SUMMARY OF PRODUCT CHARACTERISTICS

1. NAME OF THE MEDICINAL PRODUCT

Herbal Classics Diet Aid Holland & Barrett Diet Aid Tesco Slimming Aid Superdrug Diet Aid Gerard House Slimmers Aid Herbalstore Slimming Aid Wilko Slimming Aid Asda Slimming Aid

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Each tablet contains:

16 mg of extract (as dry extract) from Bladderwrack thallus (Fucus vesiculosus L. or Fucus serratus L.) (5:1). Extraction solvent: Water

200 mg Bladderwrack thallus (Fucus vesiculosus L.)

Each tablet contains approximately 45 mg sucrose and between 76 - 448 pg of iodine (See section 4.4. ‘Special warnings and precautions for use.’)

For full list of excipients, see section 6.1.

3 PHARMACEUTICAL FORM

Grey-green, circular biconvex, uncoated tablet

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

A traditional herbal medicinal product used as an aid to slimming as part of a calorie controlled diet, based on traditional use only.

4.2    Posology and method of administration

For oral use only

Adults (18 years and above)

One tablet three times daily after meals

This product must be used in conjunction with a calorie controlled diet and extra exercise.

If symptoms do not improve or worsen during the use of this medicinal product, a doctor or qualified healthcare professional should be consulted.

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

4.3 Contraindications

Hypersensitivity to Bladderwrack or to iodine or any of the excipients. Patients with a thyroid disorder.

4.4 Special warnings and precautions for use Do not exceed the stated dose.

The use in children and adolescents under 18 years of age and the elderly is not recommended because data are not sufficient and medical advice should be sought.

Do not take with other medicines or dietary supplements containing iodine.

Contains sucrose. Patients with rare hereditary problems of fructose intolerance, glucose-galacatose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.

4.5 Interaction with other medicinal products and other forms of interaction No studies have been carried out to determine if drug interactions occur with this product.

Do not take with other medicines or dietary supplements containing iodine.

Do not take with medicines for thyroid disorders

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 of this product on the ability to drive or use machinery have been performed.

4.8 Undesirable effects

May cause diarrhoea. The frequency is unknown.

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 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

An overdose may lead to thyroid disorders such as hyperthyroidism, thyrotoxicosis, Subclinical hypothyroidism, Hashimoto's thyroiditis.

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

Tests on reproductive toxicity, genotoxicity and carcinogenicity have not been performed.

6    PHARMACEUTICAL PARTICULARS

6.1    List of excipients

Extract excipient Maltodextrin

Core excipients Sucrose

Sodium Starch Glycolate Purified Talc Magnesium Stearate Pregelatinised Maize Starch Maltodextrin Gum Acacia

Colloidal Anhydrous Silica

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 container.

6.5    Nature and contents of container

Polyethylene tablet container and tamper-evident polyethylene cap closure. Three pack sizes are available - 100, 200, and 60 tablets.

PVC/PVdC (250/60gsm) Laminate blister pockets with aluminium foil backing. Each pack containing 30, 60 and 120 tablets.

6.6    Special precautions for disposal

No special requirements

7    MARKETING AUTHORISATION HOLDER

Brunel Healthcare Manufacturing Limited

William Nadin Way

Swadlincote

Derbyshire

DE11 0BB

8 MARKETING AUTHORISATION NUMBER(S) THR 20894/0075

9    DATE OF FIRST AUTHORISATION/RENEWAL OF THE

AUTHORISATION

26/03/2013

10 DATE OF REVISION OF THE TEXT

02/06/2015