HRI Clear Complexion – SPC
SUMMARY OF PRODUCT CHARACTERISTICS
1. Name of the medicinal product
HRI Clear Complexion Tablets
2. Qualitative and quantitative composition
Each tablet contains:
34 mg of extract (as dry extract) from Burdock root (Arctium lappa L.) (equivalent to 90 mg – 180 mg of burdock root).
Extraction solvent: water
30 mg of extract (as dry extract) from Blue Flag Iris rhizome (Iris versicolor L.) (equivalent to 60 mg – 105 mg of Blue Flag Iris rhizome).
Extraction solvent: water
Each tablet also contains 191 mg of sucrose.
For full list of excipients, see section 6.1
3. Pharmaceutical form
Deep convex white tablet.
4. Clinical particulars
4.1 Therapeutic indications
Traditional herbal medicinal product used for the symptomatic relief of minor skin conditions such as spots, pimples, blemishes, mild acne, and mild eczema, based on traditional use only.
4.2 Posology and method of administration
For oral use only.
Adults, elderly, children over 12 years
One tablet to be taken two or three times a day.
Children under 12 years
The use in children under 12 years of age is not recommended (See Section 4.4 Special warnings and precautions for use).
If symptoms worsen, or persist for more than 2 weeks a doctor or a qualified healthcare practitioner should be consulted.
Hypersensitivity to the active substances, plants of the Asteraceae (Compositae) family or any of the excipients. Infected spots or inflamed spots associated with infection.
4.4 Special warnings and precautions for use
Do not exceed the stated dose.
The use of this product in children under 12 years of age is not recommended because data are not sufficient and medical advice should be sought.
If symptoms worsen or persist for more than 2 weeks, a doctor or qualified healthcare practitioner should be consulted.
If not treated adequately, acne may cause scarring. Do not use this product and consult your doctor or qualified healthcare practitioner if you have widespread redness, oozing or infected skin sores, infected or inflamed spots, if the skin is broken, or if the affected area has suddenly become inflamed.
This product contains sucrose. One tablet contains 191 mg sucrose. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrose-isomaltase insufficiency should not take this medicine.
4.5 Interaction with other medicinal products and other forms of interaction
4.6 Fertility, pregnancy and lactation
Safety during human pregnancy and lactation had not been established. In the absence of sufficient data the use in pregnancy and lactation is not recommended.
Studies on fertility have not been performed.
4.7 Effects on ability to drive and use machines
No studies on the effects on the ability to drive and use machines have been performed.
4.8 Undesirable effects
Anaphylactic shock has been reported with Burdock root. The frequency is not known.
Blue flag root may cause nausea, vomiting and irritation of mucous membranes. The frequency is not known.
If other adverse reactions not mentioned above occur, a doctor, pharmacist 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 at: www.mhra.gov.uk/yellowcard
No case of overdose has been reported.
Supportive and symptomatic treatment should be provided 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 16 c (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
Calcium Hydrogen Phosphate
Colloidal Hydrated Silica
Mastercote Cream FP9002 (containing Beeswax, Shellac, Carnauba Wax, Industrial Methylated Spirit)
Titanium Dioxide (E171)
6.3 Shelf life
6.4 Special precautions for storage
Glass bottles: Do not store above 25oC. Store in the original packaging.
Blister strip: No special storage precautions. Store in the original packaging.
6.5 Nature and contents of container
Amber glass bottle with foil tamper evident seal and white polypropylene screw cap. Pack sizes: 30, 40, 45, 50, 60, 80, 100
A1/PVC/PVDC blister strip
Pack sizes: 30, 40, 45, 50, 60, 80, 100
Not all pack sizes may be marketed.
6.6 Special precautions for disposal
No special requirements.
7. Marketing authorisation holder
The Herbal Research Company Limited,27 Old Gloucester Street
27 Old Gloucester Street
London WC1N 3XX
8. Marketing authorisation number(s)
9. Date of first authorisation / renewal of the authorisation
10. Date of revision of the text