Summary of Product Characteristics (SmPC) - Potters Fatigue Relief capsules
1 NAME OF THE MEDICINAL PRODUCT
Potter’s Fatigue Relief capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains:
30 – 55 mg of extract (as dry extract) from Panax ginseng C.A. Mayer
(ginseng root) G115 (DER 3-7:1), corresponding to 4% ginsenosides.
Extraction solvent: ethanol 40% v/v.
Each capsule contains 43 - 68 mg of lactose monohydrate (see Section 4.4
Special warnings and precautions for use)
For full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Capsule, hard.
Green opaque, hard gelatin capsules, containing a brown powder.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
Traditional herbal medicinal product used for the temporary relief of fatigue, weakness and exhaustion, based on traditional use only.
4.2 Posology and method of administration
For oral use only.
The capsules should be taken with water.
Adults and the elderly:
The recommended daily dose is 2 capsules with breakfast.
Children and adolescents under 18 years of age:
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
Duration of use up to 3 months. If symptoms worsen, or persist for more 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 substance or to any of the excipients.
4.4 Special warnings and precautions for use
Contains lactose monohydrate. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.
The use in children and adolescents under 18 years of age has not been established due to lack of adequate data.
If the symptoms worsen, or persist for more 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
None reported.
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.
No fertility data available
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
Hypersensitivity reactions (urticaria, itching), insomnia and gastrointestinal disorders like stomach discomfort, nausea, vomiting, diarrhoea, and constipation have been reported. The frequency is not known.
If other adverse reactions not mentioned above occur, a doctor or a qualified health care practitioner should be consulted.
Reporting of suspected adverse reactions
Reporting of 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: Yellow card scheme Website: 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.
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
No signs of genotoxicity were observed in an AMES-test (Salmonella typhimurium strains TA 1535, TA 1537, TA 1538, TA 98 and TA 100) with and without metabolic activation using an extract prepared with ethanol 40% v/v (identical to extract in this product) This was confirmed with an extract prepared with ethanol 80% in a guideline-conform AMES-test (OECD-471) with and without metabolic activation as well as in a micronucleus test.
After 2 years of oral administration of an extract prepared with ethanol 80% in dosages of up to 5000 mg/kg b.w. no signs of carcinogenicity were observed in mice or rats.
Adequate tests on reproductive toxicity have not been performed.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Extract excipients
Silica, colloidal anhydrous
Lactose monohydrate
Capsule contents
Silicon dioxide
Mannitol
Magnesium stearate
Capsule shell
Copper complex of chlorophyllins Titanium dioxide
Gelatin
6.2 Incompatibilities
Not applicable.
6.3 Shelf life
36 months
6.4 Special precautions for storage
Do not store above 25°C. Protect from light. Store in the original container.
6.5 Nature and contents of container
Amber glass bottle with tamper proof aluminium cap.
Al/PVC/PVDC blister strip
Pack sizes: 30 capsules and 60 capsules
Not all pack sizes may be marketed.
6.6 Special precautions for disposal
No special requirements.
7 MARKETING AUTHORISATION HOLDER
Soho Flordis UK Limited (trading as Potter’s)
1 Botanic Court
Martland Park
Wigan
WN5 0JZ
8 MARKETING AUTHORISATION NUMBER(S)
THR 44893/0038
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION