HEALTHSPAN DEVILS CLAW JOINTAID TABLETS - summary of medicine characteristics

Healthspan Devil’s Claw JointAid tablets

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Each film-coated tablet contains 450mg of extract (as dry extract) from Devil’s Claw root (Harpagophytum procumbens D.C. and/or H. zeyheri L. Decne, radix) (Equivalent to 1575mg to 2250mg 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

4.1 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).

Not recommended for use in children and adolescents under the age of 18 years (see section 4.4 ‘Special warnings and precautions for use’).

Tablets should be swallowed whole with some water or other liquid.

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

4.3 Contraindications

Hypersensitivity to the active substance or to any of the excipients.

Patients with active gastric or duodenal ulcer

4.4 Special warnings and precautions for use

Do not exceed the stated dose.

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

The use in children or adolescents under 18 years of age is not recommended because of the lack of available data and medical advice should be sought.

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

Patients with gallstones should consult a doctor before using 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.

No studies on the effects on fertility have 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. 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. Hypersensitivity reactions: rash, hives, facial oedema. The frequency is not known.

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

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme website www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store

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

Reverse mutation assays (Ames test) on bacteria indicated that the extract in product was not mutagenic in Salmonella typhimurium (strains TA 98, TA 100, TA 102, TA 1535 and TA 1537) mutation assays with or without metabolic activation.

Tests on reproductive toxicity and carcinogenicity have not been performed.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Extract

Maltodextrin

Silica colloidal anhydrous

Tablet Core

Maltodextrin

Microcrystalline cellulose Sodium croscarmellose Stearic Acid

Magnesium Stearate Silica colloidal anhydrous

Tablet coating

Hypromellose

Titanium Dioxide

Copper Chlorophyllin (E141)

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 or 90 film coated 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

THOMPSON & CAPPER (UK) LTD

HARDWICK ROAD

ASTMMOOR

RUNCORN

CHESHIRE

WA7 1PH

8 MARKETING AUTHORISATION NUMBER(S)

THR 01359/0003

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

10/01/2018