Digestisan Oral Drops
SUMMARY OF PRODUCT 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 xpiperita 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.
3 PHARMACEUTICAL FORM
Oral drops, solution It is a brown clear liquid.
4 CLINICAL PARTICULARS
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 PHARMACEUTICAL PARTICULARS
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
Brown glass dropper bottles (Type III glass) with a two part dropper (PE-LD)/dispenser cap (PP) and ring (PE-HD).
Pack sizes: 15 ml
30 ml 50 ml 100 ml
Not all pack sizes may be marketed.
6.6 Special precautions for disposal
No special requirements.
7 MARKETING AUTHORISATION HOLDER
Bioforce (UK) Ltd
2 Brewster Place
Irvine, Ayrshire
KA11 5DD, United Kingdom
Tel: 01294 277344
8 MARKETING AUTHORISATION NUMBER(S)
THR 13668/0018
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
05/08/2011
10 DATE OF REVISION OF THE TEXT
05/08/2011