Summary of Product Characteristics (SmPC) - Weber & Weber dry Cough Relief oral drops
1 NAME OF THE MEDICINAL PRODUCT
Weber & Weber Dry Cough Relief Oral Drops
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml (35 drops) contains:
- Aralia racemosa 2X
- Cephaelis ipecacuanha 4X
- Cetraria islandica 3X
- Drosera 2X
- Grindelia robusta 3X
- Inula helenium 3X
- Sanguinaria canadensis 3X
- Solanum dulcamara 4X
3 PHARMACEUTICAL FORM
Oral drops; solution
Clear, yellowish solution.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
A homeopathic medicinal product used within the homeopathic tradtion for the symptomatic relief of dry cough associated with the common cold.
4.2 Posology and method of administration
For oral use only.
Adults, the elderly and children over 12 years of age
Take 5 - 10 drops, approximately every 90 minutes, up to 12 times a day, in a glass of water.
Maximum daily dose = 12 x 10 drops (120 drops).
This product is not recommended for use in children under 12 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 7 days of using the product a doctor or qualified healthcare practitioner should be consulted.
4.3 Contraindications
Hypersensitivity to any of the active ingredients, Inula or to other plants of the Asteraceae (Compositae) family or to ethanol.
4.4 Special warnings and precautions for use
Do not exceed the stated dose.
If breathing difficulties, high fever or purulent phlegm occur, a doctor or qualified healthcare practitioner should be consulted.
If symptoms worsen during the use of the product, or persist after 7 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 younger than 12 years of age and medical advice should be sought.
This medicine contains 63 vol.-% ethanol (alcohol), i.e. up to 142 mg per dose (10 drops), which is equivalent to 3.6 ml beer or 1.5 ml wine per dose. The small amount of alcohol in this medicine will not have any noticeable effects if taken as recommended.
The concomitant use of other medicinal products that contain ethanol should be avoided.
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
Weber & Weber Dry Cough Relief 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.
No studies on the effects on fertility have 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
This product may cause allergic skin reactions (e.g. rash) in very rare cases, less than 1 in 10,000 people.
Reporting of suspected adverse reactions
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
No case of overdose has been reported.
The amount of alcohol in a full bottle of the largest pack size (24.8 g in 50 ml) is equivalent to 262 mls of wine or 628 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
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 of 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
No special requirements.
7 MARKETING AUTHORISATION HOLDER
NR 57560/0007
8 MARKETING AUTHORISATION NUMBER(S)
Weber & Weber GmbH
Herrschinger Str. 33
82266 Inning/Ammersee
Germany
Phone +49 (0)8143 9270
Fax +49 (0)8143 927 270
information@weber-weber.net
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
29/03/2022
10 DATE OF REVISION OF THE TEXT
04/01/2024