Phytoslim
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
PHYTOSLIM
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 130 mg of Bladderwrack thallus (Fucus vesiculosus L.)
Each capsule contains between 33 and 245 micrograms of iodine.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Capsule, hard
Colourless and transparent hard capsule containing greenish brown powder
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.
For adults (18 years and above) : 1 capsule to be taken twice a day, morning and evening, 15 minutes before meals with a large glass of water.
This product must be used in conjunction with a calorie controlled diet and extra exercise.
If symptoms do not improve or worsen during the use of this medicinal product, a doctor or a qualified healthcare practitioner should be consulted.
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)
4.3 Contraindications
Patients with known hypersensitivity to Bladderwrack, any of the excipients or to iodine should not use this product.
Patients with a thyroid disorder
4.4 Special warnings and precautions for use
Do not exceed the stated dose.
If symptoms do not improve or worsen during the use of this medicinal product, a doctor or a qualified healthcare practitioner should be consulted.
Do not take with other medicines or dietary supplements containing iodine.
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.
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
Safety during pregnancy and lactation has not been established. In the absence of sufficient data, the use during pregnancy and lactation is not recommended.
Studies 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
None known.
If adverse reactions occur, a doctor or a 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 according to Article 16c (1)(a)(iii) of Directive 2001/83/EC as amended
5.2 Pharmacokinetic properties
Not required according to Article 16c (1)(a)(iii) of Directive 2001/83/EC as amended
5.3 Preclinical safety data
Tests on reproductive toxicity, genotoxicity, carcinogenicity have not been performed
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Alginic acid
Hypromellose (capsule shell)
6.2 Incompatibilities
None reported.
6.3 Shelf life
3 years.
6.4 Special precautions for storage
Store below 25°C. Store in the original package
6.5 Nature and contents of container
Brown polyvinyl chloride container of 45 capsules, with a security cap made of low density polyethylene.
6.6 Special precautions for disposal
No special requirements.
7 MARKETING AUTHORISATION HOLDER
LABORATOIRES ARKOPHARMA Lid de Carros Le Broc-1ere avenue, 2709 m 06510 CARROS FRANCE
Tel.: +33 (0)4 93 29 11 28 Fax.:+33 (0)4 93 29 11 62
Trading as :
ARKOPHARMA
LABORATOIRES PHARMACEUTIQUES Lid de Carros Le Broc-1ere avenue, 2709 m 06510 CARROS FRANCE
8 MARKETING AUTHORISATION NUMBER(S)
THR 12297/0018
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
05/02/2013
10 DATE OF REVISION OF THE TEXT
05/02/2013