WELEDA MUSCULAR PAIN RELIEF OROMUCOSAL SPRAY - summary of medicine characteristics

Weleda Muscular Pain Relief Oromucosal Spray

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Each metered spray contains Arnica montana 6X, Ruta graveolens 6X and Rhus toxicodendron (Toxicodendron quercifolium) 6X

Each metered spray contains 12.5mg – 20.4mg of ethanol

Alcohol concentration, 16.1% w/w Ethanol

Oromucosal Spray: colourless, clear liquid in an amber glass pump spray

4.1 Therapeutic indications

Weleda Muscular Pain Relief Oromucosal Spray is a homeopathic medicinal product used within the homeopathic tradition for the symptomatic relief of muscular strains and associated aches and pains.

4.2 Posology and method of administration

Adults, 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

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 Muscular Pain 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 other plants of the Asteraceae (Compositae) family or ethanol.

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

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

4.5 Interaction with other medicinal products and other forms of interaction

This medicinal product contains small amounts of alcohol, therefore concurrent use should be avoided with other medications 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 should be avoided unless under the guidance of a medical practitioner.

This product contains small amounts of alcohol.

There is no evidence to suggest that the product should not be used during lactation.

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

If adverse effects occur a doctor or pharmacist should be consulted.

4.9 Overdose

No studies have been performed. Symptomatic and supportive measures should be taken as appropriate.

The amount of alcohol per metered spray is 0.016 – 0.026ml, 12.5–20.4mg of ethanol.

The amount of alcohol in a full bottle (20ml) is 3.98ml/3.14g ethanol.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Pharmacotherapeutic dosage (ATC code) Homeopathic preparations (2) – V3X6

5.2 Pharmacokinetic properties

Not applicable to product of this type

5.3 Preclinical safety data

None 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

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