clearskin_packHRI Clear Complexion – SPC

Download the patient information leaflet here.

 

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

Excipients:

Each tablet also contains 191 mg of sucrose.

For full list of excipients, see section 6.1

3. Pharmaceutical form 

Coated tablet.

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.

4.3 Contraindications

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

None reported.

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

4.9 Overdose

             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

Tablet Core

Sugar Powder

Calcium Hydrogen Phosphate

Croscarmellose Sodium

Magnesium Stearate

Purified Talc

Colloidal Hydrated Silica

Tablet Coating

Sucrose

Calcium Carbonate

Purified Talc

Mastercote Cream FP9002 (containing Beeswax, Shellac, Carnauba Wax, Industrial Methylated Spirit)

Acacia

Titanium Dioxide (E171)

Shellac

6.2 Incompatibilities

None known.

6.3 Shelf life

3 years.

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) 

THR 02231/0010

9. Date of first authorisation / renewal of the authorisation

October 2016

10. Date of revision of the text 

October 2016