Summary of Product Characteristics (SmPC) - Silamarie

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 longer than a week, 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 longer 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 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 (dry mouth, nausea, gastric irritation, upset stomach, diarrhoea), headache, allergic reactions (dermatitis, urticaria, skin rash, pruritis, anaphylaxis, asthma).

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 website www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card 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

Reverse mutation assays (Ames test) on bacteria indicated that the product was not mutagenic in Salmonella typhimurium (strains TA 98, TA 100, TA 1535 and TA 1537) and E.Coli strain WP2 uvrA mutation assays with or without metabolic activation.

Adequate tests on reproductive toxicity and carcinogenicity have not been performed

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Hypromellose (capsule shell)

6.2 Incompatibilities

Not Applicable.

6.3 Shelf life

2 years

6.4 Special precautions for storage

Store below 25°C

Store in the original container.

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.

6.6 Special precautions for disposal

There are no special precautions for disposal.

7 MARKETING AUTHORISATION HOLDER

Bio-Health Limited

Culpeper Close

Medway City Estate

Rochester

Kent

ME2 4HU

8 MARKETING AUTHORISATION NUMBER(S)

THR 15817/0009

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

29/08/2019

10 DATE OF REVISION OF THE TEXT