SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

DigestAid coated tablets

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

One coated tablet contains 300 mg of extract (as dry extract) from Artichoke leaf (Cynara scolymus L.) (5.8-7.5 :1).

Extraction solvent: Water.

One coated tablet contains 104 mg lactose and 47 mg sucrose.

For a full list of excipients, see section 6.1.

3 PHARMACEUTICAL FORM

Coated tablet.

Round coated tablet, white-coloured

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 (wind), 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, elderly and children over 12 years: Take one coated tablet twice daily.

The tablets should be swallowed whole with some water before food.

The use in children under 12 years of age is not recommended (see section 4.4 “Special warnings and precautions for use”).

Duration of use:

If the symptoms persist for more than 2 weeks during the use of the medicinal product, a doctor or qualified healthcare practitioner should be consulted.

4.3 Contraindications

Hypersensitivity to the active ingredient, to plants of the Asteraceae family (Compositae) or to any of the excipients.

Patients with:

•    obstruction of the bile duct or intestinal tract,

•    cholangitis,

•    liver disease,

•    gallstones and any other biliary disorders

4.4 Special warnings and precautions for use

Do not exceed the stated dose.

The use in children under 12 years of age is not recommended due to the lack of adequate data.

If the symptoms worsen or do not improve after two weeks, consult a doctor or a qualified healthcare practitioner.

Since the tablet contains lactose monohydrate and sucrose (see section 6.1), patients with rare hereditary problems of galactose intolerance, fructose intolerance, the Lapp lactase deficiency, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.

4.5 Interaction with other medicinal products and other forms of interaction

None reported.

4.6 Fertility, pregnancy and lactation

The safety of the product during pregnancy and lactation has not been established.

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

Studies on the effects on fertility have not 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 such as nausea, flatulence 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 a qualified healthcare practitioner should be consulted.

4.9 Overdose

None reported.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Not required as per Article 16c(1)(a)(iii) of Directive 2001/83/EC as amended.

Pharmacokinetic properties

Not required as per Article 16c(1)(a)(iii) of Directive 2001/83/EC as amended.

5.3 Preclinical safety data

The non-clinical toxicology data available are limited. Tests on reproductive toxicity and on carcinogenicity have not been performed.

An in vitro mutagenicity study (Ames test) test conducted with the artichoke leaf dry extract to investigate genotoxic or mutagenic potential was negative.

6    PHARMACEUTICAL PARTICULARS

6.1    List of excipients

Maltodextrin

Excipients of the dry extract:

Precipitated silicon dioxide Precipitated silicon dioxide Excipients of the tablet core:

Povidone K 90 Maize starch

Sodium starch glycolate (Type A)

Lactose monohydrate Cellulose

Magnesium stearate Hypromellose

Excipients of the tablet film-coat:

Glycerol

Titanium dioxide E 171

Talc

Sucrose

Excipients of the tablet sugar-coat:

Talc

Calcium carbonate Heavy kaolin Spray-dried acacia Titanium dioxide E 171 Macrogol 6000

6.2 Incompatibilities

None known.

6.3 Shelf life

3 years.

6.4 Special precautions for storage

None.

6.5 Nature and contents of container

The coated tablets are packed in PVC/PVdC-aluminium blisters. Pack sizes: 30, 60 or 90 coated tablets Not all pack sizes may be marketed.

6.6 Special precautions for disposal

No special requirements.

7    MARKETING AUTHORISATION HOLDER

Swiss Caps GmbH GrassingerstraBe 9 D-83043 Bad Aibling Germany

tel: +49 (0) 80 61 / 9 31 01 fax: +49 (0) 80 61 / 9 31 200

8    MARKETING AUTHORISATION NUMBER(S)

THR 18397/0009

9    DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

19/11/2012

10    DATE OF REVISION OF THE TEXT

19/11/2012