Summary of Product Characteristics (SmPC) - Weleda Relaxing oral drops
1 NAME OF THE MEDICINAL PRODUCT
Weleda Relaxing Oral Drops
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1ml of oral liquid contains:
Avena sativa mother tincture 0.25ml [equivalent to 121mg fresh Avena sativa herb].
Extraction solvent: Ethanol 62% w/w
Humulus lupulus mother tincture 0.04ml [equivalent to 3mg Hops Strobile]. Extraction solvent: Ethanol 86% w/w
Passiflora incarnata mother tincture 0.075ml [equivalent to 23mg fresh Passion Flower herb].
Extraction solvent: Ethanol 86% w/w
Valeriana officinalis mother tincture 0.3ml [equivalent to 26mg Valerian root]. Extraction solvent: Ethanol 43% w/w
Coffea tosta 60X 0.15ml
1 ml is equivalent to 34 drops.
1 ml of oral liquid contains approximately 357 mg of ethanol (alcohol) equivalent to 9.5 ml beer or 3.9 ml wine.
For full list of excipients see Section 6.1.
3 PHARMACEUTICAL FORM
Oral drops, solution
Clear, yellow-brown liquid
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
A homeopathic medicinal product used within the homeopathic tradition for the temporary relief of mild symptoms associated with stress and to aid sleep.
4.2 Posology and method of administration
Adults and the elderly:
For the temporary relief of mild stress symptoms: 0.75ml – 1.0ml in a small glass of water, three times a day.
To aid sleep: 1.0 ml – 2.0ml in a small glass of water, half an hour before retiring to bed.
Maximum daily dose is 5.0 ml.
Not recommended for use in children and adolescents under 18 years of age (see Section 4.4 ‘Special warnings and precautions for use’).
How to use the dropper:
- Unscrew the cap by pushing the cap down and twisting in an anti-clockwise direction
- Hold the bottle upright and place the dropper inside the bottle
- Squeeze the bulb to draw the amount of solution required into the dropper to either the 0.75ml or 1ml marking on the side of the dropper as appropriate (see the recommended dose section for the correct dose)
- If too much solution has been drawn up into the dropper, gently squeeze the bulb to release the solution back into the bottle until the correct dose has been measured
- If too little solution has been drawn up, replace the dropper into the bottle and gently squeeze to draw up more solution
- After use, screw the dropper back onto the bottle.
Method of administration
For oral, short term use only.
Duration of use
If the symptoms worsen, or persist after one week, a doctor or qualified healthcare practitioner should be consulted.
4.3 Contraindications
Hypersensitivity to the active substances or any of the excipients listed in section 6.1.
4.4 Special warnings and precautions for use
Do not exceed the stated dose.
If the symptoms worsen, or persist after one week, a doctor or qualified healthcare practitioner should be consulted.
Not to be used repeatedly without consulting a doctor or qualified healthcare practitioner.
The use of this product in children and adolescents under 18 years of age is not recommended because data are not sufficient and medical advice should be sought.
The amount of alcohol in 1ml is 357 mg. The maximum recommended dose of this medicine (5.0 ml) will increase the concentration of alcohol in the body by approximately 380 mg/L. This is equivalent to drinking 47.5ml of beer or 19.5ml of wine.
The small amount of alcohol in this medicine will not have any noticeable effects.
4.5 Interaction with other medicinal products and other forms of interaction
Contains alcohol and should be avoided in patients taking other medicines known to interact with alcohol (e.g. metronidazole, disulfiram).
Additive effects with hypnotics and other sedatives cannot be excluded and therefore co-medication is not recommended as a general precaution.
The effects of this product may be potentiated by alcohol. Excessive concomitant consumption of alcohol should therefore be avoided.
4.6 Fertility, pregnancy and lactation
The safety of this product during pregnancy and lactation has not been established, therefore in the absence of sufficient data the use of this product during pregnancy and lactation is not recommended.
Studies on the effects of fertility have not been performed.
4.7 Effects on ability to drive and use machines
May impair the ability to drive or use machines. Affected patients should not drive or use machines.
This product contains alcohol (see Section 4.4).
4.8 Undesirable effects
The following side effects have been reported with Valerian root preparations: Gastrointestinal symptoms such as nausea, vomiting, abdominal cramps and diarrhoea may occur. Dizziness, headaches and nightmares or vivid dreams may also occur. The frequency is not known.
One case of hypersensitivity (vasculitis) and one case of nausea and tachycardia have been reported after ingestion of much higher levels of Passion Flower herb preparations.
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 of Apple App Store.
4.9 Overdose
No case of overdose has been reported. Overdose of this product may result in alcohol intoxication. The amount in a full bottle [17.86g in 50ml], is equivalent to 475ml of beer or 195ml of wine and may result in intoxication and should be treated accordingly.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Not required
5.2 Pharmacokinetic properties
Not required
5.3 Preclinical safety data
Tests on reproductive toxicity, genotoxicity 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
4 years
6.4 Special precautions for storage
Do not store above 25oC.
Store in the original container.
6.5 Nature and contents of container
Violet glass bottle with a TPE bulb and graduated glass dropper incorporating a HDPE child resistant and tamper evident cap.
25ml, 50ml and 100ml pack sizes available. Not all pack sizes may be marketed.
6.6 Special precautions for disposal
No special requirements
7 MARKETING AUTHORISATION HOLDER
Weleda UK Ltd
Etiquette Park
Ilkeston
Derbyshire
DE7 8FU
UK
8 MARKETING AUTHORISATION NUMBER(S)
NR 00298/0298
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
04/05/2021
10 DATE OF REVISION OF THE TEXT
11/02/2026