SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

•    Holland & Barrett Devil’s Claw Capsules

•    GNC Live Well Devil’s Claw Capsules

•    Lifecycle Devil’s Claw Capsules

•    Nature’s Garden Devil’s Claw Capsules

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Each hard capsule contains 427mg of extract (as dry extract) from Devil’s Claw root (Harpagophytum procumbens D.C. and /or H. zeyheri L. Decne, radix) (Equivalent to 1493mg - 2133mg of Devil’s Claw root).

Extraction solvent: Ethanol 60% v/v.

For full list of excipients, see section 6.1

3 PHARMACEUTICAL FORM

Capsule, hard

Two piece clear hard capsules with grey/brown powder fill.

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. This is based on traditional use only.

Posology and method of administration

For oral use only

Adults and elderly- Take 1 capsule 2 times daily. Swallow the whole capsule with water. Take one capsule in the morning and one in the evening

Not for use in children or adolescents under 18 years (see section 4.4 ‘Special Warnings and Precautions for use’).

Duration of 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 the Devil’s claw or any of the excipients

4.4 Special warnings and precautions for use

•Not recommended for children and adolescents under 18 years of age because data are not sufficient and medical advice should be sought.

•Articular pain accompanied by swelling of joints, redness or fever should be examined by a doctor

•As a general precaution, patients with gastric or duodenal ulcer should not use Devil’s Claw root preparations

•Caution should be taken when Devil’s Claw is administered to patients affected by cardiovascular disorders

•If symptoms worsen or not improve after 4 weeks consult, a doctor or qualified Healthcare practitioner.

•Do not exceed the stated dose.

Interaction with other medicinal products and other forms of interaction

Not known.

4.6 Pregnancy and lactation

Safety during pregnancy and lactation has not been established. Due to the lack of data, use during pregnancy and lactation is not recommended.

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. However some patients have experienced dizziness and somnolence while taking Devil’s claw, which may affect the ability to drive and use machines.

4.8 Undesirable effects

•Gastrointestinal disorders such as, diarrhoea, nausea, vomiting and abdominal pain. •Central Nervous system disorders such as headache and dizziness.

•Skin disorders such as allergic skin reactions (rash and itching).

The frequency is not known.

If other adverse reactions not mentioned above occur, a doctor or qualified health care practitioner should be consulted.

4.9 Overdose

No case of overdose has been reported.

Symptomatic and supportive measures should be taken as appropriate.

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

Not required as per Article 16c(1)(a)(iii) of Directive 2001/83/EC as amended.

Tests on reproductive toxicity, genotoxicity and carcinogenicity have not been performed.

6    PHARMACEUTICAL PARTICULARS

6.1    List of excipients

Calcium Hydrogen phosphate dihydrate

Microcrystalline cellulose Magnesium stearate Silica colloidal hydrated

Excipients in the extract: Maltodextrin

Silica colloidal anhydrous

Capsule shell: Hypromellose

6.2 Incompatibilities

Not applicable

6.3 Shelf life

Three 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

Green Polyethylene terephthalate (PET) bottles with a chiffon green hinge cap (Polypropylene), with an inner seal liner designed to lift ‘n’ peel. The inner seal acts as a tamper evident seal under the cap. The Inner seal liner is made up of polyester film, polymer adhesive layer, polyester tab, polyolefin foam, aluminium foil and sealable polyester film

Pack size: 50 capsules and 100 capsules

6.6 Special precautions for disposal

No special requirements

7 MARKETING AUTHORISATION HOLDER

NBTY Europe Limited Samuel Ryder House Barling Way Nuneaton Warwickshire

CV10 7RH, United Kingdom

8    MARKETING AUTHORISATION NUMBER(S)

THR 21710/0005

9    DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

25/02/2011

10    DATE OF REVISION OF THE TEXT

04/01/2013