Potters Tension Relief
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Potter’s Tension Relief
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film coated tablet contains: -
90 mg Jamaica Dogwood (Piscidia erythrina L.)
54 mg of extract (as dry extract) from Wild Lettuce leaf (Lactuca virosa L.) (5:1)(equivalent to 270 mg Wild Lettuce leaf)
Extraction solvent: Water
36 mg of extract (as dry extract) from Passion Flower herb (Passiflora incarnata L.) (5:1) (equivalent to 180 mg Passion Flower herb)
Extraction Solvent: Water
30 mg Hop stobile (Humulus lupulus L.)
For full list of excipients see Section 6.1.
3 PHARMACEUTICAL FORM
Tablet.
A brown, round film coated tablet.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
A traditional herbal medicinal product used for the short term relief of minor aches, tenseness and irritability, based on traditional use only.
4.2 Posology and method of administration
For oral use only.
Adults and the elderly: One or two tablets three times daily.
Or three tablets at once and repeat after three hours if necessary.
Maximum daily dose: 6 tablets
Not recommended for children and adolescents under 18 years of age. (see section 4.4 “Special warnings and precautions for use”).
If symptoms worsen or persist for more than 4 weeks, a doctor or a qualified health care practitioner should be consulted.
4.3 Contraindications
Hypersensitivity to the active ingredients or any of the excipients.
4.4 Special warnings and precautions for use
Do not exceed the stated dose.
If symptoms worsen or persist for more than 4 weeks, a doctor or a qualified health care practitioner should be consulted.
Not recommended for children and adolescents under 18 years of age because data are not sufficient and medical advice should be sought.
4.5 Interaction with other medicinal products and other forms of interaction
Although no clinical data about interactions with synthetic sedatives are available, concomitant use with synthetic sedatives (such as benzodiazepines) is not recommended unless advised by a doctor.
The effect 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 the use of this product during pregnancy and lactation is not recommended.
Studies on fertility have not been carried out.
4.7 Effects on ability to drive and use machines
May impair ability to drive and use machines. Affected patients should not drive or operate machinery.
4.8 Undesirable effects
One case of hypersensitivity (vasculitis) and one case of nausea and tachycardia have been reported with the use of Passion flower herb. The frequency is not known.
If other adverse reactions not mentioned above occur, a doctor or qualified healthcare practitioner 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
No cases of overdose have been reported.
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
Tests on reproductive toxicity, genotoxicity and carcinogenicity have not been performed.
6.1 List of excipients
Calcium Hydrogen Phosphate Microcrystalline Cellulose Stearic Acid
Colloidal Anhydrous Silica Magnesium Stearate Maltodextrin
Clear film coating containing hypromellose, glycerol and hydroxypropyl cellulose
6.2 Incompatibilities
None known.
6.3 Shelf life
Three years.
6.4 Special precautions for storage
Do not store above 25°C. Store in the original container.
6.5 Nature and contents of container
Tamper evident polyethylene/polypropylene pot packed in a cardboard box: 28, 30, 50, 60, 75, 84 and 100 tablets.
Not all pack sizes may be marketed.
6.6 Special precautions for disposal
There are no special precautions for disposal.
7
MARKETING AUTHORISATION HOLDER
Soho Flordis UK Limited 1 Botanic Court,
Martland Park,
Wigan,
WN5 0JZ,
UK.
Trading as: Potters, Wigan WN5 0JZ
8 MARKETING AUTHORISATION NUMBER(S)
THR 44893/0010
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
20/02/2013
10 DATE OF REVISION OF THE TEXT
28/09/2015