Potters Period Cramps Relief
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Potter’s Period Cramps Relief
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains: -
113 mg of extract (as dry extract) from Raspberry Leaf (Rubus idaeus L.ssp. idaeus) (4:1) (equivalent to 452 mg Raspberry leaf)
Extraction solvent: Water
Excipient(s):
Each tablet contains 173 mg sucrose and 140 mg lactose. (See section 4.4 Special warnings and precautions for use.)
For full list of excipients see Section 6.1
3 PHARMACEUTICAL FORM
Tablet.
A fawn-brown round uncoated tablet.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
A traditional herbal medicinal product used for the symptomatic relief of menstrual cramps, based on traditional use only.
4.2 Posology and method of administration
For oral use only.
Women experiencing menstrual cramps: One or two tablets after each meal.
Elderly: there is no relevant indication
Not recommended for use in the elderly, children and adolescents under 18 years of age. (See section 4.4 ‘Special warnings and precautions for use’).
If the symptoms worsen or do not improve after one week a doctor or a qualified healthcare 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.
Do not take this product for at least 2 hours after taking iron, calcium and / or magnesium supplement.
If the symptoms worsen or do not improve after one week a doctor or a qualified healthcare practitioner should be consulted.
The use in the elderly, children and adolescents under 18 years of age has not been established due to lack of adequate data.
This product contains sucrose and lactose.
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency, fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.
4.5 Interaction with other medicinal products and other forms of interaction
Due to high tannin contents, raspberry leaf may decrease absorption of iron, calcium
and magnesium.
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.
Studies on the effects on fertility have not been performed.
4.7 Effects on ability to drive and use machines
No studies on the effect on the ability to drive and use machines have been performed.
4.8 Undesirable effects
Gastrointestinal disorders such as, flatulence, bloating, diarrhoea, nausea and vomiting have been reported.
The frequency is not known.
If other adverse reactions occur, a doctor or a 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 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Sucrose
Lactose
Maize Starch
Cocoa
Acacia
Talc
Magnesium Stearate Calcium Hydrogen phosphate
6.2 Incompatibilities
None known.
6.3 Shelf life
3 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 with polyethylene/polypropylene cap packed in a cardboard box: 30, 60 and 100 tablets.
Not all pack sizes may be marketed.
6.6 Special precautions for disposal
There are no special precautions for storage.
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 44893/0025
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
08/04/2013
10 DATE OF REVISION OF THE TEXT
28/09/2015