Silamarie
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
SILAMARIE
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each hard capsule contains 450mg of Milk Thistle fruits (Silybum marianum L. Gaertner)
For full list of excipients see section 6.1.
3 PHARMACEUTICAL FORM
Hard capsules.
Clear size 0 hard capsules.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
SILAMARIE is 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 or 2 capsules 3 times daily swallowed with water up to a maximum of 6 capsules daily.
Duration of use:-
If the condition worsens or symptoms persist, a doctor or a qualified healthcare practitioner should be consulted.
This product is not recommended for children or adolescents under 18 years of age (see Section 4.4 Special Warnings and Precautions for Use).
4.3 Contraindications
Hypersensitivity to Milk Thistle or other members of the Asteraceae (Compositae) family or any of the excipients.
4.4 Special warnings and precautions for use
Do not exceed the stated dose.
The use of this product is not recommended in children and adolescents below the age of 18 years as there is no relevant indication.
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 medicine).
If the condition worsens, or symptoms persist, 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 SILAMARIE during pregnancy and lactation has not been established.
Due to the lack of sufficient data, use during pregnancy and lactation is not recommended.
Studies on fertility have not been carried out.
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
Gastrointestinal reactions (nausea, upset stomach, diarrhoea), headache, allergic reactions (urticaria, skin rash, pruritis, analphylaxis).
The frequency is not known.
If other adverse reactions not mentioned above occur, a doctor or a 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
Test on reproductive toxicity, genotoxicity and carcinogenicity have not been performed.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Hypromellose (capsule shell)
6.2
Incompatibilities
Not Applicable.
6.3
6.4
6.5
Nature and contents of container
Duma 110ml HDPE plastic container and tamper evident threaded Duma cap. Duma 200ml HDPE plastic container and tamper evident Duma cap. SILAMARIE pack contains 60 or 120 Capsules.
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MARKETING AUTHORISATION HOLDER
Bio-Health Limited Culpeper Close Medway City Estate Rochester Kent
ME2 4HU
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13/12/2011
10 DATE OF REVISION OF THE TEXT
13/12/2011