Boxs Herbals Far-Famed Indigestion Tablets
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Napiers Herbease Indigestion Tablets Box's Herbals Far-Famed Indigestion Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains :-
25 mg of Ginger rhizome (Zingiber officinale Roscoe)
25 mg of Capsicum fruit (Capsicum frutescens L.)
3.75 mg of dry extract of Gentian root (Gentiana lutea L.) (2:1) (equivalent to 7 mg Gentian root). Extraction solvent: Water.
For a full list of excipients, see section 6.1.
Each tablet contains 9.5 mg of sucrose (see Section 4.4. Special warnings and precautions for use’)
3 PHARMACEUTICAL FORM
Tablet; pink biconvex
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
A traditional herbal medicinal product used for the symptomatic relief of indigestion, based on traditional use only.
4.2 Posology and method of administration
Adults and the elderly: One or two tablets night and morning, after meals.
The use is not recommended in children and adolescents under 18 years of age. (See section 4.4 “Special warnings and precautions for use.”)
If 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 to any of the excipients. Peptic or duodenal ulcer.
Obstruction of the bile duct, cholangitis or galls stones
4.4 Special warnings and precautions for use
Do not exceed the stated dose.
The use 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 one week, a doctor or a qualified healthcare practitioner should be consulted.
This product contains sucrose. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.
Ginger may inhibit platelet aggregation and may decrease platelet thromboxane production thus theoretically may increase the risk of bleeding. The product should be discontinued at least 2 weeks prior to elective surgery due to the potential increased risk of bleeding and for potential interactions with medicinal products used during general and regional anesthesia (see Section 4.5)
4.5 Interaction with other medicinal products and other forms of interaction
No studies have been carried out to determine if drug interactions occur with this product.
Ginger may increase the risk of bleeding when taken with drugs that affect coagulation and bleeding e.g. aspirin, anticoagulants such as warfarin, phenprocoumon, heparin, antiplatelet drugs such as clopidogrel, and non-steroidal anti-inflammatory drugs such as aspirin, ibuprofen and naproxen.
4.6 Fertility, Pregnancy and lactation
The safety of this product during pregnancy and lactation has not been established. In the absence of sufficient data the use of this product during pregnancy and lactation is not recommended.
Studies on the effect of this product on fertility have not been performed.
4.7 Effects on ability to drive and use machines
In some cases patients have experienced drowsiness while taking ginger. Affected patients should not drive or operate machines.
4.8 Undesirable effects
Minor gastrointestinal complaints, particularly stomach upset, eructation, dyspepsia and nausea have been reported with Ginger. Frequency: common (>1/100 and <1/10).
Drowsiness has also been reported with Ginger.
There is one case report of inhibition of platelet aggregation, following chronic consumption of large quantities of ginger marmalade.
Gastrointestinal disorders have been observed with Gentian root. The frequency was uncommon.
In rare cases, tachycardia and pruritus have been reported. Headache may occur. The frequency is not known.
If other adverse reaction not mentioned above occur, a doctor or qualified health care practitioner should be consulted.
4.9 Overdose
No cases have been reported with this product.
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.
Reproductive and developmental toxicity of ginger has been investigated in 3 studies in rats. One study demonstrated advanced skeletal development and increased embryo resorption with the administration of ginger tea (20 g/l and 50 g/l) during gestation days 6-15. Another study using dried powder extract in dosages of 500 and 1000 mg/kg/day during gestation days 5-15 found increased embryo resorption. No maternal toxicity or gross foetal toxicity or defects were observed.
One repeated dose toxicity study in rats (600 mg/kg per day of an aqueous extract of ginger root for 6 days) demonstrated increased testicular weight and increased levels of testosterone in the testes. Another study, in which rats were administered ginger rhizome powder in daily dosages of 50 and 100 mg/kg for 20 days, did not demonstrate any changes in morphology or weight of testes compared to control rats. Chronic toxicity studies have not raised suspicion of other organ changes.
For some xanthones which are among the constituents of Gentiana lutea, positive results were found in the AMES test (pre-incubation method).
Assessment of preclinical safety requires further studies towards these effects
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Myrrh Cajaput oil
Magnesium carbonate Calcium hydrogen phosphate Acacia Sucrose
Pre-gelatinised starch
Magnesium stearate
Shellac
Kaolin light
Beetroot powder
Talc
Water
6.2 Incompatibilities
Not applicable
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
Polyethylene bottle with a polyethylene tamper-proof closure, packed in a cardboard carton: 100 tablets and 200 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
Highland Herbs Limited 10 Payne Street Glasgow G4 0LF
8 MARKETING AUTHORISATION NUMBER(S)
THR 43751/0020
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
26/03/2013
10 DATE OF REVISION OF THE TEXT
20/01/2015