Summary of medicine characteristics - DIGESTOVOWEN ORAL DROPS
Digestovowen Oral Drops
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml (24 drops) contains:
Atropa belladonna 6X
Carbo vegetabilis 8X
Citrullus colocynthis 4X
Plumbum metallicum 8X
Strychnos nux-vomica 6X
Each ml (24 drops) contains 335 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
abdominal discomfort
stomach cramp
feeling of fullness
wind
4.2 Posology and method of administration
For oral use only.
Adults and the elderly
Take 5 drops up to 6 times a day in a glass of water.
Maximum daily dose = 6 × 5 drops (30 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 ethanol.
4.4 Special warnings and precautions for use
Do not exceed the stated dose.
A doctor or qualified healthcare practitioner should be consulted if any of the following symptoms are present or develop: abdominal pain, fever, vomiting, diarrhoea, haematemesis, melaena or jaundice.
A doctor or qualified healthcare practitioner should be consulted before starting to take the product if the patient is currently suffering from, or has a history of, the following conditions:
Gastrointestinal ulceration, haemorrhage or perforation
Cholelithiasis
Hepatic disease
Inflammatory bowel disease
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.
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 due to lack of adequate data and medical advice should be sought.
This medicine contains 42 vol.-% alcohol. This product contains small amounts of ethanol (alcohol), less than 100 mg per 5 drops (single dose).
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
Digestovowen 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 (16.6 g in 50 ml) is equivalent to 178 mls of wine or 432 mls of beer.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Not applicable.
ATC code: V03A All other therapeutic products
5.2 Pharmacokinetic properties
Not applicable.
5.3 Preclinical safety data
5.3 Preclinical safety dataTests on genotoxicity, carcinogenicity or reproductive toxicity 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 bottle of the hydrolytic class 3 with tamper evident cap (white), 2-part, cap of PP, ring of HDPE; dropper insert of LDPE.
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.
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 16672/0017
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THEAUTHORISATION
09/04/2020