Summary of medicine characteristics - EASIGEST ORAL DROPS
1 NAME OF THE MEDICINAL PRODUCT
Easigest Oral Drops
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml (28 drops) contains:
Apomorphinum hydrochloricum 12X
Artemisia absinthium 0
Semecarpus anacardium 2X
Strychnos nux-vomica 6X
Each ml (28 drops) contains 404 mg of ethanol (see section 4.4 ‘Special warnings and precautions for use’).
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Oral drops; solution (oral drops); clear, colourless solution.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
A homeopathic medicinal product used within the homeopathic tradition for the symptomatic relief of mild stomach ache and nausea.
4.2 Posology and method of administration
For oral use only.
Take 5–10 drops, approximately every 90 minutes, up to 12 times a day, in a glass of water.
Maximum daily dose = 12 × 10 drops (120 drops).
This product is not recommended for use in children or adolescents under 18 years of age (see section 4.4 ‘Special warnings and precautions for use’).
If symptoms worsen during the use of the product, or persist after 2 days of using the product, a doctor or qualified healthcare practitioner should be consulted.
4.3 Contraindications
Hypersensitivity to any of the active ingredients or to other plants of the Asteraceae/Compositae family or to ethanol.
Obstruction of the bile duct, cholangitis or liver disease.
Nut allergy
4.4 Special warnings and precautions for use
Do not exceed the stated dose.
Patients with gallstones and any other biliary disorders should consult a doctor before using this product.
If symptoms worsen during the use of the product, or persist after 2 days a doctor or qualified healthcare practitioner should be consulted.
Not to be used repeatedly in case of recurrent symptoms without consulting a doctor or qualified healthcare practitioner.
This product is not recommended for use in children or adolescents under 18 years of age and medical advice should be sought.
This medicine contains 51 vol.-% ethanol (alcohol), i.e. up to 144 mg per dose (10 drops), equivalent to 3.6 ml beer or 1.5 ml wine per dose. Harmful for those suffering from alcoholism. To be taken into account in pregnant or breastfeeding women and high-risk groups such as patients with liver disease, or epilepsy.
Drinking alcohol whilst taking this product should be avoided, because the effects of alcohol may be increased.
4.5 Interaction with other medicinal products and other forms of interaction Easigest Oral Drops should not be taken with other medicines known to interact with alcohol e.g. metronidazole, disulfiram.
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, this product should not be used during pregnancy or lactation.
Studies on the effects on fertility have not been performed.
4.7 Effects on ability to drive and use machines
No studies on the effects on driving or operating machines have been performed.
This product contains alcohol (see section 2).
4.8 Undesirable effects
There are no known side effects with this product.
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 at:
www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
4.9 Overdose
4.9 OverdoseNo case of overdose has been reported.
The amount of alcohol in a full bottle of the largest pack size (20 g in 50 ml) is equivalent to 214 mls of wine or 520 mls of beer.
5.1
Not applicable.
ATC code: V03A All other therapeutic products
5.2 Pharmacokinetic properties
Not applicable.
5.3 Preclinical safety data
5.3 Preclinical safety dataArtemisia absinthium mother tincture contains thujone. Thujone is reported to be neurotoxic.
However the maximum total intake of thujone with the maximum daily dose of Easigest Oral Drops is 8 Lig according to 0.016 |ig/kg related to a 50 kg person. No toxic effects are known by this small dose from animal studies.
Tests on reproductive toxicity have been performed with a dry ethanolic extract of Absinthii herba administered orally to pregnant rats. Results showed reduced sites of implantations and a reduced rate of born pups. Thujone is known for its uterus stimulating activity.
Test on genotoxicity, reproduction and carcinogenicity have not been performed.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Ethanol
Purified water
6.2 Incompatibilities
Not applicable
6.3 Shelf life
Unopened: 5 years.
Shelf life after first opening: 6 months.
6.4 Special precautions for storage
No special storage conditions are required. Store in the original container.
6.5 Nature and contents of container
Amber glass bottle (Ph. Eur. Type III) with a low density polyethylene (LDPE) dropper unit and a polypropylene tamper evident cap (white) incorporating a high density polyethylene (HDPE) ring.
Pack sizes: 30 ml and 50 ml.
Not all pack sizes may be marketed.
6.6 Special precautions for disposal
6.6 Special precautions for disposalNo special requirements
7 MARKETING AUTHORISATION HOLDER
Weber & Weber GmbH & Co. KG
Herrschinger Str. 33
82266 Inning/Ammersee
Germany
Phone +49 (0)8143 9270
Fax +49 (0)8143 927 270
information@weber-weber.net
8 MARKETING AUTHORISATION NUMBER(S)
NR 16672/0018
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
09/04/2020