SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

Vitabiotics 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.

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 product during pregnancy and lactation has not been established. In the absence of sufficient data the use in 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.

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 in this leaflet 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

VITABIOTICS 1 ASPLEY WAY LONDON NW2 7HF

8    MARKETING AUTHORISATION NUMBER(S)

THR 00387/0056

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

26/09/2011

10 DATE OF REVISION OF THE TEXT

26/09/2011