Summary of medicine characteristics - WELEDA DIGESTIVE RELIEF OROMUCOSAL SPRAY
Weleda Digestive Relief Oromucosal Spray
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each metered spray contains:
Carbo vegetabilis 6X
Citrullus Colocynthis 6X
Excipient with known effect:
15.1% w/w Ethanol (See Section 4.4 ‘Special warnings and precautions for use.’) Each metered spray contains 11.8mg to 19.2mg of ethanol and 0.4 to 0.65mg lactose
Oromucosal Spray; colourless, clear liquid in an amber glass pump spray
4.1 Therapeutic indications
Weleda Digestive Relief Oromucosal Spray is a homeopathic medicinal product used within the homeopathic tradition for the symptomatic relief of indigestion and bloating.
4.2 Posology and method of administrationAdults and elderly:
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
do not swallow
ideally doses should be taken half an hour before or half an hour after food or drink
do not spray into the throat or eyes
if symptoms worsen, or persist after 7 days of taking this product, consult a doctor or qualified healthcare practitioner
do not exceed the stated dose
Weleda Digestive Relief Oromucosal Spray is not recommended for children or adolescents under 18 years of age
4.3 Contraindications
Hypersensitivity to any of the active ingredients, ethanol (alcohol) or lactose
4.4 Special warnings and precautions for use
Do not exceed the stated dose.
If symptoms worsen, or persist after 7 days of taking this product, consult a doctor or qualified healthcare practitioner
This product is not recommended for use in children or adolescents under 18 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
This product contains lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not 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. 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.
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 0.015 – 0.024 mls, 11.8mg to 19.2mg of ethanol.
The amount of alcohol in a full bottle (20ml) is 3.74ml/2.95g 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
Lactose
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
Keep the container in the outer carton
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
6.6 Special precautions for disposal
6.6 Special precautions for disposalThere are no special precautions
7 MARKETING AUTHORISATION HOLDER
Weleda (UK) Ltd
Heanor Road, Ilkeston.
DE7 8DR,UK
0115 944 8200
0115 944 8210
info@weleda.co.uk
8 MARKETING AUTHORISATION NUMBER(S)
NR 00298/0273