SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

Natural Pharmacy Supa Slim Tablets Natural Pharmacy Anti-Fat Tablets Sea Herb Anti-Fat Tablets Swiftrim Tablets

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Each coated tablet contains 40 mg extract (as dry extract) from Bladderwrack (Fucus vesiculosus L.)(5:1) (equivalent to 200 mg Bladderwrack)

Extraction solvent: water Excipients:

Each tablet contains 109 mg sucrose and 87 mg lactose.

For full list of excipients see section 6.1

3    PHARMACEUTICAL FORM

Coated tablet

White round coated tablet.

4    CLINICAL PARTICULARS

4.1 Therapeutic indications

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

One tablet taken 3 times a day.

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

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

If symptoms do not improve or worsen after the use of this product a doctor or qualified healthcare practitioner should be consulted.

4.3 Contraindications

Hypersensitivity to the active substances or iodine or to 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 of this product in the elderly or children or adolescents under 18 years of age 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.

Each tablet contains 109 mg sucrose and 87 mg lactose. Patients with rare hereditary problems of fructose intolerance, galactose intolerance, the Lapp-lactase deficiency, 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.

In-vitro studies have shown anti-coagulant activity. Due to a theoretical effect on anti-coagulant medication, patients on anti-coagulant medication should not take this medicine as a precaution.

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

May cause diarrhoea. The frequency is unknown.

If adverse reactions not mentioned above occur, a doctor or qualified healthcare practitioner should be consulted.

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

Tablet core_

Lactose

Sodium starch glycollate Calcium phosphate Magnesium stearate

Tablet coat Sucrose Talc Shellac

Calcium carbonate Acacia

White beeswax Titanium dioxide (E171)

6.2    Incompatibilities

None known

6.3    Shelf life

3 years

6.4    Special precautions for storage

Store below 25 °C. Store in the original packaging.

6.5 Nature and contents of container

Amber glass bottle with tamper-evident seal and white polypropylene screw cap.

Polypropylene or polyethylene container with tamper-evident seal and white polypropylene screw cap.

21, 30, 45, 50, 60, 84, 100, or 180 tablets.