Lifeplan Devils Claw Joint Relief Tablets
List of outstanding points after assessment of response received 23/12/2014 for applications PL 03551/0028- 0028, PL 03551/0032 - 0021, PL 03551/0030 - 0022, PL 03551/0031 -
0024
1. The given response to point no2 of the RFI letter dated 04/09/2014 is not clear and in contradiction with what had been said before in the previous response. The applicant is urged to clearly explain this point and provide clear response; given that in the latest response it has been mentioned that the emulsions are colourless and transparent. This description is not in line with description given in section 6.6 section of the SPC and quote ““The mixture is a milky white homogenous oil-in-water emulsion.” End of the quote. Further clarification is required.
2. SPC: Whilst the fragment 6.6 of each of the applications has been suitably amended to include this new statement “When making additions, the final osmolarity of the mixture must be calculated before administration” proposed; however and with the exception of PL 03551/0028 - 0028, the final SPC of PL 03551/0032 - 0021, PL 03551/0030 - 0022, and PL 03551/0031- 0024 does not contain it. Amendment is required.
3. PIL: Whilst the PIL have been amended to reflect most of the proposed changes in the SPC, however and with the exception of PL 03551/0028 - 0028the new statement “When making additions, the final osmolarity of the mixture must be calculated before administration” proposed, is not present in the PIL of the other applications PL 03551/0032 - 0021, PL 03551/0030 - 0022, and PL 03551/0031- 0024. Amendment is required.
Dr Muhaned AL-Hindawi
Senior Pharmaceutical Assessor
11th Feb 2015
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Lifeplan Devil’s Claw Joint Relief Tablets.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 95.75mg of extract (as dry extract) from Devil’s Claw root (Harpagophytum procumbens DC. and / or H.zeyheri L. Decne.) root (equivalent to 335.13mg - 478.75mg). Extraction solvent: Ethanol 60% v/v.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Beige brown circular tablet.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
A traditional herbal medicinal product used for 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.
Adults and elderly: 2 tablets three times daily immediately after food.
This product is not recommended for use in children or adolescents less than 18 years old (See Section 4.4 Special warnings and precautions for 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 Devils claw, or any of the other excipients
4.4 Special warnings and precautions for use
Do not exceed the stated dose.
If symptoms worsen or persist for more than 4 weeks, a doctor or a 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 old 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 a 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
Safety 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. In rare cases some patients have experienced dizziness and somnolence while taking Devil’s claw. If affected, patients should not drive or use machinery.
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 effects not mentioned above occur, a doctor or qualified health care 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 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 applicable -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
Excipients in the extract Maltodextrin
Silica colloidal anhydrous.
Excipients in the tablet Dicalcium phosphate dihydrate Microcrystalline cellulose Magnesium stearate Stearic acid
Croscarmellose sodium
6.2 Incompatibilities
Not applicable
6.3 Shelf life
3 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
Amber glass bottle with polypropylene cap and induction seal in cardboard carton. Pack size 60 tablets.
6.6 Special precautions for disposal
No special requirements.
7 MARKETING AUTHORISATION HOLDER
Lifeplan Products Ltd Elizabethan Way, Lutterworth,
Leicestershire, United Kingdom LE17 4ND
Telephone: +44 (0) 1455 556281
8 MARKETING AUTHORISATION NUMBER(S)
THR 20093/0003
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
11/02/2015
10 DATE OF REVISION OF THE TEXT
11/02/2015