Summary of Product Characteristics (SmPC) - Silygalon Milk Thistle capsules
1 NAME OF THE MEDICINAL PRODUCT
Silygalon Milk Thistle capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each hard capsule contains:
173.0 mg – 186.7 mg of standardised extract (as dry extract) from Milk Thistle fruits (Silybum marianum (L.) Gaertner) (equivalent to 6,228 mg - 8,215 mg of Milk Thistle fruits) corresponding to 108 mg of silymarin, calculated as silibinin.
Extraction solvent: Ethyl acetate
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Hard capsules
Brown, opaque hard gelatin capsule.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
A traditional herbal medicinal product used to relieve 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
Posology
Adults and the elderly
Take one capsule 3 times daily.
Children or adolescents under 18 years
Not for use in children or adolescents under 18 years (see section 4.4 Special warning and precautions for use).
Method of administration
Swallow the capsule whole with water or other liquid.
Duration of use:
If symptoms worsen, or do not improve after 1 week, a doctor or a qualified healthcare practitioner should be consulted.
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 has not been established due to lack of adequate data.
If symptoms worsen, or do not improve after 1 week, a doctor or a 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
Safety during pregnancy and lactation has not been established. Due to the lack of data, use during 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 effect on the ability to drive and use machines have been performed.
4.8 Undesirable effects
Mild gastrointestinal disorders (such as dry mouth, nausea, upset stomach, gastric irritation, diarrhoea), headache, hypersensitivity reactions (such as dermatitis, urticaria, skin rash, pruritus, asthma and anaphylaxis).
The frequency is not known.
If other adverse reactions not mentioned above occur, a doctor 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 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
No cases of overdose have been reported.
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
Not required as per Article 16c(1)(a)(iii) of Directive 2001/83/EC as amended, unless necessary for the safe use of the product.
Adequate tests on reproductive toxicity, genotoxicity and carcinogenicity have not been performed.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Capsule contents:
Microcrystalline cellulose
Sodium starch glycolate
Maize starch
Magnesium stearate
Sodium lauryl sulphate
Capsule shell:
Gelatin
Iron oxide, Red E 172
Titanium dioxide E 171
Iron oxide, Black E 172
6.2 Incompatibilities
Not applicable
6.3 Shelf life
3 years
6.4 Special precautions for storage
Store in the original package.
6.5 Nature and contents of container
PVC film / aluminium foil blister strips. Pack sizes: 30, 60 and 100 capsules
Not all pack sizes may be marketed.
6.6 Special precautions for disposal
No special requirements.
7 MARKETING AUTHORISATION HOLDER
Mylan Products Ltd.,
Station Close,
Potters Bar,
Hertfordshire,
EN6 1TL,
UK
8 MARKETING AUTHORISATION NUMBER(S)
PL 46302/0202
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
26/07/2016
10 DATE OF REVISION OF THE TEXT
15/03/2019