Summary of Product Characteristics (SmPC) - Weber & Weber Cold & Flu Relief oral drops
1 NAME OF THE MEDICINAL PRODUCT
Weber & Weber Cold & Flu Relief Oral Drops
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml (27 drops) contains
- Apis mellifica 2X
- Bryonia 1X
- Echinacea purpurea ∅
- Eupatorium perfoliatum 1X
- Lachesis 8X
- Thuja occidentalis 1X
Each ml (27 drops) contains 407 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 yellow-green to yellow-brown solution.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
A homeopathic medicinal product used within the homeopathic tradition for the symptomatic relief of the common cold with flu-like symptoms.
4.2 Posology and method of administration
For oral use only.
Start at the first signs of a common cold.
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, or high fever occurs, a doctor or qualified healthcare practitioner should be consulted.
4.3 Contraindications
Hypersensitivity to any of the active ingredients, Echinacea or to other plants of the Asteraceae/Compositae family, or to ethanol.
Severe reaction to a bee sting.
Because of its immunostimulating activity, Echinacea must not be used in cases of
- progressive systemic disorders (tuberculosis, sarcoidosis)
- autoimmune diseases (e.g. collagenoses, multiple sclerosis)
- immunodeficiencies (e.g. HIV infection, AIDS)
- immunosuppression (e.g. oncological cytostatic therapy, history of organ or bone marrow transplant)
- diseases of the white blood cell system (e.g. agranulocytosis, leukaemias)
- allergic diathesis (e.g. urticaria, atopic dermatitis, asthma)
4.4 Special warnings and precautions for use
Do not exceed the stated dose.
Atopic patients should consult their doctor or qualified healthcare practitioner before using products containing Echinacea. There is a possible risk of anaphylactic reactions in atopic patients.
If an allergic reaction is experienced causing symptoms such as breathing difficulties, dizziness or a swollen face or mouth, the patient should stop taking the drops and seek medical advice immediately.
If symptoms worsen during the use of the product, or high fever, purulent phlegm or breathing difficulties occur or symptoms persist for more than 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 51 vol.-% alcohol, i.e. up to 151 mg per dose (10 drops), equivalent to
3.8 ml beer or 1.6 ml wine per dose.
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
Weber & Weber Cold & Flu Relief Oral Drops should not be taken with other medicines known to interact with alcohol e.g. metronidazole, disulfiram.
Not to be used concomitantly with any immunosuppressant medications such as ciclosporin, methotrexate, azathioprine, sirolimus, tacrolimus, canakinumab, basiliximab, belimumab, mycophenolate mofetil, belatacept.
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.
Limited data (several hundreds of exposed pregnancies) indicate no adverse effects of Echinacea on pregnancy or on the health of the foetus/newborn child. Data concerning the immune system of the newborn child are not available. To date no other relevant epidemiological data are available. The potential risk to humans is unknown.
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
Echinacea can trigger allergic reactions in atopic patients. Hypersensitive reactions in the form of rash, urticaria, itching, swelling of the face may occur with Echinacea. Cases of severe hypersensitivity reactions, such as Stevens-Johnson Syndrome, angioedema of the skin, Quincke oedema, bronchospasm with airway obstruction, asthma and anaphylactic shock have been reported. The frequency is not known.
Association with autoimmune diseases cannot be excluded for Echinacea:
- disseminated encephalitis
- erythema nodosum
- immunothrombocytopenia
- Evans Syndrome
- Sjögren Syndrome
Leucopenia may occur in long-term use (more than 8 weeks).
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 (20.4 g in 50 ml) is equivalent to 214 mls of wine or 512.5 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
Tests on genotoxicity, reproduction toxicity 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 mland 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 57560/0006
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
20/01/2022
10 DATE OF REVISION OF THE TEXT
04/01/2024