Summary of medicine characteristics - NATURES BEST MILK THISTLE TABLETS, LAMBERTS MILK THISTLE TABLETS
1 NAME OF THE MEDICINAL PRODUCT
Lamberts Milk Thistle Tablets
Natures Best Milk Thistle Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film coated tablet contains 150mg of standardised extract (as dry extract) from Milk Thistle fruits (Silybum marianum (L.) Gaertner) (equivalent to 3600–4050mg of Milk Thistle fruits) corresponding to 87mg of silymarin, calculated as silibinin.
Extraction solvent: Acetone 95% v/v
For full list of excipients, see section 6.1.
Film-coated tablets
Clear coated yellow/beige slightly speckled tablet.
4.1 Therapeutic indications
A traditional herbal medicinal product used to relieve the symptoms associated with occasional over indulgence of food and drink such as indigestion and upset stomach based on traditional use only
4.2 Posology and method of administration
For oral administration
Adult and the elderly: the recommended dosage is 1 to 2 tablets daily.
Tablets should be swallowed whole with water or other liquid.
This product is not recommended for children or adolescents under 18 years of age (See Section 4.4 special warnings and precautions for use)
If symptoms worsen during the use of the product or persist longer than one week, a doctor or a qualified healthcare practitioner should be consulted.
4.3 Contraindications
Hypersensitivity to Milk Thistle or plants of the Asteraceae/ Compositae family or to any of the excipients.
4.4 Special warnings and precautions for use
Do not exceed the stated dose.
Patients suffering from active liver disease should consult their doctor before taking this product.
Milk Thistle may alter the way that certain drugs are broken down by the liver (see section 4.5 ‘Interaction with other medicinal products and other forms of interaction’)
If the symptoms worsen during the use of the product or if symptoms persist longer than one week, a doctor or qualified healthcare practitioner should be consulted.
The use of this product in children and adolescents under 18 years of age is not recommended as there is no relevant indication.
4.5 Interaction with other medicinal products and other forms of interaction In vitro Milk Thistle extract resulted in inhibition of CYP isoenzymes. However the clinical relevance of these findings is not established.
4.6 Fertility, pregnancy and lactation
The safety of this product during pregnancy 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 on the ability to drive and use machines have been performed.
4.8 Undesirable effects
Mild gastrointestinal reactions (such as dry mouth, nausea, upset stomach, gastric irritation, diarrhoea). Headache, allergic reactions (dermatitis, urticaria, skin rash, pruritis, anaphylaxis, asthma)
The frequency is not known
If other adverse reactions not mentioned above occur, a doctor or qualified healthcare practitioner should be consulted.
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 in the Google Play or Apple App Store.
4.9 Overdose
4.9 OverdoseNo case of overdose has been reported.
Supportive and symptomatic treatment should be provided as appropriate.
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
5.3 Preclinical safety dataMilk Thistle extract was not mutagenic in the mammalian murine micronucleus test.
Tests on reproductive toxicity and carcinogenicity have not been performed.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Tablet Core
Maltodextrin
Microcrystalline Cellulose
Sodium Croscarmellose
Stearic Acid
Magnesium Stearate
Colloidal Hydrated Silica
Tablet Coating
Hypromellose
Glycerol
6.2 Incompatibilities
Not applicable
6.3 Shelf life
2 years
6.4 Special precautions for storage
Do not store above 25 °C. Store in the original packaging
6.5 Nature and contents of container
6.5 Nature and contents of containerTablets are packed into PVC/PVDC blister strips in the following pack sizes; 30, 60, 90 Tablets and packed into a Carton.
Not all pack sizes may be marketed
6.6 Special precautions for disposal
No special requirements.
7 MARKETING AUTHORISATION HOLDER
Lamberts Healthcare Limited
1 Lamberts Road
Tunbridge Wells
Kent
TN2 3EH
8 MARKETING AUTHORISATION NUMBER(S)
THR 34425/0008
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
04/09/2019