Potters Slippery Elm Indigestion Relief
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Potter’s Slippery Elm Indigestion Relief
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains: -
400 mg Slippery Elm Bark Powder (Ulmus rubra Muhl.)
For full list of excipients see Section 6.1.
3 PHARMACEUTICAL FORM
Tablet.
A light brown or buff, oval uncoated tablet.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
A traditional herbal medicinal product used to relieve the symptoms of indigestion, heartburn and flatulence, based on traditional use only.
4.2 Posology and method of administration
For oral use only.
Adults and the elderly: Take one or two tablets after each meal, up to five times a day. Tablets should be chewed and may be broken into quarters first.
The use in children and adolescents under 18 years of age is not recommended (see section 4.4 ‘Special warnings and precautions for use’).
If symptoms worsen or do not improve after 1 week, a doctor or a qualified healthcare practitioner should be consulted.
4.3 Contraindications
Hypersensitivity to the active ingredients or any of the excipients.
Patients with obstruction of the bile duct, cholangitis, liver disease, gallstones and other biliary disorders.
4.4 Special warnings and precautions for use
Do not exceed the stated dose.
The use of this product in children and adolescents under 18 years of age is not recommended because data are insufficient and medical advice should be sought.
If symptoms worsen or do not improve after 1 week, a doctor or a qualified healthcare practitioner should be consulted.
4.5 Interaction with other medicinal products and other forms of interaction
None known.
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
No studies on the effect on the ability to drive and use machines have been performed.
4.8 Undesirable effects
None known.
If any 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
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
Calcium Hydrogen Phosphate Maltodextrin Hydroxypropyl Cellulose Magnesium Stearate Colloidal Anhydrous Silica Cinnamon Oil Clove Oil Peppermint Oil
6.2
Incompatibilities
None known.
6.4
6.5
7
8
Nature and contents of container
Tamper evident polyethylene/polypropylene pot packed in a cardboard box: 30, 60, 84, 100 and 120 tablets.
Not all pack sizes may be marketed.
MARKETING AUTHORISATION HOLDER
Soho Flordis UK Limited 1 Botanic Court,
Martland Park,
Wigan,
WN5 0JZ,
UK.
Trading as: Potters, Wigan WN5 0JZ
MARKETING AUTHORISATION NUMBER(S)
THR 44893/0009
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
21/01/2013
10 DATE OF REVISION OF THE TEXT
28/09/2015