SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

Cypar Artichoke Capsules

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Each hard capsule contains: 320 mg of extract (as dry extract) from Artichoke leaf (Cynara scolymus L.) (equivalent to 1280-1920 mg of Artichoke leaf)

Extraction solvent: water

One capsule contains 93 mg of lactose monohydrate.

For full list of excipients see section 6.1

3 PHARMACEUTICAL FORM

Hard capsules.

Green, opaque.

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

Traditional herbal medicinal product used for the relief of digestive complaints, such as indigestion, upset stomach, nausea, feelings of fullness and flatulence, particularly caused by over indulgence of food and drink, based on traditional use only.

4.2 Posology and method of administration

For oral use only.

Adults and the elderly take 2 capsules twice daily. The capsules should be swallowed whole with a little liquid before food.

If symptoms worsen or do not improve after 1 week a doctor or qualified healthcare practitioner should be consulted.

The use in children or adolescents under 18 years of age is not recommended (see section 4.4 “Special warnings and precautions for use”).

4.3 Contraindications

Hypersensitivity to Artichoke or other plants of the Asteraceae (Compositae) family or to any of the excipients.

Obstructions of bile ducts, cholangitis, gallstones and any other biliary diseases and hepatitis

4.4 Special warnings and precautions for use

Do not exceed the stated dose.

This product contains lactose monohydrate.

Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactase malabsorption should not take this medicine.

The use in children under 18 years of age is not recommended due to the lack of adequate data.

4.5 Interaction with other medicinal products and other forms of interaction

None known.

4.6 Fertility, pregnancy and lactation

Safety during pregnancy and lactation has not been established. In the absence of sufficient data, use during pregnancy and lactation is not recommended.

No studies on the effect on fertility have been performed.

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

Slight diarrhoea with abdominal spasm, epigastric complaints like nausea, and heartburn have been reported. The frequency is not known.

Allergic reactions may occur. 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

A small overdose (up to 10 capsules) may not cause any symptoms. In the event of a large overdose (more than 10 capsules), advice should be sought from a doctor.

Management of an overdose should include appropriate symptomatic and supportive treatment as warranted by the clinical situation.

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

The genotoxic potential of the dry extract was investigated in the bacterial reverse mutation test and was not mutagenic at concentrations of up to 5000 pg/plate under test conditions.

There is no information on any components within the drug product composition which gives cause for mutagenic concern.

Tests on the reproductive toxicity and carcinogenic potential have not been performed.

PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Extract:

Lactose Monohydrate Colloidal anhydrous silica

Capsule filling:

Lactose monohydrate Magnesium stearate Talc

Colloidal anhydrous silica

Capsule shell: Hypromellose Titanium dioxide (E 171) Quinoline yellow (E104) Brilliant blue (E133)

6.2 Incompatibilities

Not applicable

6.3    Shelf life

30 months

6.4    Special precautions for storage

Do not store above 25 °C Keep in the original packaging

6.5 Nature and contents of container

Blister packs containing 30, 60, 100 or 200 capsules.

Cypar Artichoke capsules are packed in PVC/PVDC-aluminium blisters in a cardboard box.

Not all pack sizes may be marketed