Summary of Product Characteristics (SmPC) - Weleda Period Pain Relief oral drops
1 NAME OF THE MEDICINAL PRODUCT
Weleda Period Pain Relief Oral Drops
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 1 ml contains: Melissa Cupro culta 3X (Lemon balm)
1 ml = 19 drops
1 ml of oral liquid contains approximately 290 mg of ethanol (alcohol).
For full list of excipients see Section 6.1.
3 PHARMACEUTICAL FORM
Oral drops, solution
Clear, colourless to slightly yellowish liquid
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
A homeopathic medicinal product used within the homeopathic tradition for the symptomatic relief of menstrual cramps associated with period pains.
4.2 Posology and method of administration
For oral use only
Adult women and girls over 12 years:
10-15 drops, to be taken in a small glass of water 2 – 4 times a day.
Not recommended for use in children under 12 years of age (See Section 4.4. Special warnings and precautions for use).
Maximum daily dose is 60 drops.
Duration of use: up to 7 days depending on how long period lasts.
If symptoms worsen, or do not improve within 5-7 days, depending on how long period lasts, talk to a doctor or qualified healthcare practitioner.
4.3 Contraindications
Hypersensitivity to the active ingredient.
4.4 Special warnings and precautions for use
Do not exceed the stated dose.
Not recommended for use in children under 12 years of age and medical advice should be sought.
A doctor or qualified healthcare practitioner should be consulted if abdominal pain persists, bloating, unexplained weight loss or blood in stools occurs.
Patients with persistent cramps should consult a doctor or qualified healthcare practitioner before starting to take this product.
The product may be used for up to 7 days, depending on length of period
If symptoms worsen, or do not improve within 5-7 days, depending on how long period lasts, a doctor, pharmacist or qualified healthcare practitioner should be consulted.
This medicine contains 229mg of alcohol (ethanol) in each dose (15 drops). The amount in each dose is equivalent to less than 6 ml of beer or 3 ml of wine. The small amount of alcohol in this medicine will not have any noticeable effects.
Not to be used repeatedly without consulting a doctor or qualified healthcare practitioner.
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).
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. In the absence of sufficient data, the use 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
This product contains alcohol (see Section 4.4). May impair the ability to drive or use machines. Affected patients should not drive or use machines.
High levels of the ingredient (Melissa officinalis) included in this product may impair the ability to drive or use machines.
4.8 Undesirable effects
None known.
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 and no studies have been performed. Symptomatic and supportive measures should be taken as appropriate.
Overdose of this product may result in alcohol intoxication. The amount in a full bottle (7.25g in 25ml), is equivalent to 181 ml of beer or 73 ml 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
Data from in vitro and animal studies indicate that the water extract of Melissa officinalis L. folium may inhibit the activity of thyroid stimulating hormone (TSH). The clinical relevance of these findings is not known.
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
25 ml amber glass bottle (Type III, Ph. Eur.) fitted with a two-part white tamper evident plastic screw cap (polypropylene) complete with dropper assembly (low-density polyethylene).
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 00298/0322
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
10 DATE OF REVISION OF THE TEXT
11/02/2026