Summary of Product Characteristics (SmPC) - Potters Fatigue Relief syrup
1 NAME OF THE MEDICINAL PRODUCT
Potter’s Fatigue Relief Syrup
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 15 mL of syrup contains:
140 mg of extract (as dry extract) from Panax ginseng C.A Meyer (ginseng root) G115 (DER (3-7:1), corresponding to 4% ginsenosides
Extraction solvent: ethanol 40% v/v
Excipients with known effect
Each 15 mL dose of syrup contains: 1.4 g of sorbitol (E420), 2.1 g of sucrose,
12.7 mg of sodium benzoate (E211), maximum 30 mg of ethanol, maximum of 30 mg of sulphur dioxide (E220), 5.3 mg of potassium and 34.05 mg sodium.
See section 4.4 ‘Special warnings and precautions for use’. For full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Syrup.
Dark red-brown liquid with aromatic, sweetish odour.
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.
Adults and the elderly:
Using the measuring cup provided, 15 mL of syrup should be taken once a day preferably with breakfast. The bottle should be shaken well before use. Measuring the dose
The measuring cup provided should be filled up to the graduated 15 mL mark. The cup should not be overfilled and should be rinsed after use.
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 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.
4.3 Contraindications
Hypersensitivity to the active substance, plants of the Araliaceae family or to any of the excipients listed in Section 6.1.
4.4 Special warnings and precautions for use
This product contains sorbitol (E420) and sucrose. May be harmful to teeth.
Patients with hereditary fructose intolerance (HFI), glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take/be given this medicine.
The additive effect of concomitantly administered products containing sorbitol or fructose and dietary intake of sorbitol or fructose should be taken into account.
The content of sorbitol in medicinal products for oral use may affect the bioavailability of other medicinal products for oral use administered concomitantly.
This product contains sodium benzoate (E211). Increase in bilirubinaemia following its displacement from albumin may increase neonatal jaundice which may develop into kernicterus (non-conjugated bilirubin deposits in the brain tissue).
This product contains sulphur dioxide (E220) which may rarely cause severe hypersensitivity reactions such as bronchospasm.
This product contains up to 30 mg of ethanol in each 15 mL (one dose). The amount in 15 mL (one dose) is equivalent to less than 1 mL beer or 1 mL wine. The small amount of alcohol in this medicine will not have any noticeable effects.
This product contains 34.1 mg of sodium in each 15 mL (one dose). This is equivalent to 1.7% of the WHO recommended maximum daily intake of 2g sodium for an adult.
This product contains potassium, less than 1 mmol (39 mg) per 15 mL dose, i.e. essentially potassium free.
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
Severe hypersensitivity reactions such as bronchospasm may occur rarely due to the excipient sulphur dioxide.
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. 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
Sucrose
Herbal product excipients
Liquid sugar (sucrose)
Sorbitol (E420), liquid (non-crystallising)
Cherry concentrate (containing anthocyanins (E163), kirsch, propylene glycol
(E1520), water, flavouring, ethanol, flavouring preparations, sulphur dioxide (E220)
Aroma Tutti Frutti (containing flavouring substances, flavouring preparations, natural flavouring substances, propylene glycol (E1520), triacetine (E1518) Sodium benzoate (E211)
Potassium sorbate (E202)
Sodium citrate dihydrate
Citric acid, monohydrate
Purified water
6.2 Incompatibilities
Not applicable.
6.3 Shelf life
24 months
After first opening: 30 days
6.4 Special precautions for storage
Do not store above 25°C. Store in the original container.
6.5 Nature and contents of container
Amber glass bottle with tamper proof white aluminium cap.
Dosing device: 15mL measuring cup
Pack size: 250 mL.
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 44893/0039
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION