Napiers Herbal Slimming Aid
Out of date information, search anotherSUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Napiers Herbal Slimming Aid Slimwell Herbal Slimming Tablets Quantrim Herbal Slimming Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains:-
40 mg of extract (as dry extract) from Bladderwrack (Fucus vesiculosus L.) (5:1) (equivalent to 200 mg of Bladderwrack)
Extraction solvent: Water
50 mg of extract (as dry extract) from Clivers (Galium aparine L.) (4:1) (equivalent to 200 mg of Clivers)
Extraction solvent: Water
Each tablet contains 61.8 mg of sucrose. (See section 4.4 ‘Special warnings and precautions for use’.)
For full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablets.
White glossy round, convex, unscored 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 over 18 years of age: Two tablets to be taken three times daily after meals. This product must be used in conjunction with a calorie controlled diet and exercise.
If symptoms do not improve or worsen during the use of this product, a doctor or qualified healthcare professional should be consulted.
The use in children and adolescents under the age of 18 years of age is not recommended (see section 4.4 ‘Special warnings and precautions for use’).
4.3 Contraindications
Hypersensitivity to Fucus (Bladderwrack), Clivers or 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 in children and adolescents under 18 years of age is not recommended because data are insufficient and medical advice should be sought.
This product contains 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 reactions occur with this product.
This product can theoretically have an effect on anticoagulant treatments. Patients taking anticoagulant treatments should not use this product.
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 fertility have not been carried out.
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
None known.
If adverse reactions occur a doctor or qualified health care practitioner should be consulted.
4.9 Overdose
No cases known.
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
Tricalcium Phosphate
Sucrose
Acacia (E414)
Talc (E553(b))
Maize Starch Stearic Acid Shellac (E904)
Kaolin Heavy (E559)
Titanium Dioxide (E171)
Kaolin Light (E559)
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.
6.5 Nature and contents of container
Plastic pot with tamper-proof closure, or amber glass bottle with bakelite-type screw-cap packed in a cardboard carton: 100 tablets.
6.6 Special precautions for disposal
No special requirements.
7 MARKETING AUTHORISATION HOLDER
Rickard Lane’s and W.H. Box Ltd.
24 Tennant Street Edinburgh EH5 5ND
8 MARKETING AUTHORISATION NUMBER(S)
THR 15670/0020
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
08/11/2012
10 DATE OF REVISION OF THE TEXT
08/11/2012