Summary of Product Characteristics (SmPC) - Sinuweliplex oral drops
1 NAME OF THE MEDICINAL PRODUCT
SinuWeliplex Oral Drops
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml (29 drops) contains:
- Hydrargyrum sulfuratum rubrum 8X
- Kalium bichromicum 6X
- Luffa operculata 6X
Each ml (29 drops) contains 350 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
Clear, colourless solution.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
A homeopathic medicinal product used within the homeopathic tradition to relieve symptoms affecting the nasal sinuses, such as blocked or runny nose.
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.
If symptoms improve, the number of doses may be reduced to 1-3 times a day but should not be taken for more than 7 days.
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, chrome 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 before starting to take the product if the patient is currently suffering from, or has a history of, liver problems.
A doctor or a qualified health care practitioner should be consulted if any of the following symptoms are present or develop: dyspnoea, fever or purulent nasal secretion.
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 under 12 years of age due to lack of adequate data and medical advice should be sought.
This medicinal product contains 44.5 vol % ethanol (alcohol), i.e. up to 120 mg per dose (10 drops), equivalent to 3 ml beer or 1.25 ml wine per dose (10 drops).
The small amount of alcohol in this medicine will not have any noticeable effects.
Drinking alcohol whilst taking this product should be avoided, because the effects of alcohol may be increased.
The concomitant use of other medicinal products that contain ethanol should be avoided.
4.5 Interaction with other medicinal products and other forms of interaction
SinuWeliplex 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
There have been single reports of skin reactions e.g. itchy rash. Additionally there is a potential for an increase in the amount of saliva produced. If these effects occurs, the patient should stop taking the medicine.
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 (17.5 g in 50 ml) is equivalent to 175 ml of wine or 437.5 ml 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
Tests 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
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
8 MARKETING AUTHORISATION NUMBER(S)
NR 57560/0005
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
20/01/2022
10 DATE OF REVISION OF THE TEXT
18/12/2023