Summary of Product Characteristics (SmPC) - Sedorma tablets
1 NAME OF THE MEDICINAL PRODUCT
Sedorma tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each coated tablet contains the active substances:
67.5 mg of extract (as dry extract) from Lavender flower (Lavandula angustifolia
Miller) (4-8:1), extraction solvent ethanol 70% v/v
37.5 mg of extract (as dry extract) from Hop strobile (Humulus lupulus L.)
(3-7:1), extraction solvent ethanol 50% v/v
75 mg of extract (as dry extract) from Lemon balm leaf (Melissa officinalis L.)
(4-8:1), extraction solvent ethanol 50% v/v
- 112.5 mg of extract (as dry extract) from Passion flower herb (Passiflora incarnata L.) (3-6:1), extraction solvent ethanol 50% v/v
100 mg of extract (as dry extract) from Valerian root (Valeriana officinalis L.) (3-
6:1), extraction solvent ethanol 70% v/v
Each coated tablet contains 6.1 mg of glucose and 220.3 mg of sucrose (see Section 4.4. `Special warnings and precautions for use`)
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Coated tablets for oral use.
Light green, round, biconvex, shiny sugar-coated tablets.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
Sedorma is a traditional herbal medicinal product used for the temporary relief of symptoms associated with stress such as mild anxiety and to aid sleep, based on traditional use only.
4.2 Posology and method of administration
Recommended dose for adults
1 tablet twice a day with some water.
The use in children and adolescents under 18 years of age is not recommended (see section 4.4 `Special warnings and precautions for use`).
Duration of use:
For short term use only.
If the symptoms worsen, or persist longer than 2 weeks during the use of the medicinal product, a doctor or a qualified health care practitioner should be consulted.
4.3 Contraindications
Hypersensitivity to the active substances or to any of the excipients listed in section 6.1.
4.4 Special warnings and precautions for use
Do not exceed the stated dose.
Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.
The use of this product is not recommended in children and adolescents below the age of 18 years because data are not sufficient and medical advice should be sought.
If the symptoms worsen, or persist longer than 2 weeks during the use of the medicinal product, a doctor or a qualified health care practitioner should be consulted.
4.5 Interaction with other medicinal products and other forms of interaction
Only limited data on pharmacological interactions with other medicinal products are available. Additive effects with hypnotics and other sedative drugs cannot be excluded and therefore co-medication is not recommended as a general precaution. The effect of the product may be potentiated by alcohol. Excessive concomitant consumption of alcohol should therefore be avoided.
4.6 Fertility, Pregnancy and lactation
Safety during pregnancy and lactation has not been established. In the absence of sufficient data, the use during pregnancy and lactation is not recommended.
4.7 Effects on ability to drive and use machines
May cause dizziness and impair ability to drive and use machines. If affected, patients should not drive or operate machinery.
4.8 Undesirable effects
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.
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
Valerian root at a dose of approximately 20 g (equivalent to 30 to 100 tablets) caused symptoms such as fatigue, abdominal cramp, chest tightness, light headedness, hand tremor and mydriasis, which disappeared within 24 hours. If symptoms arise, treatment should be supportive.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Not required as per Article 16c(1)(a)(iii) of Directive 2001/83/EC as amended.
5.2 Pharmacokinetic properties
Not required as per Article 16c(1)(a)(iii) of Directive 2001/83/EC as amended.
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 finding is not known.
AMES-test on mutagenicity with extracts of Valeriana officinalis L., radix, representing the two extremes of the polarity range did not give any reason for concern.
Further tests on genotoxicity and tests on reproductive toxicity and carcinogenicity have not been performed.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Extract excipients
Maltodextrin
Silica, colloidal anhydrous.
Tablet core
Cellulose
Croscarmellose sodium
Silica, colloidal anhydrous
Talc
Stearic acid.
Tablet coating
Sucrose
Talc
Shellac
Titanium dioxide
Acacia
Calcium carbonate
Tragacanth
Glucose
Riboflavin
Brilliant blue
Beeswax, white
Carnauba wax.
6.2 Incompatibilities
Not applicable.
6.3 Shelf life
36 months.
6.4 Special precautions for storage
Do not store above 25°C. Store in the original package.
6.5 Nature and contents of container
Blisters of hard aluminium lidding foil against PVC/PVDC foil.
Pack sizes: 10, 20 and 60 coated tablets.
Not all pack sizes may be marketed.
6.6 Special precautions for disposal
No special requirements.
7 MARKETING AUTHORISATION HOLDER
Weber & Weber GmbH
Herrschinger Str. 33
82266 Inning/Ammersee
Germany
Phone: +49 (0)8143 9270
information@weber-weber.net
8 MARKETING AUTHORISATION NUMBER(S)
THR 57560/0001
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
06/03/2019
10 DATE OF REVISION OF THE TEXT
13/10/2023