Thisilyn – SPC Summary of Product Characteristics 1 Name of the medicinal product Thisilyn® Milk Thistle capsules Tesco Milk Thistle capsules Boots Digestion Relief Milk Thistle capsules Simply Supplements Milk Thistle capsules 2 Qualitative and quantitative composition Each hard capsule contains: 89 mg – 121 mg of extract (as dry extract) from Milk Thistle fruits (Silybum marianum (L.) Gaertner)(equivalent to 1.721 g – 5.000 g of Milk Thistle fruits) corresponding to 50 mg of silymarin, calculated as silibinin. Extraction solvent: Acetone 95% v/v. For full list of excipients, see section 6.1 3 Pharmaceutical form Hard capsule. Ivory, opaque, hard gelatin capsule. 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. Adults and the elderly Take 1 capsule up to twice daily. The capsules should be swallowed whole with some water or other liquid. The capsules should not be chewed. Children and adolescents under 18 years of age This medicine is not recommended for children and adolescents under 18 years of age (see Section 4.4 Special warnings and precautions for use). If symptoms worsen or persist for more than one week a doctor or 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 the 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 for more than one week 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 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 of the effect on the ability to drive and use machines have been performed. 4.8 Undesirable effects Gastrointestinal reactions (nausea, upset stomach, diarrhoea), headache, allergic reactions (urticaria, skin rash, pruritis, anaphylaxis). 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 No cases of overdose have 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 Milk 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 Extract excipients: Mannitol Capsule contents: Capsule filling mass: Mannitol Cellulose microcrystalline Croscarmellose sodium Silica, colloidal anhydrous Magnesium Stearate Capsule shell: Gelatin Purified water Titanium dioxide E171 Sodium lauryl sulphate Iron oxide hydrate E172 (= yellow iron oxide) 6.2 Incompatibilities Not applicable. 6.3 Shelf life 3 years 6.4 Special precautions for storage Do not store above 25°C. tore in the original packaging. 6.5 Nature and contents of container Original packages containing 21, 28, 30, 56, 60 or 90 Thisilyn Milk Thistle hard capsules. Original packages containing 30 hard capsules (Boots Digestion Relief Milk Thistle capsules, Tesco Milk Thistle capsules) or 60 hard capsules (Simply Supplements Milk Thistle capsules). The hard capsules are packed in PVC/ PVDC- aluminium blisters and inserted into a carton together with the package leaflet. Not all pack sizes may be marketed 6.6 Special precautions for disposal No special requirements 7 Registration holder Schwabe Pharma (UK) Ltd Alexander House Mere Park Dedmere Road Marlow Buckinghamshire SL7 1PD 8. Marketing authorisation number(s) THR 23056/0012 9 Date of first authorisation/renewal of the authorisation 13/03/2017 10 Date of revision of the text 13/03/2017
