Summary of Product Characteristics (SmPC) - Gerard House Max strength Milk Thistle tablets
1 NAME OF THE MEDICINAL PRODUCT
Gerard House Max Strength Milk Thistle Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film coated tablet contains 500 mg of standardised extract (as dry extract) from Milk Thistle fruits (Silybum marianum (L.) Gaertner) (equivalent to 10.0 - 20.0 g of Milk Thistle fruits) corresponding to 250 – 300 mg of silymarin calculated as silibinin.
Extract solvent: Ethyl acetate 100 % v/v
For full list of excipients, see 6.1
3 PHARMACEUTICAL FORM
Film coated tablet.
Pale yellow caplet shaped tablet
4 CLINICAL PARTICULARS
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 use only.
Swallow the tablets whole with water. Do not chew.
Adults and the elderly: The recommended dosage is 1 tablet daily, before a meal. Children and adolescents under 18 years old: This medicine is not recommended for children and adolescents under 18 years of age (see Section 4.4 Special warnings and precautions for use).
4.3 Contraindications
Hypersensitivity to Milk Thistle or to 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).
The use in children and adolescents under 18 years of age is not recommended as there is no relevant indication.
If symptoms worsen, or persist longer than one week during the use of the product a doctor or qualified healthcare practitioner should be consulted.
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 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.
Animals studies are insufficient with respect to reproductive toxicity (see Section 5.3).
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 symptoms (such as dry mouth, nausea, upset stomach, gastric irritation and diarrhoea), headache, allergic reactions (dermatitis, urticaria, skin rash, pruritus, anaphylaxis and asthma). The frequency is not known.
If other adverse reactions not mentioned above occur, a doctor, pharmacist or 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 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
No 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
In the mouse, the acute oral toxicity of silymarin in milk thistle extracts was found to be in excess of 2000 mg/kg. No deaths occurred within 48 hours of administration. In the rat, repeated oral administration of 1000 mg/kg/day for 15 days or 100 mg/kg for 16, or 22 weeks showed no adverse effects when compared to controls. In a separate study, repeated oral administration of 1050, 2180 or 4500 mg/kg/day for 14 weeks caused reductions in sperm motility and the number of spermatid heads per testis by up to 11% and 21%, respectively. However, the observed effects were not associated with any histopathological findings and were not evident in mice following repeated oral administration of up to 11620 mg/kg for 3 months.
Following repeated oral administration of silymarin to pregnant rats (at 1000mg/kg/day from day 8 to day 12 of gestation) and rabbits (at 100 mg/kg from day 8 to day 17) ,no embryotoxic effects were evident in rats on day 21 of pregnancy.
Milk Thistle extract was considered to be mutagenic in the TA98 strain (but not the TA100, TA1535, TA1537, and TA102 strains) of S typhimurium. It was also considered to be mutagenic in a mammalian chromosomal aberration assay at the maximum concentration evaluated (240 mcg/mL). However, it was not mutagenic in an in vivo chromosomal aberration assay at a dose that was substantially (47-fold) higher than the maximum proposed clinical dose of 522 mg or 10.4 mg/kg/day. In addition, no indication of carcinogenic potential was observed during two-year studies in the mouse or rat following repeated oral administration of up to 7180 or 2750 mg/kg/day, respectively.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Tablet core:
Calcium Carbonate
Maltodextrin
Croscarmellose Sodium
Microcrystalline Cellulose
Colloidal Anhydrous Silica
Magnesium Stearate
Film Coating:
Hypromellose
Purified Talc
6.2 Incompatibilities
None applicable.
6.3 Shelf life
36 months
6.4 Special precautions for storage
Do not store above 25oC. Store in the original package.
6.5 Nature and contents of container
30, 60 or 120 tablets in a PVC/PVDC blister pack with aluminium foil with cardboard outer.
Not all pack sizes may be marketed
6.6 Special precautions for disposal
No special requirements.
7 MARKETING AUTHORISATION HOLDER
Brunel Healthcare Manufacturing Limited
William Nadin Way
Swadlincote
Derbyshire
DE11 0BB
8 MARKETING AUTHORISATION NUMBER(S)
THR: 20894/0071
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
09/01/2020
10 DATE OF REVISION OF THE TEXT
28/02/2022