Summary of medicine characteristics - WELEDA COLD RELIEF OROMUCOSAL SPRAY
1 NAME OF THE MEDICINAL PRODUCT
Weleda Cold Relief Oromucosal Spray
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each metered spray contains:
Allium cepa 6X
Drosera rotundifolia 6X
Gelsemium sempervirens 6X
Excipient with known effect:
16.6% w/w Ethanol (See Section 4.4 ‘Special warnings and precautions for use.’)
Each metered spray contains 12.9mg to 20.9mg of ethanol
3 PHARMACEUTICAL FORM
Oromucosal spray, colourless, clear liquid in an amber glass pump spray.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
Weleda Cold Relief Oromucosal Spray is a homeopathic medicinal product used within the homeopathic tradition for the symptomatic relief of the common cold, cough associated with the common cold, and related flu-like symptoms.
4.2 Posology and method of administrationAdults, elderly and children over 12 years:
for oral use only
hold the spray upright, a few centimetres from the mouth
open your mouth, and apply one or two metered sprays into the mouth up to 3 times daily. Change the site of application each time to minimise any potential irritation
administration to children aged 12 to 18 years should be supervised by an adult
do not swallow
ideally doses should be taken half an hour before or half an hour after food or drink
if symptoms worsen or persist after 7 days of taking this product, consult a doctor or qualified healthcare practitioner
Weleda Cold Relief Oromucosal Spray is not for use in children below 12 years of age.
4.3 Contraindications
Hypersensitivity to any of the active ingredients or ethanol.
4.4 Special warnings and precautions for use
Do not exceed the stated dose.
If fever develops or if symptoms worsen or persist after 7 days of taking this product, consult a doctor or qualified healthcare practitioner
The formulation of this product is not suitable for use in children under 12 years of age.
Do not spray into the throat or eyes.
The effects of alcohol may be increased and therefore concurrent use should be avoided
This medicinal product contains small amounts of ethanol (alcohol), less than 100mg per dose
If fever is experienced or if there is a history of asthma or other chronic respiratory conditions, consult a doctor or qualified healthcare practitioner before starting to take this medicine.
4.5 Interaction with other medicinal products and other forms of interaction This medicinal product contains small amounts of ethanol (alcohol), therefore concurrent use should be avoided with other medication known to interact with alcohol e.g. metronidazole and disulfiram.
4.6 Fertility, pregnancy and lactation
There is no evidence of the safety of the product in human pregnancy and lactation. The use of the product during pregnancy and lactation should be avoided unless under the guidance of a medical practitioner.
This product contains small amounts of alcohol.
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 the ability to drive and use machines have been performed.
This product contains small amounts of alcohol (see section 2)
4.8 Undesirable effects
There are no reports of adverse effects.
If adverse effects occur a doctor or pharmacist should be consulted.
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.
4.9 Overdose
4.9 OverdoseNo studies have been performed. Symptomatic and supportive measures should be taken as appropriate.
The amount of alcohol per metered spray is 0.016 – 0.027ml, 12.9–20.9mg of ethanol.
The amount of alcohol in a full bottle (20ml) is 4.09ml/3.23g ethanol.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Pharmacotherapeutic dosage (ATC code) Homeopathic preparations –
V03AX
5.2 Pharmacokinetic properties
Not applicable to product of this type
5.3 Preclinical safety data
5.3 Preclinical safety dataNone available
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Purified Water
Ethanol
6.2 Incompatibilities
None known
6.3 Shelf life
5 years
Discard 6 months after first opening.
6.4 Special precautions for storage
Do not store above 25°C
Discard 6 months after first opening
Store in the original package
6.5 Nature and contents of container
20ml Type I glass amber bottle with a plastic atomiser closer, covered with a plastic dust cap.
Each metered dose contains 0.08 – 0.13ml of Spray
Each vial contains approximately 200 metered doses