Adios
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Adios
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains:
20 mg Butternut bark (Juglans cineraria L.)
30 mg Dandelion Root (Taraxacum officinale Weber ex Wigg.).
34 mg of extract (as dry extract) from Boldo leaf (Peumus boldus Molina) (4:1). Extraction solvent: water
45 mg of extract (as dry extract) from Bladderwrack thallus (Fucus vesiculosus L.)
(5:1).
Extraction solvent: 30% methanol For full list of excipients, see section 6.1.
Each tablet contains 186 mg sucrose and 54 micrograms iodine (See section 4.4. ‘Special warnings and precautions for use.’)
3 PHARMACEUTICAL FORM
Coated Tablet
Peachy orange biconvex sugar-coated tablets.
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): One tablet three or four times a day at meal times. This product should be taken as part of 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 and the elderly is not recommended (see Section 4.4. Special warnings and precautions for use).
4.3 Contraindications
Hypersensitivity to the active substances or to iodine or to plants of the Asteraceae (Compositae) family or any of the excipients.
Patients with a thyroid disorder.
Obstruction of bile duct, cholangitis, liver disease, gallstones, active
peptic ulcer and any other biliary disorders that require medical supervision and
advice.
4 CLINICAL PARTICULARS
4.4 Special warnings and precautions for use
Do not exceed the stated dose.
The use in children and adolescents under 18 years and the elderly is not recommended because data are insufficient and medical advice should be sought.
The use in patients with renal failure and/or diabetes, and/or heart failure because of possible complications due to hyperkalemia.
Do not take with other medicines or dietary supplements containing iodine.
Contains sucrose; patients with rare hereditary problems of galactose or fructose intolerance, glucose-galactose malabsorption, the Lapp lactase deficiency 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.
This product can theoretically have an effect on anticoagulant treatments. Patients taking anticoagulant treatments should not use 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 in 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 effects of this product on the ability to drive or operate machinery have been performed.
4.8 Undesirable effects
May cause diarrhoea. The frequency is unknown.
Epigastric pain and hyperacidity may occur with Dandelion root. The frequency is not known.
Hypersensitivity (anaphylaxis) has been reported with Boldo leaf. The frequency is not known.
If other adverse reactions not mentioned above 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 at: www.mhra.gov.uk/yellowcard
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.
Tests on reproductive toxicity have been performed with a dry ethanolic extract of boldo leaf and boldine administered orally to pregnant rats. Results showed anatomical alterations in the foetus and a few cases of abortion at high doses.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Sucrose
Cellulose
Sodium starch glycollate Talc
Silicon dioxide Pre-gelatinised starch Magnesium stearate Kaolin Shellac
Titanium dioxide (E171)
Red Iron oxide (E172)
Yellow Iron oxide (E172)
6.2 Incompatibilities
None.
6.3 Shelf life
3 years
6.4 Special precautions for storage
Do not store above 25°C Store in the original package
6.5 Nature and contents of container
White polypropylene containers with tamper-evident polyethylene moulded cap or
integral polypropylene cap. Containing 50 or 100 tablets.
6.6 Special precautions for disposal
No special requirements.
7 MARKETING AUTHORISATION HOLDER
Brome and Schimmer Limited
T/A Diomed Herbals
Tatmore Place
Gosmore
Hitchin
Herts SG4 7QR UK
8 MARKETING AUTHORISATION NUMBER(S)
THR17418/0027
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
10/04/2013
10 DATE OF REVISION OF THE TEXT
16/07/2015