Napiers Herbal High Strength Slimming Aid
Out of date information, search anotherSUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Napiers Herbal High Strength Slimming Aid Slimwell Max Herbal Slimming Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each coated tablet contains:-
120 mg of extract (as dry extract) from Bladderwrack thallus (Fucus vesiculosus L. or Fucus serratus L) (equivalent to 600 mg of Fucus) Extraction solvent: Water.
Each tablet contains 86.7 mg of lactose, 0.085mg of sucrose and 132 micrograms of iodine. (See section 4.4 ‘Special warnings and precautions for use’.)
For full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablets.
White biconvex 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): Two tablets to be taken three times a day after meals.
This product must be used in conjunction with a calorie controlled diet and exercise.
The use in children, adolescents under the age of 18 and the elderly is not recommended (see section 4.4 ‘Special warnings and precautions for use’).
If symptoms do not improve or worsen during the use of this medicinal product, a doctor or qualified healthcare practitioner should be consulted.
4.3 Contraindications
Hypersensitivity to the active ingredient or to iodine or any of the excipients. Patients with thyroid disorders.
4.4 Special warnings and precautions for use
Do not exceed the stated dose.
The use in children, adolescents under 18 years of age and the elderly is not recommended because data are insufficient and medical advice should be sought.
Do not take with other medicines or dietary supplements containing iodine. This product contains lactose 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, therefore the use of this product during pregnancy and lactation is not recommended.
Studies on the effect of this product 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 conducted.
4.8 Undesirable effects
May cause diarrhoea. The frequency is unkown.
If other adverse reactions not mentioned above occur a doctor or qualified health care practitioner should be consulted.
4.9 Overdose
No cases known.
An overdose may lead to thyroid disorders such as hyperthyroidism, thyrotoxicosis, subclinical hypothyroidism, Hashimoto’s thyroiditis.
PHARMACOLOGICAL PROPERTIES
5
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
Lactose
Calcium Hydrogen Phosphate (E341)
Talc (E553(b))
Magnesium Stearate (E572)
Sodium starch glycolate Sucrose
Titanium Dioxide (E171)
Kaolin Light (E559)
Maltodextrin
Colloidal anhydrous silica Water
6.2 Incompatibilities
Not applicable.
6.3 Shelf life
Three 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 pot with polyethylene tamper-proof closure, or amber glass bottle with bakelite-type screwcap with/without foam insert, packed in a cardboard carton: 100 tablets.
6.6 Special precautions for disposal
There are no special precautions for disposal.
7 MARKETING AUTHORISATION HOLDER
Rickard Lanes and WH Box Ltd 24 Tennant Street Edinburgh EH6 5ND
8 MARKETING AUTHORISATION NUMBER(S)
THR 15670/0055
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
14/03/2013
10 DATE OF REVISION OF THE TEXT
14/03/2013