SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

Aspar Herbal B-Slim Tablets

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Each coated tablet contains:

150 mg of Bladderwrack (Fucus vesiculosus L. )

20 mg of extract (as dry extract) from Bladderwrack (Fucus vesiculosus L. ) (5:1) (equivalent to100mg of Bladderwrack)

Extraction solvent: Water

Each coated tablet contains 20mg of sucrose (See section 4.4 ‘Special warnings and precautions for use’.)

For list of excipients, see Section 6.1

3 PHARMACEUTICAL FORM

Coated tablet Black, round biconvex

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 - two tablets to be taken in the morning and two tablets in the evening.

Tablets should be taken before meals with a glass of water Maximum recommended daily dose: Four tablets

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.’)

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

If symptoms worsen or persist during the use of this medicinal product, a doctor or a qualified healthcare practitioner should be consulted.

4.3 Contraindications

Hypersensitivity to Fucus (Bladderwrack) , iodine or to any of the excipients.

Patients with thyroid disorders.

4.4 Special warnings and precautions for use

Do not exceed the stated dose.

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

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

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.

If symptoms worsen or do not improve, a doctor or a qualified healthcare practitioner should be consulted.

4.5 Interaction with other medicinal products and other forms of interaction

Do not take with other medicines or dietary supplements containing iodine. Do not take with medicines for a thyroid disorder.

4.6 Fertility, pregnancy and lactation

Safety during pregnancy and lactation has not been established. Due to the lack of data, use during pregnancy and lactation is not recommended. Studies on fertility have not been carried out.

4.7 Effects on ability to drive and use machines

No studies on the effect of this product on the ability to drive or operate machines have been performed.

4.8 Undesirable effects

Diarrhoea may occur. The frequency is not known.

If adverse reactions 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 (www.mhra.gov.uk/yellowcard).

4.9 Overdose

No cases of overdose have been reported.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Not required as per article 16c(1)(a)(iii) of Directive 2001/83EC as amended.

5.2 Pharmacokinetic properties

Not required as per article 16c(1)(a)(iii) of Directive 2001/83EC 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:

Maltodextrin Sucrose Tablet coating

Talc

Magnesium stearate

Colouring ingredient: Ferric oxide black (172).

6.2    Incompatibilities

Not applicable

6.3    Shelf life

3 years

6.4    Special precautions for storage

Store below 25°C

Keep in the original package

6.5 Nature and contents of container

1.    White high-density polyethylene tub.

Closure: White high-density polyethylene cap (tamper evident). Pack sizes: 100 and 200 tablets.

2.    White opaque, polyvinyl chloride film, minimum thickness 250 pm, coated with 40g/m2 PVC

Closure: Aluminum foil of 20 pm thickness printed on the brighter side and coated on the dull side with a heat sealable lacquer.

Pack sizes: 24 and 60 tablets

Not all pack sizes may be marketed

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