1. Name Of The Medicinal Product
Potter's Boldex
Femmeherb slim aid
Tesco Slim aid
Boots slim aid
2. Qualitative And Quantitative Composition
Each tablet contains: -
27 mg of extract (as dry extract) from Peumus boldus Molina (5:1) (equivalent to 135 mg of Boldo)
Extraction solvent: Methanol 70% V/V
10 mg of Juglans cinerea L. (Butternut Bark)
30 mg of Taraxacum officinale Wiggers (Dandelion Root)
45 mg of extract (as dry extract) from Fucus vesiculosus L. (5:1) (equivalent to 225 mg of Fucus)
Extraction solvent: Ethanol 21% m/m
Excipients:
Each tablet contains 90 mg of Dextrose Monohydrate and is coated with sucrose. See Section 4.4 for further information
For full list of excipients see Section 6.1.
3. Pharmaceutical Form
Oral Tablets
A pinky orange round biconvex sugar-coated tablet.
4. Clinical Particulars
4.1 Therapeutic Indications
A herbal remedy traditionally used as an aid to slimming as part of a calorie controlled diet.
4.2 Posology And Method Of Administration
For oral administration.
Adults: Take one or two tablets three times a day.
Elderly: Take one tablet three or four times a day.
The use in children and adolescents under 18 years of age is not recommended (see section 4.4 'Special warnings and precautions for use'). Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.
If the symptoms persist more than two weeks during the use of the medicinal product, a doctor or qualified healthcare practitioner should be consulted.
To ensure an increase in the amount of urine, adequate fluid intake is required during treatment.
4.3 Contraindications
Hypersensitivity to the active substances, including plants of the Asteraceae (Compositae) family, or any of the excipients.
Patients with:
• obstruction of the bile duct or intestinal tract
• cholangitis
• liver disease
• gallstones acute gallbladder inflammation and any other biliary disorders
• active peptic ulcer
4.4 Special Warnings And Precautions For Use
To be used in conjunction with a calorie controlled diet
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.
Patients with renal failure and/or diabetes, and/or heart failure should avoid taking the product because of possible complications due to hyperkalaemia.
If complaints or symptoms such as fever, dysuria, spasms or blood in the urine occur during the use of the medicinal product, a doctor or a qualified healthcare practitioner should be consulted.
Keep all medicines out of the sight and reach of children.
4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction
None known.
4.6 Pregnancy And Lactation
The safety of this product during pregnancy and lactation has not been established
In view of the preclinical safety data (see section 5.3), the use of this product during pregnancy and lactation should be avoided.
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
Hypersensitivity reactions have been reported including reports of anaphylaxis with products containing Boldo. The frequency of occurrence of these reactions is not known.
Epigastric pain and hyperacidity may occur. The frequency of occurrence of these side-effects is not known..
If other adverse reactions not mentioned above occur, a doctor or a qualified healthcare practitioner should be consulted.
4.9 Overdose
No cases of overdose have been reported. Give fluids for diuresis.
5. Pharmacological Properties
5.1 Pharmacodynamic Properties
ATC Code:- CO3BX
There are no preclinical data of relevance to the prescriber, which are additional to those already included in other sections of the SPC.
5.2 Pharmacokinetic Properties
No relevant pharmacokinetic data are available.
5.3 Preclinical Safety Data
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 fetus and a few cases of abortion at high doses.
Tests on reproductive toxicity, genotoxicity and carcinogenicity have not been performed.
6. Pharmaceutical Particulars
6.1 List Of Excipients
Dextrose Monohydrate
Dicalcium Phosphate
Talc (E553(b))
Magnesium Stearate (E572)
Croscarmellose
Shellac (E904)
Sucrose
Kaolin Light (E559)
Titanium Dioxide (E171)_
Red Iron Oxide 17266 (E172)
Yellow Iron Oxide 17268 (E172)
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 instructions
6.5 Nature And Contents Of Container
Polyethylene pot with polyethylene push-in closure: 90, 100 and 120 tablets.
Taped polyethylene bag in a cardboard carton, tape-sealed: 500 and 1000 tablets.
Polypropylene pot with HD polyethylene or polypropylene closure; 84, 100, 120 and 180 tablets.
Not all pack sizes may be marketed.
6.6 Special Precautions For Disposal And Other Handling
There are no special precautions for disposal.
7. Marketing Authorisation Holder
Potters Ltd
1 Botanic Court
Martland Park
WIGAN
WN5 0JZ
8. Marketing Authorisation Number(S)
PL 00250/5200R
9. Date Of First Authorisation/Renewal Of The Authorisation
25/02/1991 / 30/01/2002
