JOINTEEZE DEVILS CLAW TABLETS - summary of medicine characteristics

1 NAME OF THE MEDICINAL PRODUCT

JointEeze Devil’s Claw Tablets

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

One film-coated tablet contains 300mg of extract (as dry extract) from Devil’s Claw root (Harpagophytum procumbens D.C. and/or H. zeyheri L. Decne) (equivalent to 1050 – 1500mg Devil’s Claw root).

Extraction solvent: Ethanol 60%v/v.

Also contains glucose monohydrate.

For a full list of excipients, see section 6.1.

3 PHARMACEUTICAL FORM

Film coated tablet

Brown circular, biconvex tablets

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: swallow one tablet three times daily after food.

The use in children or adolescents under 18 years old is not recommended (see Section 4.4 Special warnings and precautions for use).

Duration of use:

If symptoms do not improve or worsen after 4 weeks, a doctor or qualified healthcare practitioner should be consulted.

4.3 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, or symptoms persist for more than 4 weeks, a doctor or qualified healthcare practitioner should be consulted.

If articular pain accompanied by swelling of joint, redness or fever are present a doctor should be consulted.

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.

Caution should be taken when Devil’s Claw is administered to patients with cardiac disorders.

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

Patients with rare glucose-galactose malabsorption should not take this medicine.

4.5 Interaction with other medicinal products and other forms of interaction None known.

4.6 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.

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, itching).

The frequency is not known.

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

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued 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

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 non-clinical toxicology data available for Devil’s Claw is limited. Tests to investigate reproductive toxicity, genotoxicity and carcinogenicity have not been performed.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Herbal extract:

Maltodextrin

Silica colloidal anhydrous

Tablet core:

Calcium hydrogen phosphate dihydrate

Cellulose microcrystalline

Croscarmellose sodium

Silica colloidal hydrated

Magnesium stearate

Coating:

Crosscarmellose sodium

Lecithin

Glucose monohydrate

Sodium citrate

Dextrin

6.2 Incompati­bilities

Not applicable

6.3 Shelf life

3 years

6.4 Special precautions for storage

Do not store above 250C. Store in original package.

6.5 Nature and contents of container

Ph Eur type III amber glass bottles with polypropylene closure incorporating an induction heat seal liner. Printed outer carton containing Patient Information Leaflet.

Pack sizes: 30, 60, 90, 120 tablets. Not all pack sizes may be marketed.

6.6 Special precautions for disposal

No special requirements.