)
The frequency is not known.
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
The active constituents of Devil's claw have not been definitively established. However, the iridoid glycoside constituents, such as harpagoside, are considered to play an important role in its activity. It is thought that Devil's claw root does not produce the biochemical effects on arachidonic acid metabolism characteristic of anti-arthritic drugs such as the NSAIDs.
5.2 Pharmacokinetic properties
Non-clinical pharmacokinetic studies have not been conducted.
5.3 Preclinical safety data
The preclinical toxicology data available are limited. Tests on reproductive toxicity, genotoxicity 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.
6.3 Shelf life
The shelf life is 3 years
6.4 Special precautions for storage
Do not store above 25°C.
6.5 Nature and contents of container
Original packages contain 30, 40, 60 and 80 film-coated tablets FlexiHerb film-coated tablets are packed in PVC/ PVDC- aluminium blisters and inserted into a carton.
6.6 Special precautions for disposal
No special requirements
7 Registration holder
Schwabe Pharma (UK) Ltd Alexander House Mere Park Dedmere Road Marlow Buckinghamshire SL7 1PD
8 Registration number
9 Date of first registration
26th January 2007
10 Date of revision for the text
31st August 2010