DIGESTISAN ORAL DROPS - summary of medicine characteristics

1 NAME OF THE MEDICINAL PRODUCT

Digestisan Oral drops

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

1 ml of oral liquid contains:

414 mg of tincture from fresh Artichoke leaves (Cynara scolymus L., folium) (1:30–31). Extraction solvent: Ethanol 65% V/V.

414 mg of tincture from fresh Dandelion root and herb (Taraxacum officinalis WEB., radix cum herba) (1:17–18). Extraction solvent: Ethanol 51% V/V.

64 mg of tincture from Boldo leaves (Peumus boldus MOLINA., folium) (1:10–11). Extraction solvent: Ethanol 70% V/V

28 mg of tincture from fresh Peppermint herb (Mentha x piperita L., herba) (1:18–19). Extraction solvent: Ethanol 65% V/V

1 ml is equivalent to 38 drops.

1 ml of oral liquid contains approximately 478 mg ethanol (alcohol) equivalent to 12 ml beer or 5 ml wine.

For a full list of excipients, see section 6.1.

Oral drops, solution

It is a brown clear liquid.

4.1 Therapeutic indications

A traditional herbal medicinal product used for indigestion, sensation of fullness and flatulence associated with over-indulgence in food or drink, or both, based on traditional use only.

4.2 Posology and method of administration For oral use only.

Adults and the elderly: Take 15–20 drops three times a day.

If symptoms worsen or do not improve after 2 weeks a doctor or qualified healthcare practitioner should be consulted.

Not for children or adolescents under 18 years (see also 4.4 Special warnings and precautions for use).

4.3 Contraindications

Hypersensitivity to any of the active substances, to plants of the Asteraceae (Compositae) family or to menthol.

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 stated dose.

Patients with gastro-oesophageal reflux (heartburn) should avoid taking the product as heartburn may increase due to the peppermint leaf.

Patients with renal failure and/or diabetes, and/or heart failure should avoid taking the product because of possible complications due to hyperkalaemia.

If the condition worsens or does not improve after two weeks, consult a doctor or a qualified healthcare practitioner.

This product contains 60 vol% ethanol (alcohol).

This corresponds to:

255 mg alcohol equivalent to 6.4 ml beer or 2.7 ml wine (20 drops)

187 mg alcohol equivalent to 4.6 ml beer or 1.9 ml wine (15 drops)

Harmful for those suffering from alcoholism. To be taken into account in pregnant, or breastfeeding women, children and high-risk groups such as patients with liver disease or epilepsy.

Use in children and adolescents under 18 years of age is not recommended because data are insufficient and medical advice should be sought.

4.5 Interaction with other medicinal products and other forms of interaction

Limited data on pharmacological interactions with other medicinal products are available. Clinically relevant interactions with drugs metabolized by the CYP 2D6, CYP 3A4/5, CYP 1A2 or CYP 2E1 pathway have not been observed.

Contains alcohol and should be avoided in patients taking other medicines known to interact with alcohol (e.g. metronidazole).

4.6 Fertility, Pregnancy and lactation

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

In view of the pre-clinical safety data (see section 5.3), the use of this product during pregnancy and lactation should be avoided.

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.

This product contains alcohol (See Section 4.4 for details of alcohol content).

4.8 Undesirable effects

Hypersensitivity reactions have been reported including reports of anaphylaxis with products containing Boldo.

Epigastric pain, hyperacidity and mild gastrointestinal symptoms (eg flatulence) may occur. Gastro-oesophageal reflux may worsen and heartburn may increase.

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

Overdose of this product may result in alcohol intoxication: the amount of alcohol in a full bottle (24 g in 50 ml: 48.1 g in 100 ml: equivalent to 1 or 2 large glasses of wine, respectively) may result in intoxication and should be treated accordingly.

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

Tests on reproductive toxicity have been performed with a dry ethanolic extract of boldo leaf and boldine administered orally to pregnant rats. Results showed anatomical alterations in the fetus and a few cases of abortion at high doses.

Tests on reproductive toxicity, genotoxicity and carcinogenicity have not been performed with the product.

6.1 List of excipients

From tinctures:

Ethanol

Purified water

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

3 years

6.4 Special precautions for storage

This medicinal product does not require any special storage conditions.

6.5 Nature and contents of container

7   MARKETING AUTHORISATION HOLDER

8 MARKETING AUTHORISATION NUMBER(S)

THR 13668/0018

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THEAUTHORISATION

05/08/2011