Cypar Milk Thistle Capsules
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Cypar® Milk Thistle Capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each hard capsule contains:
193mg - 261mg of extract (as dry extract) from Milk Thistle fruits (Silybum marianum (L.) Gaertner) (21 - 45 : 1) (equivalent to 3.725 - 10.818 g of Milk Thistle fruits), corresponding to 108 mg silymarin, calculated as silibinin.
Extraction Solvent: Acetone 95% (v/v).
For full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Hard capsule.
Red, 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.
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)
Duration of use.
If the symptoms worsen or persist more than 1 week during the use of the medicinal product, a doctor or a qualified health care practitioner should be consulted.
4.3 Contraindications
Hypersensitivity to Milk thistle or other plants from the Asteraceae (Compositae) family or to any of the excipients listed in section 6.1.
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 the symptoms worsen or persist more than 1 week during the use of the medicinal product, a doctor or a qualified health care practitioner should be consulted.
Interaction with other medicinal products and other forms of interaction
4.5
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.
No studies on the effects on fertility have 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
Mild gastrointestinal reactions (dry mouth, nausea, upset stomach, gastric irritation and diarrhoea) may occur, headache, allergic reactions (dermatitis, urticaria, skin rash, pruritis, anaphylaxis, asthma) have been reported.
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:
Website: 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 the Directive 2001/83/EC as amended.
5.2 Pharmacokinetic properties
Not required as per Article 16c(1)(a)(iii) of the 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
List of excipients
6.1
Extract excipients:
Mannitol
Capsule contents:
Mannitol
Cellulose, microcrystalline Croscarmellose sodium Silica, colloidal anhydrous Magnesium stearate
Capsule shell:
Gelatin
Purified water
Sodium lauryl sulphate
Titanium dioxide E 171
Iron (III) oxide E 172 (= red iron oxide)
Iron oxide hydrate E 172 (= yellow iron oxide)
6.2 Incompatibilities
Not applicable
6.3 Shelf life
5 years
6.4 Special precautions for storage
Do not store above 25 °C. Store in the original package.
Cypar® Milk Thistle Capsules are packed in PVC/PVDC aluminium blisters and inserted into a carton.
Original packages containing 30 or 60 hard capsules.
6.6 Special precautions for disposal
No special requirements.
7 MARKETING AUTHORISATION HOLDER
Cassella-med GmbH & Co.KG Gereonsmuehlengasse 1 50567 Cologne Germany
8 MARKETING AUTHORISATION NUMBER(S)
THR 29860/0007
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
21/11/2016
10
DATE OF REVISION OF THE TEXT
21/11/2016