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

1 film-coated tablet contains 600 mg of extract (as dry extract aqueous) from Devil’s Claw root (Harpagophytumprocumbens) (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.

4.3 Contraindications

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 adolescents, and safety is not established.

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

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

There is no evidence, from limited interaction studies, that Devil’s claw root extracts will interact with other medicinal products.

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.

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 above occur, a doctor or a 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

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.

6.2    Incompatibilities

Not applicable

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 containing 40 or 60 film-coated tablets (Flexiherb Muscle & Joint Pain Relief tablets, Simply Supplements Devil’s Claw Muscle and Joint Pain Relief tablets)

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

REGISTRATION HOLDER

Schwabe Pharma (UK) Ltd Alexander House Mere Park Dedmere Road Marlow

Buckinghamshire SL7 1FX

8 MARKETING AUTHORISATION NUMBER(S)

THR 23056/0001

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

10 DATE OF REVISION OF THE TEXT

08/08/2014