milkthistle_packHRI Milk Thistle – SPC

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1. Name of the medicinal product
HRI Milk Thistle Tablets
2. Qualitative and quantitative composition
Each film-coated tablet contains 300 mg of standardised extract (as dry extract) from Milk Thistle fruits (Silybum marianum (L.) Gaertner) (equivalent to 7200mg – 8100mg of Milk Thistle fruits) corresponding to 174 mg of silymarin, calculated as silibinin.
Extraction solvent: Acetone 95% v/v
For full list of excipients, see section 6.1.
3. Pharmaceutical form
Film-coated tablet.
Pale purple oval shaped biconvex film coated 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 administration.
Adult and the elderly: the recommended dosage is 1 or 2 tablets daily.
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 a doctor or a qualified healthcare practitioner should be consulted.
4.3. Contraindications
Hypersensitivity to Milk Thistle or plants of the daisy (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, consult a doctor or qualified healthcare practitioner.
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. 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.
Tests 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
Gastrointestinal reactions (nausea, upset stomach, diarrhoea). Headache, allergic reactions (urticaria, skin rash, pruritus, anaphylaxis)
The frequency is not known.
If other adverse reactions not mentioned above occur, a doctor or qualified healthcare practitioner should be consulted.
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
Tests on reproductive toxicity, genotoxicity and carcinogenicity have not been performed.
6. Pharmaceutical particulars
6.1. List of excipients
Tablet Core
• Calcium Carbonate
• Pregelatinised Starch
• Sodium Croscarmellose
• Silicon Dioxide
• Magnesium Stearate
• Stearic Acid
Tablet Coating
• Hypromellose 4.8-7.2 mPas
• Purified Talc
• Spectracoat Purple containing:
Anthocyanin (E163)
Titanium Dioxide (E171)
Hypromellose
Citric Acid
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
Tablets are packed into PVC/PVDC blister strips of 15 tablets in the following pack sizes; 30, 60, 90
Tablets and packed into a Carton.
Not all pack sizes may be marketed.
6.6. Instructions for Use/Handling
No special requirements.
7. Traditional registration holder
THE HERBAL RESEARCH COMPANY LIMITED
(TRADING AS JESSUP MARKETING)
27 OLD GLOUCESTER STREET
LONDON
WC1N 3XX
8. Marketing Authorisation number
THR 02231/0004
9. Date of first authorisation/renewal of the authorisation
11th August 2011
10. Date of revision of the text
Aug 2011