SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

English Herbal Medicines Seaweed Slimix Herbs Hands Healing Slimming Aid Brooke Green Herbal Slimming Aid Swiss Herbal Remedies Slimming Aid

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Each 1 ml of oral liquid contains 1 ml of liquid extract from dried Bladderwrack (Fucus vesiculosus L.) thallus (1:1). Extraction solvent: ethanol 21% v/v.

Each 1 ml of oral liquid also contains approximately 166 mg Ethanol (alcohol). (See section 4.4 'Special warnings and precautions for use').

For list of excipients see Section 6.1.

3 PHARMACEUTICAL FORM

Oral Liquid.

Brown liquid.

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.

For oral use only.

Adults (18 years and above)

5ml twice a day with water.

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 a qualified healthcare professional should be consulted.

The use in children and 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

Patients with known hypersensitivity to Bladderwrack or any of the excipients should not use this product.

Patients with a thyroid disorder

4.4 Special warnings and precautions for use

Do not exceed the stated dose.

Contains alcohol - up to 828 mg ethanol per dose (equivalent to 21 ml of beer or 8.3 ml of wine).

Harmful for those suffering from alcoholism. To be taken into account in pregnant or breast-feeding women, children and high-risk groups such as patients with liver-disease, or epilepsy.

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

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.

This product can theoretically have an effect on anticoagulant treatments. Patients taking anticoagulant treatments should not use this product.

Contains alcohol, and should therefore be avoided in patients taking other medication known to interact with alcohol (e.g. Metronidazole).

4.6 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.

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.

This product contains alcohol (see Section 2).

4.8 Undesirable effects

No adverse reactions are known.

If adverse reactions occur, a doctor or qualified healthcare practitioner should be consulted.

4.9 Overdose

No case of overdose has been reported.

Overdose of this product may result in alcohol intoxication. The amount of ethanol in a full bottle (8.3g in 50ml, 16.6g in 100ml and 33.1 g in 200 ml; equivalent to 0.5, 1 and 2 large glasses of wine respectively)cases known. may result in intoxication and should be treated accordingly.

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

Ethanol (From tincture)

6.2    Incompatibilities

Not applicable.

6.3    Shelf life

Three years.

6.4    Special precautions for storage

This medicinal product does not require any special storage conditions.

Glass bottle with polypropylene screwcap: 50ml and 100ml. Glass bottle with bakelite screwcap: 200 ml

Not all pack sizes may be marketed.

6.6 Special precautions for disposal

No special requirements.

7    MARKETING AUTHORISATION HOLDER

Rutland Biodynamics Ltd, Town Park Farm, Brooke, Rutland, LE15 8DG.

8    MARKETING AUTHORISATION NUMBER(S)

THR 28255/0020

9    DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

01/03/2011

10    DATE OF REVISION OF THE TEXT

01/03/2011