SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

Potter’s Slim Aid Tablets Boots Herbal Slim Aid Tablets

2    QUALITATIVE AND QUANTITATIVE COMPOSITION

Each coated tablet contains: -

45 mg of extract (as dry extract) from Bladderwrack thallus (Fucus vesiculosus L.) (5:1) (equivalent to 225 mg of Fucus)

Extraction solvent Water

30 mg Dandelion root (Taraxacum officinale Weber ex Wigg)

27 mg of extract (as dry extract) from Boldo leaf (Peumus boldus Molina) (46:1) (equivalent to 108 - 162 mg of Boldo leaf)

Extraction solvent: Methanol 70% v/v

10 mg Butternut bark (Juglans cineraria L.)

Excipient(s):

Each tablet contains 90 mg glucose monohydrate and also small amounts of sucrose. (See Section 4.4 for further information.)

For full list of excipients see Section 6.1.

3    PHARMACEUTICAL FORM

Tablets

A peach round coated 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: Take one or two tablets three times a day.

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

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’.)

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

4.3 Contraindications

Hypersensitivity to the active substances, plants of the Asteraceae (Compositae) family, or to iodine or any of the excipients.

Thyroid disorder

Obstruction of the bile duct, cholangitis, liver disease, active peptic ulcer, gall stones or any other biliary disorders

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 insufficient and medical advice should be sought.

Patients with renal failure and/or diabetes, and/or heart failure should avoid taking the product because of possible complications due to hyperkalaemia. Do not take with other medicines or dietary supplements containing iodine. This product contains glucose monohydrate and sucrose.

Patients with rare hereditary problems of fructose intolerance, glucose galactose 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

The safety of this product during pregnancy and lactation has not been established.

In view of the preclinical safety data for Boldo leaf (see section 5.3), the use of this product during pregnancy and lactation should be avoided.

Tests 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.

4.8 Undesirable effects

May cause diarrhoea. The frequency is unknown.

Hypersensitivity reactions have been reported including reports of anaphylaxis with products containing Boldo leaf. The frequency is not known.

Epigastric pain, hyperacidity and allergic reactions may occur with Dandelion root. The frequency is not known.

If other adverse reactions not mentioned above occur, a doctor or a 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 cases of overdose have been reported.

An overdose may lead to thyroid disorders such as hyperthyroidism, thyrotoxicosis, subclinical hyperthyroidism, Hashimoto’s thyroiditis.

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.

Tests on reproductive toxicity have been performed with a dry ethanolic extract of boldo leaf and boldine administered orally to pregnant rats. Results showed anatomical alterations in the fetus and a few cases of abortion at high doses.Tests on genotoxicity and carcinogenicity have not been performed with preparations of Boldo leaf.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Glucose monohydrate Calcium hydrogen phosphate Talc

Magnesium Stearate Croscarmellose Sodium Shellac (E904)

Sucrose

Kaolin Light

Titanium Dioxide (E171)

Red Iron Oxide 17266 (E172) Yellow Iron Oxide 17268 (E172) Maltodextrin

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

Tamper evident polyethylene/polypropylene pot packed in a cardboard box: 84, 90, 100, 120 and 180 tablets.

Not all pack sizes may be marketed.

6.6 Special precautions for disposal

There are no special precautions for disposal

7 MARKETING AUTHORISATION HOLDER

Soho Flordis UK Limited 1 Botanic Court,

Martland Park,

Wigan,

WN5 0JZ,

UK.

Trading as: Potters, Wigan WN5 0JZ

8    MARKETING AUTHORISATION NUMBER(S)

THR 44893/0028

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

11/04/2013

10 DATE OF REVISION OF THE TEXT

28/09/2015