This information is intended for use by health professionals

1. Name of the medicinal product

ADIOS TABLETS

2. Qualitative and quantitative composition

Butternut bark (Juglans cineraria L.) 20 mg; Dandelion root (Taraxacum officinale Weber ex Wigg.) 30 mg; Dry extract Boldo leaf (Peumus boldus Molina) (4:1) 34 mg, Extraction solvent: water; Dry extract Bladderwrack thallus (Fucus vesiculosus L.) (5:1) 45 mg, Extraction solvent: 30% methanol.

For full list of excipients, see section List of excipients.

Sucrose 186 mg; Iodine 54 micrograms (see section 'Special warnings and precautions for use').

3. Pharmaceutical form

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 mealtimes.

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 '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.

4.4 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 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

36 months.

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 plastic container with tamper-evident moulded cap or integral plastic cap, containing 100 tablets.

6.6 Special precautions for disposal and other handling

No special requirements.

7. Marketing authorisation holder

Diomed Herbals

Tatmore Place, Gosmore

Hitchin, Herts SG4 7QR, UK.

8. Marketing authorisation number(s)

17418/0027.

9. Date of first authorisation/renewal of the authorisation

10 April 2013.

10. Date of revision of the text

June 2015.